TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Care Coordination in Managing Medically Complex Patients
Brief Summary: Patients treated at Veterans Affairs (VA) medical centers are older and have multiple chronic conditions. Two of the most common conditions in the VA population are hypertension (HTN) and Type 2 diabetes (DM). Unfortunately, DM and HTN have few perceptible symptoms on a daily basis that motivate patients to comply with treatment recommendations and lifestyle changes. Thus, serious complications and long-term adverse outcomes are common in both of these conditions.

Home telehealth is a general term used to describe the delivery of health care services to the patient's home using audio, video, or other telecommunications technologies. Although home telehealth offers a number of theoretical advantages, few well-designed controlled clinical trials have been conducted to establish efficacy and cost benefit. Furthermore, projects to date have focused on special populations, e.g., heart failure or mental illnesses. Since home telehealth may hold the most promise for individuals dealing with multiple chronic illnesses, there is a need for population-based studies addressing the needs of patients in primary care settings.

Care coordination, as defined by the VHA Office of Care Coordination, is a process of assessment and ongoing monitoring of patients using home telehealth to proactively enable prevention, investigation, and treatment that enhances the health of patients and prevents unnecessary and inappropriate use of resources. Care coordination embeds technology into a care management process. This results in the right care, at the right time, in the right place.


Options:
A: Primary composite outcome (4 years)
B: Adherence to ART and HIV RNA suppression (6,12 months)
C: Blood Pressure and Hemaglobin A1c
D: Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) (Baseline); Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) (6 months); Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Care Coordination in Managing Medically Complex Patients
Brief Summary: Patients treated at Veterans Affairs (VA) medical centers are older and have multiple chronic conditions. Two of the most common conditions in the VA population are hypertension (HTN) and Type 2 diabetes (DM). Unfortunately, DM and HTN have few perceptible symptoms on a daily basis that motivate patients to comply with treatment recommendations and lifestyle changes. Thus, serious complications and long-term adverse outcomes are common in both of these conditions.

Home telehealth is a general term used to describe the delivery of health care services to the patient's home using audio, video, or other telecommunications technologies. Although home telehealth offers a number of theoretical advantages, few well-designed controlled clinical trials have been conducted to establish efficacy and cost benefit. Furthermore, projects to date have focused on special populations, e.g., heart failure or mental illnesses. Since home telehealth may hold the most promise for individuals dealing with multiple chronic illnesses, there is a need for population-based studies addressing the needs of patients in primary care settings.

Care coordination, as defined by the VHA Office of Care Coordination, is a process of assessment and ongoing monitoring of patients using home telehealth to proactively enable prevention, investigation, and treatment that enhances the health of patients and prevents unnecessary and inappropriate use of resources. Care coordination embeds technology into a care management process. This results in the right care, at the right time, in the right place.


Options:
A: Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale (Baseline and 1 year); Changes in Minutes of Moderate Physical Activity (Baseline and 1 year); Changes in Minutes of Vigorous Exercise (Baseline and 1 year)
B: Hemoglobin A1c
C: Blood Pressure and Hemaglobin A1c
D: HBA1c Glycosylated hemoglobin (one year for every patient)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Care Coordination in Managing Medically Complex Patients
Brief Summary: Patients treated at Veterans Affairs (VA) medical centers are older and have multiple chronic conditions. Two of the most common conditions in the VA population are hypertension (HTN) and Type 2 diabetes (DM). Unfortunately, DM and HTN have few perceptible symptoms on a daily basis that motivate patients to comply with treatment recommendations and lifestyle changes. Thus, serious complications and long-term adverse outcomes are common in both of these conditions.

Home telehealth is a general term used to describe the delivery of health care services to the patient's home using audio, video, or other telecommunications technologies. Although home telehealth offers a number of theoretical advantages, few well-designed controlled clinical trials have been conducted to establish efficacy and cost benefit. Furthermore, projects to date have focused on special populations, e.g., heart failure or mental illnesses. Since home telehealth may hold the most promise for individuals dealing with multiple chronic illnesses, there is a need for population-based studies addressing the needs of patients in primary care settings.

Care coordination, as defined by the VHA Office of Care Coordination, is a process of assessment and ongoing monitoring of patients using home telehealth to proactively enable prevention, investigation, and treatment that enhances the health of patients and prevents unnecessary and inappropriate use of resources. Care coordination embeds technology into a care management process. This results in the right care, at the right time, in the right place.


Options:
A: Blood Pressure and Hemaglobin A1c
B: MEMS Adherence (12 months follow up)
C: Adherence to ART and HIV RNA suppression (6,12 months)
D: Framingham 10-year risk index (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Care Coordination in Managing Medically Complex Patients
Brief Summary: Patients treated at Veterans Affairs (VA) medical centers are older and have multiple chronic conditions. Two of the most common conditions in the VA population are hypertension (HTN) and Type 2 diabetes (DM). Unfortunately, DM and HTN have few perceptible symptoms on a daily basis that motivate patients to comply with treatment recommendations and lifestyle changes. Thus, serious complications and long-term adverse outcomes are common in both of these conditions.

