TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Prebiotic Fiber on Gut Microbiota, Intestinal Permeability and Glycemic Control in Children With Type 1 Diabetes: A Pilot Randomized, Double Blind, Placebo Controlled Study
Brief Summary: The gut microbiome is increasingly recognized as a contributor to disease states. In type 1 diabetes, alterations in gut microbiota may be linked to changes in intestinal permeability, inflammation and insulin resistance. Prebiotic fiber is a dietary supplement that alters gut microbiota and could potentially improve insulin sensitivity in children with type 1 diabetes. This pilot study aims to determine the feasibility of a 12-week dietary intervention with prebiotic fiber in children with type 1 diabetes. The investigators hypothesize that consumption of prebiotic fiber will alter gut microbiota and intestinal permeability, leading to improved glycemic control. Prebiotic fiber is a potentially novel, inexpensive, low-risk treatment addition for type 1 diabetes that may improve glycemic control by changes in gut microbiota, gut permeability and inflammation.


Options:
A: Development and evaluation of the CFAbd-Score (initially named JenAbdomen CF-Score), a CF-specific PROM following FDA recommendations (7 years); Development and evaluation of a diary for assessment and quantification of abdominal symptoms, a CF-specific PROM following FDA recommendations (7)
B: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
C: Glycemic control (serum hemoglobin A1c) (3 month after start of trial)
D: Absolute Mean Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24 (baseline through 24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir: A Randomized, Double-blind, Crossover Study
Brief Summary: Dyslipidemia as a risk factor for cardiovascular disease (CVD) is an increasing problem in HIV-infected patients who are on antiretroviral therapy especially protease inhibitors including atazanavir. Pitavastatin is a new HMG-CoA reductase inhibitor with lesser drug-drug interactions and demonstrable efficacy in decreasing lipid levels in non HIV-infected individuals. The study was conducted as a randomized, double-blind, crossover study comparing the safety and efficacy of pitavastatin versus placebo in HIV-infected patients with dyslipidemia and receiving atazanavir/ritonavir. Patients were randomized to receive either placebo or pitavastatin for 12 weeks, underwent a 2-week washout period, and then were given the other treatment for an additional 12 weeks. Patients were observed for lipid profiles including total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL) and high density lipoprotein (HDL); and the side effects including clinical and laboratory (serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and creatinine phosphokinase (CPK)). The follow-up visits were every 4 weeks until the end of the study.


Options:
A: Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir (12 weeks)
B: The change of LDL-C (Baseline to 12 weeks)
C: Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks (Baseline to 12 weeks)
D: Percent Change From Baseline in LDL-C (Baseline to 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Teens Against Tobacco Use: A Model for Universal Tobacco Prevention and Youth Advocacy
Brief Summary: This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on tobacco use susceptibility in 4th-8th grade. Classrooms are randomly assigned to either receive a series of two presentations or wait listed to receive them later in the school year.


Options:
A: Acceptability: follow-up survey (5 months); Feasibility: recruitment and retention rates (5 months)
B: Standardized Tobacco Susceptibility as assessed by 12 likert scale items drawn primarily from the global youth tobacco survey (within 24 hours of receiving presentation)
C: Number of Participants With Self-reported 30-day Point Prevalence Abstinence (ITT) (7 months post enrollment)
D: Point Prevalent Abstinence (PPA) from vaping (1 month); Point Prevalent Abstinence (PPA) from vaping (3 months); Point Prevalent Abstinence (PPA) from vaping (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Adult Male Circumcision With Unicirc Under Topical Anesthetic vs Open Surgical Circumcision: a Randomized Controlled Trial
Brief Summary: RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical circumcision under local anesthetic with suturing.


