TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation
Brief Summary: Pain associated with fibromyalgia interferes with daily function, work, and social activities resulting in a decreased quality of life. People with fibromyalgia also have a significant amount of fatigue and a fear of movement. People with fibromyalgia show enhanced excitability of pain neurons in the central nervous system and reduced pain inhibition. Therefore, one of the main treatments for patients with fibromyalgia must focus on pain relief to allow the person to function more independently both at home and at work. Transcutaneous electrical nerve stimulation is used by health professionals to deliver electrical stimulation through the skin for pain control. Basic science studies, from the PI's laboratory show that TENS activates descending pain inhibitory pathways to inhibit excitability of pain neurons. Thus the ideal patient population for the treatment of TENS would be one in which there is enhanced central excitability and reduced inhibition; fibromyalgia is such a condition.

Hypothesis: The investigators hypothesize that application of Transcutaneous Electrical Nerve Stimulation (TENS) to patients with fibromyalgia will reduce resting and movement-related pain and reduce central excitability by restoring diffuse noxious inhibitory controls (DNIC), and that this decrease in pain and/or central excitability will reduce fatigue and fear of movement, thereby improving function and quality of life


Options:
A: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
B: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
C: Pain Rating With Movement (0-10 Low to High Scale) During Six Minute Walk Test (Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS); Pain Rating With Movement (0-10 Low to High Scale) During Five Time Sit to Stand Test (Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS))
D: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Glycemic control is fundamental in the management of diabetes mellitus .If lifestyle intervention and full tolerated doses of one or two oral glucose lowering drugs (OGLDs) fail to achieve or sustain glycemic goals, insulin should be initiated. New insulin analogs are generated to improve glycemic control .New insulin analogs are generated to improve glycemic control,However, the cost of these analogs is a major problem .The aim of this piggy back evaluation was to assess the effect of BIAsp 30 versus NPH plus regular human insulin on metabolic control as well as its cost-effectiveness in people with type 2 diabetes in the Iranian setting.


Options:
A: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
B: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)
C: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
D: Number Of Hypoglycemic events (3 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cost-effectiveness Study of Nicotine Patches Distributed Through a Quitline
Brief Summary: The study is to understand whether distribution of two different supplies of nicotine patches through a telephone quitline has an effect on quit rates. The two different supplies are four vs. eight (in two separate four-week mailings) weeks of nicotine patches. The hypothesis is that eight weeks will be slightly more efficacious but four weeks will be more cost-effective.


Options:
A: 7-day smoking abstinence (7 days); 6-month smoking abstinence (6 months); cost-effectiveness (6 months)
B: Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement (6 months)
C: The daily number of intakes during the first three weeks recorded with an electronic device fixed on the spray unit (microswitch-actuated metered-dose inhaler chronology, MDILog™, model MDC-511, Medtrac, Denver, Colorado). (first 3 weeks)
D: 6 Month Self-reported Abstinence From Smoking (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cost-effectiveness Study of Nicotine Patches Distributed Through a Quitline
Brief Summary: The study is to understand whether distribution of two different supplies of nicotine patches through a telephone quitline has an effect on quit rates. The two different supplies are four vs. eight (in two separate four-week mailings) weeks of nicotine patches. The hypothesis is that eight weeks will be slightly more efficacious but four weeks will be more cost-effective.


Options:
A: 7-day smoking abstinence (7 days); 6-month smoking abstinence (6 months); cost-effectiveness (6 months)
B: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)
C: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
D: Self-Reported 7-Day Point-Prevalence Abstinence (Assessed at 52 weeks after target quit day)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Partners and Alerts: A Study of Social Forces in Medication Adherence
Brief Summary: The overall objectives of this study are to improve medication adherence of patients and subsequent health outcomes.

