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NCT05653258 | Single Nuclei RNA-seq to Map Adipose Cellular Populations and Senescent Cells in Older Subjects | All participants will undergo baseline biopsies of subcutaneous abdominal adipose tissue for cellular/molecular profiling via snRNA-seq and metabolic/physiological assessments (insulin sensitivity, glucose tolerance, and β-cell function). Older obese participants will be randomized into three arms: lifestyle interventi... | All participants after consent and enrollment will undergo adipose tissue single nuclei RNA sequencing and metabolic phenotyping. Subjects will undergo glucose tolerance testing to document glucose tolerance status. Each subject will be provided an accelerometer to be worn on their dominant wrist for 7 days for assessm... | Single Nuclei RNA-sequencing to Map Adipose Cellular Populations and Senescent Cells in Older Subjects | Obesity, Healthy Lifestyle | * Other: Lifestyle Intervention
* Drug: Dasatinib 100 MG
* Drug: Quercetin 1000mg
* Drug: Placebo
* Procedure: Abdominal adipose tissue biopsy
| Inclusion Criteria:~Both Sexes~Age: younger lean group 18-30 years with BMI 18.5-24.9 kg/m2; older lean group ≥ 65 years with BMI~All races and ethnic groups~Community dwelling~Sedentary (≤1.5 h of exercise per week)~Nondiabetic (fasting plasma glucose < 126 mg/dl, 2-h glucose during oral glucose tolerance test (OGTT) ... | 18 Years | null | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All participants will undergo cellular/molecular profiling and older obese participants will be randomized into 3 arms.
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity | Change in skeletal muscle insulin sensitivity | Week 4 and Week 15 |
| Glucose tolerance | Measurement of change in glucose tolerance using a glucose tolerance test | Baseline to Week 14 |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Senescence-associated secretory phenotype (SASP) | Measurement of change of SASP in adipose tissue | Baseline to Week 16 |
| Lifestyle intervention, Single RNA sequencing, Cell Senescence | Dasatinib, Quercetin, Antineoplastic Agents, Protein Kinase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Antioxidants, Protective Agents, Physiological Effects of Drugs | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Younger Lean Group<br>Participants will be aged 18-30 years and have a BMI of 18.5 - 24.9 kg/m2 | Procedure: Abdominal adipose tissue biopsy<br>* All participants will undergo baseline biopsies of subcutaneous abdominal adipose tissue for cellula... | Single Nuclei RNA-seq to Map Adipose Cellular Populations and Senescent Cells in Older Subjects
Study Overview
=================
Brief Summary
-----------------
All participants will undergo baseline biopsies of subcutaneous abdominal adipose tissue for cellular/molecular profiling via snRNA-seq and metabolic/physiolo... |
NCT02876107 | Carboplatin and Paclitaxel With or Without Panitumumab in Treating Patients With Invasive Triple Negative Breast Cancer | This randomized phase II trial studies how well carboplatin and paclitaxel with or without panitumumab work in treating patients with invasive triple negative breast cancer. Drugs used in the chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing th... | PRIMARY OBJECTIVES:~I. To determine the pathologic complete response (pCR) rate in patients with primary triple-receptor negative (estrogen receptor [ER]-negative, progesterone receptor [PgR]-negative, and human epidermal growth factor receptor 2 [HER2]-negative) inflammatory breast cancer (TN-IBC) by using a combinati... | A Randomized Phase II Study of Neoadjuvant Carboplatin/Paclitaxel (CT) Versus Panitumumab/Carboplatin/Paclitaxel (PaCT) Followed by Anthracycline-Containing Regimen for Newly Diagnosed Primary Triple-Negative Inflammatory Breast Cancer | Peau d'Orange, Breast Carcinoma, Breast Lump, Edema, Erythema, Estrogen Receptor Negative, HER2/Neu Negative, Inflammatory Breast Carcinoma, Invasive Breast Carcinoma, Progesterone Receptor Negative, Triple-Negative Breast Carcinoma | * Drug: Carboplatin
* Other: Laboratory Biomarker Analysis
* Drug: Paclitaxel
* Biological: Panitumumab
| Inclusion Criteria:~Patients must have histological confirmation of breast carcinoma~Patients must have invasive breast cancer (IBC), confirmed according to international consensus criteria:~Onset: Rapid onset of breast erythema, edema, and/or peau d'orange, and/or warm breast, with or without an underlying breast mass... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete pathologic response | Will be estimated for each treatment arm with exact 95% confidence intervals. A Chi-square test or Fisher's exact test will be used to compare the differences in complete pathologic response rate between the two ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | The method of Kaplan-Meier method will be used to estimate the time-to-event outcomes. | Up to 5 years |
| Overall survival | The method of Kaplan-Meier method will be used to estimate the time-to-event outcomes. | Up ... | Paclitaxel, Carboplatin, Albumin-Bound Paclitaxel, Panitumumab, Antineoplastic Agents, Immunological, Antibodies, Immunoglobulins, Antibodies, Monoclonal, Antineoplastic Agents, Phytogenic, Antineoplastic Agents, Tubulin Modulators, Antimitotic Agents, Mitosis Modulators, Molecular Mechanisms of Pharmacological Action,... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (panitumumab, paclitaxel, carboplatin)<br>Patients receive panitumumab IV over 1 hour on day 1 of cycle 0 and over 30 minutes on days 1, 8, and 15 of cycles 1-4. Patients also receive paclitaxel IV over 1-3 hours on days 1, 8, and ... | Carboplatin and Paclitaxel With or Without Panitumumab in Treating Patients With Invasive Triple Negative Breast Cancer
Study Overview
=================
Brief Summary
-----------------
This randomized phase II trial studies how well carboplatin and paclitaxel with or without panitumumab work in treating patients with ... | |
NCT01893177 | Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains (2013-14) | The study is to assess whether the influenza vaccine Inflexal V for season 2013/2014 fulfills the EMA requirements for re-registration of influenza vaccines. | Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2013/2014-season Virosomal Subunit Influenza Vaccine in Elderly and Young Subjects According to EMA Regulations | Influenza | * Biological: Inflexal V
| Inclusion Criteria:~Healthy female and male adults aged ≥18 on Day 1~Written informed consent~Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years~Exclusion Criteria:~Acut... | 18 Years | null | All | Accepts Healthy Volunteers | Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with seroconversion, seroprotection, and fold increase in geometric mean titer (GMT) | Immunogenicity variables are analyzed according to the EMA re-licensing criteria; at least one of the criteria has to be fulfilled fo... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of solicited local adverse events | | Days 1 to 4 inclusive |
| Incidence of solicited systemic adverse events | | Days 1 to 4 inclusive |
| Incidence of unsolicited adverse events | | Days 1 to 22 inclusive |
| Influenza, Virus, Vaccination, Inflexal V | Vaccines, Immunologic Factors, Physiological Effects of Drugs | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elderly subjects aged over 60 years<br> | Biological: Inflexal V<br>* Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V<br>* Other names: • 15 µg HA antigen of B/Massachusetts/2/2012-like virus;|
| Experime... | Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains (2013-14)
Study Overview
=================
Brief Summary
-----------------
The study is to assess whether the influenza vaccine Inflexal V for season 2013/2014 fulfills the EMA requirements for re-registration of influenza vaccin... | |
NCT02615314 | Clinical Aspects of Patients With Benign Paroxysmal Positional Vertigo (BPPV) and Migraine | The aim of this study is to analyze the clinical aspects of patients with BPPV associated with migraine. It is our purpose to clarify weather migraine is a risk factor for BPPV if the clinical aspect and the therapeutic outcome is different. | Two hundred and sixty-three patients with BPPV were enrolled in this retrospective study. All patients' charts were reviewed by independent observer. The type of BPPV and associated problems were noted. Patients with migraine were investigated in terms of age, gender, symptoms, affected side and the cure rate. Their da... | Clinical Aspects of Patients With Benign Paroxysmal Positional Vertigo (BPPV) and Migraine | Migraine, Positional Vertigo | * Procedure: Particle re-positioning maneuver
| Inclusion Criteria:~Patients who had history of head-induced positional and brief vertigo and who have been confirmed by VNG were included~Exclusion Criteria:~Patients with balance problem other than BPPV,~Patients receiving any medication prior to therapeutic maneuver were excluded | 10 Years | 84 Years | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who had normal vestibular response to provocative tests 7 days after re-positioning maneuver | Every patient with BPPV who had positional nystagmus during Dix-Hallpike and head-roll provocative maneuvers will be treated with... | migraine, benign paroxysmal positional vertigo | Vertigo, Benign Paroxysmal Positional Vertigo, Migraine Disorders, Dizziness, Headache Disorders, Primary, Headache Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vestibular Diseases, Labyrinth Diseases, Ear Diseases, Otorhinolaryngologic Diseases, Neurologic Manifestations, Sensat... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BPPV without migraine<br>Two hundred and sixty-three patients with BPPV (2009-2014), confirmed by videonystagmography (VNG), were enrolled in the study. Patients' charts were reviewed. They were grouped as those with or without migraine. Distribution of... | Clinical Aspects of Patients With Benign Paroxysmal Positional Vertigo (BPPV) and Migraine
Study Overview
=================
Brief Summary
-----------------
The aim of this study is to analyze the clinical aspects of patients with BPPV associated with migraine. It is our purpose to clarify weather migraine is a risk fa... | ||
NCT01505777 | Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea | The purpose of this study is to Evaluate the Optimal Dosage of Mosapride (Medirac) and Probitics in Irritable Bowel Syndrome Without Predominant Diarrhea. | Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea: Double Blinded, Randomized, Placebo Drug Controlled, Parallel Designed, Multi-centered, Phase 2 Study | Irritable Bowel Syndrome Without Diarrhea | * Drug: Probiotics (Medirac)
* Drug: Probiotics (Medirac)
* Drug: Probiotics (Medirac)
* Drug: Probiotics (Medirac)
* Drug: Probiotics (Medirac) placebo/mosapride placebo
| Inclusion Criteria:~Aged 18-75 years who satisfied RomeIII criteria for the diagnosis of IBS~Signed informed consent~Exclusion Criteria:~IBS-D~evidence of cathartic colon or history laxative abuse | 18 Years | 75 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms | | baseline and 4 week |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in improvment of abdominal discomfort, pain, bloating, stool frequency, stool consistency, straining urgency over 4 weeks of treatment and during each week(4 weeks,6 weeks) | | baseline and 4 weeks, 6 weeks |
| irritable bowel syndrome without predominant diarrhea, Probiotics(Medirac) 10/mosapride 10mg, Probiotics(Medirac) 15/mosapride 10mg, Probiotics(Medirac) 15/mosapride 15mg, Probiotics(Medirac) 30/mosapride 15mg, Probiotics(Medirac) placebo/mosapride placebo | Mosapride, Gastrointestinal Agents, Serotonin Receptor Agonists, Serotonin Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics(Medirac) 10/mosapride 10mg<br> | Drug: Probiotics (Medirac)<br>* 10/mosapride 10mg three times a day, P.O. 4week<br>|
| Experimental: Probiotics(Medirac) 15/mosapride 10mg<br> | Drug: Probiotics (Medirac)<br>* 15/mosapride 10mg ... | Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to Evaluate the Optimal Dosage of Mosapride (Medirac) and Probitics in Irritable B... | |
NCT04720092 | A Trial to Learn How a New Liquid Form of Rivaroxaban Behaves and How Safe it is Compared to the Current Tablet Form of Rivaroxaban in Healthy Male Participants | Researchers were looking for another way to treat people with a blood clot in their veins. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it behaves.~In this trial, the researchers learned how a new liquid form of rivaroxaban behaved compare... | Single-dose, Open-label, Randomized, 2-way Crossover Bioequivalence Study of 10 mg Granules for Oral Suspension Rivaroxaban Versus 10 mg Tablets Rivaroxaban Under Fasted Condition in Healthy Subjects | Thromboembolic Disorders | * Drug: Rivaroxaban (Xarelto, BAY59-7939)
* Drug: Rivaroxaban (Xarelto, BAY59-7939)
| Inclusion Criteria:~The informed consent had to be signed before any study specific tests or procedures were done~Healthy male subjects~Age: 18 to 55 years (inclusive) at the screening examination/visit~Race: White~Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m^2~Ability to understand and follow instru... | 18 Years | 55 Years | Male | 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 rivaroxaban in plasma after single dose | | Pre-dose up to 72 hours post-dose |
| AUC from time zero to the last data point greater than (>) lower limit of quantif... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with treatment-emergent adverse events (TEAEs) | | From start of study drug administration up to 30 days after last study drug administration |
| Thromboembolism | Rivaroxaban, Factor Xa Inhibitors, Antithrombins, Serine Proteinase Inhibitors, Protease Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Anticoagulants | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A-B<br>Subjects received a single oral dose of 10 mg rivaroxaban tablet in the fasted state on Day 1 (Treatment A) during intervention period 1; and then a single oral dose of 10 mg rivaroxaban oral suspension in the fasted state... | A Trial to Learn How a New Liquid Form of Rivaroxaban Behaves and How Safe it is Compared to the Current Tablet Form of Rivaroxaban in Healthy Male Participants
Study Overview
=================
Brief Summary
-----------------
Researchers were looking for another way to treat people with a blood clot in their veins. Be... | |
NCT05636033 | Semantic Networks in Alcohol Use Disorder Patients: Exploratory Study | Alcohol Use Disorder (AUD) is a major public health problem, characterized by a high rate of relapse. Chronic and excessive alcohol consumption notably induces frontal brain alterations and cognitive impairments such as executive dysfunction and an attentional bias for alcohol, participating to the risk of relapse. In ... | Semantic Networks in Alcohol Use Disorder Patients: Exploratory Study | Alcohol Use Disorder | Inclusion Criteria:~For alcohol use disorder patients~Severe alcohol use disorder~French as mother tongue~Right-hander~Patient abstinent from alcohol since 15 to 30 days at the inclusion~Patient free from benzodiazepine since at least 48hours at the inclusion~Patient who gave his informed written consent~Currently in o... | 30 Years | 60 Years | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the semantic associations using FGAT | The Free Generation Associated Tasks will be used in Alcohol use disorder patients and Healthy controls | At baseline (T1) |
| Description of the semantic associations using AJT | The Asso... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of medications on the semantic association performance | | At baseline (T1) |
| Impact of age on the semantic association performance | | At baseline (T1) |
| Impact of the study level on the semantic association performance | | At... | alcohol use disorder, semantic association, semantic networks, cognition | Alcoholism, Alcohol Drinking, Drinking Behavior, Alcohol-Related Disorders, Substance-Related Disorders, Chemically-Induced Disorders, Mental Disorders | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alcohol use disorder patients<br> | |
| Healthy controls<br> | |
| Semantic Networks in Alcohol Use Disorder Patients: Exploratory Study
Study Overview
=================
Brief Summary
-----------------
Alcohol Use Disorder (AUD) is a major public health problem, characterized by a high rate of relapse. Chronic and excessive alcohol consumption notably induces frontal brain alteration... | |||
NCT03458390 | Use of a Colon Irrigation Device as a Preparation for a Colon Visualization Procedure | A prospective, single center, study to evaluate the effectiveness of the HyGIeaCare Prep when used in combination with the PillCam COLON; the hypothesis is that the HyGIeaCare Prep will be easier for the patients to tolerate, and the results will be as good as the existing oral preparation. | Patients who agree to participate in the study will have their HyGIeaCare procedure and then will present to the PillCam COLON room, in the same suite for the PillCam COLON procedure.~The commercial preparations for the PillCam COLON procedure will be the same, except the HyGIeaCare procedure will replace the split pol... | Colon Irrigation Using HyGIeaCare as Prep for PillCam COLON Procedure | Screening Colonoscopy | * Device: HyGIeaCare colon irrigation
| Inclusion Criteria:~Patient referred for the PillCam COLON procedure~Exclusion Criteria:~-~HyGIeaCare:~Patient has any condition that, in the opinion of the investigator, may adversely affect the compliance or safety of the patient or would limit the patient's ability to complete the study~Patient is treated long-term ... | 18 Years | 80 Years | All | Accepts Healthy Volunteers | Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: HyGIeaCare colon irrigation procedure and PillCam COLON procedure
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of colon irrigation | Effectiveness of the HyGIeaCare Prep will be measured using a 5-point scale to evaluate the visual quality of bowel cleanliness identified in the PillCam Colon video (Excellent, Good, Fair, Adequate, Poor). ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of adverse events | The CTCAE tool will be used to evaluate outcomes | To be evaluated the day of the procedure |
| Evaluation of patient satisfaction | A standardized questionnaire will be used to measure outcomes | To be evaluate... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HyGIeaCare and PillCam COLON<br>Patient will receive the HyGIeaCare colon irrigation prior to their PillCam COLON procedure | Device: HyGIeaCare colon irrigation<br>* PillCam COLON for visualization of bowel lining<br>* Other names: PillCa... | Use of a Colon Irrigation Device as a Preparation for a Colon Visualization Procedure
Study Overview
=================
Brief Summary
-----------------
A prospective, single center, study to evaluate the effectiveness of the HyGIeaCare Prep when used in combination with the PillCam COLON; the hypothesis is that the HyG... | ||
NCT04563884 | Validity of the French Version of Deafness Questionnaires for Children and Adolescents | The care of deafness in children is difficult and the relevance of interventions is difficult to evaluate based on audiometric measurements alone.~Generic pediatric quality of life tools have been validated and used, among other things, to assess the quality of life of children with deafness. However, these non-specifi... | Neonatal sensorineural hearing loss is a frequent pathology, affecting around 800 newborns per year in France, or an incidence of 0.8 to 1.3 per 1000 births, comparable to other industrialized countries. It can affect the development of speech and language and lead to impaired quality of life.~Studies have shown that c... | Validity of the French Version of Deafness Questionnaires for Children and Adolescents | Deafness | * Other: Questionnaires
| Inclusion Criteria:~Minors aged 12 months to 17 years (inclusive)~Patients followed in consultation at Necker Hospital in the Pediatric ENT department~holders of parental authority not opposed to participation in the study~Patients :~Patients with deafness with mean tonal thresholds of at least 30dB, uni- or bilateral~... | 12 Months | 17 Years | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paired student t-test | Reproducibility of the questionnaire completed by a subject at 15 days apart | 1 year |
| Cronbach alpha test | Internal consistency | 1 year |
| Item-total Pearson correlation | Measure of reliability | 1 year |
| P... | Deafness, Children, SSQ questionnaire, PEACH questionnaire | Deafness, Hearing Loss, Hearing Disorders, Ear Diseases, Otorhinolaryngologic Diseases, Sensation Disorders, Neurologic Manifestations, Nervous System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with deafness<br>Patients aged 12 months to 17 years with deafness | Other: Questionnaires<br>* Children 12 months to 5 years old will receive PEACH alone, children 5 years old to 11 years old will receive PEACH and SSQ-P, and children and adol... | Validity of the French Version of Deafness Questionnaires for Children and Adolescents
Study Overview
=================
Brief Summary
-----------------
The care of deafness in children is difficult and the relevance of interventions is difficult to evaluate based on audiometric measurements alone. Generic pediatric qu... | ||
NCT00003580 | Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer | RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Drugs such as amifostine may protect normal cells from the side effects of chemotherapy and radiation therapy.~PURPOSE: Phase II trial ... | OBJECTIVES: I. Determine the efficacy of amifostine in alleviating treatment related mucositis associated with targeted supradose cisplatin and concurrent radiotherapy (RADPLAT protocol) in patients with stage III or IV squamous cell carcinoma of the head and neck. II. Determine the efficacy of amifostine in alleviatin... | Phase II Study - Efficacy of Amifostine in Alleviating Toxicity Associated With Targeted Supradose Cisplatin and Concomitant Radiation Therapy (RADPLAT) in Head and Neck Cancer | Drug/Agent Toxicity by Tissue/Organ, Head and Neck Cancer, Oral Complications, Radiation Toxicity | * Drug: amifostine trihydrate
* Drug: cisplatin
* Radiation: radiation therapy
| DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the oral cavity, nasopharynx, oropharynx, hypopharynx, or larynx Previously untreated Stage III or IV No distant metastatic disease~PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified ... | 18 Years | null | All | No | Primary Purpose: Supportive Care
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiation toxicity, oral complications, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the nasopharynx... | Amifostine, Radiation-Protective Agents, Protective Agents, Physiological Effects of Drugs | | Intervention/Treatment |
| --- |
|Drug: amifostine trihydrate|nan|
|Drug: cisplatin|nan|
|Radiation: radiation therapy|nan|
| Amifostine to Treat Side Effects of Treatment in Patients Receiving Radiation Therapy and Cisplatin for Advanced Head and Neck Cancer
Study Overview
=================
Brief Summary
-----------------
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different way... | |
NCT05074797 | Epidemology of Acute Kidney Injury in Diabetic Patients Infected With covid_19 In Assiut University Hospital | The novel coronavirus SARS-CoV-2 was identified as the causative agent for a series of atypical respiratory diseases in Wuhan, China in December of 2019(.1) The disease termed COVID-19, was officially declared a pandemic by the World Health Organization on March 11, 2020. SARS-CoV-2 contains a single-stranded, positive... | Notably, in several studies, diabetes is one of the most reported comorbidities with poor prognosis in patients with severe COVID-19 due to Compromised innate immunity, pro-inflammatory cytokine reduced expression of ACE2 and use of renin-angiotensin-aldosterone system antagonists. (3) On the other hand, COVID-19 contr... | Epidemology of Acute Kidney Injury in Diabetic Patients Infected With covid_19 In Assiut University Hospital | Acute Kidney Injury Due to covid_19 | * Diagnostic Test: laboratory
| Inclusion Criteria:~patients admitted because of COVID-19 infetion.~Exclusion Criteria:~Patients with ESRD on regular dialysis ,Patients with stage 4 or 5 non-dialysis if the condition proven to be progression of the already known diagnosis. | null | null | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of AKI in covid_19 in diabetic pt | diabetic pt with AKI due to infection with covid _19 | 6 months |
| Acute Kidney Injury, Wounds and Injuries, Renal Insufficiency, Kidney Diseases, Urologic Diseases, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Male Urogenital Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| covid not diabetic with AKI<br>AKI in pt with covid_19 not diabetic | Diagnostic Test: laboratory<br>* laboratory data<br>|
| AKI in covid_19 in diabetic<br>AKI in covid_19 in diabetic pt | Diagnostic Test: laboratory<br>* laboratory data<br>|
| covid_1... | Epidemology of Acute Kidney Injury in Diabetic Patients Infected With covid_19 In Assiut University Hospital
Study Overview
=================
Brief Summary
-----------------
The novel coronavirus SARS-CoV-2 was identified as the causative agent for a series of atypical respiratory diseases in Wuhan, China in December ... | |||
NCT01963052 | ASG-15ME is a Study of Escalating Doses of AGS15E Given as Monotherapy in Subjects With Metastatic Urothelial Cancer | The objectives of this study are to assess the safety, pharmacokinetics, immunogenicity and anti-tumor activity of AGS15E in subjects with metastatic urothelial cancer who failed at least one prior chemotherapy regimen for metastatic disease. | All subjects will receive a single intravenous infusion of AGS15E once weekly for 3 weeks of every 4 weeks. A cycle is 4 weeks. Subjects will continue treatment until disease progression, intolerability of AGS15E, investigator decision, or consent withdrawal.~In subjects who discontinue therapy without documented disea... | A Phase 1 Study of the Safety and Pharmacokinetics of Escalating Doses of AGS15E Given as Monotherapy in Subjects With Metastatic Urothelial Cancer | Metastatic Urothelial Cancer | * Drug: AGS15E
| Inclusion Criteria:~Histologically confirmed Transitional Cell Carcinoma of the Urothelium (TCCU) (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Subjects with Urothelial Carcinoma with squamous differentiation or mixed cell types are eligible.~Part A: Subject must have failed at least one prior chemot... | 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 | | up to 36 months |
| Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Concentration at the end of infusion (CEOI) | | Days 1-4, 8, 15-18 an... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Anti-Drug Antibody (ADA) | | Up to 26 months |
| Tumor response | Incidence of tumor response defined as either a complete response (CR) or partial response (PR) per RECIST criteria (version 1.1) that should be confirmed ≥ 28 da... | Metastatic Urothelial Cancer, AGS15E-13-1, ASG-15ME, Pharmacokinetics of AGS15E, AGS15E | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: AGS-15E Dose Escalation (Dose Levels 1-6)<br>Subjects will receive a single 30 minute intravenous (IV) infusion of AGS15E once weekly for 3 weeks of every 4 weeks (Days 1, 8, and 15). A cycle is 4 weeks. Additional subjects may be ... | ASG-15ME is a Study of Escalating Doses of AGS15E Given as Monotherapy in Subjects With Metastatic Urothelial Cancer
Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to assess the safety, pharmacokinetics, immunogenicity and anti-tumor activity of AGS15E in subjects wit... | |
NCT03473574 | Durvalumab and Tremelimumab With Gemcitabine or Gemcitabine/Cisplatin Compared to Gemcitabine/Cisplatin in CCA Patients | To determine the efficacy in terms of objective response rate (ORR) of the combination of durvalumab and tremelimumab in addition with gemcitabine or in addition with gemcitabine and cisplatin in treatment-naïve patients with advanced, unresectable and/or metastatic cholangio- and gallbladder carcinoma (CCA). | Patients with CCA have poor outcomes, as a consequence of the very aggressive nature of the disease, and the limited treatment options. Thus there is a significant unmet medical need for additional treatment options for use in this patient population. As in most other tumor entities however, only a fraction of patients... | A Randomized Phase II Trial of Durvalumab and Tremelimumab With Gemcitabine or Gemcitabine and Cisplatin Compared to Gemcitabine and Cisplatin in Treatment-naïve Patients With Cholangio- and Gallbladder Carcinoma (IMMUCHEC) | Cholangiocarcinoma, Gall Bladder Carcinoma, Cholangiocarcinoma Non-resectable, Gallbladder Carcinoma Non-Resectable | * Biological: Durvalumab
* Drug: Gemcitabine
* Drug: Cisplatin
* Biological: Tremelimumab
| Inclusion Criteria:~Fully-informed written consent and locally required authorization (European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.~Age ≥ 18 years.~Histologically documented diag... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Treatment Arm A: Combination of Durvalumab, Tremelimumab (Regimen 1) and Gemcitabine Treatment Arm B: Combination of Durvalumab, Tremelimumab (Regimen 1), Gemcitabine and Cisplatin Treatment Arm C... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | Response Rate (RR) according to RECIST V1.1 | 30 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | Efficacy of the combination of durvalumab and tremelimumab in addition with gemcitabine or in addition with gemcitabine and cisplatin in treatment naïve patients with advanced, unresectable and/or metastatic cholangio- ... | Gemcitabine, Durvalumab, Tremelimumab, Antineoplastic Agents, Antimetabolites, Antineoplastic, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Immunological | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Durvalumab in combination with Tremelimumab (Regimen 1) and Gemcitabine | Biological: Durvalumab<br>* immune checkpoint inhibitor<br>Drug: Gemcitabine<br>* standard chemotherapy<br>Biological: Tremelimumab<br>* immune checkpoint i... | Durvalumab and Tremelimumab With Gemcitabine or Gemcitabine/Cisplatin Compared to Gemcitabine/Cisplatin in CCA Patients
Study Overview
=================
Brief Summary
-----------------
To determine the efficacy in terms of objective response rate (ORR) of the combination of durvalumab and tremelimumab in addition with... | |
NCT03568734 | Cesarean Section and Intestinal Flora of the Newborn | Mode of delivery affects gut microbiome of the infant. Infants born by caesarean section have a less heterogenous microbiome for the first weeks of life. This has been associated with an increased risk for atopy-related diseases, such as allergy and asthma. In this proof-of-principle study the investigators evaluate wh... | Background~The immune system is affected by the colonizing microbiome. The gut microbiome has been associated with a multitude of inflammatory diseases, such as the development of autoimmune diseases. The association between microbiome and allergic diseases, asthma, type I diabetes and inflammatory bowel diseases have ... | Cesarean Section and Intestinal Flora of the Newborn | Intestinal Microbiome | * Other: Fecal transplant
| Inclusion criteria:~healthy pregnancy~planned cesarean section delivery~Exclusion criteria:~Maternal exclusion criteria:~positive GBS status~maternal refusal~maternal antibiotic treatment within the last 3 months~any travel outside of European Union within the last 3 months~multiple pregnancy and CS after the onset of ... | null | null | Female | Accepts Healthy Volunteers | Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: 12 mothers participating in the study (due for caesarean section) are screened for transmissible diseases. A transplant sample is gathered from the mother, processed, and given to the infant at delivery by caesarea... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | Clinical condition, inflammatory markers | 0-3 postnatal days |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attachment of transplant | Evaluation of microbiome in comparison to transplant from samples taken from infants weekly at 1-4 weeks of life and at 3 months of age. | 1 to 12 weeks of age |
| microbiome, transplant, infant, newborn | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transplant arm<br>Fecal transplant sample given to child at delivery | Other: Fecal transplant<br>* At delivery, i.e. 39-40 weeks of gestation, the newborn infant is given 0.1 g maternal fecal sample (in 0.5 ml of the isotonic saline+10 % ... | Cesarean Section and Intestinal Flora of the Newborn
Study Overview
=================
Brief Summary
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Mode of delivery affects gut microbiome of the infant. Infants born by caesarean section have a less heterogenous microbiome for the first weeks of life. This has been associated with an increased risk... | |
NCT06063278 | Step by Step Group Therapy for Bulimia Nervosa: Effectiveness and Mechanisms of Change. | This a pseudo-randomized clinical trial that examines if a specific group therapy for BN is effective in improving its symptomatology, and what variables mediate such improvements. To do so a sample of 100 patients with BN will be pseudorandomized in a Group Therapy for BN or in a control waiting list group. Patients w... | This is a controlled non randomized study that will compare a group of patients with BN that participate in the SBS group therapy with a group of BN patients who will be in wait list as a control condition.~Patients for this single center trial will be recruited from the outpatient facility of the Hospital de la Santa ... | Step by Step Group Therapy for Bulimia Nervosa: Effectiveness and Mechanisms of Change. | Bulimia Nervosa | * Behavioral: l Group Therapy for BN.
