TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Usual Care Versus Specialized, Phase-specific Care in the Public Sector for First Episode Psychosis.
Brief Summary: The purpose of this study is to understand the effectiveness of a specialized package of phase-specific treatments for individuals in the midst of their first episode of psychosis. The pharmacologic and psychosocial treatments will be delivered within a state public mental health center.


Options:
A: Rehospitalizations and psychotic relapse at two years
B: Number of Patients Hospitalized (1 year after enrollment)
C: Prognosis of patients. (6 months)
D: Psychotic symptoms at one and two year follow-up; Negative symptoms at one and two year follow-up

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Usual Care Versus Specialized, Phase-specific Care in the Public Sector for First Episode Psychosis.
Brief Summary: The purpose of this study is to understand the effectiveness of a specialized package of phase-specific treatments for individuals in the midst of their first episode of psychosis. The pharmacologic and psychosocial treatments will be delivered within a state public mental health center.


Options:
A: Rehospitalizations and psychotic relapse at two years
B: Number of Patients Hospitalized (1 year after enrollment)
C: Relapses (9 months); Positive and negative symptoms (change from baseline at 9 month follow-up)
D: Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Study Comparing Epirubicin, Docetaxel and Capecitabine + G-CSF to Epirubicin and Docetaxel + G-CSF as Neoadjuvant Treatment for Early HER-2 Negative Breast Cancer and Comparing Epirubicin, Docetaxel and Capecitabine + G-CSF ± Trastuzumab to Epirubicin and Docetaxel + G-CSF ± Trastuzumab as Neoadjuvant Treatment for Early HER-2 Positive Breast Cancer
Brief Summary: Primarily, this clinical investigation compares the rates (percentages) of pathological complete remissions attained at the time of final surgery following 6 cycles each of epirubicin + docetaxel + capecitabine-containing chemotherapy ± trastuzumab (in HER-2 positive disease) vs. epirubicin + docetaxel-containing chemotherapy ± trastuzumab (in HER-2 negative disease).


Options:
A: Rate of pathological complete remissions (20 weeks)
B: Relapse-free Survival Rates at 2.4 Years (randomization until date of first event, or date last known to be event free if no event was reported (up to 5 years))
C: Disease-free survival (DFS) at 5 years
D: Overall Survival (PP Population) (Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years); Overall Survival (ITT Population) (Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or More Risk Factors for Coronary Heart Disease
Brief Summary: The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin in patients with risk factors for heart disease.


Options:
A: Percent Change From Baseline in LDL-C (Baseline to 12 weeks)
B: Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks (Baseline to 12 weeks)
C: Thiobarbituric acid reactive substance; high sensitive C-reactive protein (12 weeks)
D: Percent Change From Baseline in LDL-C (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
Brief Summary: The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.


Options:
A: Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir (12 weeks)
B: Percent Change From Baseline in LDL-C (Baseline to 12 weeks)
C: Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks (12 weeks minus baseline)
D: Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks (Baseline to 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CHAARTED: ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer
Brief Summary: RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether androgen-ablation therapy is more effective with or without docetaxel in treating metastatic prostate cancer.

PURPOSE: This randomized phase III trial is studying androgen-ablation therapy and chemotherapy to see how well they work compared to androgen-ablation therapy alone in treating patients with metastatic prostate cancer.


Options:
A: Overall survival at 36 months; Progression-free survival (biological progression and/or clinical progression) at 24 months; Quality of life; Treatment costs; Toxicity and tolerance; Tumor profiles of gene expression as measured by biochips with DNA and tissue microarrays
B: Time to treatment failure (TTF)
C: Radiographic Progression-Free Survival (PFS) (Up to 44 months); Overall Survival (OS) (Up to 66 months)
D: Overall Survival (Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CHAARTED: ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer
Brief Summary: RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether androgen-ablation therapy is more effective with or without docetaxel in treating metastatic prostate cancer.

PURPOSE: This randomized phase III trial is studying androgen-ablation therapy and chemotherapy to see how well they work compared to androgen-ablation therapy alone in treating patients with metastatic prostate cancer.


