TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet Arthritis Self-Management Study
Brief Summary: Individuals with with arthritic conditions (rheumatoid arthritis, osteoarthritis, or fibromyalgia) and internet and email access were randomized to receive an internet-based arthritis self-management program (treatment group) or to continue with usual care (control group). Questionnaires measuring health indicators, health behaviors, self efficacy and health care utilization were administered at baseline, six months and one year after the course. It was hypothesized that those participating in the course would have better outcomes than the control group at six months and one year.


Options:
A: Pain severity (Week 3)
B: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year
C: Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score (wks 12)
D: Decrease of pain and use of specific medicine for fibromyalgia (16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet Arthritis Self-Management Study
Brief Summary: Individuals with with arthritic conditions (rheumatoid arthritis, osteoarthritis, or fibromyalgia) and internet and email access were randomized to receive an internet-based arthritis self-management program (treatment group) or to continue with usual care (control group). Questionnaires measuring health indicators, health behaviors, self efficacy and health care utilization were administered at baseline, six months and one year after the course. It was hypothesized that those participating in the course would have better outcomes than the control group at six months and one year.


Options:
A: Fibromyalgia Impact Questionnaire (Baseline, 16 wks and 10 months)
B: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year
C: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up
D: The primary outcome measure will be the change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final week of Qigong treatment. (7 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet Arthritis Self-Management Study
Brief Summary: Individuals with with arthritic conditions (rheumatoid arthritis, osteoarthritis, or fibromyalgia) and internet and email access were randomized to receive an internet-based arthritis self-management program (treatment group) or to continue with usual care (control group). Questionnaires measuring health indicators, health behaviors, self efficacy and health care utilization were administered at baseline, six months and one year after the course. It was hypothesized that those participating in the course would have better outcomes than the control group at six months and one year.


Options:
A: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year
B: Health-related quality of life among patients with fibromyalgia (FIQ: Fibromyalgia Impact Questionnaire) (6 months)
C: Overall impact of fibromyalgia (Participants will be followed over 24 weeks)
D: Pain (10 sessions, in 5 weeks, 2 times a week)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategies for the Treatment of HIV Associated Metabolic Syndrome
Brief Summary: A healthy diet and exercise have improved the health of people without human immunodeficiency virus (HIV) who have Metabolic Syndrome. In this study we would like to find out if the same benefit can be seen in people with HIV and Metabolic Syndrome. Patients with Metabolic Syndrome usually have a large waist, high blood cholesterol levels, high blood pressure, and high blood sugar levels. These are risk factors, which may increase one's chance of developing heart disease and/or diabetes. The purpose of the study is to evaluate the effects of different methods of treating HIV associated Metabolic Syndrome. The groups are: 1) a lifestyle modification program plus metformin (also known as glucophage), 2) lifestyle modification plus placebo, 3) metformin alone or 4) placebo alone. The lifestyle modification program consists of nutrition and exercise sessions with the goal of improving body composition, heart health, and ways to lower the risk of developing diabetes.


Options:
A: body weight (12 months)
B: Carotid Intima Media Thickness (baseline and 12 months); Waist Circumference (baseline and 12 months); High Density Lipoprotein (HDL) (baseline and 12 months); Glucose (baseline and 12 months); Systolic Blood Pressure (baseline and 12 months); Coronary Artery Calcium Score (baseline and 12 months)
C: body mass index (24 months)
D: Weight (Measured at Month 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: CHUSPAN SCS BP Treatment of Churg-Strauss Syndrome Without Poor-Prognosis Factors: a Prospective Randomized Study in 72 Patients.
Brief Summary: To assess the efficacy of systemic corticosteroids alone as first-line treatment of Churg-Strauss syndrome without poor-prognosis factors as defined by the five-factor score (FFS=0), and to compare the efficacy and safety of azathioprine vs pulse cyclophosphamide as adjunctive immunosuppressive therapy to treat failure or relapse


Options:
A: Disease free period, time from remission to relapse or study end.
B: Number of events (failures, relapses and/or deaths) occurring in each group, defining the disease-free survival rate, measured at study end (mean follow-up of 5 years)
C: Safety/Efficacy; Frequency of severe adverse events in each arm. Hypothesis based upon NIH data was a rate of 6% severe adverse event with methotrexate compared to 30% with azathioprine (24% in one study on RA and 46% in one study on Sjögren syndrome).; Evaluation was planned after the last included patient has completed the assigned trial regimen (after 12 months of maintenance regimen or because of drug withdrawal).
D: the remission rate after 9 months of therapy with intravenous immunoglobulins,; in relapsing patients with ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome); during 6 months, after relapse

