TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Milnacipran and Neurocognition, Pain and Fatigue in Fibromyalgia: A 13-week Randomized, Placebo Controlled Cross Over Trial
Brief Summary: This study was designed to investigate whether milnacipran is safe and effective in improving cognitive function in fibromyalgia. In addition, this study was aimed to investigate whether improvement in neurocognitive status due to milnacipran correlates with improvements in pain, to investigate whether improvement in neurocognitive status due to milnacipran correlates with improvements in fatigue, and to determine whether treatment with improvement in neurocognitive status, pain and fatigue correlates with functional improvement.


Options:
A: Reduction in nociceptive brain response after duloxetine (Baseline, week six); Neural network change (resting condition) induced by duloxetine (Baseline, week six); Predicting response to duloxetine from baseline fMRI metrics using univariate and multivariate analysis (Baseline, week six); Differences in brain response and network change between responders and non-responders (Baseline, week six)
B: Change in Weekly Average Pain Intensity (Baseline and Week 21clinic visits)
C: 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)
D: Visual Analogue Scale for Pain (Baseline, Week 1, 2,4, and 6 weeks); Changes in The Fatigue Severity Scale (FSS) (Baseline, Week 1, 2,4, and 6 weeks); Composite Brief Assessment of Cognition (BAC) Score (Baseline, Week 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Milnacipran and Neurocognition, Pain and Fatigue in Fibromyalgia: A 13-week Randomized, Placebo Controlled Cross Over Trial
Brief Summary: This study was designed to investigate whether milnacipran is safe and effective in improving cognitive function in fibromyalgia. In addition, this study was aimed to investigate whether improvement in neurocognitive status due to milnacipran correlates with improvements in pain, to investigate whether improvement in neurocognitive status due to milnacipran correlates with improvements in fatigue, and to determine whether treatment with improvement in neurocognitive status, pain and fatigue correlates with functional improvement.


Options:
A: 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)
B: Change in Weekly Average Pain Intensity (Baseline and Week 21clinic visits)
C: Time to Loss of Therapeutic Response (LTR) (From baseline Visit 3 (week 5) to Visit 7 (week 17))
D: Visual Analogue Scale for Pain (Baseline, Week 1, 2,4, and 6 weeks); Changes in The Fatigue Severity Scale (FSS) (Baseline, Week 1, 2,4, and 6 weeks); Composite Brief Assessment of Cognition (BAC) Score (Baseline, Week 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial
Brief Summary: In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial, the investigators propose to establish which immunosuppressive therapy, methotrexate or mycophenolate mofetil, is more effective as a first-line, corticosteroid-sparing agent for the treatment of non-infectious uveitis in a block-randomized, observer-masked, comparative effectiveness trial.


Options:
A: Time to First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline (Baseline to 24 weeks)
B: Number of Participants Achieving Treatment Success (6 months)
C: Mean Change in Vitreous Haze Grade in the Study Eye From Baseline to 28 Weeks or at Time of Rescue, if Earlier. (baseline to 28 weeks)
D: Number of Participants Achieving Treatment Success at 6 Months (Phase I, 0-6 Months) (6 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Protocol for Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence An RCT: Hypnotherapy Or Pharmacotherapy
Brief Summary: This study is randomized controlled trial in which urgency incontinent women (approximately 150-160) will be randomized to hypnotherapy or pharmacotherapy and evaluated at months 2, 6 \&12 Hypotheses: Among patients with urgency urinary incontinence (UUI), hypnotherapy will be non-inferior pharmacotherapy in diminishing UUI episodes. Hypnotherapy may be superior or may not differ from pharmacotherapy in diminishing symptoms or quality of life based on validated questionnaires and/or other diary parameters.