Home telehealth is a general term used to describe the delivery of health care services to the patient's home using audio, video, or other telecommunications technologies. Although home telehealth offers a number of theoretical advantages, few well-designed controlled clinical trials have been conducted to establish efficacy and cost benefit. Furthermore, projects to date have focused on special populations, e.g., heart failure or mental illnesses. Since home telehealth may hold the most promise for individuals dealing with multiple chronic illnesses, there is a need for population-based studies addressing the needs of patients in primary care settings.

Care coordination, as defined by the VHA Office of Care Coordination, is a process of assessment and ongoing monitoring of patients using home telehealth to proactively enable prevention, investigation, and treatment that enhances the health of patients and prevents unnecessary and inappropriate use of resources. Care coordination embeds technology into a care management process. This results in the right care, at the right time, in the right place.


Options:
A: Primary outcome: heart failure hospitalizations, time to death or hospitalization
B: Adherence; Self-efficacy; Quality of life
C: Dosing compliance: pill taking total taken vs number prescribed
D: Blood Pressure and Hemaglobin A1c

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of the Safety and Efficacy of Daily Tenofovir to Prevent HIV Infection Among Injection Drug Users in Bangkok, Thailand
Brief Summary: The primary goals of this study are to assess the safety and efficacy of daily tenofovir to prevent parenteral HIV infection among injection drug users (IDUs). Assessment of changes in HIV associated risk behaviors, adherence to study drug, and, among IDU who become HIV-infected during the trial, evaluation of HIV viral load set point, CD4 counts, genetic characterization of infecting HIV viruses, and antiretroviral resistance will also be done.


Options:
A: Rates of HIV Seroconversion (From date of randomization until the date of first documented seroconversion or date of death from any cause, whichever came first, assessed for an average of 4.0 years, with a maximum duration of 6.9 years); Renal Toxicity (Blood tested for creatinine level at enrollment and every 3 months, up to 6.9 years); Adverse Events (Up to 6.9 years)
B: Primary Outcome Measure (3 years)
C: Three consecutive weeks of negative urine tests (benzoyl ecgonine) for cocaine use (no slips allowed). (These must be the last three weeks (7,8,9) of the trial.)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of the Safety and Efficacy of Daily Tenofovir to Prevent HIV Infection Among Injection Drug Users in Bangkok, Thailand
Brief Summary: The primary goals of this study are to assess the safety and efficacy of daily tenofovir to prevent parenteral HIV infection among injection drug users (IDUs). Assessment of changes in HIV associated risk behaviors, adherence to study drug, and, among IDU who become HIV-infected during the trial, evaluation of HIV viral load set point, CD4 counts, genetic characterization of infecting HIV viruses, and antiretroviral resistance will also be done.


Options:
A: Rates of HIV Seroconversion (From date of randomization until the date of first documented seroconversion or date of death from any cause, whichever came first, assessed for an average of 4.0 years, with a maximum duration of 6.9 years); Renal Toxicity (Blood tested for creatinine level at enrollment and every 3 months, up to 6.9 years); Adverse Events (Up to 6.9 years)
B: A reduction in the use of drugs and alcohol (12 months)
C: Primary Outcome Measure (5 years); Primary Outcome Measure (5 years); Primary Outcome Measure (5 years)
D: Efficacy of PR OROS methylphenidate on ADHD-symptoms in adult male prison inmates with ADHD, as measured by changes from baseline until endpoint in the observer-rated CAARS. (Changes from baseline until endpoint at week 5)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study Of Impact Of Intermittent Preventive Treatment In Children With Amodiaquine Plus Artesunate Versus Sulphadoxine-Pyrimethamine On Hemoglobin Levels And Malaria Morbidity In Hohoe District Of Ghana
Brief Summary: Intermittent preventive treatment for malaria in children (IPTc) is a promising new approach to malaria control. Preliminary studies of IPTc in Senegal and Mali indicate that this approach can be very effective. Although the results of these studies suggest that IPTc with sulphadoxine-pyrimethamine (SP) plus artesunate (AS) or SP alone is an efficacious and safe intervention for reducing the burden of malaria and anaemia in children in high transmission areas with short transmission periods, there is no data from areas with long transmission periods. This study aims to evaluate the effectiveness of IPTc in reducing anaemia and malaria in an area with up to 6 months of transmission in Ghana. Two thousand two hundred forty children aged 3-59 months will be randomly allocated to four groups (560 per arm) to receive amodiaquine plus artesunate (AQ+AS), given at two different intervals (monthly or bimonthly), SP or placebo. The children will also be followed to determine if there is any rebound in the incidence of severe malaria and anaemia in the year following IPTc.