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Multicenter, Randomized, Phase 3 Study of S-1 in Combination With Cisplatin Against 5-Fu in Combination W/ Cisplatin in Patients W/ Advanced Gastric Cancer Previously Untreated W/ Chemotherapy for Advanced Disease
Brief Summary: This is an open-label, international, two-arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1/cisplatin versus 5-FU/cisplatin in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be randomly assigned (1:1) to S-1/cisplatin (experimental arm) or 5-FU/cisplatin (control arm). Patients will be stratified by number of metastatic sites (one vs. more than one), locally advanced or metastatic disease, prior adjuvant therapy (yes or no), measurable or non-measurable disease, and center.


Options:
A: Overall Survival (OS) - Percentage of Participants With an Event (Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis); Overall Survival - Time to Event (BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis)
B: Overall survival (every course for first three courses, then every other course)
C: Overall survival (OS) rate (1 year)
D: Median Survival (The cutoff date for survival analysis was 07 March 2008 (12 months after last patient randomized).)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Multicenter, Randomized, Phase 3 Study of S-1 in Combination With Cisplatin Against 5-Fu in Combination W/ Cisplatin in Patients W/ Advanced Gastric Cancer Previously Untreated W/ Chemotherapy for Advanced Disease
Brief Summary: This is an open-label, international, two-arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1/cisplatin versus 5-FU/cisplatin in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be randomly assigned (1:1) to S-1/cisplatin (experimental arm) or 5-FU/cisplatin (control arm). Patients will be stratified by number of metastatic sites (one vs. more than one), locally advanced or metastatic disease, prior adjuvant therapy (yes or no), measurable or non-measurable disease, and center.


Options:
A: Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm I (12 weeks up to 3 years); Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm II (12 weeks up to 3 years)
B: Median Survival (The cutoff date for survival analysis was 07 March 2008 (12 months after last patient randomized).)
C: Overall Survival (OS) (Randomization up to 28 months post-randomization)
D: Overall Survival (OS) - Percentage of Participants With an Event (Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis); Overall Survival - Time to Event (BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Study Analyzing the Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss
Brief Summary: With this clinical trial the investigators will analyze whether the rate of pregnancy losses before the 24th week of gestation can be reduced by dalteparin treatment in habitual aborters.


Options:
A: ongoing intact pregnancy at 24 weeks of gestation (at 24 weeks of gestation)
B: Pregnancy outcome: livebirths (>37 weeks of gestation), premature livebirths (> 24, but <37 weeks of gestation) (gestational weeks >37 and gestational weeks > 24, but <37)
C: Live Birth Rate = (Number of Live Births / Total Number of Pregnancies) (pregnancy > 24weeks gestation)
D: Study Feasibility: Mean Recruitment Rate Per Center Per Month (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Study Analyzing the Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss
Brief Summary: With this clinical trial the investigators will analyze whether the rate of pregnancy losses before the 24th week of gestation can be reduced by dalteparin treatment in habitual aborters.


Options:
A: ongoing intact pregnancy at 24 weeks of gestation (at 24 weeks of gestation)
B: Feasibility of Recruitment and Trial Operations. (4 months)
C: The primary objective of the study is to identify if LMWH prophylaxis in thrombophilic pregnant women results in a greater than 33% relative risk reduction in the composite outcome measure (VTE, pre-eclampsia, IUGR and fetal loss) (6 weeks post-partum)
D: Live Birth (after delivery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Is the Routine Pressure Dressing After Thyroidectomy Necessary? A Prospective Randomized Controlled Study
Brief Summary: Thyroidectomy is an operation that is commonly performed. After an operation a pressure dressing by Hypafix is usually used due to the belief that it will help to reduce complications such as post-operative bleeding or haematoma. However, the practice is uncomfortable to patients and makes it hard to detect early haematomas.

We carried out a prospective randomised study to study the role of pressure dressing after thyroid surgery by evaluating the amount of fluids collected in the operative bed by ultrasonography compared with normal dressing.