Options:
A: Percent Change in Urgency Urinary Incontinence Episodes (Baseline and 2 month follow-up)
B: "Much Better" or "Very Much Better" on PGI-I at 3 Months (Outcome was measured at three months following randomization.); No Bothersome Stress Incontinence Symptoms at 3 Months (Outcome was measured at three months following randomization.)
C: Evaluation of subjective cure (At the end of 3 months of supervised treatment)
D: 24-hour Voiding Frequency (post-treatment (week 8))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Protocol for Brain-Centered Therapy Versus Medication for Urgency Urinary Incontinence An RCT: Hypnotherapy Or Pharmacotherapy
Brief Summary: This study is randomized controlled trial in which urgency incontinent women (approximately 150-160) will be randomized to hypnotherapy or pharmacotherapy and evaluated at months 2, 6 \&12 Hypotheses: Among patients with urgency urinary incontinence (UUI), hypnotherapy will be non-inferior pharmacotherapy in diminishing UUI episodes. Hypnotherapy may be superior or may not differ from pharmacotherapy in diminishing symptoms or quality of life based on validated questionnaires and/or other diary parameters.


Options:
A: Baseline Average Number of Daily Incontinence Episodes (Baseline); Change From Baseline in Average Daily Number of Incontinence Episodes (Baseline to Week 12)
B: Percent Change in Urgency Urinary Incontinence Episodes (Baseline and 2 month follow-up)
C: Change in the total weekly number of incontinence episodes (Baseline to Treatment Week 12/Premature Discontinuation)
D: Patient Perception of Bladder Condition at 12 weeks of treatment compared to placebo.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact Evaluation of a Parenting Program to Improve Parenting, Education, and Health Outcomes for Young Children in Liberia
Brief Summary: The aim of this study is to assess the impact of an intervention to improve parenting practices, pre-academic and developmental skills, and use of mosquito nets for children in kindergarten in Liberia. A rigorous impact evaluation using a randomized, waitlist controlled design will be conducted to measure the impact of the intervention on three primary outcomes: positive parenting skills, children's cognitive and educational skills, and malaria knowledge and prevention behaviors.


Options:
A: Eyberg Child Behavior Inventory (Baseline, post- intervention and 12-month post-intervention follow-up); Parenting Young Children Scale (Supporting Positive Behaviour subscale; Setting Limits subscale) (Baseline, post- intervention and 12-month post-intervention follow-up); Sinovuyo Observational Coding System (Baseline, post- intervention and 12-month post-intervention follow-up)
B: Difference in Diabetes Empowerment Scale (DES) scores between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time (Week 1, Week 5, Week 18, Week 30); Difference in Diabetes Management Self-Efficacy Scale (DMSES) scores between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time (Week 1, Week 5, Week 18, Week 30)
C: Parenting Behavior Assessment (adapted from multiple scales for this context) (1 month); Parenting Self-Efficacy and Beliefs Assessment (adapted from other scales for this context; includes unique items developed for this context) (1 month); Child Behavior Assessment (items adapted from the Strengths and Difficulties Questionnaire) (1 month); Parent-Child Interaction Observation (1 month); Child Cognitive / Pre-Academic Abilities and Emotional Well-being (1 month)
D: Recovery from Common Mental Disorder (defined by ICD10) (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: HIGH Altitude CArdiovascular REsearch in the ANDES
Brief Summary: This study is aimed to assess the efficacy of combined treatment with two antihypertensive agents (telmisartan and nifedipine) in subjects with mild hypertension exposed to high altitude.


Options:
A: Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen). (The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia)
B: acute mountain sickness (during ascent)
C: Effect of study treatment on 24 h ambulatory systolic blood pressure at high altitude (After 6 weeks of study treatment, during high altitude visit)
D: Change in Optic Nerve Sheath Diameter by Ultrasonography (Optic Nerve Sheath Diameter: baseline, 24 hours.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: HIGH Altitude CArdiovascular REsearch in the ANDES
Brief Summary: This study is aimed to assess the efficacy of combined treatment with two antihypertensive agents (telmisartan and nifedipine) in subjects with mild hypertension exposed to high altitude.


Options:
A: incidence of acute mountain sickness (2 days)
B: Effect of study treatment on 24 h ambulatory systolic blood pressure at high altitude (After 6 weeks of study treatment, during high altitude visit)
C: Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen). (The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia)
D: Acute mountain sickness score (At 3230m and 4,130m(Annapurna base camp))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: HIGH Altitude CArdiovascular REsearch in the ANDES
Brief Summary: This study is aimed to assess the efficacy of combined treatment with two antihypertensive agents (telmisartan and nifedipine) in subjects with mild hypertension exposed to high altitude.