Options:
A: Overall Survival (From the date of randomization up to 104 weeks (study cut-off))
B: Overall Survival (Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry)
C: Overall Survival (During study period (up to 101 months))
D: Radiographic Progression-Free Survival (PFS) (Up to 44 months); Overall Survival (OS) (Up to 66 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Self-Management on Improving Sleep Apnea Outcomes
Brief Summary: Obstructive sleep apnea syndrome (OSA) is a common sleep disorder that is associated with serious medical and psychological complications. Nasal continuous positive airway pressure (CPAP) is the treatment of choice for this condition because it is highly effective in reducing the frequency of nocturnal respiratory events, improving sleep architecture, decreasing daytime sleepiness and improving blood pressure. Incomplete patient adherence, however, limits the effectiveness of CPAP therapy and results in sub-optimal patient outcomes. Previous efforts to enhance CPAP adherence have resulted in only modest improvements, have generally not been theory-driven, and have had minimal effects on key patient outcomes such as reduction in OSA symptoms or increase in health-related quality of life (HRQOL). The planned intervention in this proposal, the Sleep Apnea Self-Management Program (SASMP), is based on the rationale that sleep apnea is a chronic disease that requires significant self-care on the part of the patient. We draw on the extensive chronic disease self-management literature to provide a solid theoretical justification for this pragmatic intervention both to better manage key aspects of OSA and to increase CPAP adherence. Chronic disease management programs help reduce symptoms, improve HRQOL, improve treatment adherence, and decrease medical utilization.


Options:
A: Structural and functional brain changes (at baseline and after 3 months of treatment)
B: CPAP Adherence (1 month); CPAP Adherence (6 months)
C: Hopkins Verbal Learning Test-Revised (HVLT-R) (Change from baseline at 6 months and 1 year); Digit Symbol Subtest (DS) (Change from baseline at 6 months and 1 year); Mini Mental State Evaluation Exam (MMSE) (Change from baseline at 6 months and 1 year); Stroop Color and Word Test (SCW) (Change from baseline at 6 months and 1 year); The Psychomotor Vigilance Task (PVT) (Change from baseline at 6 months and 1 year); Epworth Sleepiness Scale [ESS] (Change from baseline at 6 months and 1 year)
D: CPAP adherence in minutes used per night (after 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Double Blind Dose Ranging Study of Amphotericin B in Visceral Leishmaniasis
Brief Summary: This study is being conducted to assess the safety and efficacy of amphotericin B deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses. In each arm the drug is given in the conventional way every alternate day against the daily administration regimen being tested.


Options:
A: Final cure rate at six months after the end of treatment
B: Wound closure time (75 days)
C: (1) To compare the safety of injectable paromomycin to amphotericin B when administered in the proposed dosage regimens.; (2) To compare the efficacy of injectable paromomycin to amphotericin B with regards to final cure rates.
D: Wound closure time

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Double Blind Dose Ranging Study of Amphotericin B in Visceral Leishmaniasis
Brief Summary: This study is being conducted to assess the safety and efficacy of amphotericin B deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses. In each arm the drug is given in the conventional way every alternate day against the daily administration regimen being tested.


Options:
A: Final Clinical Cure Rate (Day 42, 98, and 168)
B: Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure (Assessment of cure is made at 2 months after treatment)
C: Final cure rate at six months after the end of treatment
D: Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days) (180 days); Safety of WR 279,396 (AEs and SAEs) (180 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Part 1:Phase I Open-Label, Single-Center to Evaluate the Safety of a Commercially Available Adjuvanted Influenza Vaccine When Administered to Elderly Subjects Part 2: A Phase III, Randomized, Controlled, Observer-Blind, Single-Center Study to Evaluate the Immunogenicity and Safety of a Commercially Available Influenza Vaccine and a Conventional Commercially Available Influenza Vaccine When Administered to Elderly Subjects
Brief Summary: Clinical Trial in Two parts:

Part 1: Phase I, Open-Label, Single-Center Study to Evaluate the Safety of an adjuvanted Influenza Vaccine When Administered to Elderly Subjects.

