TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: For Moms: Culturally Relevant Treatment Services for Perinatal Depression
Brief Summary: The study will evaluate the effectiveness of a culturally relevant, multi-component intervention for antenatal depression. The intervention includes an engagement session, and the woman's choice of brief interpersonal psychotherapy and/or pharmacotherapy in a stepped care treatment for depression model.


Options:
A: Change in family economic hardship (Quarterly change for up to 15 months)
B: Depressive symptoms, social functioning, and health (Measured at Months 3, 6, and 12 postpartum); Preferences for depression treatment (Measured at baseline and Month 12)
C: SCL-20 depression (baseline, 3, 6 12, 18 month follow-ups)
D: Change in PTSI symptoms (Baseline, Immediately Post- intervention, 2 months post-intervention, 6 months post-intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: For Moms: Culturally Relevant Treatment Services for Perinatal Depression
Brief Summary: The study will evaluate the effectiveness of a culturally relevant, multi-component intervention for antenatal depression. The intervention includes an engagement session, and the woman's choice of brief interpersonal psychotherapy and/or pharmacotherapy in a stepped care treatment for depression model.


Options:
A: Shared Decision Making (OPTION) Independent Blind Coder Assessment Scores (Follow-up assessment (2 months)); Shared Decision Making Questionnaire (SDM-Q-9 Patient Version) (End-of-intervention Assessment (5 months)); Provider Shared Decision Making in Behavioral Health (SDM -BH) Provider Version (Follow-up Assessment (2 months)); Shared Decision Making Questionnaire (SDM-Q-9 Provider Version) (Follow-up Assessment (2 months)); Perceptions of Care Survey - Global Evaluation of Care Scale (PoC) (End-of-intervention Assessment (5 months)); Patient Shared Decision Making in Behavioral Health (SDM -BH)- Patient Version (End-of-intervention Assessment (5 months))
B: SCL-20 depression (baseline, 3, 6 12, 18 month follow-ups)
C: Recruitment Rate (Up to one year from when the study starts enrolling participants)
D: Occurrence of Discussion About Goals of Care at Target Visit (2 weeks after target visit)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Prospective Cohort of Patient With Coronary Stents Undergoing Non Cardiac Surgery or Invasive Procedures.
Brief Summary: Non cardiac surgery in patients with coronary stents is complicated with cardiovascular and hemorrhagic events associated with perioperative management of antiplatelet agents. Several guidelines have outlined the importance of maintaining antiplatelet agents throughout surgical procedures to prevent cardiovascular complications. On the other hand, interruption of antiplatelet agents is still a usual standard to avoid surgical complications. We investigate the impact of perioperative antiplatelet drugs management on these complications, through a multicenter, prospective cohort (RECO stands for "Registre des patients porteurs d'Endoprothèses Coronaires, Opérés de chirurgie non cardiaque"), including all patients with coronary stents undergoing non cardiac surgery or invasive procedures. The aim of this study is primarily to measure the incidence of cardiovascular (including stent thrombosis) and hemorrhagic complications and to identify pre and postoperative risk factors associated with these complications.


Options:
A: All-cause mortality at 30-days after surgery (30 days after surgery); Myocardial injuries that were not identified clinically during the first 5 days after surgery (5 days after surgery); Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device (30 days after surgery); Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device (1 year after surgery)
B: perioperative copeptin concentrations (perioperative from induction of anesthesia to the third postoperative day); composite events composed of all-cause mortality and/or major adverse cardiac and cerebrovascular events (MACCE) (12 months); myocardial injury in non-cardiac surgery (MINS) (3 postoperative days)
C: Progression-free Survival (PFS) (Median observation time at time of analysis was approximately 21 months); Final Analysis: Time to Progression-free Survival Event (Median observation time was approximately 66.4 months)
D: Composite cardiovascular and hemorrhagic postoperative complications (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study To Evaluate Various Methodologies For Assessing The Treatment Of Low Back Pain
Brief Summary: The study is designed to assess methods used in clinical research.


Options:
A: Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake) (Baseline and Day 2)
B: Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire (Baseline and one week after discharge from emergency department)
C: Time to First Perceptible Relief (Confirmed by Meaningful Relief) (Baseline (time of wrap application or oral treatment administration) up to 4 hours)
D: Change from Baseline in numerical rating scale of back pain (Before treatment, At 30 minutes, 2, 4, and 24 weeks after treatment.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Metformin Treatment Before IVF in Women With Ultrasound Evidence of Polycystic Ovaries; a Prospective, Randomised, Double Blind, Placebo Study
Brief Summary: The aim of study was to investigate whether pre-treatment with metformin before and during IVF increases the live birth rate compared to placebo in women with sonographic evidence of polycystic ovaries (PCO), but without any clinical manifestations of polycystic ovary syndrome (PCOS).