| Inclusion Criteria:~Diagnostic of Bulimia Nervosa~Exclusion Criteria:~Not understanding Spanish or Catalan Language | 18 Years | 65 Years | All | No | Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating Attitudes Test, E-40. | A self report questionarie that assesses eating disorder symptomatology. The range of scores is 0-78. Higher scores mean higher eating disorders sympthoms. | 3 months |
| Eating Disorder Inventory, EDI | A self ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Working alliance Inventory -short, WAIS. | A self report questionarie that assesses bulimia nervosa symptomatology. Values range from 12 to 84. Hihger scores meaning higher therapeutic alliance. | 3 months |
| Autism-Spectrum Quotient, AQ | A... | Bulimia, Bulimia Nervosa, Hyperphagia, Signs and Symptoms, Digestive, Feeding and Eating Disorders, Mental Disorders | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BN Group<br>Patients will take part of a Therapeutic BN Group | Behavioral: l Group Therapy for BN.<br>* 9 to 10 group sessions of 90 to 120min each<br>|
| No Intervention: Waiting List<br>Participants will be in the waiting list. | |
| Step by Step Group Therapy for Bulimia Nervosa: Effectiveness and Mechanisms of Change.
Study Overview
=================
Brief Summary
-----------------
This a pseudo-randomized clinical trial that examines if a specific group therapy for BN is effective in improving its symptomatology, and what variables mediate such... | |
NCT03201354 | Efficacy and Safety of the ExPRESS Implant Versus Deep Sclerectomy in Combined Surgery | The Ex-PRESS Glaucoma Filtration Device is a small, non-valved implant that was designed to lower intraocular pressure (IOP) by shunting aqueous humor from the anterior chamber into the subconjunctival space. The implant was developed in response to the need for more straightforward, standardized and safe surgical tech... | Hypothesis:~In combined procedure (cataract and filtering surgery), the effect of Ex-PRESS device has similar efficacy reducing intraocular pressure than non penetrant deep sclerectomy and with good level of safety.~Objective:~To evaluate and compare the efficacy and safety at 12 months of the filtering surgery with th... | Efficacy and Safety of the ExPRESS Implant Versus Deep Sclerectomy in Combined Surgery: Prospective, Multi-center, Comparative Study | Open Angle Glaucoma, Ocular Hypertension | * Procedure: Filtration surgery with Ex-PRESS
* Procedure: Non penetrating deep sclerectomy
* Procedure: Cataract extraction
| Inclusion Criteria:~Diagnosis of open-angle glaucoma. Points a, b and c will be required:~Glaucomatous visual field. Defined as the field presenting at least:~A group of 3 or more points with p < 5% in the pattern deviation map AND~One of them with a p < 1% in the pattern deviation map AND~Repeated in at least 2 VF.~Gl... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure | mmHg | Up to 12 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate at IOP <18 | percentage of patients with < of 18 mmHg in intraocular pressure | Up to 12 months |
| Number of participants with adverse events assesed by questionare in case report file. | Bullet list of complications to check fo... | Glaucoma, Ocular hypertension, Filtration surgery, Trabeculectomy with Ex-PRESS, Non penetrating deep sclerectomy, Phacoemulsification, Combined surgery | Glaucoma, Glaucoma, Open-Angle, Ocular Hypertension, Hypertension, Vascular Diseases, Cardiovascular Diseases, Eye Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Filtration surgery with Express<br>Filtration surgery with Ex-PRESS + cataract extraction (Cataract surgery and IOL implantation) | Procedure: Filtration surgery with Ex-PRESS<br>* Filtration surgery with Ex-PRESS<br>Procedure: Catara... | Efficacy and Safety of the ExPRESS Implant Versus Deep Sclerectomy in Combined Surgery
Study Overview
=================
Brief Summary
-----------------
The Ex-PRESS Glaucoma Filtration Device is a small, non-valved implant that was designed to lower intraocular pressure (IOP) by shunting aqueous humor from the anterio... |
NCT05597397 | Effect of Repeated Low-Level Red-Light Therapy on Retinal Function and Structure | The purpose of this clinical trial is to evaluate the effect of repeated low-level red-light (RLRL) therapy on the retinal function and structure among myopic teenagers. | Myopia constitutes a major threat to personal health globally for its increased prevalence. Moreover, its dose-related association with irreversible blindness complications such as myopic macular degeneration has been demonstrated. It is crucial to look for effective ways to control myopia in children to reduce risk of... | Effect of Repeated Low-Level Red-Light Therapy on Retinal Function and Structure Among Myopic Teenagers | Myopia, Refractive Errors, Eye Diseases, Retina; Change | * Device: RLRL
| Inclusion Criteria:~Age: 15-16 years at enrolment.~Myopia: cycloplegic spherical equivalent refractions (SERs) range from -1.00 to -5.00 diopters (D) and astigmatism less than -2.5 D in either eye.~Best corrected visual acuity equal to or better than 0.8 in either eye.~Normal fundus, or tessellated fundus.~Provision of... | 15 Years | 16 Years | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the amplitudes of waves. | Changes in the amplitudes are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by electroretinogram. | 1 and 2 months |
| Changes in the la... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in retinal sensitivity | Changes in retinal sensitivity are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by microperimetry. | 1 and 2 months |
| Changes in fixation ... | Eye Diseases, Refractive Errors | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Repeated Low-Level Red-Light Therapy (RLRL)<br>Single vision spectacles (SVS) & RLRL. | Device: RLRL<br>* In addition to SVS with power for correcting distance refraction, RLRL will be performed twice per school day with an interval of at ... | Effect of Repeated Low-Level Red-Light Therapy on Retinal Function and Structure
Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to evaluate the effect of repeated low-level red-light (RLRL) therapy on the retinal function and structure among myopic teenagers.
De... | |
NCT00457210 | The Influence of Radiotherapy on Cognitive Function | The cognitive function of 150 patients that undergone any Radiotherapy treatment to the brain will be assessed at 3 time points before and after the treatment. | The basic cognitive function and QOL of 150 oncologic patients that undergone Radiotherapy or Radiosurgery treatment to the brain due to primary tumor, metastases or increased risk of brain metastases, will be assessed at 3 time points: before the treatment, immediately after the treatment, and on the next follow up vi... | The Influence of the Radiotherapy or Stereotactic Radiosurgery on the Cognitive Function of the Patients With the Neurotrax Assessment System and a Cognitive Questionnaire. | Radiotherapy, Brain Neoplasms, Quality of Life | * Procedure: Brain Radiotherapy/Stereotactic Radiosurgery
| Inclusion Criteria:~20-80 years old oncologic patients, of both genders, that are referred to Brain Radiotherapy or Stereotactic Radiosurgery due to primary brain tumor/ brain metastases or increased risk for brain metastases.~Are able to follow instructions in Hebrew.~Exclusion Criteria:~Non-Hebrew speakers can not pa... | 20 Years | 80 Years | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychology | Brain Neoplasms, Central Nervous System Neoplasms, Nervous System Neoplasms, Neoplasms by Site, Neoplasms, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases | | Intervention/Treatment |
| --- |
|Procedure: Brain Radiotherapy/Stereotactic Radiosurgery|nan|
| The Influence of Radiotherapy on Cognitive Function
Study Overview
=================
Brief Summary
-----------------
The cognitive function of 150 patients that undergone any Radiotherapy treatment to the brain will be assessed at 3 time points before and after the treatment.
Detailed Description
-----------------
Th... | ||
NCT00789503 | Nursing-Home Residents Given Bread Fortified With Vitamin D3 | Background. For older adults, serum 25-hydroxyvitamin D (25(OH)D) higher than 75 nmol/L lowers fracture risk and attainment of this 25(OH)D target may require 125 mcg (5000 IU)/d of vitamin D3.~Objective: We wanted to characterize the safety and efficacy of fortifying bread with a biologically meaningful amount of vita... | Methods: In a single-arm design, 45 nursing-home residents consumed one bun/d that had been fortified with 125 mcg (5,000 IU) of vitamin D3 and 320 mg elemental calcium. | Long-Term Effects of Giving Nursing-Home Residents Bread Fortified With 125 Micrograms (5000 IU) Vitamin D3 Per Daily Serving | Vitamin D Deficiency, Low Bone Density | * Dietary Supplement: Bread fortified with vitamin D3 and calcium
| Inclusion Criteria:~Healthy seniors in an institution in Romania~Exclusion Criteria:~Known hypercalcemic or hypercalciuric disease | 58 Years | 89 Years | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum 25-hydroxyvitamin D response | | 12 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on serum calcium | | 12 months |
| Effects on urine calcium | | 12 months |
| Change in spine and hip bone mineral density, baseline vs final | | 12 months |
| Change in parathyroid hormone, baseline vs final | | 12 months |
| dietary fortification, Vitamin D3, Osteomalacia, bread, bone mineral density, geriatrics, cholecalciferol, calcidiol, osteoporosis, dual-energy photon absorptiometry, bread fortification | Vitamin D, Cholecalciferol, Calcium, Vitamins, Micronutrients, Physiological Effects of Drugs, Calcium-Regulating Hormones and Agents, Bone Density Conservation Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bread fortified with vitamin D3 and calcium<br> | Dietary Supplement: Bread fortified with vitamin D3 and calcium<br>* Bread fortified with vitamin D3 (5000 IU per bun) and calcium<br>|
| Nursing-Home Residents Given Bread Fortified With Vitamin D3
Study Overview
=================
Brief Summary
-----------------
Background. For older adults, serum 25-hydroxyvitamin D (25(OH)D) higher than 75 nmol/L lowers fracture risk and attainment of this 25(OH)D target may require 125 mcg (5000 IU)/d of vitamin D3.... |
NCT00549172 | Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear | Degenerative meniscal tears are the most common etiology for knee pain, swelling and loss of function. Partial arthroscopic meniscectomy is the most common orthopaedic procedure to treat meniscal tears. Improvements have been reported both after arthroscopy and with conservative treatment, however no direct comparison ... | Middle-aged men and women with degenerative meniscal tears constitute a large group of patients presenting with knee pain, sometimes accompanied with swelling and loss of function. Many meniscal tears occur without a trauma in physically active individuals as well as in older people and could be a part of early osteoar... | Efficacy of Arthroscopic Partial Resection for the Degenerative Tear of the Medial Meniscus of a Knee | Osteoarthritis, Knee | * Procedure: Operative (partial arthroscopy)
* Procedure: Conservative (diagnostic arthroscopy)
| Inclusion Criteria:~Age: 35 to 65 years of age.~A pain located on the medial joint line of the knee that has persistent at least for 3 months.~Pain that can be provoked by palpation or compression of the joint line or a positive McMurray sign.~Tear of the medial meniscus on MRI.~Degenerative rupture of the medial menis... | 35 Years | 65 Years | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Lysholm Knee Score | The Lysholm knee score is based on an eight-item questionnaire designed to evaluate knee function and symptoms in activities of daily living. Scores range from 0 to 100; higher scores indicate less severe symptoms. | O... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 15-D (General Quality of Life -Assessment Tool) | The 15D instrument is a generic health-related quality-of-life instrument comprising 15 dimensions. The maximum 15D score is 1 (full health), and the minimum score is 0 (death). | One year |
|... | Osteoarthritis, Knee, Arthroscopic Surgery, Menisci, Medial, Placebo Effect, Treatment Efficacy | Osteoarthritis, Osteoarthritis, Knee, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Operative (O)<br>Partial resection of degenerative tear of medial meniscus | Procedure: Operative (partial arthroscopy)<br>* Partial arthroscopic resection of degenerative rupture of the medial meniscus<br>|
| Sham Comparator: Conserv... | Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear
Study Overview
=================
Brief Summary
-----------------
Degenerative meniscal tears are the most common etiology for knee pain, swelling and loss of function. Partial arthroscopic meniscectomy is the most common orthopaedic procedure to treat m... |
NCT03489876 | Synthetic Cartilage Implant vs Osteochondral Autograft Transfer for Advanced 1st Metatarsal Phalangeal Joint Arthritis | This is a prospective, randomized, controlled clinical trial comparing synthetic cartilage implantation versus osteochondral autograft transfer for treatment of first metatarsophalangeal (MTP) arthritis. This data will allow for accurate comparisons between the two groups in regards to functional outcome, clinical outc... | First MTP joint arthritis or hallux rigidus is the most common arthritic condition of the foot. Historically, there have been several options to treat this condition surgically, but the current standard for advanced hallux rigidus is first MTP anthrodesis. Newer joint preserving procedures offer patients effective reli... | Comparison of Synthetic Cartilage Implant Versus Osteochondral Autologous Transfer for Advanced Hallux Rigidus, A Prospective Randomized Controlled Clinical Trial | Metatarsophalangeal Joint Arthritis | * Device: Synthetic Cartilage Implant
* Procedure: Osteochondral Autograft Transfer
| Inclusion Criteria:~Between the ages of 18 and 80 years old~Grade 2 or 3 hallux rigidus based on Coughlin and Shurnas classification~Presence of good bone stock as determined on pre-operative x-rays not requiring bone grafting~Capable of consenting for self~Exclusion Criteria:~Patients <18 years of age~Grade 1 or 4 hal... | 18 Years | 80 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Upon eligibility verification and informed consent, computer-based randomization will allot patients into one of the two treatment groups, either synthetic cartilage implant or osteochondral autog... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion | Pre-operative and post-operative clinical range of motion of the first MTP joint | 2 years |
| Patient's Pain Level | Pre-operative and post-operative visual analog pain scale | 2 years |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Quality of Life | Foot and Ankle Ability Measure (FAAM) sports score uses patient-report to determine function | 2 years |
| Clinically-Assessed Foot and Ankle Function | American Orthopedic Foot and Ankle Score (AOFAS) Hallux Metat... | Metatarsophalangeal Joint, Arthritis, Synthetic Cartilage Implant, Cartiva, Osteochondral Autograft Transfer | Arthritis, Joint Diseases, Musculoskeletal Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synthetic Cartilage Implant<br>Participants receive the synthetic cartilage implant. The synthetic cartilage implant that will be used is the Cartiva implant. | Device: Synthetic Cartilage Implant<br>* The Synthetic Cartilage Implant will ... | Synthetic Cartilage Implant vs Osteochondral Autograft Transfer for Advanced 1st Metatarsal Phalangeal Joint Arthritis
Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized, controlled clinical trial comparing synthetic cartilage implantation versus osteochondral autograft ... |
NCT05326555 | Dynamic Vision Testing and Concussion Management Dream Team 65 | The purpose of this study is to determine the value of including dynamic vision testing into California State University, Northridge (CSUN) Athletics' established concussion protocol. The study's hypotheses are 1) dynamic vision testing will reveal vision impairments right after a person sustains a concussion, 2) these... | The subjects of interest are CSUN student-athletes who give consent to participate in the study. Dynamic vision will be assessed through the administration of the Dynamic Visual Acuity (DVA) test and the Gaze Stabilization Test (GST). Additionally, the 6-condition Balance Error Scoring System (BESS), which is currently... | Dynamic Vision Testing and Concussion Management Dream Team 65 | Head Injury, Sport Injury, Concussion, Brain | * Diagnostic Test: Dynamic Vision Testing (Bertec Vision Advantage System) and Balance Error Scoring System
| Inclusion Criteria:~• California State University Northridge athletes~Participants are able to give consent to participate in the study~Completion of preseason testing for the 6-condition, BESS, DVA, GST with the research team~Sustained a concussion as diagnosed by the medical staff during the 2020-2021 season of play.... | null | null | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-Condition BESS | Number of errors and time subject was able to hold position | October 1, 2021 - October 1, 2024 |
| Gaze Stabilization Test (GST) | Maximum head velocity in degrees/second | October 1, 2021 - October 1, 2024 |
| Dynamic Vi... | Imidacloprid, Cholinergic Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs | | Intervention/Treatment |
| --- |
|Diagnostic Test: Dynamic Vision Testing (Bertec Vision Advantage System) and Balance Error Scoring System|Assessment tool and computerized tests designed to evaluate postural stability and vestibulo-ocular reflex (VOR) function while assisting with return to play decision after a spo... | Dynamic Vision Testing and Concussion Management Dream Team 65
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the value of including dynamic vision testing into California State University, Northridge (CSUN) Athletics' established concussion protocol. The stu... | |||
NCT04341896 | Healthcare Utilization in Obese Caregiver Living Donors | The goal of this study is to estimate risk of post-donation healthcare use attributable to informal caregiving among obese living donors. Improving our understanding of the relationship between caregiving, donation, and healthcare use will allow us to improve living donor informed consent and post-donation care, partic... | Caregiver burden is a well-known issue of primary caregiving for individuals with chronic disease, including transplant candidates and recipients. Informal caregiving is associated with an estimated $306 billion in unpaid labor costs and an average of $7,000 in out-of-pocket expenses related to the caregiving role. In ... | The Role of Caregiving in Healthcare Utilization Among Obese Living Kidney Donors | Utilization, Health Care, Obesity | * Other: Caregivers
* Other: Non-caregivers
| Inclusion Criteria:~Age 18 years or greater~Underwent living donor nephrectomy at a transplant center in the United States between 1968 to present~Obesity: had a body mass index of 30 kg/m2 or greater at time of kidney donation~Exclusion Criteria:~Age < 18 years~Non-obese at time of donation~Does not consent to study p... | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergency department utilization | Proportion self-reporting at least one visit to the emergency department since donation/previous questionnaire | Baseline (kidney donation) through 40 years |
| Hospital admission | Proportion self-reporting... | living kidney donor | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Caregivers<br>Prior obese living kidney donors who served as the primary caregiver for their recipient | Other: Caregivers<br>* Individuals who cared for themselves and their transplant recipient before and after kidney donation<br>|
| Non-caregivers<br... | Healthcare Utilization in Obese Caregiver Living Donors
Study Overview
=================
Brief Summary
-----------------
The goal of this study is to estimate risk of post-donation healthcare use attributable to informal caregiving among obese living donors. Improving our understanding of the relationship between care... | |||
NCT02902406 | Validation of DNA Methylation Biomarkers for Oral Cancer Detection-Follow up Study | This is a follow up study which aims to evaluate the correlation between several methylated genes (potential biomarkers) and oral cancers. A prospective case control trial is designed with sample size of at least 300 cases with estimated 200 subjects with precancerous lesion or oral cancer, and 100 subjects with normal... | Validation of DNA Methylation Biomarkers for Oral Cancer Detection-Follow up Study | Oral Cancer | Inclusion Criteria:~Subject with age over 20.~Subjects with oral mucosal findings (normal, oral mucosal lichen planus, precancerous lesion, and oral cancer) or subjects who have involved in the previous study (NCT01945697).~Subjects agrees to sign the informed consent form.~Exclusion Criteria:~Pregnant woman.~Subject d... | 20 Years | null | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA methylation | | 2 years |
| Mouth Neoplasms, Lip Neoplasms, Head and Neck Neoplasms, Neoplasms by Site, Neoplasms, Mouth Diseases, Stomatognathic Diseases, Lip Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| normal oral mucosa<br> | |
| oral precancerous lesion or oral cancer<br> | |
| Validation of DNA Methylation Biomarkers for Oral Cancer Detection-Follow up Study
Study Overview
=================
Brief Summary
-----------------
This is a follow up study which aims to evaluate the correlation between several methylated genes (potential biomarkers) and oral cancers. A prospective case control trial... | |||||
NCT03660839 | Study to Investigate the Clinical and Parasiticidal Activity and Pharmacokinetics of Different Doses of Artefenomel and Ferroquine in Patients With Uncomplicated Plasmodium Falciparum Malaria | Primary Objective:~To show the contribution of artefenomel (OZ439) to the clinical and parasiticidal effect of OZ439/Ferroquine (FQ) combination by analyzing exposure-response of OZ439 measured by Day 28 polymerase chain reaction (PCR)-corrected adequate clinical and parasitological response (ACPR) for the effect and t... | The duration of the study was up to 32 days, including up to 1 day screening period before the single-dose treatment, 5 days of post-treatment surveillance (included 2 to 4 days hospitalization) and 24±2 days follow-up period. | A Randomized, Open Label, Parallel-group, Single Dose Regimen, Phase 2a Study, to Investigate the Clinical and Parasiticidal Activity and the Pharmacokinetics of 3 Dose Levels of Artefenomel (OZ439) Given in Combination With Ferroquine (FQ) and FQ Alone, in African Patients With Uncomplicated Plasmodium Falciparum Mala... | Plasmodium Falciparum Infection | * Drug: Artefenomel (OZ439)
* Drug: Ferroquine (SSR97193)
| Inclusion criteria :~Participants (14-69 years old inclusive) with body weight within 35 and 90 kilograms (kg), with uncomplicated Plasmodium falciparum (P. falciparum) malaria, with a fever as defined with axillary temperature greater than or equal to (>=) 37.5 degree Celsius (°C) or oral/ rectal/ tympanic temperature... | 14 Years | 69 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 28 (ACPR28) | ACPR:absence of parasitemia at Day 28, irrespective of axillary temperature(AT), participants ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 28 | ACPR: absence of parasitemia at Day 28, irrespective of AT, in participants not meeting any criteria of ETF: DS/SoC/SM at Day 1, 2 or 3 in presenc... | Artefenomel, Ferroquine, Antimalarials, Antiprotozoal Agents, Antiparasitic Agents, Anti-Infective Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferroquine 400 milligram (mg)<br>On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition. | Drug: Ferroquine (SSR97193)<br>* Pharmaceutical form: Capsule Route of administration: Oral<br... | Study to Investigate the Clinical and Parasiticidal Activity and Pharmacokinetics of Different Doses of Artefenomel and Ferroquine in Patients With Uncomplicated Plasmodium Falciparum Malaria
Study Overview
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Brief Summary
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Primary Objective: To show the contribution of artefenomel (OZ... | |
NCT02731014 | Dry Needling for Patients With Neck Pain | The aim of this trial will be to examine the short and long term effectiveness of dry needling on pain, disability, and patient perceived improvements in patients with neck pain attending physical therapy. The investigators hypothesize that patients who receive dry needling, manual therapy, and exercise will achieve gr... | Background: Neck pain is a costly and common problem. Current treatments are not adequately effective for a large proportion of patients who continue to experience recurrent pain. Therefore, new treatment strategies should be investigated in an attempt to reduce the disability and high costs associated with neck pain.~... | Dry Needling for Patients With Neck Pain: A Randomized Clinical Trial | Neck Pain | * Other: Dry Needling
* Other: Sham Dry Needling
* Other: Manual Therapy
* Other: Exercise
| Inclusion Criteria:~Age between >18 years old~Primary complaint of neck pain~Neck Disability Index > 10 points=20%~Exclusion Criteria:~Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, Rheumatoid Arthritis, osteoporosis, prolonged history of steroid use, sy... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on the Neck Disability Index (NDI) | The Neck Disability Index (NDI) was created to measure pain related disability associated with activities of daily living in people with neck pain. The NDI contains ten focused sections... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on The Global Rating Of Change Scale (GROC) | The GROC is a 15-point scale used to quantify a patient's improvement with treatment or to record the clinical course of a condition over time. Patients are asked to describe t... | Dry Needling | Neck Pain, Pain, Neurologic Manifestations | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dry Needling Group<br>Dry Needling, Manual Therapy, and Exercise. | Other: Dry Needling<br>* Dry Needling targeting the posterior musculature of the cervical and thoracic spine.<br>Other: Manual Therapy<br>* Manual Therapy(mobilization/ ma... | Dry Needling for Patients With Neck Pain
