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NCT04602923 | Keratometric Change After XEN, Trabeculectomy and Tube Shunts | The main goal of this study is to assess the severity of postoperative corneal astigmatism induced by implantation of the XEN Gel Stent compared to that induced by traditional filtering surgery (trabeculectomy and GDDs). Corneal astigmatism can be assessed using corneal topography, a non-invasive tool which provides an... | Following glaucoma surgery, patients often experience decreased visual acuity (VA) which can partly be explained by induced changes to the optical properties of the cornea. Corneal astigmatism can be assessed using corneal topography, a non-invasive tool which provides an accurate estimate of corneal curvature in all m... | Comparison of Keratometric Change After Xen Gel Stent Implantation, Trabeculectomy, and Tube Shunts | Glaucoma, Open-Angle, Glaucoma, Angle-Closure, Glaucoma Secondary, Glaucoma Eye | * Diagnostic Test: Corneal topography: OPD-Scan
* Diagnostic Test: Corneal topography: Pentacam
| Inclusion Criteria:~Eyes with an IOP above target and/or progressing on maximally tolerated medical therapy;~Patients aged 18 years or older;~Ability to provide informed consent;~Ability to be followed for the entire duration of the study.~Exclusion Criteria:~Patients less than 18 years old;~Inability to provide inform... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 3 groups will be compared:~Group 1: 30 participants suffering from glaucoma who are candidates for XEN Gel Stent implantation~Group 2: 30 participants suffering from glaucoma who are candidat... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keratometric values (OPD-Scan) | Change in simulated keratometric (K) values obtained by OPD-Scan between the indicated timepoints. | Baseline, 2 months, 6 months, 12 months |
| Keratometric values (Pentacam) | Change in simulated keratometri... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected visual acuity change | Evaluation of visual acuity change, measured using the Snellen chart. | Baseline, 2 months, 6 months, 12 months |
| Intraocular pressure change | Evaluation of intraocular pressure control, measured using... | Xen Gel Stent, Baerveldt glaucoma implant, Ahmed glaucoma implant, Trabeculectomy, Glaucoma drainage devices | Glaucoma, Glaucoma, Open-Angle, Glaucoma, Angle-Closure, Ocular Hypertension, Eye Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XEN Gel Stent implantation<br>Participants suffering from glaucoma who are candidates for XEN Gel Stent implantation | Diagnostic Test: Corneal topography: OPD-Scan<br>* Corneal topography photography, taken by specular reflection (OPD-Sca... | Keratometric Change After XEN, Trabeculectomy and Tube Shunts
Study Overview
=================
Brief Summary
-----------------
The main goal of this study is to assess the severity of postoperative corneal astigmatism induced by implantation of the XEN Gel Stent compared to that induced by traditional filtering surger... |
NCT04828330 | Flares of Low Back Pain With Activity Research Study | Low back pain (LBP) is the most common cause of disability worldwide. Although general activity is encouraged in the treatment of LBP, there is limited empirical information available on the specific types of activities that are beneficial or harmful for patients seen in primary care for LBP. This study will identify t... | This research will use a novel approach to distinguish the short-term effects on LBP of physical activities from the long-term effects of such activities, by conducting a longitudinal case-crossover study nested within a cohort study. This design accounts for measured and unmeasured confounds by using each case as his/... | Effects of Physical Activities on Pain and Functional Recovery in Low Back Pain | Low Back Pain | Inclusion Criteria:~Veterans age 18-65 years seen in VA primary care for LBP~Must have regular access (every day, during most hours of the day) to a computer, tablet, or smartphone with internet access at home or at work~Basic computer literacy~Having a mobile phone capable of receiving alerts using text messages~Must ... | 18 Years | 65 Years | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant-reported flares of low back pain (Aim 1) | At each study assessment, participants are presented with the flare definition used in this study, which was derived from a previously validated flare definition by Costa et al (2000). The... | Back Pain, Low Back Pain, Pain, Neurologic Manifestations | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational cohort<br>This is a case-crossover study nested within a cohort study. | |
| Flares of Low Back Pain With Activity Research Study
Study Overview
=================
Brief Summary
-----------------
Low back pain (LBP) is the most common cause of disability worldwide. Although general activity is encouraged in the treatment of LBP, there is limited empirical information available on the specific t... | ||||
NCT03632018 | Heart Exercise And Resistance Training - Peer Lead ActivitY | Numerous studies show that regular physical activity / exercise significantly improves exercise tolerance as well as clinical outcomes in cardiovascular disease (CVD). Exercise as a reliable adjunctive intervention, however, remains limited due to poor short- as well as long-term adherence. The study examines the effec... | This study examines the effectiveness of the Heart Exercise And Resistance Training - Peer Lead ActivitY (HEART-PLAY) intervention to significantly sustain exercise adherence in patients referred for Cardiac Rehabilitation (CR). CR Clinic staff and CR patients who meet study inclusion criteria and are willing to serve ... | Heart Exercise And Resistance Training - Peer Lead ActivitY (HEART-PLAY) | Cardiovascular Diseases | * Behavioral: HEART-PLAY
* Behavioral: Standard Cardiac Rehabilitation
| Inclusion Criteria:~Age 18+~Referred to the UCSD Step Clinic for 36 sessions of cardiac rehabilitation across 12-14 weeks for one of the following medical conditions: myocardial infarction, coronary artery bypass surgery, stable angina, heart valve repair or replacement, coronary angioplasty or stenting, or congestive ... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized controlled trial
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Minutes of Moderate Physical Activity (PA) | 7-day actigraphy records will be used to assess amount of moderate PA | 3 months, 6 months, and 12 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health-related quality of life (QoL) | Demonstrate improved QoL as determined by the NIH-supported PROMIS-29 | 3 months, 6 months, and 12 months |
| Improved Cost-effectiveness | Determine cost-effectiveness using Markov Models | 12... | cardiac rehabilitation, physical activity | Cardiovascular Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Cardiac Rehabilitation<br>Participants in the STANDARD condition will receive the standard of care cardiac rehabilitation, consisting of 36 sessions across 12 weeks of prescribed, supervised exercise sessions. | Behavioral: S... | Heart Exercise And Resistance Training - Peer Lead ActivitY
Study Overview
=================
Brief Summary
-----------------
Numerous studies show that regular physical activity / exercise significantly improves exercise tolerance as well as clinical outcomes in cardiovascular disease (CVD). Exercise as a reliable adj... |
NCT00821158 | The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study | The investigators will examine whether administration of certain medications will decrease or prevent ischemia-reperfusion injury. | The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study | Ischemia-Reperfusion | * Drug: Antioxidant
* Other: Placebo
* Drug: Anti-inflammatory drug
| Inclusion Criteria:~Patients undergoing breast reconstruction~Exclusion Criteria:~Diabetes mellitus~Kidney or liver disease~Use of immunosuppressants | 18 Years | null | Female | No | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antioxidant concentrations | | 0,5-24 hours |
| Anti-Inflammatory Agents, Antioxidants, Molecular Mechanisms of Pharmacological Action, Protective Agents, Physiological Effects of Drugs | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo tablet and iv | Other: Placebo<br>* Placebo tablet and iv<br>|
| Experimental: 2<br>Placebo tablet and intervention iv | Drug: Antioxidant<br>* Antioxidant iv bolus<br>|
| Experimental: 3<br>Intervention tablet and place... | The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study
Study Overview
=================
Brief Summary
-----------------
The investigators will examine whether administration of certain medications will decrease or prevent ischemia-reperfusion injury.
Official Title
-----------------
The DIEP Flap as ... | |||
NCT03159715 | Internet-based Depression Treatment: Differential Efficacy of Different Therapeutic Components | The objective of the present project is to study the differential effectiveness of three brief self-applied via the Internet interventions for mild to moderate depression: a global protocol composed of several therapeutic components (psychoeducation, cognitive restructuring, behavioral activation, positive psychology, ... | Depression is one of the most important health problems worldwide, which generates important costs, both from the economic point of view as from the social and personal one. If not properly treated, it may become chronic and therefore interferes significantly in all areas of operation. Hence, one of the most important ... | Internet-based Depression Treatment. Differential Efficacy of Different Specific Therapeutic Components: Behavioral Activation and Positive Psychology. | Depression | * Behavioral: Internet-based Global Protocol
* Behavioral: Internet-based Behavioral Activation Protocol
* Behavioral: Internet-based Positive Psychology Protocol
| Inclusion Criteria:~18-65 years old.~Having mild to moderate depression symptoms.~Providing written, informed consent.~Being able to understand and read Spanish.~Having daily access to the Internet in their natural environment.~Exclusion Criteria:~Being diagnosed a severe mental disorder (people with the following ment... | 18 Years | 65 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Beck Depression Inventory II (BDI-II) (Beck, Steer, & Brown, 1996) at pre, post intervention and at 3 and 12 months follow-ups. | The BDI-II is one of the most widely used questionnaires to evaluate the severity of depression in ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Positive and Negative Affect Schedule (PANAS) (Watson, Clark y Tellegen, 1988; Sandín et al., 1999) at pre, post intervention and at 3 and 12 months follow-ups. | The PANAS consists of 20 items that evaluate two independent dimensions: pos... | Internet, Behavioral Activation, Positive Psychology | Depression, Depressive Disorder, Behavioral Symptoms, Mood Disorders, Mental Disorders | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based Global Protocol<br>Intervention group that carries out the Internet-based Global Protocol and receives therapist support. | Behavioral: Internet-based Global Protocol<br>* Internet-based Global Protocol is an Internet-based ... | Internet-based Depression Treatment: Differential Efficacy of Different Therapeutic Components
Study Overview
=================
Brief Summary
-----------------
The objective of the present project is to study the differential effectiveness of three brief self-applied via the Internet interventions for mild to moderate... |
NCT05542537 | Nurturing Healthy Teachers | The purpose of this trial is to compare the impact of a fruit and vegetable access plus nutrition education intervention to a nutrition education-only control on the health, well-being, and food security of early care and education (ECE) professionals. The intervention, called Nurturing Healthy Teachers, combines strat... | The purpose of this trial is to evaluate the impact of the Nurturing Healthy Teachers program on food insecurity, dietary behaviors, mental health, and cardiometabolic health among early care and education (ECE) professionals who teach Pre-Kindergarten or Kindergarten. Nurturing Healthy Teachers is a novel, comprehensi... | Nurturing Healthy Teachers: A Cluster-RCT to Improve the Health, Well-being, and Food Security of Early Care and Education (ECE) Professionals | Nutrition, Healthy, Mental Health Wellness 1, Diabetes Mellitus Risk, Obesity | * Behavioral: Brighter Bites (BB) Produce Distribution
* Behavioral: Brighter Bites (BB) Nutrition Education
* Behavioral: Create Healthy Futures (CHF) Weekly Wellness Groups
* Behavioral: Create Healthy Futures (CHF) Web-Based Module
| Inclusion Criteria for Teachers:~Employed as a pre-K or kindergarten teaching staff at the participating study schools in the 2022-2023 school year.~Ability to read English at the 4th grade reading level~Ability to complete study measures~Exclusion Criteria for Teachers:~Have recently (in the past 6 months) or are curr... | 18 Years | null | All | Accepts Healthy Volunteers | Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Household Food Insecurity as assessed by the U.S. Department of Agriculture self-report food insecurity survey | Household Food insecurity will be measured on an electronically administered using the 10-item self-report previously validated U.... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary intake as assessed by self-report survey | Dietary intake will be self-reported on an electronically administered survey using a food frequency screener. The survey items will measure the frequency of consumption of various foods inclu... | food insecurity, nutrition, healthy eating, wellness, teachers | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BB Produce Distribution + BB Nutrition Education + CHF Weekly Wellness Groups + CHF Web-Based Module<br>BB is Brighter Bites. CHF is Create Healthy Futures. | Behavioral: Brighter Bites (BB) Produce Distribution<br>* For 16 weeks in the sc... | Nurturing Healthy Teachers
Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to compare the impact of a fruit and vegetable access plus nutrition education intervention to a nutrition education-only control on the health, well-being, and food security of early care and educa... | |
NCT02714478 | Equistasi and Gait in Hemiparesis | The purpose of the study is to evaluate the effect of Equistasi device on quantitative and qualitative gait characteristics in patients affected by hemiparesis. | Efficacy of Equistasi on the Gait of Patients Affected by Hemiparesis Due to Cerebrovascular Accident | Hemiparesis | * Device: equistasi
* Device: placebo
| Inclusion Criteria:~subacute hemiparesis~Functional Ambulation Classification <4~Exclusion Criteria:~previous neurological deficits~Glasgow Coma Scale <13~Complete sensory deficit in the lower limbs~Levels of Cognitive Functioning ≤5~polyneuropathy~contraindications to mobilization/verticalization | 18 Years | 80 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disability change assessed using Functional Independence Measure scale | | 0. 30. 60. 120 days |
| balance change assessed using Berg Balance Scale | | 0. 30. 60. 120 days |
| gait pattern change assessed using Functional Ambulation Classi... | Paresis, Neurologic Manifestations, Nervous System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>3 Equistasi devices will be placed during physiotherapy, 5 times per week, for 4 weeks | Device: equistasi<br>* 3 devices will be placed in each patient: 1 at the spinosus process of L5; 1 at the insertion of transverse abdomi... | Equistasi and Gait in Hemiparesis
Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effect of Equistasi device on quantitative and qualitative gait characteristics in patients affected by hemiparesis.
Official Title
-----------------
Efficacy of Equistasi on ... | |||
NCT05627219 | Peer Genetic Coaches for Enhancing Genetic Testing Awareness, Navigation, and Delivery Among African American Men With Metastatic Prostate Cancer, The EXPAND Network | This trial evaluates whether a network of peer genetic coaches is useful for addressing disparities in genetic testing and screening among African American men with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). While genetic testing has become centr... | PRIMARY OBJECTIVES:~I. Identify and train 6 African American (AA) men as peer genetic coaches (PGCs) for the Extending Prostate Genetic Awareness, Navigation, and Delivery (EXPAND) Network. (Train peer genetic coaches) II. Conduct a feasibility study of peer genetic coaching. (Provide individual coaching)~SECONDARY OBJ... | Extending Prostate Genetic Awareness, Navigation, and Delivery: The EXPAND Network | Metastatic Prostate Carcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8 | * Behavioral: Training and Education
* Other: Educational Intervention
* Procedure: Discussion
| Inclusion Criteria:~AIM 1: Are 18 years old or older~AIM 1: Are able to read and speak English comfortably~AIM 1: Men who have experience with both prostate cancer (PCA) and genetic counseling and testing will be a priority for training, as well as men who have considerable peer education or navigation experience~AIM 2... | 18 Years | null | Male | Accepts Healthy Volunteers | Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of inquiries to the central number (feasibility) | | Up to 1 year |
| Percent of callers screened and eligible to participate (feasibility) | | Up to 1 year |
| Percent of eligible callers who enroll in the study (feasibility) | | ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in decisional conflict for genetic counseling | Reported with mean and standard deviation. | Baseline up to 1 year |
| Change in acceptability/attitude toward genetic counseling and testing | Reported with mean and standard deviation. ... | Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms by Site, Neoplasms, Genital Diseases, Male, Genital Diseases, Urogenital Diseases, Prostatic Diseases, Male Urogenital Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (training, education, discussion)<br>AIM 1: Peer genetic coaches undergo training and education on study.~AIM 2: Patients receive an educational booklet and attend a discussion with a peer genetic coach on study. | Behavior... | Peer Genetic Coaches for Enhancing Genetic Testing Awareness, Navigation, and Delivery Among African American Men With Metastatic Prostate Cancer, The EXPAND Network
Study Overview
=================
Brief Summary
-----------------
This trial evaluates whether a network of peer genetic coaches is useful for addressing ... | |
NCT01411267 | AC220 for Children With Relapsed/Refractory ALL or AML | This is a phase I study of the investigational drug AC220 combined with cytarabine and etoposide in pediatric patients with relapsed acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML). | This is a study for pediatric patients with relapsed acute lymphoblastic leukemia (ALL) or acute myelogenous leukemia (AML). Some people diagnosed with leukemia have changes in a receptor located on the surface of white blood cells called FLT3. This is known as a FLT3 mutation. FLT3 plays an important role in the way c... | A Phase I Study of AC220 for Children With Relapsed or Refractory ALL or AML | Lymphoblastic Leukemia, Acute, Childhood, Myelogenous Leukemia, Acute, Childhood | * Drug: AC220
* Drug: Cytarabine
* Drug: Etoposide
* Drug: Methotrexate
| Inclusion Criteria:~Patients must be greater than 1 month and ≤ 21 years of age at study entry.~Patients must have a diagnosis of relapsed/refractory AML, ALL or acute leukemia of ambiguous lineage and meet the following criteria:~Patients with AML or leukemia with ambiguous lineage must have greater than or equal to 5... | 1 Month | 21 Years | All | No | Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Dose of AC220 That is Safe and Biologically Active When Given in Sequential Combination With Ara-C/Etoposide | The incidence of dose limiting toxicity (DLT) will be measured. The maximum tolerated dose will be the highest study dose at whi... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Response | Possible outcomes are: Complete Remission (CR), Complete Remission without Platelet Recovery (CRp), complete response with incomplete hematologic recovery (CRi), Stable Disease, Progressive Disease, Induction Death, or Relap... | Refractory, Myelogenous, Acute, Childhood, Pediatric, ALL, AML, Relapse, Lymphoblastic, Leukemia, AC220 | Cytarabine, Methotrexate, Etoposide, Etoposide phosphate, Abortifacient Agents, Nonsteroidal, Abortifacient Agents, Reproductive Control Agents, Physiological Effects of Drugs, Antimetabolites, Antineoplastic, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Dermatologic Agents, E... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALL AC220 @ 25mg/m2/day (Dose Level 1)<br>The starting dose is Dose Level 1 at 25 mg/m2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etopos... | AC220 for Children With Relapsed/Refractory ALL or AML
Study Overview
=================
Brief Summary
-----------------
This is a phase I study of the investigational drug AC220 combined with cytarabine and etoposide in pediatric patients with relapsed acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia ... |
NCT03535701 | Ketogenic Diet and Chemotherapy in Affecting Recurrence in Patients With Stage IV Breast Cancer | This pilot clinical trial studies how well a ketogenic diet and chemotherapy work in affecting the return of cancer in patients with stage IV breast cancer. Ketogenic diet may be more effective than standard nutrition and may affect quality of life, inflammation, and tumor-related changes. Drugs used in chemotherapy, s... | PRIMARY OBJECTIVES:~I. To evaluate the feasibility of implementing a diet that induces nutritional ketosis in women who are initiating palliative chemotherapy to treat advanced stage breast cancer (BC).~II. To determine the effects of a ketogenic diet on tumor progression. III. To determine the effects of nutritional k... | Ketogenic Diet and Chemotherapy to Affect Recurrence of Breast Cancer (The KETO-CARE Study) | Stage IV Breast Cancer AJCC v6 and v7 | * Dietary Supplement: Dietary Intervention
* Other: Laboratory Biomarker Analysis
* Drug: Paclitaxel
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
| Inclusion Criteria:~Body mass index (BMI) >= 22 kg/m^2~Confirmed diagnosis of metastatic or stage IV BC~Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET) avid tumors~Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (0=participant has either normal activity, 1= participant has some symptom... | 18 Years | null | All | No | Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence and compliance to the ketogenic diet | Summaries from diet assessments and ketone logs will be plotted over time to assess adherence and compliance to the ketogenic diet. | Up to 26 weeks |
| Changes in psychosocial measures | Summa... | Paclitaxel, Albumin-Bound Paclitaxel, Antineoplastic Agents, Phytogenic, Antineoplastic Agents, Tubulin Modulators, Antimitotic Agents, Mitosis Modulators, Molecular Mechanisms of Pharmacological Action | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (standard of care)<br>Patients receive standard of care therapy with paclitaxel. | Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Drug: Paclitaxel<br>* Given standard of care therapy with paclitaxel<br>* Other ... | Ketogenic Diet and Chemotherapy in Affecting Recurrence in Patients With Stage IV Breast Cancer
Study Overview
=================
Brief Summary
-----------------
This pilot clinical trial studies how well a ketogenic diet and chemotherapy work in affecting the return of cancer in patients with stage IV breast cancer. K... | ||
NCT01603862 | ThinkingFit: Combined Physical, Cognitive and Social Treatment in Mild Cognitive Impairment (MCI) | Dementia is serious problem and around 700 000 people are affected in the UK alone. Currently there is no cure however early diagnosis and effective treatment offers hope for reducing the impact. Dementia sufferers require care due to physical disability, cognitive deficits, social isolation and emotional symptoms (dep... | Piloting a Complex Intervention Involving Physical Exercise, Cognitive Training and Socialising to Delay the Onset of Dementia in Mild Cognitive Impairment | Mild Cognitive Impairment | * Procedure: ThinkingFit programme
| Inclusion criteria for patients with MCI~Patients fulfilling criteria for AMCI [Petersen et al. 2001b]:~i. Memory impairment for age and education ii. No impairment in other cognitive domains iii. Normal social activities iv. Patient is not demented~For the other subtypes of MCI, cognitive impairment in one or more non... | 40 Years | null | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity Compliance | Number of participants to have completed 50% or more of the programmed activity sessions during the intervention period. | Compliance with programmed activities will be assessed at the end of participation which is expect... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular fitness measure | Cardiovascular fitness will be measured with a modified Siconolfi Step Test. | This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at aroun... | Cognitive Dysfunction, Cognition Disorders, Neurocognitive Disorders, Mental Disorders | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ThinkingFit<br> | Procedure: ThinkingFit programme<br>* Combined physical, cognitive and social stimulation activties.<br>|
| ThinkingFit: Combined Physical, Cognitive and Social Treatment in Mild Cognitive Impairment (MCI)
Study Overview
=================
Brief Summary
-----------------
Dementia is serious problem and around 700 000 people are affected in the UK alone. Currently there is no cure however early diagnosis and effective treatme... | ||
NCT00999063 | Prevalence of Gastroesophageal Reflux Disease (GERD) in Patients With Upper Gastrointestinal Track (GIT) Symptoms in Thailand | This is a prospective , epidemiological, multi-centre, phase IV study, approximately 5,000 patients who suffer with upper gastrointestinal tract symptoms. Each patient will be assessed for GERD with GerdQ Thai Version. | Prevalence of GERD in Patients With upperGITsymptoms in Thailand | Upper GIT Symptoms | Inclusion Criteria:~Provision of informed consent prior to any study specific procedures~Female or male aged at least 18 years~Patient must be having symptoms suggestive of upper gastrointestinal tract symptoms such as heart burn/ regurgitation~Exclusion Criteria:~Involvement in the planning and /or conduct of the stud... | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of gastroesophageal reflux disease (GERD) in patients presented with upper gastrointestinal tract symptoms | | |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to various treatments for patients who have been diagnosed of GERD | | |
| GerdQ | Prevalence of Gastroesophageal Reflux Disease (GERD) in Patients With Upper Gastrointestinal Track (GIT) Symptoms in Thailand
Study Overview
=================
Brief Summary
-----------------
This is a prospective , epidemiological, multi-centre, phase IV study, approximately 5,000 patients who suffer with upper gastro... | |||||
NCT00262431 | Efficacy of Early Tracheostomy to Reduce Incidence of Ventilator Acquired Pneumonia (VAP) | The study aims to assess early (one to three days after intubation) tracheostomy effectiveness in terms of reduction in ventilator associated pneumonia (VAP) incidence. | Tracheostomy is an essential and irreplaceable procedure for critically ill patients requiring mechanical ventilatory support and adequate airway control. The therapeutical choice of performing a tracheostomy is supported by a number of clinical benefits, such as less use of drugs for sedation, fewer days of mechanical... | null | Respiratory Insufficiency | * Procedure: Tracheostomy on day 3-5 in early group and 10-12 in late group
| Inclusion Criteria:~Oro/nasotracheal intubation for less than three days~Simplified Acute Physiology Score (SAPS II) between 35 and 65 upon admission to Intensive Care Unit (ICU)~Exclusion Criteria:~Oro/nasotracheal intubation > three days~Age < 18 years~Previous otolaryngologic or maxillofacial procedures~Brain injury... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of ventilator associated pneumonia-free days | | Follow-up terminates on day 28 from the date of oro/nasotracheal intubation. |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of ventilator-free days | | Follow-up terminates on day 28 from the date of oro/nasotracheal intubation |
| Reduction of mortality | | one year |
| Tracheostomy, Tracheostomy timing, Ventilator associated pneumonia, Mechanical ventilation | Respiratory Insufficiency, Respiratory Tract Diseases, Respiration Disorders | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early (A)<br>Patients of the EARLY group (A) will be submitted to tracheostomy on day 3-5 from oro/nasotracheal intubation. | Procedure: Tracheostomy on day 3-5 in early group and 10-12 in late group<br>* Upon admission to ICU, acute ... | Efficacy of Early Tracheostomy to Reduce Incidence of Ventilator Acquired Pneumonia (VAP)
Study Overview
=================
Brief Summary
-----------------
The study aims to assess early (one to three days after intubation) tracheostomy effectiveness in terms of reduction in ventilator associated pneumonia (VAP) incide... |
NCT00073840 | Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma | The primary objective of this study is to investigate the efficacy of levalbuterol 90 ug (2 actuations, 45 ug each) versus placebo (2 actuations) in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID). | A double-blind, randomized, placebo- and active-controlled, multicenter, parallel-group trial of levalbuterol in subjects 12 years of age and older with asthma. Study participation will include one 1-week single-blind placebo run-in and an 8-week, randomized,double-blind, active-treatment period with four treatment gro... | An Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma | Asthma | * Drug: levalbuterol
| Inclusion Criteria~Must give written informed consent (IC) prior to participation in the study. For subjects 12 - 17 years of age, the IC must be signed parent or legal guardian. Females must sign the Women of Childbearing Potential Addendum~Be willing and able to comply with the study procedures and visit schedules~Ma... | 12 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 (peak percent change from pre-dose averaged over the double-blind period). | | 8 weeks |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| --FEV1 [area under the % change from pre-dose FEV1 curve] and FEV1 [area under the % change from study baseline FEV1 curve] | | 9 weeks |
| levalbuterol, asthma, bronchoconstriction, adolescent, adult | Albuterol, Bronchodilator Agents, Autonomic Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Anti-Asthmatic Agents, Respiratory System Agents, Tocolytic Agents, Reproductive Control Agents, Adrenergic beta-2 Receptor Agonists, Adrenergic beta-Agonists, Adrenergic Agonists, Adrenergic Agents, Ne... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I<br>Levalbuterol 90 ųg QID (manufacturing site A or B) | Drug: levalbuterol<br>* Levalbuterol 90 ųg QID (manufacturing sites A or B);~Racemic Albuterol 180 ųg QID;~Placebo QID<br>* Other names: Xopenex HFA (levalbuterol tartrate)Inha... | Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma
Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to investigate the efficacy of levalbuterol 90 ug (2 actuations, 45 ug each) versus placebo (2 actuations) i... |
NCT02319408 | Immune Boost In Non-Small Cell Lung Cancer | Insufficient migration and activation of tumour specific effector T cells seems to be the one important reason for inadequate host anti-tumour immune response. Ionizing radiation can induce a variety of immune responses. The goal of this randomized trial is to assess if a preoperative single fraction low dose radiation... | A Randomized Phase II Study of Radiation Induced Immune Boost in Operable Non-small Cell Lung Cancer | Non-small Cell Lung Cancer | * Radiation: Preoperative radiation
| Inclusion Criteria:~Histologically proven clinical stage I to IIA pulmonary adenocarcinoma~Lung tumor is felt to be curatively resectable by the treating physicians~Sufficient pulmonary function for lobectomy according to current guidelines~The patient is free of distant metastases as confirmed by contrast-enhanced che... | 50 Years | null | All | No | Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cluster of differentiation (CD)8+ T cells in resected NSCLC | Frequencies of CD8+ T cells in resected NSCLC tumors determined by immunohistochemistry | 7 days |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T cell subtypes in resected NSCLC | Frequencies of CD3+, CD4+, CD45RO and Foxp3+ T cells in resected NSCLC tumors determined by immunohistochemistry and flow cytometry | 7 days |
| Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases, Carcinoma, Bronchogenic, Bronchial Neoplasms | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No radiation<br>Lobectomy for lung cancer without preoperative radiation | |
| Experimental: Preoperative radiation<br>Lobectomy for lung cancer with preoperative radiation | Radiation: Preoperative radiation<br>* Lobectomy for lung can... | Immune Boost In Non-Small Cell Lung Cancer
Study Overview
=================
Brief Summary
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Insufficient migration and activation of tumour specific effector T cells seems to be the one important reason for inadequate host anti-tumour immune response. Ionizing radiation can induce a variety of immune r... | ||
NCT00273702 | An Open-Label Study of N-Acetyl Cysteine in Pathological Gambling | After completing all screening evaluations, subjects will receive unblinded N-Acetyl Cysteine 600 mg/day for 2 weeks. The dose will be raised to 1200 mg/day at visit 4 and to 1800 mg/day at visit 6 unless clinical improvement has been attained at a lower dose (clinical improvement will be assessed by the investigator w... | Before beginning N-Acetyl Cysteine, all subjects will receive a psychiatric, medical, and family history evaluation as well as the Structured Clinical Interview for DSM-IV (SCID-P) for Axis I disorders. At the screening visit, patients will also receive standard laboratory tests (including ß-HCG), and a physical examin... | An Open-Label Study of N-Acetyl Cysteine in Pathological Gambling | Pathological Gambling | * Drug: N-Acetyl Cysteine
| Inclusion Criteria:~Men and women age 18-65~Current DSM-IV PG~Exclusion Criteria:~Unstable medical illness on physical examination~History of seizures~Myocardial infarction within 6 months~Current pregnancy or lactation, or inadequate contraception in women of childbearing potential~Clinically significant suicidality~L... | 18 Years | 65 Years | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PG-YBOCS | | |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| G-SAS | | |
| Gambling, Gambler, Gamble, Pathological | Acetylcysteine, N-monoacetylcystine, Antiviral Agents, Anti-Infective Agents, Expectorants, Respiratory System Agents, Free Radical Scavengers, Antioxidants, Molecular Mechanisms of Pharmacological Action, Protective Agents, Physiological Effects of Drugs, Antidotes | | Intervention/Treatment |
| --- |
|Drug: N-Acetyl Cysteine|nan|
| An Open-Label Study of N-Acetyl Cysteine in Pathological Gambling
Study Overview
=================
Brief Summary
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After completing all screening evaluations, subjects will receive unblinded N-Acetyl Cysteine 600 mg/day for 2 weeks. The dose will be raised to 1200 mg/day at visit 4 and to 1800 mg/day a... |
NCT04851535 | Study of Jaktinib In Patients With Myelofibrosis Who Were Relapsed or Refractory of Ruxolitinib Treatment. | This was a phase 2, single-arm, open-label, non-randomised, multicentre, study to evaluate the efficacy and safety of Jaktinib in patients with myelofibrosis who were relapsed or refractory of ruxolitinib treatment. | All subjects will receive a minimum of 6 treatment cycles or 24 weeks (a 28-day treatment cycle is defined as one treatment cycle). | A Phase II Study To Evaluate The Efficacy And Safety of Jaktinib Hydrochloride Tablets In Patients With Myelofibrosis Who Were Relapsed or Refractory of Ruxolitinib Treatment | Myelofibrosis | * Drug: Jaktinib Hydrochloride Tablets
| Inclusion Criteria:~Subjects voluntarily sign the informed consent form (ICF);~Age ≥ 18 years, either male or female;~Subjects diagnosed with a PMF according to World Health Organization (WHO) criteria (2016 Edition), or patients diagnosed with a Post-PV-MF or Post-EF-MF according to International Working Group for Mye... | 18 Years | null | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spleen Volume Response rate (SVRR) at Week 24 | The proportion of subjects with spleen volume reduction from baseline ≥ 35% measured by MRI or CT. | at Week 24 |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Objective Response Rate (complete remission (CR) + partial remission (PR)) | International Working Group for Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) response criteria. | Baseline, up to Year 2 |
| Spleen Respons... | Primary Myelofibrosis, Myeloproliferative Disorders, Bone Marrow Diseases, Hematologic Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jaktinib 100mg Bid<br>Jaktinib twice daily for 6 consecutive 28-day cycles, orally, empty stomach | Drug: Jaktinib Hydrochloride Tablets<br>* Jaktinib 100mg Bid<br>|
| Study of Jaktinib In Patients With Myelofibrosis Who Were Relapsed or Refractory of Ruxolitinib Treatment.
