TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Distress and Improving Self-Care in Diabetes
Brief Summary: To date, there have been few practical, evidenced based interventions that are directed at patients with Type II Diabetes who are experiencing depressed and/or emotional distress in primary care settings. This study will (1) combine two existing, evidenced-based, interventions (a computer automated, diabetes specific self-management program (CASM) vs. a self-care program plus a live problem solving distress-reduction program (CAPS) vs. a lifestyle and activities education program (LEAP-AHEAD)) into a practical, 3-arm clinical trial with a highly distressed multi-ethnic patient sample, and (2) evaluate the intervention using the RE-AIM framework, sharing the results through a comprehensive dissemination package.

Hypothesis 1: The combined CASM and CAPS arms will be superior to the LEAP-AHEAD group on the primary outcomes at follow-up.

Hypothesis 2: The CAPS arm will be superior to the CASM arm on primary outcomes at follow-up.


Options:
A: Depressive Symptoms (CES-D Score) (Baseline, 12 month FU)
B: Weight in kilograms (kg) (Baseline, 3-month follow-up, and 9-month follow-up); Physical functioning measured by a 6-minute walk test (Baseline, 3-month follow-up, and 9-month follow-up)
C: change in hemoglobin A1c (6 and 12 months)
D: Diet. Starting the Conversation is a 9 items measure of eating patterns (including 2 items from the NCI Fruit and Vegetable Screener). NCI Percent Energy from Fat Screen (PFAT) contains 17 items concerning frequency of intake for 15 food groups. (Baseline, 16 weeks, and 12 months); Physical Activity. The CHAMPS (28 items) will be used to measure physical activity. (Baseline, 16 weeks, and 12 months); Medication Adherence. Medication taking will be assessed by the Hill-Bone Medication Adherence scale. Questions will also cover smoking and alcohol use. (Baseline, 16 weeks, and 12 months); Distress. Patient distress will be assessed across several measures including: the 20-item CES-D, the 17-item DDS, the PHQ8, and screening items from the SCID to rule out psychosis. (Baseline, 16 weeks, and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude
Brief Summary: The purpose of the study is to investigate the effect of acetazolamide as a treatment for sleep related breathing disturbances in patients with the obstructive sleep apnea syndrome living at low altitude during a sojourn at moderate altitude


Options:
A: sleep disordered breathing, sleep structure, vigilance, subjective sleep quality acute mountain sickness (during treatment while at altitude)
B: Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline) (Baseline and 12 weeks (or last observation after baseline)); Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline) (12 weeks (or last observation after baseline))
C: Polysomnography parameters: sleep structure, respiratory, limb movements (onset, 3 and 6 months of treatment)
D: Obstructive Apneas (at one month of treatment); Desaturations (at one month of treatment); Sleep Time With Oxygen Saturation Below 90% (at one month of treatment); Apneas (at one month of treatment); Hypopneas (at one month of treatment); Index Apnea/Hypopnea (at one month of treatment); Mixed Apneas (at one month of treatment); Central Apneas (at one month of treatment); Index of Apneas (at one month of treatment); Index of Hypopneas (at one month of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Referral From Primary Health Care Centers to a Physical Activity Program: Establishing Long-Term Adherence? A Randomized Controlled Trial
Brief Summary: Declining physical activity and the associated rising burden of disease is a major public-health problem and it has long been known that being physically active has positive health effects. The virtual absence of a public health practice infrastructure for the promotion of physical activity at the local level presents a critical challenge to control policy for chronic disease. We aimed to assess the efficacy of a 3-months physical activity program in primary health care to create adherence to physical activity in sedentary individuals.


Options:
A: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)
B: 7-Day Physical Activity Recall (7-Day PAR) (6 months)
C: This randomized controlled trial was designed to assess the effectiveness of a primary care physical activity intervention, in increasing adherence to physical activity in general population, as well as their self-reported physical activity. (baseline-3-6-12-18)
D: Physical activity level

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Referral From Primary Health Care Centers to a Physical Activity Program: Establishing Long-Term Adherence? A Randomized Controlled Trial
Brief Summary: Declining physical activity and the associated rising burden of disease is a major public-health problem and it has long been known that being physically active has positive health effects. The virtual absence of a public health practice infrastructure for the promotion of physical activity at the local level presents a critical challenge to control policy for chronic disease. We aimed to assess the efficacy of a 3-months physical activity program in primary health care to create adherence to physical activity in sedentary individuals.


