TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Patients With Idiopathic Membranous Nephropathy at Risk for Renal Insufficiency: Comparison of Early Versus Late Start of Immunosuppressive Therapy
Brief Summary: Patients with idiopathic membranous nephropathy at risk for renal failure can be identified in an early stage by measuring urinary low molecular weight proteins and urinary immunoglobulin G (IgG). This study evaluates the possible benefit of early start of immunosuppressive therapy in these high-risk patients.


Options:
A: renal function (serum creatinine); proteinuria; side effects
B: N/A
C: Remission Status (24 months after randomization)
D: Evaluation of efficacy of Rituximab associated with Non Immunosuppressive Symptomatic Treatment (NIST) in (IMN) in reducing the rate of proteinuria (patients with persistent urinary protein excretion rate ≥3,5g/24 h and albuminemia < 30g/l ) (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Sequential Clinical Trial of Sodium Valproate in ALS
Brief Summary: The purpose of this study is to determine whether the use of sodium valproate is effective in slowing the disease progression in Amyotrophic Lateral Sclerosis.


Options:
A: Survival
B: Change in function as detected by the ALS Functional Rating Scale (ALSFRS-R) in patients taking minocycline compared to those taking placebo.
C: to evaluate the long-term safety and tolerability of thalidomide; to compare the total number of adverse events (AE), abnormal laboratory tests, and number of patients who completed the study between groups
D: Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire (ALSFRS-R) (9 months: Baseline to study termination (January 2009 - October 2009))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Posttraumatic Stress Disorder in Kosovar High School Students Using Mind-Body Skills Groups: A Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine whether the participation in a group program which includes meditation, biofeedback, drawings, autogenic training, genograms, and a variety of movement and breathing techniques will decrease symptoms of posttraumatic stress in high school students.


Options:
A: Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index (baseline, post-intervention and 3-months)
B: Harvard Trauma Questionnaire (Baseline, 12 weeks, 3 months)
C: HSCL 25 (Symptoms were assessed at baseline); HSCL 25 (3-month follow-up); HSCL 25 (Assessment at 12-month-follow-up)
D: Change in scores on the Oxford Measure of Psychosocial Adjustment & World Health Organization Disability Assessment Schedule, 2.0 (WHODAS 2.0) (Administered at 4 timepoints: (1) baseline; (2) within 15 days of YRI completion; (3) 6 months post-YRI; (4) 12 months post-YRI)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Posttraumatic Stress Disorder in Kosovar High School Students Using Mind-Body Skills Groups: A Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine whether the participation in a group program which includes meditation, biofeedback, drawings, autogenic training, genograms, and a variety of movement and breathing techniques will decrease symptoms of posttraumatic stress in high school students.


Options:
A: Stunting (One year starting with baseline (August-September 2014) and finishing with end line (September 2015); Amendment: also measured at year two (extension) endline); Cognitive function (End line (after one year); Amendment: BSID-III at year two (extension) endline)
B: The proportion of participants who have a response to treatment when assessed by change in the symptoms of depressive symptoms measured by Beck Depression Inventory (0 months, 1 month, 6 months)
C: Change from baseline post traumatic stress symptoms at 6 months (baseline and 6 month follow up); Change from baseline depression symptoms at 6 months (baseline and 6 month follow up); Change from baseline hope at 6 months (baseline and 6 month follow up)
D: Harvard Trauma Questionnaire (Baseline, 12 weeks, 3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Posttraumatic Stress Disorder in Kosovar High School Students Using Mind-Body Skills Groups: A Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine whether the participation in a group program which includes meditation, biofeedback, drawings, autogenic training, genograms, and a variety of movement and breathing techniques will decrease symptoms of posttraumatic stress in high school students.


Options:
A: Hamilton depression rating Scale (HAM-D) (baseline, and change in scores at 1 month prenatally, 3 months and 12 months postnatally)
B: Mental health symptoms (6 weeks); Idiographic problems (6 weeks)
C: Brief Psychiatric Rating Scale, Expanded Version (BPRS-E) (12 months post-randomisation (18 months for secondary outcome))
D: Harvard Trauma Questionnaire (Baseline, 12 weeks, 3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Serious Neonatal and Maternal Peripartum Infections in Developing Country Settings With a High Prevalence of HIV Infection: Assessment of the Disease Burden and Evaluation of an Affordable Intervention in Soweto, South Africa
Brief Summary: The purpose of this study is to evaluate whether use of the disinfectant chlorhexidine administered to the birth canal during labour and newborn at delivery can protect a woman and her baby from bacterial infections after birth. If effective, this could be used as an inexpensive alternative to antibiotics to prevent newborn infections in resource-poor countries.