Options:
A: HIV incidence (2 years); surgical complications (2 years)
B: Procedure time (9 weeks)
C: Measure the protective effect of medicalized male circumcision on HIV infection (M3, M12 and M21)
D: Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing (Up to 30 minutes)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pharmacokinetic Analysis of Tacrolimus ER Dosing in Obese Kidney Transplant Recipients
Brief Summary: Tacrolimus extended release (Astagraf) has recently been approved by the FDA as a once a day dosing regimen. This formulation has the potential to improve compliance. Current dosing recommendation for the extended release formulation in renal transplant is 0.15 mg/kg/day administered once daily in the morning. There are no specifications on appropriate dosing in obese patients or on whether to use actual, ideal or and adjusted weight. It will be advantageous to understand the pharmacokinetics of this medication in the obese to determine the appropriate dosing regimen. In this study, obese patients will be randomized to receive tacrolimus extended release 0.15 mg/kg/day based on either ideal body weight (IBW) or adjusted body weight (aBW).


Options:
A: Percentage change of 24-hour proteinuria (6 months)
B: To determine the change in eGFR from baseline in patients with type 2 diabetes and CKD (baseline eGFR = 20 - 45 mL/min/1.73m2) after receiving bardoxolone methyl for 6 months (24 weeks) following randomization (6 months (24 weeks)); To determine the safety and tolerability of bardoxolone methyl when administered for 12 months (52 weeks)following randomization to type 2 diabetic patients with CKD (eGFR 20 - 45 mL/min/1.73m2). (1 year (52 weeks))
C: Change in Proteinuria (12 weeks minus baseline); Change in Proteinuria (52 weeks minus baseline)
D: Difference in Tacrolimus Exposure (AUC-0-24)) in Obese Patients Who Received an Initial TAC -ER Dose of 0.15 mg/kg Using aBW Versus IBW (Days 1-14)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study on Improved Prevention Methods for Cerebro-cardiovascular Diseases Based on a Computer-aided Prevention System
Brief Summary: Stroke is one of the most frequent and life-threatening diseases in Europe. About four stroke events occur per day in Luxembourg alone, and about 30% of these patients are affected by recurrent stroke within the following five years. Thus, new methods of primary and secondary prevention are needed to better control lifestyle-related risk factors.

The development and maintenance of a healthy lifestyle (smoking cessation, healthy nutrition, moderate physical exercises etc.) is a major objective concerning the primary and secondary prevention of cerebro- and cardiovascular diseases. CAPSYS is a computer-based lifestyle coaching system developed by researchers from the Public Research Centre (CRP) Henri Tudor in Luxembourg in collaboration with neurologists from the Centre Hospitalier de Luxembourg (CHL), which aims at supporting patients in performing appropriate behavior changes in order to minimize their individual risk factors. Patients can access CAPSYS by dialing a local-rate telephone number and answer to a set of previously known questions concerning their current nutrition, physical activity, blood pressure, smoking etc. In an interactive voice response approach, questions are issued by the system in natural language using text-to-speech, and the patient can provide the required values using the phone keypad. Based on the gathered values for each patient, the system automatically generates personalized verbal feedback at runtime and presents it to the patient during the phone dialog. Depending on the individual development of the patient's risk factors, the system feedback can contain advice for improvement, praise for healthy behavior and motivation to pursue a certain goal.

The user acceptance and effectiveness of the CAPSYS system is evaluated in a six-month randomized controlled study with participants recruited at CHL's neurology department.


Options:
A: Change in Systolic Blood Pressure (baseline and 6 months); Change in HDL Level (baseline and 6 months); Change in LDL Level (baseline and 6 months); Change in Triglyceride Level (baseline and 6 months); Change in HbA1c Level (baseline and 6 months); Change in Glycaemia Level (baseline and 6 months); Change in BMI Value (baseline and 6 months)
B: Blood Pressure (12 months)
C: Low Density Lipoprotein Value (1 year); Systolic Blood Pressure Value (1 year); Hemoglobin A1C Value (1 year); Pill count of antiplatelet therapy medications (1 year)
D: blood pressure (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study on Improved Prevention Methods for Cerebro-cardiovascular Diseases Based on a Computer-aided Prevention System
Brief Summary: Stroke is one of the most frequent and life-threatening diseases in Europe. About four stroke events occur per day in Luxembourg alone, and about 30% of these patients are affected by recurrent stroke within the following five years. Thus, new methods of primary and secondary prevention are needed to better control lifestyle-related risk factors.

