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NCT05001243 | Comparison of a Compound With Pilocarpine and Brimonidine to Improve Near Vision in Healthy Presbyopic Patients | Safety and Efficacy of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) ophthalmic compound compared to Pilocarpine and Brimonidine to improve uncorrected near vision in healthy presbyopic patients one hour after instillation. | To determine the safety and efficacy of a novel pharmacological compound of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) to improve uncorrected near vision in healthy presbyopic patients compared to Pilocarpine and Brimonidine one hour after binocular instillation. | Comparison of Pilocarpine, Brimonidine, Oxymetazoline, Hialuronic Acid, Bromfenac Ophthalmic Compound With Pilocarpine and Brimonidine to Improve Uncorrected Visual Acuity in Healthy Presbyopic Individuals | Presbyopia | * Drug: Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac
* Drug: Pilocarpine Hydrochloride
* Drug: Brimonidine Tartrate
| Inclusion Criteria:~Healthy~Presbyopic~40 - 59 years~Exclusion Criteria:~Diabetics~Previous eye surgery~Previous eye disease~> 0.50 myopia~> 1.5 hyperopia or astigmatism | 40 Years | 60 Years | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single Group Assignment To determine safety and efficacy of a Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac compound compared to Brimonidine and Pilocarpine to improve near u... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of eyes improving 3 lines or more near visual acuity | Eyes instilled with PBOHB | 1 hour |
| Eyes improving 3 lines or more near visual acuity | Eyes instilled with Pilocarpine | 1 hour |
| Eyes improving 3 lines or more near VA | Ey... | Neurotransmitter Agents, Sympathomimetics, Miotics, Bromfenac, Brimonidine Tartrate, Phenylephrine, Oxymetazoline, Hyaluronic Acid, Pilocarpine, Adjuvants, Immunologic, Immunologic Factors, Physiological Effects of Drugs, Viscosupplements, Protective Agents, Antihypertensive Agents, Adrenergic alpha-2 Receptor Agonists... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental PBOHB<br>Pilocarpine, brimonidine, Oxymetazoline combined with Hyaluronic Acid and Bromfenac combined in an ophthalmic solution to be randomly instilled in one eye. | Drug: Pilocarpine Hydrochloride<br>* Apply in the fellow ey... | Comparison of a Compound With Pilocarpine and Brimonidine to Improve Near Vision in Healthy Presbyopic Patients
Study Overview
=================
Brief Summary
-----------------
Safety and Efficacy of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) ophthalmic compound compared to Pilocarpine... | ||
NCT03440905 | Proxy-Reported Symptoms and Quality of Life Survey in Zellweger Spectrum Disorders | The purpose of this study is to characterize the symptoms of Zellweger Spectrum Disorder (ZSD) and related peroxisome disorders, and to assess the quality of life of family caregivers (parents, stepparents, legal guardians) of patients diagnosed with ZSD or a related peroxisome disorder. All family caregivers of patien... | A total of three online surveys will be provided to each family caregiver that fits the inclusion criteria and is enrolled in the RDCRN STAIR Contact Registry. All three surveys should take approximately 60 minutes total to complete.~The first survey included is the ZSD Symptom Inventory, which is comprised of both mul... | Proxy-Reported Symptoms and Quality of Life Survey in Zellweger Spectrum Disorders | Zellweger Spectrum | Inclusion Criteria:~Family caregiver (parents, stepparents, legal guardians) of child (living or deceased) diagnosed with ZSD, acyl CoA oxidase (ACOX) deficiency or D-bifunctional protein deficiency (DBPD)~Family caregiver is able to complete surveys~Exclusion Criteria:~Inability of family caregiver to provide informed... | 18 Years | null | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of Symptoms | To characterize the symptoms of Zellweger spectrum disorder (ZSD) and related peroxisome disorders through family caregiver-reported measures using a customized survey tool. | 6 months from the study start date |... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Assessment | To assess quality of life for family caregivers of children with ZSD and related peroxisome disorders through the domains of communication, medical care, emotional distress and well-being, role function, family int... | Urogenital Diseases, Zellweger Syndrome, Liver Diseases, Digestive System Diseases, Brain Diseases, Metabolic, Inborn, Brain Diseases, Metabolic, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Kidney Diseases, Urologic Diseases, Female Urogenital Diseases, Female Urogenital Diseases and Pregn... | Proxy-Reported Symptoms and Quality of Life Survey in Zellweger Spectrum Disorders
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the symptoms of Zellweger Spectrum Disorder (ZSD) and related peroxisome disorders, and to assess the quality of life of famil... | ||||
NCT00156377 | Prophylaxis With Intranasal Mupirocin for Prevention of S. Aureus Infections | In order to evaluate the effect of eliminating nasal carriage by mupirocin prophylaxis on subsequent Staphylococcus aureus infection, a prospective randomized trial was performed particularly including patients with predisposing risk factors for S. aureus infections. | In a past study, we showed that there is a strong correlation between strains colonizing the anterior nares, strains isolated from the presumed foci of infection, and strains isolated from blood in patients with Staphylococcus aureus bacteremia. These results suggested that a substantial proportion of cases of systemic... | Investigation of the Influence of Intranasal Mupirocin on the Prevalence of S. Aureus Nosocomial Infections by Eradication of Intranasal S. Aureus | Cross Infection, Staphylococcal Infections | * Drug: Mupirocin
| Inclusion Criteria:~All patients admitted to selected units in clinics for anaesthesiology, hemato-oncology, cardiac surgery, and orthopedics at the University Hospital of Muenster (following information on the study and agreement of the patient).~Exclusion Criteria:~Patients infected with S. aureus at admission~S. aur... | 18 Years | null | All | No | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Staphylococcus aureus infection any time after 5 days of mupirocin ointment | | |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or abscence of risk factors associated with S. aureus infections at any time during the hospital stay | | |
| Mupirocin, Staphylococcus aureus, Nasal Cavity, Preventive measures | Mupirocin, Anti-Bacterial Agents, Anti-Infective Agents, Protein Synthesis Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action | | Intervention/Treatment |
| --- |
|Drug: Mupirocin|nan|
| Prophylaxis With Intranasal Mupirocin for Prevention of S. Aureus Infections
Study Overview
=================
Brief Summary
-----------------
In order to evaluate the effect of eliminating nasal carriage by mupirocin prophylaxis on subsequent Staphylococcus aureus infection, a prospective randomized trial was performe... |
NCT03940573 | Pursuit: Real World Use of the Eclipse System | A prospective, open label post-market registry to collect Patient Reported Outcomes and Fitting metrics (e.g. sizes used) in subjects using the Eclipse System in a commercial setting. | Up to 150 subjects enrolled, in up to 25 sites. Population of all adult female patients with Fecal Incontinence (FI) who present at, or are identified at, participating sites are eligible. This includes patients who are newly prescribed Eclipse, and those already using Eclipse who return for an annual renewal visit dur... | A Registry to Further Develop the Understanding of the Real World Use of the Eclipse System for Fecal Incontinence in Women | Fecal Incontinence | * Device: Eclipse Insert
| Inclusion Criteria:~Adult female~Diagnosis of Fecal Incontinence~Clinician recommendation of the Eclipse System~Subject provides informed consent and HIPAA authorization~No Exclusion Criteria. | 19 Years | null | Female | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fit Rate | Proportion of patients successfully fit | Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening |
| Device Size Distribution | Size distribution of devices among successfully fit patients | Data collec... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| St. Mark's Score (Vaizey) | Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence) | 3 months |
| St. Mark's Score (Vaizey) | Change from baseline in mean scores (scored 0-24 with 0 = total con... | Fecal Incontinence, Rectal Diseases, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>All patients fitted with the device. | Device: Eclipse Insert<br>* Rectal Control System.<br>|
| Pursuit: Real World Use of the Eclipse System
Study Overview
=================
Brief Summary
-----------------
A prospective, open label post-market registry to collect Patient Reported Outcomes and Fitting metrics (e.g. sizes used) in subjects using the Eclipse System in a commercial setting.
Detailed Description
--... | |
NCT04809714 | The Role of Blood Flow Restriction Therapy in Postoperative Elderly Patients With Hip Fracture | The investigators aim to study the use of blood flow restriction therapy (BFR) to augment routine post-operative physical therapy in elderly patients (age >= 65) after recovering from surgical treatment of hip fractures. | For elderly patients, a hip fracture is a life-altering event associated with poor overall outcomes despite early surgical treatment. The elderly population and those with significant osteopenia is growing exponentially and thus the optimal treatment and rehabilitation of hip fractures warrants increased investigation.... | The Role of Blood Flow Restriction Therapy in the Postop Rehabilitation of Elderly Patients With Hip Fractures: A Randomized Controlled Pilot Study | Hip Fractures, Muscle Atrophy | * Device: Blood Flow Restriction with Delfi Tourniquet System Cuff
* Other: Routine Post-operative Physical Therapy
| Inclusion Criteria:~Age >= 65 years old, any sex, any ethnicity~Isolated, closed proximal femur fracture without any prior surgery or orthopedic implants to affected proximal femur. This includes all fractures with primary fracture line that is proximal to the lesser trochanter. For example, subtrochanteric femur fract... | 65 Years | null | All | No | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants thigh circumference measurement | 10cm proximal to superior pole patella and leg circumference measured at 10 distal to inferior pole patella for both extremities | At enrollment |
| Participants thigh circumference measurement |... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go Test (TUG) | Measurement of the time in seconds for a person to rise from sitting from a standard arm chair, walk 3 meters, walk back to the chair, and sit down. | Post op 2 weeks |
| Modified 30-second sit-to-stand test | Mea... | Hip Surgery, Geriatric, Blood flow restriction therapy, Muscle atrophy, Muscle disuse | Muscular Atrophy, Atrophy, Fractures, Bone, Hip Fractures, Wounds and Injuries, Pathological Conditions, Anatomical, Femoral Fractures, Hip Injuries, Leg Injuries, Neuromuscular Manifestations, Neurologic Manifestations, Nervous System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Routine Post-operative Physical Therapy<br>The control group will undergo routine post-op and undergo a modified version of the graduated therapy protocol. | Other: Routine Post-operative Physical Therapy<br>* The control group with u... | The Role of Blood Flow Restriction Therapy in Postoperative Elderly Patients With Hip Fracture
Study Overview
=================
Brief Summary
-----------------
The investigators aim to study the use of blood flow restriction therapy (BFR) to augment routine post-operative physical therapy in elderly patients (age >= 6... |
NCT05496855 | Remote Care in People With Rheumatoid Arthritis | This study is a 24-months, non-inferiority randomized, controlled trial with two parallel arms to determine if a new follow-up strategy for patients with RA is non-inferior in maintaining comprehensive disease control measured as simultaneous maintenance of structural, functional and clinical treatment target at 2-year... | The study will include Norwegian adult males and females with rheumatoid arthritis. Eligible patients that consent to participation will be randomized to two groups:~Control group: conventional follow-up strategy with blood tests, patient-reported outcomes (PROs), and pre-scheduled visits at the hospital every 6th mont... | Can Machine Learning and Patient-reported Outcomes be Used in Remote Care in People With Rheumatic Diseases | Rheumatoid Arthritis | * Other: Conventional follow-up
* Other: Remote monitoring
| Inclusion Criteria:~Male or non-pregnant, non-nursing female ≥18 years of age at screening~Patients with a diagnosis of RA who fulfil the 2010 ACR/EULAR diagnostic criteria24 (see Appendix 5, 10.4)~Medical treatment with cs/ts/bDMARDs (incl. prednisolone) considered stable by the healthcare provider the last 6 months~L... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled non-inferiority trial
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion maintaining comprehensive disease control | Comprehensive disease control measured as simultaneous maintenance of structural, functional and clinical treatment target at 2-year follow-up.~Structural: Radiographs of hands and feet ac... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in joint damage progression | Joint damage progression from inclusion to 2-year follow-up assessed with radiographs of hands and feet according to the van der Heijde modified Sharpe score (subscores for erosions (0-280) and joint space ... | remote care | Arthritis, Arthritis, Rheumatoid, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Connective Tissue Diseases, Autoimmune Diseases, Immune System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional follow-up<br>Conventional follow-up strategy with blood tests and face-to-face visits at the hospital every 6 months | Other: Conventional follow-up<br>* Patients in the conventional/usual care arm will be treated accordi... | Remote Care in People With Rheumatoid Arthritis
Study Overview
=================
Brief Summary
-----------------
This study is a 24-months, non-inferiority randomized, controlled trial with two parallel arms to determine if a new follow-up strategy for patients with RA is non-inferior in maintaining comprehensive dise... |
NCT03434717 | Optimized Rehabilitation Following Primary Breast Cancer Surgery | This study aims to evaluate the effects of an intervention based on systematic screening of psychological distress as the basis for individualised support and rehabilitation following primary breast cancer surgery focusing on psychological , physical and health-economics outcomes. The aim is also to illuminate patients... | Breast cancer survivors are known to suffer from remaining problems from their treatment after surgery. Despite numerous of studies evaluating the effect of various rehabilitation programs it is know that patients often receive rehabilitation recommendations that are general rather than individualised to their needs. T... | Optimized Rehabilitation Following Primary Breast Cancer Surgery - Systematic Screening as a Tool for Individualised Rehabilitation: Study Protocol for the RE-SCREEN Randomized Controlled Trial | Rehabilitation, Breast Neoplasms, Psychological Distress | * Other: Individualised rehabilitation
* Other: Care as usual
| Inclusion Criteria:~Undergone treatment for primary breast cancer~≤18 years old~Ability to communicate in Swedish~Written informed consent~Exclusion Criteria:~Recurrent disease~Palliative diagnosis~Pregnancy~Prior history of breast cancer~Inability to participate in the study due to cognitive impairment | 18 Years | null | Female | No | Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological Distress | Psychological Distress measured by the Distress thermometer. A instrument that the patients answer themselves measuring the level of distress and the potential problems the may have. | Instrument will be answered appro... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Quality of life | The instrument QLQ-C30 is developed by the EORTC (European Organization for Research and Treatment of Cancer) and measurers quality of life | Instrument will be answered approximately 1 week pre-operative and after su... | Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control (high distress)<br>Control group receiving care as usual | Other: Care as usual<br>* Patients will get care as usual<br>|
| Experimental: Individualised rehabilitation<br>Patients with high distress receive the intervention individ... | Optimized Rehabilitation Following Primary Breast Cancer Surgery
Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the effects of an intervention based on systematic screening of psychological distress as the basis for individualised support and rehabilitation following prima... | |
NCT03255057 | Extracorporeal CO2 Removal With the Hemolung RAS for Mechanical Ventilation Avoidance During Acute Exacerbation of COPD | This study evaluates the safety and efficacy of using the Hemolung RAS to provide low-flow extracorporeal carbon dioxide removal (ECCO2R) as an alternative or adjunct to invasive mechanical ventilation for patients who require respiratory support due to an acute exacerbation of Chronic Obstructive Pulmonary Disease (CO... | The Hemolung RAS provides low-flow ECCO2R using a single, 15.5 French dual-lumen catheter inserted percutaneously in the femoral or jugular vein. Low-flow ECCO2R offers an alternative or supplement to invasive mechanical ventilation (MV) for patients suffering from acute, reversible, hypercapnic respiratory failure. In... | A Prospective, Multi-Center, Randomized, Controlled, Pivotal Trial to Validate the Safety and Efficacy of the Hemolung® Respiratory Assist System for COPD Patients Experiencing an Acute Exacerbation Requiring Ventilatory Support | Acute Exacerbation of COPD | * Device: Hemolung Respiratory Assist System
* Device: Invasive mechanical ventilation
| Inclusion Criteria:~Age ≥ 40 years~Confirmed diagnosis of underlying COPD or ACOS (Asthma-COPD Overlap Syndrome)~Experiencing acute hypercapnic respiratory failure~Informed consent from patient or legally authorized representative~Meets one of the three following criteria:~Is at high risk of requiring intubation and in... | 40 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, multi-center, randomized, controlled, two-arm, open-label, adaptive, two-strata, pivotal trial
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of time in the first five days following randomization that a patient is free of Invasive MV and alive | Statistically analyzed as Ventilator-Free Days during the 5 days from randomization (VFD-5) | 5 days |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiologic benefit | Based on blood gases and concomitant ventilation parameters | Time to extubation from first intubation up to 60 days from randomization |
| Avoidance of intubation | Incidence of subjects who did not require intubation a... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemolung plus SOC IMV<br>Low-flow ECCO2R with the Hemolung Respiratory Assist System as an alternative or adjunct to standard-of-care (SOC) invasive mechanical ventilation (IMV) | Device: Hemolung Respiratory Assist System<br>* Treatment w... | Extracorporeal CO2 Removal With the Hemolung RAS for Mechanical Ventilation Avoidance During Acute Exacerbation of COPD
Study Overview
=================
Brief Summary
-----------------
This study evaluates the safety and efficacy of using the Hemolung RAS to provide low-flow extracorporeal carbon dioxide removal (ECCO... | ||
NCT01365715 | Preoperative Embolization in Surgical Treatment of Spinal Metastases. | The main purpose of this study is to assess the efficacy of preoperative embolization in decreasing operative blood loss, decreasing the need for intraoperative transfusion and facilitate surgical resection in metastatic spine surgery. Furthermore the study aims at describing the vascularity in a series of spinal metas... | Preoperative Embolization in Surgical Treatment of Spinal Metastases. A Randomized Controlled Trial. | Spinal Metastases | * Procedure: Arteriography and preoperative embolization
* Procedure: Arteriography
| Inclusion Criteria:~Patients scheduled for decompression and posterior thoracic and/or lumbar instrumented spinal fusion because of spinal metastasis/metastases.~Informed signed consent.~Exclusion Criteria:~Contrast fluid allergy.~Clotting disorders.~Renal failure.~Not suitable for arterial access.~Pregnancy. | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative blood loss | | Measured intraoperatively and 24 hours postoperatively. |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative blood transfusion volume | | Intraoperatively and until 48 hours postoperatively. |
| Surgical procedure time. | Defined as the amount of time (measured in minutes) from skin incision to skin closure. | At skin closure. |
| Va... | Therapeutic angiography, Preoperative embolization, Transcatheter arterial embolization, Embolization, Surgical blood loss, Spinal metastases, Spinal neoplasms, Vertebral metastases, metastatic spine surgery, Spinal surgery | Neoplasms, Neoplasm Metastasis, Neoplasms, Second Primary, Neoplastic Processes, Pathologic Processes | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative embolization<br>32 patients with spinal metastasis/metastases will undergo arteriography and receive transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery. | Procedure: Arteriography a... | Preoperative Embolization in Surgical Treatment of Spinal Metastases.
Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to assess the efficacy of preoperative embolization in decreasing operative blood loss, decreasing the need for intraoperative transfusion and facilit... | |
NCT05094583 | The SmokeFree App Smoking Cessation Study | SmokeFree is a theory-driven and evidence-based stop smoking mobile application. Based on NICE guidance and best practice for smoking cessation, the application employs over 30 behaviour change techniques used in NHS Stop Smoking Services. It has been downloaded over 4 million times and has an average user rating of 4.... | The SmokeFree App Smoking Cessation Study | Smoking Cessation, Smoking, Smoking Reduction, Smoking Habit | * Behavioral: Use of SmokeFree app
| Inclusion Criteria:~Intervention:~≥ 18 years~All new patients admitted via the Acute medical via AAU (or AEC)~Current smoker and willing to quit~Smartphone owner~Fluent in English (verbal and written)~Able to give informed consent~Able and willing to attend a follow up visit in 12 weeks.~Control:~- Meet above inclusion... | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking abstinence | Percentage of participants who achieved sustained abstinence over 4 weeks, within 12 weeks from starting to use the SmokeFree app, compared against outcomes for patients who expressed wish to quit but declined use of the S... | Acute Assessment Unit, Ambulatory Emergency Care | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention Arm<br>Patients who expressed wish to quit smoking and accept use of the SmokeFree app | Behavioral: Use of SmokeFree app<br>* Intervention Arm<br>|
| Control Arm<br>Patients who expressed wish to quit smoking but declines all support or us... | The SmokeFree App Smoking Cessation Study
Study Overview
=================
Brief Summary
-----------------
SmokeFree is a theory-driven and evidence-based stop smoking mobile application. Based on NICE guidance and best practice for smoking cessation, the application employs over 30 behaviour change techniques used in... | ||||
NCT04573894 | Diagnostic Performance of Plasma Procalcitonin for the Detection of Blood Cultures Contaminations | In blood cultures, species considered as potentially contaminating (coagulase negative staphylococci (CNS), Bacillus spp., Corynebacterium spp., Cutibacterium acnes, Micrococcus spp., viridans group streptococci, and Clostridium perfringens) can, however, be responsable for true bacteremia.~Blood levels of the prohormo... | Blood culture contamination is defined by the introduction into of a microorganism into blood culture bottles from either the patient's or healthcare worker's flora, or the immediate environment during specimen collection. Species considered as potentially contaminating (coagulase negative staphylococci (CNS), Bacillus... | Diagnostic Performance of Plasma Procalcitonin in Screening for Contamination When Detecting Potential Contaminants in Blood Cultures | Blood Culture Contamination, Bacteremia, Contamination | * Diagnostic Test: Procalcitonin dosage
| Inclusion Criteria:~At least one blood culture positive for of the following microorganisms: coagulase negative staphylococci, viridans group streptococci~PCT levels measurement on the day of blood culture specimen collection~Adult patients~Exclusion Criteria:~Patients with less than 3 blood culture bottles collected | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the diagnostic potential of plasma procalcitonin in detecting blood culture contamination | True contamination will be considered if all of the following biological criteria are met:~Only one bottle collected is positive~The growth... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare plasma PCT levels in patients with true bacteremia, probable bacteremia and contamination caused by the presence of bacterial species with high contaminant potential | Bacteremia will be considered as present ( true bacteremia ) if ... | Procalcitonin | Bacteremia, Bacterial Infections, Bacterial Infections and Mycoses, Infections, Sepsis, Systemic Inflammatory Response Syndrome, Inflammation, Pathologic Processes | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Positives blood cultures<br>Collection of clinical and biological data of patients with blood cultures positives for potential contaminants, as well as PCT levels measurements, from January 2016 to May 2019 at the Nancy CHRU | Diagnostic Test: Procalcit... | Diagnostic Performance of Plasma Procalcitonin for the Detection of Blood Cultures Contaminations
Study Overview
=================
Brief Summary
-----------------
In blood cultures, species considered as potentially contaminating (coagulase negative staphylococci (CNS), Bacillus spp., Corynebacterium spp., Cutibacteri... | |
NCT00628693 | Quantitative Measurement of Cardiopulmonary Resuscitation (CPR) During In Hospital Cardiac Arrest | The design of this protocol is a prospective observational study to objectively measure the rate, depth and quality of chest compressions and ventilations delivered during cardiac arrest in the Pediatric Intensive Care Unit (PICU) and Emergency Department (ED) settings utilizing the MRx/Q-CPR. The data collected will b... | Context: Cardiopulmonary Resuscitation (CPR) guidelines recommend target values for selected CPR parameters related to rate and depth of chest compressions and ventilations, and avoidance of CPR-free intervals. Recent studies on adult patients however show that rescuers often do not adhere to these guidelines. There is... | Quantitative Measurement of Cardiopulmonary Resuscitation During In Hospital Cardiac Arrest | Cardiac Arrest, Cardiopulmonary Resuscitation | Inclusion Criteria:~Cardiac Arrest Inclusion Criteria:~Cardiac arrests occurring in the PICU or ED at The Children's Hospital of Philadelphia equipped with the MRx/Q-CPR~Patient experiencing the arrest must be greater than or equal to 8 years old and receive chest compressions with the Q-CPR sensor employed~Clinical St... | 8 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the rate, depth, and quality of chest compressions and ventilations delivered to children during in-hospital CPR. | | Ongoing |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the chest wall stiffness of children in order to improve quantitative CPR modeling efforts and to facilitate the construction of more biofidelic pediatric manikins for CPR simulation and test dummies for automotive safety. | | On... | CPR | Heart Arrest, Heart Diseases, Cardiovascular Diseases | Quantitative Measurement of Cardiopulmonary Resuscitation (CPR) During In Hospital Cardiac Arrest
Study Overview
=================
Brief Summary
-----------------
The design of this protocol is a prospective observational study to objectively measure the rate, depth and quality of chest compressions and ventilations d... | |||
NCT01792206 | Effect Of Paricalcitol (Zemplar) On Endothelial Function And Inflammation In Type 2 Diabetes And Chronic Kidney Disease | The purpose of this research study is to study the effects of paricalcitol on endothelial function and inflammation, cardiovascular risk factors which are associated with patient populations that have Type 2 diabetes and Stage 3 and 4 Chronic Kidney Disease (CKD).~Hypothesis 1: The state of CKD is associated with oxida... | EFFECT OF PARICALCITOL (ZEMPLAR) ON ENDOTHELIAL FUNCTION AND INFLAMMATION IN TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE | Type 2 Diabetes, Chronic Kidney Disease | * Drug: Zemplar
* Drug: Placebo
| Inclusion Criteria:~Patients with Type 2 diabetes and CKD~Age 18 - 70 years~Stable anti-hypertensive and lipid lowering therapy for at least 2 months. All patients should be on an ACEI or ARB unless contraindicated because of side effects (standard of care). No changes in lipid lowering therapy during the 3 months of t... | 18 Years | 70 Years | All | No | Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in brachial artery Flow Mediated Dilataion with paracalcitol (1mcg/day)compared with placebo for 3 months. | We therefore propose a study of the effects of Zemplar compared to placebo in patients with diabetes and stage 3-4 CKD on e... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker Measurement | Determine the prevalance of abnormalities in biomarkers of inflammation, oxidative stress and endothelial function in patients with CKD compared to a healthy population~The following are the biomarkers of inflammation a... | Stage 3 chronic kidney disease (CKD), Stage 4 chronic kidney disease (CKD), CKD | Kidney Diseases, Renal Insufficiency, Chronic, Diabetes Mellitus, Diabetes Mellitus, Type 2, Inflammation, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Pathologic Processes, Urologic Diseases, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital ... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Zemplar<br>Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months | Drug: Zemplar<br>* Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months<br>|
| Placebo Comparator: Placebo<br>Zemplar 1 mc... | Effect Of Paricalcitol (Zemplar) On Endothelial Function And Inflammation In Type 2 Diabetes And Chronic Kidney Disease
Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to study the effects of paricalcitol on endothelial function and inflammation, cardiovascular ri... | |
NCT01703624 | Dose Ranging Study of Glycopyrronium Bromide in Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease | This is an investigation of the beneficial effects, tolerability and safety of a range of single doses of orally inhaled glycopyrronium bromide (PSX1002GB pMDI) in male and female patients with moderate or severe chronic obstructive pulmonary disease (COPD). COPD is a long term and progressive disease of the lungs, gen... | An Investigation of the Efficacy, Tolerability and Safety of a Range of Doses of Orally Inhaled Glycopyrronium Bromide (PSX1002-GB pMDI) in Male and Female Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease | * Drug: glycopyrronium bromide
| Inclusion Criteria:~Male or female age 40-75 years, inclusive~A clinical diagnosis of moderate to severe COPD (GOLD guidelines)~Current smokers or ex-smokers with at least 10-pack year smoking history~Post-bronchodilator FEV1/FVC ratio < 70 % at Screen~Post-bronchodilator FEV1 ≥ 40 % to < 80 % of predicted at Screen~De... | 40 Years | 70 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC) | FEV1 time-adjusted AUC(0-24 hours) | From time zero to 24-hours |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC) | FEV1 time-adjusted AUC(0-12 hours) | From time zero to 12-hours |
| Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC) | FEV1 time-adjusted AUC(1... | glycopyrronium bromide, glycopyrrolate, oral inhalation, COPD, chronic obstructive pulmonary disease, lung function, pharmacokinetics, tolerability, safety, cross-over, single-dose, dose-ranging | Bromides, Glycopyrrolate, Anticonvulsants, Adjuvants, Anesthesia, Muscarinic Antagonists, Cholinergic Antagonists, Cholinergic Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glycopyrronium bromide 12.5mcg<br>glycopyrronium bromide 12.5mcg single dose via pressurised metered dose inhaler (pMDI) | Drug: glycopyrronium bromide<br>* glycopyrronium bromide suspension in HFA<br>* Other names: PSX1002-GB;|
| Experime... | Dose Ranging Study of Glycopyrronium Bromide in Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease
Study Overview
=================
Brief Summary
-----------------
This is an investigation of the beneficial effects, tolerability and safety of a range of single doses of orally inhaled glycopyrronium... | |
NCT04600505 | A Study to Assess Drug Absorption of Fixed Dose Combinations of Budesonide, Glycopyrronium, and Formoterol | The study will evaluate bioavailability, pharmacokinetics, safety, and tolerability of budesonide, glycopyrronium and formoterol (BGF) metered dose inhaler (MDI) formulated with 3 different propellants: Propellant 1 (Treatment A [test]), Propellant 2 (Treatment B [test]) and Hydrofluoroalkane (HFA) (Treatment C [refere... | The study will comprise:~Screening period: up to 28 days prior to first dosing;~Three treatment periods of maximum 3 days each: participants will be resident from the morning of the day before the first dosing with BGF MDI (Day -1) in Treatment Period 1, throughout all treatment and washout periods up to discharge on D... | A Randomized, Single Blind, 3-Period, 3-Treatment, Single-dose, Crossover Study to Assess the Relative Bioavailability of BGF Propellant 1 and BGF Propellant 2 Compared With BGF MDI HFA in Healthy Subjects | Chronic Obstructive Pulmonary Disease (COPD) | * Drug: Treatment A
* Drug: Treatment B
* Drug: Treatment C
| Inclusion Criteria:~Provision of signed and dated, written informed consent prior to any study specific procedures.~Non-smoking male participants with suitable veins for cannulation or repeated venipuncture.~Participants must agree to follow the reproductive restrictions.~Have a body mass index between 18 and 30 kg/m^2... | 18 Years | 60 Years | Male | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Concentration (Cmax) of BGF MDI | Evaluation of the relative bioavailability between the test formulations and the reference formulation for fixed dose combinations (FDCs) of BGF when delivered as BGF MDI with 3 different prop... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Reach Maximum Observed Concentration (Tmax) of BGF MDI | Assessment of tmax of BGF when administered as 3 different propellant formulations. | Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post... | Budesonide, Glycopyrronium, Formoterol, Hydrofluoroalkane, Metered dose inhaler | Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Respiratory Tract Diseases, Chronic Disease, Disease Attributes, Pathologic Processes | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Sequence ABC<br>Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment A; Treatment B; Treatment C) in 3 treatment periods, with... | A Study to Assess Drug Absorption of Fixed Dose Combinations of Budesonide, Glycopyrronium, and Formoterol
Study Overview
=================
Brief Summary
-----------------
The study will evaluate bioavailability, pharmacokinetics, safety, and tolerability of budesonide, glycopyrronium and formoterol (BGF) metered dose... |
NCT00577343 | Hospital Acquired and Community Acquired MRSA in GI Lab | Hospital acquired and community acquired methicillin resistant staph aureus (MRSA) has become an important health issue for in recent years. Up to two thirds of patients that are hospitalized may be colonized with MRSA. The prevalence in the community is also on the rise and affects the young and healthy. It is unclear... | Hospital Acquired and Community Acquired Methicillin Resistant Staph Aureus in the Outpatient Gastrointestinal Lab: A Prospective Study of Prevalence | Hospital Acquired MRSA, Community Acquired MRSA | Inclusion Criteria:~No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol.~Subjects must provide signed written informed consent.~Exclusion Criteria:~Inability ... | 18 Years | 90 Years | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective of this prospective study is to identify the prevalence of MRSA in patients that use the Indiana University GI lab. | | less than one year |
| Hospital Acquired and Community Acquired MRSA in GI Lab
Study Overview
=================
Brief Summary
-----------------
Hospital acquired and community acquired methicillin resistant staph aureus (MRSA) has become an important health issue for in recent years. Up to two thirds of patients that are hospitalized may be... | |||||||
NCT01491516 | TELAMON P™ Implant/INFUSE® Bone Graft/CD HORIZON® Spinal System Pilot Study | The purpose of this pilot study is to evaluate the feasibility of the implant ( TELAMON P™ Implant/INFUSE Bone Graft System used in conjunction with the CD HORIZON® Spinal System) as a method of facilitating lumbar spinal fusion utilizing a posterior surgical approach in patients with symptomatic degenerative disc dise... | A Pilot, Prospective, Non-Randomized Clinical Investigation of TELAMON P™ Implant With INFUSE® Bone Graft and the CD HORIZON® Spinal System for Posterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease | Degenerative Disc Disease | * Device: TELAMON P™ /INFUSE® Bone Graft/CD HORIZON® Spinal System
| Inclusion Criteria:~Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history and radiographic studies to include one or more of the following:~instability (defined as angulation >= 5° and/or translation >= 4mm, based o... | 18 Years | 70 Years | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Success | A patient will be considered an overall success if all of the following conditions are met:~fusion;~pain/disability (Oswestry) success;~neurological status success;~no serious adverse event classified as implant associated or... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disc Height Measurement | | 24 month |
| General Health Status (SF-36) | | 24 month |
| Pain Status (back pain, leg pain) | | 24 month |
| Patient Satisfaction | | 24 month |
| Patient Global Perceived Effect | | 24 month |
| Lumbar degenerative disc disease | Spinal Diseases, Bone Diseases, Musculoskeletal Diseases, Intervertebral Disc Degeneration | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational<br> | Device: TELAMON P™ /INFUSE® Bone Graft/CD HORIZON® Spinal System<br>* The TELAMON P™/INFUSE™ Bone Graft Implant in conjunction with the CD HORIZON® Spinal System for single level lumbar fusion from L1 to S1<br>* Other... | TELAMON P™ Implant/INFUSE® Bone Graft/CD HORIZON® Spinal System Pilot Study
Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to evaluate the feasibility of the implant ( TELAMON P™ Implant/INFUSE Bone Graft System used in conjunction with the CD HORIZON® Spinal System... | |
NCT05615025 | Influence of Sevoflurane and Propofol on Maximum Muscular Strength, Speed of Contraction and Relaxation | Many drugs have an influence on neuromuscular transmission. In clinical practice, neuromuscular blocking agents are commonly used, but even in the absence of neuromuscular blocking agents, anesthetic drugs can influence neuromuscular transmission. Especially volatile anesthetic agents have a clinical impact on neuromus... | Influence of Sevoflurane and Propofol on Maximum Muscular Strength, Speed of Contraction and Relaxation, in Humans: A Pilot Study | Anesthesia, General, Neuromuscular Transmission Disorders | * Drug: Sevoflurane
* Drug: Propofol
| Inclusion criteria~Patients (male or female) from 18 - 80 years~Scheduled for surgery without the use of neuromuscular blocking agents~Health care insurance in Belgium~Written informed consent~Exclusion Criteria:~Any pathology involving neuromuscular transmission~Confirmed neuropathy of any origin~Expected anesthesia d... | 18 Years | 80 Years | All | No | Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum force at the adductor pollicis | Maximum force developed by a voluntary contraction of the adductor pollicis will be measured during isometric contraction. Maximum force developped before and after anesthesia will be compared. The diff... | Propofol, Sevoflurane, Hypnotics and Sedatives, Central Nervous System Depressants, Physiological Effects of Drugs, Anesthetics, Intravenous, Anesthetics, General, Anesthetics, Platelet Aggregation Inhibitors, Anesthetics, Inhalation | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sevoflurane arm<br>In this arm, anesthesia will be maintained by sevoflurane. | Drug: Sevoflurane<br>* Anesthesia will be maintained by sevoflurane.<br>|
| Experimental: Propofol arm<br>In this arm, anesthesia will be maintained by propofo... | Influence of Sevoflurane and Propofol on Maximum Muscular Strength, Speed of Contraction and Relaxation
Study Overview
=================
Brief Summary
-----------------
Many drugs have an influence on neuromuscular transmission. In clinical practice, neuromuscular blocking agents are commonly used, but even in the abs... | |||
NCT03103711 | Promotion of Emotional Well-being in Hospitalized Cancer Patients by Virtual Reality | The aim of this study is to analyze the effect of a brief psychological intervention supported by Information and Communication Technologies, on the subjective well-being of hospitalized cancer patients. Participants are randomly assigned to one of 2 conditions: Intervention condition (4 Virtual reality sessions) and C... | A Brief Psychological Intervention Using Virtual Reality for the Promotion of Emotional Well-being in Hospitalized Cancer Patients | Cancer | * Behavioral: Virtual Reality Intervention
| Inclusion Criteria:~adults with any cancer diagnosis~hospitalized for at least 1 week~Karnofsky functional state ≥50~life expectancy ≥2 months~Exclusion Criteria:~serious psychopathology~cognitive impairment | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983; adapted version of Tejero, Guimerá, Farré & Peri, 1986) | | change from baseline at 1 week |
| Fordyce Happiness Scale (Fordyce, 1988). | | change from baseline at 1 ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale: Mood. | Subjective mood change after each intervention session. | 4 days along 1 week |
| Visual Analog Scale: Emotional State. Change from pre to post session. | Assessment of general mood, joy, sadness, anxiety, relax a... | Virtual reality, Well-being, Hospital | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The entire intervention is composed by four 30 minutes sessions along 1 week. Its focus is on the promotion of well-being by the use of two virtual environments (Emotional Parks and Walk through Nature). These environments ... | Promotion of Emotional Well-being in Hospitalized Cancer Patients by Virtual Reality
Study Overview
=================
Brief Summary
-----------------
The aim of this study is to analyze the effect of a brief psychological intervention supported by Information and Communication Technologies, on the subjective well-bein... | ||
NCT01757392 | Candin Safety & Efficacy Study for the Treatment of Warts | The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at a 0.3 ml dose level at up to 6 monthly injections for treating common warts (Verruca vulgaris). | The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at either 0.3 mL dose levels at up to 6 monthly injections (a maximal, cumulative dose of 1.9 mL, including the delayed-type hypersensitivity (DTH) test) for treating common warts (Verruca vulgaris). A seconda... | Study of the Safety and Effectiveness of Candin for the Treatment of Common Warts | Warts, Human Papilloma Virus | * Biological: Candida albicans Skin Test Antigen
| Inclusion Criteria:~Must have at least 3 and not more than 10 common warts not located on the palms or digits~Positive DTH response to Candin® required~Exclusion Criteria:~No previous medical treatment for warts other than OTC~No immunocompromising medical conditions or medicines allowed~No preexisting inflammatory con... | 18 Years | 65 Years | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Complete Resolution of Primary Injected Wart | | Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits | | Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total o... | Treatment, common wart lesions, (verruca vulgaris) | Warts, Papilloma, Neoplasms, Squamous Cell, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Papillomavirus Infections, DNA Virus Infections, Virus Diseases, Infections, Skin Diseases, Viral, Tumor Virus Infections, Skin Diseases, Infectious, Skin Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Candin® 0.3 mL<br>Monthly intralesional injections of Candin® 0.3 ml until lesion resolves or up to 6 injections. | Biological: Candida albicans Skin Test Antigen<br>* 0.3 ml injected intralesionally monthly. Number of injections: until wa... | Candin Safety & Efficacy Study for the Treatment of Warts
Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at a 0.3 ml dose level at up to 6 monthly injections for treating common warts (Verru... |
NCT01139294 | Descriptive Study of Cardiac Output During Rehydration With Recombinant Human Hyaluronidase in Pediatrics | The purpose of this study is to non-invasively study the reflective changes in cardiac output as response to fluid therapy in the pediatric moderate hypovolemia/dehydrated pediatric patients using sub-q rehydration using Hylenex augmented subcutaneous infusion of fluids and electrolytes compared to intravenous methods. | This is an open-labeled, single-center Phase IV clinical trial. The study will consist of patients with moderate hypovolemia/dehydration requiring parenteral rehydration. It is expected that this study will describe the onset or change in cardiac output using Hylenex augmented subcutaneous rehydration from ages 2 month... | Phase IV Randomized Study of Hylenex or Standard IV Hydration in the Pediatric Population With Moderate Dehydration | Dehydration, Cardiac Output, Pediatrics | * Drug: Hylenex
| Inclusion Criteria:~patients presenting to the Emergency Department (ED) with moderate dehydration (gorelick dehydration classification : presence of 3-6 moderate signs and symptoms) requiring parenteral rehydration.~Patient has not successfully received oral or IV fluids immediately prior to enrollment~patient's legal... | 2 Months | 3 Years | All | Accepts Healthy Volunteers | Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Output Trends | Describe the cardiac output trends measured in liters per minute (onset and changes in slope over time) by noninvasively monitoring methods in pediatric patients being rehydrated by Hylenex augmented subcutaneous rehydr... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gorelick Assessment | Gorelick assessment of hydration status at baseline, and at the end of sub-q or IV hydration treatment or at discharge from the emergency dept.~volume of fluid infuse over time~time to discharge from ED to home or transfe... | cardiac output, dehydration, pediatrics | Dehydration, Water-Electrolyte Imbalance, Metabolic Diseases, Pathologic Processes | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard IV therapy<br>control arm of the study | |
| Experimental: Hylenex<br>1ml subcutaneous with initiation of intravenous fluids then every 24 hours with a maximum dose of 3 injections in 72 hours | Drug: Hylenex<br>* 1ml subcutane... | Descriptive Study of Cardiac Output During Rehydration With Recombinant Human Hyaluronidase in Pediatrics
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to non-invasively study the reflective changes in cardiac output as response to fluid therapy in the pediatric moderate... |
NCT05349435 | A Healthy Volunteer Study to Compare Fezagepras (PBI-4050) With Sodium Phenylbutyrate | The purpose of this study is to compare the safety, tolerability and pharmacokinetic profile of fezagepras (PBI-4050) to that of sodium phenylbutyrate (PBA) when both products are given as single ascending doses to healthy adult subjects. | A Phase 1, Randomised, Open-Label, Crossover Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of PBI-4050 Compared to Sodium Phenylbutyrate in Healthy Subjects | Hyperammonemia | * Drug: Fezagepras
* Drug: Sodium phenylbutyrate
| Inclusion Criteria:~Healthy, adult, male or female (of non childbearing potential only*), 18 to 65 years of age, inclusive, at the screening visit.~Females of childbearing potential are defined as fertile, following menarche and until becoming post menopausal unless permanently sterile. Permanent sterilization methods ... | 18 Years | 65 Years | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | Number and Severity of Treatment Emergent Adverse Events | Day -2 to Day 8 (+/- 3 days) |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | Area under the concentration-time curve | Day 1 and Day 3 |
| Cmax | Maximum plasma concentration | Day 1 and Day 3 |
| Tmax | Time to reach maximum plasma concentration | Day 1 and Day 3 |
| 4-phenylbutyric acid, Antineoplastic Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 Dose Level 1<br>Drug: Fezagepras and sodium PBA | Drug: Fezagepras<br>* Investigational drug<br>* Other names: PBI-4050;Drug: Sodium phenylbutyrate<br>* Investigational drug<br>|
| Experimental: Cohort 2 Dose Level 2<br>Drug: Feza... | A Healthy Volunteer Study to Compare Fezagepras (PBI-4050) With Sodium Phenylbutyrate
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety, tolerability and pharmacokinetic profile of fezagepras (PBI-4050) to that of sodium phenylbutyrate (PBA) when both p... | ||
NCT02289001 | Simulation Training in Undergraduate Nursing Education as a Means to Improve Awareness of Team Member Roles | Based on investigator's hypothesis, that incorporating the SBAR worksheet into the training of undergraduate Nursing students will increase their capacity to work in an interdisciplinary team, the investigators will assess whether introducing the SBAR improves the students' knowledge of their own role and that of other... | Students assigned to the intervention group will receive one hour of additional training in teamwork skills, communication between team members, and the relationship with patient safety, as well as how to distribute roles and responsibilities and how to use the SBAR worksheet. They will not be given the materials used ... | Study to Evaluate the Use of the SBAR (Situation-Background-Assessment-Recommendation) Checklist as a Means to Help Undergraduate Nursing Students Understand Team Member Roles and Improve Healthcare Team Communication | Communication | * Behavioral: Education on SBAR worksheet
