TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Prophylactic Micronutrient Supplementation of Morbidity and Growth in HIV-infected and HIV-uninfected Children in South Africa
Brief Summary: The purpose of the study is to see if giving vitamin and mineral supplements helps to protect infants and children from diarrhea, which vitamins and minerals help to improve a child's weight and growth, and if the same results occur in infants and children with HIV. HIV is the virus that causes AIDS. Study participants will include 516 infants aged 4-6 months. Participants will include: (1) HIV-infected children, (2) HIV-uninfected children with HIV-infected mothers, and (3) HIV-uninfected children with HIV-uninfected mothers. Subjects will have an equal chance of receiving one of three different vitamin and/or mineral supplements during the study. Study procedures will include up to 7 blood samples and stool samples every 3 months and body composition every 6 months. Participants will be involved in the study for up to 18 months.


Options:
A: Time to cessation of severe pneumonia (Within 2 weeks after enrollment); The period starting from enrolment to the beginning of a 24-hour consecutive period of absence of lower chest indrawing, of hypoxia and of any danger signs. (Recovery from pneumonia within 2 weeks)
B: Time (hours) to resolution of clinical signs of pneumonia (31 months)
C: Death among children 1-36 months of age
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Prophylactic Micronutrient Supplementation of Morbidity and Growth in HIV-infected and HIV-uninfected Children in South Africa
Brief Summary: The purpose of the study is to see if giving vitamin and mineral supplements helps to protect infants and children from diarrhea, which vitamins and minerals help to improve a child's weight and growth, and if the same results occur in infants and children with HIV. HIV is the virus that causes AIDS. Study participants will include 516 infants aged 4-6 months. Participants will include: (1) HIV-infected children, (2) HIV-uninfected children with HIV-infected mothers, and (3) HIV-uninfected children with HIV-uninfected mothers. Subjects will have an equal chance of receiving one of three different vitamin and/or mineral supplements during the study. Study procedures will include up to 7 blood samples and stool samples every 3 months and body composition every 6 months. Participants will be involved in the study for up to 18 months.


Options:
A: N/A
B: - To measure the impact of zinc and vitamin A on the duration of diarrheal illness (Weekly home visits for 6 months)
C: Stool output (g/kg/24h); Duration of diarrhoea (days).
D: Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial) (25 days following week 52 visit); Number of Participants With One or More Episodes of Rotavirus-associated Diarrhea (Rotavirus Trial) (Birth to one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Prophylactic Micronutrient Supplementation of Morbidity and Growth in HIV-infected and HIV-uninfected Children in South Africa
Brief Summary: The purpose of the study is to see if giving vitamin and mineral supplements helps to protect infants and children from diarrhea, which vitamins and minerals help to improve a child's weight and growth, and if the same results occur in infants and children with HIV. HIV is the virus that causes AIDS. Study participants will include 516 infants aged 4-6 months. Participants will include: (1) HIV-infected children, (2) HIV-uninfected children with HIV-infected mothers, and (3) HIV-uninfected children with HIV-uninfected mothers. Subjects will have an equal chance of receiving one of three different vitamin and/or mineral supplements during the study. Study procedures will include up to 7 blood samples and stool samples every 3 months and body composition every 6 months. Participants will be involved in the study for up to 18 months.


Options:
A: Pregnancy-related mortality and all cause mortality (Continuous)
B: Breast milk immune regulators (Four months)
C: All-cause, Pregnancy-related Mortality (Deaths during pregnancy through 12 weeks postpartum)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Prophylactic Micronutrient Supplementation of Morbidity and Growth in HIV-infected and HIV-uninfected Children in South Africa
Brief Summary: The purpose of the study is to see if giving vitamin and mineral supplements helps to protect infants and children from diarrhea, which vitamins and minerals help to improve a child's weight and growth, and if the same results occur in infants and children with HIV. HIV is the virus that causes AIDS. Study participants will include 516 infants aged 4-6 months. Participants will include: (1) HIV-infected children, (2) HIV-uninfected children with HIV-infected mothers, and (3) HIV-uninfected children with HIV-uninfected mothers. Subjects will have an equal chance of receiving one of three different vitamin and/or mineral supplements during the study. Study procedures will include up to 7 blood samples and stool samples every 3 months and body composition every 6 months. Participants will be involved in the study for up to 18 months.


