TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Metformin in Gestational Diabetes and type2 Diabetes in Pregnancy in a Developing Country
Brief Summary: The study hypothesis was In women with gestational diabetes and type 2 diabetes in pregnancy metformin treatment compared with insulin will result in better perinatal and maternal outcome and improved treatment acceptability with low or noadditional insulin requirement.


Options:
A: Birth Weight Per Arm (delivery)
B: Glycemic Control (up to 41 weeks)
C: Blood Glucose Measurements (Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery)
D: Alive baby (At birth, up to 28 days after birth); Neonatal morbidity (at birth upto 28 days after birth)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Metformin in Gestational Diabetes and type2 Diabetes in Pregnancy in a Developing Country
Brief Summary: The study hypothesis was In women with gestational diabetes and type 2 diabetes in pregnancy metformin treatment compared with insulin will result in better perinatal and maternal outcome and improved treatment acceptability with low or noadditional insulin requirement.


Options:
A: A composite of: pregnancy loss, preterm birth, birth injury, moderate/severe respiratory distress, neonatal hypoglycemia, and NICU admission > 24 hours. (conception to 28 days after birth)
B: Mean Fetal Weight at Birth (Immediately after delivery of fetus)
C: Blood Glucose Measurements (Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery)
D: Alive baby (At birth, up to 28 days after birth); Neonatal morbidity (at birth upto 28 days after birth)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Economic Incentives to Promote Walking Among Full Time Employees
Brief Summary: This study aims to assess the uptake, effectiveness, and cost-effectiveness of a scalable walking programme for full-time employees both with and without incentives.


Options:
A: Six minute walking distance (3 months); New York Heart Association (NYHA) functional class (3 months)
B: Changes in MVPA (Moderate-to-Vigorous Physical Activity) bouts of participants from baseline to months 6 and 12 (Baseline, 6 and 12 months)
C: The Primary Endpoint is Success at 180 Days Which is Defined as Alive on the Originally Implanted HeartWare® LVAD or Transplanted or Explanted for Recovery. Patient Must Survive 60 Days Post-explant for Recovery to be Considered Successful. (180 days)
D: Aerobic fitness (before and after the 10 week intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Economic Incentives to Promote Walking Among Full Time Employees
Brief Summary: This study aims to assess the uptake, effectiveness, and cost-effectiveness of a scalable walking programme for full-time employees both with and without incentives.


Options:
A: Changes in MVPA (Moderate-to-Vigorous Physical Activity) bouts of participants from baseline to months 6 and 12 (Baseline, 6 and 12 months)
B: Mean Daily Step Count (Change from baseline mean daily step count at 3 weeks (end of unblinded digital activity tracker intervention)); Mean Daily Step Count (Change from 3 weeks mean daily step count at 5 weeks (end of smart text messaging intervention))
C: Jette Late Life Functional and Disability Instrument (LLFDI) (3 months)
D: Rate of recruitment to the studies (12 weeks (pilot study))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of the Auto-acupressure for Diminishing Neck Pain of Benign Origin
Brief Summary: The purpose of this study is to evaluate the effectiveness of the auto-acupressure (digital pressure in points of acupuncture) added to the conventional treatment.


Options:
A: Pain intensity (at T2 (Day 25))
B: Improvement in neck related dysfunction (4 weeks); Improvement in pain levels (4 weeks)
C: Pain intensity (Ninety days)
D: Change of pain (Baseline and end of treatment(4 weeks)); Change of range of motion (Baseline and end of treatment (4 weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Two Mental Health Interventions Based on the Community for Violence-Displaced Afro-Descendants in Colombia.
Brief Summary: This study is a community prevention randomized trial with three parallel groups: two intervention groups and one control group in Buenaventura and Quibdó.

The aim of the trial is to evaluate the impact of two community interventions on mental health; the intervention groups are designed to decrease depression, anxiety, post-traumatic stress disorders symptoms as well as the level of dysfunctionality in Afro-Colombian victims of violence.