Study Overview
=================
Brief Summary
-----------------
This was a phase 2, single-arm, open-label, non-randomised, multicentre, study to evaluate the efficacy and safety of Jaktinib in patients with mye... | |
NCT04244864 | Cross-sectoral Collaboration in Multidisciplinary Treatment of Trauma-affected Refugees | INTRODUCTION Trauma-affected refugees are at high risk of developing mental health problems including post-traumatic stress disorder (PTSD) and depression. In addition to traumatic stress, refugees are furthermore subject to a range of post-migration stressors e.g. unemployment, poor finances and language difficulties.... | INTRODUCTION Treatment-seeking trauma-affected refugees possess a complexity involving past trauma and ongoing social stressors, which challenges treatment of mental health problems. There is therefore a great need for developing holistic cross-sectoral interventions, where dealing with these complex challenges are int... | The Effect of Integrating Cross-sectoral Collaboration With the Municipality in Multidisciplinary Treatment of Trauma-affected Refugees; a Randomised Controlled Trial | Post Traumatic Stress Disorder, Depression, Psychosocial Problem | * Behavioral: Cross-sectoral psychosocial intervention
* Behavioral: Treatment as usual (TAU)
| Inclusion Criteria:~Adults (18 years or older).~Refugees or persons who have been family reunified with a refugee.~PTSD pursuant to the ICD-10 research criteria.~Psychological trauma experienced outside Denmark in the anamnesis. Trauma is imprisonment or detention with torture (according to the United Nations' definiti... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), interviewer administered 12-item version | Measure of health and disability across cultures. Scoring range: 0-48, lower scores reflect better outcome. | Change from... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Harvard Trauma Questionnaire (HTQ) Part IV | Self-administered rating scale assessing the severity of PTSD symptoms. Scoring range: 0-4, lower scores reflect better outcome. | Change from baseline to end-of-treatment after approximately 10... | Post Traumatic Stress Disorder, Refugees, Cross-sectoral collaboration, Treatment | Stress Disorders, Traumatic, Stress Disorders, Post-Traumatic, Trauma and Stressor Related Disorders, Mental Disorders | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment as usual (TAU)<br>8-12 months of treatment | Behavioral: Treatment as usual (TAU)<br>* Medical doctor, 10 sessions: Pharmacological treatment according to standard algorithm and psychoeducation.~Psychologist 16-21 sessions: ... | Cross-sectoral Collaboration in Multidisciplinary Treatment of Trauma-affected Refugees
Study Overview
=================
Brief Summary
-----------------
INTRODUCTION Trauma-affected refugees are at high risk of developing mental health problems including post-traumatic stress disorder (PTSD) and depression. In additio... |
NCT00887146 | Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma | Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomid... | This study will be a randomized phase III for patients with newly diagnosed co-deleted 1p/19q anaplastic glioma or high risk low grade glioma. The trial will only enroll patients with 1p/19q co-deletion. This study includes two arms as described in the Arms section. A dynamic allocation procedure will be used to alloca... | Phase III Intergroup Study of Radiotherapy With Concomitant and Adjuvant Temozolomide Versus Radiotherapy With Adjuvant PCV Chemotherapy in Patients With 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma | Brain and Central Nervous System Tumors | * Drug: concomitant temozolomide (TMZ)
* Radiation: radiotherapy
* Drug: procarbazine
* Drug: adjuvant temozolomide (TMZ)
* Drug: CCNU
* Drug: vincristine
| Pre-Registration Inclusion Criteria:~United States (US) and Canadian sites:~* This review is mandatory prior to registration to confirm eligibility; patients must be willing to submit tissue samples for mandatory central pathology review submission; it should be initiated as soon after surgery as possible~Tissue must h... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | The distribution of progression free survival for Arms A and B will be estimated using the Kaplan-Meier method. The hazard ratios and median progression free survival (PFS) will be estimated with their confidence in... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression | Estimated by Kaplan-Meier method and analyzed by Cox regression model adjusting all stratification factors. Correlations among baseline neurocognitive test scores and progression free survival will be analyzed using Cox p... | adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult mixed glioma | Vincristine, Temozolomide, Procarbazine, Antineoplastic Agents, Phytogenic, Antineoplastic Agents, Tubulin Modulators, Antimitotic Agents, Mitosis Modulators, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Alkylating, Alkylating Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A (RT, procarbazine, lomustine, vincristine)<br>Patients undergo 3D-CRT or IMRT on days 1-5 for 5-7 weeks. Patients also receive procarbazine hydrochloride PO on days 8-21, lomustine PO on day 1 and vincristine sulfate IV on days 8 and... | Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma
Study Overview
=================
Brief Summary
-----------------
Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemo... |
NCT01864070 | Phase 1 TheraSphere + Everolimus With Neuroendocrine Tumors (NETs) + Liver Only or Liver Dominant Disease | The goal of this clinical research study is to find the highest tolerable dose of the combination of everolimus with TheraSphere that can be given to patients with advanced NETs that have spread to the liver. The safety of everolimus and TheraSphere will also be studied.~Everolimus is designed to block a protein inside... | Study Groups:~If patient is are found to be eligible to take part in this study, they will be assigned to a dose level of everolimus based on when they joined this study. Up to 3 dose levels of everolimus will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will rece... | Phase I Study of TheraSphere and Everolimus Among Patients With Neuroendocrine Tumors and Liver Only or Liver Dominant Disease | Liver Cancer | * Other: TheraSphere
* Drug: Everolimus
* Other: Phone Call
| Inclusion Criteria:~All patients must sign an informed consent indicating that they are aware of the investigational nature of this study.~Patients must have histologically or cytologically confirmed low or intermediate grade neuroendocrine tumor, for which standard curative measures do not exist. Patients with neuroen... | 18 Years | null | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Limiting Toxicities (DLT) for Combination of TheraSphere and Everolimus | Dose limiting toxicity (DLT) defined as any toxicity occurring during the first 56 days of therapy with definite, possible or probable attribution to TheraSphere an... | Liver dominant disease, Liver cancer, Neuroendocrine tumors, NET, TheraSphere, Yttrium-90, Y-90, Everolimus, Afinitor, Zortress, RAD001, Microspheres | Everolimus, MTOR Inhibitors, Protein Kinase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Immunosuppressive Agents, Immunologic Factors, Physiological Effects of Drugs, Antineoplastic Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TheraSphere + Everolimus<br>Each cycle is 28 days. Target dose of TheraSphere is fixed at 120 Gy to entire tumor bearing portion of liver given at a single session on Cycle 1 Day 15. The dose of everolimus will be escalated in 2 sequential... | Phase 1 TheraSphere + Everolimus With Neuroendocrine Tumors (NETs) + Liver Only or Liver Dominant Disease
Study Overview
=================
Brief Summary
-----------------
The goal of this clinical research study is to find the highest tolerable dose of the combination of everolimus with TheraSphere that can be given t... | |
NCT04808297 | Trehalose in Subjects With Neuronal Ceroid Lipofuscinoses | Neuronal Ceroid Lipofuscinoses (NCL) or Batten's disease are the most common juvenile neurodegenerative disease, characterized by early blindness, movement disorders, cognitive and behavioral impairment, epilepsy, and retinopathy.~This study aims to collect clinical and laboratory data of patients with NCL taking Treha... | This study aims to collect clinical and laboratory data of patients with NCL taking Trehalose. | A Study in Subjects With Neuronal Ceroid Lipofuscinoses Taking Trehalose | Neuronal Ceroid-Lipofuscinoses | Inclusion Criteria:~NCL genetic diagnosis (mutation in genes CLN3 or CLN6)~Signed informed consent~Exclusion Criteria:~Other concomitant neurodegenerative diseases.~Therapeutic and eating changes in the last four months prior to the study~Unstable clinical conditions (myoclonus worsening, instability in sleep, parenter... | 7 Years | 45 Years | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline clinical status assessed using Annex VII of the Unified Batten Disease Rating Scale (UBDRS) (score 0-5 where 5 is the worst outcome) at 12 and 24 months | Blood samples | month 0, month 12, month 24 |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline using Annex VII of Unified Batten Disease Rating Scale (UBDRS) (score 0-5 where 5 is the worst outcome) at 12 and 24 months | Blood samples | month 0, month 12, month 24 |
| Juvenile Neuronal Ceroid-Lipofuscinoses, Unified Batten Disease Rating Scale | Neuronal Ceroid-Lipofuscinoses, Heredodegenerative Disorders, Nervous System, Neurodegenerative Diseases, Nervous System Diseases, Genetic Diseases, Inborn, Lipidoses, Lipid Metabolism, Inborn Errors, Metabolism, Inborn Errors, Lipid Metabolism Disorders, Metabolic Diseases | Trehalose in Subjects With Neuronal Ceroid Lipofuscinoses
Study Overview
=================
Brief Summary
-----------------
Neuronal Ceroid Lipofuscinoses (NCL) or Batten's disease are the most common juvenile neurodegenerative disease, characterized by early blindness, movement disorders, cognitive and behavioral impa... | |||
NCT04191824 | Genetic Testing to Understand and Address Renal Disease Disparities Across the United States | The primary aim is to determine the effect of participant and provider knowledge of a positive APOL1 status and accompanying guideline based clinical decision support (CDS) on blood pressure management on change in systolic blood pressure (SBP) from baseline to 3 months after randomization among the APOL1 positive part... | Genetic Testing to Understand and Address Renal Disease Disparities Across the United States | Renal Disease | * Diagnostic Test: APOL1 status
| Inclusion Criteria:~Self reported African ancestry~English Speaking~Age 18-70 years~Have diagnosis of hypertension~Diagnosis of hypertension is defined by either:~ICD10 diagnosis codes (i.e., I10; I11.x; I12.x; I13.x; I16.x) OR~On active antihypertensive therapy for indication of hypertension OR~Having systolic blood p... | 18 Years | 70 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Immediate versus delayed return of Apolipoprotein L1 (APOL1) gene testing results to provider and participant.
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic blood pressure from baseline to 3 months | Change in systolic blood pressure | Baseline to 3 month study visit |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urine microalbuminuria/proteinuria | Change in urine microalbuminuria/proteinuria | From baseline to 6 months |
| Appropriate order of microalbuminuria/proteinuria tests | Appropriate order of microalbuminuria/proteinuria tests | ba... | Kidney Diseases, Urologic Diseases, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Male Urogenital Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate Return of Results<br>Immediate return of results to inform participant of APOL1 status (either positive or negative). | Diagnostic Test: APOL1 status<br>* Participants will be randomized to immediate versus delayed return of... | Genetic Testing to Understand and Address Renal Disease Disparities Across the United States
Study Overview
=================
Brief Summary
-----------------
The primary aim is to determine the effect of participant and provider knowledge of a positive APOL1 status and accompanying guideline based clinical decision su... | ||
NCT03355664 | Study to Compare the Triple ACT AL+AQ With the ACT AL in Cambodia and Vietnam | This study is a multi-centre, open-label randomised trial to assess the efficacy, safety and tolerability of the Triple ACT artemether-lumefantrine+amodiaquine (AL+AQ) compared to the ACT artemether-lumefantrine (AL) in uncomplicated falciparum malaria in Cambodia and Vietnam. The estimated total sample size is 600 pat... | The study of artemether-lumefantrine or artemether-lumefantrine combined with amodiaquine will be a two-arm randomized open label comparative study.~The main activity proposed is a series of detailed in vivo clinical, parasitological and pharmacological assessments in 600 subjects across 2 sites in Cambodian (400 subje... | A Multi-centre, Open-label Randomised Trial to Assess the Efficacy, Safety and Tolerability of the Triple ACT Artemether-lumefantrine+Amodiaquine (AL+AQ) Compared to the ACT Artemether-lumefantrine (AL) in Uncomplicated Falciparum Malaria in Cambodia and Vietnam | Malaria, Falciparum | * Drug: ACT
* Drug: TACT
| Inclusion Criteria:~Male or female, aged from 2 years to 65 years old~Acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum (or mixed with non-falciparum species)~Asexual P. falciparum parasitaemia: 16 to 200,000/microlitre, determined on a thin or thick blood ... | 2 Years | 65 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: open-label randomised trial
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polymerase Chain Reaction Corrected Efficacy Defined as Adequate Clinical and Parasitological Response (ACPR) by Study Arm | Efficacy is defined as participants, following initial parasite and fever clearance, not having a recrudescence of the... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 42-day Polymerase Chain Reaction Corrected Efficacy According to Site/Geographic Region | 42-day polymerase chain reaction corrected efficacy defined as adequate clinical and parasitological response (ACPR) according to site/geographic region.... | Malaria, Falciparum, Malaria, Protozoan Infections, Lumefantrine, Artemether, Amodiaquine, Piperaquine, Artemether-lumefantrine combination, Artemisinins, Dihydroartemisinin, Mefloquine, Artemisinin, Antimalarials, Antiparasitic Agents, Anti-Infective Agents, ACT, TACT, Triple ACT(s), Resistance, Antimalarial resistanc... | Malaria, Malaria, Falciparum, Protozoan Infections, Parasitic Diseases, Infections, Vector Borne Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ACT<br>Artemether-lumefantrine for 3 days plus primaquine at hour 24 | Drug: ACT<br>* Artemether-lumefantrine (20/120 mg) as a fixed dose combination twice daily for 3 days according to weight plus low dose primaquine at hour 24<br>|
... | Study to Compare the Triple ACT AL+AQ With the ACT AL in Cambodia and Vietnam
Study Overview
=================
Brief Summary
-----------------
This study is a multi-centre, open-label randomised trial to assess the efficacy, safety and tolerability of the Triple ACT artemether-lumefantrine+amodiaquine (AL+AQ) compared... |
NCT04229043 | Gastric Emptying of Water and Sports Drink in Labor | To determine the half time of the emptying of the stomach of women in early labor with and without epidural pain relief when drinking either water or a carbohydrate-based sports drink. | This is a randomized un-blinded study comparing the gastric emptying halftime of water versus a carbohydrate-based sports drink.~Cohorts Women in early labor who have not received pain medication will be enrolled in the study. This will be called the 'unmedicated' group. A second cohort of women who have received an ep... | Examining the Gastric Emptying Halftime of Water Versus a Carbohydrate in Early Labor | Pregnancy, Gastric Emptying | * Dietary Supplement: Sports drink
* Dietary Supplement: Water
| Inclusion Criteria:~Gestational age of 36 weeks or greater~American Society of Anesthesiology Physical Status 2 or 3~Induction of labor or early labor (cervical dilation < 6cm)~Singleton gestation~Exclusion Criteria:~Recent food ingestion (<3 hours)~Preeclampsia~Receiving magnesium sulfate~Having received narcotics wit... | 18 Years | 50 Years | Female | No | Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects in each group will drink one of two drinks: water or sports drink. We will measure the changing volume in the stomach using ultrasound over the next 60 minutes.
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying half time | The time in minutes that half of the volume of the stomach has emptied | 60 minutes |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hunger | The amount of hunger that the subject feels measured on a visual analogue 10-centimeter line, with the left (0 cm) being labeled 'No Hunger' and the right (10 cm) being labeled 'Maximum hunger' | 60 minutes |
| | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early labor, no analgesia: Sports drink<br>Subject will ingest 100 ml of a carbohydrate sports drink | Dietary Supplement: Sports drink<br>* Drink that will be ingested<br>|
| Placebo Comparator: Early Labor, no analgesia: Water<br>Su... | Gastric Emptying of Water and Sports Drink in Labor
Study Overview
=================
Brief Summary
-----------------
To determine the half time of the emptying of the stomach of women in early labor with and without epidural pain relief when drinking either water or a carbohydrate-based sports drink.