Study Overview
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Brief Summary
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The aim of this trial will be to examine the short and long term effectiveness of dry needling on pain, disability, and patient perceived improvements in patients with neck pain attending physical therapy. The inv... |
NCT05375942 | This is a Retrospective Observational Study Looking at the Characteristics and Outcomes of Participants Taking Inflectra Using the CorEvitas Rheumatoid Arthritis Registry | This is a retrospective observational study looking at the characteristics and outcomes of participants taking Inflectra using the CorEvitas Rheumatoid Arthritis Registry. | Characteristics and 6-month Outcomes Among Real-World Rheumatoid Arthritis Patients Initiating Inflectra | Arthritis, Rheumatoid | * Drug: Inflectra
* Drug: Inflectra
| Inclusion Criteria:~Be at least 18 years of age~Have been diagnosed with RA by a rheumatologist~Have initiated treatment with Inflectra~Had assessment of effectiveness in patients who have at least one follow up visit.~Exclusion Criteria:~No additional exclusion criteria | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving Low Disease Activity (LDA) | Response is defined as the achievement of LDA (CDAI≤10) among patients with moderate or high disease activity (CDAI>10).~CDAI = Clinical Disease Activity Index (Physician Global... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving clinical remission | Clinical remission is defined as CDAI ≤ 2.8~Rate of response at follow up visit-achievement of remission (CDAI≤2.8) among patients with LDA, moderate, or high disease activity (CDAI>2.8... | Infliximab, Tumor Necrosis Factor Inhibitors, Anti-Inflammatory Agents, Dermatologic Agents, Gastrointestinal Agents, Antirheumatic Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| characteristics of patients newly initiated on Inflectra<br> | Drug: Inflectra<br>* 1. To describe the characteristics of patients newly initiated on Inflectra.<br>|
| outcomes after initiating Inflectra<br> | Drug: Inflectra<br>* 2. To describe 6-month... | This is a Retrospective Observational Study Looking at the Characteristics and Outcomes of Participants Taking Inflectra Using the CorEvitas Rheumatoid Arthritis Registry
Study Overview
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Brief Summary
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This is a retrospective observational study looking at the characteristics and outc... | |||
NCT05577702 | Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer | This is a randomized, open-label, multicenter, Phase 2, umbrella study to evaluate the preliminary efficacy, safety, and pharmacodynamics of tislelizumab as monotherapy and in combination with investigational agents as neoadjuvant treatment in Chinese participants with resectable Stage II to IIIA non-small cell lung ca... | A Randomized, Open-Label, Multicenter, Phase 2, Umbrella Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations With and Without Chemotherapy as Neoadjuvant Treatment in Chinese Patients With Resectable Stage II to ... | Non Small Cell Lung Cancer | * Drug: Tislelizumab
* Drug: Ociperlimab
* Drug: LBL-007
* Drug: Cisplatin
* Drug: Carboplatin
* Drug: Pemetrexed
* Drug: Paclitaxel
| Inclusion Criteria:~Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1~Histologically confirmed Stage II-IIIA NSCLC (per the Eighth American Joint Committee on Cancer/Union Internationale Contre le Cancer [NSCLC] staging system)~Evaluation by an attending thoracic surgeon to confirm eligibility f... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Pathological Response (MPR) | MPR is defined as the proportion of participants with ≤ 10% residual viable tumor in the resected primary tumor and all resected lymph nodes as assessed by blinded independent pathology review (BIPR) | Up to... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological complete response (pCR) | pCR is defined as the proportion of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes as assessed by the BIPR | Up to approximately 18 weeks after firs... | Paclitaxel, Carboplatin, Pemetrexed, Tislelizumab, Antineoplastic Agents, Phytogenic, Antineoplastic Agents, Tubulin Modulators, Antimitotic Agents, Mitosis Modulators, Molecular Mechanisms of Pharmacological Action, Enzyme Inhibitors, Folic Acid Antagonists, Nucleic Acid Synthesis Inhibitors, Antineoplastic Agents, Im... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1A: Tislelizumab Monotherapy<br>Tislelizumab on a 3-week cycle for 2 to 4 cycles, followed by surgical resection (each cycle is 21 days) | Drug: Tislelizumab<br>* Administered as an intravenous infusion<br>* Other names: Tevimbra;|
| E... | Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer
Study Overview
=================
Brief Summary
-----------------
This is a randomized, open-label, multicenter, Phase 2, umbrella stud... | ||
NCT02730754 | Emotional Disorders and Outcomes in Adults With Type 2 Diabetes Mellitus at Primary Care | This study aims to determine which factors are related to change in diabetes-related distress and change in depressive symptoms after three years of follow-up in Asian adults with type 2 diabetes mellitus in primary care. The investigators will explore the impact of patient demographics, cardiometabolic control, medica... | Patients with type 2 diabetes mellitus (T2DM) have been shown to experience psychological burden and distorted illness perception. These psychological burden include feeling of burned-out, fatigue, distress and depression, and in addition of distorted illness perception often lead to difficulty in coping with the deman... | Relationship Between Emotional Disorders (Diabetes Distress and Depression) and Outcomes (Self-care and Clinical) in Adults With Type 2 Diabetes Mellitus in Primary Care: A Retrospective Cohort Study | Type 2 Diabetes Mellitus | Inclusion Criteria:~Those who participated in the EDDMQoL study~Adults aged at least 30 year-old~Diagnosed of T2DM more than three years ago~On regular follow-up with at least three visits in the previous year~Exclusion Criteria:~Patients who are pregnant or lactating~Having psychiatric/psychological disorders that cou... | 30 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes-related distress measured with Diabetes Distress Scale-17 | Change in diabetes-related distress | Baseline and 3 year |
| Depressive symptoms measured with Patient Health Questionnaire-9 | Change in depressive symptoms | Baseline and... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes-related distress and depression combined | Change in both diabetes-related distress and depressive symptoms combined | Baseline and 3 year |
| Illness perceptions measured with Brief Illness Perception Questionnaire | Cross-sectional... | Mood Disorders, Illness Perception, Primary Care, Medication Adherence | Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases | Emotional Disorders and Outcomes in Adults With Type 2 Diabetes Mellitus at Primary Care
Study Overview
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Brief Summary
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This study aims to determine which factors are related to change in diabetes-related distress and change in depressive symptoms after three years of follow-up in Asi... | |||
NCT04784754 | Dose-Ranging Study to Assess the Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19 | A pilot placebo-controlled randomized double-blind trial of Melatonin in outpatients with COVID-19 infection to evaluate Safety, Efficacy and Dose-ranging. | Studies have shown in the blood of patients with COVID-19 there was a marked increase in the cytokines and chemokines interleukin 1β (IL-1β), interferon-γ (IFN-γ), interferon-inducible protein 10 (IP-10), monocyte chemoattractant protein 1 (MCP-1) and interleukin-4 (IL-4). Consequently, treatments that reduce cytokine/... | A Pilot Placebo-controlled Randomized Double-blind Trial of Melatonin in Outpatients With COVID-19 Infection | COVID-19 | * Drug: Melatonin
* Drug: Placebo
| Inclusion Criteria:~Male or non-pregnant female adult ≥18 years of age at time of enrollment.~Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study.~Positive testing for COVID-19 infection by standard RT-PCR assay or equivalent test.~Meets criteria fo... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Placebo-controlled randomized double-blind trial
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Incidence of Treatment-Emergent Adverse Events | Evaluate the incidence of serious adverse effects and discontinuation secondary to toxicity through 42 days of follow-up as compared to the control arm as assessed by: Cumulative inci... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of COVID-19 related hospitalization | Incidence of COVID-19 related hospitalization at 42 days | 42 days |
| COVID-19 related symptoms | COVID-19 related symptoms as self-reported and on interview. | 42 days |
| Rate of resolution ... | Melatonin, COVID-19, outpatient, SARS-CoV-2 | Melatonin, Antioxidants, Molecular Mechanisms of Pharmacological Action, Protective Agents, Physiological Effects of Drugs, Central Nervous System Depressants | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo capsules will be prepared using hypromellose capsules, filled using microcrystalline cellulose. This is the same excipient used in the preparation of the interventional drug. Placebo will be administered orally thr... | Dose-Ranging Study to Assess the Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19
Study Overview
=================
Brief Summary
-----------------
A pilot placebo-controlled randomized double-blind trial of Melatonin in outpatients with COVID-19 infection to evaluate Safety, Efficacy and Dose-ran... |
NCT01243372 | Biomarkers in Predicting Response to Cetuximab in Patients With Advanced Colorectal Cancer | RATIONALE: Studying samples of tissue in the laboratory from patients who received cetuximab may help doctors understand and predict how well patients will respond to treatment.~PURPOSE: This research study is studying biomarkers in predicting response to cetuximab in patients with advanced colorectal cancer. | OBJECTIVES:~Primary~To determine, among patients with advanced CRC, whether the effect of treatment (cetuximab vs bevacizumab) on progression-free survival (PFS) depends on tumor BRAF V600E mutational status.~Secondary~To study the relationships between tumor BRAF V600E mutational status, OS, and tumor response.~OUTLIN... | Evaluating BRAF Mutations as Predictors of Efficacy in Cetuximab-Treated Colorectal Cancer Patients: A Retrospective Study of Tissues From CALGB / SWOG | Colorectal Cancer | * Genetic: mutation analysis
* Other: laboratory biomarker analysis
| DISEASE CHARACTERISTICS:~Participation in CALGB-C80405~Have KRAS WT or KRAS mut tumor~Randomized to treatment with either bevacizumab or cetuximab alone~Patients randomized to the combination therapy are not eligible~Available specimens at the PCO for BRAF mutation detection~Patient consent for use of samples | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival as measured by RECIST | | Up to 36 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | | Up to 36 months |
| tumor response as measured by RECIST | | Up to 36 months |
| recurrent colon cancer, stage IIIA colon cancer, stage IIIB colon cancer, stage IIIC colon cancer, stage IVA colon cancer, stage IVB colon cancer, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer | Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Intestinal Diseases, Rectal Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Correlative (BRAF V600E mutation analysis)<br>Previously collected formalin-fixed and paraffin-embedded baseline tumor samples are analyzed for BRAF V600E mutation. Mutation status is correlated with clinical response and outcome data from patients enro... | Biomarkers in Predicting Response to Cetuximab in Patients With Advanced Colorectal Cancer
Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tissue in the laboratory from patients who received cetuximab may help doctors understand and predict how well patients will respond... | |
NCT05372276 | Comparison of Mental Skills of Professional Esports Players With Different Levels of Physical Activity | Competitive video games, defined as esports, have been increasing in popularity especially in the last ten years.~In this study, our primary aim is; to compare the mental abilities of professional esport players with different physical activity levels. | Competitive video games, defined as esports, have been increasing in popularity especially in the last ten years.~In this study, our primary aim is; to compare the mental abilities of professional esport players with different physical activity levels.~The second aim of our study is; to reveal information about the phy... | A Comparison of Mental Toughness and Mental Imagination Skills of Professional Esports Players With Different Levels of Physical Activity | Healthy, Physical Inactivity | * Other: Assessment 1
* Other: Assessment 2
* Other: Assessment 3
* Other: Assessment 4
| Inclusion Criteria:~Beingover 18 years old~Being a professional esports player~Being contracted with an esports club~Esports branch includes games played on a computer platform, in sitting position, using mouse, keyboard and monitor.~Volunteering for the study~Exclusion Criteria:~Sports branches in which different equi... | 18 Years | null | All | null | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The International Physical Activity Questionnaires (IPAQ) | The short form of the International Physical Activity Questionnaire (UFAA) will be used to determine the physical activity levels of the participants. The UFAA-Short Form is a valid t... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental Toughness Questionnaire in Sports | The mental toughness parameters of the participants will be evaluated face-to-face with the Mental Toughness Questionnaire in Sports. It was developed by Sheard, Golby and Van Wersch in 2009. It is a ... | esport, physical activity, mental toughness, mental imaginery | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inactive<br>The score obtained by multiplying the duration, frequency and MET values of the physical activities in which the participants participated in 7 days and for at least 10 minutes is <600 MET - min/week.~After the participants are divided into ... | Comparison of Mental Skills of Professional Esports Players With Different Levels of Physical Activity
Study Overview
=================
Brief Summary
-----------------
Competitive video games, defined as esports, have been increasing in popularity especially in the last ten years. In this study, our primary aim is; to... | ||
NCT01763073 | Beliefs and Practice Intentions of Future Ob/Gyn Residents Regarding Reproductive Healthcare | The objective of this study is to ascertain factors shaping medical students' pre-residency intention to provide abortion through an in-depth qualitative investigation into the context and experiences that shape intention to provide. | Beliefs and Practice Intentions of Future Ob/Gyn Residents Regarding Reproductive Healthcare | Focus: Pre-residency Intention to Provide Abortion | Inclusion Criteria:~current 4th-year medical student~US accredited medical school~has applied to, but not yet been accepted into, obstetrics and gynecology residency programs~Exclusion Criteria:~age less than 18 years~former student reapplying to residency (e.g., not current 4th-year student)~has not yet applied to res... | 18 Years | null | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors affecting pre-residency intention to provide abortion | Factors will be identified by systematically coding qualitative data using a combination of deductive and inductive analytical strategies. | Up to 15 months. Each participant will... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Medical Students<br>Fourth-year students in accredited US medical schools who have applied to, but not yet been matched with, residency programs in obstetrics and gynecology. | |
| Beliefs and Practice Intentions of Future Ob/Gyn Residents Regarding Reproductive Healthcare
Study Overview
=================
Brief Summary
-----------------
The objective of this study is to ascertain factors shaping medical students' pre-residency intention to provide abortion through an in-depth qualitative investi... | ||||||
NCT00970840 | Acceptability of Lipid-Based Nutrient Supplements (LNS) for Women and Infants | Inadequate micronutrient intakes during pregnancy, lactation and infancy remain a major problem in Ghana. Lipid-based nutrient supplements (LNS) made using vegetable oil, groundnut paste, milk, sugar, and micronutrients may offer a solution.~The proposed study will test the acceptability of a lipid-based nutrient suppl... | This study is a taste test to confirm the acceptability of lipid-based nutrient supplements (LNS), which are semi-solid pastes comprising groundnut paste, milk, sugar, vegetable oil and micronutrients, for home fortification of foods consumed by infants and by pregnant and lactating women. Two types of supplements will... | Acceptability of Lipid-based Nutrient Supplements (LNS) for Women and Infants | Anemia, Malnutrition | * Dietary Supplement: LNS-20gM or LNS-P&L
| Inclusion Criteria (infants):~6-12 months of age~currently receiving breast milk~has been consuming complementary foods for at least 30 days~Inclusion Criteria (women):~being ≥ 18 years of age~confirmed to be pregnant or breastfeeding~Exclusion Criteria:~intolerance to milk or peanut~illness requiring referral | 6 Months | null | All | Accepts Healthy Volunteers | Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of test-meal consumed | | One day |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of liking for appearance, aroma, flavor and consistency of LNS product mixed with koko | | 14 days |
| Amount of LNS consumed during the 14-day study period | | 14 days |
| Acceptability, Supplements, Home-fortification | Malnutrition, Nutrition Disorders | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LNS-20gM or LNS-P&L<br> | Dietary Supplement: LNS-20gM or LNS-P&L<br>* Participants consumed a test meal (45 g or 50 g) consisting of LNS-20gM or LNS-P&L mixed with fermented maize porridge, after which they were provided with the respecti... | Acceptability of Lipid-Based Nutrient Supplements (LNS) for Women and Infants
Study Overview
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Brief Summary
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Inadequate micronutrient intakes during pregnancy, lactation and infancy remain a major problem in Ghana. Lipid-based nutrient supplements (LNS) made using vegetable oil, groun... |
NCT01077661 | Regulatory Nebilet PMS | An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and effectiveness of Nebivolol administered in Korean patients according to the prescribing information | An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and effectiveness of Nebivolol administered in Korean patients according to the prescribing information~Nebivolol will be administered to Hypertension or Chronic heart failure (CHF) patients as described the prescrib... | An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of Nebilet Administered in Korean Patients According to the Prescribing Information | Hypertension, Heart Failure | * Drug: Nebivolol
| All subjects must satisfy the following criteria at PMS entry according to KFDA PMS regulation:~Subjects with indication in the prescribing information~Subjects administrated Nebivolol by physician's decision~Subjects with no contraindication according to the prescribing information | null | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events after Nebivolol administration | | 3months, 6months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of unexpected or serious adverse event after Nebivolol administration and effectiveness of Occurrence of unexpected or serious adverse event after Nebivolol administration and effectiveness of Nebivolol | | 3 months, 6months |
| Nebivolol, PMS (post-marketing surveillance) | Nebivolol, Antihypertensive Agents, Vasodilator Agents, Adrenergic beta-1 Receptor Agonists, Adrenergic beta-Agonists, Adrenergic Agonists, Adrenergic Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients administrated Nebivolol<br>There is only one group. This group includes patients administrated Nebivolol | Drug: Nebivolol<br>* patients administrated Nebivolol according to the prescribing information<br>|
| Regulatory Nebilet PMS
Study Overview
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Brief Summary
-----------------
An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and effectiveness of Nebivolol administered in Korean patients according to the prescribing information
Detailed Description
-... | |
NCT03007485 | Telehealth Pulmonary Rehabilitation for Hispanic and African-American Patients Admitted With Exacerbation of COPD | Chronic Obstructive Pulmonary Disease (COPD), also known as emphysema, is the leading cause of hospitalization for older adults in the U.S., and a leading cause of death. Although there is no cure for COPD, a program called pulmonary rehabilitation (PR), which combines exercise and education, can help decrease re-hospi... | Telehealth-delivered PR has been shown to be as effective as standard PR (patients go to an outpatient setting) at improving quality of life, and patients' exercise capacity. However, this has not been studied in the Latino and African-American population and it is not known how effective telehealth PR will be among th... | A Comprehensive Disease Management Program to Improve Quality of Life in Disparity Hispanic and African-American Patients Admitted With Exacerbation of Chronic Pulmonary Diseases | COPD Exacerbation | * Other: Telehealth Pulmonary Rehabilitation
| Inclusion Criteria:~Adult patients with a diagnosis of COPD (defined by one pulmonary function tests (PFT) and who have not done pulmonary rehabilitation within the past 1 year and~Hispanic or African-American (as defined by the patient him/herself).~Exclusion Criteria:~individuals who completed PR in the past year or~... | 18 Years | null | All | No | Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge | The investigators will analyze the change in the rate of patients' rehospitalizations following completion of pulmonary rehabilitation (PR). COPD Hospital Readmission w... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Capacity Before and After Pulmonary Rehabilitation 6-minute Walk Test (SPR) Tested in Meters) Between Day 1 and 8-weeks | The investigators will analyze the change in patients' functional capacity, as measured prior to beginning PR ... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Standard pulmonary rehabilitation | |
| Experimental: Intervention<br>Telehealth delivered pulmonary rehabilitation | Other: Telehealth Pulmonary Rehabilitation<br>* Exercise bikes equipped with software that enables... | Telehealth Pulmonary Rehabilitation for Hispanic and African-American Patients Admitted With Exacerbation of COPD
Study Overview
=================
Brief Summary
-----------------
Chronic Obstructive Pulmonary Disease (COPD), also known as emphysema, is the leading cause of hospitalization for older adults in the U.S.,... | ||
NCT01893541 | PROPRANOLOL PLUS LIGATION REDUCES RECURRENCE OF ESOPHAGEAL VARICES? | This prospective randomized controlled trial will compare endoscopic band ligation (EBL) with propranolol and EBL alone in primary prophylaxis of variceal bleeding among cirrhotic patients with high-risk varices. | BACKGROUND AND AIMS~Bleeding from esophagogastric varices (EV) is a major complication of portal hypertension. Beta-blockers are a well-established cornerstone of portal hypertension treatment. Band ligation is the best endoscopic treatment to prevent EV bleeding. The exact benefit of beta-blocker association to band l... | PROPRANOLOL ASSOCIATED WITH ENDOSCOPIC BAND LIGATION REDUCES RECURRENCE OF ESOPHAGEAL VARICES FOR PRIMARY PROPHYLAXIS OF VARICEAL BLEEDING?: A RANDOMIZED CONTROLLED TRIAL | CIRRHOSIS, ESOPHAGEAL VARICES | * Procedure: ENDOSCOPIC BAND LIGATION
* Drug: PROPRANOLOL
* Device: a multiband ligation device
| Inclusion Criteria:~Liver cirrhosis with esophageal varices~Age between 18 and 78 years~Accept to participate~Exclusion Criteria:~Portal hypertension by schistosomiasis~Contraindications for propranolol use~Do not accept to participate | 18 Years | 78 Years | All | No | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome of this study will be esophageal varices recurrence | Esophageal varices recurrence will be defined as the reappearance of uninterrupted EV of any caliber, with or without red color signs in patients in which varices had be... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcomes of this study will be variceal eradication, bleeding before eradication, mortality and complications. | Esophageal varices eradication will be defined as absence of varices in the lower third of the esophagus Bleeding be... | CIRRHOTIC, VARICEAL BLEEDING, PRIMARY PROPHYLAXIS | Propranolol, Adrenergic beta-Antagonists, Adrenergic Antagonists, Adrenergic Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs, Anti-Arrhythmia Agents, Antihypertensive Agents, Vasodilator Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EBL PLUS PROPRANOLOL<br>The EBL procedures will be performed using standard technique with a multiband ligation device. Elastic bands will be placed according to physician decision, starting at esophagogastric junction. Endoscopic ban... | PROPRANOLOL PLUS LIGATION REDUCES RECURRENCE OF ESOPHAGEAL VARICES?
