TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis
Brief Summary: The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.


Options:
A: angiographic binary re-restenosis (12 months)
B: Primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (CFDU) and without target lesion revascularization (TLR) within 12 months. (1 year); Proportion of subjects who experience serious device-related adverse events within 30 days post-procedure (30 days)
C: Freedom From Target Lesion Revascularization (TLR) (6 months); Freedom From Major Adverse Events (MAE) (30 days)
D: primary patency rate (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Open-label, 52-Week Extension Study to Evaluate the Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Brief Summary: The purpose of this study is to evaluate the long-term safety and efficacy of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.


Options:
A: Adverse Events (Baseline (Visit 1) to Week 53 (Visit 9))
B: Change in Weekly Average Pain Intensity (Baseline and Week 21clinic visits)
C: To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily (12 months)
D: Number of Awakenings After Sleep Onset (NAASO) (4-Week maintenance treatment with milnacipran and placebo); Sleep Efficiency (SE) (4-Week maintenance treatment with milnacipran and placebo); Wake After Sleep Onset (WASO) (4-Week maintenance treatment with milnacipran and placebo)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pulsed Short Wave in Females With Knee Osteoarthritis: A Multicenter, Randomized, Placebo-controlled Clinical Trial
Brief Summary: Study design: Randomized clinical trial. Objective: To evaluate the effect of PSW treatment in different doses and to compare to the control and placebo group.

Background: Several forms of conservative treatment have been the focus of many recent studies in knee osteoarthritis (OA). Among these techniques, the application of pulsed short wave has been widely used, but the optimal dose and application time still have not been well established.


Options:
A: Pain evaluation (1 year follow up)
B: Pain: Numerical pain scale (Baseline, 6 weeks, 3 months, 1 year)
C: Recruitment Rate (Baseline); Feasibility of Assessment Procedures: completion rate (Through study completion (16 weeks)); Retention Rate (Through study completion (16 weeks)); Feasibility of Research Assistant (RA) Training: rating (Baseline); Monitoring Treatment Fidelity (Through study completion (16 weeks))
D: Numerical Pain Rating Scale (NPRS) (Time 0 - baseline); Numerical Pain Rating Scale (NPRS) (Time 1 - after 10min of the baseline); Numerical Pain Rating Scale (NPRS) (Time 2 - after 72 hours of baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Diagnosis of Tuberculosis in HIV Infected Children in Asia (Cambodia, Vietnam) and Africa (Burkina Faso, Cameroon) ANRS 12229 PAANTHER 01 (Pediatric Asian African Network for Tuberculosis and HIV Research)
Brief Summary: Childhood tuberculosis (TB) accounts for 11% of the total 9 million annual TB cases and the difficulty of its diagnosis is increased in case of HIV infection in children.

The aim of this study is to improve TB diagnosis in HIV-infected children by developing a new diagnostic algorithm incorporating new tools available such as:

* interferon gamma release assays (IGRAs), as alternative to the tuberculin skin test
* alternative specimen collection methods such as string test (or Enterotest (R)), nasopharyngeal aspirates and stools samples, as alternatives to gastric aspirate
* the Xpert MTB/RIF assay


Options:
A: Retention in care with viral suppression (48 weeks after HIV testing)
B: Treatment time (Up to 8 weeks)
C: Time to TB treatment initiation (8 weeks follow up)
D: Tuberculosis diagnostic algorithm (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Diagnosis of Tuberculosis in HIV Infected Children in Asia (Cambodia, Vietnam) and Africa (Burkina Faso, Cameroon) ANRS 12229 PAANTHER 01 (Pediatric Asian African Network for Tuberculosis and HIV Research)
Brief Summary: Childhood tuberculosis (TB) accounts for 11% of the total 9 million annual TB cases and the difficulty of its diagnosis is increased in case of HIV infection in children.