Options:
A: Maternal malaria at delivery (Delivery)
B: Incidence of clinical malaria (2008-2009)
C: Mean Hb at the end of the high transmission season.
D: 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

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study Of Impact Of Intermittent Preventive Treatment In Children With Amodiaquine Plus Artesunate Versus Sulphadoxine-Pyrimethamine On Hemoglobin Levels And Malaria Morbidity In Hohoe District Of Ghana
Brief Summary: Intermittent preventive treatment for malaria in children (IPTc) is a promising new approach to malaria control. Preliminary studies of IPTc in Senegal and Mali indicate that this approach can be very effective. Although the results of these studies suggest that IPTc with sulphadoxine-pyrimethamine (SP) plus artesunate (AS) or SP alone is an efficacious and safe intervention for reducing the burden of malaria and anaemia in children in high transmission areas with short transmission periods, there is no data from areas with long transmission periods. This study aims to evaluate the effectiveness of IPTc in reducing anaemia and malaria in an area with up to 6 months of transmission in Ghana. Two thousand two hundred forty children aged 3-59 months will be randomly allocated to four groups (560 per arm) to receive amodiaquine plus artesunate (AQ+AS), given at two different intervals (monthly or bimonthly), SP or placebo. The children will also be followed to determine if there is any rebound in the incidence of severe malaria and anaemia in the year following IPTc.


Options:
A: Incidence of clinical malaria (2008-2009)
B: Parasite clearance time
C: Changes in Haemoglobin Concentration From Day 3 Post Treatment of Malaria Episode to Day 90 in the Weekly Chloroquine and Placebo Arms (90 days)
D: Mean Hb at the end of the high transmission season.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study Of Impact Of Intermittent Preventive Treatment In Children With Amodiaquine Plus Artesunate Versus Sulphadoxine-Pyrimethamine On Hemoglobin Levels And Malaria Morbidity In Hohoe District Of Ghana
Brief Summary: Intermittent preventive treatment for malaria in children (IPTc) is a promising new approach to malaria control. Preliminary studies of IPTc in Senegal and Mali indicate that this approach can be very effective. Although the results of these studies suggest that IPTc with sulphadoxine-pyrimethamine (SP) plus artesunate (AS) or SP alone is an efficacious and safe intervention for reducing the burden of malaria and anaemia in children in high transmission areas with short transmission periods, there is no data from areas with long transmission periods. This study aims to evaluate the effectiveness of IPTc in reducing anaemia and malaria in an area with up to 6 months of transmission in Ghana. Two thousand two hundred forty children aged 3-59 months will be randomly allocated to four groups (560 per arm) to receive amodiaquine plus artesunate (AQ+AS), given at two different intervals (monthly or bimonthly), SP or placebo. The children will also be followed to determine if there is any rebound in the incidence of severe malaria and anaemia in the year following IPTc.


Options:
A: The safety and tolerability of AQ plus SP, PQP plus SP, and PQP plus DHA when used for seasonal IPT in children (Onset of IPT to end of malaria season)
B: Incident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants (6 to 24 months of age); Incident Malaria Cases Per Person Year at Risk in HIV-exposed Participants (Randomization to 24 months of age)
C: Malaria incidence (the number of study subjects seen at the OPD clinic with clinical malaria during the surveillance period). (During the surveillance period (September to December 2008))
D: Mean Hb at the end of the high transmission season.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study Of Impact Of Intermittent Preventive Treatment In Children With Amodiaquine Plus Artesunate Versus Sulphadoxine-Pyrimethamine On Hemoglobin Levels And Malaria Morbidity In Hohoe District Of Ghana
Brief Summary: Intermittent preventive treatment for malaria in children (IPTc) is a promising new approach to malaria control. Preliminary studies of IPTc in Senegal and Mali indicate that this approach can be very effective. Although the results of these studies suggest that IPTc with sulphadoxine-pyrimethamine (SP) plus artesunate (AS) or SP alone is an efficacious and safe intervention for reducing the burden of malaria and anaemia in children in high transmission areas with short transmission periods, there is no data from areas with long transmission periods. This study aims to evaluate the effectiveness of IPTc in reducing anaemia and malaria in an area with up to 6 months of transmission in Ghana. Two thousand two hundred forty children aged 3-59 months will be randomly allocated to four groups (560 per arm) to receive amodiaquine plus artesunate (AQ+AS), given at two different intervals (monthly or bimonthly), SP or placebo. The children will also be followed to determine if there is any rebound in the incidence of severe malaria and anaemia in the year following IPTc.