Study Overview
=================
Brief Summary
-----------------
This prospective randomized controlled trial will compare endoscopic band ligation (EBL) with propranolol and EBL alone in primary prophylaxis of variceal bleeding among cirrhotic patien... |
NCT05517226 | Pharmacokinetics of Cotadutide in Participants With Hepatic Impairment | This study will assess the pharmacokinetics (PK), safety, and tolerability of a single subcutaneous injection of cotadutide in participants with mild, moderate or severe hepatic impairment compared to participants with normal hepatic function. | This study will consist of four cohorts (Cohort 1, Cohort 2, Cohort 3, and Cohort 4).~Participants will be assigned to each of the cohorts as per Child-Pugh classification:~Cohort 1: Mild hepatic impairment (Child-Pugh A), cotadutide 50 μg~Cohort 2: Moderate hepatic impairment (Child-Pugh B), cotadutide 50 μg~Cohort 3:... | A Phase I, Parallel-group, Multi-center, Open-label, Investigation of the Pharmacokinetics, Safety and Tolerability of a Single Subcutaneous Injection of Cotadutide in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Participants With Normal Hepatic Function | Hepatic Impairment | * Combination Product: Cotadutide
| Inclusion Criteria:~Participant must be ≥ 18 to ≤ 85 years of age at the time of signing the Informed Consent Form (ICF).~Body mass index ≥ 18 kg/m2 to < 40 kg/m2.~Female participants of childbearing potential must use at least one highly effective form of birth control.~Capable of giving signed informed consent.~Parti... | 18 Years | 85 Years | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma (peak) drug concentration [Cmax] | The Cmax of a single dose of cotadutide in participants with mild, moderate, or severe hepatic impairment compared to those with normal hepatic function will be assessed. | Day 1 to Da... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events (AEs) | The safety, and tolerability of a single dose of cotadutide in participants with hepatic impairment will be assessed. | From time of first dose to the final follow-up visit (Day 29) |
| Incid... | Cotadutide, Hepatic impairment | Liver Diseases, Digestive System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Participants in each cohort will receive Dose A cotadutide subcutaneously. | Combination Product: Cotadutide<br>* Participants will receive cotadutide subcutaneously.<br>|
| Experimental: Cohort 2<br>Participants in each cohort... | Pharmacokinetics of Cotadutide in Participants With Hepatic Impairment
Study Overview
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Brief Summary
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This study will assess the pharmacokinetics (PK), safety, and tolerability of a single subcutaneous injection of cotadutide in participants with mild, moderate or severe hepatic impai... |
NCT04226313 | Self-sampling for Non-attenders to Cervical Cancer Screening | The trial will evaluate whether self-sampling and human papillomavirus (HPV) testing may increase cervical cancer screening attendance among under-screened women in Czech Republic. Different ways of offering self-sampling device will be evaluated. | Despite the existence of an effective cervical cancer screening in the Czech Republic, cervical cancer is the cause of about 800 new cases and 400 deaths every year. One of the major problem of the Czech cervical cancer screening is low participation. An effective strategy to increase cervical cancer screening attendan... | Cervical Cancer Prevention Using Self-sampling and Human Papillomavirus Detection | Cervical Cancer, Cervical Dysplasia, Human Papillomavirus Infection | * Diagnostic Test: Self-sampling by Evalyn Brush
* Diagnostic Test: Self sampling by Evalyn Brush home or in GP´s clinic
| Inclusion Criteria:~Women with age 30-65 years; for arm A women > 65 years are allowed~Women live in the Czech Republic.~Women who have not participate in cervical cancer screening program in the Czech Republic for at least 3 years (Arm B and C).~Women with completed informed consent.~Women capable of self-sampling of ... | 30 Years | 65 Years | Female | Accepts Healthy Volunteers | Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening participation | Comparison of the percentages of women who return a cervicovaginal swab sampled by self-sampling device in different arms of the study. Identification of the best approach to address women who do not participate in st... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociodemographic characteristics | Comparison the distribution of sociodemographic characteristics (education, age, place of residence) and reasons for previous non-attendance for screening by intervention and attendance status in women who re... | human papillomavirus, HPV, self-sampling, cervicovaginal swab, cervical cancer screening, non-attendance | Papillomavirus Infections, Uterine Cervical Neoplasms, Uterine Cervical Dysplasia, Uterine Neoplasms, Genital Neoplasms, Female, Urogenital Neoplasms, Neoplasms by Site, Neoplasms, Uterine Cervical Diseases, Uterine Diseases, Genital Diseases, Female, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self-sampling device sent at home<br>Women randomly selected from a commercial vendor database (both attenders and non-attenders) receive a mail inviting them to perform a cervicovaginal self-sampling at their home (with the device pr... | Self-sampling for Non-attenders to Cervical Cancer Screening
Study Overview
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Brief Summary
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The trial will evaluate whether self-sampling and human papillomavirus (HPV) testing may increase cervical cancer screening attendance among under-screened women in Czech Republic. Different wa... |
NCT04280796 | Changes in Affective Pain Processing in Human Volunteers | The experience of pain is more than the conscious perception of nociceptive signals. Emotional and motivational aspects accompany pain, leading to its aversiveness and motivation for avoidance. In chronic pain, a negative hedonic shift has been proposed that is characterized by disproportionally increased emotional-mot... | The experience of pain is more than the conscious perception of nociceptive signals. Emotional and motivational aspects accompany pain, leading to its aversiveness and motivation for avoidance. In chronic pain, a negative hedonic shift has been proposed that is characterized by disproportionally increased emotional-mot... | Mechanisms of Emotional-motivational Pain Processing in Health and Disease | Pain, Acute, Pain, Chronic, Low Back Pain | * Behavioral: psychophysical tasks
* Behavioral: cognitive task
| For Healthy participants~Inclusion Criteria:~good overall health status~sufficient knowledge of German or English to follow instructions~ability to give written informed consent~Exclusion Criteria:~pain longer than >3 consecutive days and on more than 30 days within the last 12 months~major psychiatric or neurological ... | 18 Years | 60 Years | All | Accepts Healthy Volunteers | Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Study comprises an intervention that is neither a therapeutic or transplant product nor a transplant. Study involves minimal risks for participants. Used methods are within the range of stand... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ratio of sensory to emotional pain responses | Ratio of the number of correct responses (%) in a task assessing sensory-discriminative pain responses to number of correct responses (%) in a task assessing emotional-motivational pain responses.... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reaction time (RT) | reaction times | during the procedure |
| pain threshold | Individual pain threshold assessed with experimental heat pain | baseline |
| pain tolerance | Individual pain tolerance assessed with experimental heat pain | b... | acute pain, chronic pain, low back pain, hedonic shift, emotional-motivation components of pain, sensory-discriminative components of pain, operant conditioning, metacognition | Back Pain, Low Back Pain, Acute Pain, Chronic Pain, Pain, Neurologic Manifestations | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Substudy 1<br>All participants will perform two psychophysical tasks to assess sensory-discriminative and emotional-motivational pain responses independently from each other. No arms will perform. In addition, in Substudy 1 an operant lear... | Changes in Affective Pain Processing in Human Volunteers
Study Overview
=================
Brief Summary
-----------------
The experience of pain is more than the conscious perception of nociceptive signals. Emotional and motivational aspects accompany pain, leading to its aversiveness and motivation for avoidance. In ... |
NCT03144284 | Assessment of Knowledge, Attitude, and Practice of Minimal Intervention Dentistry in a Group of Dental Interns | Minimal intervention dentistry (MID) is a modern medical approach that aims to maximize preservation of healthy dental tissues. When operative intervention is required it is as minimally invasive as possible. This study will assess the knowledge of a group of dental interns regarding minimal intervention dentistry in E... | Healthy oral tissues enable the child to eat, speak and socialize which contributes to general wellbeing. Dental caries during childhood is a major public health problem and throughout the 20th century, the dominant practice patterns of managing dental caries relied on the purely surgical approach of G.V Black such as ... | Assessment of Knowledge, Attitude, and Practice of Minimal Intervention Dentistry in a Group of Dental Interns in Egypt: A Cross-sectional Study | Pediatric Dentistry | * Other: Knowledge, attitude, and practice survey
| Inclusion Criteria:~Dental interns attending pediatric dentistry in the faculty of dentistry, Cairo University.~Exclusion Criteria:~Interns refusing to participate in the study. | null | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge, attitude and practice mean score | Scores will be calculated according to the options selected by dental interns. The primary outcome is the mean score of the knowledge, attitude and practice survey. | Through study completion, an a... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate | percentage of dental interns who agree to participate in the study. | Through study completion, an average of 1 year. |
| | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| dental interns<br>dental interns in pediatric dentistry department, faculty of dentistry, Cairo University. | Other: Knowledge, attitude, and practice survey<br>* A knowledge, attitude, and practice questionnaire is going to be distributed to dental int... | Assessment of Knowledge, Attitude, and Practice of Minimal Intervention Dentistry in a Group of Dental Interns
Study Overview
=================
Brief Summary
-----------------
Minimal intervention dentistry (MID) is a modern medical approach that aims to maximize preservation of healthy dental tissues. When operative ... | |||
NCT00236730 | A Study of the Efficacy and Safety of Topiramate in the Treatment of Patients With Difficult to Control Epilepsy | The purpose of the study is to evaluate the effectiveness and safety of topiramate as add-on therapy in patients with difficult to control partial onset seizures who are taking one or two standard anti-epileptic drugs. | Epilepsy is characterized by seizures, which are abnormal electrical discharges in the brain that temporarily disrupt normal brain function. Seizures are classified as generalized, originating in both sides of the brain simultaneously, or partial-onset, starting in one area of the brain. Antiepilepsy medications, such ... | Double-Blind Parallel Comparison of Three Doses of Topiramate and Placebo in Refractory Partial Epilepsy | Epilepsy, Epilepsies, Partial, Seizures | * Drug: topiramate
| Inclusion Criteria:~History of simple or complex partial epilepsy that has been documented or witnessed~during a 12-week baseline phase, patient must have at least 12 partial seizures while maintaining therapeutic levels of antiepileptic drugs (AEDs)~and have no more than one seizure-free interval of up to 3 weeks and ... | 18 Years | 65 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction in the average monthly seizure rate from baseline to end of treatment | | |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients responding to treatment (>= 50% reduction in seizure rate from baseline to end of treatment); patient's and investigator's global assessments at end of study; incidence of adverse events throughout study | | |
| topiramate, epilepsy, partial epilepsies, partial epilepsy, seizures, epileptic seizures, partial seizure disorder, brain diseases | Topiramate, Anticonvulsants, Hypoglycemic Agents, Physiological Effects of Drugs | | Intervention/Treatment |
| --- |
|Drug: topiramate|nan|
| A Study of the Efficacy and Safety of Topiramate in the Treatment of Patients With Difficult to Control Epilepsy
Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effectiveness and safety of topiramate as add-on therapy in patients with difficult to control pa... |
NCT00270127 | Epoetin Alfa for Anemia in Patients With Cancer Receiving Non-platinum Chemotherapy | The purpose of this study is to evaluate the effectiveness of epoetin alfa versus placebo in reducing or preventing the need for transfusions in anemic patients with non-myeloid cancer on non-platinum chemotherapy, and to investigate quality-of-life benefits associated with the use of epoetin alfa. Epoetin alfa is a ge... | Cancer patients often experience anemia due to the disease itself, chemotherapy, or both. Quality of life is also affected, due in part to the fatigue associated with anemia. Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level may improve quality of life and help patients live lon... | Double-Blind, Placebo-Controlled Study to Assess the Effect of Early Intervention and/or Treatment With Epoetin Alfa on Anemia in Cancer Patients Receiving Non-Platinum-Containing Chemotherapy | Anemia, Cancer, Neoplasm | * Drug: Epoetin alfa
| Inclusion Criteria:~Confirmed diagnosis of non-myeloid malignancy~undergoing treatment with non-platinum-containing chemotherapy, or non-platinum-containing chemotherapy is imminent~Eastern Cooperative Oncology Group (which is a scale used by researchers to represent the level of activity that a patient is capable of) ... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients transfused after one month | | |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in hemoglobin, hematocrit, and developing red blood cells from the start of the study until study completion; Changes in quality-of-life; Safety | | |
| Anemia, cancer, quality of life, chemotherapy, hemoglobin, transfusion, epoetin alfa, epoetin, erythropoietin | Epoetin Alfa, Hematinics | | Intervention/Treatment |
| --- |
|Drug: Epoetin alfa|nan|
| Epoetin Alfa for Anemia in Patients With Cancer Receiving Non-platinum Chemotherapy
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of epoetin alfa versus placebo in reducing or preventing the need for transfusions in anemic patients with non-... |
NCT00185991 | Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis | To compare once daily versus 8 hour dosing of gentamicin for the treatment of chorioamnionitis. | Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis | Chorioamnionitis | * Drug: gentamicin
| Inclusion Criteria:~- clinical diagnosis of chorioamnionitis~Exclusion Criteria:~- maternal renal disease, intrauterine fetal death, allergy to gentamicin | 18 Years | null | Female | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Afebrile at 24 hours and no endometritis | | 24 hours after delivery |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal outcomes | | Time of delivery to time of discharge |
| Gentamicins, Anti-Bacterial Agents, Anti-Infective Agents, Protein Synthesis Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Once daily Gentamicin<br> | Drug: gentamicin<br>* Daily gentamicin (5 mg/kg intravenously, then placebo doses IV after 8 and 16 hours).~Eight hour gentamicin (2 mg/kg intravenously, then 1.5 mg/kg IV after 8 and 16 hours).<br>|
| Acti... | Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis
Study Overview
=================
Brief Summary
-----------------
To compare once daily versus 8 hour dosing of gentamicin for the treatment of chorioamnionitis.
Official Title
-----------------
Comparison of ... | ||
NCT02876926 | Evaluating a Real-Time, Remote Monitoring System for Home-Based HIV Testing | This study explores whether offering follow-up counseling and referral over the phone after using a home-based HIV test increases rates of ever and repeat testing, compared with home-based testing with no follow-up (HBST alone) or mailing reminders for clinic-based testing. | Exploring Use of a Real-time, Remote Monitoring and Follow-up System for Home-based, HIV Self-testing Among High-risk Men Who Have Sex With Men (MSM) | HIV | * Behavioral: Smart home-based test for HIV
* Behavioral: Home-based testing only
* Behavioral: Reminder letters for clinic-based testing
| Inclusion Criteria:~Sex with a partner met online in the past year~Anal sex (either insertive or receptive) with a casual male partner in the past 6 months without using condoms or pre-exposure prophylaxis~Own a smartphone (iOS or Android) with a service contract and data plan~Have a stable address where mail can be re... | 18 Years | null | Male | Accepts Healthy Volunteers | Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Received HIV Testing | Count of the number of participants who reported receiving HIV testing. | Up to 28 weeks |
| Number of Participants Who Reported Having Been Referred for Pre-exposure Prophylaxis | Count of th... | HIV testing, Self-testing, Counseling, Referral | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced home-based testing<br>These participants will download a study-specific smartphone app (eTEST), and receive home-based HIV test kits in the mail every 3 months. These kits will have been fit with sensors that enable remote detecti... | Evaluating a Real-Time, Remote Monitoring System for Home-Based HIV Testing
Study Overview
=================
Brief Summary
-----------------
This study explores whether offering follow-up counseling and referral over the phone after using a home-based HIV test increases rates of ever and repeat testing, compared with ... | |||
NCT03644979 | Skydiving as a Model of Psychological Stress and Its Effect on Intestinal Barrier Function | In this study, it will be investigated how psychological stress evoked by skydiving affects the intestinal permeability in 20 healthy subjects. Participants attend two visits: 1) Skydiving visit, 2) Negative control visit. At all visits, saliva samples, blood samples, and faecal samples are collected, and the multi-sug... | Skydiving as a Model of Psychological Stress and Its Effect on Intestinal Barrier Function | Psychological Stress Due to Skydiving | * Other: Skydiving
| Inclusion Criteria:~Written informed consent prior to any study related procedures~Age > 18 till <50~Novice skydivers (first or second tandem jump)~Signed up for tandem skydive~Willing to abstain from probiotic products or medications known to alter gastrointestinal function throughout the study~Exclusion Criteria:~Abd... | 18 Years | 50 Years | All | Accepts Healthy Volunteers | Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 1) Skydiving visit, 2) Negative control visit
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in small intestinal permeability after skydiving measured as the urinary lactulose/rhamnose secretion ratio compared to negative control | | 2-4 weeks |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in whole gut permeability after skydiving measured as the urinary sucralose/erythritol secretion ratio compared to negative control | | 2-4 weeks |
| Change in colonic permeability after skydiving measured as the urinary sucralose/ery... | Stress, Psychological, Behavioral Symptoms | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skydiving<br>Tandem skydiving | Other: Skydiving<br>* Tandem skydiving (with an experienced instructor)<br>|
| No Intervention: Negative control<br>No skydiving | |
| Skydiving as a Model of Psychological Stress and Its Effect on Intestinal Barrier Function
Study Overview
=================
Brief Summary
-----------------
In this study, it will be investigated how psychological stress evoked by skydiving affects the intestinal permeability in 20 healthy subjects. Participants attend... | ||
NCT02206698 | Pediatric Blunt Abdominal Trauma Clinical Prediction Model | The submitted proposal is designed to reduce morbidity and mortality to injured children. Significant variability in the initial trauma assessment exists among institutions. The proposed project is a prospective, observational, multi-institutional study of children following blunt abdominal trauma. The specific goals o... | The proposed research project is a prospective, observational study. Data will be collected from each institution and entered into a secure REDCap database. Two phases of data collection will occur: 1) patient demographics and specific clinical variables which may be associated with IAI which are available and recorded... | Multicenter, Prospective Development of a Clinical Prediction Model to Determine Which Children Can Safely Avoid Abdominal CT Scanning During the Initial Evaluation of Blunt Abdominal Trauma | Pediatric Abdominal Trauma | Inclusion Criteria:~Patients presenting as a Trauma system activation with suspicion for blunt abdominal trauma. (Fall >10 feet; Motor vehicle accident >40mph, pedestrian struck by auto, Motor vehicle crash with ejection or death in vehicle or rollover, assault, bicycle accident, ATV accident).~<16 years of age~The nee... | null | 15 Years | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-abdominal Injury (IAI) | Intra-abdominal injury (IAI) (presence of solid or hollow organ injury (spleen, liver, kidney, GI tract, adrenal, pancreas, intra-abdominal vascular structure, bladder, ureter, gallbladder, abdominal wall fascia)... | Pediatric trauma, Intraabdominal Injury, CT Abdomen and Pelvis, blunt abdominal injury, blunt trauma, clinical prediction model | Wounds and Injuries, Abdominal Injuries | Pediatric Blunt Abdominal Trauma Clinical Prediction Model
Study Overview
=================
Brief Summary
-----------------
The submitted proposal is designed to reduce morbidity and mortality to injured children. Significant variability in the initial trauma assessment exists among institutions. The proposed project ... | ||||
NCT05141552 | The Safety of Dapagliflozin in Hemodialysis Patients With Heart Failure | SGLT2 inhibitor is a new type of sugar-lowering medicine and is recommended to treat heart failure. eGFR lower than 30ml/min/1.73M2 is contraindication of SGLT2 inhibitor. Heart failure is one of the most frequency CVD events for hemodialysis patients. But hemodialysis patient is unable to be treated with SGLT2 inhibit... | Evaluate the safety of dapagliflozin in hemodialysis patients with heart failure is the main purpose of this study. and Estimate the change of NT-proBNP is the secondary purpose.~This is a randomized, control and open study.~The including criteria are 1. Understand the present study and sign informed consert 2. Age is ... | The Safety of Dapagliflozin in Hemodialysis Patients With Heart Failure | Hemodialysis Complication | * Drug: Dapagliflozin 10Mg Tab
| Inclusion Criteria:~Understand the present studyAgree and sign informed consert~Age is between 18 and 70 Men or women ≧18 years and <70 years of age at screening~Treated with maintenance blood purification 2 or 3 times blood purification treatments (including hemodialysis, hemofiltration, hemoperfusion) every week2 or ... | 18 Years | 70 Years | All | No | Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of patients with hypoglycemia or urinary tract infection | the number of patients with hypoglycemia or urinary tract infection | 12 weeks |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of NT-proBNP | Change of NT-proBNP | 12 weeks |
| Dapagliflozin, Sodium-Glucose Transporter 2 Inhibitors, Molecular Mechanisms of Pharmacological Action, Hypoglycemic Agents, Physiological Effects of Drugs | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dapa group<br>subjects will be treated with dapagliflozin (10mg per day) and standard anti-heart failure therapy (including RAS inhibitors, beta-blocker, Aldosterone inhibitors) | Drug: Dapagliflozin 10Mg Tab<br>* In both group, subjects k... | The Safety of Dapagliflozin in Hemodialysis Patients With Heart Failure
Study Overview
=================
Brief Summary
-----------------
SGLT2 inhibitor is a new type of sugar-lowering medicine and is recommended to treat heart failure. eGFR lower than 30ml/min/1.73M2 is contraindication of SGLT2 inhibitor. Heart fail... | |
NCT03147001 | Protein Ingestion Before Training Low | A randomized interventions study using a crossover design. Ten well trained triathletes or bikeriders will be included for to undergo two trail separated by about 3 weeks. The night before the trail each subject will performe a high intense interval trainings session on an ergometer bike. during the night an infusion o... | Nutritional Strategies for Optimizing Adaptations and Recovery Following Training 'Low'. | Protein Metabolism | * Other: Protein ingestion
* Other: Non-caloric placebo ingestion
| Inclusion Criteria:~Healthy well-trained triathletes or cyclists~VO2max > 55 ml O2/kg/min~Training and has been training more than 7 times a week the last 6 months.~Exclusion Criteria:~VO2max < 55 ml O2/kg/min~Has chronic disease~has incjected with tracer on a previous occasion. | 18 Years | 50 Years | Male | Accepts Healthy Volunteers | Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle protein fractional synthetic rate (FSR) | | FSR was measure over at time period of six hours |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tracer kinetics dilution model | A-V tracer dilution model was applied across the forearm. | six hours |
| Muscle signalling | Muscle signalling will be determined using western blotting in each muscle biopsy | Determined in biopsies sampled ... | Dietary protein, Endurance exercise | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protein ingestion<br>Subjects ingested protein drinks | Other: Protein ingestion<br>* A protein drink was ingested prior to the 90min bike ride in one of the completed trails (order randomised).<br>|
| Placebo Comparator: Placebo<br>Subjec... | Protein Ingestion Before Training Low
Study Overview
=================
Brief Summary
-----------------
A randomized interventions study using a crossover design. Ten well trained triathletes or bikeriders will be included for to undergo two trail separated by about 3 weeks. The night before the trail each subject will... | ||
NCT02612142 | Physical EXercise as an Adjunct Treatment for Depression | 35 participants diagnosed with major depressive disorder were randomized in 3 intervention groups: (1) aerobic exercise (AE) ; (2) placebo (stretching) exercise (ST); and (3) no intervention (control group; NI). The intervention length was 10 consecutive days. In groups 1 (aerobic exercise) and 2 (sham exercise), parti... | In the aerobic exercise (AE) group, the intervention consisted of 30 minutes of daily brisk walking or jogging. This was done individually and supervised. Participants who missed > 2 training sessions were considered as non-completers. Exercise intensity had to be maintained within 65%-75% of age-predicted maximal hear... | Efficacy of Exercise as an Adjunct Treatment for Clinically Depressed Inpatients During the Initial Stages of Antidepressant Therapy. | Major Depressive Disorder | * Behavioral: physical exercise
