TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinic and Home Family Based Behavioral Treatment for Obese Preschoolers
Brief Summary: This study is a 3 arm, randomized, parallel group randomized clinical trial to test a clinic and home family behavioral intervention (LAUNCH) against 1) motivational interviewing (attention control; MI) and 2) standard of care (true standard of care control; STC) with 168 children ages 2 to 5 years who meet the criteria for obesity (\>95th percentile for body mass index; BMI). Participants will be randomized to receive a 6 month intervention (LAUNCH, MI) or standard of care. The primary end-point will be change in BMI z-score at the end of treatment. The investigators will also assess maintenance of treatment gains at 6 and 12 months after treatment, and changes in factors thought to be mechanisms for change in weight (food intake and activity level), changes in the obesiogenic environment (parent weight, food intake and activity, and changes in the home food environment) and factors that could be negatively impacted (parent and child eating and feeding interactions).


Options:
A: Body mass index (BMI) at 1 year.
B: Change in screening and assessment of childhood obesity at the point of care, including BMI, blood pressure, and laboratory screening, and provision of nutrition and physical activity counseling (Baseline and 1 Year)
C: Number of weight management visits/ practitioner Full Time Equivalent(FTE) (Data will be collected monthly and analyzed at 6, 12 and 18 Months); Change in BMI (3,6,12,and 18 month where possible); Change in Self-reported health measures-SF12 (3,6,12 months and 18 months where possible)
D: Change in BMIz score (Baseline to 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Prediction and Aspirin for Prevention of Preeclampsia
Brief Summary: This is a randomized controlled trial to estimate the efficacy of low dose aspirin for preventing preeclampsia in women identified as high risk. The investigators hypothesize that the risk of preeclampsia in women identified by a first trimester multiparameter predictive model to be at high risk will be significantly reduced by initiating low dose aspirin early in pregnancy.


Options:
A: Number of Participants With Preeclampsia (within 3 months prior to delivery)
B: Delivery with preterm-preeclampsia (Before 37 weeks of gestation)
C: Preeclampsia - Change in blood pressure (Hypertension) (From 20 weeks gestation to delivery); Preeclampsia - Change in Proteinuria (From 20 weeks gestation to birth); Birth weight (weight will be measured on the day of birth and plotted on standard WHO UK RCPCH growth charts (per gender).); Preterm birth (Gestational age at birth will be verified with respect to the Estimated Date of Delivery calculated at the first study visit.); Perinatal mortality (Stillbirth or neonatal death after 24 completed weeks of gestation and within 28 days of birth.)
D: Incidence of Preterm Birth (At delivery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Supplementation of Fish Oil on Non-alcoholic Fatty Liver Disease in Children - a Randomized, Double Blind, Placebo Controlled, Multicenter Study
Brief Summary: The aim of this study is to evaluate efficacy of fish oil (EPA/DHA) in children with non-alcoholic fatty liver disease.


Options:
A: Improvement in hepatic histology (after 96 weeks of treatment)
B: Liver enzyme (1year)
C: Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies (12 months); Alanine Transaminase (ALT) Levels (3 month endpoint); Alanine Transaminase (ALT) Levels (6 months)
D: Serum alanine transaminase level decrease min. 0.3 upper limit of normal (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIa Safety and Tolerability Study to Investigate the Effect on Sleep of 3 Doses of AZD5213 and Placebo in Patients With Mild Alzheimer's Disease and Mild Cognitive Impairment During 4 Weeks of Treatment, Placebo-Controlled
Brief Summary: This is a study where AZD5213 or placebo is given to patients with Mild Alzheimer's Disease or Mild Cognitive Impairment in a blinded and random assignment. The main study objective is to estimate the relationship of sleep duration versus dose after 4 weeks of treatment.


Options:
A: Change From Baseline in Total Sleep Time (TST) After 4 Weeks of Treatment, Based on PSG Measurement. (Baseline and Week 4.)
B: Change From Baseline in Polysomnography-derived Total Sleep Time (TST) at Week 4 (Baseline and Week 4); Percentage of Participants Who Experienced One or More Adverse Events (Up to 6 weeks); Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Up to 4 weeks)
C: Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) (Quarterly over 6 months)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose Study of the Efficacy, Safety, Tolerability, and Pharmacodynamics of Subcutaneously-Administered REGN668 in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis
Brief Summary: The primary objective was to assess the clinical efficacy of repeated subcutaneous (SC) doses of Dupilumab in adult participants with moderate-to-severe atopic dermatitis (AD).