Options:
A: - To measure the impact of zinc and vitamin A on the duration of diarrheal illness (Weekly home visits for 6 months)
B: Changes in Maternal Serum B12 Concentration From 1st to 3rd Trimester (from 1st to 3rd trimester)
C: Plasma zinc concentration (3 weeks)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Prophylactic Micronutrient Supplementation of Morbidity and Growth in HIV-infected and HIV-uninfected Children in South Africa
Brief Summary: The purpose of the study is to see if giving vitamin and mineral supplements helps to protect infants and children from diarrhea, which vitamins and minerals help to improve a child's weight and growth, and if the same results occur in infants and children with HIV. HIV is the virus that causes AIDS. Study participants will include 516 infants aged 4-6 months. Participants will include: (1) HIV-infected children, (2) HIV-uninfected children with HIV-infected mothers, and (3) HIV-uninfected children with HIV-uninfected mothers. Subjects will have an equal chance of receiving one of three different vitamin and/or mineral supplements during the study. Study procedures will include up to 7 blood samples and stool samples every 3 months and body composition every 6 months. Participants will be involved in the study for up to 18 months.


Options:
A: Thymus size measured by ultrasound (through 15 wk of age); peripheral blood naive T-helper lymphocyte concentration (through 15 wk of age); T-cell receptor excision circle (TREC) level in peripheral blood mononuclear cells (PBMC) (through 15 wk of age); T-cell response to BCG (Bacillus Calmette-Guérin; to protect against tuberculosis) and oral polio virus (OPV) immunization (through 15 wk of age); Antibody response to oral polio virus (OPV) immunization (through 15 wk of age); T-cell and antibody response to tetanus toxoid (TT) and hepatitis B virus (HBV) vaccinations given at 6, 10 and 14 wk of age (through 15 wk of age); bacterial translocation to blood (through 15 wk of age)
B: N/A
C: Seric retinol (six months)
D: Exclusive Breastfeeding Rates in Burkina Faso (at 3 months of age); Infant Morbidity, 2 Week Diarrhoea Prevalence (at 3 months of age); Exclusive Breastfeeding Rates in Uganda (at 3 months of age); Exclusive Breastfeeding Rates in South Africa (at 3 months of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Prophylactic Micronutrient Supplementation of Morbidity and Growth in HIV-infected and HIV-uninfected Children in South Africa
Brief Summary: The purpose of the study is to see if giving vitamin and mineral supplements helps to protect infants and children from diarrhea, which vitamins and minerals help to improve a child's weight and growth, and if the same results occur in infants and children with HIV. HIV is the virus that causes AIDS. Study participants will include 516 infants aged 4-6 months. Participants will include: (1) HIV-infected children, (2) HIV-uninfected children with HIV-infected mothers, and (3) HIV-uninfected children with HIV-uninfected mothers. Subjects will have an equal chance of receiving one of three different vitamin and/or mineral supplements during the study. Study procedures will include up to 7 blood samples and stool samples every 3 months and body composition every 6 months. Participants will be involved in the study for up to 18 months.


Options:
A: N/A
B: Incidence of diarrhea (from ages 6 weeks to 18 months); respiratory tract infections (from ages 6 weeks to 18 months)
C: Incidence acute diarrheal disease and acute respiratory infection (Up to 16 weeks)
D: Death among children 1-36 months of age

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This is a 60 week study including a double-blind phase followed by an open-label extension phase.


Options:
A: 100 mm visual analog scale (VAS)
B: Change in Frequency of Headache Days (Baseline, Week 24)
C: Mean change from baseline of Area undercurve of headache diary ( total headache score).; Mean change from baseline of total duration of migraine attack( hours) in 4 weeks.; Mean change from baseline of migraine frequency
D: Change in Frequency of Headache Episodes (Baseline, Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis
Brief Summary: The purpose of the study was to evaluate the effects of integrated treatment for patients with a first episode of psychotic illness. We conducted a randomised clinical trial in Copenhagen Hospital Corporation and Psychiatric Hospital Aarhus, Denmark. We included 547 patients with first episode of schizophrenia spectrum disorder, who has not received antipsychotic medication for more than 12 weeks.

Patients were randomised to integrated treatment or standard treatment. The integrated treatment lasted for two years and consisted of assertive community treatment with programmes for family involvement and social skills training. Standard treatment offered contact with a community mental health centre.

We wanted to study the effect on psychotic (hallucinations and delusions)and negative (lack of initiative, apati, blunted affect) symptoms (each scored from 0 to a maximum of 5) at one and two years' follow-up.