| Inclusion Criteria:~diagnosis of major depressive disorder (MDD)~antidepressant drug therapy initiated for less than 2 weeks~score of 29 or more on the Beck depression inventory~Exclusion Criteria:~medical contraindication for exercise practice~inability to understand written French~beta-blocking drugs or another forms... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score change on the 21-item Beck depression inventory (BDI-II). Each item has a set of severity-graded self-evaluative statements that are rated 0 (neutral) to 3 (maximum severity). | | Baseline and 10 days |
| Depressive Disorder, Depressive Disorder, Major, Mood Disorders, Mental Disorders | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aerobic exercise (AE)<br>Intervention type: Behavioral. Intervention name: Aerobic exercise Intervention description: 10 days of daily aerobic exercise (brisk walking, jogging); duration: 30 minutes per session; intensity: 65%-75% of age-p... | Physical EXercise as an Adjunct Treatment for Depression
Study Overview
=================
Brief Summary
-----------------
35 participants diagnosed with major depressive disorder were randomized in 3 intervention groups: (1) aerobic exercise (AE) ; (2) placebo (stretching) exercise (ST); and (3) no intervention (contr... | ||
NCT01249092 | Pentoxifylline for Primary Biliary Cirrhosis | Primary biliary cirrhosis (PBC) is cholestatic liver disease characterized by progressive destruction of small bile ducts within the liver that can lead to end stage liver disease and all its complications.~Although ursodeoxycholic acid (UDCA) is associated with increased survival in many patients with PBC, there is ab... | A Pilot Study of Pentoxifylline for the Treatment of Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | * Drug: Pentoxifylline
| Inclusion Criteria:~Male and female patients ages 18 to 76 years.~Established diagnosis of PBC based on at least three of the following criteria:~Detectable anti-mitochondrial antibodies (AMA)~Cholestatic biochemical pattern~Liver biopsy compatible with PBC~Appropriate exclusion of other liver diseases.~Therapy with UD... | 18 Years | 76 Years | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum Alkaline Phosphatase Levels. | Serum alkaline phosphatase levels at entry and at 6 months of therapy with PTX will be measured and compared. | 6 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum Concentration of Tissue Inhibitor Metalloproteinase 1 (TIMP-1) After PTX Therapy. | Serum concentration of tissue inhibitor metalloproteinase 1 (TIMP-1), a fibrosis biomarker of interest, will be measured and the change in seru... | biliary cirrhosis | Pentoxifylline, Phosphodiesterase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Platelet Aggregation Inhibitors, Radiation-Protective Agents, Protective Agents, Physiological Effects of Drugs, Vasodilator Agents, Free Radical Scavengers, Antioxidants | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pentoxifylline 400 mg TID<br>This study is an open label pilot with only one arm. | Drug: Pentoxifylline<br>* Patients will take 400mg of pentoxifylline three times daily for a total duration of 6 months.<br>|
| Pentoxifylline for Primary Biliary Cirrhosis
Study Overview
=================
Brief Summary
-----------------
Primary biliary cirrhosis (PBC) is cholestatic liver disease characterized by progressive destruction of small bile ducts within the liver that can lead to end stage liver disease and all its complications. Al... | |
NCT04544930 | Therapist-guided Internet Treatment for Hazardous and Harmful Alcohol Use. A Feasibility Study | The aim of the present study is to test the feasibility of therapist-guided Internet treatment for hazardous (risky) and harmful alcohol use among adults 18 years and older. The hypothesis is that the intervention is feasible and that it can help people change risky drinking habits at an early stage before developing i... | Background:~A significant proportion of people with substance abuse do not seek help for their problems and therefore do not receive the necessary help at an early stage. An important reason for this is the stigma associated with substance abuse. Therapist-guided Internet treatment has been developed and tested in rece... | Therapist-guided Internet Treatment for Hazardous and Harmful Alcohol Use. a Feasibility Study | Alcohol Abuse, Internet-Based Intervention | * Behavioral: therapist-guided
| Inclusion Criteria:~18 years or older~access to the Internet~interested in receiving Internet treatment for changing drinking habits~a score of 6 or higher for women and 8 or higher for men on the Alcohol Use Disorder Identification Test (AUDIT)~Exclusion Criteria:~diagnosed alcohol dependence or addiction to other dru... | 18 Years | null | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Alcohol Use Disorders Identification Test (AUDIT) | AUDIT is a screening instrument consisting of 10 questions designed to identify hazardous (risky) and harmful use of alcohol in adults. Based on the 10 questions, a score is calculated in... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Drug-Taking Confidence Questionnaire (DTCQ). | DTCQ measures the person's confidence in his or her abilities to cope in situations that are high-risk for substance use. The tool yields information about client strengths and needs in the ar... | Mental Disorders, Alcoholism, Alcohol-Related Disorders, Substance-Related Disorders, Chemically-Induced Disorders | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: therapist-guided<br>Therapist-guided Internet treatment based on cognitive behavior therapy (ICBT). | Behavioral: therapist-guided<br>* Therapist-guided Internet treatment comprises eight text modules on the Internet that include psychoedu... | Therapist-guided Internet Treatment for Hazardous and Harmful Alcohol Use. A Feasibility Study
Study Overview
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Brief Summary
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The aim of the present study is to test the feasibility of therapist-guided Internet treatment for hazardous (risky) and harmful alcohol use among adults 18 ye... | |
NCT04948970 | Steroid Panel for One-step Diagnosis of Adrenal Diseases | The aim of this study is to develop a one-step diagnostic method for adrenal diseases, Patients with adrenal diseases including non-functioning adrenal adenoma, adrenal Cushing's syndrome, primary aldosteronism, and pheochromocytoma will be recruited. Using mass spectrometry analysis based on a multisteroid panel, seru... | Adrenal diseases consist of heterogenous diseases. To differentiate various adrenal diseases, multiple steps of diagnostic tests are needed. In this study, the investigators aimed to develop a one-step diagnostic method to differentiate various adrenal diseases using multisteroid panel.~About 400 patients with adrenal ... | Development of New Technology for One-step Diagnosis of Adrenal Diseases Based on Adrenal Hormone Panel | Adrenal Disease | Inclusion Criteria:~Patients who are diagnosed with adrenal diseases~Exclusion Criteria:~Taking medications that can affect steroid metabolism~Major depression, chronic alcoholism~Suspected cancer metastasis to adrenal glands~Other acute stress conditions | 18 Years | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of multisteroid panel for differentiating adrenal diseases | Evaluate how accurately the developed multisteroid panel diagnoses adrenal disease by measuring sensitivity (%) and specificity (%) for diagnosis of Cushing's syn... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of each steroid component for differentiating adrenal diseases | Evaluate how accurately each component of the steroid panel differentiate adrenal diseases.~Sensitivity (%) and specificity (%) of each steroid measures for a... | Adrenal Gland Diseases, Endocrine System Diseases | Steroid Panel for One-step Diagnosis of Adrenal Diseases
Study Overview
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Brief Summary
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The aim of this study is to develop a one-step diagnostic method for adrenal diseases, Patients with adrenal diseases including non-functioning adrenal adenoma, adrenal Cushing's syndrome, primary ... | ||||
NCT02057068 | Improving Sleep in Veterans and Their CGs | This study addresses the neglected topic of sleep disturbance in older caregiving dyads-a topic that has important implications for the safety, health, functioning and quality of life of older Veterans living at home and being cared for by a family caregiver (CG). The purpose of the study was to develop and field test ... | Research Plan:~Sample. Veteran care receivers(CR s) or carepartners (CP) over the age of 60 who require assistance from a spousal or cohabitating caregiver (CG) and Veteran caregivers providing care for a cohabitating carepartner were recruited. Dyads underwent comprehensive baseline assessments consisting of in-person... | Improving Sleep In Veterans and Their Family Caregivers | Sleep Quality | * Behavioral: SLEEP-E Dyads Intervention
| Inclusion Criteria:~Care recipient must be age 60 and over and require assistance from the identified caregiver with more than one Activity of Daily Living or three or more Instrumental Activities of Daily Living,~have a life expectancy of greater than or equal to six (6) months,~have no plans for transitioning out of ... | 18 Years | null | All | Accepts Healthy Volunteers | Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Randomization to an immediate intervention group or a no-contact wait list control group. Following post intervention assessments the wait-list control group received the intervention.
Mas... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Sleep Quality | Pittsburgh Sleep Quality Index Scores (PSQI) The Pittsburgh Sleep Quality Index is a standardized and validated measure of subjective sleep quality and sleep disturbance. The inventory has 18-items. PSQI scores range... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Sleep Efficiency | Average sleep efficiency over 7 nights of actigraphic measurement . Sleep efficiency is calculated as the number of hours asleep divided by the number of hours in bed with the intention to sleep. | Baseline (T1) and Pos... | Caregivers, Telemedicine, Sleep Disorders, Meditation, Cognitive Behavioral Therapy, Activity Enhancement, Technology, Non-pharmacological sleep intervention | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SLEEP-E Dyads Intervention<br>SLEEP-E Dyads Six-Week Tele-Health Intervention~. Daily core video modules on sleep education, sleep hygiene and behavioral and environmental factors influencing sleep.~. Daily and on-demand video modules desi... | Improving Sleep in Veterans and Their CGs
Study Overview
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Brief Summary
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This study addresses the neglected topic of sleep disturbance in older caregiving dyads-a topic that has important implications for the safety, health, functioning and quality of life of older Veterans living at ... | |
NCT03654339 | Microsurgical vs Macro Surgical Approach for Grade II Gingival Recessions Employing Laterally Repositioned Flap | This study was conducted to assess the evaluation of micro and Macro surgical approach in the treatment of grade II gingival recessions using the laterally repositioned flap | In this study total, 30 patients were selected The patients initially received a comprehensive periodontal examination and complete plaque control program including oral hygiene to eliminate habits related to the aetiology of recession. Scaling, root planning and occlusal adjustments were done The patients were randoml... | Comparison of Conventional vs Microsurgical Method for Root Coverage by Lateral Displacement Flap | Gingival Recession, Localized | * Procedure: root coverage
| Inclusion Criteria:~Age 20-50 yrs~ClassII gingival recession~Vital teeth that were free from caries or inadequate restorations~Sufficient width of attached gingiva~Exclusion Criteria:~Any systemic diseases and smokers~ClassI,III&IV gingival recession~Abnormal frenal attachments~Interdental bone loss with tooth mobility | 20 Years | 50 Years | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The patients will be equally divided into two test groups. Group A and Group B after phase I therapy. the group A patients will be treated with laterally repositioned flap to obtain root coverage using microsurgical... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vertical depth of recession | The height of gingival recession: From cementoenamel junction to the free gingival margin. | Change in level of gingival margin from baseline to 6 months. |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| horizontal width of recession | The width of gingival recession: Horizontal dimension of gingival defect at the level of Cementoenamel junction.. | Change in horizontal dimension of gingival margin from baseline to 6 months. |
| Gingival Recession, Gingival Diseases, Periodontal Diseases, Mouth Diseases, Stomatognathic Diseases, Periodontal Atrophy | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Group A-15 patients were allocated to the microsurgical group for root coverage. following scaling and root planning, the laterally repositioned flap was done using the microsurgical approach~Group B-15 Patients were ... | Microsurgical vs Macro Surgical Approach for Grade II Gingival Recessions Employing Laterally Repositioned Flap
Study Overview
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Brief Summary
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This study was conducted to assess the evaluation of micro and Macro surgical approach in the treatment of grade II gingival recessions using ... | |
NCT05465863 | Humoral and Cellular İmmune Response to SARS-CoV-2 mRNA BNT162b2 Vaccine in Children With Chronic Kidney Diseases | Coronavirus 2019 (COVID-19) infection is associated with higher morbidity and mortality in adult patients on dialysis, and kidney transplant recipients (KTRs). Although children had lower morbidity and mortality, KTRs are more vulnerable than healthy children.~It has already known that the general immune responses to v... | This is a prospective, multicenter case-control study performed between September 2021 and March 2022 in the Pediatric Nephrology Units of IU- Cerrahpaşa School of Medicine, Memorial Hospital, Marmara University School of Medicine, IU- Istanbul School of Medicine, Medeniyet University School of Medicine, and Istinye Un... | Humoral and Cellular İmmune Response to SARS-CoV-2 mRNA BNT162b2 Vaccine in Pediatric Kidney Transplant Recipients Compared to Dialysis Patients and Healthy Children | Chronic Kidney Disease 5D, Chronic Kidney Disease 5T | * Biological: SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®)
| Inclusion Criteria:~12-21 year-old chronic kidney diseases and dialysis patients~Exclusion Criteria:~Patients with primary immune deficiencies and not vaccinated with SARS-CoV-2 mRNA BNT162b2 vaccine~Patients who did not completed 2 series of SARS-CoV-2 mRNA BNT162b2 vaccine | 12 Years | 19 Years | All | Accepts Healthy Volunteers | Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the antibody response following vaccination | Anti-SARS-CoV-2 IgG Quantification and Neutralisation test | one month after the second dose of the vaccine |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the cellular response following vaccination | Interferon Gamma Release Assay | one month after the second dose of the vaccine |
| children, chronic kidney disease, covid19, vaccination, antibody response | Kidney Diseases, Renal Insufficiency, Chronic, Urologic Diseases, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Male Urogenital Diseases, Renal Insufficiency, Chronic Disease, Disease Attributes, Pathologic Processes | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients<br> | Biological: SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®)<br>* When permitted by local guidelines, children and adolescents who were over 12 years old were notified of vaccine eligibility and encouraged to schedul... | Humoral and Cellular İmmune Response to SARS-CoV-2 mRNA BNT162b2 Vaccine in Children With Chronic Kidney Diseases
Study Overview
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Brief Summary
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Coronavirus 2019 (COVID-19) infection is associated with higher morbidity and mortality in adult patients on dialysis, and kidney transplant... |
NCT05697263 | The Impact of the Menstrual Cycle on Physical Exercise and Performance | The menstrual cycle implies a basic difference in the biology of women and men but the effect of the hormonal variation on training protocols and physical performance is still not fully understood. Despite no existing evidence, the advice to periodize exercise according to the menstrual cycle has been widely spread amo... | The Impact of the Menstrual Cycle on Physical Exercise and Performance | Women's Health, Menstrual Cycle, Exercise, Athletic Performance | * Other: Periodization of training
| Inclusion Criteria:~Women exercising at least 3-4 times a week on a high level~Regular menstrual cycle with 26-32 cycle days.~Fully healthy and be able to follow the training program.~Exclusion Criteria:~Hormonal contraceptive users,~Users of regular medication~Chronic disease~Past or present neurological disorder~Rece... | 18 Years | 35 Years | Female | Accepts Healthy Volunteers | Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in aerobic performance | Cosmeds K5 Wearable Metabolic System will be used for breath-by-breath gas exchange measurements. Change in VO2peak from baseline to end of study will be evaluated. | Change from baseline aerobic performance at ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle strength | A standardized isokinetic device (Biodex®, Corp, Shirley, NY, USA) will be used for measurements of maximal muscle torque (Nm) in the leg extensor muscles at 90 and 120 gr/sec (11). Change in muscle strength from ba... | Menstrual Cycle, Exercise, Women's Health, Athletic Performance | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Follicle phase based training<br>Follicular phase-based training five times a week during the follicular phase (the first two weeks of the menstrual cycle) and thereafter once a week for the rest of the cycle. | Other: Periodization of tra... | The Impact of the Menstrual Cycle on Physical Exercise and Performance
Study Overview
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Brief Summary
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The menstrual cycle implies a basic difference in the biology of women and men but the effect of the hormonal variation on training protocols and physical performance is still not ful... | ||
NCT01832168 | Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy | The purpose of this study is to determine whether the AmnioFix dehydrated human amniotic membrane is effective in protecting nerves in men receiving robotic assisted laparoscopic prostatectomies. | A Prospective Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy (RALP)- Effect on Nerve Protection. | Pudendal Nerve | * Procedure: Robotic Assisted Laparoscopic Prostatectomy
* Other: Application of Absorbable Hemostat
* Other: Application of dehydrated human amniotic membrane
| Inclusion Criteria:~Ages 45-70~Clinically localized prostate cancer with Gleason score 6 or 7~SHIM Score greater than or equal to 16 in the absence of medication~Feasibility to perform unilateral or bilateral nerve sparing RALP~Exclusion Criteria:~Clinically locally advanced cancer and/or with Gleason score 8 or 9.~Dif... | 45 Years | 70 Years | Male | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients achieving return to baseline Sexual Health Inventory for Men (SHIM) score in the AmnioFix group versus the Control group. | | 4 weeks |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to return of erectile function. | | Up to 6 months |
| Pain scores. | | 10 days, 4 weeks, 3 months, and 6 months |
| | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Robotic Assisted Laparoscopic Prostatectomy with application of absorbable hemostat. | Procedure: Robotic Assisted Laparoscopic Prostatectomy<br>* Robotic Assisted Laparoscopic Prostatectomy with nerve-sparing technique<br>Other: Appli... | Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy
Study Overview
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Brief Summary
-----------------
The purpose of this study is to determine whether the AmnioFix dehydrated human amniotic membrane is effective in protecting nerves in men receiving robotic ... | |||
NCT00305812 | Lenalidomide and Melphalan in Treating Patients With Previously Untreated Multiple Myeloma | RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing ... | OBJECTIVES:~Primary~Evaluate the tolerability of 2 different doses of lenalidomide when administered with melphalan in patients with previously untreated multiple myeloma who are not planning to undergo future autologous stem cell transplantation.~Secondary~Characterize the toxicity profile of lenalidomide in combinati... | A Randomized Phase II Dose Finding Study of Revlimid™ and Melphalan in Patients With Previously Untreated Multiple Myeloma | Multiple Myeloma and Plasma Cell Neoplasm | * Drug: dexamethasone
* Drug: lenalidomide
* Drug: melphalan
| DISEASE CHARACTERISTICS:~Histologically confirmed multiple myeloma by one of the following:~Biopsy of an osteolytic lesion or soft tissue tumor composed of plasma cells~Bone marrow aspirate and/or biopsy demonstrating ≥ 10% plasmacytosis~Bone marrow < 10% plasma cells but with ≥ 1 bony lesion AND meets the M-protein cr... | 18 Years | 120 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dose-limiting toxicity within first 3 courses of treatment | | |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity | | |
| Disease response after 2 courses, 6 courses, 12 courses, and 6 months of maintenance therapy | | |
| Time to progression | | |
| Overall survival | | |
| Duration of disease-free interval | | |
| Time to dose mo... | stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma | Dexamethasone, Lenalidomide, Melphalan, Anti-Inflammatory Agents, Antiemetics, Autonomic Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Gastrointestinal Agents, Glucocorticoids, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists, Antineoplastic Agents, Hormonal, Antineoplastic A... | | Intervention/Treatment |
| --- |
|Drug: dexamethasone|nan|
|Drug: lenalidomide|nan|
|Drug: melphalan|nan|
| Lenalidomide and Melphalan in Treating Patients With Previously Untreated Multiple Myeloma
Study Overview
=================
Brief Summary
-----------------
RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and... |
NCT01708447 | Feasibility Study: Evaluate the Effectiveness of Using a Topical Anesthetic Prior to Ultherapy™ Treatment | This study will evaluate the efficacy of a lidocaine topical anesthetic (numbing cream) for reducing discomfort associated with Ultherapy™ treatment. | All subjects will receive a full face and neck Ultherapy™ treatment. Thirty (30) minutes prior to treatment, a topical anesthetic (numbing cream) will be applied to one side of the face and neck and a placebo cream with similar consistency and color will be applied to the other side of the face and neck, in a randomize... | Feasibility Study: Evaluation of the Efficacy of a Liposome-encapsulated Lidocaine Topical Anesthetic for Reducing Discomfort Associated With Ultherapy™ Treatment | Skin Laxity | * Drug: L.M.X.4.® cream
* Other: A placebo cream
* Device: Ulthera System Treatment
| Inclusion Criteria:~Male or female, aged 30 to 65 years.~Chosen an Ultherapy™ treatment as part of their treatment regimen.~Subject in good health.~Skin laxity on the face and neck.~Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period.~Willing... | 30 Years | 65 Years | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-related pain | The validated 10-point pain NRS scale will be used to measure average pain scores reported by subject immediately after each facial region is treated. | During treatment |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in skin laxity. | Improvement in overall lifting and tightening of skin as determined by a masked, qualitative assessment of photographs. | 90 days post-treatment |
| Lidocaine, Anesthetics, Anesthetics, Local, Central Nervous System Depressants, Physiological Effects of Drugs, Sensory System Agents, Peripheral Nervous System Agents, Anti-Arrhythmia Agents, Voltage-Gated Sodium Channel Blockers, Sodium Channel Blockers, Membrane Transport Modulators, Molecular Mechanisms of Pharmaco... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical anesthetic - L.M.X.4.® cream<br>Topical anesthetic cream, L.M.X.4.® cream, applied to one side of the face and neck prior to Ulthera System treatment. | Drug: L.M.X.4.® cream<br>* A lidocaine topical anesthetic cream<br>* Othe... | Feasibility Study: Evaluate the Effectiveness of Using a Topical Anesthetic Prior to Ultherapy™ Treatment
Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy of a lidocaine topical anesthetic (numbing cream) for reducing discomfort associated with Ultherapy™ treatment... | |
NCT02172235 | Relative Bioavailability of Pioglitazone After Co-administration With Different Doses of BI 10773 in Healthy Volunteers | The objective was to investigate the effect of different doses of BI 10773 on the bioavailability of pioglitazone after multiple oral doses of both drugs | Relative Bioavailability of Pioglitazone After Co-administration With Different Doses of BI 10773 in Healthy Volunteers (an Open-label, Randomised, Crossover, Clinical Phase I Study) | Healthy | * Drug: Pioglitazone
* Drug: Pioglitazone - low dose
* Drug: BI 10773 - low dose
* Drug: BI 10773 - medium dose
* Drug: BI 10773 - high dose
| Inclusion Criteria:~Healthy male subjects according to the following criteria:~medical history, physical examination, vital signs ((blood pressure (BP), pulse rate (PR), 12-lead electrocardiogram (ECG)), clinical laboratory tests~Age 18 to 55 years (incl.)~BMI 18.5 to 29.9 kg/m2 (incl.)~Signed and dated written informe... | 18 Years | 55 Years | Male | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) | | Before each dosing, up to 10 days |
| Cmax,ss (maximum measured concentration of the analyte in plasma at steady ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C24,N (concentration of the analyte in plasma at 24 h after administration of the Nth dose) | | Before each dosing, up to 10 days |
| λz (terminal elimination rate constant of the analyte in plasma) | | Before each dosing, up to 10 days |
... | Pioglitazone, Empagliflozin, Hypoglycemic Agents, Physiological Effects of Drugs, Sodium-Glucose Transporter 2 Inhibitors, Molecular Mechanisms of Pharmacological Action | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pioglitazone<br> | Drug: Pioglitazone<br> <br> |
| Experimental: Pioglitazone + BI 10773 low<br> | Drug: Pioglitazone<br> <br> Drug: BI 10773 - low dose<br> <br> |
| Experimental: Pioglitazone + BI 10773 medium<br> | Drug: Pioglitazon... | Relative Bioavailability of Pioglitazone After Co-administration With Different Doses of BI 10773 in Healthy Volunteers
Study Overview
=================
Brief Summary
-----------------
The objective was to investigate the effect of different doses of BI 10773 on the bioavailability of pioglitazone after multiple oral ... | ||