Detailed Descrip... | ||
NCT03824054 | Quality of Life in Patients Undergoing Colorectal Resection for Deep Infiltrating Endometriosis | The aim of this study is to evaluate the quality of life of patients undergoing colorectal resection for deep infiltrating endometriosis of the bowel. Questionnaires about pre operative status have been submitted retrospectively, while post operative questionnaires have been submitted prospectively during last follow u... | All patients fit for the study will be asked to complete a visual analogue scales (VAS) for dysmenorrhea, deep dyspaurenia, dysuria, dyschesia and chronic pelvic pain (CPP) Patients will fill in the Endometriosis QoL Questionnaire (EHP30), the gastrointestinal well-being questionnaires Bristol Stool Chart, GSCG (Gastro... | Evaluation of Quality of Life and Gastrointestinal Well-being in Patients Undergoing Colorectal Resection for Deep Infiltrating Endometriosis. Retrospective Observational Cohort Study | Endometriosis | * Procedure: colorectal resection
| Inclusion Criteria:~Women aged between 18 and 45 years~Clinical diagnosis of deep endometriosis infiltrating the bowel~Women undergoing surgical removal with colorectal resection with or without loop ileostomy creation~Exclusion Criteria:~History of previous or ongoing neoplastic pathology~Contraindications to surgical... | 18 Years | 45 Years | Female | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-post colorectal resection-and-anastomosis evaluation of gastrointestinal symptoms (stipsi, dyschezia, regurgitation, nausea and vomit, abdominal distension and belching) | Pre-post colorectal-resection-and-anastomosis evaluation (mean diff... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-post colorectal resection-and-anastomosis evaluation of anxiety, depression, positivity and well-being, self control, general health and vitality | Pre-post colorectal-resection-and-anastomosis evaluation (mean difference or percentage var... | deep infiltrating endometriosis, colorectal resection, quality of life | Endometriosis, Genital Diseases, Female, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Genital Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| colorectal resection arm<br>Patients affected by symptomatic deep infiltrating endometriosis involving the bowel and submitted to colo-rectal resection | Procedure: colorectal resection<br>* Surgery includes laparoscopic resection of all visible endomet... | Quality of Life in Patients Undergoing Colorectal Resection for Deep Infiltrating Endometriosis
Study Overview
=================
Brief Summary
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The aim of this study is to evaluate the quality of life of patients undergoing colorectal resection for deep infiltrating endometriosis of the bowel. Questio... | |
NCT01322503 | Susceptibility of Human Volunteers With Different Histo-Blood With Different Histo-Blood Group Antigens to Norovirus | Objectives: To evaluate the role of human histo-blood group antigens in susceptibility to Norovirus infections.~Description of Study Design: Healthy volunteers with different blood types and low antibody titers to the challenge strain will be challenged orally with a Norovirus in the CCCR inpatient facility. Subjects w... | Noroviruses are single-stranded, positive-sense RNA viruses that cause acute gastroenteritis in humans. The prototype Norwalk virus (NV) was identified in a large outbreak of acute gastroenteritis in an elementary school in Norwalk, Ohio, in 1968. Since then, many strains have been described and named by the locations ... | Evaluation of the Susceptibility of Human Volunteers With Different Histo-Blood Group Antigens to Norovirus | Healthy Adults | * Biological: Norovirus
| Inclusion Criteria:~Healthy adults between the ages of 18 and 49 years~Willing and able to provide written informed consent~Able to comply with all study procedures~Have a body mass index of at least 19~Have a serum IgG antibody titer of < 1:1,600 to Norovirus~Female subjects of child bearing potential must have negati... | 18 Years | 49 Years | All | Accepts Healthy Volunteers | Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the number of people who develop symptomatic illness after challenge with Norovirus | The number of subjects that become infected, as measured by the number of subjects found to be shedding norovirus in their stool, as well as t... | Disease Susceptibility, Disease Attributes, Pathologic Processes | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Norovirus Challenge<br> | Biological: Norovirus<br>* Norovirus challenge pool administered to each subject<br>* Other names: Norovirus challenge pool;|
| Experimental: Norovirus challenge<br> | Biological: Norovirus<br>* Norovirus challeng... | Susceptibility of Human Volunteers With Different Histo-Blood With Different Histo-Blood Group Antigens to Norovirus
Study Overview
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Brief Summary
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Objectives: To evaluate the role of human histo-blood group antigens in susceptibility to Norovirus infections. Description of Study Desi... | ||
NCT04755907 | 3D Bioprinted Models for Predicting Chemotherapy Response in Colorectal Cancer With/Without Liver Metastases | The therapeutic regimens of adjuvant and neoadjuvant chemotherapy for colorectal cancer (CRC) remain largely relied on clinical experience, and thus preclinical models are needed to guide individualized medicine. The investigators are going to establish 3D bioprinted CRC models and organoids from surgically resected tu... | Validation of the Three-dimensional Bioprinted Tumor Models as a Predictive Method of the Response to Chemotherapy for Colorectal Cancer With or Without Liver Metastases | Colorectal Cancer, Colorectal Cancer Liver Metastasis | * Procedure: surgical resection
* Other: adjuvant chemotherapy
* Other: neoadjuvant therapy
| Inclusion Criteria:~More than 18 years old~Diagnosed as colorectal cancer with or without liver metastases before~Pathologically proven colorectal cancer after surgery~Exclusion Criteria:~Medical history with other malignancies or serious diseases~Disable to sign the informed consent independently | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response of 3D tumor models/organoids to the same chemotherapy drugs as the corresponding patients. | The investigators will establish and culture 3D colorectal cancer models and organoids. The 3D models and organoids will be treated with the ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response of the colorectal cancer patients to neoadjuvant chemotherapy. | For patients who receive neoadjuvant chemotherapy before surgery, the response to neoadjuvant chemotherapy will be evaluated according to clinical imaging results and th... | colorectal cancer, colorectal cancer liver metastasis, three-dimensional bioprinting, chemotherapy | Colorectal Neoplasms, Neoplasm Metastasis, Liver Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Intestinal Diseases, Rectal Diseases, Neoplastic Processes, Pathologic Processes... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>colorectal cancer patients at resectable stage II/III who will receive adjuvant chemotherapy after surgery | Procedure: surgical resection<br>* Surgical resection will be performed for locoregional lesions or liver metastases.<br>Other: adjuv... | 3D Bioprinted Models for Predicting Chemotherapy Response in Colorectal Cancer With/Without Liver Metastases
Study Overview
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Brief Summary
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The therapeutic regimens of adjuvant and neoadjuvant chemotherapy for colorectal cancer (CRC) remain largely relied on clinical experience, and t... | ||
NCT00063141 | Study of Irinotecan and Cetuximab Versus Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Cancer | The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyr... | Revised Protocol 07 to Protocol CA225006 - A Phase III Randomized, Open-Label, Multicenter Study of Irinotecan and Cetuximab vs. Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Carcinoma | Colorectal Cancer | * Drug: cetuximab
* Drug: Irinotecan
* Drug: Irinotecan
| Inclusion Criteria:~Histologically documented colorectal cancer which is EGFR-positive by immunohistochemistry [IHC] (may be based on archival samples) and is metastatic.~Prior oxaliplatin administered for the first-line treatment of metastatic colorectal cancer.~Prior fluoropyrimidine-containing regimen (5-fluorouraci... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | | Every 3 months after subject off-treatment |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | | Q6 Weeks |
| Response | | Q6 Weeks |
| Duration of Response | | Q6 Weeks |
| Time to Response | | Q6 Weeks |
| Disease Control Rate | | Q6 Weeks |
| Safety | | Q3 Weeks |
| Quality of Life | | Q6 Week... | Irinotecan, Cetuximab, Topoisomerase I Inhibitors, Topoisomerase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Antineoplastic Agents, Immunological | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br> | Drug: cetuximab<br>* Vial, IV, 400 mg/m² week 1 then 250 mg/m², weekly, until PD/Toxicity/Pt-PI Decision<br>* Other names: Erbitux;Drug: Irinotecan<br>* Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision<br>|
| Ac... | Study of Irinotecan and Cetuximab Versus Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Cancer
Study Overview
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Brief Summary
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The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, epiderm... | ||
NCT01831089 | Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors | Clinical trial of PM01183 in combination with paclitaxel, with or without bevacizumab, in patients with solid tumors | Clinical trial to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with weekly paclitaxel, with or without bevacizumab. Once a recommended dose is defined for the PM01183 and weekly paclitaxel combination, the feasibility of adding bevacizumab to this combination will b... | Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Weekly Paclitaxel, With or Without Bevacizumab, in Patients With Selected Advanced Solid Tumors | Breast Cancer, Ovarian Cancer, Gynecological Cancer, Head and Neck Carcinoma, Non-small Cell Lung Cancer, Small Cell Lung Cancer, Non-squamous Cell Lung Cancer | * Drug: PM01183 + paclitaxel +/- bevacizumab
| Inclusion Criteria:~Voluntarily signed and dated written informed consent~Age between 18 and 75 years old (both inclusive)~Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 1~Life expectancy ≥ 3 months.~Patients with a histologically/cytologically confirmed diagnosis of advanced and/or unresectable... | 18 Years | 75 Years | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose (MTD) | The MTD will be the lowest level at which one third or more evaluable patients experience a DLT in Cycle 1.~DLTs are defined as AEs or laboratory abnormalities related to the study drugs occurred during Cycle 1. ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Tumor Response | Best overall response:Best response recorded from the start of the study treatment until the end of treatment Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or no... | Paclitaxel, Bevacizumab, Antineoplastic Agents, Phytogenic, Antineoplastic Agents, Tubulin Modulators, Antimitotic Agents, Mitosis Modulators, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Immunological, Angiogenesis Inhibitors, Angiogenesis Modulating Agents, Growth Substances, Physiological E... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>PM01183 + paclitaxel +/- bevacizumab | Drug: PM01183 + paclitaxel +/- bevacizumab<br>* PM01183: 1 mg and 4 mg vials. Powder for concentrate for solution for infusion~paclitaxel: 6 mg/ml concentrate for solution for infusion~be... | Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors
Study Overview
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Brief Summary
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Clinical trial of PM01183 in combination with paclitaxel, with or without bevacizumab, in patients with solid tumors
... | |
NCT02288793 | Focused Assessment With Sonography in Trauma | The study evaluates the knowledge and attitude about Focused Assessment with Sonography in Trauma examination among medical students and medical staff in Poland. | Prepared for Focused Assessment With Sonography in Trauma Examination? | Trauma, Ultrasonography | * Other: Survey
| Inclusion Criteria:~Give voluntary consent to participate in the study~Exclusion Criteria:~not meet the above criteria | 18 Years | null | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results of the Medical Knowledge Tool (Questionnaire) | Percentage of healthcare workers and medical students with appropriate knowledge assessed by 10- items questionnaire about basic information about Focused Assessment With Sonography in Tr... | attitudes, knowledge, examination | Wounds and Injuries | | Intervention/Treatment |
| --- |
|Other: Survey|Survey about Knowledge and Attitude About Focused Assessment With Sonography in Trauma|
| Focused Assessment With Sonography in Trauma
Study Overview
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Brief Summary
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The study evaluates the knowledge and attitude about Focused Assessment with Sonography in Trauma examination among medical students and medical staff in Poland.
Official Title
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Prepared for ... | |||
NCT02535156 | Schizotypal Personality Disorder Risperidone | Neurophysiological indices of self-monitoring were assessed in a group of patients with Schizotypal Personality Disorder (SPD) and a control group. Both groups were assessed after the administration of risperidone and placebo. | The electroencephalogram (EEG) was recorder while participants (SPD participants and controls) performed a behavioral task: the Eriksen Flanker Task. The continuous EEG was segmented, corrected for artifacts and averaged. A component of the event-related brain potential known as the error-related negativity (ERN) was i... | null | Schizotypal Personality Disorder | * Drug: Risperidone
* Drug: Placebo
| Inclusion Criteria:~Schizotypal Personality Disorder~Exclusion Criteria:~Major Psychiatric Disorder~Medical condition | 18 Years | null | All | Accepts Healthy Volunteers | Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurophysiological indices of self-monitoring (Error Related Negativity) | Amplitude of the Error Related Negativity was assessed prior to and 2 hours after treatment administration | During acute effects of pharmacological treatment (up to 2 ... | Risperidone, Serotonin Antagonists, Serotonin Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs, Antipsychotic Agents, Tranquilizing Agents, Central Nervous System Depressants, Psychotropic Drugs, Dopamine Antagonists, Dopamine Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Schizotypal Personality Disorder<br>Schizotypal Personality Disorder (SPD) patients. They received two interventions: risperidone 1 mg and placebo (lactose). | Drug: Risperidone<br>* 1 mg Risperidone<br>Drug: Placebo<br>* Lactose Placebo<b... | Schizotypal Personality Disorder Risperidone
Study Overview
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Brief Summary
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Neurophysiological indices of self-monitoring were assessed in a group of patients with Schizotypal Personality Disorder (SPD) and a control group. Both groups were assessed after the administration of risperi... | ||
NCT04282512 | Evaluation of the Effect of Sodium Bicarbonate Water on Blood Pressure in Normotensive Subjects | ROX_TENSIO18 is a randomised cross-over trial and the main objective is to evaluate the effect of daily consumption of sodium bicarbonate water for 15 days on blood pressure.~Secondary objective are:~Evaluation of the effect of daily consumption of sodium bicarbonate water on total salt intake~Evaluation on blood press... | Volunteers are normotensive subjects divided into two equivalent groups. Group A subjects will begin their first 15-day period with the consumption of St-Yorre mineral water.~Group B will begin the first 15-day period by drinking tap water. After a washout period of 15 days, each group alternates with a new period of 1... | Evaluation of the Effect of Daily Consumption of Sodium Bicarbonate Water for 15 Days on Blood Pressure in Normotensive Subjects | Blood Pressure | * Other: Sodium bicarbonate-rich mineral water
| Inclusion Criteria:~Normal blood pressure between 90/60 and 140/90 mm Hg~Usually drinks tap water;~Knowing read and write French routinely,~Possessing an internet connection at home,~Possessing and knowing how to use a computer or tablet,~Affiliated with a social security scheme~Not Trust~Having signed the informed con... | 18 Years | 65 Years | All | Accepts Healthy Volunteers | Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Group A subjects: first 15-day period drinking a sodium bicarbonate-rich mineral water Group B subjects: first 15-day period drinking tap water Washout period of 15 days Group A subjects: las... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline mean number of systolic and diastolic blood pressure at 15 days | The primary endpoint is the difference between mean number of blood pressure of the volunteers drinking sodium bicarbonated-rich water during 15 days and th... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sodium intake | The sodium intake per day is assessed using two three-day food records and the ExSel test. | Day 1 to Day 15 - Day 31 to Day 45 |
| Nutrition, Blood pressure, Sodium bicarbonate | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A : sodium bicarbonate-rich mineral water and tap water<br>First 15-days period with daily intake of 1.5l of sodium bicarbonate-rich mineral water.~15-days washout period Last 15-days period with daily intake of 1.5l of tap water. | ... | Evaluation of the Effect of Sodium Bicarbonate Water on Blood Pressure in Normotensive Subjects
Study Overview
=================
Brief Summary
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ROX_TENSIO18 is a randomised cross-over trial and the main objective is to evaluate the effect of daily consumption of sodium bicarbonate water for 15 days on... | |
NCT03494764 | Hyperbaric Oxygen Therapy for Ulcerative Colitis Flares | Ulcerative colitis (UC) is a chronic inflammatory bowel disease associated with recurrent mucosal inflammation. Clinically, the disease is characterized by bloody diarrhea, abdominal pain, and constitutional symptoms such as fever and weight loss. Treatment strategies vary based on disease activity and target various a... | Hyperbaric Oxygen Therapy for Moderate to Severe Ulcerative Colitis Flares: A Multi-Center Randomized Trial | Colitis, Ulcerative | * Other: Hyperbaric Oxygen Therapy
| Inclusion Criteria:~Hospitalized patients with known or newly diagnosed moderate to severe ulcerative colitis (as defined by the Mayo score ≥6)~Consented within the first 48 hours of initiating IV steroids~Risk score of >3 points (pts)~Mean stool frequency/24 hrs (<4 = 0 pts, 4-6 = 1 pt, 7-9 = 2 pts, >9 = 4 pts)~Coloni... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of HBOT on clinical response/remission | Impact of HBOT on clinical response/remission to medical therapy as measured by the partial Mayo score at study day 5. | 5 Days |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relative and absolute reduction in the Mayo score | Relative and absolute reduction in the Mayo score | Day 5, 10 |
| Flair duration | time to reduction in mayo score | day 5, 10 |
| Hospitalization duration | time in the hospital | day5, 10... | Hyperbaric Oxygen Therapy | Colitis, Colitis, Ulcerative, Ulcer, Gastroenteritis, Gastrointestinal Diseases, Digestive System Diseases, Colonic Diseases, Intestinal Diseases, Pathologic Processes, Inflammatory Bowel Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5 Days Hyperbaric Therapy<br>Patients will be enrolled and follow an identical medical treatment algorithm. At day 3 responders (based on partial Mayo score) will be re-randomized in a 1:1 fashion to complete 5 total days of HBOT (1 s... | Hyperbaric Oxygen Therapy for Ulcerative Colitis Flares
Study Overview
=================
Brief Summary
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Ulcerative colitis (UC) is a chronic inflammatory bowel disease associated with recurrent mucosal inflammation. Clinically, the disease is characterized by bloody diarrhea, abdominal pain, and const... | |
NCT03052777 | Using Telephone Counselling to Improve Exercise Participation in Hematologic Cancer Survivors | This study evaluates the impact of a 12-week theory-based exercise telephone counselling program (versus a self-directed exercise group) on closing the exercise intention-behavior gap in a sample of hematologic cancer survivors. | Problem: Regular exercise participation improves quality of life and physical function for cancer survivors. Unfortunately, the most effective way of promoting exercise to cancer survivors has yet to be determined, and as a result, many survivors are inactive. Theory-based efforts have typically focused on promoting in... | Improving Quality of Life in Hematologic Cancer Survivors by Closing the Exercise Intention-Behavior Gap: a Phase II Randomized Controlled Trial of a Theory-based, Telephone-delivered Exercise Counselling Intervention | Leukemia, Lymphoma, Lymphoma, Non-Hodgkin, Behavior, Health | * Behavioral: Telephone counselling
| Inclusion Criteria:~The inclusion criteria for this study will be survivors who have had a histologically confirmed hematologic cancer, and who are between 18-80 years of age, living in Alberta, can speak and comprehend English, and willing to participate in a 12-week exercise telephone counseling intervention.~Exclusi... | 18 Years | 80 Years | All | No | Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Exercise Levels | Exercise levels assessed using the Godin Leisure-Time Exercise Questionnaire | Baseline and within 7 days of completing the 12-week intervention |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Exercise Motivation | Exercise motivation assessed via validated questionnaires that align with the Multi-Process Action Control Framework | Baseline and within 7 days of completing the 12-week intervention |
| Change ... | Lymphoma, Lymphoma, Non-Hodgkin, Hematologic Neoplasms, Neoplasms by Histologic Type, Neoplasms, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders, Immune System Diseases, Neoplasms by Site, Hematologic Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone Counselling<br>Participants will be asked to increase their exercise by at least 60 minutes per week and will receive a copy of Canada's Physical Activity Guideline plus 12 weekly telephone counseling sessions aimed at helping su... | Using Telephone Counselling to Improve Exercise Participation in Hematologic Cancer Survivors
Study Overview
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Brief Summary
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This study evaluates the impact of a 12-week theory-based exercise telephone counselling program (versus a self-directed exercise group) on closing the exercise... | |
NCT04420221 | Safety, Immunogenicity and Efficacy of GSK S. Aureus Candidate Vaccine (GSK3878858A) When Administered to Healthy Adults (Dose-escalation) and to Adults 18 to 64 Years of Age With a Recent S. Aureus Skin and Soft Tissue Infection (SSTI) | Safety, immunogenicity and efficacy of GSK S. aureus candidate vaccine (GSK3878858A) when administered to healthy adults (dose-escalation) and to adults 18 to 64 years of age with a recent S. aureus skin and soft tissue infection (SSTI). In the dose-escalation safety lead-in phase in healthy adults safety and immunogen... | A Phase I/II, Observer-blind, Randomised, Placebo-controlled Study to Assess Safety, Immunogenicity and Efficacy of GSK S. Aureus Candidate Vaccine When Administered to Healthy Adults (Dose-escalation) and to Adults 18 to 64 Years of Age With a Recent S. Aureus Skin and Soft Tissue Infection (SSTI) | Infections, Soft Tissue | * Biological: Sa-5Ag half dose non-adjuvanted
* Biological: Sa-5Ag full dose non-adjuvanted
* Biological: Sa-5Ag half dose adjuvanted
* Biological: Sa-5Ag full dose adjuvanted
* Biological: Placebo
| Inclusion Criteria:~All subjects must satisfy all the following criteria at study entry:~Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).~Written or witnessed informed consent obtained from the ... | 18 Years | 64 Years | All | Accepts Healthy Volunteers | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with solicited local adverse events (AEs) (any, grade 3) | The solicited local AE(s) assessed are pain, redness and swelling. Any = any solicited local AE, regardless of intensity; Grade 3 pain = Significant pain at rest... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with at least one culture confirmed case of recurrent S. aureus SSTI | This key secondary outcome measure is to evaluate efficacy in terms of number of participants with at least one culture confirmed case of recurrent S... | S. aureus, skin and soft tissue infection, first time in human, S. aureus vaccine | Infections, Communicable Diseases, Soft Tissue Infections, Disease Attributes, Pathologic Processes | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Half dose non-adj Group 1a<br>Subjects aged 18 to 50 at the time of first vaccination who receive 1 dose of Sa-5Ag (5 antigens of S. aureus) half dose, non-adjuvanted at Day 1. | Biological: Sa-5Ag half dose non-adjuvanted<br>* 1 dose of S... | Safety, Immunogenicity and Efficacy of GSK S. Aureus Candidate Vaccine (GSK3878858A) When Administered to Healthy Adults (Dose-escalation) and to Adults 18 to 64 Years of Age With a Recent S. Aureus Skin and Soft Tissue Infection (SSTI)
Study Overview
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Brief Summary
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Safety, immunogen... | |
NCT04826588 | Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY) | The study is to provide reliable estimates of the effect of study treatment on hospital length of stay through to 28 days after randomisation.~The protocol describes an overarching trial design to provide reliable evidence on the efficacy of candidate therapies for children hospitalised with PIMS-TS. It is an adaptive ... | In May 2020 a new COVID-associated inflammatory syndrome in children was identified, Paediatric Inflammatory Multisystem Syndrome - Temporally associated with SARS-CoV-2 (PIMS-TS). A rapid international consensus process identified the need to evaluate corticosteroids and intravenous immunoglobulin (IVIg) as initial th... | Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY) | Paediatric Inflammatory Multisystem Syndrome-Temporally Associated With SARS-CoV-2 (PIMS-TS) | * Drug: Methylprednisolone sodium succinate 10 mg/kg intravenously
* Biological: Human normal immunoglobulin (IVIg)
| Inclusion Criteria:~Hospitalised children (aged <18 years old)~SARS-CoV-2 infection associated disease (clinically suspected or laboratory confirmed) with evidence of single or multi-organ dysfunction (called Pediatric Multisystem Inflammatory Syndrome temporally associated with COVID-19 [PIMS-TS]).~No medical history ... | 44 Weeks | 18 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Overarching trial design with treatment arms that are both available at the hospital and not believed by the enrolling doctor to be contraindicated (e.g. by particular co-morbid conditions or conc... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | effect of study treatment on hospital length of stay | Within 28 days after randomisation |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality among patients | For each pairwise comparison with the 'no additional treatment' arm, the primary objective is to provide reliable estimates of the effect of study treatments on all-cause mortality. | Within 28 days and up ... | coronavirus-disease (COVID-19), SARS coronavirus 2 (SARS-CoV-2), tocilizumab, anakinra, Human normal immunoglobulin (IVIg), Methylprednisolone sodium succinate | Methylprednisolone, Methylprednisolone Acetate, Methylprednisolone Hemisuccinate, Prednisolone, Prednisolone acetate, Prednisolone hemisuccinate, Prednisolone phosphate, Immunoglobulins, Anti-Inflammatory Agents, Antiemetics, Autonomic Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Gastrointe... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methylprednisolone sodium succinate 10 mg/kg<br>Methylprednisolone sodium succinate 10 mg/kg intravenously once daily for 3 days (max 1 g per dose) | Drug: Methylprednisolone sodium succinate 10 mg/kg intravenously<br>* Methylpredniso... | Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY)
Study Overview
=================
Brief Summary
-----------------
The study is to provide reliable estimates of the effect of study treatment on hospital length of stay through to 28 days after randomisation... |
NCT05239182 | 9-ING-41 Plus Retifanlimab and Gemcitabine/Nab-Paclitaxel in Patients With Advanced Pancreatic Adenocarcinoma | This trial examines how Pancreatic Adenocarcinoma reacts to the addition of 9-ING-41 and retifanlimab to the standard of care chemotherapy treatment, to see if using this combination will help and is able to effect disease progression. | Given the role of GSK-3β in immune regulation, the combination of GSK-3β inhibition with PD 1 inhibition may be expected to provide synergistic anti-tumor efficacy. The excellent safety profile of 9-ING-41, along with preclinical and clinical evidence of anti-tumor activity in pancreatic cancer, provides a strong ratio... | A Phase 2 Study of 9-ING-41, a Glycogen Synthase Kinase 3-beta (GSK-3β) Inhibitor, Combined With Retifanlimab, a PD-1 Inhibitor, Plus Gemcitabine/Nab-Paclitaxel as Frontline Therapy for Patients With Advanced Pancreatic Adenocarcinoma (RiLEY) | Pancreatic Adenocarcinoma | * Drug: 9-ING-41
* Drug: Retifanlimab
* Drug: Gemcitabine
* Drug: Abraxane
| Inclusion Criteria:~Voluntarily written informed consent and willingness/ability to comply with the protocol requirements~Has pathologically confirmed advanced, recurrent, or metastatic pancreatic cancer AND is previously untreated with systemic agents in the advanced/metastatic setting.~Must have at least 1 measurable... | 18 Years | null | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate (DCR) | Percentage of patients with stable disease for ≥ 16 weeks, Complete Response (CR), or Partial Response (PR) during treatment. Per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathol... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | Percentage of patients with Complete Response (CR) or Partial Response (PR) per RECIST v1.1 Per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non... | glycogen biosynthesis, Glycogen synthase kinase-3 (GSK-3), NF-κB pathway | Gemcitabine, Albumin-Bound Paclitaxel, Antimetabolites, Antineoplastic, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 9-ING-41 plus Retifanlimab plus Gem/Abraxane<br>intravenous (IV) infusion of nab-paclitaxel at a dose of 125 mg per square meter, followed by an infusion of gemcitabine according to the gemcitabine label at a dose of 1000 mg per square met... | 9-ING-41 Plus Retifanlimab and Gemcitabine/Nab-Paclitaxel in Patients With Advanced Pancreatic Adenocarcinoma
Study Overview
=================
Brief Summary
-----------------
This trial examines how Pancreatic Adenocarcinoma reacts to the addition of 9-ING-41 and retifanlimab to the standard of care chemotherapy treat... |
NCT05631639 | Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -A Pilot Study | This is a multi-center, prospective, non-randomized, open-label, exploratory clinical investigation performed to evaluate safety and effectiveness of the PillSense System when used for detection of blood in the stomach of patients suspected to have an Upper Gastrointestinal Bleed (UGIB). | The PillSense System consists of the PillSense Capsule, an atraumatic, ingestible, and disposable capsule and PillSense Receiver, an external real-time monitor for results display. The PillSense Capsule is a non-invasive, single use device designed to detect blood in the stomach and wirelessly transmit the data to the ... | Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -A Pilot Study | Upper Gastrointestinal Bleeding | * Device: PillSense System
| Inclusion Criteria:~Age 18 -80 years~Ability to give written informed consent~Clinical suspicion of bleeding~Exclusion Criteria:~Circulatory or hemodynamic instability with a clear need for urgent endoscopy or surgery (systolic blood pressure <100 mmHg,heart rate > 100 / min)~Known current stenosis of the GI tract~Subj... | 18 Years | 80 Years | All | No | Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device feasibility | Ability of PillSense Capsule to detect the presence or absence of blood and send the results to the PillSense receiver | within 30 minutes |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device sensitivity | Subjects with positive findings for blood based on PillSense and EGD | within 2 hours |
| Device Specificity | Subjects with negative findings for blood based on PillSense and EGD | within 2 hours |
| Safety | Number of ... | Gastrointestinal Hemorrhage, Hemorrhage, Pathologic Processes, Gastrointestinal Diseases, Digestive System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PillSense System<br>The device is composed of an orally ingested sensor capsule and a wireless handheld receiver for real-time display of sensor data. The capsule contains a measuring slot for blood entry. The sensor capsule is used for di... | Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -A Pilot Study
Study Overview
=================
Brief Summary
-----------------
This is a multi-center, prospective, non-randomized, open-label, exploratory clinical investigation performed to evaluate safety and effectiveness of t... | |
NCT01240655 | A Study of LCL161 in Combination With Weekly Paclitaxel in Adult Patients With Advanced Solid Tumors | This is a dose escalation study that will assess the safety and efficacy of LCL161 in combination with weekly paclitaxel in adult patients with advanced solid tumors. | A Phase Ib Study of LCL161 in Combination With Weekly Paclitaxel in Adult Patients With Advanced Solid Tumors | Solid Tumors | * Drug: LCL161
* Drug: Paclitaxel
| Inclusion Criteria:~Patients with breast cancer must have a histologically or cytologically confirmed diagnosis of disease that has metastasized or is resistant to therapy.~Patients with ovarian cancer must have histological evidence of recurrent epithelial ovarian, fallopian tube or peritoneal cancer.~Patients must ha... | 18 Years | 100 Years | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose (MTD)/RP2D of LCL161 when administered in combination with once weekly paclitaxel | | 24 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of the combination, including acute and chronic toxicities | | 24 months |
| Pharmacokinetics of both LCL161 and paclitaxel when administered in combination (AUC0-∞, Cmax, tmax and other parameters as appropriate) | ... | LCL161, solid tumors, paclitaxel | Paclitaxel, Antineoplastic Agents, Phytogenic, Antineoplastic Agents, Tubulin Modulators, Antimitotic Agents, Mitosis Modulators, Molecular Mechanisms of Pharmacological Action | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LCL161 + Paclitaxel<br> | Drug: LCL161<br> <br> Drug: Paclitaxel<br> <br> |
| A Study of LCL161 in Combination With Weekly Paclitaxel in Adult Patients With Advanced Solid Tumors
Study Overview
=================
Brief Summary
-----------------
This is a dose escalation study that will assess the safety and efficacy of LCL161 in combination with weekly paclitaxel in adult patients with advanced ... | |
NCT01126177 | Comparing Efficacy and Safety of Inhaled SNG001 to Placebo | When people with asthma get respiratory virus such as a cold or flu it often increases asthma symptoms. The investigators will test the study medication to find out if it can prevent the virus spreading from the nose to the lungs.~SNG001 contains Interferon-beta that occurs naturally in the body. In this study, SNG001 ... | The study will consist of a Pre-Treatment Phase into which subjects potentially eligible for the Treatment Phase will be recruited. Subjects will remain in the Pre-Treatment Phase until they experience respiratory virus symptoms at which time they will be further screened for eligibility for entry into the Treatment Ph... | A Randomised, Double-blind, Placebo-controlled Phase II Study, Comparing the Efficacy and Safety of Inhaled SNG001 to Placebo Administered to Asthmatic Subjects After the Onset of a Respiratory Viral Infection for the Prevention or Attenuation of Asthma Symptoms Caused by Respiratory Viruses | Asthma | * Drug: Interferon beta 1a
* Drug: Placebo
| Male or female aged 18 to 65 years of age at the time of screening.~Symptoms of asthma for at least 2 years pri or to the Screening Visit, confirmed by a medical history and:~≥12% and 200mL bronchodilator reversibility at screening or documented in the past, OR,~evidence of bronchial hyper-responsiveness at screening o... | 18 Years | 65 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| S-ACQ | To evaluate the superiority of inhaled SNG001 compared to placebo administered to asthmatic subjects after the onset of a respiratory viral infection for the prevention or attenuation of asthma symptoms caused by respiratory viruses in... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Index | To evaluate the superiority of inhaled SNG001 compared to placebo administered to asthmatic subjects after the onset of a respiratory viral infection for the prevention or attenuation of asthma symptoms caused by respiratory vir... | asthma | Interferons, Interferon-beta, Interferon beta-1a, Antineoplastic Agents, Antiviral Agents, Anti-Infective Agents, Immunologic Factors, Physiological Effects of Drugs, Adjuvants, Immunologic | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo once daily for 14 days | Drug: Placebo<br>* Placebo (excipients of the SNG001 solution only)<br>|
| Experimental: SNG001<br> | Drug: Interferon beta 1a<br>* SNG001, IFN-β1a solution for inhalation<br>|
| Comparing Efficacy and Safety of Inhaled SNG001 to Placebo
Study Overview
=================
Brief Summary
-----------------
When people with asthma get respiratory virus such as a cold or flu it often increases asthma symptoms. The investigators will test the study medication to find out if it can prevent the virus sp... |
NCT03633045 | Observational Study of Ibrutinib Use in CLL | IB-RU-SCOPE is a routine-clinical practice oriented cohort observational study of ibrutinib efficacy and safety in approx. 70 patients with chronic lymphocytic leukemia in the Russian Federation | Ibrutinib is approved in Russia for treatment of CLL patients both in first line and in relapsed/refractory setting. There is a discrepancy in reported ibrutinib toxicity profile, efficacy and tolerability between registrational clinical trials and observational studies, which to some extent may be explained by patient... | Analysis of Ibrutinib Efficacy and Safety in the Treatment of Chronic Lymphocytic Leukemia Patients in Routine Clinical Practice | Chronic Lymphocytic Leukemia | Inclusion Criteria:~Age older than 18 years.~Diagnosis of chronic lymphocytic leukemia, established according to iwCLL criteria (Hallek et al., 2018).~Presence of indications for initiating treatment as listed in iwCLL guidelines (Hallek et al., 2018) before start of ibrutinib therapy.~Treatment with ibrutinib per inst... | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of adverse events (including serious adverse events) | In order to evaluate ibrutinib toxicity, all adverse events (AEs), which will occur in study patients, will be collected and analyzed. CTCAE v4.03 criteria and iwCLL criteria wil... | CLL, chronic lymphocytic leukemia, ibrutinib | Neoplasms, Lymphoproliferative Disorders, Leukemia, Leukemia, Lymphoid, Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasms by Histologic Type, Lymphatic Diseases, Immunoproliferative Disorders, Immune System Diseases, Leukemia, B-Cell, Chronic Disease, Disease Attributes, Pathologic Processes | Observational Study of Ibrutinib Use in CLL
Study Overview
=================
Brief Summary
-----------------
IB-RU-SCOPE is a routine-clinical practice oriented cohort observational study of ibrutinib efficacy and safety in approx. 70 patients with chronic lymphocytic leukemia in the Russian Federation
Detailed Descr... | ||||
NCT02893228 | Does Saline Injection Around Phrenic Nerve Reduce Incidence of Diaphragmatic Paresis Following Interscalene Block? | Hemi-diaphragmatic palsy is a common undesirable effect of interscalene block, with an incidence of up to 100%. Mechanism of palsy is thought to be related to spread of local anaesthetic anterior to the anterior scalene muscle. We hypothesize that by injecting saline in this anatomical location prior to performing an i... | Patients will be randomised to either group S (saline group) or group C (conventional group) by computer generated random numbers and allocation will be enclosed in sealed envelope. Anaesthetist performing and/or supervising the block will be the only personnel who will be aware of the randomisation. Patients will be b... | Does Saline Injection Around Phrenic Nerve Reduce Incidence of Diaphragmatic Paresis Following Interscalene Block? | Phrenic Nerve Palsy | * Procedure: Saline
* Drug: Levobupivacaine
| Inclusion Criteria:~Patients undergoing surgery on shoulder, humerus, or clavicle~Exclusion Criteria:~Patient refusal~Allergy to local anaesthesia~Severe coagulopathy~Contralateral phrenic nerve palsy~Local infection~Moderate to severe pulmonary dysfunction (GOLD II, II, IV) | 18 Years | 80 Years | All | No | Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of diaphragmatic paresis recorded in the post-operative period identified by ultrasound assessment | Diaphragmatic paresis will be documented with greater than 75% reduction in excursion compared to baseline | 4 hours |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 | Forced expiratory volume in 1 second (FEV1) | 4 hours |
| FVC | Forced vital capacity (FVC) | 4 hours |
| PEFR | Peak expiratory flow rate (PEFR) will be assessed and compared to baseline | 4 hours |
| Pain control | Intra-operative ... | forced expiratory volume in 1 second, forced vital capacity, peak expiratory flow rate, interscalene block, diaphragmatic paresis | Levobupivacaine, Anesthetics, Local, Anesthetics, Central Nervous System Depressants, Physiological Effects of Drugs, Sensory System Agents, Peripheral Nervous System Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group S (saline group)<br>In plane posterior approach will be used with a 50mm short bevel block needle (Braun), advanced through the middle scalene muscle. At the location chosen for interscalene block the needle tip will be positioned an... | Does Saline Injection Around Phrenic Nerve Reduce Incidence of Diaphragmatic Paresis Following Interscalene Block?