| Inclusion Criteria:~Passing grade on the emergency care topics in the required course Adult Patient II, which focuses on nursing care planning related to various clinical pathologies or syndromes and surgical procedures~Current student in the required course Techniques and Procedures III, which incorporates simulation ... | 18 Years | null | All | No | Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the use of the SBAR checklist as a means to help undergraduate nursing students identify their own role, understand the roles of other health professionals (assess skill level (KidSIM Team Performance Scale) | The study will use th... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the SBAR instrument to improve patient assessment and intervention skills of undergraduate nursing students using human patient simulators (assess skill level using the Wolf scale) | The Wolf scale was specifically designed to ev... | patient simulation, simulation, teamwork, interdisciplinary health team, healthcare team, nursing, training programs | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education on SBAR worksheet<br>Training in the use of the SBAR worksheet created to structure information exchange between healthcare professionals | Behavioral: Education on SBAR worksheet<br>* The intervention group will receive one hour... | Simulation Training in Undergraduate Nursing Education as a Means to Improve Awareness of Team Member Roles
Study Overview
=================
Brief Summary
-----------------
Based on investigator's hypothesis, that incorporating the SBAR worksheet into the training of undergraduate Nursing students will increase their ... | |
NCT01187732 | Washing Without Water: Cost-effectiveness of a Rapidly Spreading Nursing Intervention in Bedridden Patients' | The purpose of this study is to compare the traditional bed bath with 'washing without water' on~1) effects on skin integrity~2) patient and nurse satisfaction and 3) costs. In a cluster randomized trial we will randomize 50 nursing home wards (576 patients) to 'washing without water' or traditional bed baths. Bathing ... | RAPID IMPLEMENTATION of new interventions while cost-effectiveness and acceptability for patients and care providers are unclear, is never desirable. 'Washing without water' is such an intervention.~The traditional bed bath is executed by using tap water, towels, washcloths and soap. As an alternative, 'WASHING WITHOUT... | WASHING WITHOUT WATER Cost-effectiveness of a Rapidly Spreading Nursing Intervention om Bedridden Patients' | Skin Disease | * Device: Washing without water
| Inclusion Criteria:~long stay psychogeriatric nursing home residents~long stay somatic nursing home residents~100 randomly selected nurses from the participating nursing home wards~Exclusion Criteria:~- | 45 Years | null | All | No | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the primary outcome is prevalence of care associated skin damage | Skin damage is defined as intertrigo, dermatitis and/or other erythema on skin areas which were not exposed to pressure directly before observation. | 6 weeks |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and nurse satisfaction with bathing technique | patient perceived discomfort during bathing~nurse perceived work load~observed bathing quality | 6 weeks |
| Cost bathing | Bathing and skin damage associated costs will be calculated fr... | skin damage, intertrigo, dermatitis, erythema, aggression, body Wipes, soaps, no rinse, cost effectiveness, nursing home residents, nurse | Skin Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Washing without water<br>The experimental intervention is 'washing without water' and consists of disposable washing cloths made of a mix of soft synthetic fibers, saturated with a no rinse, quickly vaporizing skin cleaning and caring loti... | Washing Without Water: Cost-effectiveness of a Rapidly Spreading Nursing Intervention in Bedridden Patients'
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the traditional bed bath with 'washing without water' on 1) effects on skin integrity 2) patient and nurs... |
NCT03167996 | Chronic Cardiovascular Risk Outpatient Management in South Asians Using Digital Health Technology | This platform will enable investigation the cardiovascular risk reduction and the increase in participant engagement in their heart-healthy goals, through the use of virtual care/telemedicine with a digital platform that connects them to their own doctors, nurses, and dietitians. | The study will use telemedicine and the mobile health capabilities of smartphones to facilitate communication of medical goals set by the treating physician to the subject in between clinic visits, and to assess the daily medical and lifestyle change compliance of enrolled Stanford subjects and provide virtual health c... | Chronic Cardiovascular Risk Outpatient Management in South Asians Using Digital Health Technology | Coronary Artery Disease, Cardiovascular Risk Factor, Insulin Resistance, PreDiabetes, Diabetes, Hypertension, Prehypertension, Dyslipidemias | * Behavioral: Use of HealthPals (Telemedicine supported by digital health platform)
| Inclusion Criteria:~adult smartphone users~Exclusion Criteria:~Subjects who do not own a smartphone or cannot access their mobile health data~Patients unable to read English, as the initial version of the research app will be in English~Participants who are children (under 18 years old)~Participants who are pregnant wo... | 18 Years | 60 Years | All | Accepts Healthy Volunteers | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group A Control Group B HealthPals
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in exercise activity over 6 months | Patients are given exercise recommendations (or physical activity goals depending on the patient's capacity for exercise) at the time of the initial visit by the HealthPals health coach. The patients... | South Asian, Cardiovascular Risk Reduction, Metabolic Disorders, Lifestyle modifications | Dyslipidemias, Coronary Artery Disease, Prehypertension, Insulin Resistance, Vascular Diseases, Cardiovascular Diseases, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Hyperinsulinism, Glucose Metabolism Disorders, Metabolic Diseases, Lipid Metabolism Disorders | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group B/ HealthPals<br>Group B have access to HealthPals app where they will coordinate with a trained health coach Group B patients will only come into SSATHI clinic to see their doctor for an initial visit and 6 month follow up, and they... | Chronic Cardiovascular Risk Outpatient Management in South Asians Using Digital Health Technology
Study Overview
=================
Brief Summary
-----------------
This platform will enable investigation the cardiovascular risk reduction and the increase in participant engagement in their heart-healthy goals, through t... | |
NCT03745846 | A Efficacy and Safety Study of Composite Gel Containing Black Raspberry Extract in Removing HPV From Patients With Cervical Intraepithelial Neoplasia(CIN) After Cervical Conization | To evaluate the efficacy and safety of composite gel containing black raspberry extract in removing HPV From patients With cervical intraepithelial neoplasia(CIN) after cervical conization | A large number of basic research and animal experiments have confirmed that black raspberry and its active ingredients are used for chemo-prevention of tumors. In recent years, it has been reported that black raspberry extract can effectively inhibit the proliferation of human oral cancer cells and colorectal cancer ce... | A Phase 2 Trial to Evaluate the Efficacy and the Safety of Composite Gel Containing Black Raspberry Extract in Removing HPV From Patients With Cervical Intraepithelial Neoplasia(CIN) After Cervical Conization | Cervical Intraepithelial Neoplasia, HPV | * Biological: Composite Gel Containing Black Raspberry
* Biological: placebo
| Inclusion Criteria:~Subjects were able and willing to sign informed consent.~Patients with CIN who underwent cervical conization were at high risk of persistent HPV infection.~Age must be between 20-55 years old.~Subjects should begin receiving protocol studies at least two months after cervical conization.~Patients mu... | 20 Years | 55 Years | Female | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| negative rate | the effective rate and clearance rate of HPV infection from baseline as compared to placebo | 3 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | The Rate of Solicited Adverse Events and the Related Features | 3 months |
| recurrence rate | The recurrence rate after HPV clearance was assessed | 3 months |
| Neoplasms, Carcinoma in Situ, Uterine Cervical Dysplasia, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Precancerous Conditions, Uterine Cervical Diseases, Uterine Diseases, Genital Diseases, Female, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urog... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Composite Gel Containing Black Raspberry<br>Drug:Composite Gel Containing Black Raspberry 3,000mg Dosage and duration: 1 preparation every other day for 3 months. | Biological: Composite Gel Containing Black Raspberry<br>* Composite Gel Co... | A Efficacy and Safety Study of Composite Gel Containing Black Raspberry Extract in Removing HPV From Patients With Cervical Intraepithelial Neoplasia(CIN) After Cervical Conization
Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of composite gel containing black ras... | |
NCT02791854 | Improving the Quality of Care for Adults With Inflammatory Bowel Disease | Innovative programs exist that suggest that care for people with chronic conditions is optimized when patients and providers have the information they need at the point of care and over time, to engage in shared planning and execution of treatment goals and care plans. This project aims to build an Inflammatory Bowel D... | To demonstrate the impact of an Adult Inflammatory Bowel Disease (IBD) Learning Health System approach the study collaborators will design, build, implement, and evaluate in up to 90 IBD care sites the the following four key components of the IBD Learning Health System: 1) a Health Information Technology (HIT) environm... | Improving the Quality of Care for Adults With Inflammatory Bowel Disease | Ulcerative Colitis, Inflammatory Bowel Diseases, Crohn's Disease | Inclusion Criteria:~18 years of age or older~Diagnosis of Crohn's disease or ulcerative colitis or IBD unclassified~Accept the terms and conditions of Informed Consent and Authorization~Affiliated with a participating IBD Qorus site~Exclusion Criteria:~Inability to provide informed consent~Study key personnel cannot en... | 18 Years | 99 Years | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients enrolled | count of number of patients consented | annually, up to 5 years |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients in remission | assessed using a validated disease activity scale | annually, up to 5 years |
| Proportion of patients on steroids | assessed by patient report | annually, up to 5 years |
| Proportion of patients admitt... | Gastroenteritis, Gastrointestinal Diseases, Digestive System Diseases, Crohn Disease, Intestinal Diseases, Inflammatory Bowel Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Registry participant<br>This is a registry study, the same information is collected from all participants. | |
| Improving the Quality of Care for Adults With Inflammatory Bowel Disease
Study Overview
=================
Brief Summary
-----------------
Innovative programs exist that suggest that care for people with chronic conditions is optimized when patients and providers have the information they need at the point of care and ... | |||
NCT04630548 | Safety and Efficacy of Immediate Post Placental IUD Insertion in Patients Undergoing Cesarean Delivery | Sixty six women who plan to deliver a live birth singleton via cesarean delivery who desire a Copper IUD for postpartum contraception will be approached for study participation thenvwill be randomized equally into two groups using computer generated numbers.~Group (A): (n=33) women IUD insertion post placental delivery... | Full history taking including a detailed history including medical and obstetric history, full obstetric examination and ultrasound evaluation to confirm gestational age and to exclude any of the exclusion criteria. Women who plan to deliver a live birth singleton via cesarean delivery at Kasr El-Ainy teaching will be ... | The Safety and Efficacy of Immediate Post Placental IUD Insertion Versus the Post Puerperal IUD Insertion in Patients Undergoing Cesarean Delivery | IUD | * Device: Intrauterine copper device
| Inclusion Criteria:~Singleton full term pregnancy at ≥37 weeks gestation confirmed by LMP and first trimesteric ultrasound.~Desired copper IUD placement for postpartum contraception.~Candidate for cesarean delivery.~Regional anesthesia.~Exclusion Criteria:~Anatomic uterine abnormalities distorting the uterine cavity (o... | 20 Years | 40 Years | Female | Accepts Healthy Volunteers | Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IUD expulsion rate | to measure the frequency of IUD expulsion (IUD not found in ultrasound) following insertion by ultrasound examination. | 6 months (following the insertion) |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Missed threads rate (threads not seen by speculum examination) | to measure the frequency of absent threads (threads not seen by speculum examination) following insertion. | 6 months (following the insertion) |
| displaced IUD rate | to measu... | IUD insertion, post placental insertion, puerperal insertion, cesarean section | Copper, Trace Elements, Micronutrients, Physiological Effects of Drugs | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: post placental IUD insertion<br>Following placental delivery, uterine cavity will be examined to exclude the presence of malformations or fibroids. Uterus will be stabilized by grasping it at fundus and the copper IUD (CuT 380 IUD) wi... | Safety and Efficacy of Immediate Post Placental IUD Insertion in Patients Undergoing Cesarean Delivery
Study Overview
=================
Brief Summary
-----------------
Sixty six women who plan to deliver a live birth singleton via cesarean delivery who desire a Copper IUD for postpartum contraception will be approache... |
NCT00038402 | Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer | The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy treatment of patients newly diagnosed with operable breast cancer.~Other objectives: 1) to evaluate the potential of this therapy to reduce the size of the tumor and increase the possibility of breast conservative surgery, 2) ev... | Participants will receive Herceptin in addition to chemotherapy with Taxol and FEC. 'FEC' is Fluorouracil, Cyclophosphamide and Epirubicin.~During the first course of therapy Herceptin will be given on day 1 through a needle in a vein over 90 minutes. Participants will then be observed for 1 hour after that for harmful... | Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer | Breast Cancer | * Drug: Herceptin
* Drug: Taxol
* Drug: Fluorouracil
* Drug: Cytoxan
* Drug: Epirubicin
| Inclusion Criteria:~All patients with histologic confirmation of invasive, but non-inflammatory carcinoma of the breast with T2-3 (greater than 2 cm), N0-1, M0 will be eligible. Patients with T1N1 (after histological confirmation of nodal disease) will be eligible for the study.~Histologic confirmation of invasive tumo... | null | null | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Achieved Pathological Complete Remission | Response criteria for Complete Remission defined as disappearance of all clinical evidence of active tumor by clinical evaluation, mammogram and/or ultrasound, and free of all s... | FEC, Breast Cancer, Non-Inflammatory Breast Cancer, Operable Breast Cancer, Herceptin, Taxol, Fluorouracil, Cyclophosphamide, Epirubicin, Trastuzumab, Paclitaxel, Neosar | Paclitaxel, Cyclophosphamide, Fluorouracil, Trastuzumab, Epirubicin, Antineoplastic Agents, Phytogenic, Antineoplastic Agents, Tubulin Modulators, Antimitotic Agents, Mitosis Modulators, Molecular Mechanisms of Pharmacological Action, Immunosuppressive Agents, Immunologic Factors, Physiological Effects of Drugs, Antirh... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Herceptin + Taxol Followed by FEC<br>Herceptin starting 4 mg/kg intravenous (IV), then 2 mg/kg weekly for all other cycles neo-adjuvant chemotherapy and during FEC therapy for total 24 doses. Taxol 225 mg/m^2 continuous IV over 24 hours ea... | Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy treatment of patients newly diagnosed with ... | |
NCT04262076 | Remineralization of Caries Affected Dentin | Remineralization of carious affected dentin | Remineralization of Carious affected dentin by using Pulpine alone and combination of Pulpine with Polyamidoamine Dendrimer. | Effect of Pulpine and Combination of Pulpine With Polyamidoamine Dendrimer on Remineralization of Carious Affected Human Dentin | Deep Caries | * Other: Pulpine with Polyamidoamine Dendrimer
| Inclusion Criteria:~Presence of at least one class one carious posterior teeth in both left and right side.~Absence of spontaneous pain, Mobility and tenderness on percussion.~Radiographically, the preoperative inclusion criteria are, no internal or external resorption and no widening of the periodontal membrane space.... | 18 Years | 25 Years | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: split mouth design
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remineralization & increase dentin density that is measured by using Vista Scan Radiography. | Vista scan Radiography used to measure pixel grey value after 6 months. | 6 months |
| | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination of pulpine with Polyamidoamine Dendrimer<br>Removal of Caries infected dentin from the walls and floor of the cavity and then apply polyamidoamine Denrimer for 30 secs ,then washed out of the cavity followed by placement of Pul... | Remineralization of Caries Affected Dentin
Study Overview
=================
Brief Summary
-----------------
Remineralization of carious affected dentin
Detailed Description
-----------------
Remineralization of Carious affected dentin by using Pulpine alone and combination of Pulpine with Polyamidoamine Dendrimer.
O... | |||
NCT04771169 | Vestibular Rehabilitation Verses Virtual Reality on Dizziness, Balance and Gait in Subacute Stroke | There is paucity of literature in studying the comparative effects of Vestibular Rehabilitation and Virtual Reality. This study will determine the effects of these interventions on dizziness, balance and gait. This study will also deduce the role of vestibular rehabilitation and Virtual reality in subacute stroke patie... | Stroke is defined as rapidly developing clinical signs of focal disturbance of cerebral function that lasts more than 24 hours or leading to death. It arises from vascular causes such as cerebral infarction, intracerebral hemorrhage or subarachnoid hemorrhage. Stroke refers to any damage to the brain due to abnormality... | Comparison of Vestibular Rehabilitation With Virtual Reality on Dizziness, Balance and Gait in Subacute Stroke Patients | Vestibular Rehabilitation | * Other: vestibular Training Group
* Other: Virtual Reality Group
| Inclusion Criteria:~• Subacute stroke patients. 1 to 6 months~Both male and female subacute stroke patients with age 40-70 years.~Patients with positive Head Thrust Test.~Patients with Vestibular Disorders.~Modified Rankin scale score 1-4~Score >25 on MMSE~Exclusion Criteria:~• Patients presented with neurological cond... | 40 Years | 70 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed up and Go test (TUG): | Timed Up and Go test (TUG) is used to assess balance and mobility in patients with stroke. An older adult who takes ≥12 seconds to complete the TUG is at risk for falling. | Change from Baseline mobility and balan... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dizziness Handicap Inventory | The Dizziness Handicap Inventory measures the self-perceived level of handicap associated with the symptom of dizziness. Its total score is 100 | Change from Baseline dizziness and balance to 8 Weeks |
| Dizziness, balance, Subacute stroke | Vertigo, Dizziness, Nervous System Diseases, Sensation Disorders, Neurologic Manifestations, Vestibular Diseases, Labyrinth Diseases, Ear Diseases, Otorhinolaryngologic Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vestibular Training Group<br>This Group will receive vestibular Adaptation and Balance exercises | Other: vestibular Training Group<br>* this Group will receive vestibular Adaptation & Balance exercises<br>|
| Active Comparator: Virtual Re... | Vestibular Rehabilitation Verses Virtual Reality on Dizziness, Balance and Gait in Subacute Stroke
Study Overview
=================
Brief Summary
-----------------
There is paucity of literature in studying the comparative effects of Vestibular Rehabilitation and Virtual Reality. This study will determine the effects ... |
NCT02165644 | Carbonic Anhydrase Antagonism in Subarachnoid Hemorrhage | Subarachnoid Hemorrhage (SAH) can occur commonly in the setting of trauma or brain aneurysm. SAH accounts for 10% of all the strokes. Aneurysmal SAH accounts for 80 % of cases of non-traumatic cases of SAH, 6-8% of all strokes and 22-25% of all cerebrovascular deaths. Mortality can be 50% in the first few years of aneu... | If the subject decides to take part in this study, they will receive acetazolamide with standard of care or standard of care only for four days. This means:~The subject will be given acetazolamide tablet orally with standard care for subarachnoid hemorrhage or standard of care only, for a maximum of 4 days. If the subj... | Targeting Carbonic Anhydrase Mediated Coupling as a Novel Vasospasm Prophylaxis in Aneurysmal Sub Arachnoid Hemorrhage | Acute Cerebrovascular Accident, Vasospasm | * Drug: Acetazolamide
* Drug: Nimodipine
| Inclusion Criteria:~All aneurysmal SAH patients with clinical and or radiological diagnosis.~Subjects with age ≥18 years and ≤80 years at the time of screening.~The subject or his/ her legal representative is willing to undergo informed consent process prior to enrollment into this study.~World Federation of Neurosurge... | 18 Years | 80 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Score | The modified Rankin Scale (m-RS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people after they have suffered a stroke including subarachnoid hemorrhage. The s... | Subarachnoid Hemorrhage, Vasospasm, Acetazolamide | Nimodipine, Acetazolamide, Anticonvulsants, Carbonic Anhydrase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Diuretics, Natriuretic Agents, Physiological Effects of Drugs, Antihypertensive Agents, Calcium Channel Blockers, Membrane Transport Modulators, Calcium-Regulating Hormones and A... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetazolamide<br>Acetazolamide 250 mg QID oral for 4 days along with current standard of care which is Nimodipine 60 mg orally every 4 hours, with therapy starting within 96 hours of the event and continued for 21 days.~If the drug can't b... | Carbonic Anhydrase Antagonism in Subarachnoid Hemorrhage
Study Overview
=================
Brief Summary
-----------------
Subarachnoid Hemorrhage (SAH) can occur commonly in the setting of trauma or brain aneurysm. SAH accounts for 10% of all the strokes. Aneurysmal SAH accounts for 80 % of cases of non-traumatic case... | |
NCT04872660 | Efficacy and Safety of Gushen Antai Pill on Ongoing Pregnancy Rate in Women With Normal Ovarian Reserve Undergoing IVF-ET | The purpose of this study is to investigate whether oral Gushen Antai pills supplementation for luteal phase support will improve ongoing pregnancy rate in women with normal ovarian reserve in fresh embryo transfer cycles. | Infertility is a growing reproductive health problem, and it is estimated that approximately 15% of couples of reproductive ages are affected. The invention and popularity of IVF-ET technology, although improving sperm egg encounter and fertilization barriers and implanting early embryos from the uterine cavity in vitr... | Efficacy and Safety of Gushen Antai Pill on Ongoing Pregnancy Rate in Women With Normal Ovarian Reserve Undergoing in Vitro Fertilization Embryo Transfer: A Prospective, Multicentre, Randomised, Double-blind, Placebo-controlled Trial | Infertility, Female | * Drug: Gushen Antai Pill
* Drug: Placebo pill
| Inclusion Criteria:~Patients with normal ovarian function reserve (5 ≤ AFC ≤ 15, 1.2 ng/ml ≤ AMH ≤ 3.5 ng/ml).~Patients with regular menstrual cycle (21-35 days) and normal ovulation.~Initial IVF / ICSI treatment.~At least one embryo or blastocyst available for transfer.~Exclusion Criteria:~Age ≥ 43 years old.~Body mas... | 21 Years | 42 Years | Female | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate | A fetal heartbeat detected by transvaginal ultrasonography over 12 gestational weeks. [Detected via ultrasound] | 10 weeks after the day of embryo transfer |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive pregnancy rate | Serum β-hCG level ≥ 10mIU/mL, 14 days after embryo transfer. [Detected via ELISA] | 2 weeks after the day of embryo transfer |
| Embryo implantation rate | The number of intrauterine gestational sacs observed divided... | Traditional Chinese Medicine, In vitro fertilization-embryo transfer, Gushen Antai Pill, Normal ovarian reserve, Ongoing pregnancy rate | Infertility, Infertility, Female, Genital Diseases, Urogenital Diseases, Genital Diseases, Female, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSATP group<br>Gushen Antai Pill (GSATP, 6g* 9 bags, Beijing boran Pharmaceutical Inc.) was required to be taken orally, 6g three times daily combined with vaginal progesterone (90 mg/day Crinone, Merck) from the day of embryo transfer unt... | Efficacy and Safety of Gushen Antai Pill on Ongoing Pregnancy Rate in Women With Normal Ovarian Reserve Undergoing IVF-ET
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether oral Gushen Antai pills supplementation for luteal phase support will improve on... |
NCT03748329 | Ultrasound-guided Inferior Alveolar Nerve Block Study | The primary objective is to compare the success of the inferior alveolar nerve block using ultrasound versus a traditional landmarking technique (which historically has an approximate failure rate as high as 33.8%). The secondary objective is to demonstrate that delivering a block under ultrasound guidance does not cau... | Inferior alveolar nerve blocks are necessary to perform dental procedures in the mandible. The standard mandibular block (also known as the Halsted Technique, or the Inferior Alveolar Nerve Block) is based on intraoral landmarks but due to anatomical variation between patients, the failure rate, and therefore incomplet... | Ultrasound-guided Inferior Alveolar Nerve Block Study | Ultrasound, Local Anesthetic | * Device: Ultrasound
| Inclusion criteria include male and female volunteers been the ages of 18 and 65 years old who can understand the study protocol and are able to give consent. Subjects must weigh between 40 kg and 100kg and fall under the American Society of Anesthesiology (ASA) classification I or II. At least one unrestored tooth dis... | 18 Years | 60 Years | All | Accepts Healthy Volunteers | Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Split mouth study
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound vs Traditionally Landmarked Method | Compare the success of the inferior alveolar nerve block using ultrasound versus a traditional landmarking technique using pulpal anaesthesia as assessed by an electric pulp tester. | Immediate |... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Demonstrate that delivering a block under ultrasound guidance does not cause any additional pain to patients comparing techniques using a 100mm VAS. | Immediate |
| Comfort of ultrasound | Reconfirm data shown in a previous study that ... | | Intervention/Treatment |
| --- |
|Device: Ultrasound|Will deposit local anaesthetic intra-orally with the aid of ultrasound to guide the location of the final deposition.|
| Ultrasound-guided Inferior Alveolar Nerve Block Study
Study Overview
=================
Brief Summary
-----------------
The primary objective is to compare the success of the inferior alveolar nerve block using ultrasound versus a traditional landmarking technique (which historically has an approximate failure rate as ... | ||
NCT01170312 | Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation | Rotator cuff tears are a common injury that lead to pain and loss of function for those who suffer from it. Treatment includes the use of arthroscopic surgery to return function to the patient and reduce their pain. This study is interested in a technique that has the potential to improve patient outcomes in terms of l... | Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation (A.S.P.I.R.E.): The Use of Platelet Rich Plasma Following Arthroscopic Repair of Rotator Cuff Tears, A Pilot Study | Rotator Cuff Tear | * Biological: Autologous conditioned plasma (ACP)
