TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Buprenorphine Effectiveness Evaluation in HIV Enhancement (BEEHIVE): A Randomized Trial of HIV Clinic-based Buprenorphine/Naloxone vs. Case Management and Referral in Opioid-dependent Individuals
Brief Summary: The purpose of this study is to compare the effectiveness of two approaches to treating HIV-infected patients who are addicted to opioid drugs (e.g., heroin) in an inner-city HIV clinic. The two approaches are:

* Case management and referral - participants are managed by a case manager and referred to a specialized drug treatment center where they receive counseling and medications for opioid-dependence (e.g., methadone or buprenorphine); or
* Clinic-based treatment - participants receive counseling and treatment with buprenorphine at the HIV clinic.


Options:
A: Retention to substance abuse treatment (12 months)
B: Time to resumption of heroin use; Time to relapse; Maximum consecutive weeks of opiate abstinence; Reduction of HIV risks
C: Opiate abstinence
D: The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1 (12 weeks); The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition, Phase 2 End of Treatment (12 weeks in Phase 2 period (i.e., 24 weeks into the study))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A SU011248 Expanded Access Protocol For Systemic Therapy Of Patients With Metastatic Renal Cell Carcinoma Who Are Ineligible For Participation In Other SU011248 Protocols But May Derive Benefit From Treatment With SU011248
Brief Summary: The primary objective of this protocol is to provide access to SU011248 treatment for patients with metastatic RCC who are ineligible for participation in ongoing SU011248 clinical studies and have the potential to derive clinical benefit from treatment with SU011248 based on the judgment of the investigator.


Options:
A: Overall Survival (OS) (Baseline up to Month 80)
B: N/A
C: 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)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double Blind, Placebo Controlled Trial of Albendazole in Soil-Transmitted Helminth and HIV-1 co-Infected Kenyan Individuals to Determine the Effect of Such Treatment on HIV-1 Disease Progression and Genital Shedding.
Brief Summary: Identifying methods to slow disease progression in patients with HIV-1 infection remains a top priority in many regions of the world. In many countries, medications known to slow progression are not readily affordable or available. Many of the individuals living in these countries are also co-infected with a variety of other diseases such as tuberculosis, malaria and soil-transmitted helminths. There are data to suggest that infection with these agents may activate the immune system in HIV-1 co-infected individuals and may lead to more rapid HIV disease progression. This study will evaluate the potential impact of treating helminths in HIV-1 seropositive individuals. Markers of disease progression and immune activation will be assessed. We will also measure the amount of virus in genital secretions to determine if treatment of co-infection can reduce the infectiousness of HIV in these individuals.


Options:
A: Cure Rate (CR) of Mebendazole Against Hookworm (baseline (before treatment) and 18 to 22 days post-treatment)
B: Change in markers of HIV-1 disease progression (12 weeks); CD4 count (12 weeks); HIV-1 RNA level (12 weeks); Genital HIV-1 RNA levels (12 weeks)
C: intestinal parasitic infections (6 months)
D: Bidirectional measurements will be taken of the subjects' lesions at each visit and will be categorized as active or healed by a dermatologist. (90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double Blind, Placebo Controlled Trial of Albendazole in Soil-Transmitted Helminth and HIV-1 co-Infected Kenyan Individuals to Determine the Effect of Such Treatment on HIV-1 Disease Progression and Genital Shedding.
Brief Summary: Identifying methods to slow disease progression in patients with HIV-1 infection remains a top priority in many regions of the world. In many countries, medications known to slow progression are not readily affordable or available. Many of the individuals living in these countries are also co-infected with a variety of other diseases such as tuberculosis, malaria and soil-transmitted helminths. There are data to suggest that infection with these agents may activate the immune system in HIV-1 co-infected individuals and may lead to more rapid HIV disease progression. This study will evaluate the potential impact of treating helminths in HIV-1 seropositive individuals. Markers of disease progression and immune activation will be assessed. We will also measure the amount of virus in genital secretions to determine if treatment of co-infection can reduce the infectiousness of HIV in these individuals.


Options:
A: Change in markers of HIV-1 disease progression (12 weeks); CD4 count (12 weeks); HIV-1 RNA level (12 weeks); Genital HIV-1 RNA levels (12 weeks)
B: CD4 count (every 6 months for 24 months (enrollment and months 6, 12, 18, and 24 )); HIV-1 RNA level (enrollment, 12, and 24 months.)
C: Change in TB-score compared to baseline (Wejse et al 2007) (2 months)
D: cure rate (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Risperidone Long-Acting for Alcohol and Schizophrenia Treatment (R-LAST)
Brief Summary: The purpose of this study is to compare the efficacy of oral risperidone (Risperdal) to risperidone long-acting (Consta) in reducing alcohol use in persons diagnosed with schizophrenia or schizoaffective disorder.