Options:
A: prevention of high altitude pulmonary edema
B: acute mountain sickness (during ascent)
C: Pulmonary Artery Systolic Pressure (PASP)
D: Effect of study treatment on 24 h ambulatory systolic blood pressure at high altitude (After 6 weeks of study treatment, during high altitude visit)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention
Brief Summary: The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban treatment strategies and one Vitamin K Antagonist (VKA) treatment strategy utilizing various combinations of dual antiplatelet therapy (DAPT) or low-dose aspirin (ASA) or clopidogrel (or prasugrel or ticagrelor).


Options:
A: Time to First Adjudicated ISTH MBE or CRNMBE (up to 30 months)
B: Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition (6 Months)
C: Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis (From 22 to 165 minutes)
D: Percentage of Participants With Clinically Significant Bleeding (Up to Month 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility and Impact of an Evidence-based Electronic Decision Support System on Diabetes Care in Family Medicine: a Cluster Randomized Controlled Trial
Brief Summary: The purpose of this study is to assess the feasibility of the use of an evidence-based decision support system (EBMeDS) in daily Belgian family medicine and to study the effectiveness of EBMeDS use on improving diabetes care.


Options:
A: Changes of glycosilated haemoglobin (HbA1c) (At least 12 weeks from baseline (visit 3))
B: HbA1c (12 months)
C: Pre- to post-implementation change in HbA1c. (Outcome will be collected at five points in time: before the start of the study, at 3 months, at 6 months, at 9 months and at 12 months)
D: changes in HbA1c (from baseline to 12 and 24 weeks); changes in systolic and diastolic blood pressure (from baseline to 8, 16, and 24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Evaluation of Oral Midazolam for Anxiety and Pain in First-trimester Surgical Abortion: a Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine the level of pain, anxiety and side effects that women experience with a surgical abortion and the effect that the anti-anxiety medication, midazolam, might have when used along with ibuprofen and a paracervical block (PCB) instead of the standard pain treatment of only ibuprofen and a PCB.


Options:
A: Pain scale
B: Patient Perception of Pain (At time of uterine aspiration (baseline))
C: Subject Perception of Pain and Anxiety During Uterine Aspiration (at time of uterine aspiration (30-60 minutes after premedication))
D: Pain reported with cervical dilation (1 Year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Randomized Study to Evaluate the Safety and the Humoral and Intestinal Immunogenicity of One or Two Additional Doses of Licensed Inactivated Polio Vaccines (IPVs) in Latin American Infants Previously Vaccinated With Bivalent Oral Polio Vaccines (bOPVs)
Brief Summary: This study is a Phase IV, open, randomized, multi-center, controlled vaccine trial conducted in healthy Latin American infants, utilizing one or two supplemental doses of IPV in children previously vaccinated with 3 doses of bOPV. We will examine the impact of supplemental IPV on stool shedding and humoral immunity, as well as intra-IPV manufacturer comparability, and safety.


Options:
A: Mortality by sex
B: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 (At Month 3, one month after the third vaccine dose)
C: Types 1 and 3 poliovirus humoral immune response (12 months)
D: Change in the stool poliovirus excretion after mOPV2 challenge (shedding index) (Within 28 days of mOPV2 challenge); Seroconversion and seroprotection to type 1, 2 and 3 poliovirus (At 6 and 14 weeks, and then before and 1 week after mOPV2 challenge)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Collagen Cross-linking in Infectious Keratitis Trial
Brief Summary: The purpose of this study is to evaluate the efficacy of collagen cross-linking for treatment of infectious keratitis.


