TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of the Nutritional Fatty Acids During Pregnancy and Lactation for Early Human Adipose Tissue Development
Brief Summary: Pregnant and lactating women receive n-3 fatty acids starting from week 15 of gestation until 4 months post-partum (pp) in comparison to a control group, who only gets information about adequately healthy nutrition during pregnancy and lactation.

The amount of fat in newborns is measured through skinfold thickness, ultrasound, and magnetic resonance imaging (MRI).

It is hypothesised that a reduction in arachidonic acid intake and an increase of n-3 LC PUFAs (long chain polyunsaturated fatty acids) via supplements containing docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) could lead to less expansive fat tissue development in the first year of life.


Options:
A: amount of fat mass in the offspring (at birth, 6 weeks, 4 months, 1 year postpartum)
B: NeuroCognitive Assessment (Change from baseline, 36 - 40 weeks); Structural Magnetic Resonance Imaging (Change from baseline, 36 - 40 weeks); Functional Magnetic Resonance Imaging (Change from baseline, 36 - 40 weeks); Academic Achievement (Change from baseline, 36 - 40 weeks); Eye Tracking (Change from baseline, 36 - 40 weeks); Task Performance (Change from baseline, 36 - 40 weeks)
C: Number of months of breast feeding (6 and 12 months)
D: Change in Body Mass Index Z-score (9 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Longitudinal Diabetes Care: A Randomized Controlled Trial to Prevent Glycemic Relapse
Brief Summary: This purpose of this study is to determine the optimal frequency of maintenance intervention needed to prevent glycemic relapse.


Options:
A: Week 4 Change in Systolic Blood Pressure (4 weeks)
B: Glycemic relapse: increase in HbA1c by 1% over baseline and >8%
C: HbA1c (1 year)
D: Number of patients with hypoglycaemia in usual care versus telemedicine during Ramadan (Week 4)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Cross-Over Study to Evaluate the Suppressive Effect of High-Dose Acyclovir Versus Once Daily Valacyclovir on Herpes Simplex Virus Type 2 Genital Shedding in Herpes Simplex Virus-2 Seropositive Adults
Brief Summary: The purpose of the research study is to evaluate the effectiveness of high-dose acyclovir compared to valacyclovir for reduction of asymptomatic genital shedding in persons with genital herpes.

The study will enroll men and women who are 18 years or older, test positive to HSV-2 (by blood test) and have had a first outbreak of HSV-2 within the past 6 months or have had at least 4 genital herpes outbreaks in the past year. Participants must be HIV negative and willing to stop taking suppressive therapy for HSV for the one week wash out period. (Females only: You must not be pregnant or breast-feeding). Both men and women will be asked to use an effective form of birth control.

Involvement in the study will last 15-weeks and you will be asked to visit the clinic every 2-weeks. At each visit, you will be given medication to take daily (either valacyclovir or acyclovir; you will receive both medications at some point during this study). There will be a total of 9 study visits and each visit will last approximately 30 minutes. We will ask that you complete a daily symptom diary and collected daily home swabs 4-times a day, everyday during the study. Each daily home swab will take less than 3 minutes to perform.


Options:
A: Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir. (15 weeks)
B: Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Valacyclovir as Compared to Once-daily Valacyclovir. (11 weeks)
C: To assess the impact of HSV-2 suppressive therapy on HIV shedding among co-infected women taking highly active antiretroviral therapy (HAART) or not needing HAART
D: Rates of HIV acquisition in HIV-negative (neg) males and HIV-neg female partners; Rates of STD acquisition in HIV-neg and HIV positive (+) males and HIV-neg and HIV+ female partners

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Cross-Over Study to Evaluate the Suppressive Effect of High-Dose Acyclovir Versus Once Daily Valacyclovir on Herpes Simplex Virus Type 2 Genital Shedding in Herpes Simplex Virus-2 Seropositive Adults
Brief Summary: The purpose of the research study is to evaluate the effectiveness of high-dose acyclovir compared to valacyclovir for reduction of asymptomatic genital shedding in persons with genital herpes.