Options:
A: Reduction of PANSS total score (Admission, discharge/ 6 weeks if not discharged, 3, 6, 12, 24 months after admittance.)
B: Change Over Time in Frequency of Heavy Drinking Days (Used to Evaluate Treatment Efficacy) (6 months)
C: To compare the treatment effects of risperidone and quetiapine on cognitive function due to sedation
D: Mean Relapse Free Period(Risperidone LAI Versus Quetiapine) (Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-center Evaluation of the Experimental Program for Physical Activity Promotion (PEPAF), Carried Out by Family Physicians
Brief Summary: The potential health gains from active lifestyles are very well-known and it is recommended that all adults dedicate at least 30 minutes to activities of at least moderate intensity at least five days a week. What is still not known is how to help sedentary people follow this recommendation, by means of brief interventions feasible in routine general practice. This multi-center study was designed to evaluate the effectiveness of a physical activity promotion program (called PEPAF) implemented in 56 general practices of the Spanish public primary health care system. The study will test the capacity of the program to increase the physical activity level, physical fitness and health related quality of life of sedentary people.


Options:
A: Physical activity measured by accelerometry. (3 months post-randomisation)
B: Minutes of physical activity per week based on 7-Day Physical Activity Recall Interview.
C: Physical activity level (7-day Physical Activity Recall [PAR]) (six months from the start of the intervention)
D: Physical activity level

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-center Evaluation of the Experimental Program for Physical Activity Promotion (PEPAF), Carried Out by Family Physicians
Brief Summary: The potential health gains from active lifestyles are very well-known and it is recommended that all adults dedicate at least 30 minutes to activities of at least moderate intensity at least five days a week. What is still not known is how to help sedentary people follow this recommendation, by means of brief interventions feasible in routine general practice. This multi-center study was designed to evaluate the effectiveness of a physical activity promotion program (called PEPAF) implemented in 56 general practices of the Spanish public primary health care system. The study will test the capacity of the program to increase the physical activity level, physical fitness and health related quality of life of sedentary people.


Options:
A: Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps (Baseline, 3, and 9 months); Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day) (Baseline, 3 and 9 months)
B: Physical activity level (7-day Physical Activity Recall [PAR]) (six months from the start of the intervention)
C: Minutes of physical activity per week based on 7-Day Physical Activity Recall Interview.
D: Functional performance, balance and reduced self-reported upper and lower body functional limitations in sedentary, older adults' physical activity. (Baseline, 6-month, 12-month follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-center Evaluation of the Experimental Program for Physical Activity Promotion (PEPAF), Carried Out by Family Physicians
Brief Summary: The potential health gains from active lifestyles are very well-known and it is recommended that all adults dedicate at least 30 minutes to activities of at least moderate intensity at least five days a week. What is still not known is how to help sedentary people follow this recommendation, by means of brief interventions feasible in routine general practice. This multi-center study was designed to evaluate the effectiveness of a physical activity promotion program (called PEPAF) implemented in 56 general practices of the Spanish public primary health care system. The study will test the capacity of the program to increase the physical activity level, physical fitness and health related quality of life of sedentary people.


Options:
A: 7-Day Physical Activity Recall (7-Day PAR) (6 months)
B: Absolute level of physical activity: (Assessed at baseline, 6, 12 and 24-month follow-up as kcals/wk expenditure based on survey self-report, validated against activity monitor data in a random sub-sample.); Maintenance of physical activity (Physical activity level relative to baseline assessed at all follow-ups 6, 12, 24 months.)
C: This randomized controlled trial was designed to assess the effectiveness of a primary care physical activity intervention, in increasing adherence to physical activity in general population, as well as their self-reported physical activity. (baseline-3-6-12-18)
D: Physical activity level (7-day Physical Activity Recall [PAR]) (six months from the start of the intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Lungwena Child Nutrition Intervention Study 3, LCNI-3. A Single-Centre Intervention Trial in Rural Malawi, Testing the Anthropometric and Health Benefits of Provision of Ready to - Use - Therapeutic Food RUTF as a Complementary Food
Brief Summary: This study tests the hypothesis that infants receiving fortified spread as a complementary food for one year grow better and do not become malnourished as often as infants who are provided with maize-soy flour for complementary porridge.


Options:
A: Weight gain during the 12-week follow-up (in grams)
B: Weight gain during the 12-month follow-up (in grams)
C: Recovery Under the Integrated Program and the Standard Protocol (12 weeks)
D: weight-for-height in children 6 to 60 mo of age (8 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Lungwena Child Nutrition Intervention Study 3, LCNI-3. A Single-Centre Intervention Trial in Rural Malawi, Testing the Anthropometric and Health Benefits of Provision of Ready to - Use - Therapeutic Food RUTF as a Complementary Food
Brief Summary: This study tests the hypothesis that infants receiving fortified spread as a complementary food for one year grow better and do not become malnourished as often as infants who are provided with maize-soy flour for complementary porridge.