Part 2: A Phase III, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate the Immunogenicity and Safety of an adjuvanted and a conventional Influenza Vaccine When Administered to Elderly Subjects.


Options:
A: Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection. (After the first dose during the corresponding surveillance period (from mid November 2008 to the end of April 2009 (end of influenza season))); Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups. (At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study)
B: Requirements For Drug Registration & Guide Principles For ClinicaL Trial Techniques of Vaccine e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.
C: Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1) (At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)); Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1) (At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)); Number of Subjects With Any Solicited Local Symptoms. (During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration); Number of Subjects With Any Solicited General Symptoms. (During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration); Number of Subjects With Any Unsolicited Adverse Events (AEs). (During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)); Number of Subjects With Serious Adverse Events (SAEs) (From Day 0 through Day 182 and through Day 379.); Number of Subjects With Medically Attended Events (MAEs) (From Day 0 through Day 182 and through Day 364.)
D: The primary study endpoint was the comparison of efficacy of CAIV-T versus placebo against culture-confirmed influenza-illness caused by community-acquired influenza subtypes that were antigenically similar to those contained in the vaccine.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Short Duration Exclusive Breastfeeding With Abrupt Weaning to Reduce the Risk of Mother-to-Child HIV Transmission
Brief Summary: The study is designed as a randomized, controlled trial with specific observational objectives. All HIV-seropositive pregnant subjects electing to breastfeed their child will be counselled to exclusively breastfeed through 4 months of age. All live-born children will be randomized (1:1) at birth to one of two counseling programs: A) to encourage abrupt weaning at 4 months of age, or B) to encourage exclusive breastfeeding through 6 months of age with the introduction of typical weaning foods ad lib.


Options:
A: BMI percentile at 3 years (3 years)
B: HIV infection detected by 4 months among children with no evidence of HIV infection at birth. (24 months of age); Magnitude of the reduction in mother-to-child HIV transmission and the magnitude of the increase in non-HIV-related under-2-year mortality, attributable to cessation of breastfeeding at 4 months.
C: Percent of infants sleeping 5 consecutive hours at night at 2 months of age (2.5 years)
D: Breastfeeding Initiation (Three days postpartum); Positive parenting behavior (Parent Child Observation Guide) (4 months postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Short Duration Exclusive Breastfeeding With Abrupt Weaning to Reduce the Risk of Mother-to-Child HIV Transmission
Brief Summary: The study is designed as a randomized, controlled trial with specific observational objectives. All HIV-seropositive pregnant subjects electing to breastfeed their child will be counselled to exclusively breastfeed through 4 months of age. All live-born children will be randomized (1:1) at birth to one of two counseling programs: A) to encourage abrupt weaning at 4 months of age, or B) to encourage exclusive breastfeeding through 6 months of age with the introduction of typical weaning foods ad lib.


Options:
A: HIV infection rate of infants (6 months of age); Safety of the regimens for HIV-infected mothers and their breast-fed infants (Through 12 months post-partum)
B: A. Rate of HIV infection at 9 months and assess HIV infection rates at 6-8 & 14 weeks, and 6, 12, 18, and 24 months. B.Determine HIV survival rates at ages 6, 12, 18, and 24 months. C. Evaluate safety of oral NVP and ZDV for 14 weeks. (9 months)
C: HIV infection detected by 4 months among children with no evidence of HIV infection at birth. (24 months of age); Magnitude of the reduction in mother-to-child HIV transmission and the magnitude of the increase in non-HIV-related under-2-year mortality, attributable to cessation of breastfeeding at 4 months.
D: Infant HIV infection status (At Months 6 and 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Short Duration Exclusive Breastfeeding With Abrupt Weaning to Reduce the Risk of Mother-to-Child HIV Transmission
Brief Summary: The study is designed as a randomized, controlled trial with specific observational objectives. All HIV-seropositive pregnant subjects electing to breastfeed their child will be counselled to exclusively breastfeed through 4 months of age. All live-born children will be randomized (1:1) at birth to one of two counseling programs: A) to encourage abrupt weaning at 4 months of age, or B) to encourage exclusive breastfeeding through 6 months of age with the introduction of typical weaning foods ad lib.