* Other: Normal saline
| Inclusion Criteria:~Men or women who are between 18 and 70 years of age.~Primary, traumatic or degenerative rotator cuff tears measuring 3 cm or less.~Rotator cuff tears requiring arthroscopic repair within 18 months of initial diagnosis.~Provision of informed consent.~Exclusion Criteria:~Rotator cuff tears secondary t... | 18 Years | 70 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | To investigate the effect of ACP compared to placebo on pain scores in rotator cuff tears undergoing arthroscopic repair at 6 weeks.~Pain severity will be measured using a Visual Analog Scale (VAS). Subjects will be asked to rate ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function | As measured by the Western Ontario Rotator Cuff Index (WORC), the Disabilities of the Arm, Shoulder and Hand Score (DASH), and the Constant Score, administered prior to the surgical intervention, and at 2 weeks, 4 weeks and... | Arthroscopic repair, Rotator cuff, Platelet rich plasma, Randomized, Pilot | Rotator Cuff Injuries, Rupture, Wounds and Injuries, Shoulder Injuries, Tendon Injuries | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Autologous conditioned plasma<br> | Biological: Autologous conditioned plasma (ACP)<br>* ACP is not a drug as the patient's own blood plasma is re-injected into the surgical site.<br>* Other names: Platelet rich plasma;|
| Placebo Com... | Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation
Study Overview
=================
Brief Summary
-----------------
Rotator cuff tears are a common injury that lead to pain and loss of function for those who suffer from it. Treatment includes the use of arthroscopic surgery to return functio... | |
NCT00000777 | Active Immunization of HIV-1 Infected, Pregnant Women With CD4 Lymphocyte Counts >= 400/mm3: A Phase I Study of Safety and Immunogenicity of VaxSyn Recombinant gp160 (NOTE: Some Patients Receive Placebo) | To evaluate the safety of gp160 vaccine (VaxSyn) in HIV-1 infected pregnant women with CD4 counts >= 400 cells/mm3. To evaluate the immunogenicity of this vaccine in pregnant women and the passive acquisition of vaccine-specific antibody in their infants.~Evidence suggests that an advanced stage of disease with high pl... | Evidence suggests that an advanced stage of disease with high plasma viremia is associated with increased transmission of HIV-1 to the fetus. Slowing the progression of disease, reducing the titer of virus in plasma, and increasing the titer of epitope-specific antibody are potentially attainable goals through active i... | Active Immunization of HIV-1 Infected, Pregnant Women With CD4 Lymphocyte Counts >= 400/mm3: A Phase I Study of Safety and Immunogenicity of VaxSyn Recombinant gp160 (NOTE: Some Patients Receive Placebo) | HIV Infections, Pregnancy, HIV Seronegativity | * Biological: gp160 Vaccine (MicroGeneSys)
| Inclusion Criteria~Concurrent Medication:~Allowed:~AZT.~Acyclovir.~Patients must have:~HIV-1 infection.~CD4 count >= 400 cells/mm3.~No AIDS-defining illness or other systemic manifestations related to HIV (other than generalized lymphadenopathy).~HIV p24 < 30 pg/ml.~Proven pregnancy in the 16th to 24th week of gestatio... | 16 Years | 40 Years | Female | No | Primary Purpose: Treatment
Intervention Model: Parallel Assignment
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccines, Synthetic, Pregnancy, Pregnancy Complications, Infectious, HIV Envelope Protein gp160, AIDS Vaccines, HIV Preventive Vaccine, HIV Therapeutic Vaccine | HIV Infections, Blood-Borne Infections, Communicable Diseases, Infections, Sexually Transmitted Diseases, Viral, Sexually Transmitted Diseases, Lentivirus Infections, Retroviridae Infections, RNA Virus Infections, Virus Diseases, Genital Diseases, Urogenital Diseases, Immunologic Deficiency Syndromes, Immune System Dis... | | Intervention/Treatment |
| --- |
|Biological: gp160 Vaccine (MicroGeneSys)|nan|
| Active Immunization of HIV-1 Infected, Pregnant Women With CD4 Lymphocyte Counts >= 400/mm3: A Phase I Study of Safety and Immunogenicity of VaxSyn Recombinant gp160 (NOTE: Some Patients Receive Placebo)
Study Overview
=================
Brief Summary
-----------------
To evaluate the safety of gp160 vaccine (VaxSyn) i... | |
NCT03210883 | Global Electrical Heterogeneity and Clinical Outcomes | This retrospective multicenter cohort will validate an independent association of electrocardiographic (ECG) global electrical heterogeneity (GEH) measures with sustained ventricular tachyarrhythmias and appropriate ICD therapies in systolic heart failure patients with primary prevention ICD, and will validate and re-c... | Global Electrical Heterogeneity and Clinical Outcomes | Heart Failure, Implantable Defibrillator User, Ventricular Arrythmia | Inclusion Criteria:~records of systolic heart failure patients with primary prevention ICDs/CRT-Ds implanted for routine clinical indications~Exclusion Criteria:~absent baseline pre-implant digital ECG;~missing data on clinical predictors and covariates;~missing ICD programming data (including number of intervals to de... | 18 Years | 89 Years | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome: sustained VT/VF event with appropriate ICD therapy (either ATP or shock) | Sustained ventricular tachyarrhythmia event with appropriate ICD therapy (either antitachycardia pacing or shock) | up to 15 years |
| Primary competi... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sustained monomorphic ventricular tachycardia | Sustained monomorphic ventricular tachycardia with appropriate ICD therapies (either antitachycardia pacing or ICD shock) | up to 15 years |
| sustained polymorphic ventricular tachycardia / ven... | Heart Failure, Heart Diseases, Cardiovascular Diseases | Global Electrical Heterogeneity and Clinical Outcomes
Study Overview
=================
Brief Summary
-----------------
This retrospective multicenter cohort will validate an independent association of electrocardiographic (ECG) global electrical heterogeneity (GEH) measures with sustained ventricular tachyarrhythmias ... | |||||
NCT01073891 | Bioavailability, Food Effect and Safety, Tolerability of a New Oral Suspension in Comparison to the Marketed Moxifloxacin Tablet in Healthy Adults | The purpose of this study is to describe the pharmacokinetics of a new oral liquid moxifloxacin formulation and the influence of concommitant food intake on the pharmacokinetics in healthy adults compared to the marketed oral tablet. Pharmacokinetics is to see how the body absorbs, distributes and gets rid of the study... | Single-dose, Open-label, Randomized, Non-blinded, Three-fold Crossover Study in Healthy Subjects to Compare the Bioavailability of Moxifloxacin (BAY12-8039) 400 mg Tablet and 400 mg Oral Suspension Under Fasting Conditions, and to Investigate the Effect of Food on the Bioavailability of 400 mg Suspension. | Healthy | * Drug: Moxifloxacin (Avelox, BAY12-8039)
* Drug: Moxifloxacin (BAY12-8039)
* Drug: Moxifloxacin (BAY12-8039)
| Inclusion Criteria:~Healthy male and female subjects;~Age: 18 to 55 years (inclusive)~Body mass index (BMI): above/equal 18 and below/equal 30 kg/m²;~Women of childbearing age must have a negative pregnancy test and must use adequate contraception throughout the study and for 4 weeks afterwards~Exclusion Criteria:~Clin... | 18 Years | 55 Years | All | Accepts Healthy Volunteers | Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Moxifloxacin after a Single Dose | AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrat... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose per Kilogram Body Weight (AUC,norm) of Moxifloxacin after a Single Dose | AUC is a measure of the plasma concentration of the drug over time. It is used to ch... | Pharmacokinetics, Bioavailability, Food effect, Oral liquid formulation | Moxifloxacin, Norgestimate, ethinyl estradiol drug combination, Anti-Bacterial Agents, Anti-Infective Agents, Topoisomerase II Inhibitors, Topoisomerase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Contraceptive Agents, Hormonal, Contraceptive Agents, Reproductiv... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Drug: Moxifloxacin (Avelox, BAY12-8039)<br>* Single oral dose of moxifloxacin (Avelox, BAY12-8039) IR (immediate release) tablet 400 mg under fasting conditions<br>|
| Experimental: Arm 2<br> | Drug: Moxifloxacin (BAY12-80... | Bioavailability, Food Effect and Safety, Tolerability of a New Oral Suspension in Comparison to the Marketed Moxifloxacin Tablet in Healthy Adults
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the pharmacokinetics of a new oral liquid moxifloxacin formulation... | |
NCT00001543 | Dynamics of Leptin and Endocrine Function | This is a study investigating the hormones and substances important to the stress response. The hormone that is most directly responsible for stress response is called corticotropin-releasing hormone (CRH). CRH is produced in the hypothalamus of the brain and causes the pituitary gland to produce another hormone called... | Our group has tested the hypothesis that the molecules involved in the neurobiology of the stress response are key elements in the pathophysiology, treatment, and medical consequences of major depressive disorder. Leptin is implicated in the regulation of adipose tissue, body weight and homeostasis. In the first three ... | Dynamics of Leptin and Endocrine Function | Healthy, Involutional Depression | Depressed patients must have a history of past major depression of at least four months duration, or a history of two or more briefer episodes. Must be overweight.~Must not need a hospital admission as part of their treatment.~Overweight normal volunteers.~No subjects on chronic medication which cannot be washed out fo... | null | null | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Depression, Metabolic Clearance Rate, Pulsatility, Adrenocorticotropic Hormone, Cortisol, Corticotropin Releasing Hormone Binding Protein, Pharmacokinetics, Half-Life, Bioavailability, Cushing's Syndrome | Depression, Depressive Disorder, Major, Behavioral Symptoms, Depressive Disorder, Mood Disorders, Mental Disorders | Dynamics of Leptin and Endocrine Function
Study Overview
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Brief Summary
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This is a study investigating the hormones and substances important to the stress response. The hormone that is most directly responsible for stress response is called corticotropin-releasing hormone (CRH). CRH i... | ||||
NCT03180021 | Dynamic Imaging of Variation in Lupus Nephritis | To use a variety of renal imaging modalities, including diffusion weighted imaging (DWI), blood oxygen level dependent (BOLD) imaging, T1rho (T1rho) imaging, and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) to evaluate the intra-renal blood flow, perfusion, cellularity, fibrosis and atrophy within the... | Dynamic Imaging of Variation in Lupus Nephritis | Lupus Nephritis | * Procedure: MRI
| Inclusion Criteria:~Provide written informed consent agreeing to all study procedures, before any study- specific procedures are done.~Male and female subjects 18 to 65 years of age, inclusive.~Subjects currently being evaluated for new or recurrent LN with a SOC kidney biopsy planned OR being evaluated for IgA nephrop... | 18 Years | 65 Years | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diffusion Weight Imaging | Diffusion weighted imaging (DWI) measures ADC values that quantify the combined effects of blood microcirculation and Brownian motion of water molecules within the interstitial space. | 7 Months |
| Blood Oxygen Lev... | Nephritis, Lupus Nephritis, Kidney Diseases, Urologic Diseases, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Male Urogenital Diseases, Glomerulonephritis, Lupus Erythematosus, Systemic, Connective Tissue Diseases, Autoimmune Diseases, Immune System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Lupus Nephritis<br> | Procedure: MRI<br>* This is a multicenter, non-interventional, pilot study. Eligible subjects will have a baseline MRI of the kidney, including anatomical, DWI, BOLD, T1rho, and DCE-MRI, utilizing a macrocyclic gadoli... | Dynamic Imaging of Variation in Lupus Nephritis
Study Overview
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Brief Summary
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To use a variety of renal imaging modalities, including diffusion weighted imaging (DWI), blood oxygen level dependent (BOLD) imaging, T1rho (T1rho) imaging, and dynamic contrast enhanced magnetic resonance... | ||||
NCT03392402 | Molecular Classifier for the Fine Needle-based Assessment of Malignancy Risk in Thyroid Nodules | This study evaluates the usefulness of molecular classifier to aid the diagnosis of malignancy in the material obtained by fine-needle aspiration biopsy (FNAB) of thyroid nodule. All participants will undergo FNAB with routine cytological assessment and molecular testing. Patients will undergo surgery or be followed-up... | Currently, the diagnosis of malignancy of thyroid nodule is based on cytological assessment of fine-needle aspiration biopsy (FNAB) classified according to the Bethesda System for Reporting of Thyroid Cytopathology. This does not allow for the definitive diagnosis of cancer in significant proportion of tumors, so calle... | Prospective Validation of the Molecular Classifier for the Fine Needle-based Assessment of Malignancy Risk in Thyroid Nodules | Thyroid Nodule, Thyroid Neoplasm, Thyroid Cancer | Inclusion Criteria:~a diagnosis of thyroid nodule~considerable chance for surgical procedure following biopsy result~patient's consent for collection of material during routine fine needle aspiration biopsy~Exclusion Criteria:~age below 18 years~the presence of contraindications that make surgical treatment impossible~... | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy in patients with indeterminate FNAB results who undergone surgery within 6 months from biopsy | The improvement in accuracy of classification will be compared between sole clinical criteria (Bethesda class, tumor size, age,... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy in all patients recruited to the study, who were operated on or remained in follow-up for at least 24 months from biopsy. | The improvement in accuracy of classification will be compared between sole clinical criteria (Beth... | Thyroid nodule, Indeterminate thyroid nodule, Molecular biopsy, Gene expression classifier | Neoplasms by Site, Thyroid Neoplasms, Thyroid Nodule, Thyroid Diseases, Neoplasms, Endocrine System Diseases, Endocrine Gland Neoplasms, Head and Neck Neoplasms | Molecular Classifier for the Fine Needle-based Assessment of Malignancy Risk in Thyroid Nodules
Study Overview
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Brief Summary
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This study evaluates the usefulness of molecular classifier to aid the diagnosis of malignancy in the material obtained by fine-needle aspiration biopsy (FNAB... | |||
NCT01866995 | Efficacy Study of Phytotherapy Raylis In Congestive Processes Of The Pelvic Organs (Prostatostasis) | The purpose of this study is to investigate the efficacy of Phytotherapy Raylis (Ginseng Root Powder 50 mg, False Ginseng Root Powder 50 mg, Codonopsis Root Powder 50 mg, Astragalus Membranaceus Root Powder 50 mg, Epimedium Alpinum Herbal Extract 100 mg) In Congestive Processes Of The Pelvic Organs (Prostatostasis) In ... | Phase 3 Study of Phytotherapy Raylis In Congestive Processes Of The Pelvic Organs (Prostatostasis)Caused By Decrease Of Sexual Activity In Men. | Congestive Processes Of The Pelvic Organs (Prostatostasis), Erectile Dysfunction, Sexual Function | * Drug: Raylis
* Other: standard prostatostasis therapy
| Inclusion Criteria:~Age 20-60 years~Symptoms of prostatostasis lasting for at least 3 months during the past 6 months:~Pathological changes on uroflowmetry (maximum flow rate of less than 15 ml / s, average urinary flow rate of less than 12 ml / sec)~TRUS Prostate volume more than 22 ml at TRUS~TRUS picture of Prostato... | 20 Years | 60 Years | Male | No | Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TRUS prostate | | 3 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uroflowmetry | | 3 months |
| Ginseng, Prostatostasis, Erectile Dysfunction | Erectile Dysfunction, Genital Diseases, Male, Genital Diseases, Urogenital Diseases, Sexual Dysfunction, Physiological, Male Urogenital Diseases, Sexual Dysfunctions, Psychological, Mental Disorders | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Raylis<br>This arm (10 men with symptoms of prostatostasis) will get Raylis (1 kapsule contains: ginseng root powder 50 mg, false ginseng root powder 50 mg, codonopsis root powder 50 mg, astragalus membranaceus root powder 50 mg, epimedium... | Efficacy Study of Phytotherapy Raylis In Congestive Processes Of The Pelvic Organs (Prostatostasis)
Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy of Phytotherapy Raylis (Ginseng Root Powder 50 mg, False Ginseng Root Powder 50 mg, Codonopsis Ro... | |
NCT04694872 | The Effects of Telerehabilitation-based Exercise Trainings on Gait and Balance in Parkinson's Patients | It is planned to recruit 30 individuals with Parkinson's Disease within the scope of the study. Balance, gait, activity transfers of Parkinson's Patients will be evaluated. The study will be randomly divided into two groups. In the first group, an exercise protocol called LSVT BIG will be applied via the Zoom applicati... | Parkinson's Disease (PD) is a degenerative process that affects the basal ganglia, primarily substantia nigra, and other brainstem pigmented neurons, and its main clinical symptoms are resting tremor, bradykinesia, rigidity and postural reflex disorder (1). These movement symptoms usually occur unilaterally and gradual... | The Effects of Telerehabilitation-based Exercise Trainings on Gait and Balance in Parkinson's Patients | Parkinson Disease | * Other: Telerehabilitation Based LSVT BIG Exercise Protocol
* Other: Telerehabilitation Based Functional Balance and Mobility Exercise
| Inclusion Criteria:~Having a definite diagnosis of Parkinson's disease according to the United Kingdom (UK) Brain Bank Criteria and being 1-3 on the Hoehn-Yahr scale~A score of at least 21 on the Montreal cognitive assessment scale test~To be able to walk independently on flat ground without assistive devices~Stability... | 40 Years | 75 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-Best Test | The Mini-BEST balance scale will be used in the assessment of dynamic balance, this scale is a one-dimensional and highly reliable measurement method with 14 items, requiring approximately 15 minutes to complete. The Mini-BEST... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity Specific Balance Confidence Scale - Short Form: | The short form of Activity Specific Balance Confidence Scale will be used to measure patients' balance confidence. Activity-Specific Balance Confidence Scale is answered with the self-... | Parkinson's Disease, Tele-rehabilitation, Exercise, LSVT BIG | Parkinson Disease, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Synucleinopathies, Neurodegenerative Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: a) TELEREHABILITATION BASED LSVT BIG TREATMENT GROUP<br>It is planned to recruit 16 patients with Parkinson's Disease in this group. Exercises will be applied simultaneously with the physiotherapist over the Zoom application, 4 days a week... | The Effects of Telerehabilitation-based Exercise Trainings on Gait and Balance in Parkinson's Patients
Study Overview
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Brief Summary
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It is planned to recruit 30 individuals with Parkinson's Disease within the scope of the study. Balance, gait, activity transfers of Parkinson's Patien... |
NCT03740113 | Kids SipSmartER, an Intervention to Reduce Sugar-sweetened Beverages | Overall Goal: To determine the effectiveness of Kids SIPsmartER in improving sugar-sweetened beverages behaviors among 7th grade students. Secondary aims are to determine (1) changes in secondary student outcomes (e.g. quality of life, BMI z-score, theory-related variables, health and media literacy), (2) changes in ca... | The intake of sugar-sweetened beverages (SSB, e.g., soda/pop, sweet tea, sports and energy drinks, fruit drinks) is disproportionately high in Appalachia, including among adolescents whose intake is more than double the national average and more than four times the recommended daily amount. There are strong and consist... | Kids SipSmartER: A Multi-level Behavioral and Health Literacy Intervention to Reduce Sugar-sweetened Beverages Among Appalachian Middle-school Students | Sugary Beverages | * Behavioral: Kids SipSmartER
| Inclusion Criteria:~7th grade students in the 12 enrolled schools during the years their school is randomized to one of these cohorts are eligible to participate~Parents/caregivers of enrolled middle school students~Exclusion Criteria:~Data from students with major cognitive disabilities that could compromise self-repo... | 10 Years | 85 Years | All | Accepts Healthy Volunteers | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized design of schools
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sugar sweetened beverages | ounces of sugar sweetened beverage consumption | 6 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | weight and height will be combined to report BMI in kg/m^2 | 6 months |
| Health-related quality of life | number of unhealthy days | 6 months |
| Sugar sweetened beverages, health disparities, Appalachia | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kids SipSmartER<br>Kids SIPsmartER is a 12 session, 6-month program with an integrated two-way short service message (SMS) strategy to engage caregivers in SSB role modeling and supporting home SSB environment changes | Behavioral: Kids Si... | Kids SipSmartER, an Intervention to Reduce Sugar-sweetened Beverages
Study Overview
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Brief Summary
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Overall Goal: To determine the effectiveness of Kids SIPsmartER in improving sugar-sweetened beverages behaviors among 7th grade students. Secondary aims are to determine (1) changes in... | |
NCT04277221 | ADCTA for Adjuvant Immunotherapy in Standard Treatment of Recurrent Glioblastoma Multiforme (GBM) | To confirm the result of previous Phase I/II and phase II clinical trials, this trial is to test the efficacy and safety of ADCTA immunotherapy plus the standard therapy in comparison with standard therapy alone in patients with recurrent GBM. | Autologous Dendritic Cell / Tumor Antigen (ADCTA-SSI-G1) for Adjuvant Immunotherapy in Standard Treatment of Recurrent Glioblastoma Multiforme (GBM): A Multi-center, Open-label, Randomized Phase III Clinical Trial | Glioblastoma Multiforme | * Biological: Autologous Dendritic Cell/Tumor Antigen, ADCTA
| Inclusion Criteria:~Specimen collection screening~Karnofsky performance status (KPS) ≥ 60 at assessment prior to surgery~≥ 18 and ≤ 70 years of age~Subject has been diagnosed with GBM and has undergone resection surgery followed by standard brain RT + concurrent temozolomide and adjuvant temozolomide, and progression o... | 18 Years | 70 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | | The duration will be calculated from the date of randomization until the date of death from any cause, assessed up to 60 months. |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) | | The duration will be calculated from the date of randomization until the date of first documented progression according to the modified RANO or date of death from any cause, whichever came first,assessed up... | Immunotherapy, Recurrent Glioblastoma Multiforme, Dendritic Cell | Glioma, Glioblastoma, Astrocytoma, 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: Standard therapy with ADCTA vaccine (study group)<br>- ADCTA vaccine as study treatment~Dose(s): Ten doses, including 2~4×10^7 cells for the 1st dose (double doses), and 1~2×10^7cells for the 2nd to 10th doses.~Administrative route: The AD... | ADCTA for Adjuvant Immunotherapy in Standard Treatment of Recurrent Glioblastoma Multiforme (GBM)
Study Overview
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Brief Summary
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To confirm the result of previous Phase I/II and phase II clinical trials, this trial is to test the efficacy and safety of ADCTA immunotherapy plus the sta... | |
NCT04931628 | Efficacy and Safety of Salvianolic Acid on AIS | Stroke has the characteristics of high morbidity, disability and fatality rate, which brings heavy spiritual and economic burdens to the family, society and the country. In my country, 33%-50% of ischemic strokes are attributed to intracranial atherosclerosis.~Studies have shown that oxidative stress, increased blood v... | Efficacy and Safety of Salvianolic Acid on Acute Ischemic Stroke | Stroke | * Drug: Salvianolic Acid
* Drug: 0.9% NaCl
| Inclusion Criteria:~Acute ischemic stroke with the first onset, or a history of cerebral infarction but with a modified Rankin Scale (mRS) score ≤1, onset within 72h;~CT examination to rule out cerebral hemorrhage;~With clear signs of nervous system positioning, the National Institutes of Health Stroke Scale (NIHSS) sc... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRS score | MRS score ≤2 | 90 days |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral blood flow volume (CBV) | Cerebral blood flow volume | 90 days |
| Cerebral blood flow (CBF) | Cerebral blood flow | 90 days |
| NIHSS score | NIHSS score | 90 days |
| Adverse drug reactions (ADR) | Adverse drug reactions | 90 day... | Stroke, ischemic, Acute | Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: salvianolic acid group<br>salvianolic acid group 100mg+0.9%NaCl 250ml, injection, 14 days | Drug: Salvianolic Acid<br>* salvianolic acid, injection, 100mg+0.9%NaCl 250ml, qd, 14 days<br>|
| Placebo Comparator: 0.9% NaCl<br>0.9%NaCl 25... | Efficacy and Safety of Salvianolic Acid on AIS
Study Overview
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Brief Summary
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Stroke has the characteristics of high morbidity, disability and fatality rate, which brings heavy spiritual and economic burdens to the family, society and the country. In my country, 33%-50% of ischemic st... | |
NCT01148511 | Comparison of Safety, Effectiveness and Quality of Life Outcomes Between Labeled Versus Treat and Extend Regimen in Turkish Patients With Choroidal Neovascularisation Due to Age-related Macular Degeneration (AMD) | The purpose of the study was to compare 2 treatment regimens for patients suffering from choroidal neovascularisation secondary to age-related macular degeneration (AMD). The first treatment regimen was the approved AMD treatment of 1 injection each month for 3 months and than re-treatment of patients who have a visual... | Comparison of Safety, Effectiveness, and Quality-of-life Outcomes Between Labeled Versus Treat and Extend Regimen in Turkish Patients With Choroidal Neovascularisation Due to AMD | Age-related Macular Degeneration | * Drug: Ranibizumab 0.5 mg
| Inclusion Criteria:~Male or female patients over the age of 50.~Patients with primary, secondary, or recurrent subfoveal choroidal neovascularization (CNV) to AMD with classic, minimal classic, or occult lesions.~Patients with CNV area ≥ %50 of the total lesion.~Total lesion area ≤ 12 disc areas for minimal classic/occ... | 50 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Best-Corrected Visual Acuity (logMAR) From Baseline to Month 12 | Best corrected visual acuity (BCVA) was assessed in the study eye. BCVA measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual a... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Letter Count From Baseline to Month 12 | Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Results are reported in various categorie... | Macula degeneration, Ranibizumab, Choroidal neovascularisation, Treat and extend, Treat and observe | Ranibizumab, Angiogenesis Inhibitors, Angiogenesis Modulating Agents, Growth Substances, Physiological Effects of Drugs, Growth Inhibitors, Antineoplastic Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treat and Extend<br>Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during s... | Comparison of Safety, Effectiveness and Quality of Life Outcomes Between Labeled Versus Treat and Extend Regimen in Turkish Patients With Choroidal Neovascularisation Due to Age-related Macular Degeneration (AMD)
Study Overview
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Brief Summary
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The purpose of the study was to compare 2... | |
NCT00921531 | Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma | Chemoembolization (TACE) is used in the majority of advanced hepatocellular carcinomas. Randomized clinical trials indicated that TACE improves overall survival in patients with good liver function (Child-pugh A or B). However, the shortcoming of TACE is obvious: hypoxia induced neoangiogenesis after blockage of blood ... | Phase Ⅲ Study of Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma | * Drug: Thalidomide