This study is designed to examine the existence of strong associations between social networks and health behavior. This study intends to demonstrate that social forces are particularly effective at building enduring habits for healthy behavior, specifically adherence to statin medication for this study. The investigators believe the improved medication adherence will result in fewer additional vascular events, following the most recent of these events, and will result in fewer patient hospitalizations. The investigators will leverage insights from the fields of social comparison (being provided with information about the actions of others prompts social comparison that can significantly influence behavior), social pressures (encouragement or discouragement from others is a powerful social force that can influence individual behavior), and social triggers (cues in the environment can motivate people to take certain actions and have powerful effects on purchasing behavior).

The results of this study and experience gained from the implementation of these interventions will be used to inform new versions of a larger trial intervention to be tested in new patient cohorts in a rapid cycle framework.


Options:
A: Change in Glycosylated hemoglobin (HbA1c) (Baseline and 12 months)
B: Systolic blood pressure (12-months)
C: The proportion of subjects who attain the LDL-C levels set as targets by the Guidelines for Management of Dyslipidaemias and CVR (24 months)
D: Glowcap bottle openings/Medication Adherence (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Study of the Efficacy of Antioxidant Therapy Compared With Enalapril in Slowing the Progression of Sickle Nephropathy in Children
Brief Summary: The purpose of this study is to determine whether enalapril or antioxidant therapy (N-Acetylcysteine) is effective in reducing microalbuminuria in children with sickle cell disease and and its progression to sickle nephropathy


Options:
A: Percentage of successful treatment of each arm (at 9 months of treatment)
B: DNA damage from hydroxyurea therapy-variable-diversity-joining (VDJ) recombination events defined as the number of events per microgram of genomic DNA; (Every 3 years); DNA damage from hydroxyurea therapy-percentage of HJB in immature (CD71+) erythrocytes (Every 3 years)
C: urinary albumin excretion rate (12 months)
D: Treatment Differences of the Change in Qualitative Splenic Function From Baseline (Before initiation of treatment and at 2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Open-Label Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
Brief Summary: The purpose of this study is to determine which patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib.


Options:
A: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.)
B: Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.); Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.)
C: Progression Free Survival (PFS) (Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months))
D: Progression Free Survival (PFS) (Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Open-Label Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
Brief Summary: The purpose of this study is to determine which patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib.


Options:
A: Progression-free survival (PFS) (approximately 2 years)
B: Progression-Free Survival (PFS): Independent Radiologist Review (From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years)
C: Number of Participants With Dose Limiting Toxicities of Cediranib Maleate in Combination With Olaparib (Phase I) (At 28 days); The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Metastatic Triple-negative Breast Cancer (Phase I) (At 28 Days); Progression-free Survival (PFS) at the Maximum Tolerated Dose/Recommended Phase 2 Dose of Cediranib Maleate With Olaparib Compared to That of Olaparib Alone (Phase II) (Time from start of treatment to time of objective disease progression, assessed up to 5 years); The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib Tablet Formulation in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer (Phase I-T). (At 28 days)
D: Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.); Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Open-Label Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
Brief Summary: The purpose of this study is to determine which patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib.


Options:
A: Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.); Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.)
B: Progression-free survival based on investigator assessment using RECIST and clinical findings (Assessed within 12 months following completion of accrual)
C: Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only (From initial dose through final study visit up to 44 months); Bone Scan Response (BSR) - NRE, CRPC (From initial dose through final study visit up to 15 months); Progression-Free Survival (PFS) - Randomized Stage, RDT Cohorts Only (From initial dose through final study visit up to 44 months)
D: progression free survival (6 months from randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Open-Label Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
Brief Summary: The purpose of this study is to determine which patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib.


Options:
A: PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria. (First drug administration to date of disease progression or death whichever occurs first , upto 29 months); PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis). (First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months)
B: To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by progression-free survival, defined as the time from randomization to the earliest of the dates of first radiologic disease progression per RECIST 1.1 with modifications (Radiological imaging will be performed 8 weeks ± 1 week, starting from date of randomization for the first 64 weeks, then every 16 weeks ± 1 week for the next 32 weeks, and then every 24 weeks ± 4 weeks thereafter.)
C: Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.); Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.)
D: Efficacy by progression free survival (PFS1) (phase up to a total of 15 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Open-Label Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
Brief Summary: The purpose of this study is to determine which patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib.