NCT01623791 | Random Urine Protein-creatinin Ratio to Predict Magnitude of Proteinuria | The aim of this study was to evaluate diagnostic accuracy of the spot urinary proteinuria, random urine protein- creatinin ratio for prediction of significant proteinuria (≥ 300 mg/24h) and magnitude of proteinuria in patients with in mild preeclampsia and severe preeclampsia. The cross-sectional longitudinal study des... | Group 1 consisted of mild preeclampsia and gestational preeclamptic patients and group 2 consisted of severe preeclamptic patients. The predictive values of the spot urinary dipstick proteinuria and protein/creatinin ratio were determinant and the correlations of the diagnostic test of 24 hour total proteinuria were ev... | Random Urine Protein-creatinine Ratio to Predict Magnitude of Proteinuria in Different Severity of Pre-eclamptic Patients | Pre-eclampsia | Inclusion Criteria:~16-50 years old, > 20 gestational week pregnant women pre-diagnosed preeclampsia.~Diagnosis and follow-up performed in inpatients clinic.~Exclusion Criteria:~The history of chronic hypertension~The history of systemic illness such as pre-gestational diabetes, systemic lupus erythematosis , malignanc... | 16 Years | 50 Years | Female | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of significant proteinuria | Significant proteiuria:(≥ 300 mg/24h) | 24 hour urine collection |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predict to magnitude of total proteinuria | Total proteinuria/24 hour | 24 hour |
| Pre-eclampsia, Proteinuria, Protein - creatinine ratio, Dipstick proteinuria, Severity of disease | Eclampsia, Proteinuria, Pre-Eclampsia, Hypertension, Pregnancy-Induced, Pregnancy Complications, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Urination Disorders, Urologic Diseases, Female Urogenital Diseases, Male Urogenital Diseases, Urological Manifestations | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Group 1: mild pre-eclamptic group Mild and severe pre-eclampsia were defined American College of Obstetrics and Gynecology criteria (ACOG practice bulletin no. 33: diagnosis and management of preeclampsia and eclampsia. January 2002.) | |
| G... | Random Urine Protein-creatinin Ratio to Predict Magnitude of Proteinuria
Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate diagnostic accuracy of the spot urinary proteinuria, random urine protein- creatinin ratio for prediction of significant proteinuria (≥ 300 mg/... | ||
NCT04112550 | Clinical Effectiveness of Pre-operative Methadone in Single Level Lateral Transpsoas Interbody Fusions | Spinal operations including lumbar fusions for degenerative disorders are becoming more prevalent as the population ages. Inadequate or excessive postoperative analgesia can result in medical comorbidities and prolonged hospital length of stay and patient dissatisfaction.~Existing literature has highlighted the preoper... | Lumbar spinal fusions are becoming increasingly popular and prevalent in the treatment of a variety of spinal pathologies, but predominantly for degenerative disease which is most prevalent in the obese and or older population. These operations can result in relatively high post operative surgical pain and necessitate ... | Clinical Effectiveness of Pre-operative Methadone in Single Level Lateral Transpsoas Interbody Fusions: A Randomized, Double-blinded, Controlled Trial | Degenerative Disc Disease, Spondylolisthesis, Lumbar Region | * Drug: Methadone Hydrochloride
* Drug: Oxycodone-Acetaminophen
| Inclusion Criteria:~Age: 18 - 70~Will undergo one level minimally invasive lumbar fusion surgery~Primary symptoms are back and/or leg pain~Exclusion Criteria:~Preoperative chronic renal insufficiency or failure (defined as a serum creatinine more than 2 mg/dl)~Significant liver disease (cirrhosis or hepatic failure)~Am... | 18 Years | 70 Years | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative in-hospital patient's narcotic requirement | The total Morphine Milligram Equivalent (MME) for each post-operative day | Post-operative day 0 to 4 |
| Improvement in low back pain between the two cohorts as assessed by Oswestry... | lateral lumbar interbody fusion, minimally invasive spinal surgery | Acetaminophen, Acetaminophen, hydrocodone drug combination, Oxycodone, Methadone, Analgesics, Non-Narcotic, Analgesics, Sensory System Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Antipyretics, Analgesics, Opioid, Narcotics, Central Nervous System Depressants, Antitussive Agents, Respirator... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methadone<br>This cohort will receive oral methadone 15mg po tablet pre-operatively | Drug: Methadone Hydrochloride<br>* FDA approved medication to treat pain<br>|
| Active Comparator: Oxycodone<br>This cohort will receive oxycodone/a... | Clinical Effectiveness of Pre-operative Methadone in Single Level Lateral Transpsoas Interbody Fusions
Study Overview
=================
Brief Summary
-----------------
Spinal operations including lumbar fusions for degenerative disorders are becoming more prevalent as the population ages. Inadequate or excessive posto... | |
NCT02280551 | The Australian Parental Supply of Alcohol Longitudinal Study (APSALS) | Parents can positively influence their children's alcohol use. One strategy they use is to provide their children with alcohol, believing it is the best way to teach their children how to drink responsibly. The impact of parental supply is not well understood and may be unintentionally harmful. This study will research... | Title: The Australian Parental Supply of Alcohol Longitudinal Study (APSALS): Can parents teach their children to drink alcohol responsibly? Or, is one drop a drop too many?~Background: The Australian Parental Supply of Alcohol Longitudinal Study (APSALS) was established to investigate the short- and long-term associat... | The Australian Parental Supply of Alcohol Longitudinal Study (APSALS) | Alcohol Abuse | Inclusion Criteria:~Grade 7 High School enrolment~Parental signed informed consent provided~Exclusion Criteria:~none | 11 Years | 13 Years | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of alcohol consumption | Frequency of alcohol consumption within past 12 months, categorized as: none, 1 day/month, 2-3 days/month, 1 day/week, 2 days/week, 3 days/week, 4 days/week, 5 days/week, 6 days/week, every day. | 12 month | ... | adolescent, alcohol, parent, epidemiology | Alcoholism, Alcohol-Related Disorders, Substance-Related Disorders, Chemically-Induced Disorders, Mental Disorders | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adolescents<br>1927 Grade 7 high school students | |
| Parent<br>A parent of each of the 1927 Grade 7 high school students | |
| The Australian Parental Supply of Alcohol Longitudinal Study (APSALS)
Study Overview
=================
Brief Summary
-----------------
Parents can positively influence their children's alcohol use. One strategy they use is to provide their children with alcohol, believing it is the best way to teach their children how... | |||
NCT04832399 | Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants | The purpose of this study is to evaluate the impact of an early treatment with Natalizumab on the management of the progressive nature of Relapsing Remitting Multiple Sclerosis (RRMS). | Tysabri in Early Relapsing Remitting Multiple Sclerosis Patients - TYPIFI (Tysabri Patient Initiation After Failure of the Initial DMT) | Relapsing Remitting Multiple Sclerosis | * Drug: Natalizumab
| Key Inclusion Criteria:~Documented diagnosis of Relapsing Remitting Multiple Sclerosis (McDonald 2010 Criteria).~EDSS ≤ 3.0.~Must fulfill Tysabri indication (relapse and MRI criteria).~Decision to start treatment with Natalizumab must precede enrollment.~Up to four natalizumab infusions.~Key Exclusion Criteria:~Any pri... | 18 Years | 55 Years | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Disease-Free Status at Month 12 | | Month 12 |
| Clinical Disease-Free Status at Month 12 in Comparison to the Previous Year | | Month 12 |
| Annualized Relapse Rate at Month 12 in Comparison to the Previous Year | | Month 12 |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Disease-Free Status at Months 24, 36 and 48 | | Months 24, 36 and 48 |
| Clinical Disease-free Status Every 6 Months | | Every 6 months (Up to 48 months) |
| Annualized Relapse Rate (ARR) | | Months 12, 24, 36 and 48 |
| Change F... | Natalizumab, Immunologic Factors, Physiological Effects of Drugs | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Natalizumab<br>Natalizumab 300 mg is administered by intravenous infusion once every 4 weeks. | Drug: Natalizumab<br>* As described in the treatment arm.<br>* Other names: BG00002;|
| Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants
Study Overview
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Brief Summary
-----------------
The purpose of this study is to evaluate the impact of an early treatment with Natalizumab on the management of the progressive nature of Relapsing Remitting Multiple Sclerosis... | |||
NCT02861781 | Collection of Human Metabolic Tissues | This project aims at identifying new determinants of type 2 diabetes in severe obesity. To do so, a biological collection, including tissues of interest in the field of metabolism, will be collected during bariatric surgery in obese patients. Three different groups of metabolic status of patients, corresponding to diff... | Study of New Determinants of Type 2 Diabetes in Severe Obesity | Obesity, Insulin Resistance, Diabetes Mellitus, Type 2 | * Other: Collection of blood samples and tissues
| Inclusion Criteria:~Written informed consent~Age 18 - 65 years inclusive at surgery~IMC > 35~Subject qualified for bariatric surgery (sleeve gastrectomy or gastric bypass)~Specific criteria :~Type 2 diabetes group (D) (90 patients) : type 2 diabetes according to ADA criteria~Insulin resistance non diabetes group (IR) (... | 18 Years | 65 Years | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of metabolites | | At baseline (day of surgery) |
| comparison of proteins levels | in liver, muscle, adipose tissue and plasma according to metabolic state | At baseline (day of surgery) |
| comparison of miRNA | in liver, muscl... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in metabolites in plasma level | | 3 and 12 months after the completion of surgery |
| changes in proteins in plasma level | | 3 and 12 months after the completion of surgery |
| changes in miRNA in plasma level | | 3 and 12 month... | Bariatric surgery | Obesity, Diabetes Mellitus, Type 2, Insulin Resistance, Overweight, Overnutrition, Nutrition Disorders, Body Weight, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Hyperinsulinism | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 2 diabetes<br>Type 2 diabetes according to ADA criteria | Other: Collection of blood samples and tissues<br>* Collection of blood samples and tissues during bariatric surgery and blood samples during followup visits<br>|
| Insulin resistance non di... | Collection of Human Metabolic Tissues
Study Overview
=================
Brief Summary
-----------------
This project aims at identifying new determinants of type 2 diabetes in severe obesity. To do so, a biological collection, including tissues of interest in the field of metabolism, will be collected during bariatric ... | ||
NCT01581229 | Early Use of Noninvasive Positive Pressure Ventilation for Intro-pulmonary Acute Lung Injury | To assess the safety and efficacy of noninvasive positive pressure ventilation for patients with intro-pulmonary pulmonary acute lung injury and compare this with high-concentration oxygen therapy. | null | Acute Lung Injury | * Procedure: noninvasive positive pressure ventilation
* Procedure: oxygen therapy
| Inclusion Criteria:~acute onset;~a clinical presentation of respiratory distress;~arterial oxygen tension/inspired oxygen fraction (PaO2/FIO2) < 300 mmHg but > 200 mmHg while breathing oxygen delivered by a conventional Venturi device at a maximum concentration (50%);~presence of bilateral pulmonary infiltrates on post... | 18 Years | null | All | No | Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numbers of patients who met the intubation criteria | | 1 year |
| the numbers of patients who are actually intubated | | 1 year |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inhospital mortalities | | 1 year |
| intensive care unit mortalities | | 1 year |
| ALI;noninvasive positive pressure ventilation | Lung Injury, Acute Lung Injury, Wounds and Injuries, Lung Diseases, Respiratory Tract Diseases, Thoracic Injuries | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPPV<br> | Procedure: noninvasive positive pressure ventilation<br>* Patients in the NPPV group are ventilated using the CPAP or bilevel positive airways pressure S/T mode.<br>|
| Active Comparator: Control<br> | Procedure: oxygen therapy<... | Early Use of Noninvasive Positive Pressure Ventilation for Intro-pulmonary Acute Lung Injury
Study Overview
=================
Brief Summary
-----------------
To assess the safety and efficacy of noninvasive positive pressure ventilation for patients with intro-pulmonary pulmonary acute lung injury and compare this wit... | |
NCT05290818 | Total Versus Robotic Assisted Unicompartmental Knee Replacement | The purpose of this research is to compare the functional outcomes of patients with end stage medial compartment OA of the knee undergoing a conventional mTKA to those undergoing rUKA and to assess the associated cost economics of such technology. | Unicompartmental knee arthroplasty (UKA) is an accepted surgical alternative to total knee arthroplasty (TKA) for patients with isolated medial compartmental joint disease with the potential advantages of accelerated recovery, improved functional outcomes and retention of anatomical knee kinematics. However, some surge... | Total Versus Robotic Assisted Unicompartmental Knee Replacement (TRAKER) for Medial Compartment Osteoarthritis: Randomised Controlled Trial | Osteo Arthritis Knee, Arthritis Knee, Arthropathy of Knee | * Device: MAKO™ Partial Knee Arthroplasty
* Device: Triathlon (Stryker) Total Knee Arthroplasty
| Inclusion Criteria:~Listed for elective primary TKA for end stage medial compartment osteoarthritis~Intact anterior cruciate ligament~Full thickness and good quality lateral cartilage~Correctable intra-articular varus deformity and intact medial collateral ligament~American Society of Anesthesiologists (ASA) grades 1 a... | 50 Years | 75 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised control Trial (1:2 ratio: 53 in the rUKA arm and 106 in the mTKA)
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford knee score | Knee specific functional outcome measure. It consists of twelve questions assessed on a Likert scale with values from 0 to 4, to give a summative score. This is measured on a scale from 0 (worst) to 48 (best). | Baseline to... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford knee score and Activity and Participation Questionnaire | The Oxford knee score is a knee specific functional outcome measure. It consists of twelve questions assessed on a Likert scale with values from 0 to 4, to give a summative score... | Arthroplasty, Robotic, Knee, Total, Partial, Outcome, MAKO | Arthritis, Osteoarthritis, Osteoarthritis, Knee, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual Total Knee Arthroplasty<br>This group will receive a conventional manual Triathlon (Stryker) TKA with a cruciate retaining polyethylene insert. The surgeon will then make bone cuts using a manual jig and a hand held saw to prep... | Total Versus Robotic Assisted Unicompartmental Knee Replacement
Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to compare the functional outcomes of patients with end stage medial compartment OA of the knee undergoing a conventional mTKA to those undergoing rUKA and to... |
NCT03689647 | Using the Arms to Drive the Legs During Walking | This study aims to understand and compare the metabolic and mechanical demands placed on the body while walking normally and walking with the use of an apparatus that drives leg swing through the use of the arms. This information will help the investigators identify how arm swing mechanics helps minimize energy demands... | Reducing Metabolic Cost of Walking by Exploiting Arm Swing to Drive Leg Swing | Metabolic Cost of Walking With Arm Swing Assistive Device | * Device: Arm Swing Driven Assistive Apparatus
| Inclusion Criteria:~Apparently healthy and free from neurological disease and/or body related injury~Community-dwelling young men and women 18-36 yrs~Use and be contacted by telephone~Speak, read, understand, and complete a questionnaire in English~Body mass index < 30 kg/m2~Exclusion Criteria:~not of the specified age... | 18 Years | 36 Years | All | Accepts Healthy Volunteers | Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Cost | Change in Metabolic Cost | Change from walking without assistive apparatus to walking with assistive apparatus. Measures of metabolic cost are completed within a 3-hour time window during a single laboratory visit. |
| | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Group Experimental<br>Each participant will act as their own control with variables of interest measured while walking without the assistive device and while walking with the assistive device. | Device: Arm Swing Driven Assistive Ap... | Using the Arms to Drive the Legs During Walking
Study Overview
=================
Brief Summary
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This study aims to understand and compare the metabolic and mechanical demands placed on the body while walking normally and walking with the use of an apparatus that drives leg swing through the use of the... | ||||
NCT00705562 | Tolerance of Healthy Term Infants Fed Infant Formulas | The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas. | Tolerance of Healthy Term Infants Fed Infant Formulas | Infant, Newborn | * Other: milk protein formulas, varying carbohydrate/protein sources
| Inclusion Criteria:~Healthy, term infants; singleton birth; 37-42 weeks of age; >2490gms at birth; 0-8 days of age~Exclusion Criteria:~medications/foods/formulas affecting GI tolerance;adverse medical history with possible effect on tolerance or growth | null | 8 Days | All | Accepts Healthy Volunteers | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal tolerance | | 0-8 days of age until 28 days of age |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI and intake parameters | | 0-8 to 28 days of age |
| Caseins, Chelating Agents, Sequestering Agents, Molecular Mechanisms of Pharmacological Action | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Experimental milk protein based infant formula with varying carbohydrate and protein source | Other: milk protein formulas, varying carbohydrate/protein sources<br>* ad lib for 0-8 days of age until 28 days of age<br>|
| Experimental:... | Tolerance of Healthy Term Infants Fed Infant Formulas
Study Overview
=================
Brief Summary
-----------------
The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.
Official Title
-----------------
Tolerance of Healthy Te... | ||
NCT04929509 | P11-4 and Nanosilver Fluoride Varnish in Treatment of White Spot Carious Lesions | Background: Great efforts have been undertaken for dental caries prevention. Among the recent remineralizing materials, Nano silver fluoride varnish products which are based on nanotechnology have been proposed for repairing enamel . Regenerative medicine-based approaches for caries treatment focus on biomimetic remine... | The study will be a randomized controlled double-blinded study conducted on participants aged 10 to 24 years satisfying the inclusion criteria with visible active white spot lesions on buccal surfaces of permanent teeth. Sixty six patients will be randomly allocated into 3 groups of the three materials: study group 1: ... | Effectiveness of Self-assembling Peptide (P11-4) and Nano-silver Fluoride Varnish in Management of Enamel White Spot Lesions in Young People (Randomized Controlled Clinical Trial) | White Spot Lesion | * Other: self-assembling peptide
* Other: nanosilver fluoride varnish
* Other: sodium fluoride varnish
| Inclusion Criteria:~1- An age range of 10-24 years ( age of young adolescents and youth as described by the WHO was selected (WHO, 2019). 2. The presence of at least one visible WSL in the buccal surface of permanent teeth with ICDAS II score of 1, or 2. 3. Completion of an informed consent to participate in the study~... | 10 Years | 24 Years | All | Accepts Healthy Volunteers | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the activity status of lesions scored using ICDAS-LAA | Change in the activity status of lesions scored using ICDAS-LAA from baseline to final follow up. | 12 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean DIAGNOdent readings. | Change in mean DIAGNOdent readings from baseline to each follow up period | 12 months |
| Microbial count of mutans streptococci, lactobacilli. | Microbial count of mutans streptococci, lactobacilli.from ... | Fluorides, Sodium Fluoride, Fluorides, Topical, Cariostatic Agents, Protective Agents, Physiological Effects of Drugs, Anti-Infective Agents, Local, Anti-Infective Agents, Listerine | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: self-assembling peptide (P11-4)<br>Curodont Repair; Credentis will be applied to the~white spot lesion at baseline. | Other: self-assembling peptide<br>* each Curodont Repair applicator unit contains both Curolox technology for guided enam... | P11-4 and Nanosilver Fluoride Varnish in Treatment of White Spot Carious Lesions
Study Overview
=================
Brief Summary
-----------------
Background: Great efforts have been undertaken for dental caries prevention. Among the recent remineralizing materials, Nano silver fluoride varnish products which are based... | |
NCT02004860 | Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis | Seborrheic dermatitis is a chronic inflammatory dermatological disease, evolving by relapses, affecting mainly the face and scalp. It would be important to have a maintenance treatment for severe forms of seborrheic dermatitis witch is both effective and relatively well tolerated to reduce the frequency of relapses, pr... | Phase 3 : Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis on Adult Face | Severe Seborrheic Dermatitis | * Drug: Protopic (R)
* Drug: Mycoster (R)
| Inclusion Criteria:~in Phase 1: Attack Treatment (open)~over the age of eighteen patient,~Seborrheic dermatitis Severe,~participation with an informed consent,~Women of childbearing age in effective contraception for the duration of the study or postmenopausal women.~in Phase 2: Phase 2: Randomization (blind)~Patient a... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of the maintenance of complete or almost complete clinical remission | The primary endpoint will be the duration of the maintenance of complete or almost complete clinical remission obtained after the initial treatment. This period is... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance of 2 treatments | Tolerance of 2 treatments Mycoster (R) and Protocopic (R) | between 10 days and 18 months after inclusion (V3 (Day (D)10 to D180)), 30 days after inclusion (Visit D30), after 90 days after inclusion (D90) and after ... | local immunosuppressive, Maintenance therapy | Ciclopirox, Tacrolimus, Immunosuppressive Agents, Immunologic Factors, Physiological Effects of Drugs, Calcineurin Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Antifungal Agents, Anti-Infective Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protopic Arm<br>Protopic® 0.1% ointment - 2 applications per week for 6 months | Drug: Protopic (R)<br>* Protopic® 0.1% ointment - 2 applications per week for 6 months<br>* Other names: Tacrolimus;|
| Active Comparator: Mycoster Arm<br>2 a... | Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis
Study Overview
=================
Brief Summary
-----------------
Seborrheic dermatitis is a chronic inflammatory dermatological disease, evolving by relapses, affecting mainly the face and scalp. It would be importan... | |
NCT01900093 | Evaluation of the Response to Acthar Gel Therapy in Patients Who Failed Intravenous Methylprednisolone (IVMP) for MS Relapses | Although ACTHAR gel is approved for the treatment of acute relapses, it is currently not widely used. Thus, we propose to conduct a small open-label proof-of-concept trial to evaluate the response to ACTHAR gel therapy in patients who have failed to make a satisfactory recovery after treatment with high dose IVMP. Docu... | This is an open-label, small, proof-of-concept study examining the safety, tolerability, and extent of recovery of a two-week course of subcutaneous Acthar Gel therapy in patients with MS relapse who have failed to make a satisfactory recovery after treatment with high dose methylprednisolone. Eligible patients will be... | An Open-Label Prospective Proof-Of-Concept Trial to Evaluate the Response to Acthar Gel Therapy in Patients With Multiple Sclerosis (MS) Relapses Who Have Failed To Make an Adequate Recovery After Treatment With High-Dose Intravenous Methylprednisolone | Multiple Sclerosis | * Drug: Acthar Gel
| Inclusion Criteria:~Ages 18-65~EDSS of 2.0 - 7.5 (inclusive)~Sustained a significant MS exacerbation affecting vision, brainstem, motor, or cerebellar function AND were initially treated with a 5 day course of IVMP within 10 days of the onset of symptoms.~Failed to make adequate improvement and must initiate Acthar Gel... | 18 Years | 65 Years | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Functional System Score appropriate to the Targeted Neurological Deficit | Primary outcome measure will be the percentage of patients improving by at least 1 step on the FSS appropriate to their neurological deficit (targeted ne... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Expanded Disability Status Scale | Secondary outcome measures will be improvement in TND at completion of ACTHAR Gel therapy, improvement by at least 1 step on EDSS at completion of treatment and at 1 week following completion o... | Hormones, Adrenocorticotropic Hormone, Hormones, Hormone Substitutes, and Hormone Antagonists, Physiological Effects of Drugs | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acthar Gel<br>80 units of subcutaneous Acthar Gel therapy daily | Drug: Acthar Gel<br>* 80 units of subcutaneous Acthar Gel therapy daily<br>* Other names: Repository corticotrophin injection;|
| Evaluation of the Response to Acthar Gel Therapy in Patients Who Failed Intravenous Methylprednisolone (IVMP) for MS Relapses
Study Overview
=================
Brief Summary
-----------------
Although ACTHAR gel is approved for the treatment of acute relapses, it is currently not widely used. Thus, we propose to conduc... | |
NCT02779699 | A Study of AL2846 on Tolerance and Pharmacokinetics | A study of AL2846,a C-met/Hepatocyte growth factor tyrosine kinase inhibitor,in patients with advanced cancer. | To study the pharmacokinetic characteristics of AL2846 in the human body; To recommend a reasonable dose and indication for subsequent research. | Phase I Study of Tolerance and Pharmacokinetics of AL2846 in Patients With Advanced Cancer | Advanced Cancer | * Drug: AL2846
| Inclusion Criteria:~Histological documentation of Advanced solid tumors（especially Hepatocellular Carcinoma and Lung Cancer ）,at least one measurable lesion (by RECIST1.1)~Lack of the standard treatment or treatment failure~18-65 years,ECOG PS:0-1,Life expectancy of more than 3 months~30 Days or more from the last cyto... | 18 Years | 65 Years | All | No | Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The type of dose-limiting toxicity(ies) (DLT[s]) of AL2846 | Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug ：II °or above of kidney damage，III °or above of non-hematological toxicity,IV°hemato... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | Percentage of participants with OR based assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). | each 56 days up ... | Neoplasms | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AL2846<br>AL2846 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent | Drug: AL2846<br>* AL2846 p.o. qd<br>|
| A Study of AL2846 on Tolerance and Pharmacokinetics
Study Overview
=================
Brief Summary
-----------------
A study of AL2846,a C-met/Hepatocyte growth factor tyrosine kinase inhibitor,in patients with advanced cancer.