The development and maintenance of a healthy lifestyle (smoking cessation, healthy nutrition, moderate physical exercises etc.) is a major objective concerning the primary and secondary prevention of cerebro- and cardiovascular diseases. CAPSYS is a computer-based lifestyle coaching system developed by researchers from the Public Research Centre (CRP) Henri Tudor in Luxembourg in collaboration with neurologists from the Centre Hospitalier de Luxembourg (CHL), which aims at supporting patients in performing appropriate behavior changes in order to minimize their individual risk factors. Patients can access CAPSYS by dialing a local-rate telephone number and answer to a set of previously known questions concerning their current nutrition, physical activity, blood pressure, smoking etc. In an interactive voice response approach, questions are issued by the system in natural language using text-to-speech, and the patient can provide the required values using the phone keypad. Based on the gathered values for each patient, the system automatically generates personalized verbal feedback at runtime and presents it to the patient during the phone dialog. Depending on the individual development of the patient's risk factors, the system feedback can contain advice for improvement, praise for healthy behavior and motivation to pursue a certain goal.

The user acceptance and effectiveness of the CAPSYS system is evaluated in a six-month randomized controlled study with participants recruited at CHL's neurology department.


Options:
A: Framingham Risk Score (15 months)
B: Change in Systolic Blood Pressure (baseline and 6 months); Change in HDL Level (baseline and 6 months); Change in LDL Level (baseline and 6 months); Change in Triglyceride Level (baseline and 6 months); Change in HbA1c Level (baseline and 6 months); Change in Glycaemia Level (baseline and 6 months); Change in BMI Value (baseline and 6 months)
C: Reduction in systolic blood pressure taken by study team at home visit (12 months)
D: Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II) (End of program (6 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Isotonic Solutions and Major Adverse Renal Events Trial in the Medical Intensive Care Unit
Brief Summary: The administration of intravenous fluids is ubiquitous in the care of the critically ill. Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte compositions including a range chloride concentrations. Recent studies have associated solutions with supraphysiologic chloride content with hyperchloremia, metabolic acidosis and renal vasoconstriction, acute kidney injury and renal replacement therapy, and increased mortality but no large, randomized-controlled trials have been conducted. SMART-MED will be a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from the Medical ICU at Vanderbilt University from June 2015 until April 2017. The primary endpoint will be the incidence of Major Adverse Kidney Events in 30 days after enrollment (MAKE30 is the composite of death, new renal replacement, or persistent renal dysfunction at discharge).


Options:
A: Mean base excess during hospital stay (Six month control period (before) and 6 month intervention period (after))
B: Quality of Recovery-40 Score at 24 Hours (24 hours after ED visit)
C: Change in the base deficit (24 hours after randomization)
D: Major Adverse Kidney Event Within 30 Days (30 days after enrollment censored at hospital discharge)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Open-label, Multicenter Phase-II Trial to Evaluate Efficacy and Safety of a Sequential Regimen of Bendamustine Followed by GA101 (Obinutuzumab) and CAL-101 (Idelalisib) Followed by CAL-101 and GA101 Maintenance in CLL Patients
Brief Summary: The CLL2-BCG-trial is a prospective, open-label, multicenter phase-II-trial to evaluate the efficacy and safety of a sequential regimen of a debulking with bendamustine followed by an induction with GA101 (obinutuzumab) and CAL-101 (idelalisib) followed by CAL-101 and GA101-maintenance in CLL patients


Options:
A: Progression-Free Survival (Randomization to End of Study (up to 60 months))
B: Overall response rate (ORR) (84 days after start of the last induction cycle)
C: Overall Response Rate (The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) months)
D: Progression-free Survival by IRC (Independent Review Committee) Assessment in Arm A Compared to Arm B (IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of the study is to compare efficacy and safety of palliative chemotherapy EOX and mDCF regimens in the first-line treatment of patients with advanced HER2-negative gastric and gastroesophageal junction (GEJ) adenocarcinoma