Study Overview
=================
Brief Summary
-----------------
Hemi-diaphragmatic palsy is a common undesirable effect of interscalene block, with an incidence of up to 100%. Mechanism of palsy is thoug... |
NCT03714438 | Effect of Medicago Sativa on Oral Glucose Tolerance in Healthy Adults | Previous preclinical investigations have found that Medicago sativa promotes the decrease of glucose concentrations. To evaluate the acute effect of Medicago sativa administration on glucose tolerance, insulin secretion, and insulin sensitivity in healthy individuals. | A randomized, double-blind, placebo-controlled, two-period, cross-over clinical trail will be carrie out in 15 healthy, sedentary individuals of both genders, who meet the following inclusion criteria: 25 to 40 years of age, normal fasting plasma glucose (≤ 5.5 mm/L), blood pressure (<130/90 mmHg), body mass index of 2... | Effect of Acute Administration of Medicago Sativa on Glucose Tolerance, Insulin Secretion and Insulin Sensitivity in Normoglycemic, Overweight Adults | Glucose Tolerance | * Drug: Medicago Sativa
* Dietary Supplement: Placebo
| Inclusion Criteria:~Fasting plasma glucose ≤99 mg/dL.~Two hours postload plasma glucose (100 a 139 mg/dL).~Body mass Index: 25 -39.9 kg/m2.~body weight stable over the last 3 months.~Women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of laboratory tests.~Sedentary.~Nonsmokers.~Body ... | 30 Years | 40 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma glucose (FPG) | Glucose concentration after overnight fasting (10 to 12-h) determined by spectrophotometry methods. Expressed in mmol/L. | After the acute administration of placebo and Medicago sativa. 15 days wash period betwee... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight | Measured with minimal clothing and bare feet | At baseline of the study |
| Body Mass Index (BMI) | Calculated with the Quetelet index | At baseline of the study |
| Waist circumference (WC) | Measured with a flexible tape in t... | Medicago sativa, Insulin secretion, Insulin Sensitivity | Insulin Resistance, Hyperinsulinism, Glucose Metabolism Disorders, Metabolic Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medicago sativa<br>1,500 mg unique dose, 30 min before the oral glucose tolerance test. | Drug: Medicago Sativa<br>* Single oral doses of Medicago sativa (1,500 mg), 30 min before before the oral glucose tolerance test.<br>* Other names: L... | Effect of Medicago Sativa on Oral Glucose Tolerance in Healthy Adults
Study Overview
=================
Brief Summary
-----------------
Previous preclinical investigations have found that Medicago sativa promotes the decrease of glucose concentrations. To evaluate the acute effect of Medicago sativa administration on g... |
NCT00965445 | The Comparison of Oxidative Stress Between Inhalation Anesthetics | Oxidative stress is an unavoidable event during cardiac surgery. Isoprostanes have been demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo.The aims of this study are(1)to develop an accurate liquid chromatography-tandem mass spectrometry methods for the detection of urinary isoprosta... | Enhanced production of oxygen free radicals can lead to the generation of oxidative stress, which is harmful to human tissue and organs. Reactive oxygen species are released abruptly during some surgical procedures, and they are the major causes of ischemia-reperfusion injuries.Isoprostanes have been demonstrated to be... | The Comparison of Oxidative Stress Between Inhalation Anesthetics | Oxidative Stress, Cardiac Surgery | Inclusion Criteria:~patients receiving cardiac valve surgery in ASA II-III physical status~Exclusion Criteria:~trauma, infection, low ejection fraction (less than 25%), liver cirrhosis, or acute renal failure, and emergency surgery | 25 Years | 80 Years | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| isoprostanes isomer as marker of oxidative stress | | one day |
| isoprostanes, mass spectrometry | Respiratory Aspiration, Respiration Disorders, Respiratory Tract Diseases, Pathologic Processes | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cardiac surgery with CPB<br> | |
| The Comparison of Oxidative Stress Between Inhalation Anesthetics
Study Overview
=================
Brief Summary
-----------------
Oxidative stress is an unavoidable event during cardiac surgery. Isoprostanes have been demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo.The aims of t... | |||
NCT04027075 | Mindfulness Mobile App to Reduce Adolescent Substance Use | Substance-abusing youth - especially those who are involved in the juvenile justice system - are at higher risk than nonusers for mental health problems, including depression, conduct problems, personality disorders, suicidal thoughts, attempted suicide, and completed suicide. The proposed Phase II project aims to deve... | There is growing evidence that interventions based on mindfulness have been an efficacious intervention for a variety of problems, including substance use among adolescents. We propose to adapt and test the feasibility and efficacy of a smart phone application (app) intervention prototype that would help adolescent sub... | Mindfulness Mobile App to Reduce Adolescent Substance Use | Adolescent Drinking, Adolescent Problem Behavior | * Behavioral: Rewire app users
| Inclusion Criteria:~any gender, age 13-18~recent involvement with juvenile justice system~documented substance use~English speaking~living in the community (e.g., with biological/adoptive/foster parents)~Exclusion Criteria:~non-English speaking | 13 Years | 18 Years | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study will recruit 400 adolescents to test an app designed to increase mindfulness skills and reduce substance use. Participants will be randomly assigned in equal numbers to the intervention... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Adolescent Use of Cigarettes and E-Cigarettes | Decrease in nicotine use (i.e., frequency of use and amount consumed) as measured by Youth Substance Use Interview | Baseline, 1 month (treatment completion), 3 months |
| Change in Ad... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate efficacy and feasibility of Rewire app in Substance Use Cessation among High-Risk Adolescents | Usability and satisfaction data will be assessed using participant ratings of ease of use, perceived benefits, and likeability. System log... | Adolescent, Alcohol, Marijuana, Mindfulness | Substance-Related Disorders, Problem Behavior, Underage Drinking, Chemically-Induced Disorders, Mental Disorders, Behavioral Symptoms, Alcohol Drinking, Drinking Behavior | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>This group will be asked to use the Rewire app daily in the month following the baseline assessment. This group will also receive services as usual from the Department of Youth Services. | Behavioral: Rewire app users<br>* ... | Mindfulness Mobile App to Reduce Adolescent Substance Use
Study Overview
=================
Brief Summary
-----------------
Substance-abusing youth - especially those who are involved in the juvenile justice system - are at higher risk than nonusers for mental health problems, including depression, conduct problems, pe... |
NCT01112072 | Corneal Collagen Crosslinking and Intacs for Keratoconus and Ectasia | This study will determine the efficacy of corneal collagen crosslinking (CXL) combined with Intacs for the treatment of keratoconus and corneal ectasia. The goal of CXL is to decrease the progression of keratoconus, while Intacs has been shown to decrease corneal steepness in keratoconus. This study will attempt to det... | The purpose of this is to ascertain the possible additive effect of the two treatments to both improve the quality of the corneal optics (i.e. improve corneal topography regularity) and to stabilize the cornea. Previous investigations have shown that Intacs surgery, indeed, does improve corneal topography and improve c... | Randomized Study of Safety and Effectiveness of Corneal Collagen Crosslinking and Intacs for Treatment of Keratoconus and Corneal Ectasia | Keratoconus, Corneal Ectasia | * Drug: Riboflavin
| Inclusion Criteria:~21 years of age or older~Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery (e.g., LASIK, photorefractive keratectomy [PRK], or epi-LASIK)~Subjects who meet the manufacturer's nomogram recommendations for Intacs segments~Topography consistent with keratoconus or po... | 21 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum keratometry | | 1 year |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity | | 1 year |
| keratoconus, corneal ectasia, collagen crosslinking, riboflavin, cornea, ultraviolet | Riboflavin, Vitamin B Complex, Vitamins, Micronutrients, Physiological Effects of Drugs, Photosensitizing Agents, Dermatologic Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intacs combined with CXL<br>Intacs placement followed by collagen crosslinking with UV light and riboflavin | Drug: Riboflavin<br>* Corneal epithelium removed followed by riboflavin drop administration every 2 minutes for 30 minutes f... | Corneal Collagen Crosslinking and Intacs for Keratoconus and Ectasia
Study Overview
=================
Brief Summary
-----------------
This study will determine the efficacy of corneal collagen crosslinking (CXL) combined with Intacs for the treatment of keratoconus and corneal ectasia. The goal of CXL is to decrease t... |
NCT03557970 | JNJ-40346527 in Treating Participants With Relapsed or Refractory Acute Myeloid Leukemia | This phase II trial studies how well edicotinib (JNJ-40346527) works in treating participants with acute myeloid leukemia that has come back or does not respond to treatment. JNJ-40346527 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. | PRIMARY OBJECTIVE:~Evaluate preliminary efficacy of JNJ-40346527 in participants with relapsed/refractory AML.~I. Best objective response rate (> PR).~SECONDARY OBJECTIVES:~Assess safety and survival associated with JNJ-40346527 to treat participants with relapsed/refractory AML. Assess the duration of disease response... | A Phase 2 Open-Label Study of the CSF-1R Inhibitor JNJ-40346527 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) | Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia | * Drug: Edicotinib
* Other: Pharmacokinetic Study
| Inclusion Criteria:~1. Ability to understand and the willingness to sign a written informed consent document.~2. Age >= 18 years at time of informed consent. Both men and women and members of all races and ethnic groups will be included.~3. Morphologically documented relapsed/refractory AML as defined by World Health O... | 18 Years | null | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Objective Response Rate | An objective response is defined as achievement of a PR or any type of CR (CR, CRm, CRc, CRi) during a participant's first 2 cycles of study drug. Each participant's best disease response designation (amended fro... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-related and Non-treatment Related Adverse Events Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | The overall incidence of treatment-related and non-treatment-relat... | Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Neoplasms by Histologic Type, Neoplasms | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (JNJ-40346527)<br>Participants receive JNJ-40346527 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. | Drug: Edicotinib<br>* Given PO<br>* Other names: JNJ-40346527;... | JNJ-40346527 in Treating Participants With Relapsed or Refractory Acute Myeloid Leukemia
Study Overview
=================
Brief Summary
-----------------
This phase II trial studies how well edicotinib (JNJ-40346527) works in treating participants with acute myeloid leukemia that has come back or does not respond to t... | |
NCT01926834 | The Effect of Erigeron Injection on Acute Cerebral Infarction Serum VEGF, MMP-9 and EPC Levels | To study the effects of Erigeron Injection on human serum VEGF, MMP-9 and EPC levels after acute cerebral infarction,test is made by random double-blind controlled.patients with acute cerebral infarction were divided randomly into erigeron injection+aspirin group,aspirin group,and health people. The main indexes are th... | OBJECTIVE:~To study the effects of Erigeron Injection on human serum VEGF, MMP-9 and EPC levels after acute cerebral infarction.~METHOD:~40 patients with acute cerebral infarction(in accordance with the inclusion criteria) were divided randomly into erigeron injection+aspirin group,aspirin group,and 20 health people. E... | The Effect of Erigeron Injection on Acute Cerebral Infarction Serum VEGF, MMP-9 and EPC Levels | Cerebral Infarction | * Drug: Erigeron Injection
* Drug: placebo
| Inclusion Criteria:~patients aged no younger than 18yrs~attack within 72 hours~NIHSS score in the 2-25 points~Ischemic Stroke occurred for the first time, or with a history of stroke disease but without sequelae~Signed the informed consents~Exclusion Criteria:~patients aged younger than 18yrs~Patients with tumor, coron... | 18 Years | null | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the serum level of VEGF,MMP-9 and EPC | | 0-7days |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institute of Health of stroke scale | | 0-7days |
| promoting angiogenesis in multiple targets, herbal medicine, traditional chinese medicine, random clinical trial | Stroke, Cerebral Infarction, Infarction, Ischemia, Pathologic Processes, Necrosis, Brain Infarction, Brain Ischemia, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erigeron Injection<br>Erigeron Injection, 30ml,qd,i.v., for 7 days | Drug: Erigeron Injection<br>* Erigeron Injection, 30ml, iv, qd, for 7days<br>|
| Placebo Comparator: placebo<br>normal saline, 500ml,i.v.,qd, for 7 days | Drug: placebo<b... | The Effect of Erigeron Injection on Acute Cerebral Infarction Serum VEGF, MMP-9 and EPC Levels
Study Overview
=================
Brief Summary
-----------------
To study the effects of Erigeron Injection on human serum VEGF, MMP-9 and EPC levels after acute cerebral infarction,test is made by random double-blind contro... |
NCT05437549 | Evaluating PVI Using CMR | Using state of the art cardiac magnetic resonance imaging techniques, characterization of ablation lesions in the early phase after pulmonary vein isolation ablation in atrial fibrillation patients, and relate findings to the ablation scar at 3 months follow up and atrial fibrillation-free survival at 1 year. | CMR Characterization of Ablation Lesions Following Pulmonary Vein Isolation | Atrial Fibrillation | * Procedure: MRI
| Inclusion Criteria:~Adult patients (age ≥18 years old)~Paroxysmal or persistent AF meeting guideline criteria.~Anticipated PVI using index-guided radiofrequency ablation techniques.~Availability of LGE-CMR images within 3 months before anticipated PVI.~Exclusion Criteria:~History of catheter ablation~History of cardiac... | 18 Years | null | All | No | Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ablaton scar | The correlation between ablation lesion characteristics in the early phase after PVI and ablation scar at 3 months follow up. | 3 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF recurrence | The relation between ablation lesion characteristics and AF recurrence at 1 year after the ablation procedure | 1 year |
| Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Pathologic Processes | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PVI<br> | Procedure: MRI<br>* MRI prior to PVI, acutely after PVI, and 3 months after PVI<br>|
| Evaluating PVI Using CMR
Study Overview
=================
Brief Summary
-----------------
Using state of the art cardiac magnetic resonance imaging techniques, characterization of ablation lesions in the early phase after pulmonary vein isolation ablation in atrial fibrillation patients, and relate findings to the abl... | ||
NCT01362790 | SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma | Background:~Malignant mesothelioma is a form of cancer that develops on the protective lining that covers the body's internal organs. It most often occurs on the lining of the lungs and chest wall or the lining of the abdomen. There is no known cure for malignant mesothelioma, so researchers are searching for new ways ... | BACKGROUND:~Mesothelin is a cell surface glycoprotein present on normal mesothelial cells that is highly expressed in many human cancers including mesothelioma, lung and pancreatic adenocarcinoma. SS1 (dsFv) PE38 is a recombinant anti-mesothelin immunotoxin that has undergone phase I testing and has been evaluated in c... | A Pilot/ Phase 2 Study of Pentostatin Plus Cyclophosphamide Immune Depletion to Decrease Immunogenicity of SS1P in Patients With Mesothelioma, Lung Cancer or Pancreatic Cancer | Mesothelioma, Adenocarcinoma of Lung, Pancreatic Neoplasms | * Drug: Pentostatin
* Drug: Cyclophosphamide
* Biological: SS1(dsFv)PE38 - lot 073I0809
* Biological: SS1(dsFv)PE38 - lot FIL129J01
| INCLUSION CRITERIA: Mesothelioma Cohorts (Cohorts 1 and 2 Only)~Subjects must have histologically confirmed epithelial or biphasic mesothelioma not amenable to potentially curative surgical resection. However, patients with biphasic tumors that have a less than or equal to 50% sarcomatoid component will be excluded. Th... | 18 Years | 99 Years | All | No | Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Assessment | Response was assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is complete disappearance of ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | The Kaplan-Meier was used to determine the probability of overall survival from on-study date until death or last follow-up (calculated from the date of study entry until the date of analysis). | 36 months |
| Progression-f... | Immune Therapy, Immunotoxin, T-Cell Depletion, Mesothelioma | Cyclophosphamide, Pentostatin, Antibodies, Monoclonal, Immunosuppressive Agents, Immunologic Factors, Physiological Effects of Drugs, Antirheumatic Agents, Antineoplastic Agents, Alkylating, Alkylating Agents, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Myeloablative Agonists, Adenosine Deami... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesothelioma Pilot Phase Regimen A<br>Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle~Other Names:~• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/da... | SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma
Study Overview
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Brief Summary
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Background: Malignant mesothelioma is a form of cancer that develops on the protective lining that covers the body's internal organs. It most often occurs on the lining of the lungs and chest wa... |
NCT04370574 | Discovery of Soluble Biomarkers for Pancreatic Cancer Using Innovative All-Patient Inclusive Methodology | Pancreatic ductal adenocarcinoma (PDAC) remains among cancers with a very poor prognosis (1-year survival <20%). Endoscopic ultrasound with fine needle aspiration (EUS/FNA) is the common examination for all patients with suspicious pancreatic mass. A method was recently developed : it preserves the sanitary sample, nam... | Clinical and pathological data will be prospectively collected to obtain 2 subgroups: PDAC and non-PDAC according to the final biopsy diagnosis. A combined quantitative analysis of the proteins and their peptides contained in CytoLyt® will be performed. ROC curves, AUC, sensitivity, specificity, positive predictive val... | Discovery of Soluble Biomarkers for Pancreatic Cancer Using Innovative All-Patient Inclusive Methodology (PanEXPEL2) | Pancreatic Neoplasms | * Diagnostic Test: Soluble Biomarkers dosage
| Inclusion Criteria:~Patient with pancreatic mass and suspicion of pancreatic ductal adenocarcinoma requiring endoscopic ultrasound with fine needle biopsy~Exclusion Criteria:~Vulberable person according to L1121-6 of Public health reglementation in France~Pregnant women | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of each protein contained in Cytolyt® for the positive diagnosis of pancreatic ductal adenocarcinoma | Predictive value of each protein contained in Cytolyt® for the positive diagnosis of pancreatic ductal adenocarcinoma Corre... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | Disease-free survival (percentage of patients without recurrence) .Biomarkers that are prognostically significant on disease free or overall survival in patients with pancreatic cancer, identified using the survival ana... | Biopsy, Fine-Needle, diagnostic imaging, Endosonography | Pancreatic Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Endocrine Gland Neoplasms, Digestive System Diseases, Pancreatic Diseases, Endocrine System Diseases | | Intervention/Treatment |
| --- |
|Diagnostic Test: Soluble Biomarkers dosage|CytoLyt® fluid will be first processed for routine PDAC diagnosis. In essence, the samples are filtered, tissue fragments and cells are kept for analysis while flow-through is kept until the diagnosis is confirmed. Once this is completed, th... | Discovery of Soluble Biomarkers for Pancreatic Cancer Using Innovative All-Patient Inclusive Methodology
Study Overview
=================
Brief Summary
-----------------
Pancreatic ductal adenocarcinoma (PDAC) remains among cancers with a very poor prognosis (1-year survival <20%). Endoscopic ultrasound with fine need... | |
NCT02044315 | Prevention of Inappropriate ICD Shocks | The aim of the present study is to investigate whether increasing detection zones can effectively reduce inappropriate ICD therapies in primary prevention patients. | null | Inappropriate ICD Therapy, Appropriate ICD Therapy | * Device: ICD programming
| Inclusion Criteria:~> 18 years~Cardiomyopathy (ischemic or not)~Current accepted indication for ICD implantation~Exclusion Criteria:~Previous device implantation~Secondary prevention patients~Pregnancy,~Primary electrical disorders,~Patient refusal,~<1 year of expected mortality | 18 Years | null | All | No | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First total inappropriate therapy | Occurence of first total inappropriate therapy at 12-month follow-up | 12 months |
| Occurence of first total appropriate therapy at 12-month follow-up | Occurence of first total appropriate therapy at 12-m... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Occurence of all-cause mortality at 12-month follow-up | 12 months |
| Hospitalization for heart failure | Occurence of hospitalization for heart failure at 12-month follow-up | 12 months |
| | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Conventional<br>Conventional ICD programming | Device: ICD programming<br> <br> |
| Experimental: High-zone<br>High-zone ICD programming | Device: ICD programming<br> <br> |
| Prevention of Inappropriate ICD Shocks
Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to investigate whether increasing detection zones can effectively reduce inappropriate ICD therapies in primary prevention patients.