Options:
A: Physical activity level
B: 7-Day Physical Activity Recall (7-Day PAR) (6 months)
C: Absolute level of physical activity: (Assessed at baseline, 6, 12 and 24-month follow-up as kcals/wk expenditure based on survey self-report, validated against activity monitor data in a random sub-sample.); Maintenance of physical activity (Physical activity level relative to baseline assessed at all follow-ups 6, 12, 24 months.)
D: This randomized controlled trial was designed to assess the effectiveness of a primary care physical activity intervention, in increasing adherence to physical activity in general population, as well as their self-reported physical activity. (baseline-3-6-12-18)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Referral From Primary Health Care Centers to a Physical Activity Program: Establishing Long-Term Adherence? A Randomized Controlled Trial
Brief Summary: Declining physical activity and the associated rising burden of disease is a major public-health problem and it has long been known that being physically active has positive health effects. The virtual absence of a public health practice infrastructure for the promotion of physical activity at the local level presents a critical challenge to control policy for chronic disease. We aimed to assess the efficacy of a 3-months physical activity program in primary health care to create adherence to physical activity in sedentary individuals.


Options:
A: Self-Reported physical activity (Baseline, 3 months, and 6 months)
B: Physical activity level
C: Physical activity level (7-day Physical Activity Recall [PAR]) (six months from the start of the intervention)
D: This randomized controlled trial was designed to assess the effectiveness of a primary care physical activity intervention, in increasing adherence to physical activity in general population, as well as their self-reported physical activity. (baseline-3-6-12-18)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease
Brief Summary: It is hypothesized that oral naltrexone will improve inflammation of the bowel by increasing endogenous enkephalin levels in subjects with active Crohn's disease. This is especially important in children who often are suffering from nutritional deprivation which retards their growth.

The key objectives are to:

1. Evaluate the effects of low dose naltrexone in children with Crohn's Disease by using the Pediatric Crohn's Disease Activity Index (PCDAI), plasma inflammatory markers, weight, and pediatric quality of life survey.
2. To determine the safety and toxicity of low dose naltrexone in pediatric subjects with active Crohn's Disease.
3. Assess the potential mechanism by which naltrexone exerts its action by measuring plasma opioid (enkephalin and endorphin levels) and proinflammatory cytokines.


Options:
A: Number of Patients Reporting Side Effects (8 weeks or 16 weeks)
B: Corticosteroid-free remission (At the end of the study treatment)
C: Fatigue score (20 weeks)
D: Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients
Brief Summary: A study team with extensive experience in immunization delivery research will evaluate the effectiveness of vaccination reminder/recall systems for adolescent patients in five types of clinical settings including: urban pediatric, urban family medicine and rural family medicine practices, public pediatric clinics, and school-based health centers. Randomized controlled trials of reminder/recall for adolescents will be conducted at each type of site, with randomization at the level of the patient.


Options:
A: 1) the percentage receiving any vaccine after the baseline time point (6 months after intervention); The percentage of adolescents becoming up-to-date on all needed immunizations (6 months post intervention)
B: seasonal influenza vaccination (up to 4 months following reminder notification)
C: 1 Dose Coverage of the HPV vaccine series at End of Study Period (12 months); 3 Dose Coverage of the HPV vaccine series at End of Study Period (12 months)
D: On-time Completion of the Human Papillomavirus Vaccine Series (32 weeks after receipt of initial vaccine)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: 3T Stroke MRT for Examining Mismatch in the CSB of the Charité Universitätsmedizin Berlin (3Tesla in 1000+)
Brief Summary: The purpose of this study is to compare clinical and economic parameters of stroke patients who have received acute MRI imaging (test group) to patients who have received routine CT imaging (control group) in the clinical setting of acute stroke.


Options:
A: Blood Pressure Control (Baseline, 6 months, 12 months, 18 months); Mean Systolic Blood Pressure (Baseline, 6 months, 12 months, 18 months, 54 months); Mean Diastolic Blood Pressure (Baseline, 6 months, 12 months, 18 months, 54 months)
B: change of infarct size between baseline and day 6 (day 6)
C: Dyspnea; Exercise adherence and performance; Pulmonary exacerbations
D: Weight (Measured at Assessment Visits) and Pain Intensity and Pain Related Disability (NRS-I) (baseline, 3, 6, 9, and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The aim of the current work was to evaluate, for the first time in a prospective randomized study, the effect of HBOT on patients with chronic neurological deficiency due to stroke.