We found that integrated treatment improved clinical outcome and adherence to treatment. The improvement in clinical outcome was consistent at one year and two year follow-ups. We will study further outcome measures such as social network, quality of life, depression and suicidal behaviour.


Options:
A: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)
B: Rehospitalizations and psychotic relapse at two years
C: Functioning (social and occupational) (baseline, 12-month)
D: Psychotic symptoms at one and two year follow-up; Negative symptoms at one and two year follow-up

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis
Brief Summary: The purpose of the study was to evaluate the effects of integrated treatment for patients with a first episode of psychotic illness. We conducted a randomised clinical trial in Copenhagen Hospital Corporation and Psychiatric Hospital Aarhus, Denmark. We included 547 patients with first episode of schizophrenia spectrum disorder, who has not received antipsychotic medication for more than 12 weeks.

Patients were randomised to integrated treatment or standard treatment. The integrated treatment lasted for two years and consisted of assertive community treatment with programmes for family involvement and social skills training. Standard treatment offered contact with a community mental health centre.

We wanted to study the effect on psychotic (hallucinations and delusions)and negative (lack of initiative, apati, blunted affect) symptoms (each scored from 0 to a maximum of 5) at one and two years' follow-up.

We found that integrated treatment improved clinical outcome and adherence to treatment. The improvement in clinical outcome was consistent at one year and two year follow-ups. We will study further outcome measures such as social network, quality of life, depression and suicidal behaviour.


Options:
A: Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) (3 years)
B: Psychotic symptoms at one and two year follow-up; Negative symptoms at one and two year follow-up
C: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)
D: USCD Performance-Based Skills Assessment (2009)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis
Brief Summary: The purpose of the study was to evaluate the effects of integrated treatment for patients with a first episode of psychotic illness. We conducted a randomised clinical trial in Copenhagen Hospital Corporation and Psychiatric Hospital Aarhus, Denmark. We included 547 patients with first episode of schizophrenia spectrum disorder, who has not received antipsychotic medication for more than 12 weeks.

Patients were randomised to integrated treatment or standard treatment. The integrated treatment lasted for two years and consisted of assertive community treatment with programmes for family involvement and social skills training. Standard treatment offered contact with a community mental health centre.

We wanted to study the effect on psychotic (hallucinations and delusions)and negative (lack of initiative, apati, blunted affect) symptoms (each scored from 0 to a maximum of 5) at one and two years' follow-up.

We found that integrated treatment improved clinical outcome and adherence to treatment. The improvement in clinical outcome was consistent at one year and two year follow-ups. We will study further outcome measures such as social network, quality of life, depression and suicidal behaviour.


Options:
A: Transition to PANSS defined first-episode psychosis (Baseline, 1, 2, 3, 4, 8, 12 weeks, 6, and 12 months)
B: Psychotic symptoms at one and two year follow-up; Negative symptoms at one and two year follow-up
C: Scale of Prodromal Symptoms Total Score (Baseline); Change in Scale of Prodromal Symptoms Total Score (Change from Baseline at 8 Weeks)
D: Incidence of Remission From Attenuated Psychosis Syndrome (APS) Within a 52-week Timeframe (Up to 52 weeks.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis
Brief Summary: The purpose of the study was to evaluate the effects of integrated treatment for patients with a first episode of psychotic illness. We conducted a randomised clinical trial in Copenhagen Hospital Corporation and Psychiatric Hospital Aarhus, Denmark. We included 547 patients with first episode of schizophrenia spectrum disorder, who has not received antipsychotic medication for more than 12 weeks.

Patients were randomised to integrated treatment or standard treatment. The integrated treatment lasted for two years and consisted of assertive community treatment with programmes for family involvement and social skills training. Standard treatment offered contact with a community mental health centre.

We wanted to study the effect on psychotic (hallucinations and delusions)and negative (lack of initiative, apati, blunted affect) symptoms (each scored from 0 to a maximum of 5) at one and two years' follow-up.

We found that integrated treatment improved clinical outcome and adherence to treatment. The improvement in clinical outcome was consistent at one year and two year follow-ups. We will study further outcome measures such as social network, quality of life, depression and suicidal behaviour.