Options:
A: The safety and tolerability of AQ plus SP, PQP plus SP, and PQP plus DHA when used for seasonal IPT in children (Onset of IPT to end of malaria season)
B: Mean Hb at the end of the high transmission season.
C: Clinical episodes of malaria
D: Risk of Parasitaemia (Unadjusted by Genotyping) (after 42 days of follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study Of Impact Of Intermittent Preventive Treatment In Children With Amodiaquine Plus Artesunate Versus Sulphadoxine-Pyrimethamine On Hemoglobin Levels And Malaria Morbidity In Hohoe District Of Ghana
Brief Summary: Intermittent preventive treatment for malaria in children (IPTc) is a promising new approach to malaria control. Preliminary studies of IPTc in Senegal and Mali indicate that this approach can be very effective. Although the results of these studies suggest that IPTc with sulphadoxine-pyrimethamine (SP) plus artesunate (AS) or SP alone is an efficacious and safe intervention for reducing the burden of malaria and anaemia in children in high transmission areas with short transmission periods, there is no data from areas with long transmission periods. This study aims to evaluate the effectiveness of IPTc in reducing anaemia and malaria in an area with up to 6 months of transmission in Ghana. Two thousand two hundred forty children aged 3-59 months will be randomly allocated to four groups (560 per arm) to receive amodiaquine plus artesunate (AQ+AS), given at two different intervals (monthly or bimonthly), SP or placebo. The children will also be followed to determine if there is any rebound in the incidence of severe malaria and anaemia in the year following IPTc.


Options:
A: The safety and tolerability of AQ plus SP, PQP plus SP, and PQP plus DHA when used for seasonal IPT in children (Onset of IPT to end of malaria season)
B: Prevalence of drug resistance
C: Mean Hb at the end of the high transmission season.
D: 1. Incidence of clinical malaria: [(history of fever during previous 2 days or axillary temperature >37.5ºC) + parasitaemia of any density + absence of any other obvious causes of fever] during the period of 3-11 months of age (3-11 months of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Non-Inferiority, Open-Labelled, Randomised Trial Of The Efficacy And Safety Of Artesunate-Amodiaquine, Artemether-Lumefantrine, And Artesunate-Lapdap For Treatment Of Uncomplicated P. Falciparum Malaria Among Children In Ghana
Brief Summary: Case management is one of the key strategies for malaria control in most endemic countries. Plasmodium falciparum malaria is becoming resistant to commonly used and cheap antimalarial drugs such as chloroquine, amodiaquine, and sulfadoxine-pyrimethamine (SP). Thus the safety and efficacy of new anti-malarial drugs need to be tested in sites with well-characterised malariometric indices in order to make appropriate treatment policies.

Artemisinin-based combination chemotherapies have been documented to consistently produce faster relief of clinical symptoms and parasite clearance in uncomplicated falciparum malaria than any other currently used antimalarial drugs. So far, artesunate-amodiaquine (AS-AQ) and artemether-lumefantrine (AR-LM) are the only two registered fixed-dose artemisinin combination chemotherapies produced at industrial scale, with good manufacturing practices and already used in Africa. Several African countries, including Ghana, are therefore introducing either AS-AQ or AR-LM as first-line antimalarials or evaluating the case for such a change. Clearly, a direct comparison of both the safety and efficacy profiles of the two combinations under different epidemiological conditions is urgently needed to guide informed decisions on the most appropriate antimalarial first-line treatment regimen.

This study aims to evaluate the efficacy and safety of artesunate-amodiaquine combination therapy, artemether-lumefantrine, and artesunate-lapdap in an open-labelled, randomised, non-inferiority drug trial.

The study results will inform future decisions on first- and second-line treatments for uncomplicated P. falciparum malaria with respect to efficacy and safety in Ghana.


Options:
A: Overall Cure Rate at Day 42
B: Adequate Clinical and parasitological response (Day 63)
C: adequate clinical and Parasitological response (ACPR)by day 28.
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Immunogenicity of a Killed, Oral Cholera Vaccine in Indian Subjects in Eastern Kolkata, West Bengal
Brief Summary: The purpose of the study is to confirm the safety and immunogenicity of the oral killed bivalent cholera vaccine in adult and pediatric volunteers in Eastern Kolkata, West Bengal, India.


Options:
A: Immunogenicity endpoint for Inaba O1 (28 days); Immunogenicity endpoint for Ogawa O1 (28 days); Immunogenicity endpoint O139 (28 days)
B: Number of participants with a single dose regimen oral cholera vaccine Shanchol will get protection (7 days to 6 months)
C: Number of individuals vaccinated with two dose of oral cholera vaccine. (Six months from initiation of vaccination); Decrease number of cholera cases in intervention arm compared to non-intervention arm. (Two years after completion of vaccination)
D: adverse events (immediate events - 30 minutes after each dose, adverse events - for 3 days following dose, serious adverse events throughout study - 28 days)

Answer: D