Options:
A: Rates of culture-confirmed or clinical neonatal sepsis, < 3 days of life; Rate of vertical transmission of colonization with group B streptococcus (GBS)
B: neonatal mortality (3 Month intervals); omphalitis among live born infants. (3 Month intervals)
C: Neonatal death or severe sepsis (7 days)
D: Incidence of Neonatal Omphalitis (By the end of the styudy); Rate of Neonatal Mortality (By the end of the Study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label, Phase I/II Trial of Rituximab Therapy for Steroid-Refractory Chronic Graft vs. Host Disease
Brief Summary: The purpose of this study is to determine if rituximab is a safe and effective therapy for steroid-refractory chronic graft versus host disease (GVHD).


Options:
A: Overall survival (3 years); Time to discontinuation of immunosuppression (3 years); Functional impairments (3 years)
B: To determine the safety and efficacy of up to three four week courses of rituximab in steroid-refractory chronic GVHD (2 years)
C: Number of Participants With an Overall Response at Week 28 (Week 28)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label, Phase I/II Trial of Rituximab Therapy for Steroid-Refractory Chronic Graft vs. Host Disease
Brief Summary: The purpose of this study is to determine if rituximab is a safe and effective therapy for steroid-refractory chronic graft versus host disease (GVHD).


Options:
A: Overall survival (3 years); Time to discontinuation of immunosuppression (3 years); Functional impairments (3 years)
B: To determine the safety and efficacy of up to three four week courses of rituximab in steroid-refractory chronic GVHD (2 years)
C: N/A
D: Cure of Chronic GVHD Without Resorting to Secondary Systemic Therapy (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: FIRST BREATH: Neonatal Resuscitation in Developing Countries
Brief Summary: In developing countries, neonatal death from birth asphyxia is a major problem. This study will be conducted in several countries to determine if the combined Neonatal Resuscitation Program/Essential Newborn Care Program compared to the new World Health Organization (WHO) basic perinatal care education of health care providers (Essential Newborn Care Program) results in reduced mortality due to perinatal asphyxia.


Options:
A: Neonatal mortality (7 days)
B: The primary outcome was the proportion of deliveries at greater than or equal to 20 weeks gestation in which one or more adverse maternal and/or neonatal outcomes occurred (Adverse Outcome Index).
C: institutional twenty-four hour newborn mortality rate (1 day); institutional intrapartum stillbirth rate (1 day)
D: Perinatal mortality (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: FIRST BREATH: Neonatal Resuscitation in Developing Countries
Brief Summary: In developing countries, neonatal death from birth asphyxia is a major problem. This study will be conducted in several countries to determine if the combined Neonatal Resuscitation Program/Essential Newborn Care Program compared to the new World Health Organization (WHO) basic perinatal care education of health care providers (Essential Newborn Care Program) results in reduced mortality due to perinatal asphyxia.


Options:
A: mortality (day 28)
B: Perinatal mortality (12 months)
C: Perinatal Mortality (Perinatal mortality data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months.)
D: Neonatal mortality (7 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: FIRST BREATH: Neonatal Resuscitation in Developing Countries
Brief Summary: In developing countries, neonatal death from birth asphyxia is a major problem. This study will be conducted in several countries to determine if the combined Neonatal Resuscitation Program/Essential Newborn Care Program compared to the new World Health Organization (WHO) basic perinatal care education of health care providers (Essential Newborn Care Program) results in reduced mortality due to perinatal asphyxia.


Options:
A: Neonatal mortality rate (deaths within 28 days of birth)
B: increase the proportion of institutional deliveries in intervention vs. control clusters (Up to 15 months)
C: Perinatal mortality (12 months)
D: Neonatal mortality (7 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Incentives Plus Bupropion for Smoking in Schizophrenics
Brief Summary: There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. The aims of this study are to investigate the separate and combined effects of bupropion and a voucher incentive program on smoking in people with schizophrenia.