Options:
A: Neurologic evaluation (2 and 4 months)
B: Scores on autism rating scales before and after HBOT; Measure of inflammation before and after HBOT; Measures of oxidative stress before and after HBOT
C: Blinded Therapist Autism Diagnostic Observation Schedule (ADOS); Blinded Therapist Aberrant Behavior Checklist (ABC-C); Blinded Physician Clinical Global Impression Severity Score (CGI); Parental Autism Treatment Evaluation Checklist (ATEC)
D: Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score (Baseline, 8 Weeks from baseline, and 20 Weeks from baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1 Study of Integration of Early Child Development Interventions in a Community Health Service in Sindh, Pakistan
Brief Summary: The purpose of this study is to evaluate whether the integration of an early child 'stimulation and care for development' intervention, either alone or in combination with an 'enhanced care for nutrition' intervention, delivered by Lady Health Workers to families with infants and young children aged 0-24 months living in rural Sindh in Pakistan, has beneficial outcomes on child development (cognitive, language, motor and social emotional development) and child growth.


Options:
A: Early Child Development (24 months of child age); Child Growth (24 months of child age)
B: Hemoglobin concentration (End of the 30-day fortification period)
C: Changes in GI microbiome (6 and 9 months of age)
D: Anthropometry - Recumbent Length (Change from baseline in length over 12 months); Anthropometry - Weight (Change from baseline in weight over 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1 Study of Integration of Early Child Development Interventions in a Community Health Service in Sindh, Pakistan
Brief Summary: The purpose of this study is to evaluate whether the integration of an early child 'stimulation and care for development' intervention, either alone or in combination with an 'enhanced care for nutrition' intervention, delivered by Lady Health Workers to families with infants and young children aged 0-24 months living in rural Sindh in Pakistan, has beneficial outcomes on child development (cognitive, language, motor and social emotional development) and child growth.


Options:
A: Linear Growth (6-18 mos of age)
B: Exclusive breastfeeding (EBF) among children 0-6 months of age (4 years after baseline); Child anthropometry (height, weight) among children 24-48 months of age (4 years after baseline); Complementary feeding among children 6-23.9 months of age (4 years after baseline); Anemia among children 6-23.9 months (4 years after baseline)
C: Early Child Development (24 months of child age); Child Growth (24 months of child age)
D: Prevalence of underweight among children 0-23 months; Prevalence of stunting among children 0-23 months; Prevalence of wasting among children 0-23 months; Prevalence of anemia among children 12-23 months

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1 Study of Integration of Early Child Development Interventions in a Community Health Service in Sindh, Pakistan
Brief Summary: The purpose of this study is to evaluate whether the integration of an early child 'stimulation and care for development' intervention, either alone or in combination with an 'enhanced care for nutrition' intervention, delivered by Lady Health Workers to families with infants and young children aged 0-24 months living in rural Sindh in Pakistan, has beneficial outcomes on child development (cognitive, language, motor and social emotional development) and child growth.


Options:
A: Effectiveness of a nutrition advice programme in exclusive breastfeeding. (1 year); Effectiveness of a nutrition advice programme in dietary intake (1 year); Effectiveness of a nutrition advice programme in dietary intake (4 years); Effectiveness of a nutrition advice programme in dietary intake (8 years); Effectiveness of a nutrition advice programme in dietary intake (12 years)
B: Breastfeeding Initiation (Three days postpartum); Positive parenting behavior (Parent Child Observation Guide) (4 months postpartum)
C: Early Child Development (24 months of child age); Child Growth (24 months of child age)
D: Growth (Measurements will be made for children between the ages of 3 and 12 months of age at baseline and then 2 years later, at endline, when the children are between the ages of 23 and 40 months); Hemoglobin (Measurements will be made for children between the ages of 3 and 12 months of age at baseline and then 2 years later, at endline, when the children are between the ages of 23 and 40 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of a Hospital Walking Program for Older Adults
Brief Summary: Low mobility, defined as being limited to bed or chair, is common during acute hospitalization. This study will evaluate the impact and safety of a hospital walking program for older patients during acute general medical hospitalization. Participants who are 65 years of age or older, will be randomized to usual care (UC) or to a hospital walking program (WP), which includes twice daily walks with assistance, provision of necessary ambulatory devices, and a behavioral intervention strategy designed to encourage out of bed activity. Throughout hospitalization, the WP and UC veterans will were wireless monitors on the thigh and ankle that measure activity. The primary goal will be in increase the length of time veterans spend out of bed and to assure this out of bed activity is safe.


Options:
A: Change in 30-s chair stand performance (Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge)
B: Independence level in self-care (The level of independence in self-care will be assessed at baseline (admission) and discharge through the Barthel Index)
C: Falls (18 months); Amount of Time Spent Out of Bed as Measured by Wireless Accelerometers (During hospital stay)
D: The Primary Outcome Variable for This Study Will be the Short Form of the Continuous Scale Physical Functional Performance Test (CS-PFP) Called the PFP-10 (1 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An International Randomised Controlled Trial to Establish the Effects of Early Intensive Blood Pressure Lowering in Patients With Intracerebral Haemorrhage.
Brief Summary: The purpose of this academic lead study is to determine if a treatment strategy of early intensive blood pressure (BP) lowering compared to conservative BP lowering policy in patients with elevated blood pressure within 6 hours of acute intracerebral haemorrhage (ICH) improves the outcome of death and disability at 3 months after onset.


