TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Safe Male Circumcision on Incidence of Infection by HIV, HSV-2 and of Genital Ulceration
Brief Summary: Observational studies suggest that male circumcision may provide protection against HIV-1 infection. A randomized, controlled, intervention trial was conducted in a general population of South Africa to test this hypothesis.


Options:
A: HIV incidence (2 years); surgical complications (2 years)
B: Measure the protective effect of medicalized male circumcision on HIV infection (M3, M12 and M21)
C: HIV acquisition; safety of circumcision
D: HIV sero-incidence (24 months post-baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Safe Male Circumcision on Incidence of Infection by HIV, HSV-2 and of Genital Ulceration
Brief Summary: Observational studies suggest that male circumcision may provide protection against HIV-1 infection. A randomized, controlled, intervention trial was conducted in a general population of South Africa to test this hypothesis.


Options:
A: Measure the protective effect of medicalized male circumcision on HIV infection (M3, M12 and M21)
B: Pain scores on the Visual Analog Scale (Within the first 48 hours after circumcision); Number of Participants with Adverse Events as a Measure of Safety and Tolerability (Up to six weeks after surgery)
C: The incidence of moderate and severe adverse events (AEs) associated with PrePex procedures, including both procedural and post-procedure events, and all device-related incidents such as dislodgment. (42 days)
D: The study's primary goal is to compare the PrePex™ circumcision procedure with one of the approved WHO methods of surgical circumcision. (9 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Double-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy of GlaxoSmithKline Biologicals. HPV-16/18 VLP AS04 Vaccine Compared to Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16 or HPV-18 Cervical Infection and Cervical Neoplasia, Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Females 15-25 Years of Age.
Brief Summary: Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in young adolescents and women of 15/25 years of age at study start. Approximately 18.000 study subjects will either receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Sexually transmitted disease (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Rapid repeat pregnancy (Measured at Month 12 postpartum); Sexual risk behavior (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Perinatal outcomes (e.g., birth weight, gestational age) (Measured at Months 6 and 12 postpartum)
B: Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer (Follow-up through end of study (4 years)); Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer] (Follow-up through end of study (4 years))
C: Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline) (Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post-dose 3); Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline) (at Month 48)
D: Re-infection with a non-viral sexually transmitted infection (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Double-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy of GlaxoSmithKline Biologicals. HPV-16/18 VLP AS04 Vaccine Compared to Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16 or HPV-18 Cervical Infection and Cervical Neoplasia, Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Females 15-25 Years of Age.
Brief Summary: Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in young adolescents and women of 15/25 years of age at study start. Approximately 18.000 study subjects will either receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: To evaluate the effects of celecoxib in reducing the proportion of subjects with new colorectal adenomas post baseline polypectomy after Month 13 (Year 1) and Month 37 (Year 3) of study drug administration. (3 years)
B: Percentage of subjects with newly detected adenomas, and will be estimated using the life table method for each treatment group (Year 3 (cumulative for year one and year three)); Percentage of patients with adenomas, aspirin use at baseline, and covariates (Year 5)
C: Histologic Regression (Post treatment evaluation was done 14 to 18 weeks after treatment randomization); Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 (Assessed every cycle while on treatment, 30 days after the last cycle of treatment)
D: Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline) (Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post-dose 3); Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline) (at Month 48)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Hypertension in the Very Elderly Trial (HYVET)
Brief Summary: The purpose of this study is to assess the benefits and risks of treating very elderly (those aged 80 or older) individuals with hypertension.


Options:
A: All strokes (fatal and non-fatal) (Duration of trial)
B: N/A
C: Major Mobility Disability, Defined as Incapacity to Walk 400 Meters (Median 2.7 years/Average 2.6 years)
D: Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Hypertension in the Very Elderly Trial (HYVET)
Brief Summary: The purpose of this study is to assess the benefits and risks of treating very elderly (those aged 80 or older) individuals with hypertension.


Options:
A: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) (time since randomization; follow-up period is 1.5 to 4.4 years); Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) (time since randomization; follow-up period is 1.5 to 4.4 years)
B: A composite of the following outcomes 1) all-cause death 2) nonfatal acute myocardial infarction 3) nonfatal stroke 4) hospital admission due to congestive heart failure (by the end of the study)
C: All strokes (fatal and non-fatal) (Duration of trial)
D: Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First (Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Hypertension in the Very Elderly Trial (HYVET)
Brief Summary: The purpose of this study is to assess the benefits and risks of treating very elderly (those aged 80 or older) individuals with hypertension.