Detailed Description
-----------------
To study the pharmacokinetic characteristics of AL2... | |
NCT03487159 | Using the Non Invasive Technology Magnetic Resonance Elastography for the Diagnosis of Liver Fibrosis Stage | This study evaluates the ability of Magnetic Resonance Elastography non invasive technology to identify the liver fibrosis stage in patients with chronic liver diseases compared to Shear Wave Elastography and/or Liver Biopsy. | Recent advances in magnetic resonance imaging (MRI) of the liver have led to improvements in diagnosis of chronic liver diseases. Detection and staging of liver fibrosis has become important; however, until about the last decade, it depended on an invasive liver biopsy. Liver biopsy is limited by high cost, low patient... | Using the Non Invasive Technology Magnetic Resonance Elastography for the Diagnosis of Liver Fibrosis Stage | Liver Diseases | * Device: MRE (Magnetic Resonance Elastography)
| Inclusion Criteria:~Patients with chronic liver diseases~Exclusion Criteria:~Patients who don't have chronic liver diseases | 18 Years | 100 Years | All | No | Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study model includes 2 study arms:~Patients with chronic liver diseases who will undergo a routine liver biopsy, Shear Wave elastography and the MRE in order to evaluate the liver fibrosi... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Biopsy Result for liver fibrosis grade | Liver Fibrosis score measured by Metavir scale .The Metavir score grades the degree of fibrosis on a 5-point scale from 0 to 4. The activity, which is the amount of inflammation (specifically, the... | Liver Diseases, Liver Cirrhosis, Fibrosis, Pathologic Processes, Digestive System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Liver biopsy ,Elastography and MRE<br>Performance of routine Liver biopsy,Shear Wave Elastography and investigational MRE (Magnetic Resonance Elastography) in order to evaluate liver fibrosis stage. | Device: MRE (Magnetic Resonance Elastography)... | Using the Non Invasive Technology Magnetic Resonance Elastography for the Diagnosis of Liver Fibrosis Stage
Study Overview
=================
Brief Summary
-----------------
This study evaluates the ability of Magnetic Resonance Elastography non invasive technology to identify the liver fibrosis stage in patients with ... | ||
NCT00094068 | The Effect of Sildenafil Citrate (Viagra® (Registered Trademark)) on Brain Blood Flow in Multiple Sclerosis Patients | This study will determine whether sildenafil citrate, commonly known as Viagra, can cause increased blood flow to the brain in a wide range of multiple sclerosis (MS) patients, including women. Although people with MS can have reduced blood flow in the brain as part of the disease process, it has been observed that men... | Advances in MR perfusion imaging have provided clinical researchers with the opportunity to quantify regional cerebral blood flow (CBF). It has been shown that cerebral perfusion in patients with multiple sclerosis (MS) is reduced, particularly in the grey matter. However, preliminary data in a small number of male sec... | A Pilot Study to Detect the Effect of Sildenafil Citrate on Cerebral Blood Perfusion in Multiple Sclerosis Patients by Perfusion MRI | Multiple Sclerosis | INCLUSION CRITERIA:~Any healthy normal volunteer above the age of 18 who is capable of giving informed consent recruited or self referred through the NIH Volunteer office will be eligible for this study.~All healthy normal volunteers will be included as long as there is no recorded or documented signs or symptoms of CN... | null | null | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion, Gray Matter, White Matter, Cerebral Blood Flow, Cerebral Blood Volume, MRI, Multiple Sclerosis, Perfusion, Imaging, Sildenafil, MS, Healthy Volunteer, HV | Multiple Sclerosis, Sclerosis, Pathologic Processes, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System, Nervous System Diseases, Demyelinating Diseases, Autoimmune Diseases, Immune System Diseases | The Effect of Sildenafil Citrate (Viagra® (Registered Trademark)) on Brain Blood Flow in Multiple Sclerosis Patients
Study Overview
=================
Brief Summary
-----------------
This study will determine whether sildenafil citrate, commonly known as Viagra, can cause increased blood flow to the brain in a wide ran... | ||||
NCT05344885 | A Pilot Trial Examining Digital Parent Training Programs | The purpose of this pilot study is to preliminary examine the impact of a design mechanism aimed at increasing engagement in an unguided digital parent training program for child's behavior problems. Parents will be enrolled into one of two digital parent training intervention arms, dedifferentiated by their level of c... | The purpose of this pilot study is to preliminary examine the impact of a design mechanism aimed at increasing engagement in an unguided digital parent training program for child's behavior problems. The design mechanism manipulated in this pilot relates to the extent to which program design promotes a positive behavio... | Examining the Impact of Intervention Design in Digital Parent Training for Child's Disruptive Behaviors: A Pilot Randomized Trial | Child Behavior Problem, Parenting, Engagement, Patient | * Behavioral: DPT-Standard
* Behavioral: DPT-Enhanced
| Inclusion Criteria:~Parents report they have a child between the ages of 3 and 7, who:~Has externalized behavior problems based on A) Parents report at least 1 of the two first criteria of behavior problems to be above 4 (the middle point) & the average of all items ≥ 4, on a screening scale that consists of 9 items (o... | 3 Years | 7 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Eyberg Child Behavior Inventory (ECBI) at 10 weeks | The ECBI specifies 36 behaviors commonly reported by parents of children with behavior problems. For each behavior the parent specifies how often this problem occurs on ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from Baseline Behavior and Feelings Survey Externalizing Problems at 10 weeks | The Behavior and Feelings Survey (BFS) parent report of Externalizing Problems in children and adolescents is based on summing 6 items that measure children... | Problem Behavior, Behavioral Symptoms | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DPT-standard<br>A standard digital parent training intervention | Behavioral: DPT-Standard<br>* The parent training intervention includes 7 modules, recommended to be completed within 7- to 10-weeks period. Module's content includes v... | A Pilot Trial Examining Digital Parent Training Programs
Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to preliminary examine the impact of a design mechanism aimed at increasing engagement in an unguided digital parent training program for child's behavior problem... | |
NCT00524199 | Effects of Mesna on Homocysteine in Kidney Failure | The purpose of this research study is to examine the effect of a drug called mesna on the removal of homocysteine from blood during dialysis. Homocysteine is an amino acid (protein building block) found in the blood of all people, however it is considerably elevated in dialysis patients. People with increased levels of... | Homocysteine is a thiol amino acid derived from dietary methionine. Elevated plasma total homocysteine (tHcy), termed hyperhomocysteinemia, is a graded, independent risk factor for the development of atherosclerosis. Elevated plasma tHcy can be normalized by supplementation with folic acid and vitamins B6 and B12 in mo... | The Effects of 12 mg/kg Intravenous Mesna on Plasma Total Homocysteine Concentration in Patients With End-stage Renal Disease Requiring Hemodialysis | End Stage Renal Disease | * Drug: Mesna
* Other: Saline
| Inclusion Criteria:~Patients with end-stage renal disease who have received hemodialysis thrice weekly for at least 90 days~Serum albumin > 30 g/L.~Exclusion Criteria:~Patients who refuse to sign a letter of informed consent~Women who are or are trying to become pregnant or are breast-feeding. | 18 Years | 80 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in plasma total homocysteine between placebo and mesna treatments | | Four weeks |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excretion of mesna during hemodialysis | | duration of dialytic session |
| homocysteine, hemodialysis, mesna | Mesna, Protective Agents, Physiological Effects of Drugs | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Saline IV infusion over five minutes at the beginning of dialysis. | Other: Saline<br>* Saline IV infusion over five minutes at the beginning of dialysis thrice weekly.<br>|
| Active Comparator: Mesna<br>12 mg/kg mesna IV ... | Effects of Mesna on Homocysteine in Kidney Failure
Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to examine the effect of a drug called mesna on the removal of homocysteine from blood during dialysis. Homocysteine is an amino acid (protein building block) found ... |
NCT01304628 | Cross-Over Study of Subcutaneous Study Drug for the Treatment of Patients With Mild to Moderate Asthma | The objective of this study is to evaluate if single subcutaneous (SC) doses of PL-3994, administered to patients with asthma can achieve a clinically meaningful increase in pulmonary function (Forced Expiratory Volume in one second: FEV1) while maintaining an acceptable safety profile. The study will characterize the ... | A Phase 2a, Double-Blinded, Multi-Center, Escalating Dose Group, Placebo Controlled, Cross-Over Study to Evaluate the Safety, Efficacy and Tolerability of Subcutaneously Administered PL-3994 for the Treatment of Patients With Mild to Moderate Asthma | Asthma | * Drug: PL-3994
| Inclusion Criteria:~Subject has provided written informed consent~The subject is male or female >18 to 65 years of age~Patient has a clinical history of asthma as defined by the National Asthma Education and Prevention Program.~Documented bronchodilator response to albuterol as defined by the American Thoracic Society ... | 18 Years | 65 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Forced Expiratory Volume in one second (FEV1) | Serial spirometry measures, including FEV1, assessed at specified time periods over 12 hours post dose. | Throughout 12 hours post dosing |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Forced Vital Capacity (FVC) | Serial spirometry measures, including FVC, assessed at specified time periods over 12 hours post dose. | Throughout 12 hours post dosing |
| asthma | Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases, Respiratory Hypersensitivity, Hypersensitivity, Immediate, Hypersensitivity, Immune System Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PL-3994 (4 escalating doses)<br> | Drug: PL-3994<br>* subcutaneous PL-3994, single dose, 4 escalating dose groups<br>|
| Placebo Comparator: Placebo<br> | Drug: PL-3994<br>* subcutaneous PL-3994, single dose, 4 escalating dose groups<br>|
| Cross-Over Study of Subcutaneous Study Drug for the Treatment of Patients With Mild to Moderate Asthma
Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate if single subcutaneous (SC) doses of PL-3994, administered to patients with asthma can achieve a clinically ... | |
NCT00469573 | Safety and Efficacy of Optive in Contact Lens Wearers With Dry Eyes | The purpose of this study is to determine if Optive®eye drops are safe for people who wear contact lenses and have dry eyes. The second goal of the study is to determine if using Optive®eye drops can improve my dry eye scores on a standard dry eye test (called the OSDI). | Safety and Efficacy of Optive in Contact Lens Wearers With Dry Eyes | Dry Eye | * Drug: 1. Optive
| Inclusion Criteria:~Men and women 18 and over~Self-reported use of daily-wear soft contact lenses that have been a proper fit for at least one month prior to the screening visit.~Complaint of dry eyes~OSDI score > 23~Exclusion Criteria:~Use of RGP or PMMA contact lenses~Poorly fitting contact lenses~Concurrent ocular c... | 18 Years | null | All | Accepts Healthy Volunteers | Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | | 8 months |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | | 8 months |
| Dry Eye Syndromes, Keratoconjunctivitis Sicca, Lacrimal Apparatus Diseases, Eye Diseases, Keratoconjunctivitis, Conjunctivitis, Conjunctival Diseases, Keratitis, Corneal Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1.<br> | Drug: 1. Optive<br>* Optive 15ml- (in the eye) Instill one drop twice daily in each eye<br>|
| Safety and Efficacy of Optive in Contact Lens Wearers With Dry Eyes
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if Optive®eye drops are safe for people who wear contact lenses and have dry eyes. The second goal of the study is to determine if using Optive®... | ||
NCT03374800 | Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial | Patients who are critically ill in the in the Intensive Care Unit (ICU), especially those who need a breathing machine, can develop ulcers in the stomach that bleed. To prevent bleeding, many such patients around the world receive a drug called pantoprazole that decreases acid production. However, today, compared to de... | Background: For 40 years, pharmacologic prevention of stress ulcer-related gastrointestinal (GI) bleeding with acid suppression has been the standard of care for mechanically ventilated ICU patients. Worldwide, proton pump inhibitors (PPIs) are more commonly used than histamine-2-receptor antagonists. Observational stu... | Re-EValuating the Inhibition of Stress Erosions: Prophylaxis Against Gastrointestinal Bleeding in the Critically Ill (The REVISE) Trial | Gastrointestinal Hemorrhage (Clinically Important, Upper) | * Drug: Placebo (0.9% saline)
* Drug: Pantoprazole
| Inclusion Criteria:~Age 18 years or more.~Receiving invasive mechanical ventilation in an ICU and in the opinion of the treating ICU physician mechanical ventilation will not be discontinued before the end of the day after tomorrow.~Exclusion Criteria:~The treating clinician considers either Pantoprazole or placebo are... | 18 Years | null | All | No | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective, international, multicentre, parallel group, concealed, blinded, randomized trial in critically ill mechanically ventilated adults
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinically important gastro-intestinal bleeding | Clinically important GI bleeding requires the presence of overt GI bleeding which is defined as one of the following;~Hematemesis~Overt nasogastric bleeding~Melena~Hematochezia~PLUS (in... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of ventilator associated pneumonia (VAP) in ICU | Diagnostic criteria for VAP include: previous mechanical ventilation for at least 48 hours, a new, progressive or persistent radiographic infiltrate on chest X-ray (without other obvious c... | Pantoprazole, Anti-Ulcer Agents, Gastrointestinal Agents, Proton Pump Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo (0.9% saline)<br>Withholding Stress ulcer prophylaxis (intravenous 0.9% saline as placebo) | Drug: Placebo (0.9% saline)<br>* normal saline<br>* Other names: normal saline; NaCl 0.9%;|
| Active Comparator: Stress Ulcer Prophy... | Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial
Study Overview
=================
Brief Summary
-----------------
Patients who are critically ill in the in the Intensive Care Unit (ICU), especially those who need a breathing machine, can develop ulcers in the stomach that bleed. To prevent bleeding, many... | |
NCT00120471 | Safety and Blood Levels of Tenofovir Disoproxil Fumarate in HIV Infected Pregnant Women and Their Babies | To prevent mother-to-child transmission (MTCT) of HIV in resource-limited countries, a simple yet effective treatment plan is needed. Tenofovir disoproxil fumarate (TDF) is an anti-HIV drug approved for use in the United States for the treatment of HIV infected adults. The purpose of this study is to determine the safe... | Rates of MTCT of HIV have dramatically decreased in resource-rich countries since the introduction of antiretroviral (ARV) prophylaxis; increased prenatal care, HIV testing, and counseling; elective cesarean delivery; and avoidance of breastfeeding. In resource-limited countries, however, MTCT of HIV continues to be a ... | A Phase I Open Label Trial of the Safety and Pharmacokinetics of Tenofovir Disoproxil Fumarate in HIV-1 Infected Pregnant Women and Their Infants | HIV Infections | * Drug: Tenofovir disoproxil fumarate
* Drug: Tenofovir disoproxil fumarate
* Drug: Tenofovir disoproxil fumarate
| Inclusion Criteria for HIV Infected Pregnant Women:~HIV-1 infected~Intend to deliver at the study site~Willing to be contacted or visited at home~Willing to be admitted to and remain in the delivery facility through Day 3 postpartum (Cohort 1) or Day 7 postpartum (Cohorts 2 and 3)~Exclusion Criteria for HIV Infected Pr... | 18 Years | null | All | No | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of adverse events with a severity of Grade 3 or higher attributable to receipt of TDF | | Throughout study |
| Maintenance of infant serum concentrations of TDF greater than 50 ng/ml | | Through Week 1 |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal HIV-1 RNA levels | | At study entry, Days 5 to 7, and Week 6 |
| Viral resistance to TDF in all HIV-1 infected infants, all of the corresponding mothers (transmitters), and a subset of mothers whose infants are not infected (nontran... | MTCT, Perinatal Transmission, HIV Seronegativity | Tenofovir, Antiviral Agents, Anti-Infective Agents, Reverse Transcriptase Inhibitors, Nucleic Acid Synthesis Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Anti-HIV Agents, Anti-Retroviral Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Pregnant participants will receive a single dose of TDF during active labor. These participants will be hospitalized at the delivery facility through Day 3 postpartum. | Drug: Tenofovir disoproxil fumarate<br>* 600-mg tablet taken ora... | Safety and Blood Levels of Tenofovir Disoproxil Fumarate in HIV Infected Pregnant Women and Their Babies
Study Overview
=================
Brief Summary
-----------------
To prevent mother-to-child transmission (MTCT) of HIV in resource-limited countries, a simple yet effective treatment plan is needed. Tenofovir disop... |
NCT03876106 | A Study of LUT014 in Patients With Metastatic Colorectal Cancer With EGFR Inhibitor Induced Acneiform Lesions | The purpose of this phase 1, multicenter study is to evaluate the safety, tolerability and preliminary efficacy of LUT014 in adult metastatic colorectal cancer patients with EGFR Inhibitor induced acneiform lesions | A Phase 1, Open-Label, Dose Escalation Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy Study of Topically Administered LUT014 in Metastatic Colorectal Cancer Patients With EGFR Inhibitor Induced Acneiform Lesions | EGFR Inhibitor Induced Acneiform Lesions | * Drug: LUT014
| Inclusion Criteria:~Diagnosed with mCRC;~Currently being treated with an FDA approved EGFRI for the treatment of mCRC, including but not limited to Erbitux® (cetuximab) Injection and Vectibix® (panitumumab) Injection, as directed by the approved labeling;~Treatment with the FDA approved EGFRI initiated within 12 weeks ... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: 3+3 Dose escalation of LUT014
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability (maximum tolerated dose, MTD) of LUT014 topically applied qd for 4 weeks in metastatic colorectal cancer (mCRC) patients with epidermal growth factor receptor inhibitor (EGFRI) induced acneiform lesions. | | From Day 0... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) in plasma after a single administration and after qd administrations for 8 days | | Pre-dose through Day 8 |
| Time to maximum concentration (Tmax) in plasma after a single administration and after qd administrat... | LUT014, Protein Kinase Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LUT014 dose level 1<br>LUT014 will be topically applied to the face, neck, and upper portion of the anterior and posterior chest once a day for 4 weeks. | Drug: LUT014<br>* Topical<br>|
| Experimental: LUT014 dose level 2<br>LUT014 will be... | A Study of LUT014 in Patients With Metastatic Colorectal Cancer With EGFR Inhibitor Induced Acneiform Lesions
Study Overview
=================
Brief Summary
-----------------
The purpose of this phase 1, multicenter study is to evaluate the safety, tolerability and preliminary efficacy of LUT014 in adult metastatic co... | ||
NCT04823130 | Dupilumab Effect on Pruritus Neuro-mechanisms in Patients With Atopic Dermatitis | Primary Objective:~- Assess change in neuronal architecture following long term treatment with dupilumab in skin biopsies from atopic dermatitis (AD) participants with chronic pruritus.~Secondary Objectives:~Assess change in neuronal architecture following short term treatment with dupilumab and during follow-up in ski... | AD participants: A 20-week Observation Period including 16 weeks of treatment for AD participants and a 4-week follow-up period; Healthy participants: 8 days observation period. | A Multi-center, Exploratory Study to Assess Dupilumab Effect on Pruritus Neuro-mechanisms in Patients With Atopic Dermatitis | Dermatitis Atopic | * Drug: Dupilumab (SAR231893)
| Inclusion criteria:~For AD participants~Male or female of greater than or equal to (>=)18 years of age inclusive, at the time of signing the informed consent form (ICF).~Diagnosed with moderate-to-severe chronic AD for at least 1 year before screening.~Eligible to be treated with dupilumab according to product monograp... | 18 Years | null | All | Accepts Healthy Volunteers | Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Healthy participants served as control group providing normal skin reference for baseline skin biopsy derived outcome measure and were matched for gender, age, race and anatomical site of ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Intraepidermal Nerve Fiber Density on Lesional Skin at Week 17 | Skin biopsies were used to analyze the epidermal nerve fiber density. Nerve fibers were visualized by staining consecutive sections for the pan-axonal mar... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Intraepidermal Nerve Fiber Density on Lesional Skin at Weeks 3 and 21 | Skin biopsies were used to analyze the epidermal nerve fiber density. Nerve fibers were visualized by staining consecutive sections for the pan-axo... | Dermatitis, Atopic, Dermatitis, Pruritus, Skin Diseases, Skin Diseases, Genetic, Genetic Diseases, Inborn, Skin Diseases, Eczematous, Hypersensitivity, Immediate, Hypersensitivity, Immune System Diseases, Skin Manifestations | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Healthy Participants: Control<br>Healthy participants with site, age, gender, race, location of targeted lesional and non-lesional skin area matched to selected AD participants, received no treatment, and were considered as a control gr... | Dupilumab Effect on Pruritus Neuro-mechanisms in Patients With Atopic Dermatitis
Study Overview
=================
Brief Summary
-----------------
Primary Objective: - Assess change in neuronal architecture following long term treatment with dupilumab in skin biopsies from atopic dermatitis (AD) participants with chron... | |
NCT04857125 | Prevention of Postoperative Delirium After Acute Surgery | The aim of this trial is to evaluate the implementation and effect of an evidence based, multicomponent intervention on postoperative delirium, when fast implemented throughout the patients stay in hospital before, during and after acute surgery in a risk population, the primary outcome being frequency of patients with... | Prevention of Delirium After Acute Surgery - Implementation of a Multicomponent Intervention Throughout the Hospitalization | Postoperative Delirium | * Other: Patient interventions
* Other: Staff education
| Inclusion Criteria:~Patients aged 40 or above.~Patients scheduled for acute abdominal or orthopaedic surgery in general anaesthesia with an expected duration of 30 minutes or more.~Patients who are scheduled for surgery within 72 hours of hospital admission.~Patients who are expected to stay in hospital for 24 hours or... | 40 Years | null | All | No | Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative delirium identified with the screening tool Confusion Assessment Method (CAM), assessing change from negative to positive score. | Patients are screened with the tool Confusion Assessment Method (CAM). A patient will be considere... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inadequate emergence identified with the screening tool Confusion Assessment Method (CAM) in the Post-Anaesthesia Care Unit (PACU), assessing change from negative to positive score. | Patients are screened with the tool Confusion Assessment Me... | Implementation, Prevention, Multicomponent intervention, Anaesthetics, General, Non-cardiac, Acute surgery, Non-pharmacological intervention, Postoperative care | Delirium, Emergence Delirium, Confusion, Neurobehavioral Manifestations, Neurologic Manifestations, Nervous System Diseases, Neurocognitive Disorders, Mental Disorders, Postoperative Complications, Pathologic Processes | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Multicomponent intervention<br>Pre-, intra- and postoperative interventions applied using the Fast-IM method. | Other: Patient interventions<br>* The multicomponent intervention consists of several elements regarding avoidance of spec... | Prevention of Postoperative Delirium After Acute Surgery
Study Overview
=================
Brief Summary
-----------------
The aim of this trial is to evaluate the implementation and effect of an evidence based, multicomponent intervention on postoperative delirium, when fast implemented throughout the patients stay in... | |
NCT04156438 | Airway Pressure Release Ventilation for Moderate-to-severe Acute Respiratory Distress Syndrome | This study will examine the feasibility of a large clinical trial investigating the effectiveness of airway pressure release ventilation and low tidal volume ventilation for patients with moderate-to-severe acute respiratory distress syndrome. | Acute respiratory distress syndrome (ARDS) is a disease that has an incidence of 5% of hospitalized mechanically ventilated patients. ARDS is associated with high morbidity and mortality in critically ill patients, with mortality reported as high as 45% in severe ARDS. Patients who develop ARDS will require mechanical ... | Early Use of Airway Pressure ReLease Ventilation in Critically Ill Adults With Moderate-to-severe Acute Respiratory Distress Syndrome | Acute Respiratory Distress Syndrome | * Device: Low tidal volume ventilation
* Device: Airway pressure release ventilation
| Inclusion Criteria:~Fulfilling the diagnostic criteria of ARDS, according to the Berlin definition~Moderate to severe ARDS as defined as a PaO2: FiO2 ratio of ≤150 during invasive mechanical ventilation~Endotracheal intubation and mechanical ventilation for ARDS less than 48 hours~Exclusion Criteria:~Age less than 18 y... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Informed consent rate | A successful informed consent rate will be defined as ≥70% of substitute decision makers or patients approached choosing to participate in this trial | Informed consent rate will be measured over a 1 year period of the ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | Death, measured from time of enrollment until 28 days. | Up to Day 28 |
| In-hospital mortality | Death, at hospital discharge | Up to 365 days |