Options:
A: serum Zn (September 2009-March 2010); Hemoglobin (September 2009-2010); serum retinol (September 2009-March 2010); serum ferritin (September 2009-March 2010); ZPP (September 2009- March 2010)
B: Mean birth weight (9 months)
C: Morbidity (0 months, 6 months, 12 months); Growth (0 months, 6 months, 12 months); Development (0 months, 6 months, 12 months); School performance (0 months, 6 months, 12 months); Status Indicators for iron, zinc, vitamin A and iodine (0 months, 6 months, 12 months)
D: Weight gain during the 12-month follow-up (in grams)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Lungwena Child Nutrition Intervention Study 3, LCNI-3. A Single-Centre Intervention Trial in Rural Malawi, Testing the Anthropometric and Health Benefits of Provision of Ready to - Use - Therapeutic Food RUTF as a Complementary Food
Brief Summary: This study tests the hypothesis that infants receiving fortified spread as a complementary food for one year grow better and do not become malnourished as often as infants who are provided with maize-soy flour for complementary porridge.


Options:
A: weight-for-height in children 6 to 60 mo of age (8 months)
B: Number of Participants With Nutritional Recovery (12 weeks or upon completion of recovery); Number of Patients With Absence of Bilateral Pedal Pitting Edema (12 weeks or recovery)
C: Weight gain during the 12-month follow-up (in grams)
D: Incidence of severe acute malnutrition (15 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Lungwena Child Nutrition Intervention Study 3, LCNI-3. A Single-Centre Intervention Trial in Rural Malawi, Testing the Anthropometric and Health Benefits of Provision of Ready to - Use - Therapeutic Food RUTF as a Complementary Food
Brief Summary: This study tests the hypothesis that infants receiving fortified spread as a complementary food for one year grow better and do not become malnourished as often as infants who are provided with maize-soy flour for complementary porridge.


Options:
A: Weight gain during the 12-month follow-up (in grams)
B: Change in length-for-age Z-score (LAZ, based on WHO 2005 MGRS) between enrollment and 18 months of age (Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)); Incidence of serious adverse events during the study period (12 months after enrollment (age 18 months))
C: Weight, length and Rohrer index at birth, and gestational duration in singleton pregnancies. (At birth); Mortality, morbidity and growth during the first year of life (Monthly during infancy)
D: Change in Length for Age (Once per month for 6 months, then once after 12 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Lungwena Antenatal Intervention Study. A Single-centre Intervention Trial in Rural Malawi, Testing Maternal and Infant Health Effects of Presumptive Intermittent Treatment of Pregnant Women With Sulfadoxine-pyrimethamine and Azithromycin
Brief Summary: The purpose of this study is to examine whether treatment of pregnant Malawian women with repeated doses of sulfadoxine-pyrimethamine and azithromycin antibiotics will prevent preterm deliveries and result in other health benefits both for the mother and the foetus/newborn.


Options:
A: Number of Participants With Placental Malaria (at delivery estimated to be within 10 to 30 weeks of study entry); Incidence of Malaria, Pregnant Women (Time at risk will begin following administration of first dose of study drug to delivery)
B: Level of malaria parasitemia in HIV positive women at delivery after administration of Mefloquine or sulphadoxine-pyrimethamine as prophylaxis for malaria in pregnancy (6 months)
C: Proportion of preterm births (once, after delivery); Number of serious adverse events (Cumulative during pregnancy and neonatal period)
D: Maternal malaria at delivery (Delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Lungwena Antenatal Intervention Study. A Single-centre Intervention Trial in Rural Malawi, Testing Maternal and Infant Health Effects of Presumptive Intermittent Treatment of Pregnant Women With Sulfadoxine-pyrimethamine and Azithromycin
Brief Summary: The purpose of this study is to examine whether treatment of pregnant Malawian women with repeated doses of sulfadoxine-pyrimethamine and azithromycin antibiotics will prevent preterm deliveries and result in other health benefits both for the mother and the foetus/newborn.


Options:
A: Prevalence of severe maternal anaemia (Hb < 8g/dl) at 34 to 36 weeks of gestation. (At 34 to 36 weeks of gestation)
B: proportion of infants with low birthweight (<2,500 grams)
C: Placental malaria parasitemia rates measured at time of delivery, stratified by HIV status
D: Proportion of preterm births (once, after delivery); Number of serious adverse events (Cumulative during pregnancy and neonatal period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Placebo-Controlled Evaluation of the Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Panic Disorder
Brief Summary: This study involves cognitive behavioral therapy (CBT) and a medication called D-cycloserine (DCS), which is thought to help reduce panic symptoms more effectively by interacting with N-methyl-D-aspartate (NMDA) glutamate receptors, facilitating many forms of learning including the extinction of fear. Participants will be randomly assigned (like flipping a coin) to receive either DCS or a placebo in addition to CBT.