Options:
A: Live birth rate (End of pregnancy)
B: To investigate whether four months of Metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic sperm injection) will increase clinical pregnancy rate in normal weight PCOS-women (Vaginal ultrasound in pregnancy week 7)
C: Rate of OHSS (one month)
D: Total number of retrieved oocytes (Two weeks Metformin treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Excessive Weight Gain by Reducing Carbonated Beverage and Sugar Consumption and Increasing Physical Activity Among Public School Adolescents From the Metropolitan Area of Rio de Janeiro
Brief Summary: The main objective is to evaluate the effect on BMI of a school-based program that discourages the consumption of all sweetened beverages, encourages the reduction in sugar intake, and encourages the increase in physical activity among adolescents and their families from a low socioeconomic area.


Options:
A: Body mass index (one year)
B: Body mass index (BMI) >= 85th percentile, adjusted for gender and age (baseline, end of 7th grade, end of study); Fasting glucose (mg/dL) (baseline, end of study); Fasting insulin (mU/mL) (baseline, end of study)
C: This investigation is an equivalency trial to determine whether weight loss differs between subjects consuming beverages containing no calorie sweeteners as compared to water drinkers at 12 weeks. (Data will be measured at 12 weeks.)
D: Triglycerides blood level (baseline); Triglycerides blood levels (3 months); Triglycerides blood Levels (6 months); Triglycerides blood levels (9 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Excessive Weight Gain by Reducing Carbonated Beverage and Sugar Consumption and Increasing Physical Activity Among Public School Adolescents From the Metropolitan Area of Rio de Janeiro
Brief Summary: The main objective is to evaluate the effect on BMI of a school-based program that discourages the consumption of all sweetened beverages, encourages the reduction in sugar intake, and encourages the increase in physical activity among adolescents and their families from a low socioeconomic area.


Options:
A: Behavioural determinants of physical activity and nutrition by determinant questionnaire (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention); Physical activity, physical fitness and sedentarity (questionnaire and accelerometer) (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention); Food intake by 24h recall (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention)
B: Change in Infant Growth (Baby is less than 2 months; baby is 3 months; baby is 6 months)
C: Body mass index (one year)
D: Daily physical activity > 60 minutes (4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Lactobacillus Reuteri (DSM 17938) for the Treatment of Infantile Colic: a Randomized Double-blind Placebo Controlled Trial
Brief Summary: Infantile colic is characterized by excessive crying (defined as crying that last at least 3 hours a day, for 3 days a week, for at least 3 weeks) in an otherwise healthy infant. The crying typically starts in the first few weeks of life and ends by 4-5 months of age. The condition is usually self-limited, with no long-term adverse effects; however, it may be very distressing to parents, hence, any safe and effective treatment would be desirable. Recently, it has been suggested that probiotics may offer some benefit.This is based on the results of one open randomized controlled trial. In this trial, 83 breast-fed infants with colic defined as \>3 hours of crying on \>3 days/week were randomly allocated to receive Lactobacillus reuteri DSM 17938 (108 colony-forming units, once daily 30 minutes after feeding) or simethicone (60 mg/day as 15 drops twice a day after feeding) for 28 days. Mothers followed a cow's milk free diet. By day 28 after randomization, mothers of infants in the probiotic group were significantly more likely than mothers of infants in the simethicone group to report a reduction from baseline in average crying time to less than 3 hours per day (95% vs. 7%). In addition, median crying times were significantly shorter in the probiotic group than in the simethicone group. No adverse effects of L. reuteri were reported.

Although the mechanism of action of L. reuteri for treating infantile colic has not been elucidated yet, the findings are very promising. However, there are some methodological limitations to the study, including no allocation concealment, no blinding, and no intention-to-treat analysis; these may result in selection, performance, and/or attrition biases and, eventually, invalidate the results. Another limitation of the study is the lack of a true placebo group. Given these consideration a new study is proposed that is aiming to overcome these limitations.


Options:
A: Duration of crying (minutes per day) (21 days); Reduction on the daily average crying time >50% during the study (21 days)
B: Reduction of the onset of gaseous colic, regurgitation and of constipation. (one year)
C: Presence of probiotic in the stool (weeks 0-12); Adverse events (duration of study - through study completion)
D: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I, Multi-centre, Double-blind, Placebo-controlled Parallel Group Study to Assess the pharmacoMRI Effects of AZD6765 in Male and Female Subjects Fulfilling the Criteria for Major Depressive Disorder
Brief Summary: The purpose of this study is to determine the effect of a single dose infusion of AZD 6765 compared with placebo and ketamine on the blood oxygen level dependent signal using fMRI (functional Magnetic Resonance Imaging) in depressed subjects.