The aim of this study is to improve TB diagnosis in HIV-infected children by developing a new diagnostic algorithm incorporating new tools available such as:

* interferon gamma release assays (IGRAs), as alternative to the tuberculin skin test
* alternative specimen collection methods such as string test (or Enterotest (R)), nasopharyngeal aspirates and stools samples, as alternatives to gastric aspirate
* the Xpert MTB/RIF assay


Options:
A: Tuberculosis diagnostic algorithm (3 years)
B: To evaluate the diagnostic performance of C-Tb in relation to age, HIV and CD4 counts (Onset between the injections and 28 days after the injections); To evaluate the clinical safety of C-Tb, with emphasis on children and HIV positive participants (Onset between the injections and 28 days after the injections)
C: All-cause mortality 12 weeks after inclusion (12 weeks)
D: To compare the size of induration of C-Tb and PPD RT 23 if injected alone or concomitantly in Tuberculosis infected patients (HIV positives and HIV negatives) (Onset from the injection(s) to 28 days after the injections); To assess if concomitant injections of C-Tb and PPD RT 23 influence the tests abilities to identify positive results of Tuberculosis in Tuberculosis infected patients (Onset from the injection(s) to 28 days after the injections)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Diagnosis of Tuberculosis in HIV Infected Children in Asia (Cambodia, Vietnam) and Africa (Burkina Faso, Cameroon) ANRS 12229 PAANTHER 01 (Pediatric Asian African Network for Tuberculosis and HIV Research)
Brief Summary: Childhood tuberculosis (TB) accounts for 11% of the total 9 million annual TB cases and the difficulty of its diagnosis is increased in case of HIV infection in children.

The aim of this study is to improve TB diagnosis in HIV-infected children by developing a new diagnostic algorithm incorporating new tools available such as:

* interferon gamma release assays (IGRAs), as alternative to the tuberculin skin test
* alternative specimen collection methods such as string test (or Enterotest (R)), nasopharyngeal aspirates and stools samples, as alternatives to gastric aspirate
* the Xpert MTB/RIF assay


Options:
A: Number of MDR TB Cases Amongst New TB Cases and Previously Treated TB Cases (2 months after enrollment)
B: increase TB case detection (6 months)
C: Tuberculosis diagnostic algorithm (3 years)
D: All-cause mortality 12 weeks after inclusion (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Diagnosis of Tuberculosis in HIV Infected Children in Asia (Cambodia, Vietnam) and Africa (Burkina Faso, Cameroon) ANRS 12229 PAANTHER 01 (Pediatric Asian African Network for Tuberculosis and HIV Research)
Brief Summary: Childhood tuberculosis (TB) accounts for 11% of the total 9 million annual TB cases and the difficulty of its diagnosis is increased in case of HIV infection in children.

The aim of this study is to improve TB diagnosis in HIV-infected children by developing a new diagnostic algorithm incorporating new tools available such as:

* interferon gamma release assays (IGRAs), as alternative to the tuberculin skin test
* alternative specimen collection methods such as string test (or Enterotest (R)), nasopharyngeal aspirates and stools samples, as alternatives to gastric aspirate
* the Xpert MTB/RIF assay


Options:
A: All-cause mortality 12 weeks after inclusion (12 weeks)
B: Tuberculosis diagnostic algorithm (3 years)
C: All-cause mortality (8 weeks)
D: All-cause Mortality (6 months post-HAART initiation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Continuous Saphenous Nerve Block (Adductor Channel) and Local Infiltration Analgesia (LIA) for Total Knee Arthroplasty
Brief Summary: Our study will compare the use of continuous saphenous nerve block performed at the adductor canal in addition to Local Infiltration Analgesia (LIA) versus a Sham block in addition to LIA for total knee replacement. The investigators hypothesize that the saphenous nerve block performed at the level of the adductor canal in addition to LIA provides better pain relief than the LIA alone without significantly compromising muscle strength and physiotherapy, enabling patients to mobilize early with reduced opioid consumption and les side effects.

The investigators will enroll a total of 40 patients (20 patients will receive continuous saphenous nerve block in addition to LIA and 20 will receive the sham block and LIA). Until discharge, the investigators will record patients' pain scores, opioid consumption, side effects and physical therapy progress.