Adult people (equal or more than 18 years old) belonging to Afro-Colombian communities in both cities will participate in the enter survey. The subjects will be selected based on the severity of symptoms, traumatic experiences and a level of dysfunction identified using the instruments of this research (i.e. those obtaining an score equal or higher than 49 in symptoms (25% of the total of symptoms)).

The fieldwork and the interventions will be conducted by people belonging to the community; they are called Lay Psychosocial Community Workers (LPCW). After six (6) weeks of formal training, they will be able to perform two kinds of interventions, Common Elements Treatment Approach (CETA) based on a cognitive behavioral intervention and Narrative Community Group Therapy (NCGT), for the people affected by violence and displacement that were pre-selected according to the baseline instrument.

The LPCW will be under the constant supervision by psychologists of the project, and under weekly supervision by a group of experts from Johns Hopkins University, the Heartland Alliance and The Institute for Research and Development in Violence Prevention and Promotion of Peaceful Coexistence Social (CISALVA) by means of phone calls or monthly visits to the cities. Selected subjects will be randomly allocated to any study branch: CETA, NCGT or the waiting control group.

The study subjects will follow their allocated treatment, or waiting in the control group, for 8 to 12 weeks; then they will be re-assessed using the project instrument two weeks after the last session of therapy.

The study outcome is the differences in instrument scores between the follow-up and the baseline among the interventions (CETA or NCGT) and control group.

Control subjects will be assessed by the project psychologist after the follow-up, and they will receive treatment when necessary.


Options:
A: Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders. (Within the fifteen (15) days after finishing the intervention, either Common Elements Treatment Approach (CETA) or Narrative Community Group Therapy (NCGT). In the control group, 12 weeks after the baseline assessment.)
B: Depressive disorder and suicidality (Q3 2016 after an average of 1.5 years of follow-up)
C: Referral rate into the host trial (4 weeks)
D: Psychiatric diagnosis at 6-month follow-up (6-month follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Anti-thymocyte Globulins for GVHD Prophylaxis After HLA-matched Sibling Stem Cell Transplantation in Patients at 40 Years of Age or More With Hematological Malignancies
Brief Summary: Age is a risk factor for graft-versus-host disease (GVHD) after human leukocyte antigen (HLA)-matched sibling allogeneic stem cell transplantation (allo-SCT). The incidence of acute GVHD is significantly higher in patients at 40 years of age or more than those at 18 to 39 years of age after allo-SCT. It was found that Anti-thymocyte globulins can be used for prophylaxis of both acute and chronic GVHD after allo-SCT.Prophylaxis of GVHD using ATG in patients at 40 years of age or more in matched sibling allo-SCT settings might significantly decrease the incidence of acute and chronic GVHD and the incidence of late effect after transplantation.


Options:
A: Incidence of Epstein-Barr virus(EBV) viremia (1 year)
B: cumulative incidence of cGVHD (cumulative incidence of cGVHD through study competition, an average of 24 months)
C: comparison of cumulative incidence of chronic GvHD (limited or extensive) after allogeneic SCT from HLA-identical siblings with or without anti-T-lymphocyte-globulin at 2 years after transplantation (2 years after transplantation)
D: Incidence of acute GVHD, and chronic GVHD (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Folic Acid and Zinc Supplementation Trial: A Multi-center, Double-blind, Block-randomized, Placebo-controlled Trial
Brief Summary: The overarching goal of this trial is to determine if an intervention comprising folic acid and zinc dietary supplementation improves semen quality and indirectly fertility outcomes (i.e., live birth rate) among couples trying to conceive and seeking assisted reproduction. The following study objectives underlie successful attainment of the overarching research goal:

1. To estimate the effect of folic acid and zinc dietary supplementation on semen quality parameters, including but not limited to concentration, motility, morphology, and sperm DNA integrity, relative to the placebo group.
2. To estimate the effect of folic acid and zinc dietary supplementation on fertility treatment outcomes \[fertilization, embryo quality, implantation/human Chorionic Gonadotropin (hCG) confirmed pregnancy, clinical pregnancy, live birth\], relative to the placebo group.
3. To estimate the association between semen quality parameters, sperm DNA integrity and fertility treatment outcomes (fertilization, embryo quality, clinical pregnancy, live birth) and to identify the best combination of semen quality parameters for prediction of clinical pregnancy and live birth.
4. To estimate the effect of folic acid and zinc dietary supplementation on fertilization rates among couples undergoing assisted reproductive technology procedures, relative to the placebo group.
5. To estimate the effect of folic acid and zinc dietary supplementation on embryonic quality among couples undergoing assisted reproductive technology procedures, relative to the placebo group.


Options:
A: Ongoing pregnancy rate (15 months)
B: Live Birth (At delivery); Semen Volume (6 months); Sperm Concentration (6 months); Sperm Motility (6 months); Sperm Morphology (6 months); DNA Fragmentation Index (6 months); Total Motile Sperm Count (6 months)
C: Effect of resveratrol on oocyte quality (40 days)
D: sperm motility (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Clinical Study of DU-176b (Venous Thromboembolism): Japanese, Multicenter, Open-label Study of DU-176b in Patients With Severe Renal Impairment (SRI) Undergoing Orthopedic Surgery of the Lower Limbs
Brief Summary: To assess the safety and pharmacokinetics of DU-176b administered to patients with severe renal impairment undergoing orthopedic surgery of the lower limbs, compared with DU-176b administered to patients with mild renal impairment (MiRI) undergoing orthopedic surgery of the lower limbs.

For reference, the safety of DU-176b in patients with SRI undergoing orthopedic surgery of the lower limbs will be compared with that of fondaparinux.


Options:
A: Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47 (Baseline to Day 47)
B: Incidence of Any Adjudicated Bleeding Events (14 days); Incidence of Adverse Events (1 month); Incidence of Adverse Drug Reactions (1 month); Plasma Concentration of DU-176b (14 days); Plasma Concentration of D21-2393 (14 days)
C: Primary Outcome based upon intent to treat: Composite outcome of (28 days); Ultrasound or venogram confirmed deep vein thrombosis. (28 days); Lung scan, pulmonary angiogram or CTA confirmed pulmonary embolus. (28 days); Death due to TED (28 days)
D: Number of Participants With Venous Thromboembolisms and/or Major Hemorrhages to Day 11 (11 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial
Brief Summary: The University of Sao Paulo Department of Otorhinolaryngology developed prototypes for a digital new hearing aid with an integrated sound generator. These prototypes assist both hearing rehabilitation (about 10% of the population) and tinnitus sufferers (about 17% of the population).

Currently, the Brazilian Public Heath Care does not have any such hearing aids. So, the development of devices for the hearing rehabilitation as well as the treatment of tinnitus represents an advance in the implementation of Public Policies in Brazil.

The aim of this study is to compare the efficacy of the hearing aid with an integrated sound generator and amplification alone for tinnitus control in patients with tinnitus associated hearing loss.


Options:
A: Generic Quality of Life as measured with the Health Utilities Index Mark 3 (HUI3) (At baseline and 3, 8 and 12 months follow-up)
B: Tinnitus Handicap Questionnaire (4 weeks)
C: N/A
D: THI (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Short-term add-on Therapy With Angiotensin Receptor Blocker for End-stage Inotrope-dependent Heart Failure Patients: B-type Natriuretic Peptide Reduction in a Randomized Clinical Trial
Brief Summary: The dual blockade of the renin-angiotensin-aldosterone system with an angiotensin-converting enzyme inhibitor and an angiotensin-receptor blocker used together in heart failure patients has been demonstrated to be beneficial. However, the dual inhibition has not been studied during heart failure decompensation or even when low cardiac output is present.