| ICU length of stay | Length of stay in the intensive care unit | Up to 365... | Airway pressure release ventilation, low tidal volume ventilation, APRV, ARDSNet ventilation, LTVV, acute respiratory distress syndrome, ARDS | Respiratory Distress Syndrome, Respiratory Distress Syndrome, Newborn, Acute Lung Injury, Syndrome, Disease, Pathologic Processes, Lung Diseases, Respiratory Tract Diseases, Respiration Disorders, Infant, Premature, Diseases, Infant, Newborn, Diseases, Lung Injury | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low tidal volume ventilation<br>Conventional low tidal volume ventilation | Device: Low tidal volume ventilation<br>* Conventional ventilation strategy for patient with ARDS<br>|
| Experimental: Airway pressure release ventilation<br>... | Airway Pressure Release Ventilation for Moderate-to-severe Acute Respiratory Distress Syndrome
Study Overview
=================
Brief Summary
-----------------
This study will examine the feasibility of a large clinical trial investigating the effectiveness of airway pressure release ventilation and low tidal volume v... |
NCT04149210 | FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial | This study aims :~To assess the efficacy of fluorometholone 0.1% one drop twice daily for four weeks in reducing the incidence of post-operative trachomatous trichiasis (TT) when given as adjunctive therapy with TT surgery in the programmatic setting~To assess whether such treatment is sufficiently safe for wide-scale ... | The investigators are pursuing an agenda to evaluate a new potentially cost-effective approach to improving trichiasis surgery outcomes: perioperative topical anti-inflammatory therapy. Inflammation-whether induced by the trachoma disease process or surgery itself-most likely contributes to progressive cicatrization le... | FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial | Trachomatous Trichiasis (TT), Eye Diseases, Eyelid Diseases, Trachomatous, Trichiasis | * Drug: Fluorometholone 0.1% Oph Susp
* Drug: Artificial Tears
| Inclusion Criteria:~Age 15 years or more, corresponding to the age of patients treated in the Fred Hollows Foundation/Federal Ministry of Health Program at field sites without general anesthesia.~One or both eyes with upper lid trachomatous trichiasis-with one or more eyelashes touching the eye or evidence of epilation... | 15 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a 1:1 randomized, double-masked, placebo controlled clinical trial
Masking: Triple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative TT by one year, as determined by trained study team members | The primary outcome measure is the postoperative recurrence of trachomatous trichiasis (TT), defined as one or more eyelashes touching the globe or eviden... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Measure 1 - Entropion | Entropion (presence and extent) | 1 year |
| Efficacy Measure 2 - Reoperation | Reoperation for postoperative TT (recommended or done) | 1 year |
| Efficacy Measure 3 - Lashes | Number and location of lashes ... | fluorometholone 0.1%, trachomatous trichiasis, Eye Diseases, Eyelid Diseases, trachomatous, trichiasis, FLAME, TT Surgery | Fluorometholone, Lubricant Eye Drops, Ophthalmic Solutions, Pharmaceutical Solutions, Anti-Inflammatory Agents, Glucocorticoids, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists, Physiological Effects of Drugs, Anti-Allergic Agents | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fluorometholone<br>Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks | Drug: Fluorometholone 0.1% Oph Susp<br>* fluorometholone 0.1% one drop twice daily for four weeks, beginning with one drop just before trachomatous tri... | FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial
Study Overview
=================
Brief Summary
-----------------
This study aims : To assess the efficacy of fluorometholone 0.1% one drop twice daily for four weeks in reducing the incidence of post-operative trachomatous trichiasis (TT) when ... |
NCT02145260 | Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients | Intra-dialytic hypotensive (IDH) events can be defined as an abrupt decline in blood pressure that cause symptoms and/or require an intervention. They are common, affecting up to one third of maintenance HD sessions. Detrimental associations include: development of myocardial stunning, cerebral hypo-perfusion, vascular... | Randomized Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients | Intra-dialytic Hypotension | * Drug: Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)
* Drug: Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)
| Inclusion Criteria:~Chronic HD (>90 days)~Age ≥18y~Informed consent~First admission during study period.~Exclusion Criteria:~Use of pressors~Pre-dialysis serum sodium <=128mmol/L or > 145 mmol/L~Pre-dialysis SBP >180 mmHg~Intensive care stay earlier in admission~Expected length of stay <24 hours (e.g. admission for HD ... | 18 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intra-dialytic Decline in Systolic Blood Pressure | Pre-dialysis SBP minus lowest intra-dialytic SBP. The data table reflect the change in systolic blood pressured (SBP) assessed at up to 6 HD sessions, where the change for each sess... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pre-dialysis High-sensitivity Troponin I | Cardiac injury biomarkers | The change in pre-dialysis high sensitivity troponin I concentrations will be measured between the first and second inpatient hemodialysis sessions, occuring over... | Hemodialysis, Hypotension, Hospitalization | Dialysis Solutions, Pharmaceutical Solutions | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lower dialysate sodium<br>Dialysate sodium concentration of 138 mmol/L | Drug: Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)<br>* A lower dialysate sodium will bes used in the active comparator arm (138 m... | Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients
Study Overview
=================
Brief Summary
-----------------
Intra-dialytic hypotensive (IDH) events can be defined as an abrupt decline in blood pressure that cause symptoms and/or require an intervention. They are common, affecting up to one... | |
NCT04535856 | Therapeutic Study to Evaluate the Safety and Efficacy of DW-MSC in COVID-19 Patients | This is a phase 1 clinical trial to verify the safety and efficacy of DW-MSC in COVID-19 patients. A total of 9 subjects are randomly allocated. Subjects who meet the final inclusion and exclusion criteria are randomized to the test groups (low-dose group and high-dose group) or control group (placebo group) in a ratio... | Patients with Covid-19 have a mortality rate of about 35 ~ 50% and currently, severe patients caused by the Coronavirus show respiratory distress. To date, the incidence rate has been more than 3 million each year; however, as the increase and globalization of the environmental pollution has been expanded, the number o... | Therapeutic Study to Evaluate the Safety and Efficacy of DW-MSC in COVID-19 Patients: Randomized, Double-blind, and Placebo-controlled | Covid19, Corona Virus Infection, SAR | * Drug: allogeneic mesenchymal stem cell
* Other: Placebo
| Inclusion Criteria:~Age of 19 years or older at the time of screening~Those who have been confirmed COVID-19 infection through PCR test~Patients with mild or moderate COVID-19 who meet National EWS (0~6)~Those who have given written consent and voluntarily decided to participate before the screening procedure after und... | 19 Years | null | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Double-blind, and Placebo-controlled Clinical Trial
Masking: Quadruple
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of TEAE* in Treatment group | Incidence of TEAE* in Treatment group~* TEAE: Treatment-Emergent Adverse Event All adverse reactions will be organized according to System Organ Class (SOC) and Preferred Term (PT) using MedDRA (Medical ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | Survival rate is defined as the rate of subjects surviving until Day 14 and Day 28, and the number and rate of surviving subjects for each administration group is given. | until Day 14 and Day 28 |
| Duration of hospitalizatio... | Infectious Disease, covid-19, allogeneic mesenchymal stem cell | Coronavirus Infections, Pneumonia, Viral, Pneumonia, Respiratory Tract Infections, Infections, Virus Diseases, Coronaviridae Infections, Nidovirales Infections, RNA Virus Infections, Lung Diseases, Respiratory Tract Diseases, COVID-19 | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-dose group<br>Low-dose group (5 x 10^7cells):~Drug substance and the amount: 2.5 × 107 cells/1 mL/vial, 2 vials for low-dose group | Drug: allogeneic mesenchymal stem cell<br>* Assignment of Administration Group allogeneic mesenchymal ... | Therapeutic Study to Evaluate the Safety and Efficacy of DW-MSC in COVID-19 Patients
Study Overview
=================
Brief Summary
-----------------
This is a phase 1 clinical trial to verify the safety and efficacy of DW-MSC in COVID-19 patients. A total of 9 subjects are randomly allocated. Subjects who meet the fi... |
NCT01654328 | Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy | The purpose of this study is to investigate if home-hydration is a non inferior alternative for in-hospital hydration in the prevention of Contrast Induced Nephropathy in high risk patients. | Rationale: Iodinated contrast media are regularly used in diagnostic and interventional procedures. The intravascular use of these contrast media can cause acute kidney injury (Contrast Induced Nephropathy). Contrast Induced Nephropathy is associated with increased morbidity and mortality. There are no treatment option... | Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy | Radiographic Contrast Agent Nephropathy | * Drug: Sodium chloride tablets
* Drug: Isotonic saline intravenously
| Inclusion Criteria:~Adult patients > 18 years undergoing an elective procedure involving intravascular administration of iodinated contrast media~high risk for the development of Contrast Induced Nephropathy (as defined by guideline criteria~Exclusion Criteria:~Age < 18.~Low risk for the development of CIN, therefore n... | 18 Years | null | All | No | Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint will be change in the creatinine concentration between the 48-72 hours creatinine levels and the baseline levels, expressed as ratio. | | 48-72 hours after contrast administration |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| we will evaluate the incidence of contrast nephropathy in the groups defined as a rise in serum creatinine of ≥25% or ≥44umol/L 48-72 hours after contrast administration | | 48-72 hours after contrast administration |
| patient satisfaction.... | contrast media, kidney injury, hydration | Kidney Diseases, Urologic Diseases, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Male Urogenital Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: sodium chloride tablets<br>Arm A: sodium chloride 1g/10kg of body weight /day per os on day -2 and -1 before contrast exposure. With a maximum dose of 10 gram sodium chloride a day. | Drug: Sodium chloride tablets<br>* sodium chlori... | Oral Versus Intravenous Hydration to Prevent Contrast Induced Nephropathy
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if home-hydration is a non inferior alternative for in-hospital hydration in the prevention of Contrast Induced Nephropathy in high risk... |
NCT00096681 | Prevalence of HIV and Tuberculosis in Masiphumelele Township, Cape Town, South Africa | The purpose of this study is to estimate the amount of HIV and tuberculosis (TB) infection in individuals 15 years and older in the Masiphumelele township of Cape Town, South Africa. Data collected in this study will be used to predict the effect of introducing anti-HIV therapy in this community. | TB is the most common opportunistic infection among HIV infected people, and is the most common cause of death in HIV infected people in Africa. The Masiphumelele township of Cape Town, South Africa, with its high rates of TB and HIV, is representative of many poor communities of Africa. Via random sampling, this study... | Protocol for Cross-Sectional Survey of Acid-Fast Bacilli (AFB) Smear Positive and/or Culture Positive Tuberculosis in the Masiphumelele Township | HIV Infections, Tuberculosis | Inclusion Criteria:~Resident of the Masiphumelele township for at least 1 week prior to study entry~Willing to provide informed consent~Willing to comply with study requirements | 15 Years | null | All | Accepts Healthy Volunteers | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Microbiologically Confirmed Pulmonary Tuberculosis | Confirmed Pulmonary Tuberculosis based on the sputum smear and culture results. The sputum sample was obtained at the once off study visit. | Pulmonary Tuberculos... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Positive HIV Test | Prevalence of HIV in the community based on a positive oral mucosal transudate sample obtained at the once off study visit. | HIV status at the time of the study visit |
| Tuberculosis, Infections, Mycobacterium Infections, Actinomycetales Infections, Gram-Positive Bacterial Infections, Bacterial Infections, Bacterial Infections and Mycoses | Prevalence of HIV and Tuberculosis in Masiphumelele Township, Cape Town, South Africa
Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate the amount of HIV and tuberculosis (TB) infection in individuals 15 years and older in the Masiphumelele township of Cape Town,... | ||||
NCT04295525 | Carnosine Supplementation on Quantity/Quality of Oral Salivae. | The aim of this study is to elucidate the mutual relationship between salivae characteristics and oral microbiome and to compare them with common oral disease; furthermore, by using specific bioinformatic tools to analyse the data, the potentials of Carnosine in preventing/treating oral diseases and its mechanism of ac... | The pH of the oral cavity is a synthetic parameter that underlies a multifactorial process of continuous adjustment that includes the effect of salivae as a buffer and the contribution of the oral cavity microbiome. In some diseases of the oral cavity an alteration of these adjustment mechanisms is supposed to alter th... | PHoral: Effects of Carnosine Supplementation on Quantity/Quality of Oral Salivae in Healthy Volunteer and in Subjects Affected by Common Oral Pathologies. | Oral Diseases | * Dietary Supplement: 400 mg mucoadhesive oral tablet
* Dietary Supplement: placebo mucoadhesive oral tablet
| Inclusion Criteria for Oral Diseased subjects:~dental erosions (De)~caries (Ca)~périodontopathies (Pe)~Exclusion Criteria for both:~allergies/intolerances to the consumption of Carnosine~taking other food supplements~any type of drug treatment (interview)~smoking~pregnancy/lactation~any systemic diseases such as cardio... | 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 |
| --- | --- | --- |
| Effects on oral pH. | Any change of oral pH from basal. | 7 days |
| Saliva Production unstimulated. | Change of oral saliva production, unstimulated. | 7 days |
| Saliva Production stimulated. | Change of oral saliva production, stimulated.... | dental erosions, caries, périodontopathies | Mouth Diseases, Stomatognathic Diseases | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Controls subjects placebo<br>Placebo mucoadhesive oral tablet | Dietary Supplement: placebo mucoadhesive oral tablet<br>* placebo<br>|
| Experimental: Controls subjects active Treatment<br>AqualiefTM 400 mg mucoadhesive oral tablet |... | Carnosine Supplementation on Quantity/Quality of Oral Salivae.
Study Overview
=================
Brief Summary
-----------------
The aim of this study is to elucidate the mutual relationship between salivae characteristics and oral microbiome and to compare them with common oral disease; furthermore, by using specific ... | |
NCT05304065 | Youth Partners in Care for Suicide Prevention | This randomized comparative effectiveness trial will compare two evidence-based approaches to emergency care for youth ages 15-24 who present to the Emergency Department (ED) with suicidal ideation or behavior. OUtcomes will be monitored at baseline and at 3, 6 & 12 month follow-up assessments. | Rationale and Importance of Study:~Suicide is currently the second leading cause of death for U.S. youth ages 15-24, responsible for more deaths than any major illness. Youth with serious suicidal behavior or thoughts often present to the nation's Emergency Departments (EDs), particularly youth who make potentially dea... | Youth Partners in Care for Suicide Prevention | Suicide and Self-harm | * Behavioral: SAFETY-A within usual ED Care
* Behavioral: Combined SAFETY-A within usual ED Care + CLASP Therapeutic Follow-Up Contacts
| Inclusion Criteria:~age 15-24;~past-week suicidal behavior or ideation with plan or intent~Exclusion Criteria:~symptoms or illness that precludes informed consent or engagement in study procedures (e.g., active psychosis; drug dependence, no locator information);~youth not fluent in English~parent not fluent in English... | 15 Years | 24 Years | All | No | Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicide Attempts: Primary Clinical Outcome | suicide attempts fatal, nonfatal, and interrupted | Through 12 months of follow-up |
| Mental Health Treatment Initiation: Primary Service Use Outcome | initiation of mental health treatment after ... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Harm: Secondary Clinical Outcome | Any self-harm including suicidal, nonsuicidal, and ambiguous self-harm | Through 12 months of follow-up |
| Treatment engagement: Secondary Service Use Outcome | Treatment dose received | Through 12 mon... | Suicide, Suicide Prevention, Self-Injurious Behavior, Behavioral Symptoms | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SAFETY-Acute within Usual ED Care<br>The SAFETY-Acute (A) approach to safety planning and stabilization will be integrated within usual ED Care. SAFETY-A was formerly called the Family Intervention for Suicide Prevention, FISP. | Beha... | Youth Partners in Care for Suicide Prevention
Study Overview
=================
Brief Summary
-----------------
This randomized comparative effectiveness trial will compare two evidence-based approaches to emergency care for youth ages 15-24 who present to the Emergency Department (ED) with suicidal ideation or behavio... | |
NCT01582919 | Neuroimaging Markers of Alzheimer Disease: a Longitudinal Population Study | It is now acknowledged that Alzheimer's disease is characterized by a long period of pathophysiological change. Developing new strategies to achieve diagnoses as early as possible has become a major goal for therapies aimed at slowing the progression of this disease. While diagnoses currently rely principally on clinic... | The AMImage2 project that follows AMImage1 and MRI-3C consists of an imaging study in association with longitudinal epidemiologic cohorts (AMI and 3C). The first objective is to investigate the association between the evolution of imaging markers and the evolution of cognitive performance in normal and pathological agi... | STUDY OF IMAGING MARKERS IN THE VERY EARLY STAGES OF DEMENTIA AMONG RETIRED RURAL FARM IN THE GIRONDE AND PARTICIPATING IN THE AMI COHORT EPIDEMIOLOGY: A LONGITUDINAL STUDY. | Dementia, Alzheimer Disease | * Other: Neuroimaging
| Inclusion Criteria:~At least 65 years old~Be retired from agricultural profession~live in rural area in Gironde (France)~Exclusion Criteria:~Lefthanded~having a dementia (MMSE < 13)~Having a vascular cerebral accident~Parkinson disease~RMI exclusion criteria~[18F]-FDG PET SCAN exclusion criteria~Poor health condition d... | 65 Years | null | All | No | Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of volume and diffusion parameters in the gray matter (hippocampus and cingular posterior cortex) | | Inclusion (Day 0) |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance on neuropsychological and daily life cognitive tests | | Everyday up to Day 7 after inclusion |
| dementia, Alzheimer's Disease, diagnostic, biomarkers, neuroimaging, PET, MRI, mild cognitive impairment | Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participant from AMI cohort<br> | Other: Neuroimaging<br> <br> |
| Active Comparator: Participant from 3Ccohort<br> | Other: Neuroimaging<br> <br> |
| Neuroimaging Markers of Alzheimer Disease: a Longitudinal Population Study
Study Overview
=================
Brief Summary
-----------------
It is now acknowledged that Alzheimer's disease is characterized by a long period of pathophysiological change. Developing new strategies to achieve diagnoses as early as possible... |
NCT04378335 | Assessment of Orality Disorders in Children With Food Allergies | Orality disorders are frequent in child. There are complications like growth and psychomotor development disorders.~The aim is to estimate the prevalence of orality disorder for child with one or several food allergy. | Assessment of Orality Disorders in Children With Food Allergies | Food Allergy in Children, 6 Years Old Maximum | * Other: completion of questionnaire
| Inclusion Criteria:~Every child aged between 6 month and 6 years, with one or several food allergy and under the care of allergy unity of University Hospital of Angers~obtention of informed consent~Exclusion Criteria:~Child with allergy other than food~poor understanding of french | 6 Months | 6 Years | All | No | Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of orality disorder in children with food allergy | | Enrollment |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Link between orality disorder and number of excluded food, time from excluded regimen, age of the beginning of diet diversification, breastfeeding and duration,status of the child in the family and demographic data. | All data will be collecte... | Hypersensitivity, Food Hypersensitivity, Immune System Diseases, Hypersensitivity, Immediate | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: one arm<br>oral disorder | Other: completion of questionnaire<br>* parents have to complete 2 questionnaires: demographic questionnaire and Montréal questionnaire when they come on allergy consultation.<br>|
| Assessment of Orality Disorders in Children With Food Allergies
Study Overview
=================
Brief Summary
-----------------
Orality disorders are frequent in child. There are complications like growth and psychomotor development disorders. The aim is to estimate the prevalence of orality disorder for child with o... | ||
NCT03923231 | Pharmacokinetics of Atazanavir in Special Populations | The lack of data relating to the DDI between ATV and RIF is a major limitation to the use of ATV in patients who require treatment for TB. The VirTUAL Workpackage 2 will explore the necessary dose escalation required to overcome this interaction in non-pregnant HIV-infected adults who are virologically suppressed on bP... | Overview of VirTUAL Consortium Through the VirTUAL Consortium, the investigators aim to define the optimal use of second-line ART regimens in vulnerable populations with TB co-infection. The primary objective is to 'to determine the optimal dose of boosted atazanavir (ATV/r) when used in combination with RIF-based TB t... | Investigation of the Pharmacokinetics of Atazanavir in Pregnant Women, Individuals at Extremes of BMI, Children, and Adolescents: An Observational Study Nested Within the VirTUAL Consortium | HIV/AIDS, Tuberculosis | * Drug: Atazanavir 300mg/ Ritonavir 100 mg once daily
* Drug: Atazanavir 250 mg / ritonavir 80 mg
| Inclusion Criteria:~Evidence of a personally signed and dated informed consent document indicating that the participant (or a legal representative) has been informed of all pertinent aspects of the study.~In a child aged ≥7 years (South Africa) or aged ≥8 years (Uganda), evidence of assent to participate~Participants w... | null | null | All | No | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atazanavir Cmax | To describe the maximum concentration of atazanavir reached after dosing in the different groups | 3 years |
| Atazanavir AUC0-24 | To describe the area under the concentration-time curve from 0 to 24 hours after dosing in t... | | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of geometric mean of atazanavir Cmax with healthy adult population | To compare atazanavir Cmax with typical healthy individuals treated with atazanavir who enter a dose escalation study of ATV/r + RIF as WP2 of the VirTUAL programm... | Ritonavir, Atazanavir Sulfate, HIV Protease Inhibitors, Viral Protease Inhibitors, Protease Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Anti-HIV Agents, Anti-Retroviral Agents, Antiviral Agents, Anti-Infective Agents, Cytochrome P-450 CYP3A Inhibitors, Cytochrome P-450 Enzyme Inhibito... | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children <5 years<br>Children under the age of 5 years who are receiving atazanavir as part of clinical care | Drug: Atazanavir 250 mg / ritonavir 80 mg<br>* There is no intervention in this study - participants will all be receiving atazanavir (usually... | Pharmacokinetics of Atazanavir in Special Populations
Study Overview
=================
Brief Summary
-----------------
The lack of data relating to the DDI between ATV and RIF is a major limitation to the use of ATV in patients who require treatment for TB. The VirTUAL Workpackage 2 will explore the necessary dose esc... | ||
NCT00388076 | Pazopanib (VOTRIENT) Plus Paclitaxel (TAXOL), Pazopanib Plus Paclitaxel (TAXOL) Plus Carboplatin (PARAPLATIN), and Pazopanib Plus Paclitaxel (TAXOL) Plus Lapatinib (TYKERB) | Pazopanib will be given with TAXOL in one part, in another part pazopanib will be given with TAXOL and PARAPLATIN, and in a third part pazopanib will be given with TAXOL and lapatinib (patients separated in each part). Toxicity monitoring will enable us to find the largest dose of pazopanib daily that can be safely giv... | A Phase I, Open-Label, Study of the Safety, Tolerability, and Pharmacokinetics of Pazopanib in Combination With Paclitaxel on a Weekly Schedule for Three Consecutive Weeks of a 28-Day Cycle, Paclitaxel and Carboplatin on an Every 21 Days Schedule and Lapatinib and Paclitaxel on a Weekly Schedule for Three Consecutive W... | Neoplasms, Breast | * Drug: Pazopanib
* Drug: Lapatinib
* Drug: paclitaxel
* Drug: carboplatin
| Inclusion criteria:~Confirmed diagnosis of cancer, except cervical cancer~Eastern Cooperative Oncology Group performance Status of 0 or 1~Peripheral neuropathy of Grade 1 or less~Adequate bone marrow function (absolute neutrophils, platelets and hemoglobin levels as per protocol)~Adequate renal function as per protocol... | 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 |
| --- | --- | --- |
| Adverse Effects, Laboratory parameters | | before and after taking the study medications. |
| | Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood samples | | over a 24 hour period |
| Tumors | | will be measured at routine intervals throughout (e.g. by CT scan). |
| carboplatin, lapatinib, TAXOL, PARAPLATIN, paclitaxel, TYKERB, Pazopanib | Paclitaxel, Carboplatin, Lapatinib, Antineoplastic Agents, Phytogenic, Antineoplastic Agents, Tubulin Modulators, Antimitotic Agents, Mitosis Modulators, Molecular Mechanisms of Pharmacological Action, Protein Kinase Inhibitors, Enzyme Inhibitors | | Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br>pazopanib and paclitaxel | Drug: Pazopanib<br>* pazopanib in combination with paclitaxel in Part 1, paclitaxel and carboplatin in Part 2, and paclitaxel and lapatinib in Part 3<br>Drug: paclitaxel<br>* in combination with pazopan... | Pazopanib (VOTRIENT) Plus Paclitaxel (TAXOL), Pazopanib Plus Paclitaxel (TAXOL) Plus Carboplatin (PARAPLATIN), and Pazopanib Plus Paclitaxel (TAXOL) Plus Lapatinib (TYKERB)
Study Overview
=================
Brief Summary
-----------------
Pazopanib will be given with TAXOL in one part, in another part pazopanib will be... |
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