Options:
A: Device remains localized over corneal incision (24 hours post operative)
B: amount of fluids collected in the operative bed by ultrasonography (participants will be followed for the duration of hospital stay, an expected average of 4 days)
C: Wound complication (Within 30 days of index procedure)
D: The rate of patients with a Surgical site infection (30 days after surgery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Client Centred 'Tune-ups': do They Enhance Community Reintegration and Mobility in Stroke Survivors?
Brief Summary: Once discharged from hospital many stroke survivors deteriorate medically, physically and in their mobility function and many report their level of function and quality of life to be poor 12 months after inpatient rehabilitation. There is an identified need for follow-up examinations of community dwelling stroke survivors to monitor changes in function and it has been suggested that maintenance therapy could curtail declines in function. The purpose of this trial is to determine whether brief periods of intense client-centered rehabilitation therapy (tune-ups) provided at 6 month intervals can alter the natural progression of impairment (physical capacity), function and community reintegration following stroke.


Options:
A: Change of motor function (0 week and 1 week)
B: Maximum torque around the knee joint; gait velocity
C: Subjective Index of Physical and Social Outcome (SIPSO) (baseline and 1 year); Subjective Index of Social Integration (Subscale of SIPSO) (baseline and one year); Subjective Index of Physical Integration (Subscale of SIPSO) (baseline and one year)
D: Motor Function of the Affected Upper Extremity (Change from baseline after 5 days (immediately after intervention)); Motor Function of the Affected Upper Extremity (change from baseline after 3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Client Centred 'Tune-ups': do They Enhance Community Reintegration and Mobility in Stroke Survivors?
Brief Summary: Once discharged from hospital many stroke survivors deteriorate medically, physically and in their mobility function and many report their level of function and quality of life to be poor 12 months after inpatient rehabilitation. There is an identified need for follow-up examinations of community dwelling stroke survivors to monitor changes in function and it has been suggested that maintenance therapy could curtail declines in function. The purpose of this trial is to determine whether brief periods of intense client-centered rehabilitation therapy (tune-ups) provided at 6 month intervals can alter the natural progression of impairment (physical capacity), function and community reintegration following stroke.


Options:
A: The number of steps taken per day by participants in each group (at baseline & at 6 weeks post randomisation)
B: Change in the mean number of steps per day (Baseline, 4 months, 6 months)
C: Subjective Index of Physical and Social Outcome (SIPSO) (baseline and 1 year); Subjective Index of Social Integration (Subscale of SIPSO) (baseline and one year); Subjective Index of Physical Integration (Subscale of SIPSO) (baseline and one year)
D: Trunk Impairment Scale Norwegian Version (12 weeks); ActiGraph WgtX-BT (13 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Acute Lymphoblastic Leukemia in Children
Brief Summary: RATIONALE: L-asparaginase is an important component of treatment for childhood acute lymphoblastic leukemia, but is also associated with notable side-effects, including hypersensitivity, pancreatitis, and thrombosis. We have previously reported that patients with acute lymphoblastic leukemia in whom asparaginase treatment was discontinued because of intolerable side-effects had survival outcomes that were inferior to those who received all or nearly all of their intended doses. Two bacterial sources of asparaginase exist: Escherichia coli (E coli) and Erwinia chrysanthemia (Erwinia). Generally, the E coli-derived enzyme has been used as front-line therapy and the Erwinia-derived preparation has been reserved for patients who develop hypersensitivity reactions. Pegylated E coli asparaginase (PEG-asparaginase) has a longer half-life and is potentially less immunogenic than native E coli L-asparaginase, and has been used as the initial asparaginase preparation in some pediatric acute lymphoblastic leukemia treatment regimens.

PURPOSE: Although the pharmacokinetics of each of these asparaginase preparations: intravenous PEG-asparaginase (IV-PEG) and intramuscular native E coli L-asparaginase (IM-EC) have been well characterized, their relative efficacy and toxicity have not been studied extensively.


Options:
A: Asparaginase-Related Toxicity Rate (30-week post-induction asparaginase treatment period)
B: Number of Participants With Asparaginase-Related Toxicity (30-week post-induction asparaginase treatment period. Toxicities assessed on an ongoing basis (at least 1 per month) while participant is on study, an average of 2 years.); Induction and Post-Induction Nadir Serum Asparaginase Activity Level (Samples for nadir serum asparaginase activity levels were assayed at 4,11,18,and 25 days after 1st dose, and then prior to asparaginase dose given during post-induction, at Week 7, 13, 19, and 25.)
C: To determine the rate of patients with complete asparagine (ASN) depletion in serum during induction treatment and to demonstrate non-inferiority of rASNase compared to Asparaginase medac™ with respect to this parameter (March 2012)
D: Efficacy of dexamethasone vs prednisone during the induction phase (5 years); Event-free survival (EFS) and overall survival after initial remission in intermediate-risk and high-risk patients (5 years); Safety and efficacy of treatment reduction during reintensification in standard-risk patients (5 years); EFS after second delayed reintensification in intermediate-risk patients (5 years); Outcome after extended reintensification therapy in high-risk patients (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intracoronary Injection of CD133+ Autologous Hematopoietic Cells After Myocardial Infarction
Brief Summary: TITLE Intracoronary injection of CD133+ autologous hematopoietic cells after myocardial infarction.