The objective of this study was to assess the effects of add-on therapy with angiotensin receptor blocker on plasma B-type natriuretic peptide levels and hemodynamic measurements in heart failure patients with low cardiac output during hospitalization for decompensation.

This was a randomized, double-blind, placebo-controlled clinical trial.


Options:
A: B-type natriuretic peptide (7 days)
B: Number of Dual Efficacy Endpoint Events (30 days); Number of Quad Efficacy Endpoint Events (30 days)
C: A clinical composite classification incorporating a Patient Global Assessment at 6 hours, 24 hours and Day 5, combined with clinical criteria for worsening heart failure through 5 days after the start of the study drug infusion.
D: All cause mortality at 30 days post randomization

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn in Infants Born at >34 Weeks Gestation: A Prospective, Randomized, Double Blind, Placebo Controlled Study.
Brief Summary: Transient Tachypnea of the Newborn (TTN) is a common respiratory disorder affecting late preterm and term babies caused by lung edema resulting from delayed absorption of fetal alveolar lung fluid.

The investigators hypothesize that ENAC expression will be up-regulated as a result of administration of corticosteroids. This effect will lead to enhanced absorption of fetal lung fluid finally treating TTN. The aim of our study will be to evaluate whether inhaled corticosteroids reduce respiratory distress and morbidity in late preterm and term neonates presenting with TTN.


Options:
A: Assessment of respiratory distress (48 hours)
B: Duration of Respiratory Support (every hour until patient stable without respiratory support, an average of approximately 55 hours and a maximum of 205 hours)
C: Need for admissions to NICU secondary to TTN (24 hours)
D: Difference in time (min) required to normalize the respiratory distress (modified Silverman score = 0, no need for oxygen, RF < 50 bpm and SaO2 > 92%) between the two ventilatory modes (Within the first 6 hours after birth)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized, Multi-center, Single-blinded Study for the Treatment of Subjects Presenting With De Novo Occluded/Stenotic or Re-occluded/Restenotic Lesions of the Superficial Femoral or Popliteal Arteries Using Paclitaxel or Bare Percutaneous Transluminal Angioplasty Balloon Catheter
Brief Summary: This is a prospective, randomized, multi-center, single-blind study to demonstrate the safety and effectiveness of the CVI Paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon versus bare PTA balloon for the treatment of patients with de novo occluded/stenotic or reoccluded/restenotic lesions of the superficial femoral (SFA) and popliteal arteries.


Options:
A: Percentage diameter stenosis (6 months)
B: In-stent late lumen loss (9 months)
C: Patency at 12-months (12 months); Percentage of Patients With Freedom From Device and Procedure Related Target Limb Major Amputation or Death Through 30-days Post-procedure and Clinically-driven Target Lesion Revascularization at 12-month (30-Days and 12-Months)
D: Safety: Freedom from death at 30 days post-procedure. Effectiveness: Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure. (30 Day, 6 Month, and 12 Month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Intravenous Paracetamol Versus Dipyrone for Postoperative Analgesia After Day-case Lower Abdominal Surgery in Children With Spinal Anesthesia: a Prospective Randomized Double-blind Study
Brief Summary: We conducted a prospective, randomized double-blind study to compare the effectiveness of intravenous paracetamol and dipyrone for preventing pain during early postoperative period in school-age children undergoing lower abdominal surgery with spinal anesthesia.


Options:
A: ED50s of Paracetamol, morphine and their combination (participants will be followed for the duration of hospital stay, an expected average of 8 weeks)
B: Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 1 g IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.) (Baseline to 24 hrs)
C: Postoperative pain (24 hours)
D: Change from pain intensity until postoperative 6 hours (Pain intensity recorded until postoperative 6 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Comparative, Randomized, Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate
Brief Summary: The results on the efficacy of the formulations based on alginic acid are controversial. Corvaglia et al demonstrated a significant reduction in reflux episodes in preterm infants by evaluation with pH-impedance analysis. This study concludes that the use of alginic acid reduces the acidity of the gastroesophageal reflux (GER) and has a non-systemic effect and a lesser presence of side effects compared to the use of H2-receptor antagonist(H2RA) and proton pump inhibitor (PPI).