Conditions
-----------------
Inappropriate ICD Th... | |||
NCT03170141 | Immunogene-modified T (IgT) Cells Against Glioblastoma Multiforme | This study aims to treat patients who have been diagnosed with brain cancer including glioblastoma multiforme (GBM). The treatment combines two different approaches to fight cancer: immune modulators and antigen-specific T cells. Immune checkpoint antibodies have been tested on various tumors with good outcomes. GBM is... | Background:~Glioblastoma multiforme (GBM) is the most dangerous and aggressive form of brain cancer. Chimeric antigen receptor (CAR)-modified T cells have been shown to mediate long-term durable remissions in recurrent or refractory CD19+ B cell malignancies, and thus the CAR-T therapy approach is considered a promisin... | Immunogene-modified Antigen-specific T (IgT) Cells for the Treatment of Glioblastoma Multiforme | Glioblastoma Multiforme of Brain, Glioblastoma Multiforme | * Biological: Antigen-specific IgT cells
| Inclusion Criteria:~abilities to understand and the willingness to provide written informed consent;~patients are ≥ 1 and ≤ 80 years old;~recurrent glioblastoma or brain tumor patients with measurable tumors. Patients have received standard care of medication, such as gross total resection with concurrent radio-chemoth... | 1 Year | 80 Years | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients with GBM will be treated with tumor targeting IgT cells expressing immune modulatory genes
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of infusion of autologous IgT cells with cyclophosphamide and fludarabine as lymphodepleting chemotherapy in patients with recurrent glioblastoma using the NCI CTCAE V4.0 criteria. | incidents of treatment related adverse events as asse... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response rate of recurrent glioblastoma | Defined as the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD). | 6 months |
| Overall survival Rate | P... | CAR T, Gene Therapy, GBM, PD-L1, PD1 | Glioblastoma, Astrocytoma, Glioma, Neoplasms, Neuroepithelial, Neuroectodermal Tumors, Neoplasms, Germ Cell and Embryonal, Neoplasms by Histologic Type, Neoplasms, Neoplasms, Glandular and Epithelial, Neoplasms, Nerve Tissue | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antigen-specific IgT cells<br>Patients will receive non-myeloablative chemotherapy consisting of fludarabine and/or cyclophosphamide, followed by intravenous infusion of autologous IgT cells. A standard 3+3 escalation approach will be used... | Immunogene-modified T (IgT) Cells Against Glioblastoma Multiforme
Study Overview
=================
Brief Summary
-----------------
This study aims to treat patients who have been diagnosed with brain cancer including glioblastoma multiforme (GBM). The treatment combines two different approaches to fight cancer: immune... |
NCT00686010 | Efficacy and Safety of JTT-705 300, 600 And 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia | To demonstrate the effect of JTT-705 doses from 300 mg to 900 mg on the elevation of HDL-C and on the inhibition of CETP activity versus placebo, in patients presenting with mild dyslipidaemia. These objectives will be tested after 4 weeks of treatment. | A 4-Weeks Treatment, Randomised, Double-Blind, Parallel-Group Study Evaluating The Efficacy and Safety of JTT-705 300 to 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia | Type II Hyperlipidaemia | * Drug: Placebo
* Drug: JTT-705 300mg
* Drug: JTT-705 600mg
* Drug: JTT-705 900mg
| Inclusion Criteria:~Patients with of Type II hyperlipidaemia~Patients having lipid values as indicated below:~HDL-C < 1.6 mmol/l~TG < 4.5 mmol/l~Male and females between 18 and 65 years old (If female must be post-menopausal, or pre-menopausal and surgically sterile or using an acceptable form of contraception)~Exclusi... | 22 Years | 65 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %change from baseline in HDL-C, Inhibition of CETP activity | | 4-weeks |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %change from baseline in LDL-C and TC/HDL ratio | | 4-weeks |
| CETP Inhibitor, HDL-C, LDL-C, Apolipoprotein | Dalcetrapib, Anticholesteremic Agents, Hypolipidemic Agents, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Lipid Regulating Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: Placebo<br>* Placebo tablet, 3 tablets, oral, once daily after breakfast<br>|
| Experimental: 2<br>JTT-705 300mg | Drug: JTT-705 300mg<br>* JTT-705 tablet, 1 tablet, oral, once daily, after breakfast. Placebo tab... | Efficacy and Safety of JTT-705 300, 600 And 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia
Study Overview
=================
Brief Summary
-----------------
To demonstrate the effect of JTT-705 doses from 300 mg to 900 mg on the elevation of HDL-C and on the inhibition of CETP activity versus... | |
NCT02318628 | Advanced Approach to Arterial Stiffness | The aim of the 3A Study is to assess the role of MetS on the arterial mechanics and vascular health in different age groups using the Cardio Ankle Vascular Index (CAVI) of the Vasera system and the classic carotid-femoral Pulse Wave Velocity (PWV). | Hypothesis The aim of thie 3A study is to assess the role of MetS on the arterial mechanics and vascular health in different age groups using the Cardio Ankle Vascular Index (CAVI) of the Vasera system and the classic carotid-femoral Pulse Wave Velocity (PWV).~STUDY OBJECTIVES~Objectives Primary Objective: Assess the i... | Advanced Approach to Arterial Stiffness (AAA Study - Triple A Study) | Arterial Stiffness | * Device: Cardio Ankle Vascular Index (CAVI) of the Vasera system VS1500N
| Inclusion Criteria:~All patients aged 40-85 with life expectancy over 2 years will be included. Patients will be stratified according to their age (3 groups: 40-54, 55-69, 70-85 years)) and the presence or not of MetS.~Exclusion Criteria:~Factors that may impair the quality of the CAVI and /or the PWV measurement or ma... | 40 Years | 85 Years | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardio-Ankle-Vascular Index | CAVI will be measured using the Vasera device (Fukuda Denshi co, Japan). This device is easy to use and calculates automatically the CAVI.~CAVI measurements will be performed according to the manufacturer recommen... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse Wave Velocity | Measurement of PWV will be performed using a validated automatic device (Complior®, Sphygmocor®, and PulsePen®). The method of simultaneous recordings of the pulse waves from 2 different sites (carotid and femoral arterie... | PWV, Cardio ankle vascular index, CAVI, pulse wave velocity, Non invasive arterial structure assessment | | Intervention/Treatment |
| --- |
|Device: Cardio Ankle Vascular Index (CAVI) of the Vasera system VS1500N|CAVI will be measured using the Vasera device (VS1500 n - Fukuda Denshi co, Japan). This device is easy to use and calculates automatically the CAVI.~CAVI measurements will be performed according to the manufactu... | Advanced Approach to Arterial Stiffness
Study Overview
=================
Brief Summary
-----------------
The aim of the 3A Study is to assess the role of MetS on the arterial mechanics and vascular health in different age groups using the Cardio Ankle Vascular Index (CAVI) of the Vasera system and the classic carotid-... | ||
NCT02814786 | Dynamic Evaluation of Ankle Joint and Muscle Mechanics in Children With Spastic Equinus Deformity Due to Cerebral Palsy | This research will lead to the first evaluation of intrinsic and dynamic joint and muscle mechanics of equinus in cerebral palsy. It would provide a direct cause and effect relationship between equinus and bone deformity. Mechanical insights to the pathophysiology of the targeted muscles will lead to better understandi... | Equinus is the most common deformity in children with cerebral palsy. Spastic equinus is typically defined as the inability to dorsa-flex the foot above plantigrade, with the hindfoot in neutral position and the knee in extended position. Approximately 90% of the deformities in cerebral palsy occur in the ankle and foo... | In Vivo Dynamic Evaluation of Ankle Joint and Muscle Mechanics in Children With Spastic Equinus Deformity Due to Cerebral Palsy: Implications for Recurrent Equinus. | Equinus Deformity | * Radiation: MRI scanner
* Other: Gait analysis
| Equinus cohort inclusion criteria:~children between 7 and 14 years old~with unilateral CP and GMFCS score of I or II~with the presence of fixed equinus defined as a fixed limitation of dorsiflexion inferior to 0°~Control cohort inclusion criteria:~age and gender matched to equinus cohort~no history of lower limb muscul... | 7 Years | 14 Years | All | Accepts Healthy Volunteers | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Talocrural joint flexion, pronation, and internal rotations | Talocrural (talus relative to tibia) joint rotations and translations will be compared between two cohorts. | One year |
| Subtalar joint flexion, pronation, and internal rotations... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle joint kinematics (joint angles) during walking | Walking gait parameters (ankle, knee, and hip joint angles) will be correlated with primary outcome measures | one year |
| Knee joint kinematics (joint angles) during walking | Walking g... | Equinus Deformity, Talipes, Clubfoot, Cerebral Palsy, Congenital Abnormalities, Brain Damage, Chronic, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Musculoskeletal Diseases, Foot Deformities, Acquired, Foot Deformities, Foot Deformities, Congenital, Lower Extremity Deformities, Congenital, ... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Equinus cohort<br>15 childrens who have a fixed equinus defined as a fixed limitation of dorsiflexion inferior to 0°.~Interventions: MRI scanner and gait analysis | Radiation: MRI scanner<br>* This examination is divided in 2 parts:~Passiv... | Dynamic Evaluation of Ankle Joint and Muscle Mechanics in Children With Spastic Equinus Deformity Due to Cerebral Palsy
Study Overview
=================
Brief Summary
-----------------
This research will lead to the first evaluation of intrinsic and dynamic joint and muscle mechanics of equinus in cerebral palsy. It w... | |
NCT04897295 | Neurobiological Effects of Transcranial Direct Current Stimulation Treatment in Alcohol Use Disorder | Background: Alcohol Use Disorder (AUD) is a complex psychiatric disorder, involving several brain areas and neurocircuits. Transcranial Direct Current Stimulation (tDCS) allows to stimulate superficial areas of brain using a weak electrical current. Preliminary data suggest that tDCS may reduce alcohol craving and cons... | Transcranial Direct Current Stimulation (tDCS) consists in the application on the scalp of electrodes (anode and cathode) delivering a direct current of low intensity that cannot be perceived by the stimulated subject. In recent years, tDCS stimulation has been increasingly used in psychiatric clinical research and in ... | Neurobiological Effects of Transcranial Direct Current Stimulation Treatment in Alcohol Use Disorder: a Sham-controlled Trial. | Alcohol Use Disorder (AUD), Alcohol Abuse, Alcohol Dependence, Alcohol-Related Disorders, Drug Abuse, Substance Use Disorders, Mental Disorder | * Device: Active transcranial Direct Current Stimulation
* Device: Sham transcranial Direct Current Stimulation
| Inclusion Criteria:~diagnosis of Alcohol Use Disorder (at least 12 months);~drug free/stable psychopharmacological therapy (one month), with the exception of guidelines treatments for alcoholic abstinence (treatment-as-usual);~any assumption of substances for at least 48 hours.~Exclusion Criteria:~presence of organic p... | 18 Years | 65 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blind, randomized, sham-controlled with a 1:1 allocation into 2 parallel arms
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BDNF level | BDNF levels will be evaluated by collecting a venous blood sample. BDNF is a member of the nerve growth factor (NGF) family of neurotrophic growth factors. Low levels of peripheral BDNF and NGF have been reported in mood... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Montgomery-Asberg Depression Scale (MADRS) Total Score | The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ... | Alcohol Use Disorder, transcranial Direct Current Stimulation, Non-Invasive Brain Stimulation, Craving, Brain Derived Neurotrophic Factor, Pro-Brain Derived Neurotrophic Factor | Chemically-Induced Disorders, Substance-Related Disorders, Alcoholism, Alcohol-Related Disorders, Alcohol Drinking, Mental Disorders, Drinking Behavior | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active tDCS<br>The intervention will be the stimulation with transcranial Direct Current Stimulation (tDCS). Each patient will undergo a 20 minutes session with anode placed on the right Dorso-Lateral Prefrontal Cortex (RDLPFC) and th... | Neurobiological Effects of Transcranial Direct Current Stimulation Treatment in Alcohol Use Disorder
Study Overview
=================
Brief Summary
-----------------
Background: Alcohol Use Disorder (AUD) is a complex psychiatric disorder, involving several brain areas and neurocircuits. Transcranial Direct Current St... |
NCT01798459 | The Effect of Methylphenidate Versus Placebo on State Anxiety in Children With Attention Deficit Hyperactivity Disorder. | The purpose of the study is to explore the effect of methylphenidate on state anxiety in children with attention deficit hyperactivity disorder.~Patient population: 30 children diagnosed with attention deficit hyperactivity disorder. The subjects will be of all racial, ethnical and gender categories, ranging from 8 to ... | A Double Blind Randomized Crossover Study of the Effect of Methylphenidate Versus Placebo on State Anxiety in Children With Attention Deficit Hyperactivity Disorder. | Attention Deficit Hyperactivity Disorder | * Drug: Methylphenidate
| Inclusion Criteria:~Attention deficit and hyperactivity disorder~Children aged 8-18 years~Exclusion Criteria:~Pervasive developmental disorder~Schizophrenia~Bipolar disorder~Current depressive episode~Current Anxiety disorder~Drug use during the past 6 months | 8 Years | 18 Years | All | Accepts Healthy Volunteers | Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State anxiety | State anxiety will be measured by the Spielberger's state anxiety inventory | 1 year |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function | Cognitive function will be measured by the cambridge neuropsychological test automated battery | 1 year |
| Patient's perspective | Patient's perspective will be measured by questionnaires assessing treatment adherence is... | Attention Deficit Hyperactivity Disorder, Methylphenidate, Placebo, State anxiety | Dopamine Agents, Methylphenidate, Central Nervous System Stimulants, Physiological Effects of Drugs, Dopamine Uptake Inhibitors, Neurotransmitter Uptake Inhibitors, Membrane Transport Modulators, Molecular Mechanisms of Pharmacological Action, Neurotransmitter Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methylphenidate<br>Methylphenidate 0.3 mg/kg per os is given before performing a continuous performance test. | Drug: Methylphenidate<br> <br> |
| Placebo Comparator: Placebo<br>Placebo is given before performing a continuous performa... | The Effect of Methylphenidate Versus Placebo on State Anxiety in Children With Attention Deficit Hyperactivity Disorder.
Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to explore the effect of methylphenidate on state anxiety in children with attention deficit hyperactivit... | |
NCT04263805 | A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Research Climate on Research Practices of Doctoral Students | This study aims to evaluate the impact of research climate on PhD students' research practice (i.e., an environment where their peer (i.e., a post-doc researcher) had detrimental practice in a similar situation) | PhD students are the next generation of researchers and will present the field in the future. However, several environmental factors might influence their research practice. In this study, the investigators will evaluate the impact of research climate on PhD students' research practice (exposure to an environment where... | A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Research Climate on Research Practices of Doctoral Students Facing Dilemma Situations | The Study Focus on no Specific Condition | * Other: Vignette with emphasis on research climate
| Inclusion Criteria:~PhD students in biomedical disciplines~Exclusion Criteria:~NA | 18 Years | null | All | Accepts Healthy Volunteers | Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean preference score | In each vignette, participants will have to indicate which solution they prefer on a semantic differential scale, rated from - 5 to -1 (preference for solution A) and from 1 to 5 (preference for solution B). | Immediate... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of students who chose the detrimental research practice (DRP) | Proportion of students rated from -5 to -1 for the DRP. | Immediate assessment |
| | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vignette with research climate<br>Participants in this arm will receive vignettes describing a dilemma situation in research (e.g adding honorary author) with additional sentence describing research climate (i.e. an environment where their... | A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Research Climate on Research Practices of Doctoral Students
Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the impact of research climate on PhD students' research practice (i.e., an environment where t... | ||
NCT04226521 | Extracorporeal Photopheresis and Early Cardiac Graft Vasculopathy | Heart transplantation is a golden standard for the treatment of terminal heart failure. The major cause of death in late posttransplant period is cardiac allograft vasculopathy (CAV). This posttransplant complication develops slowly over several years, and when diagnosed either by conventional coronary angiography or d... | Introduction~Heart transplant is golden standard in the treatment of terminal heart failure. Although patients' survival improved due to new advanced surgical techniques and the use of modern immunosuppressants, the posttransplant period of these patients is still fraught with complications and associated with reduced ... | Extracorporeal Photopheresis for the Prevention of Early Cardiac Allograft Vasculopathy Detected by Optical Coherence Tomography | Cardiac Allograft Vasculopathy, Heart Transplant Rejection | * Procedure: Extracoropreal photopheresis
| Inclusion Criteria:~age >18 and <65~primary orthotopic heart transplant~early photopheresis~adequate intravenous approach~signed informed consent~Exclusion Criteria:~aphakia~psoralen hypersensitivity~active retinal disease - photosensitive diseases~splenectomy~L <2000; Hb <70 g/L~coagulopathy | 18 Years | 65 Years | All | No | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are randomized after heart transplant into two groups. Those randomized for extracorporeal photopheresis undergo 10 procedures during first year, in addition to standard follow-up. Patie... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of cardiac allograft vasculopathy detected by optical coherence tomography | It will be measured as the mean change in maximal intimal thickness (mm) between matched slices and the mean change in intimal volume (mm3) between matched... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with angiographically detected coronary artery disease | Angiographically detected CAV is defined as any new luminal irregularity or new stenosis ≥50% on control coronary angiography at 12 months interval.~We will compare th... | Heart transplant, vasculopathy, extracorporeal photopheresis, prevention, optical coherence tomography | Vascular Diseases, Cardiovascular Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photopheresis<br>Patients who sign informed consent form undergo prophylactic extracorporeal photopheresis after heart transplant according to predetermined protocol | Procedure: Extracoropreal photopheresis<br>* Patients who sign informed... | Extracorporeal Photopheresis and Early Cardiac Graft Vasculopathy
Study Overview
=================
Brief Summary
-----------------
Heart transplantation is a golden standard for the treatment of terminal heart failure. The major cause of death in late posttransplant period is cardiac allograft vasculopathy (CAV). This... |
NCT02797288 | Immune Response to C.Difficile Infection | The protocol aims to address the basic mechanisms of Clostridium difficile pathogenesis by identifying how a Th 17 response impacts severity of C. difficile infection and how Type II immunity protects the gut from Clostridium difficile toxin-induced damage. This could lead to new and effective approaches to the treatme... | The study includes one cohort of hospitalized patients with acute CDI who may require diagnostic colonoscopy, a second cohort of outpatients with recurrent CDI scheduled for FMT and a third cohort of inpatients with past history of CDI without recurrence.~Blood samples and discarded stool samples for research will be o... | Clostridioides Difficile and Immune Responses in Acute CDI and Fecal Microbiota Transplant | Clostridium Difficile | Inclusion Criteria:~-Acute CDI cohort~Acute CDI diagnosis including PCR positive fecal samples~Optional diagnostic colonoscopy for clinical care~FMT cohort~At least one relapse or recurrence of C. difficile infection~Eligible for fecal microbiota transplant (FMT)~Past CDI cohort~Past CDI diagnosis and current PCR negat... | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adaptive immune response | Assessment of adaptive immunity including Th1, Th2 and TH17 immune response | 0-60 days post enrollment |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in gut health | Association of biomarkers in stool and biopsy specimens with CDI outcome | 0-60 days post enrollment |
| Gene expression of immune cells in colon | Profiling colonic gene expression and mucosal immune pathways in CDI |... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute CDI cohort<br>Hospitalized patients diagnosed with Acute CDI | |
| FMT cohort<br>Patients undergoing FMT for recurrent CDI | |
| Past CDI Control Cohort<br>Hospitalized patients with past CDI diagnosis without recurrence | |
| Immune Response to C.Difficile Infection
Study Overview
=================
Brief Summary
-----------------
The protocol aims to address the basic mechanisms of Clostridium difficile pathogenesis by identifying how a Th 17 response impacts severity of C. difficile infection and how Type II immunity protects the gut from... | ||||
NCT05658640 | HEM iSMART-D: Trametinib + Dexamethasone + Chemotherapy in Children With Relapsed or Refractory Hematological Malignancies | HEM-iSMART is a master protocol which investigates multiple investigational medicinal products in children, adolescents and young adults (AYA) with relapsed/refractory (R/R) ALL and LBL. Sub-protocol D is a phase I/II trial evaluating the safety and efficacy of trametinib in combination with dexamethasone, cyclophospha... | HEM-iSMART is a master protocol with sub-protocols. The overarching objective is that introducing targeted therapy using a biomarker driven approach for treatment stratification may improve the outcome of children with R/R acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) It is characterized by a shar... | International Proof of Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory HEMatological Malignancies in Children, Subprotocol D: Trametinib + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies | Acute Lymphoblastic Leukemia, in Relapse, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent, Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Recurrent, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory, Lymphoblastic Lymphoma (Precursor ... | * Drug: Trametinib
* Drug: Dexamethasone
* Drug: Cyclophosphamide
* Drug: Cytarabine
* Drug: Intrathecal chemotherapy
| Inclusion criteria~Children between 1 year (≥ 12 months) and 18 years of age at the time of first diagnosis and less than 21 years at the time of inclusion. Patients under 6 years old must weigh at least 7 kg at the time of enrollment. Patients over 6 years old must weigh at least 10 kg at the time of enrollment.~Perfo... | 1 Year | 21 Years | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase I: Maximum tolerated dose (MTD) / Recommended phase 2 dose (RP2D) | Defined as the highest dose level tested at which 0/6 or 1/6 patients experiences dose limiting toxicities (DLT) during course 1 with at least 2 patients experiencing DL... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | Defined as time from C1D1 until death of any cause. | 7 years |
| Event-free survival (EFS) | Defined as time from C1D1 to the first event (subsequent relapse after CR (including molecular reappearance), death of any c... | Acute lymphoblastic leukemia, Lymphoblastic lymphoma, Biomarker driven clinical trial, Trametinib, Chemotherapy, Relapse, Refractory, Children, Adolescents, Young adults | Physiological Effects of Drugs, Antirheumatic Agents, Antineoplastic Agents, Alkylating, Alkylating Agents, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Myeloablative Agonists, Anti-Inflammatory Agents, Antiemetics, Autonomic Agents, Peripheral Nervous System Agents, Gastrointestinal Agents, G... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sub-study D<br>Trametinib + dexamethasone + cyclophosphamide and cytarabine.~Each cycle lasts 28 days.~Cycle 1: Trametinib is given orally continuously once a day in tablets or oral formulation depending on the age and weight of the patien... | HEM iSMART-D: Trametinib + Dexamethasone + Chemotherapy in Children With Relapsed or Refractory Hematological Malignancies
Study Overview
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Brief Summary
-----------------
HEM-iSMART is a master protocol which investigates multiple investigational medicinal products in children, adolescents and young a... |