Options:
A: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)
B: Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) (3 years)
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: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis
Brief Summary: The purpose of the study was to evaluate the effects of integrated treatment for patients with a first episode of psychotic illness. We conducted a randomised clinical trial in Copenhagen Hospital Corporation and Psychiatric Hospital Aarhus, Denmark. We included 547 patients with first episode of schizophrenia spectrum disorder, who has not received antipsychotic medication for more than 12 weeks.

Patients were randomised to integrated treatment or standard treatment. The integrated treatment lasted for two years and consisted of assertive community treatment with programmes for family involvement and social skills training. Standard treatment offered contact with a community mental health centre.

We wanted to study the effect on psychotic (hallucinations and delusions)and negative (lack of initiative, apati, blunted affect) symptoms (each scored from 0 to a maximum of 5) at one and two years' follow-up.

We found that integrated treatment improved clinical outcome and adherence to treatment. The improvement in clinical outcome was consistent at one year and two year follow-ups. We will study further outcome measures such as social network, quality of life, depression and suicidal behaviour.


Options:
A: Schizophrenia symptoms (Measured at Year 1); Vocational functioning (Measured at Year 2); Schizophrenia symptoms (Measured at Year 2); Quality of life (Measured at Year 2); Quality of life (Measured at Year 1); Vocational functioning (Measured at Year 1)
B: Psychotic symptoms at one and two year follow-up; Negative symptoms at one and two year follow-up
C: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)
D: Labor Market Participation in Ordinary Paid Employment, or Education. (1 year (2016))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Prospective, Double-blind Study to Evaluate the Nephroprotective Effect of Delapril Alone or Combined With Manidipine in Patients With Type 2 Diabetes
Brief Summary: Diabetes mellitus is one of the most common diseases globally, and is considered epidemic in many developed and newly industrialized nations. Diabetes mellitus represents the single largest cause of end-stage renal disease in the U.S. and Europe. At the same time, the primary cause of early death in diabetic patients are cardiovascular complications. Experimental and clinical studies found that angiotensin converting enzyme inhibitors (ACEi) and calcium channel blockers (CCBs) have a specific renoprotective effect and that this effect can be magnified when the two drugs are used in combination. To formally test this hypothesis we designed the Delapril and Manidipine for Nephroprotection in Diabetes (DEMAND) study, a prospective, randomized, double blind trial aimed to compare the effect of 3 years treatment with the ACEi Delapril (30 mg/day), alone or combined to the CCB Manidipine (10 mg/day), versus conventional (non ACEi, non CCB) therapy on the rate of renal function loss and on the incidence of major cardiovascular events in 342 normo- and micro-albuminuric hypertensive type 2 diabetic patients.


Options:
A: The rate of decline of glomerular filtration rate (GFR).GFR is measured at baseline,and at 6,12,18,24,30 and 36 months after randomization
B: 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.]))
C: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)
D: Blood pressure variation and proportion of use of add-on drugs (18 months); Adverse events (18 months); Development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. (18 monyhs)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Prospective, Double-blind Study to Evaluate the Nephroprotective Effect of Delapril Alone or Combined With Manidipine in Patients With Type 2 Diabetes
Brief Summary: Diabetes mellitus is one of the most common diseases globally, and is considered epidemic in many developed and newly industrialized nations. Diabetes mellitus represents the single largest cause of end-stage renal disease in the U.S. and Europe. At the same time, the primary cause of early death in diabetic patients are cardiovascular complications. Experimental and clinical studies found that angiotensin converting enzyme inhibitors (ACEi) and calcium channel blockers (CCBs) have a specific renoprotective effect and that this effect can be magnified when the two drugs are used in combination. To formally test this hypothesis we designed the Delapril and Manidipine for Nephroprotection in Diabetes (DEMAND) study, a prospective, randomized, double blind trial aimed to compare the effect of 3 years treatment with the ACEi Delapril (30 mg/day), alone or combined to the CCB Manidipine (10 mg/day), versus conventional (non ACEi, non CCB) therapy on the rate of renal function loss and on the incidence of major cardiovascular events in 342 normo- and micro-albuminuric hypertensive type 2 diabetic patients.


Options:
A: Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks (Baseline, 8 weeks, 16 weeks, and 24 weeks); Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24 (Baseline to 24 weeks)
B: Phase A: microalbuminuria; Phase B: progression from microalbuminuria to macroalbuminuria. (3 years)
C: The rate of decline of glomerular filtration rate (GFR).GFR is measured at baseline,and at 6,12,18,24,30 and 36 months after randomization
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