Options:
A: 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))
B: Biochemically verified smoking cessation rates at 6 months post-quit date
C: Urinary Cotinine (3 weeks)
D: Smoking abstinence at 12 months post-enrollment (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Tonsillectomy on Preventing Recurrent Streptococcal Throat Infections: A Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine whether tonsillectomy is effective in preventing further streptococcal pharyngitis episodes in patients with recurrent tonsillitis.


Options:
A: Changes in polysomnographic parameter AHI (Apnea Hypopnea Index) (One, three and ten years)
B: microbiologically confirmed streptococcal pharyngitis episodes
C: Absolute percentage difference between groups of patients having pharyngitis with delayed recovery time defined by symptoms and blood sample values (crp, procalcitonin) (5 months follow up)
D: Difference between the three arms regarding serum IL1 beta, TNF alpha, IL2, IL6. (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Exubera® (Inhaled Insulin) Compared With Subcutaneous Human Insulin Therapy in Adult Subjects With Type 2 Diabetes Mellitus: A Long-Term, Outpatient, Open-Label, Parallel-Group Comparative Trial
Brief Summary: This study is being done to find out the good and bad effects of inhaled insulin that is used by oral inhalation, to adult males and females with type 2 diabetes mellitus. The other name for this inhaled insulin is Exubera®.

This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin. After this follow-up period, all eligible subjects entered a comparative extension period that was to last for 5 years. When the comparative portion of the study was terminated, all subjects were requested to return for a final extension follow-up month 3 visit.


Options:
A: Need of insulin treatment for GDM (Day of delivery)
B: Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1) (Month 3 through extension Month 60); Change From Baseline in FEV1 (Baseline through extension follow up Month 3); Annual Rate of Change in FEV1 (Week -2 through extension follow up Month 3 or end of study); Summary of ≥ 15 % Decliners in FEV1 (Month 3 through extension follow up Month 3); Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco) (Week -2 through extension follow up Month 3 or end of study); Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) (Baseline through extension follow up Month 3); Summary of ≥ 20 % Decliners in DLco (Month 3 through extension follow up Month 3)
C: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)
D: Gestational diabetes (20 and 36 weeks pregnancy and 3 months post partum); Gestational diabetes (18 months postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Multi-Center, Double-Blind, Randomized, Parallel Group, Carotid B-Mode Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 Months, Compared With Maximally Tolerated Atorvastatin Therapy Alone, in Subjects With Heterozygous Familial Hypercholesterolemia.
Brief Summary: The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To look at ultrasound images taken in the carotid arteries and to look at various lipids in the blood of people with heterozygous familial hypercholesterolemia


Options:
A: Changes from baseline in USPIO-enhanced MRI signal in carotid plaques at 6 weeks and 12-weeks in low and high dose atorvastatin groups (within groups' comparison).
B: Change in intima media thickness as measures by carotid ultrasound
C: Change in intima media thickness as measured by carotid ultrasound
D: The time to first occurrence of a major cardiovascular disease event

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: It is widely believed that people who abuse alcohol can sustain a liver injury after taking doses of acetaminophen just above the recommended maximum dose. This study is designed to look at the interaction between acetaminophen, liver injury and alcohol abuse. Subjects will undergo baseline tests to ensure that they do not have liver damage at the time of enrollment. Each subject will be randomly assigned to receive either a therapeutic dose of acetaminophen or a placebo three times a day for four days. Subjects will have blood work drawn on a daily basis to monitor the status of the liver. These tests will include conventional markers of liver injury in addition to a novel biomarker of liver function, a-GST. Previous work in the investigators' group has shown that a-GST is a more sensitive indicator of liver injury following acetaminophen overdose (Sivilotti 1999, Sivilotti 2002 x 2). However, it has never been used to study the alcoholic population. The investigators believe that a-GST may detect a subclinical acetaminophen-induced liver injury that has previously gone unrecognized in the alcoholic population.


Options:
A: The primary endpoint is the proportion of patients who do not vomit or retch within 2 hours of initiation of acetylcysteine treatment and no use of rescue medication. Retching will be defined as a vomit not producing any liquid. (2 hours post start of treatment)
B: Patient survival at six months (6 months)
C: Overall Survival (1 Year)
D: serum a-GST relative to baseline

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Comparative Evaluation of the Safety and Efficacy of Sirolimus Versus Cyclosporine When Combined in a Regimen Containing Basiliximab, Mycophenolate Mofetil, and Corticosteroids in Primary De Novo Renal Allograft Recipients
Brief Summary: The purpose of this study is to determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant.