If our study proves that the continuous saphenous nerve block in addition to LIA can effectively reduce postoperative pain scores to an acceptable level with better physical therapy progress and less opioid consumption, it could be seen as a more attractive alternative to LIA alone or other traditionally used methods of postoperative pain control that compromises muscle strength and physiotherapy.


Options:
A: Pain scores (3 days postoperative)
B: Pain during 45 degrees active flexion of the knee (1 hour postoperative)
C: Morphine Equivalents (12 hours postoperatively and 20 hours after placement of catheter)
D: Changes in Visual pain scale (Changes from the baseline visual pain scale to 1 week after surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An 11-week Randomized, Double-blind, Multi Center, Placebo-controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (300 Mg/Day) Using A Fixed Dosing Schedule In The Treatment Of Subjects S With Pain Associated With Diabetic Peripheral Neuropathy.
Brief Summary: Pregabalin has proven effective in previous clinical trails in other countries in relieving neuropathic pain associated with postherpetic neuralgia and painful diabetic neuropathy.

This study is being conducted according to China registration requirement to submit a reapplication with new local diabetic peripheral neuropathy study as a commitment plus the existing data to apply for Lyrica "pain associated with postherpetic neuralgia" indication after Lyrica "pain associated with postherpetic neuralgia" is approved.


Options:
A: Baseline Mean Pain Score (Baseline); Change From Baseline in Mean Pain Score at Endpoint (Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint))
B: Mean pain score
C: Change From Baseline to Study Endpoint in Mean Weekly Pain Scores (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Number of Responders (From baseline to Week 13 or up to study discontinuation (Study Endpoint)); Change From Baseline at Week 1 in Mean Weekly Pain Scores (From baseline to Week 1); Change From Baseline at Week 2 in Mean Weekly Pain Scores (From baseline to Week 2); Change From Baseline at Week 3 in Mean Weekly Pain Scores (From baseline to Week 3); Change From Baseline at Week 4 in Mean Weekly Pain Scores (From baseline to Week 4); Change From Baseline at Week 5 in Mean Weekly Pain Scores (From baseline to Week 5); Change From Baseline at Week 6 in Mean Weekly Pain Scores (From baseline to Week 6); Change From Baseline at Week 7 in Mean Weekly Pain Scores (From baseline to Week 7); Change From Baseline at Week 8 in Mean Weekly Pain Scores (From baseline to Week 8); Change From Baseline at Week 9 in Mean Weekly Pain Scores (From baseline to Week 9); Change From Baseline at Week 10 in Mean Weekly Pain Scores (From baseline to Week 10); Change From Baseline at Week 11 in Mean Weekly Pain Scores (From baseline to Week 11); Change From Baseline at Week 12 in Mean Weekly Pain Scores (From baseline to Week 12); Change From Baseline at Week 13 in Mean Weekly Pain Scores (From baseline to Week 13)
D: Number of Participants With Loss of Therapeutic Response. (13 Weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Provent® on Obstructive Sleep Apnea During Continuous Positive Airway Pressure Therapy Withdrawal: a Randomised Controlled Trial.
Brief Summary: Randomised, placebo-controlled trial of continuous positive airway pressure therapy (CPAP) versus Provent® and Placebo-Provent® to define the effects of Provent® on the severity of obstructive sleep apnea, daytime symptoms as well as on measures of cardiovascular risk.