Options:
A: Number of Participants Experiencing Adverse Events (AEs) (Serious AEs: Up to 90 days after last dose of treatment (Up to 28 months); nonserious AEs: Up to 30 days after last dose of treatment (Up to 26 months) - through final analysis (FA) cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C)); Number of Participants Discontinuing From Study Treatment Due to an AE (Up to last dose of study treatment (Up to approximately 25 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C)); Overall Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Response Rate Based on Blinded Independent Central Radiology (BICR) Review (Cohorts A, B, C, and D) (Every 8 weeks until disease progression (Cohorts A, B, D: Up to ~ 35 months; Cohort C: Up to ~ 28 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, D) & 01 Sep 2015 (Cohort C)); Overall RECIST 1.1 Response Rate Based on BICR Review for Participants in Cohort B2 (Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016)
B: Overall Survival (OS) - Percentage of Participants With an Event (Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis); Overall Survival - Time to Event (BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis)
C: Overall Survival (3 years)
D: Overall survival (every course for first three courses, then every other course)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of the study is to compare efficacy and safety of palliative chemotherapy EOX and mDCF regimens in the first-line treatment of patients with advanced HER2-negative gastric and gastroesophageal junction (GEJ) adenocarcinoma


Options:
A: The primary endpoint is the Progression-free survival (PFS) according to RECIST V1.1. (Average time period: up to one year (participants are followed until progression or death))
B: Time to Progression (every 8 weeks up to a maximum of 36 months)
C: Overall Survival (3 years)
D: Overall Survival (From randomization until death due to any cause (average of 51 weeks)); Overall Survival in All Randomized Participants (From randomization until death due to any cause (average of 51 weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Brief Summary: This is a multi-center, phase II study to determine the efficacy and safety of CTL019 in adult patients with relapsed or refractory DLBCL.


Options:
A: Dose-limiting toxicity (DLT) (28 days)
B: Overall Response Rate (ORR) Per Independent Review Committee (IRC) in Main Cohort (60 months)
C: Number of Adverse Events After CAR 20/19-T Cell Infusion (28 days after infusion)
D: Adverse events attributed to Tcm adoptive transfer as reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Up to 15 years); MTD of CD19-CAR-specific/truncated EGFR lentiviral vector-transduced autologous T cells based on dose limiting toxicities (Up to day 28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Post-operative Trial of Platinum Based Chemotherapy vs. Capecitabine in Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy
Brief Summary: This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin or carboplatin is more effective than capecitabine in treating patients with residual triple negative basal-like breast cancer.


Options:
A: 3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patients (No mandatory timeline, assessed at any time as a standard of care procedure or at the investigator's discretion; data reported every 3 months within 2 years from randomization, every 6 months if 2-3 years.)
B: Definition of a biomarker (profile) characterizing "good responders" to dual blockade T and P anti-HER2 blockade that have similar pCR rates as patients treated with identical dual anti-HER2 blockade + taxane backbone (After 12 weeks of therapy)
C: Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery (Up to approximately 27-30 weeks); Event-free Survival (EFS) as assessed by Investigator (Up to approximately 8 years)
D: Pathological Complete Response (pCR). (At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Randomized Placebo Controlled Trial of Electroacupuncture for Women With Pure Stress Urinary Incontinence
Brief Summary: The purpose of this study is to preliminarily assess the efficacy of electroacupuncture (EA) for women with pure stress urinary incontinence (SUI).


Options:
A: Stress test (12 weeks)
B: Change From Baseline of Urine Leakage Measured by 1-hour Pad Test (Baseline and week 6)
C: Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12 (baseline, weeks 1-12)
D: value difference of 1h pad test, compared with the baseline (the 6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Design, Development And Validation Of A On-Line Intervention For Promoting Healthy Habits And Weight Loss In Hypertensive And Risk For Diabetes Mellitus People With Overweight And Type I Obesity
Brief Summary: Efficacy of an Internet-based self-guided intervention for promoting healthy habits and weight loss in hypertensive people with overweight and obesity: A Randomized Controlled Trial


Options:
A: N/A
B: The occurrence of myocardial infarction, coronary bypass surgery, percutaneous transluminal coronary angioplasty, stroke, carotid endarterectomy, percutaneous transluminal cerebral angioplasty, carotid artery stenting, or death (Every 12 months, at the end of the study.)
C: Changes in blood pressure levels at 6 and 12 months (It will be avaluated before and after a 3 months intervention, and follow up in 6 and 12 months.)
D: N/A

Answer: C