Options:
A: The primary study outcomes are composite of non-fatal stroke, non-fatal myocardial infarction and cardiovascular death. (3-4 years)
B: The composite of; Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke. (Biannually); The composite of; cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, heart failure, arterial revascularizations (Biannually)
C: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
D: All strokes (fatal and non-fatal) (Duration of trial)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Hypertension in the Very Elderly Trial (HYVET)
Brief Summary: The purpose of this study is to assess the benefits and risks of treating very elderly (those aged 80 or older) individuals with hypertension.


Options:
A: Change from baseline in diastolic blood pressure after 52 weeks
B: The composite of; Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke. (Biannually); The composite of; cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, heart failure, arterial revascularizations (Biannually)
C: All strokes (fatal and non-fatal) (Duration of trial)
D: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Hypertension in the Very Elderly Trial (HYVET)
Brief Summary: The purpose of this study is to assess the benefits and risks of treating very elderly (those aged 80 or older) individuals with hypertension.


Options:
A: Change from baseline in diastolic blood pressure after 52 weeks
B: All strokes (fatal and non-fatal) (Duration of trial)
C: Incidence of hypertension, by blood pressure ≥ 140/90 mmHg in individuals without diabetes or ≥ 135/85 mmHg in participants with diabetes. (18 months); Adverse events. (18 months); Development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG (18 months)
D: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Hypertension in the Very Elderly Trial (HYVET)
Brief Summary: The purpose of this study is to assess the benefits and risks of treating very elderly (those aged 80 or older) individuals with hypertension.


Options:
A: Composite of fatal and non-fatal stroke (During the study period)
B: Effects of vascular risk-factor-intervention on changes in TMTA, ten-words-test and HAD (8-12 months after stroke onset)
C: All strokes (fatal and non-fatal) (Duration of trial)
D: Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event (For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Hypertension in the Very Elderly Trial (HYVET)
Brief Summary: The purpose of this study is to assess the benefits and risks of treating very elderly (those aged 80 or older) individuals with hypertension.


Options:
A: All strokes (fatal and non-fatal) (Duration of trial)
B: Change from baseline in diastolic blood pressure after 26 weeks
C: Renal Composite Outcomes (Randomization to 5 years)
D: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) (time since randomization; follow-up period is 1.5 to 4.4 years); Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) (time since randomization; follow-up period is 1.5 to 4.4 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Multiple Micronutrient Supplementation on Growth, Morbidity, and Mortality of HIV Infected Children in Uganda: a Randomised Double Blind Placebo-Controlled Trial
Brief Summary: Micronutrient deficiencies are common in HIV infected children and are aggravated by poor nutrition, especially in poor resource countries such as Uganda. It appears that micronutrient deficiencies contribute to immune dysfunction, increased morbidity and HIV disease progression. Hitherto, there has been no randomised controlled trial to assess the effect of multiple micronutrient supplementation on morbidity and mortality in HIV infected children in Africa. Therefore, the investigators shall carry out a randomised controlled trial to determine the effect of multiple micronutrient supplementation on morbidity, weight gain and mortality among HIV infected children aged 1 to 5 years in Uganda.

Hypothesis: Daily administration of twice the recommended dietary allowance (2RDA) of multiple micronutrients to HIV infected children aged one to five years, for 6 months, will reduce all cause mortality from 24% to 14.4% in one year and result in a weight gain difference of 150 grams.


Options:
A: Vitamin D plasma concentrations (12 months)
B: Number of children dying during the study period; Average weight gain in each of the treatment groups
C: Change in Z score for weight and improvement in X ray film (6 months)
D: Mortality (weekly); Incidence of disease requiring hospitalization; Morbidity and hospitalization (weekly)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Fish Oil as an Adjunct Therapy for Depression in Multiple Sclerosis
Brief Summary: This study will determine whether fish oil can reduce depression in people with multiple sclerosis (MS) who are mild to moderately depressed and are currently taking antidepressant medication.

Study hypothesis: Three months of fish oil supplementation will improve depression scores on the Montgomery-Asberg depression rating scale (MADRS) or Beck Depression Inventory (BDI) better than placebo.


