TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Which is the Optimal Treatment for Miscarriage With a Gestational ac in the Uterus and Which Factors Can Predict if the Treatment Will be Successful?
Brief Summary: The main objective of the study is to determine if there is a difference in the number of women with a complete miscarriage after 10 days between expectant management versus treatment with 800 micrograms of misoprostol intravaginally in women with an an incomplete miscarriage before 14 weeks and a gestational sac retained in the uterus.


Options:
A: complete miscarriage (10 days)
B: Complete abortion without recourse to surgical intervention (follow up visit 7 days after initial treatment)
C: Cervical Dilation in Women Following Exposure to Either Ripening Agent (3-4 hours after placement of ripening agent)
D: Complete abortion (Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.) (Day 8 from first misoprostol dose)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: U-ACT-EARLY: A Multi-center, Randomized, Double Blind, Placebo Controlled Study to Evaluate Remission in DMARD and Biological naïve Early Rheumatoid Arthritis (RA) Subjects Treated With Tocilizumab (TCZ) Plus Tight Control Methotrexate (MTX) , TCZ Monotherapy or Tight Control MTX Monotherapy
Brief Summary: This randomized, double-blind, placebo-controlled study will compare the efficacy with regard to sustained remission and safety of tocilizumab and methotrexate, in combination or as monotherapy, in treatment-naïve patients with early rheumatoid arthritis. Patients will be randomized to receive either tocilizumab (8mg/kg iv every 4 weeks) plus weekly methotrexate (po in ascending doses), or tocilizumab (8mg/kg iv every 4 weeks) plus placebo, or methotrexate plus placebo. Anticipated time on study treatment is 2 years, and target sample size is 300.


Options:
A: Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand (5 to 7 years); Symptom Severity Score (5-7 years)
B: Changes in the intensity of pain symptoms between baseline and follow-up periods (Baseline and 1, 3, 6 and 12 months after the intervention)
C: The CTS symptom severity score after treatment. (10 weeks); Rate of surgery (52 weeks)
D: Percentage of Participants Achieving Sustained Remission Rate At Week 104 (Week 104)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploratory Study to Evaluate the Effect of L-isoleucine Supplemented Oral Rehydration Solution in the Treatment of Acute Diarrhoea in Children and in Inducing Innate Immunity
Brief Summary: Efforts are continuing to improve the efficacy of oral rehydration solution in terms of reducing the severity (stool volume) and duration of diarrhoea (enhancement of recovery). Antimicrobial peptides, produced by the epithelial cells, represent an important component of the innate immunity of all epithelial surfaces of the body including intestine. Induction of expression of antimicrobial peptides on epithelial cell surface, may thus hasten recovery from infectious diarrhoea. Isoleucine is an essential amino acid that is easily available and not very expensive, and its addition to oral rehydration solution might help early clearance of diarrhoeal pathogen by inducing secretion of antimicrobial peptide by the small intestinal epithelial cells. Additionally, it is expected to hasten recovery from diarrhoea by reestablishing the commensal bacteria. The aim of this pilot study is to assess if addition of isoleucine to oral rehydration solution induces secretion of antimicrobial peptide, help establish normal bacterial populations in the intestine, and favourably impacts the severity and duration of diarrhoea in young children. If the results are found encouraging, a therapeutic trial with adequate sample size would be justified.


Options:
A: Level of fatty acids in whole blood of infants (4 months)
B: Number of withdrawal for intolerance (1 month)
C: 1. Weight of abnormal (watery/liquid) stool for each 6-hour and 24-hour (day) of the study as well as cumulative weight until resolution of diarrhoea (maximum of 5 days) (12 months)
D: occurrence of allergic reactions (14 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Investigation of Chest Pain Diagnostic Strategies
Brief Summary: Clinical decision units (CDUs) improve resource utilization and are a recommended care option by the American College of Cardiology / American Heart Association, but are underutilized in non-low risk chest pain patients due to weaknesses of traditional cardiac testing. Cardiac magnetic resonance imaging (CMR) is sensitive and specific for ischemia, can simultaneously assess cardiac function and myocardial perfusion, and could revolutionize the diagnostic process for intermediate risk patients with chest pain. The primary objective of this trial is to measure the efficiency and safety of a combined CDU-CMR care pathway compared to inpatient care among patients with non-low risk acute chest pain.


Options:
A: Therapeutic efficacy: Length of stay (Duration of Initial Hospitalization)
B: Cost of Index Hospitalization (Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours)
C: Objective cardiac testing (stress testing or cardiac imaging) within 30 days (30 Days)
D: The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days. (Index Hospitalization through 90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Effect of One Week Self-management Program in Patients With Fibromyalgia
Brief Summary: The purpose of this study is to explore the effect of one week inpatient self-management program (SMP) in patients with fibromyalgia. The SMP is delivered as group education/activities by allied health professionals.