The study will enroll men and women who are 18 years or older, test positive to HSV-2 (by blood test) and have had a first outbreak of HSV-2 within the past 6 months or have had at least 4 genital herpes outbreaks in the past year. Participants must be HIV negative and willing to stop taking suppressive therapy for HSV for the one week wash out period. (Females only: You must not be pregnant or breast-feeding). Both men and women will be asked to use an effective form of birth control.

Involvement in the study will last 15-weeks and you will be asked to visit the clinic every 2-weeks. At each visit, you will be given medication to take daily (either valacyclovir or acyclovir; you will receive both medications at some point during this study). There will be a total of 9 study visits and each visit will last approximately 30 minutes. We will ask that you complete a daily symptom diary and collected daily home swabs 4-times a day, everyday during the study. Each daily home swab will take less than 3 minutes to perform.


Options:
A: Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With Suppressive Acyclovir as Compared to no Medication in HIV Seronegative and HIV Seropositive Individuals. (9 weeks)
B: Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir. (15 weeks)
C: Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions (72 hours after initiation of study medication up to Day 20)
D: Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Valacyclovir as Compared to Once-daily Valacyclovir. (11 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine in Comparison to CombAct-HIB® Concomitantly Administered With Engerix B® Paediatric and OPV at 6, 10, and 14 Weeks of Age in South African Infants
Brief Summary: The purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule

The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP\~T combined vaccine does not induce lower immune responses than CombAct-HIB® with Engerix B® Paediatric and OPV in terms of seroprotection rates to Diphtheria (D), Tetanus (T), polio, Hepatitis B (HB), and Polyribosyl ribitol phosphate (PRP), one month after a 3-dose primary series (6, 10, and 14 weeks) with no HB vaccination at birth.

The secondary Objectives are:

To describe the safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.

To describe Immunogenicity after the primary series and prior to and after a booster vaccination.


Options:
A: Diagnosis of IgE-mediated food allergy (birth-15 years)
B: Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) (1 month post-Dose 3)
C: Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. (Day 0 up to Day 7 post-injection)
D: Phase A - Inoculum Dose Determination (Up to volunteer visit Day 14)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Intramyocardial Injection of Autologous Bone-Marrow Cells in Patients With Severe, Chronic Ischemic Heart Disease Undergoing Coronary Bypass Surgery
Brief Summary: This study was designed to test the hypothesis that direct injection of bone-marrow cells in the heart may increase the number of blood vessels, ameliorating the heart's performance, and relieving patients from symptoms like angina and/or shortness of breath.


Options:
A: Global Left Ventricular Ejection Fraction change (6 months)
B: Incidence of Any Treatment-emergent Serious Adverse Events (TE-SAEs) (One month post-catheterization)
C: Change in left ventricular ejection fraction (baseline and 1 year)
D: Reduction in the ischemic score (global/regional) at 12 months; increase in left ventricle ejection fraction (LVEF) at 12 months.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tai Chi Mind-Body Therapy for Knee Osteoarthritis: a Pilot Single-blind Randomized Controlled Trial
Brief Summary: The purpose of this study was to compare the safety and effectiveness of Tai Chi with an Attention Control intervention consisting of a stretching and wellness education program involving 40 patients with osteoarthritis (OA) of the knee. We hypothesized that the participants receiving Tai Chi would show greater improvement in knee pain, physical and psychological functioning, and health-related quality of life than participants in the Attention Control group, and that the benefit would be mediated by effects on muscle function, musculoskeletal flexibility and mental health.


Options:
A: Pain (week 0, 13, 39 and 65); Physical function (week 0, 13, 39 and 65); Patient global assessment (week 13, 39 and 65)
B: Self-reported pain and function (WOMAC)
C: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (0, 4, 10, 16 months)
D: Change in the Western Ontario and McMaster University Index (WOMAC) Pain Subscale Between Baseline and 12 Weeks (between baseline and 12 weeks.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: 9-10 Days Versus Prolonged Thromboprophylaxis in Patients Without Evidence of Ultrasound Proximal Thromboembolism After Total Knee Joint Replacement: a Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine whether stopping Low Molecular Weight Heparin (LMWH) thromboprophylaxis is safe after total knee joint replacement. The investigators select patients without proximal thromboembolism assessed by bilateral venous ultrasound examination 7-10 days after surgery. the investigators hypothesis is that stopping thromboprophylaxis is equally effective than prolonging thromboprophylaxis in order to prevent post-surgery complications in this population.