* Drug: TACE
| Inclusion Criteria:~Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features~Age ≥ 18 years and ≤ 80 years~At least one tumor nodule with one uni-dimension of ≥ 2 cm~Child-Pugh Class A or B~Total bilirubin ≤ 1.5 x upper limit of normal~ALT and AST ≤ 2.0 x the upper ... | 18 Years | 80 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | primary outcome is defined as overall survival. overall survival is calculated from the time of undergo treatment (TACE) to time of patients death. | 36 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to progression | time to progression is defined as from the time of treatment (TACE) to the time of patient's progression. the progression is defined as disease progression based on RECIST criteria. | 36 months |
| Hepatocellular carcinoma, thalidomide, TACE, Child-Pugh Class A or B | Thalidomide, Immunosuppressive Agents, Immunologic Factors, Physiological Effects of Drugs, Leprostatic Agents, Anti-Bacterial Agents, Anti-Infective Agents, Angiogenesis Inhibitors, Angiogenesis Modulating Agents, Growth Substances, Growth Inhibitors, Antineoplastic Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thalidomide and TACE<br>Thalidomide is used for adjuvant therapy for TACE | Drug: Thalidomide<br>* Thalidomide is used for adjuvant therapy for TACE~Thalidomide will be given at the dose of 200 mg/day in beginning, with dose escalation of ... | Adjuvant Therapy With Thalidomide for Chemoembolization in Advanced Hepatocellular Carcinoma
Study Overview
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Brief Summary
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Chemoembolization (TACE) is used in the majority of advanced hepatocellular carcinomas. Randomized clinical trials indicated that TACE improves overall survival ... | |
NCT00019955 | Radiofrequency Interstitial Tissue Ablation in Treating Patients With Localized Renal Cell Carcinoma (Kidney Cancer) | RATIONALE: Radiofrequency interstitial tissue ablation may kill tumor cells by heating tumors to several degrees above body temperature.~PURPOSE: This phase II trial is studying radiofrequency interstitial tissue ablation to see how well it works in treating patients with localized renal cell carcinoma (kidney cancer). | OBJECTIVES:~Primary~Evaluate the efficacy of radiofrequency interstitial tissue ablation in terms of tumor destruction or slowed tumor growth rate in patients with localized renal cell carcinoma.~Secondary~Assess the toxicity of this treatment regimen in these patients.~OUTLINE: Patients undergo percutaneous radiofrequ... | A Phase II Study to Evaluate Radiofrequency Ablation of Renal Cancer | Kidney Cancer | * Procedure: laparoscopic surgery
* Procedure: radiofrequency ablation
* Procedure: thermal ablation therapy
| DISEASE CHARACTERISTICS:~Localized renal cell carcinoma, meeting both of the following criteria:~Enlarging renal tumors on imaging studies over a minimum of 12 months~Tumor size between 0.5-4.0 cm in diameter at time of treatment~PATIENT CHARACTERISTICS:~Age:~18 and over~Performance status:~Not specified~Life expectanc... | 18 Years | null | All | No | Primary Purpose: Treatment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response | | |
| stage I renal cell cancer, stage II renal cell cancer | Kidney Neoplasms, Carcinoma, Renal Cell, Urologic Neoplasms, Urogenital Neoplasms, Neoplasms by Site, Neoplasms, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Kidney Diseases, Urologic Diseases, Male Urogenital Diseases, Adenocarcinoma, Carcinoma, Neoplasms, Gl... | | Intervention/Treatment |
| --- |
|Procedure: laparoscopic surgery|nan|
|Procedure: radiofrequency ablation|nan|
|Procedure: thermal ablation therapy|nan|
| Radiofrequency Interstitial Tissue Ablation in Treating Patients With Localized Renal Cell Carcinoma (Kidney Cancer)
Study Overview
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Brief Summary
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RATIONALE: Radiofrequency interstitial tissue ablation may kill tumor cells by heating tumors to several degrees above body temperature. ... | |
NCT01232998 | Emergency Department Patient Satisfaction Survey in the Imam Reza Hospital , Tabriz ,Iran, 2008 | The investigators want to survey Emergency Department Patient Satisfaction in the Imam Reza hospital ,Tabriz ,Iran by questionnaire form . Finally the investigators want to improve the quality services in the department based on the research result. | null | Community Sample | Inclusion Criteria:~all patients admitted to emergency department~Exclusion Criteria:~patients didn't sign consent form | null | null | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | | |
| Patient Satisfaction | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient Satisfaction with nursing care<br> | |
| satisfaction of waiting time for first time visit<br> | |
| patient satisfaction<br> | |
| Emergency Department Patient Satisfaction Survey in the Imam Reza Hospital , Tabriz ,Iran, 2008
Study Overview
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Brief Summary
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The investigators want to survey Emergency Department Patient Satisfaction in the Imam Reza hospital ,Tabriz ,Iran by questionnaire form . Finally the investi... | |||||
NCT02419651 | Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy | The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in reducing pain during outpatient hysteroscopy. Women undergoing outpatient hysteroscopy in Cairo university will be divided into 3 groups, the first group will receive Tramadol 100 mg 1 hour before the procedure, the second group wil... | Hysteroscopic examination is currently the most informative investigation for patients with abnormal uterine bleeding and infertility. Outpatient hysteroscopy involves the use of miniaturized endoscopic equipment to directly visualise the endometrial cavity, without the need of formal theatre facilities, general or reg... | Tramadol Versus Diclofenac for Reducing Pain Associated With Outpatient Hysteroscopy: A Randomized Double Blind Placebo-Controlled Trial | Pain, Post Procedural, Pain, Procedural | * Drug: Tramadol
* Drug: Diclofenac
* Drug: Placebo
| Inclusion Criteria:~Indication to do outpatient hysteroscopy~Consents to the procedure~Postmenstrual~Exclusion Criteria:~Known allergy to tramadol or diclofenac~Cardiac renal or gastric disease. | 20 Years | 50 Years | Female | No | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during the procedure | Women will be asked to score their pain using a visual analogue scale | 5 minutes after starting the procedure |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain after the procedure | Women will be asked to score their pain using a visual analogue scale | 30 minutes after competing the procedure |
| out patient hysteroscopy | Diclofenac, Analgesics, Opioid, Tramadol, Anti-Inflammatory Agents, Non-Steroidal, Analgesics, Non-Narcotic, Analgesics, Sensory System Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Anti-Inflammatory Agents, Antirheumatic Agents, Cyclooxygenase Inhibitors, Enzyme Inhibitors, Molecular Mechan... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tramadol<br>Women will receive oral Tramadol 100 mg before the procedure | Drug: Tramadol<br>* Women will receive oral tramadol 100 mg 1 hour before the procedure<br>|
| Active Comparator: Diclofenac<br>Women will receive oral diclofe... | Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy
Study Overview
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Brief Summary
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The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in reducing pain during outpatient hysteroscopy. Women undergoing outpatient hysteroscopy in ... |
NCT03516747 | Preoperational Fine Needle Aspiration of Pathological Parathyroid Gland | Identification and localization of pathological parathyroid gland before parathyroidectomy is traditionally done by a combination of two methods: ultrasound and sestamibi scan. The investigators would like to show that one exam that includes ultrasound and fine needle aspiration of the parathyroid gland for parathyroid... | A prospective, open label, single arm trial that includes participants that suffer hypercalcemia due to primary hyperparathyroidism and are candidates for parathyroidectomy.~participants visit the investigator's head and neck clinic. the investigator confirms that the participant has an indication for parathyroidectomy... | Ultrasound Guided Fine Needle Aspiration of Parathyroid Gland as a Pre Operative Localization Tool to Identify Pathological Parathyroid | Parathyroid Adenoma, Hypercalcemia | * Diagnostic Test: pre operative parathyroid hormone level measurement
* Diagnostic Test: pre operative parathyroid cytology
* Diagnostic Test: parathyroid hormone level measurement
* Diagnostic Test: parathyroid cytology
| Inclusion Criteria:~above 18 years old~participants that suffer from primary hyperparathyroidism with an indication for parathyroidectomy~Exclusion Criteria:~Chronic renal failure~kidney transplant participant~MEN (multiple endocrine neoplasia) syndrome~pregnancy | 18 Years | 99 Years | All | No | Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: open label, non- randomised, prospective
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parathyroid hormone level from a pathological parathyroid gland | Under ultrasound guidance, the investigators will locate a neck leison which based on previous localization imaging modalities, is proven to be a pathological parathyroid gland.... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parathyroid gland cytology from a pathological parathyroid gland. | Under ultrasound guidance, the investigators will locate a neck leison which based on previous localization imaging modalities, is proven to be a pathological parathyroid glan... | cytology, parathyroidectomy, parathyroid hormone level | Hormones, Parathyroid Hormone, Hormones, Hormone Substitutes, and Hormone Antagonists, Calcium-Regulating Hormones and Agents, Physiological Effects of Drugs | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: investigation group<br>participants that suffer hypercalcemia due to primary hyperparathyroidism. include all participants in the trial | Diagnostic Test: pre operative parathyroid hormone level measurement<br>* At the clinic, the particip... | Preoperational Fine Needle Aspiration of Pathological Parathyroid Gland
Study Overview
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Brief Summary
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Identification and localization of pathological parathyroid gland before parathyroidectomy is traditionally done by a combination of two methods: ultrasound and sestamibi scan. The i... |
NCT04364815 | The University of the Philippines Hydroxychloroquine PEP Against COVID-19 Trial | This COVID-19 pandemic warrants urgent strategies to protect people at high risk of infection, particularly the healthcare workers. Secondary prevention through post-exposure prophylaxis (PEP) and early treatment of infection are needed to prevent severe cases and cut secondary transmission. Hydroxycholoroquine (HCQ) i... | To compare the efficacy and safety of hydroxychloroquine with an oral loading dose of 400 mg two times a day on D1 followed by 400mg/day from Day 2-10 plus standard preventive measures and standard preventive measures alone as post-exposure prophylaxis for healthcare workers in a Metro Manila COVID Referral Center | Efficacy and Safety of Hydroxychloroquine for COVID-19 Post-Exposure Prophylaxis of Healthcare Workers in the Philippine General Hospital and UP Manila National Institutes of Health: A Randomized, Double-blind, Placebo-controlled Trial | COVID-19 | * Drug: Hydroxychloroquine plus standard preventive measures
* Drug: Placebo plus standard preventive measures
| Inclusion Criteria:~any medical or non-medical personnel of the Philippine General Hospital and the UP Manila National Institutes of Health to include physicians (consultants, fellows-in-training, residents-in-training); nurses and other nursing staff (nursing aide, institutional or utility worker); janitors and cleani... | 18 Years | 59 Years | All | Accepts Healthy Volunteers | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, assessor- and patient- blinded, placebo controlled, parallel group trial
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of HCQ Prophylaxis in Preventing COVID-19 infection | Incidence of COVID-19 infection confirmed by RT-PCR COVID-19 test within the PEP treatment period (28 days) with or without symptoms of COVID-19 infection | 30 days |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of study drug as post-exposure prophylaxis in preventing COVID-19 related symptoms (to be reported as absolute number and frequency of events) | Incidence of patient self-reported COVID-19 related symptoms anytime during follow up per... | SARS-COV-2, COVID-19, Hydroxychloroquine, Post-exposure prophylaxis, Healthcare workers | Hydroxychloroquine, Antimalarials, Antiprotozoal Agents, Antiparasitic Agents, Anti-Infective Agents, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Antirheumatic Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxychloroquine plus standard preventive measures<br>Hydroxychloroquine oral loading dose of 400mg two times per day on Day 1 then 400 mg once a day for Day 2-10 plus standard preventive measures as defined by PGH Hospital Infection Con... | The University of the Philippines Hydroxychloroquine PEP Against COVID-19 Trial
Study Overview
=================
Brief Summary
-----------------
This COVID-19 pandemic warrants urgent strategies to protect people at high risk of infection, particularly the healthcare workers. Secondary prevention through post-exposure... |
NCT05468112 | Improving Wellbeing of SHP Personnel at UAB | The main objective of this study is to evaluate the impact of a well-being program, SKY Campus Happiness, on well-being of students, faculties, and staff working/studying at School of Health Professional (SHP). SHP is leaning on the SKY Campus Happiness (SKY) program which is an integrative workshop format that include... | Students/staff/faculties of SHP will be offered to participate in the SKY Breath Happiness workshop followed by participating in a research program designed to study the potential effectiveness of the SKY Breath Happiness Program as a stress-management, resilience building wellness tool in this population. They will be... | Improving Wellbeing of SHP Personnel at UAB | Stress, Psychological | * Behavioral: SKY Meditation and Mindfulness
| Inclusion criteria:~Healthy students/faculty/staff who at UAB, School of Health Professionals~Willingness to complete all study interventional components~Exclusion criteria:~Inability to understand standard English~Previous participation in a SKY intervention~Pregnant persons~Diagnosis of bipolar disorder or schizophre... | 18 Years | null | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single group design in which participants participants are assigned to a SKY meditation treatment intervention.
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PERCEIVED STRESS SCALE | The Perceived Stress Scale(PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Open Ended Questions | Qualitative questions of well-being | Weekly after 8 weeks |
| Focus Groups | Group discussion with transcript | After participation in sessions at 12 weeks |
| Mindfulness, Breathing, Meditation, Stress reduction, SKY Yoga | Stress, Psychological, Behavioral Symptoms | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sky Meditation and Mindfulness Intervention<br>In person meditation classes will be 3 hours long on each of three consecutive days, and participants must be willing to attend all three sessions. An additional 7 online sessions will be deli... | Improving Wellbeing of SHP Personnel at UAB
Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to evaluate the impact of a well-being program, SKY Campus Happiness, on well-being of students, faculties, and staff working/studying at School of Health Professional (SHP).... |
NCT04222595 | FluPRINT Study: Characterisation of the Immune and Transcriptional Response to LAIV | In 2013 the UK government introduced the nasal flu spray vaccine (Fluenz Tetra®) for use in children from 24 months to less than 18 years of age. This is a licensed vaccine that is safe, effective and like the injectable vaccine, needs to be given yearly. There is evidence that the nasal spray flu vaccine can offer bet... | Influenza infection is related to significant morbidity and mortality in children. Although usually causing a self-limiting illness, the increased risk for children of hospitalisation and further complications, ranging from secondary pneumonia to death, reflect the need to focus on prevention. The commonly used trivale... | FluPRINT Study OVG 2018/04: Characterisation of the Immune & Transcriptional Responses to Live Attenuated Influenza Vaccine (LAIV) in Healthy 4-6-year-old Children | Immunization | * Other: Fluenz Tetra nasal spray suspension
| Inclusion Criteria:~The investigator believes that the parents/LAR(s) of the child can and will comply with requirements of the protocol (e.g. understanding of study procedure, consent process, availability at visits).~Written informed consent obtained from parent(s)/LAR(s) of the subject~Age from 4y+ 1day up to 6 year... | 48 Months | 72 Months | All | Accepts Healthy Volunteers | Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open-label study of healthy and immunocompetent children aged 4 to 6 years
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the change in molecular signature from baseline to day 28 after LAIV vaccination | To assess gene expression differences between participants at baseline and day 28 after vaccination. | Baseline and day 28 after vaccination |
| To a... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the change in functionality of the adaptive immune responses to LAIV from baseline to day 28 after LAIV vaccination | To assess the differences in activation and intracellular cytokine secretion of CD4+, CD8+ T cells and B cells afte... | Vaccines, Immunologic Factors, Physiological Effects of Drugs | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1- naive<br>Group 1: up to 10 children aged 4-6 years that never received LAIV before. | |
| Active Comparator: 2- Fluenz Tetra nasal spray suspension<br>Group 2: up to 10 children aged 4-6 years that received LAIV once before. Single d... | FluPRINT Study: Characterisation of the Immune and Transcriptional Response to LAIV
Study Overview
=================
Brief Summary
-----------------
In 2013 the UK government introduced the nasal flu spray vaccine (Fluenz Tetra®) for use in children from 24 months to less than 18 years of age. This is a licensed vacci... | |
NCT00792558 | Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced Cancers | The purpose of this study is to find the maximum tolerated dose of BMS-817378 in subjects with advanced cancers | A Phase I Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced or Metastatic Solid Tumors | Advanced Solid Tumors | * Drug: BMS-817378
| Inclusion Criteria:~Confirmed diagnosis of advanced non-hematologic malignancy. Dose expansion cohort restricted to subjects with advanced or metastatic gastroesophageal cancer, squamous cell cancers of the head and neck, and castration resistant prostate cancer~ECOG status 0-1~Exclusion Criteria:~WOCBP unwilling/unabl... | 18 Years | null | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the MTD of BMS-817378 when administered orally on a daily schedule in subjects with advanced cancers | | Within the first 21 days after first dose of BMS-817378 |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess safety and tolerability of multiple doses of BMS-817378 administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors | | All time points while subject is on study |
| Assess the safety and tolerabi... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: BMS-817378<br>* Capsule, Oral, Dose escalation to a MTD from a starting dose of 25 mg, once daily, until disease progression/subject discontinuation<br>|
| Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced Cancers
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find the maximum tolerated dose of BMS-817378 in subjects with advanced cancers
Official Title
-----------------
A Phase I Ascending Multiple-D... | |||
NCT04761133 | Antiseptic Irrigation for Pleural Infection | The antiseptic povidone-iodine can safely be instilled into the pleural for the purpose of pleurodesis. Pleural irrigation with antiseptics is used in adults with open drainage for chronic empyema and has been described in the acute management of paediatric pleural infection.~This study will investigate the safety and ... | Pleural infection is a condition that requires hospitalization for management and is associated with significant in-hospital morbidity and mortality. Predictors of poor outcome include advancing age, poor nutrition, hospital-acquired infection and impaired renal function. Medical management is centred on appropriate an... | Antiseptic Pleural Irrigation for Patients With Pleural Infection | Pleural Infection | * Drug: Povidone-Iodine pleural irrigation
| Inclusion Criteria:~All adult patients admitted to hospital with pleural infection and had a chest tube inserted for treatment of the infection. Pleural infection will be defined by the presence of one of the following: a) the presence of pus in the pleural space; b) positive pleural fluid gram stain or culture; or c) ... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Number of subjects with any adverse event (new chest pain, fever, dyspnoea or oxygen desaturation) | Within 24 hours after the second application of the study medication |
| Time to chest tube removal | Number of... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to defervescence | Numbers of days until resolution of fever | Up to 8 weeks |
| Length of hospital stay | Number of days from admission/diagnosis until discharge from hospital | Up to 8 weeks |
| Incidence of need for additional aspira... | Povidone-Iodine, Povidone, Plasma Substitutes, Blood Substitutes, Anti-Infective Agents, Local, Anti-Infective Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pleural irrigation with antiseptic<br>Two applications of 100-250 ml solution of 2% povidone-iodine will be irrigated into the pleural space of eligible patients 12 hours apart. The tube will be clamped for 15 minutes after irrigation and ... | Antiseptic Irrigation for Pleural Infection
Study Overview
=================
Brief Summary
-----------------
The antiseptic povidone-iodine can safely be instilled into the pleural for the purpose of pleurodesis. Pleural irrigation with antiseptics is used in adults with open drainage for chronic empyema and has been ... | |
NCT00240851 | An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets in Treating Muscle Aches and Soreness That Occur After a Marathon Race | The purpose of this study is to compare the effectiveness of acetaminophen extended release caplets to placebo in treating the muscle aching and pain (soreness) that occurs after a marathon. | This is a randomized, double-blind, placebo-controlled study to compare the effectiveness and safety of acetaminophen and placebo in treating muscle aching and pain (soreness) that occurs in subjects who complete a marathon. Subjects are randomized to receive acetaminophen extended release caplets, 3900 mg/day (two 650... | A Randomized, Double-Blind, Placebo-Controlled Study Evaluating Acetaminophen Extended Release Caplets (3900 mg/Day) in the Treatment of Post-Race Muscle Aching and Pain (Soreness) | Pain | * Drug: acetaminophen extended release
| Inclusion Criteria:~Patients must be able to comply with the study schedule~be able to swallow the study medication~complete the marathon~not take any analgesics after completing the marathon and before their eligibility to participate in the study has been determined~rate their muscle soreness at least a 4, on a 0 - 1... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The average change from baseline in muscle soreness on Day 1 | | |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average change from baseline in muscle soreness for both morning and evening assessments, combined and separately; Average ratings of interference with 1) sleep, 2) daily activity, and 3) ability to go for a run | | |
| muscle ache, pain, soreness, acetaminophen | Acetaminophen, Analgesics, Non-Narcotic, Analgesics, Sensory System Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Antipyretics | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 001<br>acetaminophen extended release | Drug: acetaminophen extended release<br> <br> |
| An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets in Treating Muscle Aches and Soreness That Occur After a Marathon Race
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effectiveness of acetaminophen extended release caplets to plac... |
NCT01580332 | Non-Invasive Biomarkers For Early Detection Of Lung Cancers | Recent studies have shown that low-dose chest CT scans can detect lung cancers in high-risk populations (age >50yo, >30 pack-years of tobacco use), and can lower cancer mortality. Unfortunately, the vast majority of positive findings on these CT scans are benign (>95%). Currently, an inordinate amount of expensive foll... | The study revolves around specifying the exact signatures and accuracy associated with discriminating between benign and malignant SPNs for each of the biomarkers in the specific high risk cohort under the NLST screening protocol. To help identify and quantify these signatures, we will evaluate specifically the volatil... | NON-INVASIVE BIOMARKERS FOR EARLY DETECTION OF LUNG CANCERS: ELEMENT 1: NON-RANDOMIZED PHASE II EVALUATION AND VALIDATION IN NEWLY DIAGNOSED LUNG CANCER PATIENTS | Lung Cancer | Inclusion Criteria:~newly diagnosed cancer, prior to treatment~Exclusion Criteria:~prior treatment for this cancer~a history of any other cancer | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VOC, volatile organic compounds, sputum, biomarkers, lung cancer, solitary pulmonary nodules, SPN, breath analysis, auto-antibodies | Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases | Non-Invasive Biomarkers For Early Detection Of Lung Cancers
Study Overview
=================
Brief Summary
-----------------
Recent studies have shown that low-dose chest CT scans can detect lung cancers in high-risk populations (age >50yo, >30 pack-years of tobacco use), and can lower cancer mortality. Unfortunately,... | ||||
NCT03495557 | Prevalence of Port Site Hernia After Mesh Placement in Laparoscopic Cholecystectomy. | A prophylactic mesh fixation after fascial closure in umbilical trocar after cholecystectomy may prevent the trocar site hernia incidence. Especially in patients who present certain risk factors. | Randomized controlled trial. Patients with more than two incisional hernia risk factors (age ≥70, BMI ≥30, diabetes mellitus, fascial enlargement) who undergo elective/emergent cholecystectomy. Control arm: fascial closure with simple PDS 2/0 Stitches. Study arm: fascial closure with simple PDS 2/0 stitches and onlay p... | Evaluation of Port Site Hernia Prevalence After Prophylactic Mesh Placement Following Laparoscopic Cholecystectomy: Randomized Clinical Trial | Incisional Hernia | * Procedure: Control
* Device: Experimental
| Inclusion Criteria:~Age ≥ 18 years~Laparoscopic cholecystectomy~Emergent/elective~≥2 risk factors: diabetes mellitus, age ≥70 years, BMI ≥30, fascial enlargement~Exclusion Criteria:~Conversion to laparotomy~Emergent re intervention~Immunosuppression~Umbilical hernia | 18 Years | null | All | No | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control will have simple closure while experimental group will have simple closure+mesh
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Umbilical trocar site hernia incidence | Umbilical trocar site hernia incidence after 6 months and 1 year (clinical assessment) and after 3 years (radiological confirmation) | 3 years |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroma incidence | A mass or tumefaction caused by the localized accumulation of serum within the tissue (clinical assessment) | 6 months |
| Hematoma incidence | A localized collection of extravasated blood clotted under the tissue (clinical... | Cholecystectomy, Hernia, Mesh fixation | Hernia, Incisional Hernia, Pathological Conditions, Anatomical, Postoperative Complications, Pathologic Processes | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>Simple closure | Procedure: Control<br>* Fascial closure with simple polydioxanone suture 2/0 stitches<br>|
| Experimental: Experimental<br>Simple closure + mesh | Device: Experimental<br>* Onlay polypropylene mesh placement ... | Prevalence of Port Site Hernia After Mesh Placement in Laparoscopic Cholecystectomy.