Options:
A: Number of participants enrolled per month (1 year)
B: A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS) (90 days)
C: Combination death and dependency, according to a 3-6 scores on the modified Rankin Score. (3 months)
D: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) (time since randomization; follow-up period is 1.5 to 4.4 years); Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) (time since randomization; follow-up period is 1.5 to 4.4 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An International Randomised Controlled Trial to Establish the Effects of Early Intensive Blood Pressure Lowering in Patients With Intracerebral Haemorrhage.
Brief Summary: The purpose of this academic lead study is to determine if a treatment strategy of early intensive blood pressure (BP) lowering compared to conservative BP lowering policy in patients with elevated blood pressure within 6 hours of acute intracerebral haemorrhage (ICH) improves the outcome of death and disability at 3 months after onset.


Options:
A: Combination death and dependency, according to a 3-6 scores on the modified Rankin Score. (3 months)
B: Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization (90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization)
C: Cerebral vasospasm-related morbidity and mortality of all-causes as defined by the protocol (Within 6 weeks post-aSAH)
D: A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS) (90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of the Level of Dietary Protein on Infant Growth and Body Composition in the First Year of Life
Brief Summary: The purpose of this study is to determine whether infants fed a formula with protein levels different than a standard infant formula have similar growth and development.


Options:
A: Mean weight gain (6 months)
B: BMI-for-age z-score (Age 24 months)
C: Weight gain (1- 365 days)
D: Weight Gain Velocity (0 - 16 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Study of Safety and Efficacy of Two Dosages of Epicutaneously Applied Diractin® (Ketoprofen in Transfersome® Gel) for the Treatment of Osteoarthritis of the Knee
Brief Summary: The purpose of this study is to provide replicated evidence of safety and efficacy of 50 mg and 100 mg ketoprofen in Diractin®.


Options:
A: WOMAC pain score in target knee at Week 12; WOMAC physical function score in target knee at Week 12; Global rating of disease activity by patient at Week 12
B: Visual Analogue Scale (VAS) Pain scale (14 days)
C: OA pain intensity in target hand at Week 4 and 6; Total AUSCAN score in target hand at Week 4 and 6; Global rating of disease activity by patient at Week 4 and 6
D: pain subscale of the WOMAC (week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Etoricoxibe - Preemptive and Postoperative Analgesia for Abdominal and Thoracic Surgery
Brief Summary: This randomised placebo controlled double-blinded bicentre study (phase III) was designed to evaluate the preemptive and postoperative analgetic impact of etoricoxibe in open abdominal and thoracic surgery. Etoricoxib selectively inhibits isoform 2 of cyclo-oxigenase enzyme (COX-2).

Therefore 120 patients (ASA-risk 1-2) with upcoming abdominal or thoracic surgery should be included into this study. Patients are randomly allocated to either the preemptive or the postoperative Etoricoxibe group. These two groups are divided each into two arms. Preemptive group patients get Etoricoxibe either twice (before and after surgery) or just a single preoperative dose. Postoperative group patients get placebo before surgery and either a drug application or a placebo again after surgery (so called 2x2 factorial study design).

Cumulative use of morphine as assessed within first 48 hours after surgery is the primary trial outcome indicating the analgesic potency of Etoricoxibe.

In addition, changes in patients level of sensibilisation will be measured with help of quantitative sensory testing (a standardised procedure) before and after surgery (secondary outcome). In addition pharmacogenetic testing will provide information about genetic aberrations (so called polymorphisms) of the patients enzymes that should be compared to the individual reaction regarding Etoricoxibe.

The results will give hint about the analgesic impact of etoricoxibe in acute postoperative pain. There will be findings for preemptive analgesia and nerval processes. All this could lead to an improvement of postoperative pain relief while administrating preemptively a COX-2 selective inhibitor before surgery.


Options:
A: Postoperative pain measurement employing a previous validated visual analogue scale of pain (VAS). (72 hours)
B: Morphine consumption the first 24 hours postoperatively (0-24 hours postoperatively); Serious adverse events (0-90 days postoperatively)
C: Cumulative use of morphine as assessed within first 48 hours after surgery (first 48 hours)
D: Total morphine consumption (At 48 hour postoperative)

Answer: C