Options:
A: Alleviation of depressive symptoms
B: Montgomery-Asberg Depression Rating Scale (MADRS) (baseline to 3 months)
C: ACC Glx/Water (baseline and 10-weeks); ACC GABA/Water (baseline and 10-weeks)
D: Changes from Baseline Hamilton Depression Rating Scale (HDRS) at 12 weeks (Week 12); Remission rate (Week 12); Response rate (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Fish Oil as an Adjunct Therapy for Depression in Multiple Sclerosis
Brief Summary: This study will determine whether fish oil can reduce depression in people with multiple sclerosis (MS) who are mild to moderately depressed and are currently taking antidepressant medication.

Study hypothesis: Three months of fish oil supplementation will improve depression scores on the Montgomery-Asberg depression rating scale (MADRS) or Beck Depression Inventory (BDI) better than placebo.


Options:
A: Brain Atrophy by MRI (% change brain volume from baseline to year 2)
B: Expanded Disability Status Scale (EDSS) (Change from baseline at 12 months); Multiple Sclerosis Functional Composite (MSFC) (Change from baseline at 12 months); fatigue scores (Change from baseline at 12 months); depression score (Change from baseline at 12 months); Number of active lesion in magnetic resonance imaging (MRI) number of active lesion in brain MRI (Change from baseline at 12 months)
C: Montgomery-Asberg Depression Rating Scale (MADRS) (baseline to 3 months)
D: Fasting and postprandial lipid oxidation in grams per hour, assessed by indirect calorimetry, after 3 months intake of green tea extract versus placebo (Three months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Stroke With Transfusions Changing to Hydroxyurea
Brief Summary: The purpose of this study is to compare standard therapy (transfusions and chelation) with alternative therapy (hydroxyurea and phlebotomy) for the prevention of secondary stroke and management of iron overload in children with sickle cell anemia (SCA).


Options:
A: Recurrence of an Infarct, Defined as a Stroke or a New or Enlarged Silent Cerebral Infarct (From study entry to study exit)
B: Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)); Liver Iron Content (LIC) Change-from-baseline (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months))
C: Transcranial Doppler Ultrasound examinations (0-24 months)
D: Cerebral vasculopathy (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Stroke With Transfusions Changing to Hydroxyurea
Brief Summary: The purpose of this study is to compare standard therapy (transfusions and chelation) with alternative therapy (hydroxyurea and phlebotomy) for the prevention of secondary stroke and management of iron overload in children with sickle cell anemia (SCA).


Options:
A: N/A
B: Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)); Liver Iron Content (LIC) Change-from-baseline (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months))
C: Recurrence of an Infarct, Defined as a Stroke or a New or Enlarged Silent Cerebral Infarct (From study entry to study exit)
D: Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side (Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Stroke With Transfusions Changing to Hydroxyurea
Brief Summary: The purpose of this study is to compare standard therapy (transfusions and chelation) with alternative therapy (hydroxyurea and phlebotomy) for the prevention of secondary stroke and management of iron overload in children with sickle cell anemia (SCA).


Options:
A: N/A
B: Conversion to Abnormal Maximum TAMV (30 months)
C: N/A
D: Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)); Liver Iron Content (LIC) Change-from-baseline (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Stroke With Transfusions Changing to Hydroxyurea
Brief Summary: The purpose of this study is to compare standard therapy (transfusions and chelation) with alternative therapy (hydroxyurea and phlebotomy) for the prevention of secondary stroke and management of iron overload in children with sickle cell anemia (SCA).


Options:
A: Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side (Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).)
B: Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)); Liver Iron Content (LIC) Change-from-baseline (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months))
C: Recurrence of an Infarct, Defined as a Stroke or a New or Enlarged Silent Cerebral Infarct (From study entry to study exit)
D: Cerebral vasculopathy (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Stroke With Transfusions Changing to Hydroxyurea
Brief Summary: The purpose of this study is to compare standard therapy (transfusions and chelation) with alternative therapy (hydroxyurea and phlebotomy) for the prevention of secondary stroke and management of iron overload in children with sickle cell anemia (SCA).


Options:
A: Acute Chest Syndrome (Chest x-rays (CXR) were ordered for trial eligibility, as a result of clinical indications, or at discharge or 72 hours if no prior CXR.)
B: Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)); Liver Iron Content (LIC) Change-from-baseline (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months))
C: N/A
D: Treatment Differences of the Change in Qualitative Splenic Function From Baseline (Before initiation of treatment and at 2 years)

Answer: B