Study Overview
=================
Brief Summary
-----------------
A prophylactic mesh fixation after fascial closure in umbilical trocar after cholecystectomy may prevent the trocar site hernia incidence. Especially in patients who pre... |
NCT00948519 | Laser Assisted Treatment of Chronic Sinusitis With and Without Light Activated Agents | Chronic rhinosinusitis (CRS) is common disorder which affects up to 13% of the US population. CRS affects numerous Quality of Life (QOL) factors including smell, sleep and communication. The common treatment for medically noncompliant CRS is Functional Endoscopic Sinus Surgery (FESS).~As the disease course is generally... | A prospective randomized trial that will be performed over the period of 1 year or until 20 patients in each arm meeting inclusion criteria will be recruited. One arm will be treated with a NIR laser (ARC Lasers Gmbh, Germany) alone and another arm will have an ICG+ NIR laser treatment.~FDA approved NIR lasers in the r... | Laser Microbial Killing With Photo Activated Agents | Rhinosinusitis | * Device: Laser + ICG
* Device: Laser only
| Inclusion Criteria:~Patients over 18~Patients with an established nasal culture of either~Staph aureus,~Strep species,~Pseudo monasaureginosa,~Proteus.mirabilis,~H. influenza~or other intranasal pathogens.~Exclusion Criteria:~Patients without CRS,~Patients known to have Iodide allergy or ICG allergy~Patients scheduled ... | 18 Years | null | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life improvement with disease control. Disease control without antibiotics or steroids. | | 1-2 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laser safety without compromising disease progress | | immediate and late |
| Rhinosinusitis, sinusitis, chronic, nasal polyps, phototherapy, laser,laser therapy, antibiotic, safety laser, ICG, indocyanine green, Chronic Rhinosinusitis with or without nasal polyposis | Sinusitis, Respiratory Tract Infections, Infections, Paranasal Sinus Diseases, Nose Diseases, Respiratory Tract Diseases, Otorhinolaryngologic Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser + ICG<br>ICG arm- will be defined as local application on a pledget soaked with ICG with a concentration of 200µg, upon removal of the pledget a NIR diode laser set at 6W with light emittance introduced intranasally with a 30mm diffu... | Laser Assisted Treatment of Chronic Sinusitis With and Without Light Activated Agents
Study Overview
=================
Brief Summary
-----------------
Chronic rhinosinusitis (CRS) is common disorder which affects up to 13% of the US population. CRS affects numerous Quality of Life (QOL) factors including smell, sleep ... |
NCT04770883 | Psychological and Dietary Treatment in IBS | Irritable Bowel Syndrome (IBS) is a common functional gastrointestinal (GI) condition which is strongly associated with dietary and psychosocial factors. Management of IBS remains challenging for primary health care.~The aim is to perform a comprehensive phenotyping of patients with IBS within the primary health care i... | Part 1~Study design:~Cross-sectional observational study.~Study population:~200 IBS patients, M/F, age 18-65 years, will be recruited under a period of 4 years from the primary health care in Region Örebro County. Patients will also be recruited from the general public using websites, social media and advertisements.~D... | Phenotyping and Treatment of Primary Health Care IBS Patients. A Randomized Controlled Trial | Irritable Bowel Syndrome | * Behavioral: Internet based cognitive behavioral therapy.
* Dietary Supplement: Low FODMAP diet therapy
| Inclusion Criteria:~IBS symptom severity score of at least 175 (moderate to severe symptoms).~Age 18 to 65 years.~Exclusion Criteria:~Abnormal results on standard screening laboratory tests; this means that patients with abnormal thyroid-stimulating hormone (TSH), increased f-calprotectin or positive celiac disease ser... | 18 Years | 65 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study design is an open labelled, randomized, controlled clinical trial, with a ratio 2:2:1.
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Symptom Rating Scale-IBS (GSRS-IBS) | Measures disease-specific symptoms in IBS patients | 10 weeks |
| The IBS quality of life questionnaire (IBS-QoL) | Assessment of disease-specific quality of Life | 10 weeks |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire Anxiety module (GAD-7) | Measures anxiety | 10 weeks |
| Patient Health Questionnaire Depression Module (PHQ-9) | Measures depressive symptoms | 10 weeks |
| Patient Health Questionnaire Somatic symptom severity ... | Irritable Bowel Syndrome, Cognitive Behavioral Therapy, Diet Therapy, Low FODMAP Diet, Internet Based Cognitive Behavioral Therapy, Psychological Therapy, Psychological Parameters, Phenotyping of Irritable Bowel Syndrome Patients, Gastrointestinal Symptoms, Quality of Life, Irritable Bowel Syndrome Symptom Severity | Pathologic Processes, Irritable Bowel Syndrome, Syndrome, Disease, Colonic Diseases, Functional, Colonic Diseases, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet based cognitive behavioral therapy group<br>80 patients will be randomized to receive iCBT. Psychological therapy is effective in IBS patients. The treatment takes 10 weeks and is divided into five successive steps. Patients have ... | Psychological and Dietary Treatment in IBS
Study Overview
=================
Brief Summary
-----------------
Irritable Bowel Syndrome (IBS) is a common functional gastrointestinal (GI) condition which is strongly associated with dietary and psychosocial factors. Management of IBS remains challenging for primary health ... |
NCT04070820 | Combination Treatment for Enterococcus Faecalis Bacteriemia Multicenter, Observational Study | Prospective, multicenter, observational study on the evaluation of efficacy of appropriate monotherapy vs combination treatment for non-complicated Enterococcus faecalis bloodstream infection (EF-BSI).~The aims of our study are:~Primary:~To compare the efficacy of appropriate monotherapy vs combination treatment for EF... | Combination Treatment for Enterococcus Faecalis Bacteremia: a Prospective, Multicenter, Observational Study | Enterococcal Bacteraemia, Enterococcus Faecalis Infection, Enterococcal Endocarditis, Bloodstream Infection | Inclusion Criteria:~Adult (>18 years)~First monomicrobial EF-BSI~Receipt of ≥ 5 days of at least one in vitro active drug (ampicillin, amoxicillin/clavulanate, ampicillin/sulbactam, piperacillin, vancomycin, teicoplanin, daptomycin and linezolid) with or without a synergistic drug (ceftriaxone, gentamycin, streptomycin... | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Patient alive | End of Treatment, at least 2 weeks from first negative follow-up bloodculture |
| Body temperature (Celsius degrees) | Fever resolution | End of Treatment, at least 2 weeks from first negative follow-up bloodculture... | Combination therapy, Bloodstream Infection, Enterococcus faecalis Infection, Endocarditis | Infections, Communicable Diseases, Bacteremia, Sepsis, Endocarditis, Disease Attributes, Pathologic Processes, Bacterial Infections, Bacterial Infections and Mycoses, Systemic Inflammatory Response Syndrome, Inflammation, Heart Diseases, Cardiovascular Diseases | Combination Treatment for Enterococcus Faecalis Bacteriemia Multicenter, Observational Study
Study Overview
=================
Brief Summary
-----------------
Prospective, multicenter, observational study on the evaluation of efficacy of appropriate monotherapy vs combination treatment for non-complicated Enterococcus ... | |||||
NCT02573467 | An Extension Study of the Efficacy, Safety and Tolerability of BYM338 (Bimagrumab) in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203 | This extension study will provide data to further evaluate the efficacy, safety, and tolerability of three doses of BYM338 and to assess the long-term effects of BYM338 in patients with sporadic inclusion body myositis. The extension study was planned to consist of a Screening epoch (to assess patient eligibility), fol... | Extension of the CBYM338B2203 Phase IIb/III Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Intravenous BYM338 in Patients With Sporadic Inclusion Body Myositis | Sporadic Inclusion Body Myositis | * Drug: Bimagrumab
* Drug: Placebo
| Inclusion Criteria:~Patients who completed the core study~Written informed consent must be obtained before any extension study assessment is performed.~Able to communicate well with the investigator.~Willing to participate for the entire duration of the extension study with commitment to follow study requirements and p... | 36 Years | null | All | No | Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths. | Safety monitoring was conducted throughout the study. AEs starting on or after the day of first administration of extension study drug until last adm... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Core Study Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side | Quantitative Muscle Testing (QMT) was used to describe the long-term evolution of quadriceps muscle strength on the right side. The QMT was per... | sporadic inclusion body myositis,, muscle wasting,, extension study,, BYM338,, bimagrumab, | Myositis, Myositis, Inclusion Body, Muscular Diseases, Musculoskeletal Diseases, Neuromuscular Diseases, Nervous System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BYM338/bimagrumab 10 mg/kg<br>Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. | Drug: Bimagrumab... | An Extension Study of the Efficacy, Safety and Tolerability of BYM338 (Bimagrumab) in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203
Study Overview
=================
Brief Summary
-----------------
This extension study will provide data to further evaluate the... | |
NCT02771613 | Impact on the Adverse Event (AE) Incidence of Two Types of Experience Feedback on AE Analyzed During Local Morbidity Mortality Reviews | After implementing a French version of a trigger tool validated for computerized detection of adverse events in patient's medical record, the study will be performed in three parallel randomized arms of three identical departments (each steaming from 6 types of medical, surgical or obstetrical departments with a total ... | Impact on Adverse Events (AE) Occurrence of Two Types of Experience Feedback on AE Analysed During Local Morbidity Mortality Reviews (MMR), (by Multi Professional Simulation Education Versus Simple Diffusion of MMR Decisions) | Hospital Adverse Event | * Other: Multi professional in situ simulation
* Other: Large diffusion of information
| Inclusion Criteria:~patients aged > 18 years old~patients hospitalized in the involved departments during the two-years intervention's period~Exclusion Criteria:~patient aged < 18 years old~no other exclusion criteria | null | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of adverse events related to medical care | Occurrence of any adverse effects detected by the trigger tool. Trigger tool is used to detect more patient's adverse events that voluntary medical report | During patient hospitalization, ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of adverse events related to medical care | Severity of any patient's adverse effect detected by trigger tool. Severity of adverse events is measured by a severity score scale. | During patient hospitalization, up to 2 years |
| Cont... | Morbidity Mortality Review, medical simulation, in situ simulation, multi professional simulation, hospital adverse event | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active experience feedback<br>Multi professional, in situ simulation , with scenarios based on the adverse events analyzed in MMR : After analysis of adverse effects in Morbidity Mortality reviews, we will create scenarios adapted to these events. Educa... | Impact on the Adverse Event (AE) Incidence of Two Types of Experience Feedback on AE Analyzed During Local Morbidity Mortality Reviews
Study Overview
=================
Brief Summary
-----------------
After implementing a French version of a trigger tool validated for computerized detection of adverse events in patient... | |||
NCT00782132 | Access to Infertility Services: Clinic Perspective | Since the identification of the human immunodeficiency virus (HIV) and the acquired immunodeficiency syndrome (AIDS) in the 1980s, there have been significant advances made in the management and long-term prognosis for infected individuals. Currently, with the advent of highly active antiretroviral therapy (HAART), HIV... | Access to Infertility Services in Ontario for Couples in Which One or Both Partners is HIV-Positive | Infertility | Inclusion Criteria:~All Ontario clinics offering advanced reproductive/infertility services~Exclusion Criteria:~none | null | null | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infertility Services, HIV, pregnancy planning | Infertility, Genital Diseases, Urogenital Diseases | Access to Infertility Services: Clinic Perspective
Study Overview
=================
Brief Summary
-----------------
Since the identification of the human immunodeficiency virus (HIV) and the acquired immunodeficiency syndrome (AIDS) in the 1980s, there have been significant advances made in the management and long-ter... | |||||
NCT00468949 | Health-Related Quality of Life in Patients With Dupuytren's Disease | Main Research Questions:~We want to measure the change in quality of life in Dupuytren's disease patients who do and do not undergo surgery. Also, we want to test the validity of health related quality of life measurements in patients with Dupuytren's disease.~Why is this research important? Some patients with Dupuytre... | Previous research on Dupuytren's disease has not reported the health-related quality of life (HRQL) of patients' whether related to surgical intervention or not. The primary objective of this study is to measure the change in HRQL in Dupuytren's contracture patients who do and do not undergo palmar fasciectomy. Health ... | Health-Related Quality of Life in Patients With Dupuytren's Disease: A Prospective Cohort Study. | Dupuytren's Contracture | Inclusion Criteria:~patients who have the diagnosis of Dupuytren's disease~able to comprehend English to complete the self-reported questionnaires~willing to provide informed consent.~Exclusion Criteria:~patients who have had previous Dupuytren's contracture surgery on the same hand~patients who have carpal tunnel synd... | 18 Years | null | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-Related Quality of Life, Dupuytren's Disease, Health Utilities Index, Short Form-36;, Michigan Hand Outcomes Questionnaire | Neoplasms, Fibroma, Dupuytren Contracture, Contracture, Joint Diseases, Musculoskeletal Diseases, Muscular Diseases, Neoplasms, Fibrous Tissue, Neoplasms, Connective Tissue, Neoplasms, Connective and Soft Tissue, Neoplasms by Histologic Type, Connective Tissue Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients undergoing excision surgery for their dupuytren's contracture | |
| 2<br>Patients not undergoing surgery for their excision surgery | |
| Health-Related Quality of Life in Patients With Dupuytren's Disease
Study Overview
=================
Brief Summary
-----------------
Main Research Questions: We want to measure the change in quality of life in Dupuytren's disease patients who do and do not undergo surgery. Also, we want to test the validity of health ... | |||
NCT03508999 | Effectiveness of Metronidazole Gel and Mobile SMS Reminders on Gingivitis in Orthodontic Patients | A rapid deterioration in oral hygiene occur after bonding of orthodontic appliances. Zachrisson and Zachrisson have reported that even after maintaining excellent oral hygiene, patients usually experience mild to moderate gingivitis within 1-2 months after orthodontic appliance placement. Slutzkey and Levin have report... | Gingivitis: It is defined as the inflammation of the gingiva in the absence of clinical attachment loss.~Six standard sites on incisors, canines and premolars have been used in this study as study sites as described by Gettinger et al. The investigators will not include banded first molars because the banding itself wi... | Effectiveness of Metronidazole Gel and Mobile Telephone Short- Message Service Reminders on Gingivitis in Orthodontic Patients: A Randomized Controlled Trial | Gingivitis | * Drug: Metronidazole gel
* Other: SMS text reminder
* Other: Placebo gel
| Inclusion Criteria:~Patients undergoing orthodontic treatment with fixed appliance since 6 months~Patients with all bonded teeth mesial to the first molars and not adjacent to a banded tooth~Systematically healthy patient with no co-morbid such as rheumatic fever, blood dyscrasias, congenital heart disease or diabetes ... | 18 Years | 40 Years | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Bleeding Index | Improvement in Bleeding Index Scores In Orthodontic Patients, Change from Baseline in Index at 4 weeks. All the measurements at the baseline (To) and follow ups (T1) will be recorded by the investigator on separ... | Metronidazole, Anti-Infective Agents, Anti-Bacterial Agents, Antiprotozoal Agents, Antiparasitic Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metronidazole Gel<br>Group A subjects will be given standard oral hygiene instructions on the visit with a standard 0.8 % metronidazole gel instructed to apply topically on the marginal gingiva for the next 4 weeks, twice a day for 30 minu... | Effectiveness of Metronidazole Gel and Mobile SMS Reminders on Gingivitis in Orthodontic Patients
Study Overview
=================
Brief Summary
-----------------
A rapid deterioration in oral hygiene occur after bonding of orthodontic appliances. Zachrisson and Zachrisson have reported that even after maintaining exc... | ||
NCT03267732 | A Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518) | To evaluate the pharmacokinetics of single and multiple doses of pegilodecakin in healthy participants. | This is an open-label, single-center, phase 1 study designed to evaluate the pharmacokinetics in healthy adult participants after single and multiple subcutaneous injections of pegilodecakin. | A Phase 1 Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of AM0010 in Healthy Adult Subjects | Healthy Adult Subjects | * Biological: Pegilodecakin
| Inclusion Criteria:~Male or female between 18 and 55 years of age, inclusive~Must have a body mass index (BMI) between 19 and 32 (kg/m2) at study Screening~Must be HIV negative by HIV 1/0/2 testing~Must be Hepatitis B (HBV) surface antigen negative~Must be Hepatitis C (HCV) antibody negative~Females must have a negativ... | 18 Years | 55 Years | All | Accepts Healthy Volunteers | Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters, Cmax | maximal plasma concentration (Cmax) | 43 days |
| Pharmacokinetic parameters, Tmax | maximal concentration (Tmax) | 43 days |
| Pharmacokinetic parameters, AUC | area under the plasma concentration curve (A... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | Evaluate the safety of single/multiple SQ doses of Pegilodecakin - Incidence of adverse events, injection site reactions, clinically relevant changes in laboratory valu... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Pegilodecakin (5 μg/kg) dosed on Day 1, and Days 4-9 SQ | Biological: Pegilodecakin<br>* Pegilodecakin Alone<br>* Other names: AM0010;|
| Active Comparator: 2<br>Pegilodecakin (10 μg/kg) dosed on Day 1, and Days 4-9 SQ | Biologic... | A Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518)
Study Overview
=================
Brief Summary
-----------------
To evaluate the pharmacokinetics of single and multiple doses of pegilodecakin in healthy participants.
Detailed Description
-----------------
This is a... | ||
NCT02189525 | Evaluation of Mild TBI in Collegiate Athletes | The purpose of this study is to evaluate blood-based biomarkers before and after sports-induced concussion using neuroimaging and head impact sensor technology. | AWARE: Mild Traumatic Brain Injury in Collegiate Athletes - A Prospective Study With Blood-based Biomarkers, Advanced Neuroimaging and the Head Impact Telemetry System (HITS) | Traumatic Brain Injury | Inclusion Criteria:~University of Florida student athlete involved in Men's Football, Men and Women's Basketball, Men and Women's Swimming, Men and Women's Diving, Women's Soccer, or Women's Lacrosse or University of Florida student athlete not participating in those sports who is being treated for a sports-related hea... | 18 Years | null | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of serum biomarker levels with neuroanatomic and neuropathologic changes from baseline using neuroimaging, following sports-related concussion | | Baseline and up to 48 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of serum biomarker levels with head acceleration data using head impact telemetry system following sports-related concussion | | Baseline and up to 48 months |
| Correlation of serum biomarker levels and neuroimaging results to s... | traumatic brain injury, sports head injury, sports concussion | Brain Injuries, Brain Injuries, Traumatic, Wounds and Injuries, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Craniocerebral Trauma, Trauma, Nervous System | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sports induced concussion<br>Exposure to sports induced concussion | |
| Routine Athletic Exertion<br>Exposure to routine athletic exertion without sports-induced concussion (non-concussion control) | |
| Evaluation of Mild TBI in Collegiate Athletes
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate blood-based biomarkers before and after sports-induced concussion using neuroimaging and head impact sensor technology.
Official Title
-----------------
AWARE: Mild T... | |||
NCT01366781 | Gut Hormones After Meal Ingestion in Males Versus Females | The study hypothesis is that the release of gut hormones is increased proportionally to caloric load in each meal. Three different meals with different meal size will therefore be served and gut hormones determined. | In healthy males and females, meals with 511, 743 and 1034 kcal will be given orally. Samples will be taken during the following 300 min and gut hormones (glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1) will be determined along with insulin and glucagon levels. | Effects of Varying Meal Size on Gut Hormone and Islet Hormone Secretion in Males Versus Females | Normal Non-fluency | * Other: Meal ingestion
| Inclusion Criteria:~Healthy status~Exclusion Criteria:~Diabetes~Liver disease~kidney disease~thyroid disease | 20 Years | 30 Years | All | Accepts Healthy Volunteers | Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Release of gut hormones | | 300 min |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin secretion | | 300 min |
| Gut hormones, Insulin secretion | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy males<br>Meal ingestion in healthy males | Other: Meal ingestion<br>* Meal 511 kcal, meal 743 kcal or meal 1034 kcal<br>|
| Experimental: Healthy females<br>Meal ingestion in healthy females | Other: Meal ingestion<br>* Meal 511 kc... | Gut Hormones After Meal Ingestion in Males Versus Females
Study Overview
=================
Brief Summary
-----------------
The study hypothesis is that the release of gut hormones is increased proportionally to caloric load in each meal. Three different meals with different meal size will therefore be served and gut h... | |
NCT00005688 | Cardiac Arrhythmias and the Perception of Symptoms | To investigate the differential diagnosis and longitudinal course of medical outpatients complaining of palpitations. Also, to further examine the process of cardiac perception, the psychological factors which influence it, and the accurate awareness of cardiac arrhythmias. | DESIGN NARRATIVE:~One hundred seventy-five consecutive patients referred for continuous ambulatory electrocardiographic (Holter) monitoring because of palpitations were studied. The investigators assessed cardiac symptoms, psychiatric diagnosis, life stress, beliefs about heart disease, somatization, and bodily absorpt... | null | Cardiovascular Diseases, Heart Diseases, Arrhythmia | No eligibility criteria | null | 100 Years | Male | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Diseases, Heart Diseases, Arrhythmias, Cardiac, Pathologic Processes | Cardiac Arrhythmias and the Perception of Symptoms
Study Overview
=================
Brief Summary
-----------------
To investigate the differential diagnosis and longitudinal course of medical outpatients complaining of palpitations. Also, to further examine the process of cardiac perception, the psychological factors... | |||||
NCT02959645 | Assessment of Brain Activities in Cervical Dystonia | To address joint position sense in cervical dystonia patients and how it affects the brain activity. | Assessment of Cortical Network Activities in Cervical Dystonia | Cervical Dystonia | Inclusion Criteria:~patients having cervical dystonia and aged matched healthy control group~Exclusion Criteria:~cervical dystonia patients with severe head tremor will be excluded | 18 Years | 78 Years | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand Joint Position Sense | | 30 minutes |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain Signals Recorded via Non-Invasive Surface Electromyography | | 2 hours |
| Dystonia, Dystonic Disorders, Torticollis, Dyskinesias, Neurologic Manifestations, Nervous System Diseases, Movement Disorders, Central Nervous System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cervical Dystonia<br>patients will have Cervical Dystonia | |
| Healthy control<br>Healthy Volunteers | |
| Assessment of Brain Activities in Cervical Dystonia
Study Overview
=================
Brief Summary
-----------------
To address joint position sense in cervical dystonia patients and how it affects the brain activity.