Options:
A: Acrophobia Questionnaire With Avoidance (AAVQ) (2 months)
B: Liebowitz Social Anxiety Scale (LSAS) (Week 13); CGI - Clinical Global Impression of Improvement (Week 13)
C: significant reduction in panic symptoms after completion of treatment
D: Snake Questionnaire (SNAQ) (2 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-controlled, Parallel-group, 52-week Study to Evaluate the Efficacy/Safety of Transdermal Patches Delivering Testosterone in Menopausal Women With Low Libido Not Receiving Estrogen Therapy
Brief Summary: This study is designed to evaluate the efficacy and safety of 2 doses of the transdermal testosterone patch in naturally or surgically menopausal women with low libido who are not receiving systemic estrogen or estrogen progestin therapy.


Options:
A: N/A
B: N/A
C: Total satisfying sexual activity over 24 weeks (6, 12, 24, 36, and 52 weeks)
D: Fatigue (prospective)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Double Blind Clinical Trial of Amodiaquine (AQ) and Sulphadoxine-pyrimethamine (SP) Used Singly and in Combination (AQ+SP) Compared With Chloroquine (CQ) in the Treatment of Falciparum Malaria Infection in Pregnancy
Brief Summary: Malaria in pregnancy is potentially fatal to both the mother and the foetus particularly in the primigravidae. Implementation of appropriate control and preventive measures is challenged by the fact that malaria infection in pregnancy is often asymptomatic and parasitized red blood cells sequestrated in the placental microcirculation may not be detectable in the peripheral blood. In addition, the widespread prevalence of parasites resistant to chloroquine and sulphadoxine-pyrimethamine (SP) and, the safety concerns about newer antimalarials, poverty and inadequate supply have made antimalarial treatment options available to pregnant women very limited. These have necessitated an urgent search for alternative safe and efficacious treatment options for pregnant women. The objective of this study is to assess the efficacy, safety and tolerability of four antimalarial treatment options in rural Ghana within a programme setting.


Options:
A: • Prevalence of placental malaria infection; • Prevalence of maternal peripheral parasitemia
B: Placental malaria parasitemia rates measured at time of delivery, stratified by HIV status
C: PCR corrected clinical and parasitological outcome at day 45
D: Prevalence of parasitaemia on day 28 post treatment.; Prevalence of parasitaemia on day 14 post treatment.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Chemoprophylaxis With Sulfadoxine-pyrimethamine to Prevent Recurrence of Severe Anaemia in Gambian Children Aged 3 Months to 9 Years
Brief Summary: Severe anaemia is a frequent cause of admission to hospitals in tropical Africa and about 10% of such children die. In endemic countries, anaemia has multiple causes such as nutritional deficiencies, infections and haemoglobinopathies. However, Plasmodium falciparum infection is believed to be the major contributory factor to the aetiology of severe anaemia. Severe anaemia is usually treated by blood transfusion although transfusion carries the attendant risk of transmission of HIV and other blood-borne infections. Thus, there is a need to explore novel strategies to reduce the incidence of severe anaemia in high-risk groups such as children with suboptimal haemoglobin levels because these children are at increased risk of developing severe anaemia if they develop a malaria infection before their haemoglobin level has normalized. Therefore, it is proposed to study whether monthly chemoprophylaxis with sulphadoxine/pyrimethamine (S/P) given during malaria transmission season can protect Gambian children from developing severe anaemia. After receiving treatment from the hospital, 1200 children admitted to the hospital with a haematocrit of less than 21% were randomised to receive either monthly S/P or placebo during the rest of the malaria transmission season. Morbidity was monitored throughout the rainy season. Study subjects were seen at the end of the dry season to document morbidity and mortality.


Options:
A: Proportion of children with moderate anaemia (hemoglobin [Hb] <7 g/dl (at end of the malaria transmission season); haemoglobin concentration (At the end of malaria transmission season); hemoglobin concentration (at the end of malaria transmission season)
B: Efficacy:; The proportion of children with at least one episode of anemia from 3 to 18 months of life; The proportion of children with at least one episode of malaria from 3 to 18 months of life; Safety:; The proportion of children with at least one episode of an adverse event; The proportion of children with at least one episode of a serious adverse event; Rebound:; The proportion of children with at least one episode of anemia from 18-30 months of life, the proportion of children with at least one episode of malaria from 18-30 months of life
C: Mean Hb at the end of the high transmission season.
D: Parasite clearance time

Answer: A