NCT03218982 | Vietnamese Caregiver Intervention Study | The purpose of this study is to develop and implement a culturally-appropriate intervention to reduce stress in Vietnamese dementia caregivers. A pilot intervention will be done to test the feasibility and acceptability of the intervention in a community setting. This will be done by randomly assigning a family triad (... | Twenty-four (24) caregivers, the identified secondary caregiver, and a care recipient will be randomly assigned into the active intervention or a control condition: 16 triads in the intervention condition, 8 in the control.~For the primary caregivers: Primary caregivers will attend six weekly intervention sessions last... | A Culturally-Relevant Approach to Reducing Dementia Caregiver Stress in an Underserved Population | Alzheimer's Disease (Incl Subtypes), Cognitive Impairment | * Behavioral: Enhanced psycho-education about dementia and caregiving
| Inclusion Criteria:~Caregivers will be included if they (a) are Vietnamese; (b) are age 21+; (c) speak Vietnamese and/or English (d) provide day-to-day, hands on care to a family member with Alzheimer's disease (AD) or cognitive impairment related to AD (e) have at least one family member who will also participate in t... | 21 Years | null | All | No | Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Families will then be randomized (as a team) to either the active intervention or the control condition. Caregivers in the active intervention will then be scheduled for six weekly intervent... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Randomization | % of eligible dyads who agree to randomization | assessed once all 3-month follow-ups are complete |
| Retention | Retention in both arms of the study; Note: no formal assessment tool will be used - this will be assessed via n... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alzheimer's Disease Knowledge Scale (ADKS) | This scale assesses knowledge about AD. The scale has 30 statements. Subjects are asked to rate each statement as True or False. | Baseline, 6-weeks (Post-intervention), 3 months post-intervention |... | Caregiver, Vietnamese, Alzheimer's Disease | Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Intervention<br>Six weekly intervention sessions (2 hours, each) that include enhanced psycho-education and discussion of AD and cultural impacts on beliefs about dementia and caregiving, management of problem behaviors, facilitatio... | Vietnamese Caregiver Intervention Study
Study Overview
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Brief Summary
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The purpose of this study is to develop and implement a culturally-appropriate intervention to reduce stress in Vietnamese dementia caregivers. A pilot intervention will be done to test the feasibility and acceptab... |
NCT00115726 | Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure | The purpose of this study is to determine whether continuing or discontinuing furosemide (a diuretic) on the day of elective noncardiac surgery for those who take furosemide on a chronic basis, causes more intraoperative hypotension (low blood pressure) during surgery. Our hypothesis is that the usual practice of conti... | A significant proportion of patients who undergo surgery take medications on a chronic basis. Little is known about the effects of these medications on the successful conduct of anesthesia and surgery. Diuretics like furosemide may contribute to low blood pressure during surgery, an outcome associated with cardiovascul... | Randomized Controlled Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure | Hypertension, Hypotension, Edema, Congestive Heart Failure | * Drug: furosemide
* Drug: placebo
| Inclusion Criteria:~All adults referred to preoperative assessment clinics by surgeons for elective non-cardiac surgery who routinely take furosemide.~Participants must also be able to give informed consent~Exclusion Criteria:~Less than 18 years of age~Have comorbid conditions with which brief periods of hypotension ma... | 18 Years | null | All | No | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients developing hypotension during the operative period. Hypotension is defined based on blood pressure criteria (systolic BP <90 mmHg or 35% drop in mean arterial pressure) (or vasopressor treatment during surgery). | | hos... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients will be followed up for the duration of their hospital stay for the following endpoints: (1) Development of congestive heart failure exacerbation | | hospital stay |
| (2) Total cardiovascular complications: composite of acute myoca... | anesthesia, hypotension, furosemide, blood pressure, peripheral edema, diuretic, surgery, congestive heart failure | Furosemide, Diuretics, Natriuretic Agents, Physiological Effects of Drugs, Sodium Potassium Chloride Symporter Inhibitors, Membrane Transport Modulators, Molecular Mechanisms of Pharmacological Action | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>furosemide | Drug: furosemide<br>* for patients on chronic furosemide therapy, patients are randomized to furosemide (at their previous dose) or placebo (given in identical form to ensure masking)<br>|
| Placebo Comparator: 2<br>place... | Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether continuing or discontinuing furosemide (a diuretic) on the day of elective noncardiac surgery for those who take furo... |
NCT04642287 | Immunotherapy After Transplantation for Skin Cancer Prevention in Organ Transplant Recipients | This clinical trial aims to investigate the efficacy of Calcipotriol ointment combined with 5-FU cream in Organ Transplant Recipients (OTRs) to determine if it can stimulate the immune cells against actinic keratoses precancerous skin lesions after transplantation and prevent cutaneous squamous cell carcinoma (SCC) in ... | The main goal of this investigator-initiated clinical trial is to determine the efficacy of topical calcipotriol combined with 5-fluorouracil (5-FU) treatment in OTRs on immunosuppressive medications with precancerous skin lesions called actinic keratoses (AKs) and a history of non-melanoma skin cancer in order to elim... | Calcipotriol Plus 5-Fluorouracil Immunotherapy for Skin Cancer Prevention in Organ Transplant Recipients | Immunotherapy, Cutaneous Squamous Cell Carcinoma, Actinic Keratoses, Organ Transplant Recipients, Skin Cancer | * Drug: Calcipotriol Only Product in Cutaneous Dose Form
* Drug: Vaseline
* Drug: Topical 5FU
| Inclusion Criteria:~Solid organ transplant recipients with AKs and a history of non-melanoma skin cancer in one year prior to enrollment into the study. The target population includes post-transplant OTRs.~Presence of four to fifteen clinically typical, visible, and discrete AKs in 25 cm2 on any of the four anatomical ... | 50 Years | null | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Triple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes in baseline number of AKs on treated anatomical sites in post-transplant OTRs | The changes in baseline number of AKs on treated anatomical sites in post-transplant OTRs quantified based on participants' medical records and photogr... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes in the number of SCC on treated anatomical sites in post-transplant OTRs | The changes in number of SCC on treated anatomical sites in post-transplant OTRs quantified based on participants' medical records, photographs and patholog... | Squamous Cell Carcinoma, Actinic keratoses, Calcipotriol ointment, 5-FU cream, Prevention, Organ Transplant Recipients, Immunotherapy | Fluorouracil, Calcipotriene, Petrolatum, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Antimetabolites, Antineoplastic, Antineoplastic Agents, Immunosuppressive Agents, Immunologic Factors, Physiological Effects of Drugs, Dermatologic Agents, Emollients | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical Calcipotriol ointment plus 5-Fluorouracil cream<br>Topical Calcipotriol 0.0025% ointment plus 5-Fluorouracil 2.5% cream will be administered by the participants to their face, scalp and upper extremities twice a day for 6 consecuti... | Immunotherapy After Transplantation for Skin Cancer Prevention in Organ Transplant Recipients
Study Overview
=================
Brief Summary
-----------------
This clinical trial aims to investigate the efficacy of Calcipotriol ointment combined with 5-FU cream in Organ Transplant Recipients (OTRs) to determine if it ... |
NCT02681341 | Vascular Post Market Review | The primary objective of this study is to confirm that properties of CardioCel provide operative benefit to surgeons when compared to Dacron, CorMatrix, and all other bovine pericardium not treated with proprietary ADAPT engineering. | ENDPOINTS~OR experience: suturability, handling, hemostasis, compliance to recipient vessel, blood loss, OR time.~In-hospital survival~MAE (Stroke, MI, death)~1 Month duplex US scan~6 month duplex US scan~Secondary Efficacy Endpoints~1. Less than 50% stenosis at 6 months (PSV <150 cm/s)~Safety Endpoint~Incidence of Car... | Vascular Post Market Review | Carotid Endarterectomy | Inclusion Criteria:~Scheduled for carotid endarterectomy (CEA) with patch arterioplasty~Expected lifespan of over 24 months~Age over 18 years~Exclusion Criteria:~Revision of previous CEA arterioplasty~Active infection~Cerebral ischemic event (completed stroke) within 30 days of planned surgery~Pregnant or breastfeeding... | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Month Duplex US Report to Measure Material Quality | The 6 month duplex US report will measure peak velocity and flow through the repaired carotid artery, caliber, and occlusion/lesion status as per normal parameters used in post-CEA scans. ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OR Data and Surgeon Feedback During the Procedure | The OR data from the procedure including blood loss and how long it took to achieve hemostasis in addition to surgeon feedback on bleeding, handling, and suturing of the material will be coll... | Vascular Post Market Review
Study Overview
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Brief Summary
-----------------
The primary objective of this study is to confirm that properties of CardioCel provide operative benefit to surgeons when compared to Dacron, CorMatrix, and all other bovine pericardium not treated with proprietary ADAPT engin... | |||||
NCT01388478 | Safety Study of R(+)Pramipexole to Treat Early Alzheimer's Disease | By doing this study, researchers will examine the safety and tolerability of R-pramipexole in participants with Alzheimer's disease. This study will also examine the body and brain's response to the study drug by measuring the amount of injury to the cells (oxidative stress) in the blood and spinal fluid and brain imag... | Subjects will be recruited from the Univ of Kansas Alzheimer's Center and will provide informed consent about participating.~R(+)-pramipexole will be provided as Good Manufacturing Practice powder and taken as a liquid and start at one teaspoon (5 ml) twice a day for a total dose of 100 mg/day. After 4 weeks, the dose ... | Safety/Tolerability and Effects on Cognitive Impairment, Impaired Cerebral Cortical Metabolism and Oxidative Stress of R(+)Pramipexole Administered to Subjects With Early Alzheimer's Disease | Alzheimer's Disease | * Drug: R-pramipexole
| Inclusion Criteria:~Informed consent provided by the participant or the participant's legally acceptable representative~Age 55 years or older~Possible/probable Alzheimer's Disease (AD)~Community dwelling with a caregiver able and willing to accompany the participant on all visits, if necessary. Caregiver must visit wit... | 55 Years | null | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Adverse Events | Labwork will be performed every two months. There will be frequent contact with subjects to assess for adverse events. | 6 months |
| Safety, Tolerability, R(+)Pramipexole, Alzheimer's | Dopamine Agonists, Pramipexole, Antioxidants, Molecular Mechanisms of Pharmacological Action, Protective Agents, Physiological Effects of Drugs, Antiparkinson Agents, Anti-Dyskinesia Agents, Dopamine Agents, Neurotransmitter Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R(+)pramipexole<br>Each study participant will be given the active study drug, R-pramipexole. There is no placebo arm. | Drug: R-pramipexole<br>* R-pramipexole will be taken as a liquid and start at one teaspoon (5 ml) twice a day for a to... | Safety Study of R(+)Pramipexole to Treat Early Alzheimer's Disease
Study Overview
=================
Brief Summary
-----------------
By doing this study, researchers will examine the safety and tolerability of R-pramipexole in participants with Alzheimer's disease. This study will also examine the body and brain's resp... | |
NCT05458882 | Impact of an Educational Tool on Quality of Life and Anxiety in Parents of Children With Nut Allergy | The number of young children with food allergy, in particular with nut allergy, is increasing worldwide. A diagnosis of nut allergy can cause much anxiety in parents. They worry about their child being exposed to nuts in foods when outside the home. This anxiety can lead to these young children being restricted from ta... | Over 4% of children in Ireland have a food allergy. Many studies report that parents and children with food allergy have a decreased quality of life (QOL). However maternal anxiety and parental overprotection even in the absence of FA can lead to childhood anxiety. Children with FA are at risk of exclusion from social ... | Impact of an Educational Tool on Quality of Life and Anxiety in Parents of Young Children With Newly Diagnosed Nut Allergy | Child Allergy, Food Allergy | * Behavioral: living with food allergy educational booklet
| Inclusion Criteria:~Parents of children between 6 and 36 months~Parent of children with a new diagnosis of a nut allergy defined as a clinical reaction with a skin prick test (SPT) of >3mm or sensitised with a SPT of >7mm.~Exclusion Criteria:~Parents who already had a child with a food allergy as parents would have wel... | 18 Years | null | All | Accepts Healthy Volunteers | Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome 1 | Change in score in each group on Food allergy Quality of Life Questionnaire (FAQLQ) parental proxy form | 4 weeks |
| Primary outcome 2 | Change in score in each group on Food Allergy Quality of Life (FAQOL) parental burde... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary score | Change in score on Self efficacy in Food Allergy Questionnaire (SEFAQ) | 4 weeks |
| educational intervention, Food allergy, Quality of Life, anxiety, self efficacy, maternal education, booklet | Hypersensitivity, Food Hypersensitivity, Nut Hypersensitivity, Immune System Diseases, Hypersensitivity, Immediate, Nut and Peanut Hypersensitivity | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: educational Booklet<br>Receive intervention- educational booklet describing the day to day social activities and eating out habits of children with established food allergy in Ireland | Behavioral: living with food allergy educational book... | Impact of an Educational Tool on Quality of Life and Anxiety in Parents of Children With Nut Allergy
Study Overview
=================
Brief Summary
-----------------
The number of young children with food allergy, in particular with nut allergy, is increasing worldwide. A diagnosis of nut allergy can cause much anxiet... |
NCT05342636 | A Study of Combination Therapies With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer (MK-3475-06A) | This is a phase I/II multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of investigational agents with pembrolizumab, plus chemotherapy or lenvatinib, for the treatment of participants with advanced esophageal cancer who have failed 1 prior line of therapy and have not been previ... | The master protocol is MK-3475-U06. | A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer naïve to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06A. | Esophageal Squamous Cell Carcinoma (ESCC) | * Biological: Pembrolizumab
* Biological: Coformulation favezelimab/pembrolizumab
* Biological: MK-4830
* Drug: Lenvatinib
* Drug: Irinotecan
* Drug: Paclitaxel
| The main inclusion and exclusion criteria include but are not limited to the following:~Inclusion Criteria:~Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable ESCC~Has experienced investigator documented radiographic or clinical disease progression on one prior line of st... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing a Dose-limiting Toxicity (DLT) During Safety Lead-in Phase | A DLT is defined as any drug-related adverse event (AE) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCA... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) | PFS is defined as the time from allocation to the first documented progressive disease (PD) as assessed by RECIST 1.1 or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in the su... | Esophageal cancer, Programmed Cell Death 1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL-1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL-2, PD-L2) | Paclitaxel, Pembrolizumab, Irinotecan, Lenvatinib, Immunoglobulins, Antineoplastic Agents, Phytogenic, Antineoplastic Agents, Tubulin Modulators, Antimitotic Agents, Mitosis Modulators, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Immunological, Immune Checkpoint Inhibitors, Topoisomerase I In... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pembrolizumab plus chemotherapy<br>Participants will receive pembrolizumab intravenously plus chemotherapy (investigator's choice of irinotecan or paclitaxel) at specified doses on specified days for a total treatment duration of up to app... | A Study of Combination Therapies With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer (MK-3475-06A)
Study Overview
=================
Brief Summary
-----------------
This is a phase I/II multicenter, open-label umbrella platform study that will evaluate the safety ... |
NCT01228279 | Sympathetic Activity in Patients With End-stage Renal Disease on Peritoneal Dialysis | Hypothesis:~Patients starting peritoneal dialysis with a glucose-based regimen have high sympathetic activity in response to an increase in leptin and insulin. Converting patients from a regimen of only glucose containing dialysate to a regimen with non-glucose-based solution, icodextrin, will reduce the insulin and le... | Cardiovascular mortality remains higher among patients treated with peritoneal dialysis as compared to patients treated with hemodialysis. Sympathetic hyperactivity is considered a significant emerging risk factor for cardiovascular mortality among patients with ESRD (End-Stage Renal Disease). Sympathetic activity, via... | Effects of Non-Glucose-Based Peritoneal Dialysis Solution EXTRANEAL on Changes in Leptin Levels and Sympathetic Activity Induced by Conventional Glucose-Based Dialysate DIANEAL in Patients on Peritoneal Dialysis | End-stage Renal Disease (ESRD), Kidney Disease | * Other: DIANEAL
* Other: EXTRANEAL
| Inclusion Criteria:~Adult (age 18 years and older)~Patients with end-stage renal disease(ESRD)/chronic kidney disease(CKD)stage 5~Exclusion Criteria:~Diabetes Mellitus~Acute coronary syndrome in the past 6 months~Cardiac arrhythmias (2nd and 3rd degree heart block or premature ventricular complexes in Lown classes 4 or... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in muscle sympathetic nerve activity(MSNA) | Muscle sympathetic nerve activity(MSNA) is measured by microneurography at~baseline (before starting peritoneal dialysis)~6 weeks of PD~18 weeks of PD(12 weeks after randomization)~MSNA incr... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood pressure as assessed from 24-hour ambulatory blood pressure monitor (ABPM) | Blood pressure will be assessed with 24-hour ABPM at baseline, 6 weeks on PD and 18 weeks after starting peritoneal dilaysis. Summary measures of eac... | Peritoneal Dialysis, Dialysis Solutions, Artificial Kidney, Renal Replacement Therapy, Renal Dialysis, Sympathetic Nervous System, Leptin, Icodextrin | Pharmaceutical Solutions, Icodextrin, Dialysis Solutions | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DIANEAL<br>One group of patients will start peritoneal dialysis with the glucose-based solution (DIANEAL) for 6 weeks, then will continue with the same type of solution for another 12 weeks. | Other: DIANEAL<br>* Weeks 1 to 6 (6 weeks... | Sympathetic Activity in Patients With End-stage Renal Disease on Peritoneal Dialysis
Study Overview
=================
Brief Summary
-----------------
Hypothesis: Patients starting peritoneal dialysis with a glucose-based regimen have high sympathetic activity in response to an increase in leptin and insulin. Convertin... |
NCT04796922 | To Evaluate Efficacy and Safety of Parsaclisib Plus Either Rituximab or Obinutuzumab in R/R Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) (CITADEL-302) | This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study of parsaclisib plus investigator's choice of either rituximab or obinutuzumab versus placebo plus investigator's choice of rituximab or obinutuzumab for the treatment of participants with R/R FL or MZL. The Participants will be stratifie... | A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Parsaclisib Plus Investigator's Choice of Either Rituximab or Obinutuzumab in Participants With Relapsed or Refractory Follicular Lymphoma and Marginal Zone Lymphoma | Follicular Lymphoma ( FL), Marginal Zone Lymphoma (MZL) | * Drug: parsaclisib
* Drug: rituximab
* Drug: obinutuzumab
| Inclusion Criteria:~Male and female participants aged 18 years or older (Japan, aged 20 years or older).~Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL~Prior systemic treatment with at least 1 anti-CD20 mAb (either as monotherapy or in combination as chemoimmunotherapy)~Docu... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) in R/R FL and MZL participants | Defined as the time from the date of randomization until the first documented disease progression as determined by IRC based on the Lugano criteria for response assessment (Cheso... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) in R/R FL participants | Defined as the time from the date of randomization until the first documented disease progression as determined by IRC based on the Lugano criteria for response assessment (Cheson et al ... | parsaclisib, Relapsed/Refractory, obinutuzumab, rituximab | Rituximab, Obinutuzumab, Antineoplastic Agents, Immunological, Antineoplastic Agents, Immunologic Factors, Physiological Effects of Drugs, Antirheumatic Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group A<br>Participants will be administered with parsaclisib in combination with investigator choice of rituximab or obinutuzumab. | Drug: parsaclisib<br>* parsaclisib will be administered once daily at 20 mg for 8 weeks followe... | To Evaluate Efficacy and Safety of Parsaclisib Plus Either Rituximab or Obinutuzumab in R/R Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) (CITADEL-302)
Study Overview
=================
Brief Summary
-----------------
This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study of pars... | |
NCT05070208 | Multicenter Retrospective Observatory of Patients With Acute Myeloid Leukemia to Core Binding Factor | Acute Core Binding Factor leukemias represent a specific category of acute myeloid leukemias that share prognostic factors, a specific mutational profile, and a favorable response to chemotherapy. Their management now follows the reference pattern from the French trial CBF-2006 closed to inclusions since November 2010.... | NOT PROVIDED | Multicenter Retrospective Observatory of Patients With Acute Myeloid Leukemia to Core Binding Factor | Acute Myeloblastic Leukemia Core Binding Factor | * Other: NOT PROVIDED
| Inclusion Criteria:~Patients over 18 years old~Diagnosis of acute myeloid leukemia with CBF confirmed by cytogenetics (karyotype and / or FISH): t (8; 21), inv (16) or t (16; 16) and / or molecular biology (RUNX1-RUNX1T1 fusions or CBFB-MYH11)~Initial management by intensive chemotherapy, hypomethylants or targeted the... | 18 Years | null | All | null | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival (EFS) | | December 2010 to December 2020 |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Complete remission rate (CR / CRp) | | December 2010 to December 2020 |
| - Overall survival (OS), relapse free survival (DFS) +/- censored with allogeneic transplant | | December 2010 to December 2020 |
| - Cumulative incidence of relap... | Leukemia, Leukemia, Myeloid, Acute, Neoplasms by Histologic Type, Neoplasms, Leukemia, Myeloid | | Intervention/Treatment |
| --- |
|Other: NOT PROVIDED|NOT PROVIDED|
| Multicenter Retrospective Observatory of Patients With Acute Myeloid Leukemia to Core Binding Factor
Study Overview
=================
Brief Summary
-----------------
Acute Core Binding Factor leukemias represent a specific category of acute myeloid leukemias that share prognostic factors, a specific mutational profile... | ||
NCT04174703 | Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing | Compassion-focused therapy (CFT) seeks to lower shame and help people develop compassion for personal distress and shortcomings. There is increasing evidence to support the benefits of incorporating CFT-based interventions into the treatment of eating disorders (EDs). Building on the investigators' prior research, this... | The study consists of two phases. In phase one, participants will be randomly assigned to a two-week daily letter-writing intervention condition or a two-week control condition; phase one will occur two to four weeks prior to the start date of group ED treatment. Participants will complete a brief set of online questio... | Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing | Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder, Compassion | * Other: Self-compassionate letter-writing intervention
| Inclusion Criteria:~DSM-5 diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder~Eligible to start group eating disorders treatment at St. Joseph's Eating Disorder Program~17 years of age or older~Exclusion Criteria: None | 17 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Half of the study participants (n=80) will be placed into the self-compassionate letter-writing intervention group, and half of the study participants (n=80) will be placed into a control group.
M... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight- and Body-Related Shame and Guilt Scale (WEB-SG) | Self-report questionnaire with 12 questions on a 5-point Likert scale (scored 0-4). Total scores range from 0-48, with higher decrease in score indicative of a better outcome (i.e. high... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating Disorder Examination Questionnaire (EDE-Q) | Self-report questionnaire with 28 questions, collecting two types of data. The EDE-Q collects frequency data of eating disorder behaviours. The EDE-Q also has four subscales assessing the sev... | Anorexia, Bulimia, Feeding and Eating Disorders, Anorexia Nervosa, Binge-Eating Disorder, Bulimia Nervosa, Mental Disorders, Signs and Symptoms, Digestive, Hyperphagia | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-compassionate letter-writing intervention<br>An online self-compassionate letter-writing task once per day (10-20 minutes each) for 2 weeks | Other: Self-compassionate letter-writing intervention<br>* Participants in this condition wi... | Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing
Study Overview
=================
Brief Summary
-----------------
Compassion-focused therapy (CFT) seeks to lower shame and help people develop compassion for personal distress and shortcomings. There is increasing evidence to support the ben... | |
NCT04037280 | Preoperative Exercise Training for Pelvic Floor in Urinary Incontinence Post RALP | The aim of the study is to investigate how posology and typology of preoperative strengthening training of Pelvic Floor Muscle before RALP surgery can affect the postoperative urinary incontinence. 120 subjects undergoing RALP (Robotic-assisted laparoscopic prostatectomy) will be recruited. The amount of urinary leakag... | The male urinary incontinence is one of the possible complications following radical prostatectomy surgery. It represents one of the main problems with great impact on quality of life, physical activity or social well being.~Previous studies define strengthening exercises for the pelvic floor as the most effective cons... | The Influence of Typology and Posology of Exercise for the Preoperative Strengthening Training of Pelvic Floor in Urinary Incontinence Post RALP | Urinary Incontinence | * Other: Exercise
| Inclusion Criteria:~On the list for RALP (Robotic-assisted laparoscopic prostatectomy) surgery expected 30-40 days before preoperative session~Objectivity of Pelvic Floor Muscle recruitment and contraction at manual perineal testing during pre-operative session~Exclusion Criteria:~Incontinence before surgery~Radiothera... | 18 Years | 90 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 120 subjects on the list for RALP surgery will be recruited and randomized into 4 groups. Subjects will be evaluated during the preoperative session (T0) and about 45-55 days before the surgery (T... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pad test 48h | Change in weighing of pad during 48 hours at 45 days | 45 days after surgery |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Prostatic Symptoms Score (IPSS) | IPSS evaluates the entity of urinary symptoms. It ranges from 0 (no symptoms) to 35 (severe symptoms). A higher value represents a worse outcome. The results is obtained summing the ite... | Urinary, Exercise, Posology | Urinary Incontinence, Enuresis, Urination Disorders, Urologic Diseases, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Male Urogenital Diseases, Lower Urinary Tract Symptoms, Urological Manifestations, Behavioral Symptoms, Elimination Disorders, Mental Disorders | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Isometric strenghtening 1<br>once a day (1RI): patients in this group will have to play 20 tonic contractions of Pelvic Floor Muscle with a duration of 5 seconds each, performed in supine position), in sitting position and in standing posi... | Preoperative Exercise Training for Pelvic Floor in Urinary Incontinence Post RALP
Study Overview
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Brief Summary
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The aim of the study is to investigate how posology and typology of preoperative strengthening training of Pelvic Floor Muscle before RALP surgery can affect the postoperat... |
NCT00970463 | Cardiac Function and Morphology Evaluated by Magnetic Resonance Imaging in Growth Hormone Deficiency and Acromegaly | To test the hypothesis that both lack and excess of growth hormone (GH) is associated with cardiac abnormalities. Cardiac function and morphology will be evaluated by MRI before and after treatment. | It is an open prospective noninterventional clinical study. Treatment and follow-up will be according to usual guidelines, and will be unaffected by inclusion in the study. GHD patients will be treated with daily subcutaneous GH injections. Patients with acromegaly will be treated with either transsphenoidal surgery or... | Impact of Growth Hormone on Serum N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) and on Cardiac Function and Morphology Evaluated by Magnetic Resonance Imaging in Growth Hormone Deficiency and Acromegaly | Growth Hormone Deficiency, Cardiac Function | Inclusion Criteria:~Peak GH below 6.0 ng/mL during Pyridostigmine-GHRH test.~Nadir GH above 0.4 ng/mL and elevated levels of IGF-I during oral glucose tolerance test~Exclusion Criteria:~Contraindications for magnetic resonance scan | 18 Years | 70 Years | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cardiac function i relation to changes in the activity of the GH-axis | | |
| The GH-system and cardiac function | Dwarfism, Pituitary, Acromegaly, Endocrine System Diseases, Dwarfism, Bone Diseases, Developmental, Bone Diseases, Musculoskeletal Diseases, Bone Diseases, Endocrine, Hypopituitarism, Pituitary Diseases, Hypothalamic Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Hyperpituitarism | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GH<br>Patients with GHD | |
| Pegvisomant and Somatostatin analogues<br>Acromegaly | |
| Cardiac Function and Morphology Evaluated by Magnetic Resonance Imaging in Growth Hormone Deficiency and Acromegaly
Study Overview
=================
Brief Summary
-----------------
To test the hypothesis that both lack and excess of growth hormone (GH) is associated with cardiac abnormalities. Cardiac function and mor... | |||
NCT00707902 | Clinical Trial for Assessment of Safety and Efficacy of a Echinacea/Sage Spray Compared to a Chlorhexidine/Lidocaine Spray in the Treatment of Acute Sore Throats | The aim of the study is to show non-inferiority of an echinacea/sage spray compared to a chlorhexidine/lidocaine-spray in the treatment of acute sore throat during five days of treatment.~Main outcome parameter is the non-inferiority in number of responders between the two treatment groups. A responder is defined as a ... | Further secondary parameters are :~Responders during at day 4 and 5, single symptom scores during 1 to 5 days of observation, pain at begin and end (100mm VAS), assessment of efficacy by physician and patient, consumption of rescue medication~Assessment of safety by physician and patient, frequency of adverse events | Multicentric Randomized Double Blind Double Dummy Placebo Controlled Clinical Trial for Assessment of Safety and Efficacy of a Echinacea/Sage Spray in Comparison to a Chlorhexidine/Lidocaine Spray in the Treatment of Acute Sore Throats | Pharyngitis | * Drug: chlorhexidine/lidocaine
* Drug: echinacea/sage
| Inclusion Criteria:~Age > 12 years;~Acute pharyngitis or tonsillitis with symptoms of throat pain and inflammation of the pharynx and/or tonsils;~Onset of sore throat less than 72 hours before inclusion ;~A Tonsillopharyngitis Severity Score ≥6;~Written informed consent.~Exclusion Criteria:~Analgesics <12 hours;~Antibi... | 12 Years | 75 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of responder of the two treatment groups after the first, second, and third days. A responder is defined as a reduction by 50% of the total baseline score taken prior to treatment start. | | first three days of treatment |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of response rates after 4th and 5th days of treatment; VAS throat pain; amount rescue medication used; global assessment efficacy Frequency of adverse events, global assessment of tolerability | | five days of treatment |
| Sore throats,, Pharyngitis, Acute | Chlorhexidine, Lidocaine, Anesthetics, Local, Anesthetics, Central Nervous System Depressants, Physiological Effects of Drugs, Sensory System Agents, Peripheral Nervous System Agents, Anti-Arrhythmia Agents, Voltage-Gated Sodium Channel Blockers, Sodium Channel Blockers, Membrane Transport Modulators, Molecular Mechani... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Drug: Echinacea/sage~patients received additionally a placebo-spray for the synthetical comparator (chlorhexidine/lidocaine) as the study was double dummy blinded.~Patients had to apply spray every 2 hours with two puffs to the p... | Clinical Trial for Assessment of Safety and Efficacy of a Echinacea/Sage Spray Compared to a Chlorhexidine/Lidocaine Spray in the Treatment of Acute Sore Throats
Study Overview
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Brief Summary
-----------------
The aim of the study is to show non-inferiority of an echinacea/sage spray compared to a chl... |
NCT04865601 | DNA Adductomics for Colorectal Cancer Investigation | This project seeks to identify DNA-adducts in colon tissue from different groups of patients with CRC scheduled for complete or partial colon resections. Other patients scheduled for resection of the colon serve as controls. In addition, surrogate samples such as white blood cells are investigated for the presense of a... | Colorectal cancer (CRC) develops as a result of multiple genetic mutations causing normal intestinal epithelium to transform into a colorectal carcinoma. Genetic mutations may be caused by many different genetic events including chemical damage to the DNA nucleosides. These chemical modifications are due to both exogen... | Novel DNA Adductomics Methodological Developments for Research in Colon Cancer | Colorectal Cancer, Familial Adenomatous Polyposis, Hereditary Non-polyposis Colon Cancer, Lynch Syndrome | * Other: resectomy of the colon
| Inclusion Criteria:~Patients with either FAP, Lynch syndrome, other HNPCC, sporadic colorectal cancer, ulcerative colitis or other conditions who are scheduled for whole or partial resection of their colon~Exclusion Criteria:~Any condition that makes the investigator or hospital personnel doubt that voluntary participa... | 18 Years | null | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA adductome in CRC and other diseases | Identification of DNA adducts in colon tissue from CRC and other diseases | During surgery |
| Correlation of DNA adduct and DNA repair products | Correlation of DNA adduct in colon tissues and DNA re... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of DNA adducts with microbiota | Correlation of DNA adduct in colon tissues with microbiota and microbiota metabolites in faeces | Baseline (Before surgery) |
| Correlation of DNA adducts with CRC causes | Correlation of DNA adduc... | Adenoma, Colorectal Neoplasms, Colonic Neoplasms, Colorectal Neoplasms, Hereditary Nonpolyposis, Adenomatous Polyposis Coli, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Intestinal Dise... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CRC<br>Patient affected by any sporadic colorectal cancer | Other: resectomy of the colon<br>* The patient scheduled for colon resectomy are included in the study<br>|
| FAP<br>Patients affected by familial adenomatous polyposis coli | Other: resectomy ... | DNA Adductomics for Colorectal Cancer Investigation
Study Overview
=================
Brief Summary
-----------------
This project seeks to identify DNA-adducts in colon tissue from different groups of patients with CRC scheduled for complete or partial colon resections. Other patients scheduled for resection of the co... | ||
NCT03209895 | Study to Evaluate the Safety and Efficacy of a Proprietary Joint Health Dietary Supplement in Subjects With Joint and Connective Tissue Pain | This study is designed to evaluate the effectiveness of a proprietary nutritional supplement that contains Krill Oil (KO), astaxanthin (AX) and hyaluronic acid (HA) to reduce pain and discomfort in participants, compared to an inert placebo (palm oil) control and to a positive control (glucosamine-chondroitin). The pur... | A Double-Blinded, Placebo Controlled, Human Clinical Study to Evaluate the Safety and Efficacy of a Proprietary Joint Health Dietary Supplement in Subjects With Joint and Connective Tissue Pain | Joint Pain | * Dietary Supplement: Joint Health Product
* Dietary Supplement: Placebo
* Dietary Supplement: Glucosamine / Chondroitin
| Inclusion Criteria:~Subjects must be able and willing to give Informed Consent.~Subjects must not have taken anti-inflammatory drugs or supplements for 5 days prior to their initial C-RP blood test, and must refrain from taking these products for the duration of the study.~Subjects will be required to refrain from taki... | 18 Years | 80 Years | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC Change | Change in Clinical Coordinator administered pain assessment and pain intensity evaluation over 56 days as determined by the Western Ontario and McMaster Universities Osteoarthritis Index™© (WOMAC) | Days: 0, 14, 28 and 56 |
| V... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Chemistry CBC Change | Change in CBC and differentials over 56 days | Days: 0, 14, 28 and 56 |
| Blood Chemistry hs-CRP Change | Change in hs-CRP over 56 days | Days: 0, 14, 28 and 56 |
| Arthralgia, Nociceptive Pain, Joint Diseases, Musculoskeletal Diseases, Pain, Neurologic Manifestations | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Joint Health Product<br> | Dietary Supplement: Joint Health Product<br>* Krill oil, Astaxanthin, Hyaluronic Acid Formulation, 353 mg per day; Softgel capsule<br>* Other names: FlexPro MD;|
| Placebo Comparator: Placebo<br> | Dietary Supple... | Study to Evaluate the Safety and Efficacy of a Proprietary Joint Health Dietary Supplement in Subjects With Joint and Connective Tissue Pain
Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the effectiveness of a proprietary nutritional supplement that contains Krill ... | ||
NCT05446311 | Naldebain® Extended-release Injection After Cesarean Section in Pain Management | Cesarean section is one of the surgeries most commonly leading to postoperative severe acute pain. It was reported that the mean worst pain intensity reached to 6.14 one day after cesarean section in Germany. Inadequate pain management may result in the cardiorespiratory complications, late recovery, and postoperative ... | This is an observational, prospective, single arm study. This study is aimed to investigate the efficacy and safety of dinalbuphine sebacate in subjects undergoing cesarean section. Written informed consent are obtained before subjects participate in the study. Eligible subjects will be visited twice daily during stay ... | Naldebain® Extended-release Injection After Cesarean Section in Pain Management: a Prospective Observational Study | Post Operative Pain, Caesarean Section, Analgesia | * Drug: Dinalbuphine sebacate
| Inclusion Criteria:~Female aged 20 to 45 years.~Going to have cesarean section and use dinalbuphine sebacate to alleviate postoperative pain.~Cesarean section scheduled between the 34th and 41st week of gestation.~ASA I or II.~Willing to comply with study protocol and give written informed consent.~Exclusion Criteria:~... | 20 Years | 45 Years | Female | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complication | Analgesic-related complication occurring in the period of hospital stay will be recorded, such as dizziness, nausea, vomiting, and injection site reaction. | Within 5 days after injection of dinalbuphine sebacate | ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-cesarean section pain intensity | Pain intensity is assessed by numerical rating scale (NRS) twice daily during stay | Within 5 days after delivery |
| Consumption of analgesics | Analgesics consumed during stay of hospital are recorded.... | Dinalbuphine Sebacate, NALDEBAIN, Extended-release analgesics | Pain, Pain, Postoperative, Postoperative Complications, Pathologic Processes, Neurologic Manifestations | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DS group<br>Subjects going to receive dinalbuphine sebacate for post-cesarean section pain. | Drug: Dinalbuphine sebacate<br>* After giving the birth, subjects are intramuscularly injected with a single dose of 150 mg of dinalbuphine sebacate (DS). DS i... | Naldebain® Extended-release Injection After Cesarean Section in Pain Management
Study Overview
=================
Brief Summary
-----------------
Cesarean section is one of the surgeries most commonly leading to postoperative severe acute pain. It was reported that the mean worst pain intensity reached to 6.14 one day ... | |
NCT05589844 | A Cytomegalovirus-Directed Vaccine (CMV-alphaDC1) for Preventing Cytomegalovirus Infection or Reactivation in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation | This phase Ib trial evaluates the safety and most effective dose of a cytomegalovirus (CMV) pp65 peptide-loaded alpha-type-1 polarized dendritic cell (CMV-alphaDC1) vaccination in patients who are undergoing an allogeneic hematopoietic stem cell transplant. CMV is an opportunistic infection that can occur or reactivate... | PRIMARY OBJECTIVES:~I. Determine the safety of cytomegalovirus (CMV) pp65 peptide loaded alpha-type 1 polarized dendritic cell (CMV-alphaDC1) vaccination after allogeneic hematopoietic cell transplantation (alloHCT).~II. Determine the immunogenicity of CMV-alphaDC1 vaccination after alloHCT.~SECONDARY OBJECTIVES:~I. Ev... | A Phase 1b Safety and Immunogenicity Study of Cytomegalovirus (CMV) Directed Type 1 Polarized Dendritic Cell Vaccination (αDC1) After Allogeneic Hematopoietic Cell Transplantation (alloHCT) for Hematologic Malignancies | Cytomegaloviral Infection, Hematopoietic and Lymphoid System Neoplasm | * Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
* Procedure: Biospecimen Collection
* Biological: CMV pp65 Peptide-loaded Alpha-type-1 Polarized Dendritic Cell Vaccine
| Inclusion Criteria:~Recipient age >= 18 years of age~The recipient is CMV seropositive~The recipient is planned to receive an allogeneic peripheral blood stem cell graft~The recipient is planned to receive fludarabine, melphalan, and total body irradiation for the transplant conditioning regimen~The recipient is planne... | 18 Years | null | All | Accepts Healthy Volunteers | Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dose limiting toxicities | For each dose level of cytomegalovirus (CMV) pp65 peptide loaded alpha-type 1 polarized dendritic cell (CMV-alphaDC1) vaccination that is tested. Will be summarized by dose level using frequencies and re... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of late CMV reactivation after allogeneic hematopoietic stem cell transplant | Will be summarized by dose level using the appropriate descriptive statistics; with estimates of rates obtained by 95% Jeffrey's prior confidence interval... | Vaccines, Immunologic Factors, Physiological Effects of Drugs | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (CMV-alphaDC1)<br>Patients undergo standard of care allogeneic hematopoietic stem cell transplant on day 0 and receive CMV-alphaDC1 vaccine intradermally on days 28, 42, 56, and 70. | Procedure: Allogeneic Hematopoietic Stem Cell... | A Cytomegalovirus-Directed Vaccine (CMV-alphaDC1) for Preventing Cytomegalovirus Infection or Reactivation in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Study Overview
=================
Brief Summary
-----------------
This phase Ib trial evaluates the safety and most effective dose of a cyt... | |
NCT00106145 | A Notch Signalling Pathway Inhibitor for Patients With Advanced Breast Cancer (0752-014) | An investigational study to determine the safety/tolerability, and efficacy of a notch signaling pathway inhibitor in patients with metastatic or locally advanced breast cancer and other advanced solid tumors. | A Phase I Study of MK0752, a Notch Inhibitor, in Patients With Metastatic or Locally Advanced Breast Cancer and Other Solid Tumors | Advanced Breast Cancer, Other Solid Tumors | * Drug: Comparator: MK0752, Notch Inhibitor
* Drug: Comparator: MK0752, Notch Inhibitor - 450 mg
* Drug: Comparator: MK0752, Notch Inhibitor - 3 days on, 4 off
* Drug: Comparator: MK0752, Notch Inhibitor - 1 day on, 6 off
* Drug: Comparator: MK0752, Notch Inhibitor - 3 days on, 4 off 350 mg
| Inclusion Criteria:~Women or men greater than or equal to 18 years of age~ECOG status less than or equal to 2 (a measurement to determine your ability to perform daily activities)~In Parts I, III, and IV, patient must have a histologically confirmed, metastatic or locally advanced solid tumor that has failed to respond... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability; MTD will be established | | Day 1 to Day 28 |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall tumor/disease response will be evaluated using RECIST criteria, radiographic and clinical evaluations | | radigraphic evaluation = every 56 days |
| Advanced Breast Cancer, Solid Tumors, Advanced Solid Tumors | 3-(4-((4-chlorophenyl)sulfonyl)-4-(2,5-difluorophenyl)cyclohexyl)propanoic acid, Gamma Secretase Inhibitors and Modulators, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part I - Arm 1<br> | Drug: Comparator: MK0752, Notch Inhibitor<br>* Dose escalating beginning with rising dose levels of 300, 450, and 600 mg/day in a continuous dosing schedule.<br>|
| Experimental: Part II - Arm 1<br> | Drug: Comparator:... | A Notch Signalling Pathway Inhibitor for Patients With Advanced Breast Cancer (0752-014)
Study Overview
=================
Brief Summary
-----------------
An investigational study to determine the safety/tolerability, and efficacy of a notch signaling pathway inhibitor in patients with metastatic or locally advanced br... | |
NCT04230876 | Auditory Training and Hearing Aid Satisfaction | Although hearing aids are the most common treatment for hearing loss, and have the potential to help seniors stay active and productive, almost 50% of them who receive hearing aids rarely if ever use them, a state of affairs sometimes referred to as the hearing aid in the drawer syndrome. clEAR's customized auditory br... | Auditory training as the potential to dramatically affect older persons' adjustment to a new hearing aid and to maximize the benefits they receive from wearing one. In turn, by wearing hearing aids, they experience easier and more successful communication patterns. They enhance their ability to engage in everyday conve... | Auditory Brain Training to Enhance Satisfaction and Usage of New Hearing Aids by Older Adults | Hearing Impairment, Sensorineural | * Behavioral: Auditory Brian Training Games/Activities
| Inclusion Criteria:~Must be a native English speaker~Must have a mild to severe bilateral sensorineural hearing loss~Must be a candidate for new hearing aid(s) (have never used hearing aids)~Exclusion Criteria:~Cognitive impairment or any factors that would prohibit a participant from completing questionnaires~Cognitiv... | 60 Years | null | All | Accepts Healthy Volunteers | Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: All participants experience the same interventions and assessments. Subjects are divided into either early or late intervention groups.
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hearing Aid Satisfaction After Auditory Training | The Client Orientated Scale of Improvement (COSI), a subjective measure of improvement on self-defined goals. The scale is relative to a baseline assessed before wearing hearing aids... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percent Words Correct on Speech Perception Measures After Auditory Training | The NU-6 is a standard clinical assessment of word discrimination. Lists consist of 50 words in quiet and were presented through the Amptify DTx while wear... | Auditory Training | Hearing Loss, Deafness, Hearing Loss, Sensorineural, Hearing Disorders, Ear Diseases, Otorhinolaryngologic Diseases, Sensation Disorders, Neurologic Manifestations, Nervous System Diseases | | Intervention/Treatment |
| --- |
|Behavioral: Auditory Brian Training Games/Activities|Game-based activities that encourage listening to words and sentences in noisy situations. Participants will receive subscriptions to the clEAR online auditory training activities and recommended protocol for those who recently rec... | Auditory Training and Hearing Aid Satisfaction
Study Overview
=================
Brief Summary
-----------------
Although hearing aids are the most common treatment for hearing loss, and have the potential to help seniors stay active and productive, almost 50% of them who receive hearing aids rarely if ever use them, a... |
NCT02734121 | PEGI to Improve Shared Decision-Making for Breast Reconstruction | The purpose of this study is to determine the effectiveness of a pre-consultation decision support workshop for breast reconstruction after breast cancer, in facilitating the decision-making process, compared to routine pre-surgical education. | Postmastectomy breast reconstruction is becoming increasingly utilized in breast cancer patients to provide surgical restoration of the breast mounds. The breast reconstruction discussions can be highly complex, as there are many different techniques, timing, and complications that are unique to each procedure. However... | Pre-consultation Educational Group Intervention to Improve Shared Decision-Making for Postmastectomy Breast Reconstruction | Breast Cancer | * Behavioral: pre-consultation educational group intervention
| Inclusion Criteria:~Patients > 18 years of age.~Seeking consultation for delayed Post Mastectomy Breast Reconstruction, or prophylactic mastectomy and immediate Post Mastectomy Breast Reconstruction for breast cancer prevention.~Exclusion Criteria:~Chest wall or atypical breast malignancy that require chest wall recons... | 18 Years | null | Female | No | Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional Conflict Scale | Decision conflict scale measures personal perceptions of uncertainty in choosing options and has been demonstrated to be valid and responsive to change. The decisional conflict scale is a 16-item 5-response instrume... | breast cancer, breast reconstruction, shared decision making, decision support intervention | Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational group intervention<br>The pre-consultation educational group intervention will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology. | Behavioral: p... | PEGI to Improve Shared Decision-Making for Breast Reconstruction
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of a pre-consultation decision support workshop for breast reconstruction after breast cancer, in facilitating the decision-makin... | |
NCT04664855 | A Trauma-Informed Approach for Positive Youth Development for Montana Students | Given the prevalence of suicide and mental health issues in rural Montana, this project is intended to help mitigate stressors that may contribute to poor behavioral and mental health in high school-aged children. The immediate goal is to measure physical and mental health outcomes in adolescents resulting from a traum... | mental and physical health issues (17). Stressors deriving from low socioeconomic status and/or traumatic childhood experiences such as abuse or neglect are exacerbated by today's educational culture, where mandated practices such as standardized testing and post-graduation plans are cited as primary causes for stress ... | A Trauma-Informed Approach for Positive Youth Development for Montana Students | Depression, Anxiety, Suicidal Ideation, Stress, Trauma | * Other: Trauma-Informed Yoga
| Inclusion Criteria:~Freshmen enrolled in a health and wellness/physical education class at a rural Montana High School~Exclusion Criteria:~None | 14 Years | 19 Years | All | Accepts Healthy Volunteers | Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Salivary Cortisol Levels | Students will provide a saliva sample in which cortisol levels will be analyzed through salivary assay kits (through Salimetrics.com). Samples will be collected on the first day of the intervention, halfway... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire for Adolescents | This 9 item questionnaire is designed to evaluate severity of depressive symptoms in adolescents. It is scored on a Likert scale from 0 (not at all) to 3 (nearly every day) on items linked to depr... | Wounds and Injuries, Suicidal Ideation, Behavioral Symptoms, Suicide, Self-Injurious Behavior | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Yoga Group<br>35 freshman students enrolled in a health and wellness/physical education class at a rural Montana high school | Other: Trauma-Informed Yoga<br>* 8 weeks of twice weekly trauma-informed yoga for 45 minutes per se... | A Trauma-Informed Approach for Positive Youth Development for Montana Students
Study Overview
=================
Brief Summary
-----------------
Given the prevalence of suicide and mental health issues in rural Montana, this project is intended to help mitigate stressors that may contribute to poor behavioral and menta... | |
NCT02650778 | Automated Breast Ultrasound Screening | Women with dense breasts (BIRADS 3 or 4) with a BIRADS category 1 or 2 mammogram are asked to participate in a automated volume breast ultrasound scanner. The study evaluates prospectively the changes in recall rate, positive biopsy rate, cancer detection rate when BIRADS category 3 lesions are given a 1 year follow-up... | Women with dense breasts (BIRADS 3 or 4) with a BIRADS category 1 or 2 mammogram are asked to participate in a automated volume breast ultrasound scanner. If the women agrees to participate and sign informed consent she undergoes an automated whole breast scan. The scan is interpreted independent of the mammogram. Scan... | Automated Breast Ultrasound Screening in Women With Dense Breasts (BIRADS 3 or 4) and BIRADS Category 1 or 2 Mammogram Assigning BIRADS 3 Lesions to Yearly Follow-up | Breast Cancer | * Procedure: Breast ultrasound
| Inclusion Criteria:~Women age >18 scheduled for routine screening mammogram. Women with Density 3 or 4 and BIRADS category 1 or mammogram are asked to participate in study~Exclusion Criteria:~Inability to give informed consent | 18 Years | 80 Years | Female | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased recall rate for screening breast ultrasound while maintaining cancer detection rate | | 3 years |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased positive biopsy rate | | 3 years |
| Breast Cancer, Automated whole breast ultrasound, BI-RADS category 3 lesions | Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases | | Intervention/Treatment |
| --- |
|Procedure: Breast ultrasound|automated whole breast ultrasound|
| Automated Breast Ultrasound Screening
Study Overview
=================
Brief Summary
-----------------
Women with dense breasts (BIRADS 3 or 4) with a BIRADS category 1 or 2 mammogram are asked to participate in a automated volume breast ultrasound scanner. The study evaluates prospectively the changes in recall rate,... | |
NCT03942133 | Tow Techniques of Adductor Canal Block for Analgesia After Total Knee Replacement | This study compares the tow technique of continues adductor canal block for total knee replacement surgery. Half participants will receive catheterization at the entrance of the adductor canal, while the other half will receive catheterization at the middle point of the adductor canal. | Ultrasound-guided Continuous Adductor Canal Block for Analgesia After Total Knee Replacement: Comparison of Block at the Entrance and Middle of the Canal | Total Knee Arthroplasty, Analgesia, Nerve Block | * Procedure: ultrasound-guided short-axis placement of catheter at the entrance of the adductor canal
* Procedure: ultrasound-guided long-axis placement of catheter at the middle of the adductor canal
| Inclusion Criteria:~18-80 years~Knee-arthroscopy~Written consent~ASA I-III~BMI 19-35~Exclusion Criteria:~Unable to communicate with the investigators (e.g., a language barrier or a neuropsychiatric disorder).~coagulopathy or on anticoagulant medication~Allergic reactions toward drugs used in the trial~History of substa... | 18 Years | 80 Years | All | No | Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative sulfentanil consumption at 24 hours after surgery | | 24 hours after surgery |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the strength of quadriceps femoris | Quadriceps strength was assessed on a 0-5 scale as per the Medical Research Council Scale quadriceps motor strength(0 = no voluntary contraction possible, 1 = muscle flicker, but no movement of limb, 2 = ac... | adductor canal block | Agnosia, Perceptual Disorders, Neurobehavioral Manifestations, Neurologic Manifestations, Nervous System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: entrance placement of adductor canal catheter<br> | Procedure: ultrasound-guided short-axis placement of catheter at the entrance of the adductor canal<br>* Ultrasound probe is placed at the entrance of the adductor canal in short axis ，in... | Tow Techniques of Adductor Canal Block for Analgesia After Total Knee Replacement
Study Overview
=================
Brief Summary
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This study compares the tow technique of continues adductor canal block for total knee replacement surgery. Half participants will receive catheterization at the entrance o... | |
NCT01531322 | A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects | This study will assess the safety and tolerability of a single dose of 13-valent Pneumococcal Conjugate Vaccine for approximately 1 month after vaccination sequentially in healthy Chinese adults aged 18 through 55 years, followed by children aged 3 through 5 years, and then infants aged approximately 2 months. | A Phase 1 Open-label Study to Assess the Safety and Tolerability of a Single Dose of 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Adults, Children and Infants | Pneumococcal Infection | * Biological: 13-valent Pneumococcal Conjugate Vaccine
* Biological: 13-valent Pneumococcal Conjugate Vaccine
* Biological: 13-valent Pneumococcal Conjugate Vaccine
| Inclusion Criteria:~Age at the time of enrollment is:~18 through 55 years (before the fifty sixth birthday) for Group 1.~3 through 5 years (before the sixth birthday) for Group 2.~42 to 98 days for Group 3.~Healthy subject as determined by medical history, physical examination, and judgment of the investigator.~Exclusi... | 42 Days | 55 Years | All | Accepts Healthy Volunteers | Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants reporting Adverse Events | | Baseline to Month 1 |
| 13vPnC, Healthy subjects, China | Vaccines, Heptavalent Pneumococcal Conjugate Vaccine, Immunologic Factors, Physiological Effects of Drugs | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Adults aged 18 through 55 years (before the fifty sixth birthday) | Biological: 13-valent Pneumococcal Conjugate Vaccine<br>* suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose<br>|
| Experimental... | A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects
Study Overview
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Brief Summary
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This study will assess the safety and tolerability of a single dose of 13-valent Pneumococcal Conjugate Vaccine for approximately 1 month after vaccination sequentiall... | ||
NCT04083612 | Therapeutic Drug Monitoring of Ixekizumab in Psoriasis Patients | Biologics, such as ixekizumab, are currently the most effective treatment option for patients with moderate-to-severe psoriasis. But they are costly for health care systems and prescribed according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. Within this study the investigator... | Patients will be included after siging informed consent. After inclusion, patients will continue on standard dosing schedule of ixekizumab (i.e. one loading dose of 2 subcutaneous injections (160 mg) at week 0, followed by one subcutaneous injection (80 mg) every 2 weeks for 12 weeks, and then one subcutaneous injectio... | Evaluation of the Predictive Value of Early Serum Trough Concentrations and Anti-drug Antibodies of Ixekizumab and the Development of Concentration-response Curve of Ixekizumab for Psoriasis Patients | Psoriasis Vulgaris | * Procedure: Venapuncture
* Other: Patient questionnaires
| Inclusion Criteria:~Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis~Participants must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study~Exclusion Criteria:~Participants who have... | 18 Years | null | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective, open label, non-randomized study
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of early serum trough concentrations of ixekizumab | Prediction of the clinical response (PASI) at week 12 and/or week 24 based on serum trough concentrations measurements taken from week 0, 1, 2, 3 and/or 4. | Week 0 until we... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DLQI | The DLQI (Dermatology Life Quality Index) (range 0-30) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the disease on participant's QoL. It is a ten item questionnaire that, in addition to eva... | Psoriasis, Therapeutic drug monitoring, Ixekizumab | Psoriasis, Skin Diseases, Papulosquamous, Skin Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard of care - ixekizumab<br>Patient will continue to receive ixekizumab according to standard of care dosing regimen, i.e. loading dose first (160 mg) at week 0; 80 mg every 2 weeks until week 12, then 80 mg every 4 weeks | Procedure: Venapu... | Therapeutic Drug Monitoring of Ixekizumab in Psoriasis Patients
Study Overview
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Brief Summary
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Biologics, such as ixekizumab, are currently the most effective treatment option for patients with moderate-to-severe psoriasis. But they are costly for health care systems and prescribed ac... |
NCT01024660 | The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With Donepezil | The purpose of this study is to determine if there is improvement or measurable change in cognition after only one month of treatment with donepezil when using a computerized test battery. The results at one month will be compared with the results at 3 months to evaluate this. | A Randomised, Double-blind, Placebo-controlled, Parallel Design, Multicentre Study in Patients With Mild to Moderate Alzheimer's Disease to Investigate the Effect on Cognitive Function as Measured by Repeated CogState Testing in Relation to Effects on Traditional Cognitive Measures After 12 Weeks | Alzheimer's Disease | * Drug: Donepezil
* Drug: Donepezil
* Drug: Placebo to match Aricept
| Inclusion Criteria:~Clinical diagnosis of probable AD according to NINCDS-ADRDA criteria.~The patient should live with an appropriate caregiver at home, or in a community dwelling. A caregiver should be capable of accompanying the patient to clinic visits or attending study visits in the patient's home.~Patient and car... | 55 Years | 85 Years | All | No | Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CogState Computerized Neurological Test Battery | | Tl. of 25 times: 10 times between Days 3-14, 5 times between Days 36-42, 5 times between Days 64-70, four times between Days 92-97, 1 time on Day 98 |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological Test Battery (NTB) | | Tl. of 5 times: Once between Days 1-2, Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97 |
| Alzheimer Disease Assessment Scale... | Patients with Mild to Moderate Alzheimer's Disease | Donepezil, Cholinesterase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Cholinergic Agents, Neurotransmitter Agents, Physiological Effects of Drugs, Nootropic Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>5 mg Donepezil (first 14 days), 10 mg Donepezil (next 70 days) | Drug: Donepezil<br>* 5 mg capsule, orally, once daily, first 14 days of treatment<br>* Other names: Aricept;Drug: Donepezil<br>* 10 mg, orally, once daily, for rema... | The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With Donepezil
Study Overview
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Brief Summary
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The purpose of this study is to determine if there is improvement or measurable change in cognition after only one month of treatment with... | |
NCT02023008 | Interactive Gentle Yoga in Improving Quality of Life in Patients With Stage I-III Breast Cancer Undergoing Radiation Therapy | This pilot clinical trial studies interactive gentle yoga in improving quality of life in patients with stage I-III breast cancer undergoing radiation therapy. Interactive gentle yoga may improve the quality of life in patients with breast cancer undergoing radiation therapy. | PRIMARY OBJECTIVES:~I. To determine the feasibility of implementing a 6-week biweekly yoga intervention delivered by multi-point videoconferencing in breast cancer patients undergoing radiation therapy.~SECONDARY OBJECTIVES:~I. To obtain preliminary data on changes in depression, anxiety, fatigue, sleep quality pre- an... | Convenient and Live Movement (CALM): Feasibility of Interactive Gentle Yoga for Women With Breast Cancer | Depression, Anxiety Disorder, Ductal Breast Carcinoma in Situ, Fatigue, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer | * Procedure: yoga therapy
* Other: internet-based intervention
* Other: questionnaire administration
| Inclusion Criteria:~Participants must be newly diagnosed with a histologically or cytologically confirmed breast cancer stage I-III (ductal carcinoma in situ [DCIS] is allowed)~Participants must have a score >= 8 on the depression subscale of the Hospital Anxiety and Depression Scale [HADS], indicating clinically signi... | 18 Years | null | Female | No | Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rates, calculated as the number of women enrolled divided by the number of women who screened eligible for the study | | Up to week 7 |
| Retention rates, calculated as the proportion of enrolled women who complete all study meas... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression as measured by HADS | Computed using a mixed model analysis to account for the repeated measures on each subject. | Baseline up to 7 weeks |
| Change in anxiety as measured by HADS | Computed using a mixed model analysis ... | Breast Neoplasms, Carcinoma in Situ, Carcinoma, Ductal, Breast, Breast Carcinoma In Situ, Carcinoma, Intraductal, Noninfiltrating, Anxiety Disorders, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases, Mental Disorders, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Carcinoma, D... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (internet-based integral yoga intervention)<br>Participants undergo 12 sessions of cancer-adapted integral yoga classes using an internet-based videoconferencing platform. Integral yoga includes postures, deep relaxation, b... | Interactive Gentle Yoga in Improving Quality of Life in Patients With Stage I-III Breast Cancer Undergoing Radiation Therapy
Study Overview
=================
Brief Summary
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This pilot clinical trial studies interactive gentle yoga in improving quality of life in patients with stage I-III breast cancer... | |
NCT03392532 | Comparison of Two Silicone Hydrogel Toric Contact Lenses | The purpose of this research study is to compare the performance of two different types of Alcon soft toric study contact lenses to obtain information on study lens orientation. | Axis Orientation Comparison of Two Silicone Hydrogel Toric Contact Lenses | Astigmatism | * Device: Lotrafilcon B toric contact lenses with HYDRAGLYDE
* Device: Lotrafilcon B toric contact lenses
| Inclusion Criteria:~Successful wear of soft contact lenses for vision correction in both eyes during the past 3 months for a minimum of 3 days per week and 8 hours per day~Astigmatism~Requires contact lenses~Best corrected visual acuity of 20/25 or better in each eye~Other protocol-specified inclusion criteria may appl... | 18 Years | null | All | No | Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location) | Each lens was classified based on whether the absolute difference between the axis location and 90° was less than or equal to 30° (ie, len... | Astigmatism, Axis orientation | Astigmatism, Refractive Errors, Eye Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AOHG toric, then AO toric<br>Lotrafilcon B toric contact lenses with HYDRAGLYDE, followed by lotrafilcon B toric contact lenses, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the r... | Comparison of Two Silicone Hydrogel Toric Contact Lenses
Study Overview
=================
Brief Summary
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The purpose of this research study is to compare the performance of two different types of Alcon soft toric study contact lenses to obtain information on study lens orientation.