Official Title
-----------------
Assessment of Cortical Network Activities in Cervical Dystonia
Con... | ||||
NCT00991874 | A Longitudinal Study of Exhaled Nitric Oxide in Children | Five percent of children in the UK are prescribed steroid inhalers to control asthma symptoms but there is no test to determine whether the dose of steroids is correct. Too much steroid treatment has potential side effects and too little may lead to asthma attacks. Exhaled nitric oxide (ENO) is a gas present in everyon... | Our hypotheses are that there will be different ENO values that correlate with loss of/gain in asthma control and that ENO variability is related to environmental exposures including tobacco smoke and pollen. Our research questions are:~Do determine what values or % change in ENO correlates with gain and loss of asthma... | A Longitudinal Study of Exhaled Nitric Oxide in Children | Asthma | Inclusion Criteria:~Child aged 5-10 years~Exclusion Criteria:~None | 6 Years | 10 Years | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nitric oxide, Asthma, Longitudinal studies, Child | Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases, Respiratory Hypersensitivity, Hypersensitivity, Immediate, Hypersensitivity, Immune System Diseases | A Longitudinal Study of Exhaled Nitric Oxide in Children
Study Overview
=================
Brief Summary
-----------------
Five percent of children in the UK are prescribed steroid inhalers to control asthma symptoms but there is no test to determine whether the dose of steroids is correct. Too much steroid treatment h... | ||||
NCT04083261 | Pharmacogenetic Variation: Factors That May Affect the Efficacy and Safety of Medical Marijuana | The primary purpose of this research is to identify genetic factors that may affect the efficacy and safety of medical marijuana, regardless of condition. The pharmacogenomics test detects DNA variants, which may affect the way drugs work and are metabolized in the body and/or detect potential side effects. | This observational, population-based study will examine genetic differences between ultra-rapid, intermediate and poor metabolizers of various formulations of Columbia Care's medical cannabis products in order to identify genetic factors that may affect the efficacy and safety of medical marijuana, regardless of condit... | An Observational, Population-Based Study of Pharmacogenetic Variation to Identify Genetic Factors That May Affect the Efficacy and Safety of Medical Marijuana | New York Medical Marijuana Program Qualifying Conditions | * Other: DNA Genotek Oragene 600
| Inclusion Criteria:~Males and Females age 18 and older~Currently obtaining medical marijuana products from Columbia Care LLC~Willing to participate and consent to a DNA analysis~Purchased product from Columbia Care for three consecutive encounters spanning a 6-month period~Exclusion Criteria:~Unwillingness to participa... | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of genetic factors | Saliva-based DNA sample will be tested for known genes (e.g., the cytochrome P-450 superfamily) | Day 1 |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with therapy and adverse effects: survey | Survey tool will examine patient satisfaction with current dose as a covariate and evaluate adverse outcomes (e.g., mental health indications, reported unintended effects) based on varyin... | Medical cannabis, Medical marijuana | Marijuana Abuse, Substance-Related Disorders, Chemically-Induced Disorders, Mental Disorders | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High daily dose users<br>Total Cannabinoid Daily Dose greater than 50 mg | Other: DNA Genotek Oragene 600<br>* Saliva-based DNA sample collection kit<br>|
| Control<br>Users that represent the median dose between high daily dose users and low daily dose... | Pharmacogenetic Variation: Factors That May Affect the Efficacy and Safety of Medical Marijuana
Study Overview
=================
Brief Summary
-----------------
The primary purpose of this research is to identify genetic factors that may affect the efficacy and safety of medical marijuana, regardless of condition. The... | |
NCT00836693 | Effect of Tadalafil Once a Day in Men With Erectile Dysfunction | The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg administered once a day in patients with erectile dysfunction (ED) who are naïve to PDE5 (phosphodiesterase type 5) inhibitors. Patients may be dose reduced to 2.5mg based on tolerability. | A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Assess the Efficacy and Safety of Tadalafil (LY450190) Once a Day in Subjects With Erectile Dysfunction Who Are Naïve to PDE5 Inhibitors | Erectile Dysfunction | * Drug: tadalafil
* Drug: placebo
| Inclusion Criteria:~You are male and aged at least 18 years.~Have a history of erectile dysfunction (ED)(defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) of at least 3 months duration.~Agree not to use any other treatment for ED, including ... | 18 Years | null | Male | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12 | Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night | NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections du... | Erectile Dysfunction | Urological Agents, Tadalafil, Vasodilator Agents, Phosphodiesterase 5 Inhibitors, Phosphodiesterase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tadalafil<br> | Drug: tadalafil<br>* 5 milligrams (mg) administered orally once a day for 12 weeks<br>* Other names: LY450190;|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* tablet administered orally once a day for 12 weeks.<br>|... | Effect of Tadalafil Once a Day in Men With Erectile Dysfunction
Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg administered once a day in patients with erectile dysfunction (ED) who are naïve to PDE5 (phosphodiestera... | |
NCT00077948 | Enoximone Plus Extended-Release Metoprolol Succinate in Subjects With Advanced Chronic Heart Failure | Beta-blocker medications have been shown to improve heart function and prolong the lives of patients with chronic heart failure (CHF). Some people with advanced CHF have difficulty taking beta-blocker medications due to troublesome side effects, such as low blood pressure and/or low heart rate, severe tiredness, dizzin... | Over the last decade, it has become evident that certain beta-blocking agents (beta-blockers) exert a favorable effect on the natural history of mild to moderate chronic heart failure (CHF), including reducing mortality and hospitalization rate. However, as heart failure becomes more severe, beta-blockers become diffic... | A Phase III, Randomized, Double-Blind, Double Placebo-Controlled, Multicenter, Three Parallel Group Study of Enoximone Plus Extended-Release Metoprolol Succinate in Advanced CHF Subjects Previously Intolerant to Beta-Blocker Treatment | Heart Failure, Congestive | * Drug: Enoximone
* Drug: Metoprolol succinate
* Drug: Placebo to match enoximone
* Drug: Placebo to match metoprolol succinate
| Inclusion criteria~In order to be considered an eligible subject, all of the following entry criteria must be met:~Subjects must be competent to provide informed written consent. Subjects must sign an IRB/IEC approved informed consent form prior to the initiation of any study procedures.~Subjects must be 18 years of ag... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants experiencing improved metoprolol tolerability when coadministered with enoximone | Improved tolerability measured by increased left ventricular ejection fraction (LVEF), improvement of heart failure symptoms, and imp... | positive inotrope, enoximone, beta-blocker, intolerant | Metoprolol, Enoximone, Anti-Arrhythmia Agents, Antihypertensive Agents, Sympatholytics, Autonomic Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Adrenergic beta-1 Receptor Antagonists, Adrenergic beta-Antagonists, Adrenergic Antagonists, Adrenergic Agents, Neurotransmitter Agents, Molecular M... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active enoximone plus active ER metoprolol<br> | Drug: Enoximone<br>* Enoximone administered orally<br>Drug: Metoprolol succinate<br>* Metoprolol succinate administered orally<br>|
| Active Comparator: placebo enoximone plus active ER meto... | Enoximone Plus Extended-Release Metoprolol Succinate in Subjects With Advanced Chronic Heart Failure
Study Overview
=================
Brief Summary
-----------------
Beta-blocker medications have been shown to improve heart function and prolong the lives of patients with chronic heart failure (CHF). Some people with a... | |
NCT02890342 | Natural History, Physiology, Microbiome and Biochemistry Studies of Propionic Acidemia | Background:~People s bodies need to break down food into the chemicals. These chemicals are used for energy and growth. Some people cannot process all chemicals very well. Too much of some chemicals can cause diseases. One of these diseases is called propionic acidemia (PA). People with PA can have problems with growth... | Propionic acidemia (PA) is one of the most common inborn errors of organic acid metabolism. Although this disorder is now routinely detected in the immediate neonatal period on the US newborn screen, clinical outcomes are poor despite timely and aggressive medical intervention. Worldwide, the incidence of PA varies wid... | The Natural History, Physiology, Microbiome and Biochemistry Studies of Propionic Acidemia | Metabolic Disease, Propionic Acidemia, Organic Acidemia | INCLUSION CRITERIA:~Patients 2 years of age or older, of any gender and ethnicity, with propionic acidemia are eligible to enroll in this protocol. Patients diagnosis will be confirmed based on biochemical and/or molecular and enzymatic testing. Participants of any gender and ethnicity over 1 month of age are eligible ... | 1 Month | null | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural history to asess long term complications of Propionic Acidemia | assessing the long term complications of Propionic Acidemia during a week long evaluation with imaging, labs, and consultations. | Ongoing |
| Organic Acidemia, Inborn Errors of Metabolism, Natural History | Propionic Acidemia, Metabolic Diseases, Acidosis, Acid-Base Imbalance, Amino Acid Metabolism, Inborn Errors, Metabolism, Inborn Errors, Genetic Diseases, Inborn | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Affected Patients with Propionic Acidemia<br>Patients with Propionic Acidemia, standard adult, parental permission | |
| Healthy Volunteers<br>Healthy Volunteers, standard adult, parental permission | |
| Unaffected Family Members<br>Unaffected family m... | Natural History, Physiology, Microbiome and Biochemistry Studies of Propionic Acidemia
Study Overview
=================
Brief Summary
-----------------
Background: People s bodies need to break down food into the chemicals. These chemicals are used for energy and growth. Some people cannot process all chemicals very w... | |||
NCT01340222 | Monocyte Chemotactic Protein-1 (MCP-1) Expressing Monocytes to Predict Preterm Delivery: PhenoMAP Study | The threat of preterm labour (PTL) is the first cause of hospitalization in the course of pregnancy. Its diagnostic is based on clinical examination with a positive predictive value of about 40 %. The role of the Monocyte chemotactic protein-1 (MCP-1) in delivery has been suggested by its secretion in the amniotic flui... | Evaluation of the Prognostic Value of Monocytes and Lymphocyte Phenotyping, Along With Intracellular MCP-1 Expression, to Predict Preterm Delivery for Women Hospitalized for Threat of Preterm Labor Between 24 and 34 Weeks of Amenorrhea: PhenoMAP Study | Preterm Labour | * Biological: biological samples
| Inclusion Criteria:~Threat of preterm labour (PTL) occurring between 24 and 34 WOA, defined according to validated criteria i.e. by (1) the presence of regular uterine contractions, lasting at least 30 seconds at a frequency ≥ 4 contractions every 30 minutes and confirmed by an external tocogram, (2) a cervical dilatio... | 18 Years | null | Female | No | Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of women with delivering before 7 days | Main outcome will be a delivery occurring within 7 days post admission for PTL. Women discharged from hospital before day 7 and not having delivered will not be censored; they will be classified ... | Preterm labour, monocyte, lymphocyte, MCP-1, Treg Lymphocytes, biologic markers, immunology, HLA-DR, Th17 | Premature Birth, Obstetric Labor, Premature, Obstetric Labor Complications, Pregnancy Complications, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases | | Intervention/Treatment |
| --- |
|Biological: biological samples|4 blood sampling will be made at J0, J2, J4, J6 befor delivery and 1 blood sampling 3 days after delivery|
| Monocyte Chemotactic Protein-1 (MCP-1) Expressing Monocytes to Predict Preterm Delivery: PhenoMAP Study
Study Overview
=================
Brief Summary
-----------------
The threat of preterm labour (PTL) is the first cause of hospitalization in the course of pregnancy. Its diagnostic is based on clinical examination w... | ||
NCT01929616 | Regorafenib Assessment in Refractory Advanced Colorectal Cancer(RegARd-C) | The general objectives are to evaluate activity and the safety of regorafenib in a population of patients bearing advanced, refractory colorectal cancers and to explore the different downstream molecular pathways to identify tumor response and resistance mechanisms. | The primary objective is to identify in a population of patients bearing advanced, refractory colorectal cancers, those who draw no benefit from treatment with regorafenib. There is no specific hypothesis underlying sample size and the study is therefore to be seen as exploratory.~Secondary objectives:~To analyze PFS a... | Regorafenib Assessment in Refractory Advanced Colorectal Cancer | Advanced Chemorefractory Colorectal Adenocarcinoma | * Drug: regorafenib
| Inclusion Criteria:~Histologically proven colorectal adenocarcinoma that is metastatic or unresectable and for which standard treatments do not exist or are no longer effective.~Age ≥ 18 years.~Life expectancy of greater than 12 weeks.~ECOG performance status ≤ 1.~Participants must have normal organ and bone marrow fun... | 18 Years | null | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | | 2 years from first patient in |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of Adverse events | Assessment of safety will follow the WHO guidelines and classified according to NCI-CTCAE v. 4.0 and will be performed every 28 days until 28 days (safety follow up visit) after stopping therapy. Reasons for stopp... | adenocarcinoma, colorectal,regorafenib | Adenocarcinoma, Neoplasms, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regorafenib<br>A treatment cycle is defined as a 4 weeks period. Regorafenib will be administered once a day orally at a dose of 160 mg (4 tablets of 40 mg), for 3 weeks. | Drug: regorafenib<br>* Patients will receive 160 mg regorafenib 1/... | Regorafenib Assessment in Refractory Advanced Colorectal Cancer(RegARd-C)
Study Overview
=================
Brief Summary
-----------------
The general objectives are to evaluate activity and the safety of regorafenib in a population of patients bearing advanced, refractory colorectal cancers and to explore the differe... |
NCT04315324 | Study to Test AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) in Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) | This phase II trial studies how well OBI-3424 works in treating patients with T-cell acute lymphoblastic leukemia that has come back (relapsed) or does not response to treatment (refractory). Drugs used in chemotherapy, such as OBI-3424, work in different ways to stop the growth of cancer cells, either by killing the c... | PRIMARY OBJECTIVE:~I. To assess the response rate (complete remission [CR] or CR with incomplete count recovery [CRi]) of AKR1C3-activated prodrug OBI-3424 (OBI-3424) in patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL).~SECONDARY OBJECTIVES:~I. To estimate the frequency and severity of toxi... | A Phase II Study of AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) in Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) | Recurrent T Acute Lymphoblastic Leukemia, Refractory T Acute Lymphoblastic Leukemia | * Drug: AKR1C3-activated Prodrug OBI-3424
| Inclusion Criteria:~Patients must have a diagnosis of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) based on World Health Organization (WHO) classification. Note that patients who were diagnosed initially with lymphoblastic lymphoma but who have relapsed with T-ALL are eligible~Patients must have e... | 18 Years | null | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (complete remission [CR] or CR with incomplete count recovery [CRi]) | | Up to 5 years |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Toxicities will be captured and described. The probability of any particular toxicity can be estimated to within at most +/- 17% (95% confidence interval). | Up to the time of relapse, assessed up to 5 years |
| ... | Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphoid, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Neoplasms by Histologic Type, Neoplasms, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders, Immune System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (AKR1C3-activated prodrug OBI-3424)<br>Patients receive AKR1C3-activated prodrug OBI-3424 IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptab... | Study to Test AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) in Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)
Study Overview
=================
Brief Summary
-----------------
This phase II trial studies how well OBI-3424 works in treating patients with T-cell acute lymphoblastic leukemia ... | |
NCT01576705 | Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children | Evaluation of the following in very young children with Down syndrome:~the efficacy of systematic treatment with L-thyroxine at controlled doses (clinically and by ultrasensitive thyreostimulating hormone (TSH) assay),~the efficacy of systematic folinic acid treatment at a dose of 1 mg/kg/o.i.d,~any interaction between... | Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children | Down Syndrome | * Drug: thyroid hormone and folinic acid
| Inclusion Criteria:~patient with a karyotype demonstrating homogeneous, free or Robertsonian translocation trisomy 21~patient having undergone a cardiac ultrasound not demonstrating any severe heart disease~patient aged 6 to 18 months at inclusion~Exclusion Criteria:~congenital hypothyroidism~hypothyroidism demonstrate... | 6 Months | 18 Months | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMDS (Griffiths Mental Development Scale) | GMDS for testing and estimate babies psychomotor development from birth to 2 years trough six subscales : Locomotor, Personal-social, Hearing and language, Eye-Hand coordination, Performance.Sub- and... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BL (Brunet Lezine Revised Scale) | BL includes 4 subscales : Locomotor, Coordination, Language, Sociability. Subscale and global developpemental quotients were computed by dividing the developpemental age by the chronological age multiplied by... | GMDS, Down syndrome, Young children, Psychomotor development, Thyroid hormone, Folinic acid, Psychometric tests, Griffiths, Genetic factors, Biochemical factors | Levoleucovorin, Leucovorin, Folic Acid, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists, Physiological Effects of Drugs, Antidotes, Protective Agents, Vitamin B Complex, Vitamins, Micronutrients, Hematinics | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thyroxin + folinic acid<br> | Drug: thyroid hormone and folinic acid<br>* thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules<br>|
| Active Comparator: Thyroxin+folinic acid placebo<br> | Drug: thyroid h... | Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children
Study Overview
=================
Brief Summary
-----------------
Evaluation of the following in very young children with Down syndrome: the efficacy of systematic treatment with ... | |
NCT00303901 | Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery | RATIONALE: Cryotherapy kills tumor cells by freezing them. This may be an effective treatment for primary lung cancer or lung metastases that cannot be removed by surgery.~PURPOSE: This clinical trial is studying how well cryotherapy works in treating patients with primary lung cancer or lung metastases that cannot be ... | OBJECTIVES:~Estimate the local and distant failure rates after percutaneous thoracic cryotherapy (PTC) in patients with unresectable primary lung cancer or lung metastases.~Estimate rates of PTC complications and adverse reactions.~Determine the correlations between procedural parameters and follow-up imaging parameter... | Percutaneous Thoracic Cryotherapy (PTC) for Inoperable Primary Lung Cancer and Metastatic Management | Lung Cancer, Metastatic Cancer | * Procedure: cryosurgery
* Procedure: positron emission tomography
| DISEASE CHARACTERISTICS:~Histologically or cytologically confirmed malignant pulmonary neoplasm~New lung lesion(s) with definitive clinical and imaging features of primary or metastatic disease allowed~Imaging findings compatible with localized treatment failure after prior cryotherapy allowed~Malignant pleural effusio... | 18 Years | 120 Years | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Failure Rates by CT Scan | Local Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence | at 3, 6, and 12 months |
| Distant Failure Rate | Distant Failure Rates by CT Scan Assessed as Percentage of Partic... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Complications and Adverse Reactions by Occurrences of Toxicities | Rate of complications and adverse reactions by occurrences of toxicities as measured by the number of participants with a given category of toxicity. | at 3, 6, and 12 ... | stage II non-small cell lung cancer, lung metastases, recurrent non-small cell lung cancer, recurrent small cell lung cancer, stage I non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, extensive stage small cell lung cancer, lim... | Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cryosurgery<br>cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a mo... | Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery
Study Overview
=================
Brief Summary
-----------------
RATIONALE: Cryotherapy kills tumor cells by freezing them. This may be an effective treatment for primary lung cancer or lung metastases that c... |
NCT05539196 | A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Severe Motor Complications | This registry is a prospective, multicenter, international, single arm, observational post-approval registry with follow-up at 3, 6, and 12 months, and annually for 5 years. The proposed registry will enroll 60 subjects and will be conducted at approximately 10 centers worldwide. | This is a post-approval registry which is required by of the approval under PMA P150038/S014 for the Exablate® Model 4000 (Exablate Neuro) Type 1.0 and Type 1.1 for unilateral pallidotomy in the treatment of idiopathic Parkinson's Disease with medication-refractory moderate to severe motor complications. Subjects parti... | A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Severe Motor Complications | Movement Disorders, Neurology, Parkinsons Disease | * Device: Exablate Pallidotomy, Unilateral
| Inclusion Criteria:~Men and women, age 30 years and older.~Subject undergoing a planned an Exablate procedure for their Parkinson's Disease with Motor Complications per local institution standard of care.~Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion... | 30 Years | 99 Years | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Analysis | Primary Effectiveness will be evaluated through a Responder analysis. Responder is defined as the patient reaching a minimally clinically significant difference on: 1) UDysRS Objective Assessment ON Meds, without clinicall... | Parkinson Disease, Movement Disorders, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Synucleinopathies, Neurodegenerative Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post Exablate Neuro Pallidotomy for Parkinson's Disease with Motor Complications<br>The population enrolled in this registry will be comprised of male and female patients that plan to be treated using the Exablate Neuro system for advanced, idiopathic P... | A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Severe Motor Complications
Study Overview
=================
Brief Summary
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This registry is a prospective, mu... | |||
NCT03545893 | Overnight Pain Treatment Investigating Opioids vs. Nonopioids | The purpose of this study is to compare maximum pain scores between patients seeking induced abortion and requiring cervical preparation with osmotic dilators. Patients will be randomized to receive prescription for ibuprofen alone or to receive prescription for ibuprofen + oxycodone for overnight pain management after... | A Pilot Randomized Trial of Opioids Versus Nonopioids for Pain Control After Osmotic Dilator Placement for Abortion Care | Abortion Second Trimester | * Drug: Ibuprofen 600 mg
* Drug: OxyCODONE 5 Mg Oral Tablet
| Inclusion Criteria:~English-speaking women~18 years or older~Access to cell phone with text-messaging capability/data~Receiving cervical preparation for induced abortion~Able to complete baseline survey on smartphone/tablet at screening visit~Exclusion Criteria:~History of opioid or alcohol abuse~Contraindications or a... | 18 Years | null | Female | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Pain Score | Numerical Rating Scale (NRS) pain score (scale range 0-10, with a 0 meaning no pain and 10 meaning the worst possible pain) | 24 hours |
| Oxycodone, Anti-Inflammatory Agents, Non-Steroidal, Analgesics, Non-Narcotic, Analgesics, Sensory System Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Anti-Inflammatory Agents, Antirheumatic Agents, Cyclooxygenase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action,... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ibuprofen<br> | Drug: Ibuprofen 600 mg<br>* Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.<br>|
| Active Comparator: Ibuprofen + Oxycodone<br> | Drug: Ibuprofen 600 mg<br>* Ibuprofen 600mg prescri... | Overnight Pain Treatment Investigating Opioids vs. Nonopioids
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare maximum pain scores between patients seeking induced abortion and requiring cervical preparation with osmotic dilators. Patients will be randomized to r... | |||
NCT00283868 | Stroke Team Remote Evaluation Using a Digital Observation Camera | The purpose of this trial is to determine if an experimental remote video camera system is an effective way for a stroke specialist to evaluate stroke patients from a distant site. | The Stroke Team Remote Evaluation Using a Digital Observation Camera (STRokE DOC) system is a digital video camera system that can transfer video and audio images from the clinic or emergency room to a distant (remote) place where a stroke specialist can review the images in real time (as they happen). This system uses... | A Prospective Study to Evaluate the Efficacy of a Remote Digital Observation Camera Protocol in the Evaluation and Thrombolytic Treatment of Acute Stroke Patients in the Remote Hospital Setting | Stroke | Inclusion Criteria:~18 years of age or older~Symptoms consistent with acute stroke (ischemic or hemorrhagic)~Acute presentation of stroke symptoms, per bedside physician discretion (onset generally less than 12 hours and likely less than 3 hours)~Exclusion Criteria:~Unlikely to complete study through 90-day follow-up | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appropriateness of Decision to Treat or Not Treat With Thrombolytics | This primary measure assesses the appropriateness of decision to treat or not treat with thrombolytics for patients presenting potentially within 3 hours of symptom onset.~... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Intracerebral Hemorrhage (ICH) | Intracerebral Hemorrhage (ICH) rate at 36 hours. This was assessed by determining whether there was an intracerebral hemmorhage via telephone contact to the hospital where the pa... | digital video, stroke, SPOTRIAS | Stroke, Brain Diseases, Cerebrovascular Disorders, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Telemedicine<br>Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine | |
| Telephone<br>Patients randomized to this group were evaluated using telephone only and no use of the digit... | Stroke Team Remote Evaluation Using a Digital Observation Camera
Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine if an experimental remote video camera system is an effective way for a stroke specialist to evaluate stroke patients from a distant site.
Detaile... | ||
NCT04749095 | Erector Spinae Plane Block Analgesia for Lumbar Spine Fusion Surgery | The purpose of this study was to investigate the effect of a bilateral ultrasound guided erector spinae plane block on the pain scores and opoid utiliziation in fusion surgery of the lumbar spine. | Can Bilateral Erector Spinae Plane Block Minimize Perioprative Opioid Consumption and Provide Satisfactory Analgesia for Lumbar Spine Fusion Surgery? A Randomized Controlled Study | Pain, Postoperative | * Drug: Erector spinae plane block
* Drug: sham subcutaneous infiltration
| Inclusion Criteria:~American Society of Anesthesiologists class I-III adult patients~BMI less than or equal 35 kg/m2~Exclusion Criteria:~Patient refusal~unable to give consent~age < 18 or > 65~BMI more than 35 kg/m2~known allergy to the study medication~coagulopathies or on anticoagulant medications~hepatic insufficien... | 20 Years | 65 Years | All | Accepts Healthy Volunteers | Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia | Numerical rating scale of pain every 6 hours | Up to 24 hours after surgery |
| Pain, Pain, Postoperative, Postoperative Complications, Pathologic Processes, Neurologic Manifestations | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Erector block<br> | Drug: Erector spinae plane block<br>* bilateral ESP block will be injected with 20 ml of 0.25% bupivacaine<br>|
| Active Comparator: sham block<br> | Drug: sham subcutaneous infiltration<br>* bilateral ESP block wi... | Erector Spinae Plane Block Analgesia for Lumbar Spine Fusion Surgery
Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate the effect of a bilateral ultrasound guided erector spinae plane block on the pain scores and opoid utiliziation in fusion surgery of the lu... | |||
NCT04219332 | Randomized Controlled Trial on Effect of Lymph Node Mapping by Indocyanine Green Via Submucosal or Subserosal Injection | The purpose of this study was to evaluate whether submucosal or subserous injection of indocyanine green during laparoscopic lymphadenectomy for patients with gastric cancer was different. The patients with gastric adenocarcinoma (cT1-4a, N0/+, M0) were studied. | In recent years, with the successful application of ICG (indocyanine green) fluorescence imaging technology in laparoscopic equipment, scholars have found that ICG near-infrared imaging has better tissue penetration and can better identify lymph nodes in hypertrophic adipose tissue than other dyes under visible light, ... | Comparison of Submucosal and Subserosal Approaches Toward Optimized Indocyanine Green Tracer-Guided Laparoscopic Lymphadenectomy for Patients With Gastric Cancer: The FUGES-019 Randomized Clinical Trial | Indocyanine Green, Gastric Cancer, Injection Site | * Drug: Subserosa injection of indocyanine green
* Drug: submucosal injection of indocyanine green
| Inclusion criteria:~Age from 18 to 75 years~Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy~Clinical stage tumor T1-4a (cT1-4a), N0/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer... | 18 Years | 75 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Retrieved Lymph Nodes | Total Number of Retrieved Lymph Nodes | One month after surgery |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of fluorescent lymph nodes in groups A and B | Total number of fluorescent lymph nodes in groups A and B | One month after surgery |
| Relationship between fluorescent lymph nodes and positive lymph nodes in groups A and B (true ... | Stomach Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Stomach Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subserosal injection of indocyanine green tracer group<br>Subserosal injection of indocyanine green, with a concentration of 0.5 mg /ml, 6 points along the lesser and greater curvature of the stomach, 1.5 ml for each point. | Drug: Subsero... | Randomized Controlled Trial on Effect of Lymph Node Mapping by Indocyanine Green Via Submucosal or Subserosal Injection
Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate whether submucosal or subserous injection of indocyanine green during laparoscopic lymphaden... | |
NCT01177709 | Metformin for Weight Loss in Schizophrenia | Study hypothesis is that patients on antipsychotics medication treated with metformin will show loss in weight and improved measures of glucose metabolism. | Patients who had gained more than 10 lbs of weight in the last 3 months or had BMI of 35 or greater were treated with metformin up to 2500 mg/day in an open label study of up to 3 months time. Changes in weight and glucose measures were recorded. | Evaluation of the Efficacy of Metformin for Weight Loss and Metabolic Effects In Overweight Psychiatric Patients Treated With Antipsychotic Medication | Schizophrenia, Obesity | * Drug: Metformin
| Inclusion Criteria:~Patients will be 18-70 years of age;~Currently hospitalized or an outpatient at MPC;~BMI ≥ 35 or excessive recent weight gain ( > than 10 lb weight gain in the past 3 months);~Patients will have a diagnosis of schizophrenia or schizoaffective disorder or bipolar disorder.~Exclusion Criteria:~Age bel... | 18 Years | 70 Years | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight (wt) in Pounds (Lbs).. | Patients weight in pounds | baseline, 4 weeks, 8 weeks, 12 weeks |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Levels | Fasting glucose | baseline, 4 weeks, 8 weeks, 12 weeks |
| Insulin Level | fasting serum insulin uIU/ml. | baseline, 4 weks, 8 weeks, 12 weeks |
| schizophrenia, antipsychotics, obesity, diabetes | Metformin, Hypoglycemic Agents, Physiological Effects of Drugs | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin<br> | Drug: Metformin<br>* metformin 500- 2500 mg/day. Patient received variable doses of metformin starting at 500 mg/day and increasing up to maximum of 2500 mg/day over 3-4 weeks. Dose was titrated on tolerability and side eff... | Metformin for Weight Loss in Schizophrenia
Study Overview
=================
Brief Summary
-----------------
Study hypothesis is that patients on antipsychotics medication treated with metformin will show loss in weight and improved measures of glucose metabolism.