Options:
A: Change in Weekly Average Pain Intensity (Baseline and Week 21clinic visits)
B: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up
C: Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score (wks 12)
D: EC-17 (Effective Musculoskeletal Consumer Scale) (Baseline, 3 weeks before the program, 3 weeks and 6 months after the program); GHQ20 (General Health Questionnaire) (Baseline, 3 weeks before the program, 3 weeks and 6 months after the program)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Platelet Function in Diabetic Patients With and Without Renal Impairment, and the Effects of Lipid Lowering Treatment
Brief Summary: The purpose of this study is compare the effects of simvastatin+ezetimibe with those of simvastatin alone on platelet activity, platelet-leukocyte interactions and inflammatory variables in diabetic patients with or without impaired renal function.


Options:
A: 24-hour urinary protein excretion rate, at the end of 6 months treatment phase (At 0, 2,3,4,5,6,7,8,9,10 months.)
B: Time from randomization to the occurrence of a primary clinical endpoint; i.e. major coronary event or CABG or other coronary revascularization procedure; or unstable angina or resuscitated cardiac arrest or stroke.
C: Key Outcome as Per Statistical Analysis Plan = Major Atherosclerotic Events Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo (Median follow-up 4.9 years)
D: Compare the effects of simvastatin + ezetimibe with those of simvastatin alone, on thrombogenic mechanisms, in patients with diabetes mellitus type 2. (6 weeks, 14-18 weeks, 22-24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, 28 Day, Three-arm, Parallel Group Study of A0001 in the Treatment of Subjects With Friedreich's Ataxia
Brief Summary: This is a Phase 2a double-blind, placebo-controlled study with two dose levels of A0001 given twice daily for 28 days. Potential subjects will be screened first to determine eligibility, after which they will be randomized to receive either a high dose of A0001, a low dose of A0001 or placebo for 28 days.

Eligible subjects will return within 21 days of screening for the baseline visit and randomization to one of three potential treatments. The subjects will be required to take 3 capsules of study medication in the morning with a morning meal and 3 capsules of study medication at night with an evening meal for 28 days. Additional visits to the clinic are planned for Day 14 and Day 28, at which time a number of clinical and biochemical assessments will be done.


Options:
A: Change in the International Cooperative Ataxia Rating Scale (ICARS) From Baseline Assessment to Week 24 (baseline and 6 months)
B: To examine the change in the level of oxidative stress by measuring the oxidative marker 8-hydroxy-2-deoxyguanosine from baseline and after 6 months of treatment with placebo or varying doses of idebenone (baseline and after 6 months)
C: The primary endpoint is time to treatment response and difference in time to response for the two data collection methods - daily patient electronic assessment versus weekly assessments measured in clinic.
D: Change in Disposition Index of Glucose Regulation, determined by Frequent Sampling IV Glucose Tolerance Test (Baseline, Day 14 and Day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Structured Exercise in Obese Diabetic Patients With Chronic Kidney Disease
Brief Summary: Patients with type 2 diabetes, obesity, and chronic kidney disease are generally physically inactive, have a high mortality rate, and may benefit from an exercise program. This study seeks to determine if a structured exercise program will benefit the heart (improved exercise tolerance, decreased blood pressure) and/or the kidney (decreased protein loss in urine and stabilization of kidney function) and lead to improvements in diabetes, body composition, and quality of life.


Options:
A: Percentage change of 24-hour proteinuria (6 months)
B: Change in Proteinuria (12 weeks minus baseline); Change in Proteinuria (52 weeks minus baseline)
C: 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)
D: 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))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: To Study the Safety and Efficacy of G-CSF Therapy on the CD 34 Cell Mobilization and Outcome of Patients With ACLF
Brief Summary: The purpose of the study is to determine whether Granulocyte Colony Stimulating factor(G-CSF) therapy is effective in the treatment of patients with Acute on chronic liver failure(ACLF). The investigators hypothesize that ACLF is a disease where severe hepatic impairment is accompanied by impaired hepatic regeneration. BMC mobilization using G-CSF therapy, or G-CSF therapy per se would increase the regenerative capacity of the liver and shall lead to clinical, biochemical and histological improvements in patients with ACLF.