Official Title
---... | ||
NCT02043483 | Identification of Biomarkers for Obstructive Sleep Apnoea Syndrome | Untreated Obstructive Sleep Apnea Syndrome (OSAS) has long-term complications, namely metabolic imbalances (obesity, dislipidemia, type 2 diabetes mellitus). Until now, no molecular markers for this physiopathological connection have been identified.~This project aims to determine non-invasive biomarkers that may allow... | Obstructive Sleep Apnoea and Associated Metabolic/Cardiovascular Disorders: Understanding Mechanisms Towards Early Diagnosis and Prognosis | Obstructive Sleep Apnoea Syndrome | Inclusion Criteria:~Male~25-60 years~Mild/Moderate/Severe OSAS~Exclusion Criteria:~Female~Other sleep disorders~Previous CPAP therapy~Type 1 diabetes mellitus~Familiar Dyslipidemia~Severe organ pathology~Acute disease | 25 Years | 60 Years | Male | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with clinical improvement | Treatment efficacy of CPAP will be assessed at the end of treatment through a clinical observation. | 6 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of occurence of biomarkers | Using Mass Spectrometric Immunoassay, we will identify which biomarkers have a positive association with long-term treatment effect. | 6 months |
| NOVA MEDICAL SCHOOL, CPAP, OSAS, CEDOC (Centro de Estudos de Doenças Crónicas), FCM (Faculdade de Ciências Médicas), UNL (Universidade Nova de Lisboa, FCT (Fundação para a Ciência e Tecnologia) | Sleep Apnea, Obstructive, Syndrome, Disease, Pathologic Processes, Respiration Disorders, Respiratory Tract Diseases, Signs and Symptoms, Respiratory, Sleep Disorders, Intrinsic, Dyssomnias, Sleep Wake Disorders, Nervous System Diseases, Apnea, Sleep Apnea Syndromes | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CPAP<br>Patients with moderate/severe OSAS will be treated with CPAP | |
| Control<br>Patients with snoring will not be subject to treatment with CPAP | |
| Identification of Biomarkers for Obstructive Sleep Apnoea Syndrome
Study Overview
=================
Brief Summary
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Untreated Obstructive Sleep Apnea Syndrome (OSAS) has long-term complications, namely metabolic imbalances (obesity, dislipidemia, type 2 diabetes mellitus). Until now, no molecular marke... | |||
NCT00426855 | Bendamustine and Bortezomib Combination Therapy in Indolent Non-Hodgkin's Lymphoma(NHL) | The purpose of this study is to determine whether the combination of bendamustine and bortezomib in patients with indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia is safe and tolerable. | Bendamustin and bortezomib have been shown to be effective in the treatment of patients with indolent Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). Both compounds appear not to be cross-resistant with prior therapy. Therefore, it is of interest to combine bendamustine and bortezomib in this patie... | Weekly Bendamustine and Bortezomib Combination Therapy in Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or B-CLL: A Single-Center Phase 2 Study | Lymphoma, Non-Hodgkin | * Drug: Bendamustine
* Drug: Bortezomib
| Inclusion Criteria:~Symptomatic recurrent or refractory indolent NHL or B-CLL~Adequate organ and bone marrow function~Karnofsky greater than 50%~Exclusion Criteria:~Candidates for autologous stem cell transplantation~Secondary high grade lymphoma~Concurrent severe medical condition | 18 Years | null | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal Bendamustine Dosage for Further Studies | | Three weeks after treatment termination |
| Lymphoma, Non-Hodgkin, Low-Grade | Bortezomib, Bendamustine Hydrochloride, Antineoplastic Agents, Antineoplastic Agents, Alkylating, Alkylating Agents, Molecular Mechanisms of Pharmacological Action | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bendamustine and Bortezomib<br>Combination Chemotherapy of Bendamustine and Bortezomib as described in the intervention section | Drug: Bendamustine<br>* starting with 60 mg/m^ 2, IV, dose escalation, weekly d1,8,15 q5w<br>* Other names: R... | Bendamustine and Bortezomib Combination Therapy in Indolent Non-Hodgkin's Lymphoma(NHL)
Study Overview
=================
Brief Summary
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The purpose of this study is to determine whether the combination of bendamustine and bortezomib in patients with indolent Non-Hodgkin's Lymphoma or Chronic Lymphocyt... | |
NCT04828850 | Preoperative Lymph Node Staging With EBUS-TBNA in Clinical N0 Non Small-cell Lung Cancer | The introduction of modern staging systems has increased the detection of small peripheral lung cancers at an early stage [1]. Stage I non-small-cell lung cancers (NSCLCs) are confined to the lung without lymph node involvement, and surgical resection is currently considered the standard therapeutic approach.~Nodal sta... | BACKGROUND AND RATIONALE The introduction of modern staging systems such as computed tomography (CT) and positron emission tomography/CT (PET/CT) with fluorodeoxyglucose (FDG) has increased the detection of small peripheral lung cancers at an early stage [1]. Stage I non-small-cell lung cancers (NSCLCs) are confined to... | Preoperative Lymph Node Staging by EBUS-TBNA in Clinical N0 Non Small-cell Lung Cancer | Non Small Cell Lung Cancer | * Procedure: Endobronchial ultrasound transbronchial needle aspiration lymph node staging
| Inclusion Criteria:~Suspected or proven non-small cell lung cancer (NSCLC) clinical stage I and II (diameter > 1 cm and less than 5 cm, no pleura invasion) clinical N0M0 (8th TNM)~All patients have to be staged by total body CT scan and PET-FDG~Negative preoperative staging at hilar and mediastinal level at CT and CT/P... | 18 Years | 75 Years | All | Accepts Healthy Volunteers | Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the sensitivity of EBUS-TBNA in lymph node staging for early stage lung cancer | A sample size of 12 upstaged patients will achieve 80% power to detect a difference of sensitivity >38.4% assuming that the sensitivity under the nu... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of concordance between EBUS-TBNA and surgery | Evaluation of diagnostic accuracy of both procedure in predicting the presence of lymph node metastasis | 17 months |
| Assessment of lymph node upstaging by EBUS and surgery | Predict... | EBUS-TBNA, NSCLC, Interventional bronchoscopy, Lung cancer | Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases, Carcinoma, Bronchogenic, Bronchial Neoplasms | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EBUS-TBNA procedure<br>Single arm protocol. Invasive mediastinal staging with EBUS-TBNA in clinical N0 NSCLC patients candidate to surgical resection with systematic lymphadenectomy. | Procedure: Endobronchial ultrasound transbronchial nee... | Preoperative Lymph Node Staging With EBUS-TBNA in Clinical N0 Non Small-cell Lung Cancer
Study Overview
=================
Brief Summary
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The introduction of modern staging systems has increased the detection of small peripheral lung cancers at an early stage [1]. Stage I non-small-cell lung cancers (N... |
NCT02358291 | Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy | In our study, a multicenter randomized controlled，single blind trial will be performed to evaluate the effectiveness and safety of these three procedures for the treatment of symptomatic lumbar disc herniation. | Lumbar disc herniation (LDH) is one of the most common diseases in the department of orthopedics, which produced medical and economic burdens to families and society. In spite, the majority of the patients with disc herniation can be relieved or even cured via conservative treatment; there are still a considerable numb... | Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy for the Treatment of Lumbar Disc Herniation | Lumbar Disc Herniation | * Procedure: open discectomy
* Procedure: microendoscopic discectomy
* Procedure: transforaminal endoscopic lumbar discectomy
| Inclusion Criteria:~All forms of disc herniation were included in the study~History of concordant radicular leg pain refractory to conservative treatment for longer than 6 months~Leg pain must be greater than back pain~Exclusion Criteria:~cauda equine syndrome,~progressive neurologic deficit,~bilateral lower extremity ... | 18 Years | 75 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index(ODI) | Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcom... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue scale(VAS) | Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome | up to 104 weeks |
| The generic health survey on the Short For... | Intervertebral Disc Displacement, Hernia, Pathological Conditions, Anatomical, Spinal Diseases, Bone Diseases, Musculoskeletal Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: open discectomy<br>patients diagnosed as lumbar disc herniation undergoing open simple discectomy(OD) | Procedure: microendoscopic discectomy<br>* Microendoscopic discectomy combines standard lumbar microsurgical techniques with endos... | Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy
Study Overview
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Brief Summary
-----------------
In our study, a multicenter randomized controlled，single blind trial will be performed to evaluate the effectiveness and safety of these three procedures for the... | |
NCT05346419 | Antiresorptive Effect of Treatment With Risedronate and Vitamin D in Postmenopausal Patients | Osteoporosis is defined as a systemic disease of bone mineralization, characterized by a decrease in bone mineral density that causes bone fragility and increases the risk of fractures during menopause. Recently, a high prevalence of hypovitaminosis D has been found worldwide, which could trigger a state of secondary h... | Participants were selected from the climacteric clinic of the regional hospital 1ro de Octubre-Instituto de Seguridad y Servicios Sociales para Los Trabajadores del Estado (ISSSTE), Mexico. All participants voluntarily accepted to be part of the study and provided written informed consent.This study was approved by the... | Risedronate With High-dose Vitamin D Resolves Hyperparathyroidism and Hypovitaminosis D But Not Osteoporosis in Mexican Postmenopausal Patients | Postmenopausal Osteoporosis, Hypovitaminosis D, Hyperparathyroidism | * Drug: Risedronate
* Drug: Vitamin D
| Inclusion Criteria:~Participants with a diagnosis of postmenopausal osteoporosis or osteopenia.~Participants with a diagnosis of hyperparathyroidism or hypovitaminosis D.~Participants who accepted to participate and that provided informed consent.~Exclusion Criteria:~Participants with oncological pathologies.~Participa... | 40 Years | 78 Years | Female | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 33 participants between 40 and 78 years old with a diagnosis of postmenopausal osteoporosis or osteopenia with associated hyperparathyroidism, hypovitaminosis or both conditions were selected. All participants were ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission of hyperparathyroidism | Remission of hyperparathyroidism was considered when serum parathyroid hormone [PTH] values were below 45 pg/mL. | 6 months |
| Remission of hypovitaminosis D | Remission of hypovitaminosis D was considered ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline serum calcium at 6 months | Calcium was evaluated as a bone mineralization marker. | 6 months |
| Change from baseline serum phosphorus at 6 months | Phosphorus was evaluated as a bone mineralization marker. | 6 months | ... | Postmenopause, Postmenopausal Osteoporosis, Hypovitaminosis D, Hyperparathyroidism, Risedronate, Osteopenia, Bone Mineral Density, Bone resorption | Vitamin D, Risedronic Acid, Vitamins, Micronutrients, Physiological Effects of Drugs, Bone Density Conservation Agents, Calcium Channel Blockers, Membrane Transport Modulators, Molecular Mechanisms of Pharmacological Action, Calcium-Regulating Hormones and Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postmenopausal Osteopenia-osteoporosis patients<br>All participants were treated for 6 months with risedronate 35 mg and vitamin D 2800 IU once a week, with additional daily vitamin D supplementation of 4000 IU. | Drug: Risedronate<br>* Pa... | Antiresorptive Effect of Treatment With Risedronate and Vitamin D in Postmenopausal Patients
Study Overview
=================
Brief Summary
-----------------
Osteoporosis is defined as a systemic disease of bone mineralization, characterized by a decrease in bone mineral density that causes bone fragility and increase... |
NCT02191371 | Effect of Anesthetics on Oxygenation and Microcirculation During One-lung Ventilation | One-lung ventilation during thoracic surgery may affect systemic oxygenation and peripheral microcirculation by hypoxic pulmonary vasoconstriction. Both intravenous and inhalational anesthetics can be used during one-lung ventilation. However, there is still a controversy which anesthetic would be more appropriate duri... | Patients undergoing thoracic surgery including one-lung ventilation will be randomized to receive intravenous (propofol) or inhalational (desflurane) anesthetic.~Systemic oxygenation can be evaluated by measuring partial pressure of oxygen in arterial blood analysis. Microcirculatory parameters can be obtained from vas... | Effect of Anesthetics on Oxygenation and Microcirculation During One-lung Ventilation | Mechanical Ventilation Complication | * Drug: propofol
* Drug: desflurane
| Inclusion Criteria:~undergoing thoracic surgery including one-lung ventilation~Exclusion Criteria:~refuse to enroll~BMI over 30 kg/m(2)~severe obstructive or restrictive lung disease~preoperative supplemental oxygen, intubated, or mechanical ventilatory support~preoperative arterial partial pressure of oxygen < 60 mmHg... | 20 Years | 90 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial partial pressure of oxygen | Primary outcome is arterial partial pressure of oxygen 30 min after one-lung ventilation during thoracic surgery in propofol and desflurane groups. | 30 min after one-lung ventilation |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recovery slope | Secondary outcome is recovery slope measured by vascular occlusion test 30 min after one-lung ventilation during thoracic surgery in propofol and desflurane groups. | 30 min after one-lung ventilation |
| oxygenation, microcirculation, one-lung ventilation, thoracic surgery | Physiological Effects of Drugs, Anesthetics, Desflurane, Hypnotics and Sedatives, Central Nervous System Depressants, Anesthetics, Intravenous, Anesthetics, General, Anesthetics, Inhalation, Propofol | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: propofol<br>Propofol is used as a maintenance anesthetic to patients in the propofol group. Intervention: propofol infusion by target-controlled infusion for maintaining anesthesia propofol (Fresofol MCT 2%) target effect site concentratio... | Effect of Anesthetics on Oxygenation and Microcirculation During One-lung Ventilation
Study Overview
=================
Brief Summary
-----------------
One-lung ventilation during thoracic surgery may affect systemic oxygenation and peripheral microcirculation by hypoxic pulmonary vasoconstriction. Both intravenous and... |
NCT05280223 | Dexmedetomidine Versus Hyalase Treatment of Carpal Tunnel Syndrome | Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy, this study aims to investigate if, and to what extent hydro-dissection hyalase and saline versus dexmedetomidine upon the median nerve could offer symptoms and clinical improvement | Carpal tunnel syndrome (CTS) is the most common compression syndrome the upper extremities. Its problem has a high prevalence ranged estimated prevalence of 3.8% in the general population, 3 and 7.8% in the working population. It occurs at any age, especially in individuals in their 40s to 60s, and the male: female rat... | Dexmedetomidine Versus Hyalase Local Injection for Pain Alleviation in Patients With Carpal Tunnel Syndrome; A Randomized Clinical Trial | Carpal Tunnel Syndrome, Pain, Chronic | * Drug: Dexmedetomidine
* Drug: Hyalase
| Inclusion Criteria:~adult patients~complaining of carpal tunnel syndrome of 3 month duration or more~diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study~Exclusion Criteria:~• patient refusal infection at the site of intervention~local anesthetic allergy | 18 Years | 60 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain alleviation | pain alleviation improvement of pain measured by visual analog scale , no pain the scale equal zero , and worst pain the scale equal 10 | 6 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median nerve cross sectional area | Changes in ultrasound imaging change of cross sectional area in cubic mellimeter | 6 months |
| Dexmedetomidine, Hypnotics and Sedatives, Central Nervous System Depressants, Physiological Effects of Drugs, Analgesics, Non-Narcotic, Analgesics, Sensory System Agents, Peripheral Nervous System Agents, Adrenergic alpha-2 Receptor Agonists, Adrenergic alpha-Agonists, Adrenergic Agonists, Adrenergic Agents, Neurotrans... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmeditomidine group<br>injection of 1 microgram/kg dexmedetomidine + 10 cc saline injection nearby median nerve as hydrodissection | Drug: Dexmedetomidine<br>* injection of 1 microgram/kg dexmeditomidine + 10 cc saline injection nea... | Dexmedetomidine Versus Hyalase Treatment of Carpal Tunnel Syndrome
Study Overview
=================
Brief Summary
-----------------
Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy, this study aims to investigate if, and to what extent hydro-dissection hyalase and saline versus dexmedetomidine... | |
NCT03198624 | Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects | This is a single and multiple dose, parallel group study to assess safety and pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects. | This is a single and multiple dose, parallel group study to assess safety and pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects. The study will be conducted in two parts: (A) single doses of HTL0018318 in healthy, adult, male Caucasian and Japanese subjects; (B) multiple doses of HTL0018318... | A Two-part, Single and Multiple Dose, Parallel Group Study to Assess Safety and Pharmacokinetics of Oral HTL0018318 in Healthy Japanese and Caucasian Subjects | Safety Issues, Pharmacokinetics | * Drug: HTL0018318
* Drug: Placebo oral capsule
| Inclusion Criteria:~Male subjects, either Caucasian or Japanese aged ≥20 and ≤40 years.~Japanese subjects must have lived outside of Japan for ≤ 5 years in total and be first generation Japanese, defined as born in Japan and having 4 biologic grandparents who are ethnic Japanese.~The Caucasian subjects should be distin... | 20 Years | 40 Years | Male | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Comparison of pharmacokinetics in plasma | Baseline to 72 hours |
| Tmax | Comparison of pharmacokinetics in plasma | Baseline to 72 hours |
| Area under the curve | Comparison of pharmacokinetics in plasma | Baseline to 72 hours |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay in absorption (Tlag) | Pharmacokinetics in plasma | Baseline to 72 hours |
| Rate of elimination | Pharmacokinetics in plasma | Baseline to 72 hours |
| Half life (t1/2) | Pharmacokinetics in plasma | Baseline to 72 hours |
| Amount e... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HTL0018318 Low dose, Part A.<br>Part A. 1 single dose on day 1. Discharged on day 4 of Period 1 (following 10 day washout). | Drug: HTL0018318<br>* Part A single dose Part B five doses<br>|
| Active Comparator: HTL0018318 High dose, P... | Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects
Study Overview
=================
Brief Summary
-----------------
This is a single and multiple dose, parallel group study to assess safety and pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects.
Detailed Descriptio... | ||
NCT00632788 | The Influence of Acute Myocardial Infarction Checklist on the Door-to-Balloon Time | This study was designed to investigate the influence of the acute myocardial infarction checklist on the door-to-balloon time in patients suffering from acute STEMI at Far Eastern Memorial Hospital | The Influence of Acute Myocardial Infarction Checklist on the Door-to-Balloon Time in Patients Suffering From Acute ST-Elevation Myocardial Infarction | Myocardial Infarction | * Other: acute myocardial infarction checklist
| Inclusion Criteria:~all patients who presented to the emergency department of Far Eastern Memorial Hospital within 12 hours of the onset of ischemic chest pain~patients with diagnostic criteria of acute ST-elevation myocardial infarction on electrocardiogram, e.g. at least 0.1 mV in two or more contiguous electrocardio... | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median door-to-balloon time | | at cath. lab |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-hospital mortality | | at hospital discharge |
| myocardial infarction, catheterization, angioplasty, door-to-balloon time | Myocardial Infarction, Infarction, Ischemia, Pathologic Processes, Necrosis, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Vascular Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| intervention group<br>patients presented with acute ST-elevation myocardial infarction and received emergency cardiac catheterization between March 1, 2007 and Oct. 31, 2007 | Other: acute myocardial infarction checklist<br>* For every patient fulfillin... | The Influence of Acute Myocardial Infarction Checklist on the Door-to-Balloon Time
Study Overview
=================
Brief Summary
-----------------
This study was designed to investigate the influence of the acute myocardial infarction checklist on the door-to-balloon time in patients suffering from acute STEMI at Far... |
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