Detailed Description
-----------------
Patients who ha... |
NCT04119570 | CKD Report Card Pilot Trial | The investigators will study physician-patient communication at the UCMC nephrology fellow clinic and to test an intervention, the CKD Report Card, to improve that communication and patient knowledge of CKD. | The goals of the study are to 1) characterize the effectiveness and patient-centeredness of patient-physician interaction during a nephrology clinic visit both with and without use of the CKD Report Card, and 2) to determine which physician and patient characteristics are associated with effective and patient centered ... | Pilot and Trial of the Chronic Kidney Disease Report Card | CKD | * Behavioral: CKD Report Card
| Inclusion Criteria:~English-speaking adult patients (age 18 or older)~Identified in the medical record as non-Hispanic Black or non- Hispanic White~seen in University of Chicago nephrology clinic with a participating nephrologist~Exclusion Criteria:~not able to communicate in English~lacking ability to consent to study... | 18 Years | 70 Years | All | No | Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: During the first half of the study, participants will be surveyed and observed without the intervention. During the second half, participants will be surveyed and observed with th... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CKD Knowledge | Kidney Disease Knowledge Survey (KiKs) | Change in CKD Knowledge from Baseline (pre-visit) to CKD Knowledge immediately post clinic visit (within 15-100 minutes post-clinic visit) |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient-physician interaction | Perceived efficacy in patient-physician interactions (PEPPI) | immediately post-nephrology clinic visit (on day of enrollment, within 15-100 minutes post-clinic visit) |
| communication assessment | communicati... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No intervention<br>Participants will have their clinic visit as per usual care. | |
| Active Comparator: CKD Report Card<br>Participants will receive the CKD Report Card prior to the clinic visit. | Behavioral: CKD Report Card<br>* The ... | CKD Report Card Pilot Trial
Study Overview
=================
Brief Summary
-----------------
The investigators will study physician-patient communication at the UCMC nephrology fellow clinic and to test an intervention, the CKD Report Card, to improve that communication and patient knowledge of CKD.
Detailed Descript... | ||
NCT00870818 | Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01) | The purpose of this study is to assess the long term safety and efficacy in subjects with Type 1 Diabetes Mellitus who completed the Protege Study (CP-MGA031-01). | The primary objective of the extension study is to assess long-term safety, with particular focus on the development of serious adverse events (SAEs), adverse events of special interest (AESIs) including opportunistic infections and lymphoproliferative disease, and other immediately reportable events (IREs), in subject... | An Extension of Study CP-MGA031-01 to Evaluate the Long-Term Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Patients With Recent-Onset Type 1 Diabetes Mellitus | Type 1 Diabetes Mellitus | * Diagnostic Test: Blood samples for safety
* Behavioral: Patient reported outcome questionnaires
* Diagnostic Test: Analysis of T-cell subsets
| Inclusion Criteria:~Complete Protocol CP-MGA031-01 (i.e., all subjects who complete Study Day 728, regardless of how many doses of study drug are received).~Provide written informed consent.~Exclusion Criteria:~None | 10 Years | 37 Years | All | No | Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants Who Experience an Adverse Event, Serious Adverse Event or Adverse Event of Special Interest. | | Duration of study participation up to 15 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%. | | Month 6 |
| Proportion of Subjects in Segment 2 With Both a Total Daily Insulin Dose o... | MGA031, T1DM, Teplizumab, Protege, Monoclonal antibody, Type 1 Diabetes Mellitus, MacroGenics | Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double-blind Herold Regimen<br>Patients who had been assigned to Herold Regimen in Segment 2 of Study CP-MGA031-01 were enrolled to gather additional safety and efficacy data. | Diagnostic Test: Blood samples for safety<br>* serum chemistr... | Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01)
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the long term safety and efficacy in subjects with Type 1 Diabetes Mellitus who completed the Protege S... |
NCT00227162 | Pilot Study of Changing Exercise and Physical Activity Behavior in Asthma Patients | The objective of this pilot study is to assess the feasibility and the potential differential impact of a novel intervention of induced positive affect and self-affirmation to increase physical activity in asthma patients. | The goals of this pilot study are to empirically test different interventional approaches to induce positive affect and self-affirmation. At the start of the study all patients in conjunction with their physicians will select a program of mild to moderate physical activity or exercise to be adopted and maintained on a ... | Pilot Study of Changing Exercise and Physical Activity Behavior in Asthma Patients | Asthma | * Behavioral: Group 1
* Behavioral: Group 2
* Behavioral: Group 3
| Inclusion Criteria:~Patients will be eligible for this study if their physicians consider them medically able to participate, if they are 18 years of age or older, and if they have a diagnosis of mild to moderate asthma based on the NHLBI Asthma Expert Panel's classification system which rates symptoms, frequency of ex... | 18 Years | null | All | No | Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 4 weeks. | | 1-2 weeks |
| Asthma, Behavior change, Physical activity, Risk reduction | Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases, Respiratory Hypersensitivity, Hypersensitivity, Immediate, Hypersensitivity, Immune System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Positive affect | Behavioral: Group 1<br>* Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive positive affect intervention.<br>* Other names: Control;|
| Active ... | Pilot Study of Changing Exercise and Physical Activity Behavior in Asthma Patients
Study Overview
=================
Brief Summary
-----------------
The objective of this pilot study is to assess the feasibility and the potential differential impact of a novel intervention of induced positive affect and self-affirmatio... | |
NCT00348738 | Impact of Erythropoietin Administration During Definitive Cervix Cancer Radiotherapy on Treatment Outcome | The purpose of this study is to determine whether an increase of blood haemoglobin levels through the substitution of erythropoietin during radiotherapy treatment of cervix cancer patients results in improvement for disease specific survival, tumor response and local control. | Definitive radiotherapy is the treatment of choice for patients with locally advanced cervix cancer. Low pre-therapeutic values of the intratumoral pO2 are associated with significantly worse therapeutic outcome and the blood hemoglobin levels correlate positively with the intratumoral pO2. Successful augmentation of h... | The Influence of the Pre-Therapeutic Increase in the Hemoglobin Level in the Blood Through Erythropoietin to the Therapy Results of the Primary Radiation Therapy for Carcinoma of the Cervix | Cervix Cancer | * Drug: Erythropoietin
| Inclusion Criteria:~histologically proven cervix cancer (FIGO stage I-IVA)~Age of 19-80 years~initial blood level of hemoglobin <= 14 g/dl~patients who gave their informed consent~Exclusion Criteria:~Karnofsky-Index < 50 %~known intolerance of erythropoietin~FIGO stage IVB~blood transfusion within the last four weeks~n... | 19 Years | 80 Years | Female | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remission rate 3 months after completion of the radiation therapy | | 3 months |
| local control rate | | 2 years |
| Disease specific survival | | 2 years |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The extent of increase in hemoglobin levels during the treatment with erythropoietin. | | Duration of treatment |
| The need of transfusion during the treatment. | | Duration of treatment |
| radiotherapy, clinical trial, erythropoietin, cervix cancer, Phase III, 2 Arms | Epoetin Alfa, Hematinics | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients assigned to this group are receiving Erythropoietin medication | Drug: Erythropoietin<br>* Administration of 10.000 I.U Erythropoeitin SQ 3x/week, two weeks prior to radiation therapy until a haemoglobin concentration of >14g... | Impact of Erythropoietin Administration During Definitive Cervix Cancer Radiotherapy on Treatment Outcome
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether an increase of blood haemoglobin levels through the substitution of erythropoietin during radiothe... |
NCT00905476 | Prognosis in Patients With Chronic Respiratory Failure Receiving Domiciliary Noninvasive Positive Pressure Ventilation (NPPV) | The purposes of the present study are (1) to analyze baseline patient characteristics cross-sectionally, (2) to analyze the prognosis and its predictive factors, and (3) to examine longitudinal clinical course in patients with chronic respiratory failure receiving domiciliary NPPV. | Limited data are available about the prognosis and its predictive factors in patients with chronic respiratory failure receiving domiciliary NPPV. In addition, their health status, psychological status and sleep quality seem to be highly disturbed due to severe respiratory insufficiency. Therefore, in the present study... | Analysis of the Prognosis and Clinical Course in Patients With Chronic Respiratory Failure Receiving Domiciliary NPPV | Chronic Respiratory Failure | Inclusion Criteria:~Patients with chronic respiratory failure receiving domiciliary NPPV for more than 3 months~Exclusion Criteria:~Uncontrolled severe comorbidities~Patients with tracheotomy. | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognosis/Mortality | | 3 years |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health status | | At entry and every year for 3 years |
| Dyspnea | | At entry and every year for 3 years |
| Psychological status | | At entry and every year for 3 years |
| Sleep quality | | At entry and every year for 3 years |
| Pu... | NPPV, Prognosis, Health-related quality of life, Patient reported outcomes | Respiratory Insufficiency, Respiration Disorders, Respiratory Tract Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NPPV<br>Patients with chronic respiratory failure receiving domiciliary NPPV | |
| Prognosis in Patients With Chronic Respiratory Failure Receiving Domiciliary Noninvasive Positive Pressure Ventilation (NPPV)
Study Overview
=================
Brief Summary
-----------------
The purposes of the present study are (1) to analyze baseline patient characteristics cross-sectionally, (2) to analyze the prog... | ||
NCT00384696 | Risk Perception Among Quitting Smokers | The goal of this behavioral research study is to put together and study a treatment for nicotine dependence that looks at how participant's thoughts and feelings about smoking may be related to how successfully they quit smoking. | If patient agrees to participate, they will receive free treatment to help them quit smoking, including written self-help materials, counseling, and a supply of the nicotine patch for 4 weeks. Participant will visit M. D. Anderson 5 times during this study; once for an orientation/intake visit, and then for 4 more stud... | Health Communications and Risk Processing Among Smokers | Smoking | * Drug: Nicotine Replacement Therapy
* Behavioral: Questionnaire
| Inclusion Criteria:~Age 18 to 65 years.~Current smoker with a history of at least 5 cigarettes/day for the last year~Motivated to quit within the next week.~Home address and a functioning home telephone number.~Can speak, read, and write in English at a sixth-grade literacy level.~Exclusion Criteria:~Contraindication f... | 18 Years | 65 Years | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk Perceptions Over Time Among Smokers and Non Smokers | Primary hypothesis is that abstainers will show higher risk perceptions than relapsers. | 4 weeks |
| Risk Perception, Smoking Cessation, Nicotine Replacement Therapy, Questionnaire, Nicotine | Nicotine, Ganglionic Stimulants, Autonomic Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Nicotinic Agonists, Cholinergic Agonists, Cholinergic Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Smoking Cessation<br>Treatment to help quit smoking, including written self-help materials, counseling, and 4 week supply of nicotine patch plus 5 MD Anderson Visits. | Drug: Nicotine Replacement Therapy<br>* 4 Weeks of nicotine patch. Patch therapy for... | Risk Perception Among Quitting Smokers
Study Overview
=================
Brief Summary
-----------------
The goal of this behavioral research study is to put together and study a treatment for nicotine dependence that looks at how participant's thoughts and feelings about smoking may be related to how successfully they... | ||
NCT01398176 | Immune Benefits From Mushroom Consumption | The purpose of this study is to determine whether consuming mushrooms is effective in enhancing the function of γδ T cells. | A non-therapeutic study is described. This is an intervention study at two levels of mushroom intake. The number of subjects and experimental assays are selected as a pilot study to generate the dose level and the efficacy. Subjects age 21 to 50 will be recruited and provide a baseline blood draw. The mushroom suppleme... | Immune Benefits From Mushroom Consumption | Healthy Humans | * Dietary Supplement: 3 ounces of mushrooms
* Dietary Supplement: 6 ounces of mushrooms
| Inclusion Criteria:~Healthy male or non-pregnant female~Between the ages of 21 and 50~BMI between 18 and 35~Exclusion Criteria:~Have illness at the time of enrollment~On immunosuppressive drugs, antibiotics, chronic use of NSAIDS~Ongoing infection or hypertension that requires medication~Consume any flavonoid-containin... | 21 Years | 50 Years | All | Accepts Healthy Volunteers | Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological Modifications to Gamma Delta T Cell Function | Proliferation of γδ-T cells when cultured ex vivo in autologous serum. Values are expressed as a percent of CD3 cells, which means a percent of the total T cell population. Only T ce... | gamma delta T cell, proliferation | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 ounces of mushrooms<br>3 ounces of mushrooms consumed daily for 4 weeks | Dietary Supplement: 3 ounces of mushrooms<br>* 3 ounces of mushrooms consumed daily for 4 weeks<br>|
| Experimental: 6 ounces of mushrooms<br>6 ounces of mushrooms... | Immune Benefits From Mushroom Consumption
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether consuming mushrooms is effective in enhancing the function of γδ T cells.
Detailed Description
-----------------
A non-therapeutic study is described. This is an... | ||
NCT01390324 | Efficacy and Safety of a Fixed-dose Combination of Naratriptan and Naproxen in Acute Treatment of Migraine | The purpose of this study is to determine whether a fixed-dose combination of naratriptan + naproxen is effective compared each monotherapy for the acute treatment of migraine. | A Multicenter, National, Double-blind, Randomized Study to Evaluate the Efficacy and Safety of a Fixed-dose Combination of Naratriptan 2,5 mg + Naproxen 500 mg Relative to Efficacy and Safety of Each Monotherapy for the Acute Treatment of Migraine | Migraine, Headache | * Drug: Fixed-dose combination of naratriptan+naproxen
* Drug: Naratriptan
* Drug: Naproxen
| Inclusion Criteria:~Male or female patient, age in the range of 18-65 years inclusive that has onset of migraine before age 50;~Patient has at least a 3-month history of migraine with or without aura according to the ICHD-II, 2004, IHS (International Headache Society) criteria;~Patients experienced an average migraine ... | 18 Years | 65 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache relief 2 hours after dosing, without use of rescue medication. | Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe. | 2 hours after single dose o... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache relief 4 hours after dosing, without use of rescue medication | | 4 hours after single dose of double-blind treatment |
| Sustained headache relief over 24 hours, without use of rescue medication | | 24 hours after single dose of d... | Migraine, Naratriptan, Naproxen | Naproxen, Naratriptan, Anti-Inflammatory Agents, Non-Steroidal, Analgesics, Non-Narcotic, Analgesics, Sensory System Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Anti-Inflammatory Agents, Antirheumatic Agents, Gout Suppressants, Cyclooxygenase Inhibitors, Enzyme Inhibitors, Molecular Mechan... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fixed-dose combination of naratriptan+naproxen<br>Fixed-dose combination of naratriptan+naproxen | Drug: Fixed-dose combination of naratriptan+naproxen<br>* Tablets containing naratriptan 2,5 mg + naproxen 500 mg<br>|
| Active Comparator: ... | Efficacy and Safety of a Fixed-dose Combination of Naratriptan and Naproxen in Acute Treatment of Migraine
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a fixed-dose combination of naratriptan + naproxen is effective compared each monotherapy for the... | |
NCT03329807 | Effects of Transcranial Magnetic Stimulation Associated to Sensory Therapy for Treatment of Motor Function of Upper Limb of Stroke Patients | The aim of this research will be to investigate in stroke patients whether upper limb motor function can be maximized in response to sensory stimulation by comparing protocols for the application of Transcranial Magnetic Stimulation (rTMS) in the cortical region of S1 and Sensory Therapy in the upper limb paretic. Pati... | Effects of Transcranial Magnetic Stimulation Associated to Sensory Therapy for Treatment of Motor Function of Upper Limb of Stroke Patients | Stroke | * Device: Transcranial Magnetic Stimulation
* Behavioral: conventional sensory therapy
| Inclusion Criteria:~diagnosis of ischemic or hemorrhagic stroke proven by means of computed tomography or magnetic resonance imaging,~absence of cognitive deficits (evaluated by Mini Mental State Examination, score ≥ 20 - FOLSTEIN 1975);~partially preserved motor functions (evaluated by the Fugl-Meyer Scale, score betw... | 30 Years | 75 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from Fugl-Meyer assessment | The Fugl-Meyer assessment (FMA) is considered the gold standard for evaluating the motor function recovery. It is designed to assess motor functioning, balance, sensation, and joint functioning. It is applie... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from Thermography | To verify the body symmetry of the upper limbs, Thermography will be used. The symmetry will be checked by comparing the heat emission obtained by the work of muscle contraction on both sides of the body. The procedu... | Stroke, Vascular Diseases, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Cardiovascular Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental rTMS and conventional sensory therapy<br>Device: Repetitive Transcranial Magnetic Stimulation (rTMS) The subjects were seated in a comfortable chair with head and arm rests. Focal TMS of the somatosensory cortex was performed ... | Effects of Transcranial Magnetic Stimulation Associated to Sensory Therapy for Treatment of Motor Function of Upper Limb of Stroke Patients
Study Overview
=================
Brief Summary
-----------------
The aim of this research will be to investigate in stroke patients whether upper limb motor function can be maximi... | ||
NCT03816280 | Cerebrovascular Effects of the Use of Alpha-stat or pH-stat Management of Cardiopulmonary Bypass | Type 2 diabetes mellitus (T2DM) poses a significant burden on the patients and the health care system. The increasing number of surgery performed in elderly population results in an increased number of perioperative T2DM-related adverse effects. T2DM has a prevalence of 30-40% in a population undergoing cardiovascular ... | One hour before the surgery, patients are premedicated with lorazepam (per os, 2.5 mg). Induction of anaesthesia is achieved by iv midazolam (30 μg/kg), sufentanyl (0.4-0.5 μg/kg), and propofol (0.3-0.5 mg/kg), and iv propofol (50 mg/kg/min) is administered to maintain anaesthesia. Intravenous boluses of rocuronium (0.... | Cerebrovascular Effects of the Use of Alpha-stat or pH-stat Management of Cardiopulmonary Bypass | Diabetes Mellitus, Cardiac Surgical Procedures | * Procedure: Elective cardiopulmonary bypass (CPB)
* Procedure: Alpha-stat acid-base management
* Procedure: pH-stat acid-base management
| Inclusion Criteria:~Patients undergoing cardiac surgery with or without diabetes mellitus~age between 18-80 years~Exclusion Criteria:~patients older than 80 years of age~poor ejection fraction (<40%)~unilateral internal carotid stenosis (>75%)~medical history of smoking~medical history of chronic obstructive pulmonary ... | 18 Years | 80 Years | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral tissue oxygen saturation | The spatially resolved continuous-wave NIRS technique is applied to estimate cerebral tissue oxygen saturation. This monitor uses two different wavelengths (730 and 810 nm) and has two detectors positioned 3... | Spectroscopy, Near-Infrared | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group T2DM-alpha<br>Patients with diabetes mellitus undergoing CPB with alpha-stat acid-base management | Procedure: Elective cardiopulmonary bypass (CPB)<br>* All groups undergo elective cardiopulmonary bypass (CPB)<br>Procedure: Alpha-stat acid-base m... | Cerebrovascular Effects of the Use of Alpha-stat or pH-stat Management of Cardiopulmonary Bypass
Study Overview
=================
Brief Summary
-----------------
Type 2 diabetes mellitus (T2DM) poses a significant burden on the patients and the health care system. The increasing number of surgery performed in elderly ... | |||
NCT01707082 | A Study To Test The Safety, Amount And Effects Of PF-06282999 In Healthy Overweight Adults And A Study To Test The Effects Of PF-06282999 On The Amount Of The Approved Drug, Midazolam, In Healthy Adults | Part A of the study will test the safety, the amount of drug in the body, and effects of the drug in the body after multiple doses. This will be conducted in healthy overweight adults. Part B of the study will test the effects of multiple doses of the investigational drug on the amount of midazolam, an approved drug, i... | A Phase 1, Randomized, Placebo-Controlled, Multiple Dose Study To Evaluate The Safety, Pharmacokinetics And Pharmacodynamics Of PF-06282999 In Healthy Overweight Subjects And A Fixed-Sequence Study To Assess The Effect Of PF-06282999 On The Pharmacokinetics Of Midazolam In Healthy Subjects | Healthy | * Drug: PF-06282999
* Drug: Placebo
* Drug: PF-06282999
* Drug: Placebo
* Drug: PF-06282999
* Drug: Placebo
* Drug: PF-06282999
* Drug: Placebo
* Drug: PF-06282999
* Drug: Placebo
* Drug: midazolam
* Drug: PF-06282999
* Drug: midazolam
* Drug: PF-06282999
| Inclusion Criteria:~Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory... | 18 Years | 55 Years | All | Accepts Healthy Volunteers | Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) | | Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | | Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic Blood Pressure | Mean 24-hour average diastolic blood pressure | Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A |
| Diastolic Blood Pressure | Mean 24-hour average diastolic blood pressure | Day 13 Pre-dose,1,2,4,8,12 and 16 ... | Midazolam, Adjuvants, Anesthesia, Hypnotics and Sedatives, Central Nervous System Depressants, Physiological Effects of Drugs, Anti-Anxiety Agents, Tranquilizing Agents, Psychotropic Drugs, Anesthetics, Intravenous, Anesthetics, General, Anesthetics, GABA Modulators, GABA Agents, Neurotransmitter Agents, Molecular Mech... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A Cohort 1<br> | Drug: PF-06282999<br>* Tablet, 10 mg, every 8 hours, 14 days<br>Drug: Placebo<br>* Tablet, 0 mg, every 8 hours, 14 days<br>|
| Experimental: Part A Cohort 2<br> | Drug: PF-06282999<br>* Tablet, 30 mg, every 8 hours, 1... | A Study To Test The Safety, Amount And Effects Of PF-06282999 In Healthy Overweight Adults And A Study To Test The Effects Of PF-06282999 On The Amount Of The Approved Drug, Midazolam, In Healthy Adults
Study Overview
=================
Brief Summary
-----------------
Part A of the study will test the safety, the amoun... |
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