Options:
A: Measurements of BOLD signal in the brain area BA25 (Day1 (at infusion))
B: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 of Double- Blind Induction Phase- Mixed- Effects Model Using Repeated Measures (MMRM) Analysis (Baseline up to Day 28 of Double-blind Induction Phase); Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis (Baseline up to Double-blind Endpoint (Day 28))
C: Change in MADRS Total Score From Baseline to Week 6 (6 weeks)
D: Change in depressive symptoms (After 4th treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Lactobacillus Reuteri DSM 17938 in the Prevention of Nosocomial Diarrhea in Children. Randomized Double-blind Placebo Controlled Trial
Brief Summary: Nosocomial diarrhea is any diarrhea that a patient contracts in a health-care institution. In children, it is commonly caused by enteric pathogens, especially rotavirus. The reported incidence ranges from 4.5 to 22.6 episodes per 100 admissions. Nosocomial diarrhea may prolong the hospital stay and increase medical costs. One of the potential strategies for the prevention of nosocomial infections is the use of probiotics. The number of studies have shown the efficacy of Lactobacillus reuteri (DSM 17938) in the treatment of acute diarrhea. However, there are no data on the efficacy of L. reuteri in the prevention of nosocomial diarrhea. The investigators, therefore, plan to perform the study with the aim of evaluating the role of Lactobacillus reuteri DSM 17938 administration in the prevention of nosocomial gastroenteritis in a pediatric hospital setting.


Options:
A: Reduction of the incidence of loose/watery stools following antibiotic treatment in children. (19-24 days)
B: To determine whether patients given oral Lactobacillus GG will have a smaller increase in the density of pathogenic bacterial in cultures from oral swabs, nasogastric aspirates, and minimally invasive bronchoalveolar lavage samples. (daily while intubated)
C: Incidence of Participants With Diarrhea by Parental Report (14 days)
D: Nosocomial diarrhea (passage of 3 or more loose or watery stools in a 24-hour period that will occur more than 72 hours after admission) (from 72nd hrs till the and of hospitalization no longer than 14 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Ovulation Induction With Clomiphene Citrate: to Support or Not to Support the Luteal Phase
Brief Summary: The purpose of this study is to assess the effect of luteal phase supplement (LPS) on pregnancy rate in IUI cycles stimulated with clomiphene citrate.


Options:
A: Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3 (weeks 1-3)
B: Live Birth (1 year)
C: Levels of progesterone in the mid-luteal phase. (up to 1-1½years.)
D: ongoing pregnancy rate (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: ThrombElastoGraphic Haemostatic Status and Antiplatelet Therapy After Coronary Artery Bypass Graft Surgery(TEG-CABG Trial):Does Intensified Postoperative Antiplatelet Therapy in Preoperatively Identified Hypercoagulable Patients Improve Outcome After CABG Surgery
Brief Summary: The purpose of this study is to determine whether adding clopidogrel to aspirin after coronary bypass operation (CABG) improves graft patency, in patients that have preoperatively increased platelet activity(hypercoagulable) and therefore greater risk of graft occlusion( thrombosis).


Options:
A: Change from baseline ROTEM® measurements after the administration of heparin
B: amount of transfused red blood cell concentrates (24 h after begin of surgical intervention)
C: Total amount of transfused red cell concentrate (24 hours after start of surgery)
D: Graft patency at 3 months (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Control Trial of the Clinical and Cost Effectiveness of a Specialist Expert Mood Disorder Team for Refractory Unipolar Depressive Disorder
Brief Summary: The purpose of this study is determine whether a specialised mood disorder service, which offers tailored psychological and pharmacological treatment, is more effective in the treatment of chronic unipolar depressive disorder then treatment as usual.


Options:
A: Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD) (Through month 18 of treatment); Number of Participants in Recovery According to the LIFE and HRSD (Through 36 months of treatment); Number of Participants in Recurrence According to the LIFE and HRSD (Measured up to Month 36 from recovery)
B: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))
C: BeckDepression Inventory : A questionnaire with 23 items to measure symptoms of depression
D: Hamilton Depression Rating Scale - Grid version (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIa, Randomized, Single-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of 28-day Repeat Oral Doses of GSK1278863A in Anemic Pre-dialysis and Hemodialysis-dependent Patients
Brief Summary: The purpose of this study is to characterize the safety and efficacy of repeat doses of compound 1278863A in subjects with anemia.