Options:
A: Maximum Observed Plasma Concentration (Cmax) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Time to Reach Maximum Observed Plasma Concentration (Tmax) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Plasma Decay Half-Life (t1/2) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Apparent Oral Clearance (CL/F) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Terminal-Phase Volume of Distribution (Vz/F) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Plasma Concentrations After Multiple Doses (Hours 2 and 4 on Day 7)
B: The primary objective of the study is to evaluate the safety of once daily treatment with esomeprazole in relieving GERD-associated symptoms in pediatric patients 1 to 11 years of age, inclusive.; The primary outcome variables include assessment of changes from baseline in medical history, physical examination, clinical laboratory evaluations, and adverse events.
C: efficacy on GER (2 months)
D: The Percentage of Patients With Healing by Week 12 (Short-term Double-blind Treatment Phase) (12 weeks); The Percentage of Patients With Healing by Week 36 (Double-blind Maintenance Treatment Phase) (36 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Adherence Enhancement for Renal Transplant Patients
Brief Summary: Despite significant advances in the care of kidney transplant recipients, long term graft survival after renal transplantation remains suboptimal. Medication nonadherence and clinical inertia are key contributors to graft loss. The purpose of the proposed RCT feasibility study is to evaluate impact of a "bundled" wireless real time medication reminder system and blood pressure monitoring system in combination with a cognitive behavioral adherence skills enhancement program upon medication adherence, therapeutic drug concentration, and blood pressure, in nonadherent kidney transplant recipients with hypertension. We propose to recruit 60 kidney transplant recipients in phase 1 with 20 non-adherent continuing to phase 2 for a 5-month feasibility RCT.


Options:
A: Change in Medication Knowledge Score from baseline to 3 months (Baseline and 3 months)
B: medication adherence (5 months)
C: The primary objective of this study is to compare tacrolimus formulations (Envarsus XR® versus twice a day tacrolimus) based on the difference in mean Calcineurin Inhibitor-Related Symptoms (CIRS) severity score. (12 months)
D: Taking Adherence (12 months); Timing Adherence (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Adherence Enhancement for Renal Transplant Patients
Brief Summary: Despite significant advances in the care of kidney transplant recipients, long term graft survival after renal transplantation remains suboptimal. Medication nonadherence and clinical inertia are key contributors to graft loss. The purpose of the proposed RCT feasibility study is to evaluate impact of a "bundled" wireless real time medication reminder system and blood pressure monitoring system in combination with a cognitive behavioral adherence skills enhancement program upon medication adherence, therapeutic drug concentration, and blood pressure, in nonadherent kidney transplant recipients with hypertension. We propose to recruit 60 kidney transplant recipients in phase 1 with 20 non-adherent continuing to phase 2 for a 5-month feasibility RCT.


Options:
A: Taking Adherence (12 months); Timing Adherence (12 months)
B: Referral for Kidney Transplantation (One Year)
C: medication adherence (5 months)
D: Time Specific Interdialytic Weight Gain (Baseline) (Baseline); Time Specific Interdialytic Weight Gain (8 Weeks) (8 weeks); Time Specific Interdialytic Weight Gain (12 Weeks) (12 weeks); Time Specific Interdialytic Weight Gain (16 Weeks) (16 weeks); Time Specific Dietary Sodium Intake (Baseline) (Baseline); Time Specific Dietary Sodium Intake (8 Weeks) (8 weeks); Time Specific Dietary Sodium Intake (16 Weeks) (16 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks) (Baseline to 8 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks) (Baseline to 16 weeks)

Answer: C