Options:
A: 30-day mortality (12 months)
B: resident-related preventable adverse events and near misses. (Each resident (subject) will be observed for 1 month.)
C: Sleep apnoea severity, daytime symptoms of sleep apnoea (2 weeks)
D: subjective sleepiness and other OSAS symptoms (3 months, 1 year, 2 years); quality of life (3 months, 1 year, 2 years); percentage of withdrawal and cross-over to other CPAP mode (3 months, 1 year, 2 years); objective vigilance (3 months, 1 year, 2 years); blood pressure (3 months, 1 year, 2 years); cost/utility ratios (3 months, 1 year, 2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study to Assess the Efficacy, Safety, and Pharmacokinetics of XP13512 (GSK1838262) in Patients With Restless Legs Syndrome
Brief Summary: The objective of the study was to generate the data necessary to determine the gabapentin exposure produced by 4 dose levels of GEn (600 mg, 1200 mg, 1800 mg, and 2400 mg) or placebo, and the corresponding relief of symptoms in subjects with Restless Legs Syndrome (RLS).


Options:
A: The change from baseline to the end of treatment in International Restless Legs Syndrome (IRLS) rating scale score. (12-week treatment period); The proportion of subjects at the end of treatment who are "much improved" or "very much improved" on the Investigator-rated CGI of Improvement (12-week treatment period)
B: Change From Baseline in IRLS Rating Scale Total Score at Week 12 Using Last Observation Carried Forward (LOCF) (Baseline and Week 12); Number of Participants With a Score of "Much Improved" or "Very Much Improved" on the Investigator-rated CGI-I Scale (Response) at (Week 12) Using LOCF (Week 12)
C: IRLS severity scale (24 and 48 wks)
D: Mean Css, Max and Css, Min (Weeks 4 and 12); Mean Tmax and T1/2 (Weeks 4 and 12); Mean AUCss (Weeks 4 and 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Biomarkers in Autism of Aripiprazole and Risperidone Treatment
Brief Summary: The Biomarkers in autism of aripiprazole and risperidone treatment (BAART) project will provide evidence-based guidance in the selection and monitoring of drug treatment of autism. BAART involves 3 academic centers across South Carolina. Although the FDA has approved use of the antipsychotic drug risperidone for irritability associated with autistic disorder, a moderate response rate in pivotal clinical trials and concerns over tolerability and weight gain can force clinicians to select alternative drug treatments for which evidence-based support is sparse.


Options:
A: Changes in the Irritability Subscale of the Larger ABC (Abberent Behavior Checklist) That Occur From Baseline to 10 Weeks (baseline to 10 weeks)
B: Change From Baseline in Vineland™-II Adaptive Behavior Scale Two Domain Composite (2DC) Score at Week 24 for Balovaptan (R05285119) 10 mg Equivalent Compared to Placebo (Baseline, Week 24)
C: N/A
D: Clinical Global Impression-Improvement (Change from baseline to end of week 12); Aberrant Behavior Checklist- Irritability (Change between baseline and end of each phase)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Biomarkers in Autism of Aripiprazole and Risperidone Treatment
Brief Summary: The Biomarkers in autism of aripiprazole and risperidone treatment (BAART) project will provide evidence-based guidance in the selection and monitoring of drug treatment of autism. BAART involves 3 academic centers across South Carolina. Although the FDA has approved use of the antipsychotic drug risperidone for irritability associated with autistic disorder, a moderate response rate in pivotal clinical trials and concerns over tolerability and weight gain can force clinicians to select alternative drug treatments for which evidence-based support is sparse.


Options:
A: Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) - Social Domain (16 weeks)
B: Changes in the Irritability Subscale of the Larger ABC (Abberent Behavior Checklist) That Occur From Baseline to 10 Weeks (baseline to 10 weeks)
C: Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6 (Baseline to 6 Weeks)
D: The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score. (Throughout the study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Biomarkers in Autism of Aripiprazole and Risperidone Treatment
Brief Summary: The Biomarkers in autism of aripiprazole and risperidone treatment (BAART) project will provide evidence-based guidance in the selection and monitoring of drug treatment of autism. BAART involves 3 academic centers across South Carolina. Although the FDA has approved use of the antipsychotic drug risperidone for irritability associated with autistic disorder, a moderate response rate in pivotal clinical trials and concerns over tolerability and weight gain can force clinicians to select alternative drug treatments for which evidence-based support is sparse.