Options:
A: HIV PCR (1 month)
B: Infant HIV infection status (At Months 6 and 12)
C: HIV infection detected by 4 months among children with no evidence of HIV infection at birth. (24 months of age); Magnitude of the reduction in mother-to-child HIV transmission and the magnitude of the increase in non-HIV-related under-2-year mortality, attributable to cessation of breastfeeding at 4 months.
D: Rate of HIV infection in infants born to study participants in each arm of the study (At Birth, Weeks 2, 6, and 14, and Months 6, 12, and 18); Safety and tolerance of HIVIGLOB given to pregnant women at 36-37 weeks gestation and neonates at birth in combination with NVP and of NVP alone (Throughout study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Symptomatic Pulmonary Arterial Hypertension Associated With Sickle Cell Disease
Brief Summary: The study will assess the effect of bosentan on pulmonary vascular resistance and exercise capacity in sickle cell disease (SCD) patients diagnosed with pulmonary arterial hypertension. It consists of 3 phases: Screening, Treatment and Follow-up. During the Screening visit, the study doctor will decide if patients meet the study requirements. All potential patients will have a diagnosis of increased pulmonary artery pressures that is shown by right heart catheterization conducted shortly prior to start of study treatment. Patients will be asked to perform exercise capacity test (walking as far as possible for 6 minutes). Following the Baseline visit, the treatment phase consists of 4 additional clinic visits during which the good and bad effects of the drug are reviewed and exercise capacity test will be repeated. Patients will be treated for 16 weeks. Blood samples will be collected every month, or more often, if needed. At the end of the study, patients will be asked to repeat the right heart catheterization and exercise capacity test. After completion of the study, patients will have the option of enrolling in a long-term follow-up study where all patients will receive active drug. Patients electing not to participate in the extension study will be followed up for safety assessments for about 28 days after the end of the study treatment.


Options:
A: Change from Baseline to Week 16 in 6-Minute Walk Test distance (Week 16); Change from Baseline to Week 16 in Pulmonary Vascular Resistance at rest (Week 16)
B: Change from Baseline to End of Study in 6MWT distance. A mean difference from placebo of at least 35 m is considered clinically relevant. (16 weeks)
C: Peak 6-minute Walk Distance (12 weeks)
D: Change from baseline at Week 12 of six minute walk distance

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Symptomatic Pulmonary Arterial Hypertension Associated With Sickle Cell Disease
Brief Summary: The study will assess the effect of bosentan on pulmonary vascular resistance and exercise capacity in sickle cell disease (SCD) patients diagnosed with pulmonary arterial hypertension. It consists of 3 phases: Screening, Treatment and Follow-up. During the Screening visit, the study doctor will decide if patients meet the study requirements. All potential patients will have a diagnosis of increased pulmonary artery pressures that is shown by right heart catheterization conducted shortly prior to start of study treatment. Patients will be asked to perform exercise capacity test (walking as far as possible for 6 minutes). Following the Baseline visit, the treatment phase consists of 4 additional clinic visits during which the good and bad effects of the drug are reviewed and exercise capacity test will be repeated. Patients will be treated for 16 weeks. Blood samples will be collected every month, or more often, if needed. At the end of the study, patients will be asked to repeat the right heart catheterization and exercise capacity test. After completion of the study, patients will have the option of enrolling in a long-term follow-up study where all patients will receive active drug. Patients electing not to participate in the extension study will be followed up for safety assessments for about 28 days after the end of the study treatment.


Options:
A: Change from Baseline to End of Study in 6MWT distance. A mean difference from placebo of at least 35 m is considered clinically relevant. (16 weeks)
B: Change from Baseline to End of Study in 6MWT distance. A mean difference from placebo of at least 35 m is considered clinically relevant. (16 weeks)
C: 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.)
D: Change from baseline to all assessed time points in 6MWT, in Borg dyspnea index, and in modified NYHA functional class.

Answer: B