Options:
A: Objective Response Rate (ORR) (RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months))
B: Progression free survival (up to 18 months)
C: Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines (Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.)
D: Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.); Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: In-Person VS. Computer Interventions for Increasing Probation Compliance
Brief Summary: Substance abuse treatment in the criminal justice system can reduce drug use and related criminal behavior. Although drug and alcohol treatment are common mandates in criminal justice programs, only a minority of clients actually initiate treatment. This proposal will compare two intervention formats that target motivation to initiate and engage in treatment among a group of probationers who have drug or alcohol treatment conditions. Six hundred drug and alcohol offenders in two probation sites (Baltimore, MD and Dallas, TX) will be randomized to receive: 1) an in-person motivational interviewing session (MI), 2) a motivational computer program (MC), or 3) supervision intake and monitoring as usual (SAU). The MI condition will be structured along the lines of the "Check-Up" format which consists of an assessment and personalized feedback delivered in an MI style; the content of the MC condition will be drawn from previous literature on effective motivational computer programs. Both interventions will be delivered at the start of the probation process, with follow-up assessments at 2 and 6 months. Primary outcomes include engagement and participation in substance abuse treatment; secondary outcomes include drug and alcohol use, probation progress, criminal behavior, and HIV testing and care. This project will be the first to develop and test two interventions for encouraging criminal justice clients to follow through with treatment recommendations, with the goal of increasing treatment initiation, and reducing subsequent drug use and criminal behavior. It also contributes to ongoing partnerships with two large probation agencies-the Dallas County Supervision and Corrections Department and the Maryland Division of Parole and Probation.


Options:
A: Treatment Progress (6 months)
B: Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month (6 months)
C: Primary Outcome Measure (5 years); Primary Outcome Measure (5 years); Primary Outcome Measure (5 years)
D: A reduction in the use of drugs and alcohol (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Control Trial (RCT) to Investigate the Effectiveness of a Selfmanagement Intervention and Personalised Genetic Risk Information to Reduce Risk of Coronary Heart Disease in Patients With Type 2 Diabetes.
Brief Summary: The primary objective of the CORDIA study is to use an effective evidence-based self-management intervention (SMI) for type 2 diabetes, with and without a novel test to give a personalised genetic and lifestyle risk of coronary heart disease, to examine their capacity to reduce the risk of coronary heart disease (CHD) and improve diabetes management in primary care patients with type 2 diabetes. The effect of these interventions on clinical, behavioural and psychological outcomes will be investigated.


Options:
A: N/A
B: Blood Pressure (24-hour Ambulatory Blood Pressure Monitoring, ABPM)) (one year)
C: Change in cognitive scores; Change in insulin sensitivity
D: Coronary heart disease 10 year risk (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Supplemental Zinc and Bone Turnover in Early Pubertal Females
Brief Summary: The purpose of the study is to determine the effects of zinc supplementation on bone growth over four weeks. Participants will agree to attend two visits to our laboratory and at each will complete blood and urine samples, questionnaires related to diet and physical activity and will receive a bone scan at the first appointment.


Options:
A: Death among children 1-36 months of age
B: Change in length and length-for-age Z-score (12 months); Change in weight and weight-for-age (12 months); Incidence of diarrhea and laboratory-confirmed malaria (12 months); Change in plasma zinc concentration (12 months)
C: Serum Zinc (4 weeks); Plasma IGF-1 and IGFBP-3 (4 weeks); procollagen type 1 amino-terminal propeptide (P1NP) (4 weeks)
D: Incidence of diarrhea (from ages 6 weeks to 18 months); respiratory tract infections (from ages 6 weeks to 18 months)

Answer: C