Options:
A: The change from baseline in the Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale scores (Baseline, Week 8)
B: Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents (week 10); Percentage of Participants Who Were Autism Spectrum Disorder Respondents (week 10)
C: Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale (6 Weeks)
D: Changes in the Irritability Subscale of the Larger ABC (Abberent Behavior Checklist) That Occur From Baseline to 10 Weeks (baseline to 10 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC-0156-0000-0009 When Used for Treatment and Prophylaxis of Bleeding Episodes in Patients With Haemophilia B
Brief Summary: This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for treatment and prophylaxis of bleeding episodes in patients with haemophilia B.


Options:
A: Bleeding Frequency (Number of Total Bleeds) (After the last enrolled patient has been in the study for 1 year. At the cut-off, the median follow-up duration was 616 days (minimum was 111 days and maximum was 1109 days))
B: Occurrence of FVIII Inhibitor Development (Up to Week 26 +/- 7 days, or up to 50 exposure days (EDs) if reached prior to Week 26)
C: Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units) (52 weeks after treatment start for patients on prophylaxis); Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units) (28 weeks after treatment start on on-demand treatment)
D: Mean Transformed Annualized Bleed Rate Estimates From Each of the 1-year Prophylaxis Regimens (12 months ±2 weeks); Median Annualized Bleed Rate Estimates From Each of the 1 Year Prophylaxis Regimens (12 months ±2 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Community-Based Lifestyle Promotion With Latino Women
Brief Summary: The overall goal of this randomized controlled trial is to evaluate the effects of a community-based lifestyle behavior intervention (LSBI) that is designed to improve dietary habits and physical activity (PA), and reduce weight of Latino women who are predominantly Spanish-speaking immigrants. It is hypothesized that middle-aged overweight/obese Latinas participating in a LSBI conducted by lay health advisors will demonstrate improved dietary habits, increased physical activity and a decrease in BMI compared to those in a control condition, Women in the LSBI also are expected to demonstrate improvements in selected physiologic outcomes (waist circumference, blood pressure \[BP\], measures of cholesterol and blood sugar).


Options:
A: Change in Body mass index (BMI) (Baseline, 6 and 9 month follow-up.)
B: Change in BMI (Before intervention and after (12-14 weeks after first assessment))
C: efficacy of PC-ACP
D: Use of sun protection (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Schooling Protect Young Women From HIV?
Brief Summary: This study is designed to evaluate a two-year randomized intervention in Malawi that provides cash transfers to current schoolgirls (and young women who have recently dropped out of school) to stay in (and return to) school in order to understand the possible effects of such programs on the sexual behavior of the beneficiaries and their subsequent HIV risk.


Options:
A: Targeted fruit and vegetable (TFV) intake (Intake in prior 24 hours; assessed in two follow-up rounds (4-6 mo and 9-11 mo post-implementation) with 10% replicate subsample in each round; data pooled across two follow-up rounds and replicate samples for primary analysis)
B: Growth (Measurements will be made for children between the ages of 3 and 12 months of age at baseline and then 2 years later, at endline, when the children are between the ages of 23 and 40 months); Hemoglobin (Measurements will be made for children between the ages of 3 and 12 months of age at baseline and then 2 years later, at endline, when the children are between the ages of 23 and 40 months)
C: Incidence of Diarrhea (2 weeks)
D: Sexually Transmitted Infections (18 months); Schooling (12 months/24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Schooling Protect Young Women From HIV?
Brief Summary: This study is designed to evaluate a two-year randomized intervention in Malawi that provides cash transfers to current schoolgirls (and young women who have recently dropped out of school) to stay in (and return to) school in order to understand the possible effects of such programs on the sexual behavior of the beneficiaries and their subsequent HIV risk.


Options:
A: Child nutritional status
B: Cumulative incidence of child wasting (3-monthly until 24 months after inclusion); Incremental cost-effectiveness ratio (24 months after inclusion)
C: Sexually Transmitted Infections (18 months); Schooling (12 months/24 months)
D: Recovery rate in the outpatient therapeutic program (At 6 week)

Answer: C