TRIAL DESIGN Pilot phase I/II parallel group study, with an untreated control group.

SPONSOR IRCCS Ospedale Maggiore Policlinico Milano INDICATION Acute myocardial infarction (AMI). TARGET POPULATION Patients (pts) with AMI treated with Primary Coronary Angioplasty (PTCA) with successful recanalization but unsuccessful reperfusion (myocardial blush (MB) grade 0 or 1 and less than 70% ST segment elevation resolution (STeR) (see Poli et al., Circulation, 2002).

OBJECTIVES Primary:

1. To evaluate the safety of intracoronary injection of CD133+ cells from autologous bone marrow (ABM) and mobilized peripheral blood (MPB) in the target population.
2. To evaluate the efficacy, of the selective injection of CD133+ cells from ABM and MPB in the culprit vessel of the target population, on regional and global contractile function and on perfusion and metabolism of the infarcted area, depending on cell dose and comparing to controls.

   Secondary:
3. To evaluate the disease-related morbility of the target population.


Options:
A: Freedom from occurrence of major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, re-infarction, revascularization and stroke (12 months)
B: myocardial flow (MF) (mL/g/min) evaluated by Positron Emission Tomography(PET) with Nitrogen-13 ammonia (13NH3),; Ejection fraction (%) evaluated by 2D echocardiography;
C: Comparison of treatment adverse event rates between the 0.5, 1.6 and 5.0 million mesenchymal stem cells per kilogram dose cohorts and placebo groups. (6 months)
D: Heart function (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pediatric Endurance and Limb Strengthening (PEDALS)
Brief Summary: The study is about the effect of an exercise program using stationary bicycling for children with the spastic diplegic form of cerebral palsy. Spastic diplegia is a type of cerebral palsy that involves spasticity or "tightness" of the leg muscles. We hope to learn whether this type of exercise will allow the children to develop improved strength in the muscles that bend and straighten their knees, enhance their level of physical fitness, improve their ability to walk and improve their ability to perform other activities that are important to them. We hypothesize that children who participate in the stationary cycling intervention will gain strength in the muscles that bend and straighten their knees, will be able to complete a 600 yard walk run test (a test of endurance) more rapidly, and will improve their score on a test of function called the Gross Motor Function Measure (a test designed specifically for children with cerebral palsy).


Options:
A: Gross Motor Function Measure-66 (GMFM) (Basline and Post Intervention); 600 Yard Walk-Run Test (Baseline and Post Intervention); 30 Second Walk Test (Basline and Post Intervention); Knee Flexor and Knee Extensor Torque (Basline and Post Intervention); Pediatric Quality of Life Inventory (PedsQL) (Basline and Post Intervention); Pediatric Outcomes Data Collection Instrument (PODCI) (Basline and Post Intervention)
B: Gross Motor Function Measure, Sitting Section (2 months)
C: health of children (Pediatric Quality of Life Inventory) (changes from baseline at one and two months.)
D: Upper extremity functional status (30 minutes)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV-An Open-Label Prospective Study of Memantine in Institutionalized Patients With Severe Alzheimer's Disease and Significant Behavioural and Psychological Symptoms of Dementia
Brief Summary: Alzheimer's disease (AD) is the most common form of dementia and is characterized by both cognitive and behavioural symptoms ("Behavioural and Psychological Symptoms of Dementia"; BPSD). To date, there are only modestly effective treatments for BPSD, and these treatments are associated with an increased risk of mortality in elderly dementia patients. We plan to study whether treatment with medication memantine improves BPSD in severe AD patients. Thirty-two AD patients with significant BPSD, including agitation and aggression, will be treated for three months with memantine. Assessments of behavioural symptoms and global clinical outcomes will be completed after one, two and three months of treatment.


Options:
A: Cohen-Mansfield (2 weeks)
B: Neuropsychiatric Inventory Nursing Home Version (Screening, Baseline, 1 month, 2 months, 3 months); Clinical Global Impression of Change (Baseline, 1 month, 2 months, 3 months)
C: Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF) (Baseline to week 24); Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF) (Week 24)
D: The primary outcome is safety as measured by adverse events, laboratory tests, vital signs, weight, physical exam and electrocardiogram

Answer: B