Options:
A: To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR); Non-inferiority of the composite of graft loss and death at 52 weeks
B: Reduced Exposure Cyclosporine in Renal Transplant Recipients (12 months after the time of kidney transplantation)
C: Core Study: Number of Patients With Composite Efficacy Endpoint (12 months); Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula (Month 24); Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula (Month 48)
D: incidence of CMV infection or disease (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Randomised, Placebo Controlled, Double Blind, Parallel Group Study in Female Patients to Evaluate Whether Tolterodine ER Can Reverse the Increased Bladder Wall Thickness in Patients With Overactive Bladder.
Brief Summary: The main aim of the study is to investigate whether taking Tolterodine for overactive bladder symptoms can reduce the thickness of the bladder wall, as measured by intra-vaginal ultrasound. This will help doctors to understand whether there is a link between changes in the thickness of the bladder wall and progression of symptoms.


Options:
A: N/A
B: Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours (Baseline and EoT (up to 12 weeks)); Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours (Baseline and EoT (up to 12 weeks))
C: The main outcome will be the change in bladder wall thickness, as measured by intra-vaginal ultrasound from baseline to week 12.
D: 24-hour Voiding Frequency (post-treatment (week 8))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma
Brief Summary: To evaluate the anti-tumor activity of SU011248 (sunitinib) in cytokine-refractory metastatic renal cell carcinoma (RCC) when administered in a continuous treatment regimen


Options:
A: N/A
B: Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects (4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up)
C: Progressive Free Survival (PFS) in Patients Who Receive RAD001 Plus Best Supportive Care(BSC) Versus Patients Who Receive Matching Placebo Plus BSC (Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported between date of first patient randomized until 28Feb2008 cut of date.)
D: Progression-Free Survival (PFS), Core Radiology Assessment (Day 28 of each 6-week cycle: duration of treatment phase); Progression-Free Survival (PFS), Investigator's Assessment (Day 28 of each 6-week cycle: duration of treatment phase)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Compare the Immunogenicity, Reactogenicity & Safety of 2 Different Formulations of GSK Biologicals' Live Attenuated Human Rotavirus (HRV) Vaccine Given as a Two-dose Primary Vaccination in Healthy Infants Previously Uninfected With HRV
Brief Summary: Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age (estimated nearly 500,000 annual deaths worldwide). GlaxoSmithKline (GSK) Biologicals has developed a vaccine against human rotavirus gastroenteritis. A new formulation of the vaccine, with an alternative buffer, was developed. This study will be conducted to evaluate the new formulation compared to the existing formulation of the HRV vaccine.


Options:
A: Endpoint: immunogenicity and reactogenicity; Proportion of subjects with vaccine take
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: Primary study endpoint: acute rotavirus diarrhoea occurring from 6 weeks of age to the end of the follow-up period in subjects who resided in randomized villages during the period when they were age-eligible to have received Rotarix. (24 months)
D: occurrence of Severe Rotavirus Gastroenteritis (Up to 2 years of age of participants)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Compare the Immunogenicity, Reactogenicity & Safety of 2 Different Formulations of GSK Biologicals' Live Attenuated Human Rotavirus (HRV) Vaccine Given as a Two-dose Primary Vaccination in Healthy Infants Previously Uninfected With HRV
Brief Summary: Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age (estimated nearly 500,000 annual deaths worldwide). GlaxoSmithKline (GSK) Biologicals has developed a vaccine against human rotavirus gastroenteritis. A new formulation of the vaccine, with an alternative buffer, was developed. This study will be conducted to evaluate the new formulation compared to the existing formulation of the HRV vaccine.


Options:
A: Immunogenicity (7 months)
B: Endpoint: immunogenicity and reactogenicity; Proportion of subjects with vaccine take
C: Proportion of subjects who seroconvert as measured by a 4-fold rise in serum anti-VP6 IgA antibodies between baseline and 4 weeks after the second dose of Rotarix®. (14-18 weeks of age)
D: Occurrence of RV GE

Answer: B