Options:
A: Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12 (Baseline (Day 1) and Week 12); Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12 (Week 12)
B: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) (Baseline up to end of study (up to Day 85))
C: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 12- Last Observation Carried Forward (LOCF) (Baseline to Week 12)
D: Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI 50) at Week 12 (Baseline (Day 1) and Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Shamba Maisha: Pilot Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya
Brief Summary: This pilot study aims to determine whether an agricultural intervention will improve food security, prevent treatment failure, reduce co-morbidities, and decrease secondary HIV transmission risk among people living with HIV/AIDS. The intervention will include: a) a human-powered water pump and other required farm commodities, b) a micro-finance loan (\~$75) to purchase the pump and agricultural implements, and c) education in sustainable farming practices.


Options:
A: Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year (1 year); Change From Baseline in CD4 Count at 1 Year (1 year)
B: Food security as measured by the value of food consumption through a household questionnaire (6 months); Dietary diversity as measured by dietary diversity index and food consumption score through a household questionnaire (6 months)
C: Incidence of Diarrhea (2 weeks)
D: Recovery rate in the outpatient therapeutic program (At 6 week)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Shamba Maisha: Pilot Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya
Brief Summary: This pilot study aims to determine whether an agricultural intervention will improve food security, prevent treatment failure, reduce co-morbidities, and decrease secondary HIV transmission risk among people living with HIV/AIDS. The intervention will include: a) a human-powered water pump and other required farm commodities, b) a micro-finance loan (\~$75) to purchase the pump and agricultural implements, and c) education in sustainable farming practices.


Options:
A: Cumulative incidence of child wasting (3-monthly until 24 months after inclusion); Incremental cost-effectiveness ratio (24 months after inclusion)
B: Food security as measured by the value of food consumption through a household questionnaire (6 months); Dietary diversity as measured by dietary diversity index and food consumption score through a household questionnaire (6 months)
C: Incidence of Diarrhea (2 weeks)
D: Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year (1 year); Change From Baseline in CD4 Count at 1 Year (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Shamba Maisha: Pilot Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya
Brief Summary: This pilot study aims to determine whether an agricultural intervention will improve food security, prevent treatment failure, reduce co-morbidities, and decrease secondary HIV transmission risk among people living with HIV/AIDS. The intervention will include: a) a human-powered water pump and other required farm commodities, b) a micro-finance loan (\~$75) to purchase the pump and agricultural implements, and c) education in sustainable farming practices.


Options:
A: HIV viral suppression at 6 months (6 months)
B: Cumulative incidence of child wasting (3-monthly until 24 months after inclusion); Incremental cost-effectiveness ratio (24 months after inclusion)
C: Number of Participants Who Present Children for HIV Testing (2 months); Number of Days Participants Take to Bring Children for HIV Testing (2 months)
D: Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year (1 year); Change From Baseline in CD4 Count at 1 Year (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Utilization of Nintendo Wii™ in Outpatient Rehabilitation Following Total Knee Replacement
Brief Summary: The purpose of this study is to identify whether the utilization of the Nintendo Wii™ gaming system, as an adjunct to conventional outpatient rehabilitation therapy, influence outcomes of patients following total knee replacement (TKR). The investigators hypothesize that the Nintendo Wii™ gaming system has a positive influence in the outcomes of patients following TKR.


Options:
A: Action Research Arm Test (ARAT) (End of treatment at 8 weeks post enrolment)
B: Length of outpatient rehab stay (LOS) (From admission to discharge, an expected average of 5 weeks.)
C: Change in the Function In Sitting Test (FIST) from baseline to after 10-12 treatment sessions (baseline, immediately after 10-12 treatments); Change in the Function In Sitting Test (FIST) from baseline to 1 month after second assessment (baseline,1 month after second assessment)
D: Rating Scale Score (1 day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Meditation Interventions for Treatment of PTSD in Veterans
Brief Summary: Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder which results in serious impairments in interpersonal, occupational and social functioning. Effective treatments are available for PTSD but they do not work for everyone. Alternative treatments are needed to help those veterans not helped by currently available treatments. Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on mindfulness meditation. MBSR has been found to be effective in helping people with problems with pain and anxiety. MBSR has not yet been studied in veterans with PTSD. The proposed study will compare MBSR with a standard psychotherapy treatment in veterans with PTSD. This research is relevant to Veterans' health because of the need to develop alternative treatments for veterans with PTSD who have not responded to currently available treatments.