Options:
A: Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period (First administration until 31-38 days)
B: Rate of Composite of Adjudicated Venous Thromboembolic Event (VTE)-Related (Pulmonary Embolism and Symptomatic and Asymptomatic Deep Vein Thrombosis[DVT]) and All-cause Death During the Intended Treatment Period (Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose)
C: Non-inferiority for the prevention of VTE or VTE related death
D: Thromboembolism occuring between day 7-35 ;; Major bleeding occuring between day 7-35 ;; LMWH induced thrombopenia; All cause mortality

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin C and Vitamin E Therapy in Type 2 Diabetes and Cardiovascular Risk
Brief Summary: The proposed study will examine the hypothesis that vitamin C and vitamin E given to type 2 diabetic individuals will provide effective anti-inflammatory, anti-thrombotic, and anti-oxidative atherosclerotic protection when administered at the optimal dose as determined by surrogate markers of inflammation, hypercoagulability, and oxidation.


Options:
A: effect on cerebrospinal fluid (CSF) biomarkers related to oxidative damage (baseline and 4 months)
B: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma
C: Regression of white matter lesion load in terms of numbers and size in the brain (1 to 2 years)
D: The goal is to determine the effects of the vitamin C and vitamin E on surrogate markers of atherosclerosis following an atherogenic meal in type 2 diabetes (2 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin C and Vitamin E Therapy in Type 2 Diabetes and Cardiovascular Risk
Brief Summary: The proposed study will examine the hypothesis that vitamin C and vitamin E given to type 2 diabetic individuals will provide effective anti-inflammatory, anti-thrombotic, and anti-oxidative atherosclerotic protection when administered at the optimal dose as determined by surrogate markers of inflammation, hypercoagulability, and oxidation.


Options:
A: Number of Participants With Prostate Cancer (Every six months for 7 to 12 years depending on when the participant was randomized.)
B: Cognitive Measures (6 months)
C: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma
D: The goal is to determine the effects of the vitamin C and vitamin E on surrogate markers of atherosclerosis following an atherogenic meal in type 2 diabetes (2 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin C and Vitamin E Therapy in Type 2 Diabetes and Cardiovascular Risk
Brief Summary: The proposed study will examine the hypothesis that vitamin C and vitamin E given to type 2 diabetic individuals will provide effective anti-inflammatory, anti-thrombotic, and anti-oxidative atherosclerotic protection when administered at the optimal dose as determined by surrogate markers of inflammation, hypercoagulability, and oxidation.


Options:
A: Number of Participants With Prostate Cancer (Every six months for 7 to 12 years depending on when the participant was randomized.)
B: The goal is to determine the effects of the vitamin C and vitamin E on surrogate markers of atherosclerosis following an atherogenic meal in type 2 diabetes (2 months)
C: Frequency of adverse events (baseline, monthly for 1 year, then 15 and 18 months)
D: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Crossover Trial of Acylcovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand
Brief Summary: Herpes infection is an important co-factor in HIV transmission. A recent meta-analysis demonstrated that HSV infection contributed to a 2-fold increased risk of HIV transmission. Suppressive therapy with acyclovir has been a method proposed to reduce HIV transmission. We are conducting a randomized controlled cross-over trial to evaluate the effect of acyclovir suppressive therapy on HIV genital shedding in women co-infected with HIV-1 and Herpes Simplex Virus Type-2 (HSV-2) in Thailand.


Options:
A: Difference of HIV-1 RNA and DNA shedding assessed by performing cervicovaginal lavage (CVL) HIV viral load, among groups; Difference of HSV-2 DNA shedding among groups
B: To evaluate the effect of acyclovir suppressive therapy on HIV genital shedding.
C: Plasma HIV-1 levels and HIV-1 mucosal shedding (18 weeks)
D: Serologically confirmed HIV infection (Throughout study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy, Safety, and Immunogenicity of RotaTeq™ Among Infants in Asia and Africa
Brief Summary: The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.