Options:
A: Survival rates (12 weeks)
B: The primary end point will be transplant free survival rate at 1 year in patients with decompensated cirrhosis. (1 Year)
C: mobilization of CD34 cells in the peripheral blood (1 month)
D: transplant free survival at 1 year (3 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Open-label, Multicentre, 12 Month Study to Evaluate the Efficacy and Safety of Ranibizumab (0.5mg) in Patients With Choroidal Neovascularisation Secondary to Pathological Myopia (PM)
Brief Summary: This study is designed to provide efficacy and safety data in patients with choroidal neovascularisation (CNV) secondary to myopia using an individualized as-needed (PRN) dosing schedule. Eligible patients who have provided written agreement to take part in the study will receive an intravitreal (into the study eye) injection of ranibizumab 0.5mg. Following eye examinations and tests at monthly clinic visits, the study doctor will repeat the injections on a monthly basis as required for an additional 11 months, in accordance with specified retreatment criteria.

Patients will be in the study for approximately 12 months and will visit the hospital clinic 14 times over that period. The main assessments will include visual acuity tests, eye examinations, optical coherence tomography (OCT) to assess retinal thickness, fundus photography and fluorescein angiography (FA), measurement of intraocular pressure, blood pressure and pulse measurements and completion of health-related questionnaires'.


Options:
A: Change From Baseline in Visual-acuity Score (Continuous) (Baseline and 1 Year)
B: Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye (Baseline, Month 1 through Month 3)
C: N/A
D: The difference from baseline in mean Best Corrected Visual Acuity (BCVA) (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to see whether turmeric can be effective in treatment of pruritus in hemodialysis patients.


Options:
A: The changes in pruritus symptoms assessed by VAS (Week0, week1-12, Week 14)
B: Severity of Pruritis, as measured by a visual analogue scale (3 months)
C: Severity of Pruritis (Baseline and end of study (up to 12 weeks))
D: improvement in pruritus (6 mo)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Does the Need of Arthroscopic Subacromial Decompression Change After Eccentric Physical Therapy Exercises in Patients With Subacromial Pain? - A Randomized Clinical Trial
Brief Summary: Objective:

A randomized clinical trial in order to evaluate the efficacy of structured eccentric exercises tutored by a physical therapist (PT) for patients with subacromial impingement.

Hypothesis:

H1 The exercises has a satisfactory effect and the need of an arthroscopic subacromial decompression can be reconsidered.

H0 No difference between the two exercises (experimental and active control) and the patients still need surgery

Further the study objective is to evaluate predictors for a positive or negative treatment response after three months of rehabilitation as well as after 12 months.

Method:

Patients referred to the orthopedic unit for an arthroscopic subacromial decompression, are offered a three month rehabilitation program during the waiting time for surgery which is approximately 4-6 months. All patients must have tried conservative treatments for at least 6 months in primary care with unsatisfactory results. The patients will be randomized to either the structured eccentric exercises tutored by a physical therapist or control exercises with general movements for the neck and shoulders. All patients has an equal number of sessions with the PT to offer similar attention. After three months the following key-question has to be answered: due to your current experience of your shoulder problems do you still need this surgical intervention? A blinded orthopedic surgeon evaluates the following outcomes at baseline and after three and twelve months. Primary outcomes: Constant-Murley shoulder assessment, Disabilities of the Arm Shoulder and Hans and different aspects of pain. Secondary outcomes; EQ-5D, sick-leave and return to work. All patients are evaluated with a diagnostic ultrasound in order to reveal the condition of the rotator cuff. Also long-term results in those who go thorough with the surgery and those who decline will be assessed after 12 months.

Importance of the study results:

Since there is no consensus about which intervention that should be preferred for patients with subacromial impingement the results of the current study is warranted. If this exercise program is successful it can be implemented into clinical practice. Further, clinical characteristics of patients that really need an arthroscopic subacromial decompression can be identified.


Options:
A: Shoulder Pain and Disability Index (SPADI) (Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months)
B: Oxford Shoulder Score (6 months post randomisation)
C: Shoulder Pain and Disability Index (Baseline and 11 weeks); Participant perceived global rating of change post treatment (11 weeks)
D: Constant-Murley shoulder assessment (Baseline and change after three months of exercises, 3 month follow-up); Constant_Murley shoulder assessment (Change from baseline to the 12-month follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Familias Unidas Stage III Study: Preventing Substance Abuse in Hispanic Youth
Brief Summary: The focus of this study will be to test the Familias Unidas Intervention program among Hispanic 8th graders in the Miami-Dade County Public School System. This study will contribute to the advancement of knowledge in both the scientific community and the Hispanic population in Miami-Dade County. It will shed light on whether and to what extent Familias Unidas is effective in preventing drug use and unsafe sexual behavior in Hispanic adolescents. To the scientific community, the investigators will disseminate our findings via peer-reviewed publications and presentations at scientific meetings.