Options:
A: Clinician-Administered PTSD Scale (CAPS) Diagnostic and Statistical Manual, 4th ed., Text Revision (DSM-IV) (Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.); Re-experiencing Subscale (Criterion B) on the Clinician Administered PTSD Scale (CAPS) (Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.); Avoidance Subscale (Criterion C) on the Clinician Administered PTSD Scale (CAPS) (Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.); Hyperarousal (Criterion D) on the Clinician Administered PTSD Scale (CAPS) (Baseline to post-treatment (week 8); baseline to 2 months post-treatment.); PTSD Checklist-Military Version [Diagnostic and Statistical Manual (DSM) IV-TR Version] (Baseline to post-treatment (week 8); Baseline to 2-months post-treatment.)
B: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (12 months)
C: PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up (Baseline, Weeks 3, 6, 9 and 17)
D: Posttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S) (Baseline, weekly during treatment, posttreatment, 6-month and 12-month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Placebo-controlled, Randomized, Parallel-group Study of the Safety and Effects of YisuiShengxueGranules on Thalassemia Presenting the Syndrome of Deficiency of Liver/Kidney-yin, and Asthenia of Essence/Blood.
Brief Summary: The primary objectives of this study are to evaluate whether Yisui Shengxue Granules therapy can increase the hemoglobin level in peripheral blood and alleviate the symptoms, and at the same time, evaluate its safety in the treatment of Thalassemia with the syndrome of deficiency of liver-yin and kidney-yin, and asthenia of essence and blood.


Options:
A: Clinical effects on heamoglobin changes (6 months)
B: The level of Hemoglobin (18 months)
C: Hemoglobin(Hb) (Four weeks); Adult hemoglobin(HbA) (Four weeks); Fetal hemoglobin(HbF) (Four weeks); Minor adult hemoglobin(HbA2) (Four weeks)
D: The Effective Rate of Patients (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Gum Chewing After Gynecologic Laparoscopy Stimulate Earlier Return of Bowel Motility?
Brief Summary: Gum chewing has been reported to stimulate bowel motility after open surgery, such as cesarean section and other abdominal surgeries. In general, after laparoscopic surgery problems with reduced bowel motility are not as common as after open surgery. In this study the investigators test the hypothesis that gum chewing is enhancing rapid return of bowel motility after gynecologic laparoscopic surgery. Further the investigators study patient satisfaction and potential side effects of postoperative gum chewing.


Options:
A: Small bowel transit time (6 hours)
B: Time to return to active bowel movements (participants will be followed for the duration of hospital stay)
C: time to flatus (two days)
D: Time to first bowel movement (patients postoperative in hospital stay (mean 6 days))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Polyp Detection With The Peerscope System™: A Randomized Tandem Colonoscopy Study
Brief Summary: The PeerScope System consists of Peer Medical camera heads, endoscopes, video system, light source and other ancillary equipment. The system is intended for endoscopic diagnosis, treatment and video observation of the digestive tract. The PeerScope system model B is indicated for use for endoscopy and endoscopic treatment within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) of adults patients.

Objective:To compare the additional diagnostic yield obtained by using the PeerScope System™ extended view vs. the diagnostic yield obtained by the Standard view colonoscopy.

In addition, time measurements including time to cecum, time for withdrawal and overall procedure time will be analyzed and reported for each group.


Options:
A: polyp detection rate (1 year)
B: adenoma detection rate for position 1 compared to position 2
C: Detection Rates for Adenomas and for Total Polyps (Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.)
D: The primary outcome is whether the patient is a responder or not after 8 weeks treatment.; The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.; The patient will judge their symptoms of pain or burning centered in the upper abdomen on a four-graded scale (none, mild, moderate or severe).

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Adductor-Canal-Blockade on High Pain Responders the 1. or 2. Postoperative Day After Total Knee Arthroplasty
Brief Summary: The purpose of this study is to determine whether Adductor-Canal-Blockade (ACB) is superior to placebo when it comes to analgetic efficacy in high pain responders after Total Knee Arthroplasty (TKA). High pain responders are defined as patients reporting VAS \> 60 during knee flexion the 1. or 2. day after surgery.