Options:
A: decrement of infiltration size (1 months)
B: Microbiological Cure on Repeat Culture (4 to 24 hours after enrollment)
C: Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button (1 day); Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button (1 week); Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button (2 weeks); Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button (1 month); Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button (1 month); Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button (3 months); Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button (Every 2-4 months depending on the judgment of the surgeon for at least 5 years); Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button (1 year); Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button (2 years); Examine whether the use of crosslinked cornea decreases the rate of corneal melting post-Kpro when compared to using a standard corneal button (5 years)
D: Duration of corneal complete epithelial healing in days. (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Interventions for Patients With Cervical Radiculopathy- Neck-specific Training With a Cognitive Behavioural Approach Compared With Prescribed Physical Activity in a Prospective Randomised Controlled Trial
Brief Summary: The overall objective is to evaluate if treatment with a neck-specific exercise program and cognitive behavioural approach improves the outcome compared with prescribed, self-mediated and progressive physical activity in patients with cervical radiculopathy. There is a lack of evidence of the best treatment for the patient category. Many patients are sick-listed for long periods of time with different kind of treatment approaches or without any treatment at all. The present study could fill the identified knowledge gap by strengthening of the currently weak scientific evidence for treatment of the patient category. The long-term effects of the study could be to reduce the time for sick leave and improve the rate of patients returning to work and/ or former activity by optimising treatments. Further on, to decrease the number of patients who finally have surgery for their neck problems and thus reducing the mental, physical and social costs.


Options:
A: Insomnia Severity Index (ISI) (Baseline); Insomnia Severity Index (ISI) (Post treatment- 2 months post baseline assessment); Insomnia Severity Index (ISI) (9 months post baseline assessment); Insomnia Severity Index (ISI) (18 months post baseline assessment); Global Pain Severity-Graded Chronic Pain Scale (Baseline); Global Pain Severity-Graded Chronic Pain Scale (Post treatment-2 mos. post baseline); Global Pain Severity-Graded Chronic Pain Scale (9 months post baseline assessment); Global Pain Severity- Graded Chronic Pain Scale (18 months post baseline assessment)
B: SF-36, Roland Morris Disability Questionnaire, Quebec back pain disability (before intervention)
C: Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity (12 weeks after baseline (or last observation carried forward))
D: Pain (Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Acceptance and Biomarker Response With Oral vs. Intramuscular Supplementation of Vitamin B12 in Primary Care
Brief Summary: In this study, biomarker response after supplementation with oral and intramuscular vitamin B12 will be compared in a randomized clinical trial. Electronic compliance monitoring will be used to control for non compliance as a possible confounder in oral treatment. Additionally subjective acceptance in terms of presumed preferences will be compared with oral vs. intramuscular supplementation of vitamin B12 in the view of the patient.


Options:
A: Serum vitamin B12 (1,2 and 3 months after administration of medicine)
B: Biochemical response to vitamin B12 substitution (Day 28)
C: Serum Cobalamin Normalization (61 days)
D: To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight).

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study Testing a Hatha Yoga Exercise Program in Older Women With Knee Osteoarthritis
Brief Summary: The study hypothesized that it is feasible and safe to use Hatha yoga in older women with knee osteoarthritis (OA), and practicing Hatha yoga regularly will help reduce pain and stiffness, enhance physical function, and improve quality of sleep and quality of life in older women with knee OA.


Options:
A: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (0, 4, 10, 16 months)
B: Absolute Value of OA Symptoms at 8 Weeks (8 weeks); Absolute Value of OA Pain at 8 Weeks (8 weeks)
C: Pain (week 0, 13, 39 and 65); Physical function (week 0, 13, 39 and 65); Patient global assessment (week 13, 39 and 65)
D: Self-reported pain and function (WOMAC)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1a Chronic Hepatitis C Virus (HCV) Infection (PEARL-IV)
Brief Summary: The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1a (HCV GT1a) infection without cirrhosis.


Options:
A: Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir. (Baseline and 4 weeks)
B: Proportion of Participants With Sustained Virologic Response 12 (SVR-12) (12 weeks post-therapy)
C: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event (Up to 12 weeks)
D: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses (12 weeks after last dose of study drug)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1a Chronic Hepatitis C Virus (HCV) Infection (PEARL-IV)
Brief Summary: The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1a (HCV GT1a) infection without cirrhosis.


Options:
A: Percentage of Participants Achieving SVR12 (Posttreatment Week 12); Adverse Events Leading to Permanent Discontinuation of Study Drug (Baseline to Week 16)
B: Percentage of Participants With Virologic Response at Week 12 (End of treatment (EOT) (up to Week 48))
C: Sustained Virological Response 12 Weeks Post-treatment (SVR12) (12 weeks post treatment, up to 60 weeks)
D: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses (12 weeks after last dose of study drug)

Answer: D