Options:
A: Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody. (2 months post-Dose 2 (at study Month 4))
B: Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose (At least 14 days following the third vaccination)
C: Occurrence of RV GE
D: Immunogenicity (7 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy, Safety, and Immunogenicity of RotaTeq™ Among Infants in Asia and Africa
Brief Summary: The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.


Options:
A: Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose (At least 14 days following the third vaccination)
B: Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains (From Month 1 ½ to Month 21)
C: Endpoint: immunogenicity and reactogenicity; Proportion of subjects with vaccine take
D: Demonstrate lot-to-lot consistency of HRV vaccine liquid formulation and non-inferiority of liquid formulation versus the lyophilised formulation of the HRV vaccine.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy, Safety, and Immunogenicity of RotaTeq™ Among Infants in Asia and Africa
Brief Summary: The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.


Options:
A: Occurrence of any RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period.
B: Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose (At least 14 days following the third vaccination)
C: Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype (28 days after the second dose of MCC vaccine (approximately 20 weeks))
D: Occurrence of severe RV GE caused by the wild RV strains from 2 weeks after Dose 2 until two years of age. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Multicenter Study of More Intensive Versus Less Intensive Post-Remission Therapy in Elderly Patients With Acute Myelogenous Leukemia (AML) or Transformed Refractory Anemia With Excess Blasts (RAEB-t).
Brief Summary: In this ALFA-9803 trial in AML patients aged 65 years or more, we randomly compared idarubicin or daunorubicin throughout the study (first randomization) and two different post-remission strategies (second randomization): one single intensive consolidation course similar to induction versus six ambulatory cycles with one dose of idarubicin/daunorubicin (day 1) and 2x60 mg/m2/d cytarabine SC (day 1 to 5) delivered in out-patients on a monthly basis. Primary endpoint was 2-year overall survival (OS). Study hypotheses were equivalence for the idarubicin/daunorubicin comparison and a 15% difference in 2-year OS for the post-remission therapy comparison.


Options:
A: To compare idarubicin versus daunorubicin: the duration of the event-free survival (EFS) to compare IL2 versus abstention : the relapse rate assessed during the first year following the start of maintenance treatment with interleukin
B: overall survival; relapse-free survival
C: Overall Survival (Induction Phase) (Assessed during the first 4 months, then at least every three months for 2 years. then every six months until 5 years after study entry and every 12 months thereafter.); Disease-free Survival (Consolidation Phase) (Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter.)
D: Overall survival

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Autologous Bone Marrow Celss on Acute ST-Elevation Myocardial Infarction
Brief Summary: This study is aimed to assess the effect of bone marrow cells on arrhythmia risk variables in patients with a acute myocardial infarction.


Options:
A: Global Left Ventricular Function (Measured at Baseline and Month 6); Regional Left Ventricular Function (Infarct Zone Wall Motion) (Measured at Baseline and Month 6); Regional Left Ventricular Function (Border Zone Wall Motion) (Measured at Baseline and Month 6)
B: Arrhythmia risk variables; left ventricular function; restenosis assessed by IVUS
C: Change in global left ventricular function (measured by quantitative left ventricular angiography)
D: Heart function (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine (Fluarix™) Administered Intramuscularly in Adults
Brief Summary: The purpose of this study is to demonstrate the efficacy of GSK Biologicals' influenza vaccine (Fluarix™) administered intramuscularly in adults.


Options:
A: occurrence of confirmed influenza
B: Safety (28 days)
C: Safety (local and systemic reactogenicity, laboratory tests and AEs. (6 months)
D: Adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessment). (Duration of study.); Proportion of subjects in each dose group achieving a serum neutralizing antibody titer of greater than or equal to 40 against the influenza A/H7N7 virus. (28 days after receipt of the second dose of vaccine (approximately Day 56).); Geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group and serum hemagglutination inhibition (HAI) antibody titers in each group. (1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Trial Assessing Efficacy and Safety of LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
Brief Summary: To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.


Options:
A: Trough FEV1 (L) at 28 Weeks on Treatment (Week 28); Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment (Week 12)
B: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment (Baseline and Week 24); Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment (Baseline and Week 12)
C: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) (Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks)
D: Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment (Day 7)

Answer: A