Options:
A: Difference in VAS between ACB and placebo during active 45 degrees knee flexion (45 minutes)
B: Pain-score (VAS), patient standing (2 hours postoperative)
C: Total morphine consumption (0-24 hours postoperative)
D: The difference in quadriceps muscle strength between the Adductor-Canal-Blockade and the femoral nerve block (24 h postoperatively)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a Mixture of Inulin and Fructo-oligosaccharide on Lactobacillus and Bifidobacterium Intestinal Microbiota of Patients Receiving Radiotherapy: a Randomised, Double-blind, Placebo-controlled Trial.
Brief Summary: Abdominal and pelvic radiotherapy (RT) reduces the renewal capacity of the epithelium. Rectal biopsies obtained from patients receiving pelvic RT have revealed atrophy of surface epithelium, acute cryptitis, crypt abscesses, crypt distortion and atrophy, and stromal inflammation. Modifications in intestinal microbiota, such as an increase in the number of pathogens, may contribute to intestinal injury. The prebiotic effect of a carbohydrate is assessed by its capacity to stimulate the proliferation of healthy bacteria (Bifidobacterium, Lactobacillus) rather than pathogenic bacteria (Clostridium, E. coli).

The hypothesis of the study is that a mixture of inulin and fructooligosaccharide could modulate Lactobacillus and Bifidobacterium and reduce the intestinal injury in patients affected of gynaecological cancer and treated with abdominal radiotherapy.


Options:
A: Changes in Lactobacillus and Bifidobacterium populations (2 months)
B: proctitis and cystitis (3 years)
C: Effect of Soy Isoflavones on Serum Testosterone Levels. (Two weeks)
D: Survival (3 years or death)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Polyethylene Glycolic Acid or Tachocomb to Prevent Pancreatic Fistula Following Distal Pancreatectomy: Prospective Multicenter Randomized Study
Brief Summary: To date, there has been many methods suggested to reduce pancreatic fistula. But there are no evidence of superiority to the other methods. This study is a multicenter prospective randomized phase III study of use of Tachocomb or Polyethylene Glycolic Acid (PGA) to prevent of pancreatic fistula after distal pancreatectomy.


Options:
A: Rate of postoperative complications of grade > II according to Dindo-Clavien classification (90 days); Rate of overall postoperative complications (90 days); Rate of postoperative mortality (90 days)
B: Incidence of pancreatic fistula (At 3 days after surgery); Incidence of clinically relevant pancreatic fistula (At 5 days after surgery)
C: The rate of pancreatic fistula between groups (postoperative 3rd day)
D: Pancreatic fistula development post distal pancreatectomy (30 days post surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Preparing Older Veterans With Serious and Chronic Illness for Decision Making
Brief Summary: Millions of diverse Veterans live with severe and chronic illness for which they will face complex, ongoing decisions. Although the VHA has been at the forefront of patient-centered chronic care, interventions to prepare Veterans for complex decision-making over the course of chronic illness are lacking. This proposal addresses this gap by testing the efficacy of a novel preparation guide designed to prepare Veterans to communicate with their surrogates and to work with clinicians to make complex, ongoing decisions. The multi-media guide teaches communication and preparation skill behaviors (e.g., how to choose a surrogate and ask clinicians questions) in a culturally appropriate, easy-to-use format (targeted to a 5th grade reading level). This study aims to provide an impetus for changing the paradigm of advance care planning policies within the VA by moving beyond documentation of end-of-life wishes to the activation of Veterans to participate in ongoing communication of their values and goals - a process that is essential to fully realize patient-centered care.


Options:
A: Change in standardized score (Six months after enrollment)
B: The assumed role in the decision making process, and the preferred and chosen options. (3 to 6 months)
C: New Advance Care Planning Documentation in the Medical Record at 9 Months (9 months after study enrollment)
D: All-cause mortality (within 5 years of enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3b, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis
Brief Summary: The purpose of the study is to assess the effect of extending maintenance dosing intervals beyond 12 weeks on the clinical efficacy and safety of ustekinumab in subjects with moderate-to-severe plaque psoriasis.


Options:
A: Percentage of Participants With Scalp Physician Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) With at Least a 2-Point Reduction From Baseline (Baseline to Week 16)
B: The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) (Up to 24 weeks (Week 88 up to Week 112 [total 7 visits]))
C: Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) (Week 12); Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI) (Week 12)
D: Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16 (Week 16)

Answer: B