Options:
A: Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period (Baseline and week 12 to 16)
B: Rate of response for increase from baseline of hemoglobin levels (Pre-dose, Day 1, Day 15, Day 22, Follow-up); Adverse Events reporting (throughout study); Safety Labs (Chemistry) (Screening, Day 1, 4, 8, 15, 22, 29, 36, 57); Safety Labs (Hematology) (Screening, Day 1, 4, 8, 15, 22, 29, 36, 57); Safety Labs (Urinalysis) (Screening, Day 1, 4, 8, 15, 22, 29, 36, 57); Vital Signs (blood pressure and heart rate) (Screening, Day 1, 4, 8, 15, 22, 29, 36, 57); ECG (Screening, Day 1, 4, 8, 15, 22, 29, 36, 57)
C: Change From Baseline in Hemoglobin (Hgb) at Week 4 (Baseline (Week -4, Week-2 and Day 1) and Week 4)
D: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) (Baseline; Weeks 24 to 36); Median Time to First Major Adverse Cardiovascular Event (MACE) (Up to Week 208)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: ACtive Care After Transplantation, a Lifestyle Intervention in Renal Transplant Recipients
Brief Summary: The aim of the present study is to compare the outcomes of standard care to the effects of exercise alone, and exercise combined with nutrition counseling, on post-transplantation weight gain and quality of life in renal transplant recipients (RTR). The primary outcome is subdomain physical functioning of quality of life, (SF-36 PFS).

Secondary outcomes include other evaluations of quality of life (SF-36, KDQOL-SF, EQ-5D), objective measures of physical functioning (aerobic capacity and muscle strength), level of physical activity, gain in adiposity (body fat percentage by bio-electrical impedance assessment, BMI, waist circumference), and cardiometabolic risk factors (blood pressure, lipids, glucose metabolism). Additionally it is planned to study data on renal function, medical history, medication, psychological factors (motivation, kinesiophobia, coping style), nutrition knowledge, nutrition intake, nutrition status, fatigue, work participation, process evaluation and cost-effectiveness.


Options:
A: Change in Proteinuria (12 weeks minus baseline); Change in Proteinuria (52 weeks minus baseline)
B: Quality of life - Physical Functioning Score (baseline, 12 weeks, 6 months and 15 months)
C: Percentage change of 24-hour proteinuria (6 months)
D: weight loss

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Surgical and Pharmacological Novel Interventions to Improve Overall Results of Saphenous Vein Graft Patency in Coronary Artery Bypass Grafting Surgery: An International Multi-Center Randomized Controlled Clinical Trial
Brief Summary: Surgery for blocked arteries in the heart (coronary artery bypass grafting) can be accomplished using veins from the leg sewn onto the heart to provide an alternate path for blood flow, i.e. 'bypassing' the blockages. These veins themselves can block over time. This may result in part simply from the trauma from the surgery, in other words, by removing the vein from the leg and then sewing it to the heart. Another mechanism may be the abnormal metabolic processes within the body responsible for the plaque build-up of the heart arteries in the first place - this may lead to the blockages of the veins used for bypass. In the present era of heart bypass surgery, this incidence of veins blocking remains high despite advances in blood thinners and cholesterol medications. This study is designed to determine whether two new interventions may potentially reduce the incidence of blockages in the veins used for heart bypass surgery. One is a surgical technique significantly reducing the trauma associated with removing the leg vein prior to use as a bypass graft onto the heart. The second intervention is the use of a nutritional supplement before and after surgery which is composed of fish oils. The study will recruit sufficient patients to provide strong and relevant conclusions regarding both study questions. It will be highly applicable also because it will include approximately 1,550 patients from approximately 50 hospitals across many countries. We believe these techniques will result in significantly less vein blockages in patients one year after heart bypass surgery.


Options:
A: Surgical Arm: Proportion of study SVGs which are totally occluded on cardiac CT angiography at 1-year post-CABG and death due to CV or unknown causes. (1 year post-operative); Pharmacological Arm: Proportion of patients with ≥1 graft (saphenous or arterial) totally (100%) occluded on cardiac CT angiography at 1-year post-CABG and death due to CV or unknown causes, comparing the fish-oil to placebo groups. (1-year post-operative)
B: 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)
C: COPD exacerbations in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year); Airflow obstruction/change in pulmonary function (pre-randomization and after 2 years follow-up); Pneumonia in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year)
D: N/A

Answer: A