The design for the proposed study is a randomized controlled trial. This design is considered the "gold standard" design when evaluating the efficacy of two (or more) treatment conditions. Participants for this study will be 744 Hispanic 8th grade adolescents and their parents recruited from 24 randomly selected middle schools in Miami Dade County that meet the school inclusion/exclusion criteria. A total of 12 schools (for a total of 372 Hispanic adolescents and their parents) will be randomized to Familias Unidas and a total of 12 schools (for a total of 372 Hispanic adolescents and their parents) will be randomized to the Community Practice.


Options:
A: Targeted risk and protective factors, substance use, delinquency, violence (Baseline through thirteen-year follow-up (age 23)); CTC coalition functioning, prevention system transformation, evidence-based program (EBP) implementation (Baseline through eight-year follow-up (age 18))
B: Comparison of susceptibility rate differences between the control and intervention groups (6 Months Post Intervention)
C: Substance use will be assessed using items extracted from the Monitoring the Future Study. (Three years); Adolescent unsafe sexual behavior will be measured using Jemmott, Jemmott, and Fong's (1998) 37-item Sexual Behavior instrument. (Three years)
D: Alcohol use (3 months); Alcohol use (6 months); Alcohol use (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled Trial of Integrated vs. Standard Palliative Care in Patients With Advanced NSCLC
Brief Summary: The main purpose of this study is to compare two types of treatment-standard palliative care (which usually is given towards the end of life) and integrated palliative care (which is given soon after diagnosis) to see which is better for improving quality of life of participants with advanced non-small cell lung cancer. Palliative care is care that tries to lessen the symptoms of a disease. Although many people with advanced lung cancer receive palliative care or hospice toward the end of their disease, the entire course of their disease is often complicated by physical and emotional difficulties. Palliative care may be useful when it is started soon after diagnosis.


Options:
A: Assess the impact of early integration with palliative care on QOL in patients with advanced NSCLC. (3 years)
B: Overall Survival (OS) (Randomization up to 28 months post-randomization)
C: Overall Survival Time (OS) (Randomization up to 27.5 months)
D: Overall survival (every course for first three courses, then every other course)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled Trial of Integrated vs. Standard Palliative Care in Patients With Advanced NSCLC
Brief Summary: The main purpose of this study is to compare two types of treatment-standard palliative care (which usually is given towards the end of life) and integrated palliative care (which is given soon after diagnosis) to see which is better for improving quality of life of participants with advanced non-small cell lung cancer. Palliative care is care that tries to lessen the symptoms of a disease. Although many people with advanced lung cancer receive palliative care or hospice toward the end of their disease, the entire course of their disease is often complicated by physical and emotional difficulties. Palliative care may be useful when it is started soon after diagnosis.


Options:
A: Change in patient's quality of living over time (baseline, 6,12,18,24,36 and every 12 weeks until death or end of study); Quality of end of life care (chart review at time of death and caregiver proxy interview 2-3 months after patient death); Estimate and compare the hazard ratios and median survival before and after 1 year from enrollment (From enrollment until patient death or end of study); Change in caregiver quality of life, burden and grief over time (baseline, 6,12,18,24,36, and every 12 weeks until patient death or end of study)
B: Reduction in the EORTC QLQ-C30 scale that constitutes the patient's primary need (Baseline, 3 weeks and 8 weeks)
C: Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G, QUAL-E and FACIT-Sp. (Three months after enrollment.)
D: Assess the impact of early integration with palliative care on QOL in patients with advanced NSCLC. (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled Trial of Integrated vs. Standard Palliative Care in Patients With Advanced NSCLC
Brief Summary: The main purpose of this study is to compare two types of treatment-standard palliative care (which usually is given towards the end of life) and integrated palliative care (which is given soon after diagnosis) to see which is better for improving quality of life of participants with advanced non-small cell lung cancer. Palliative care is care that tries to lessen the symptoms of a disease. Although many people with advanced lung cancer receive palliative care or hospice toward the end of their disease, the entire course of their disease is often complicated by physical and emotional difficulties. Palliative care may be useful when it is started soon after diagnosis.


Options:
A: Reduction in the EORTC QLQ-C30 scale that constitutes the patient's primary need (Baseline, 3 weeks and 8 weeks)
B: Quality of life and quality of mental health at 6 weeks and 12 weeks as compared from baseline (at baseline, 6 weeks and 12 weeks)
C: Quality of Life (QoL) (24 months)
D: Assess the impact of early integration with palliative care on QOL in patients with advanced NSCLC. (3 years)

Answer: D