TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-Selection Study of Ad2/Hypoxia Inducible Factor (HIF)-1α/VP16 in Patients With Intermittent Claudication
Brief Summary: The purpose of this Phase 2 clinical research study is to examine the safety of an experimental gene transfer agent, Ad2/HIF-1α/VP16, and its ability to stimulate the growth of new blood vessels from existing blood vessels (a process called angiogenesis) in an attempt to improve the flow of blood in the legs of patients with peripheral arterial disease (PAD).

Specifically, this study will enroll patients with severe intermittent claudication (IC) which is the stage of PAD in which a patient's walking ability is severely limited, causing pain in the legs upon exercise due to inadequate blood flow to the muscles of the lower limbs.


Options:
A: Change from baseline in Absolute Claudication Distance (ACD) evaluated by treadmill test at week 13 (13 weeks)
B: Time to major amputation of the treated leg or death from any cause, whichever comes first (From randomization up to 12 months)
C: Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...) (12 weeks)
D: Peak Walking Time (at 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Relevance of Nevirapine Resistance
Brief Summary: This study is designed to test if a sequential protease-inhibitor (PI) - / nevirapine (NVP) -based regimen is effective for the treatment of HIV-infected children when previous NVP exposure has occurred as part of programs to prevent mother-to-child transmission (pMTCT).


Options:
A: Trough concentration of LPV and pharmacokinetic parameters (Weeks 8, 16, 24, 36, 48, 60, 72, 84, and 96); Recurrent treatment-related Grade 3 and non-life threatening Grade 4 toxicity or single occurence of life-threatening Grade 4 toxicity (Throughout study)
B: Time to Failure of First Line Therapy or Death (From date of randomization up to failure of first-line therapy or death from any cause, whichever came first, assessed up to 4.8 years); Number of Participants Who Experienced Immunological Failure Defined as Failure of CD4% to Reach 20% or CD4% Falls Below 20% on Two Occasions, Within 4 Weeks, at Any Time After the First 24 Weeks of Therapy (Initial Therapy or Restart) (This outcome was assessed from the date of randomization to immunological failure. Immunological failure was assessed in the entire study duration of 4.8 years.); Number of Participants Who Experienced Regimen-limiting ART Drug Toxicity (Regimen limiting drug toxicity was monitored from randomization up to the entire study duration of 4.8 years.); Number of Participants Who Experienced Clinical Failure (Defined as Development of Severe CDC Stage B or Stage C Disease.) on Therapy. (Clinical failure on therapy was assessed at each visit for the entire study duration of 4.8 years.); Number of Participants Who Experienced Virological Failure Defined as Confirmed HIV-1 RNA Value of at Least 10,000 Copies Per/ml Recorded on Two Consecutive Separate Occasions After 24 Weeks of Treatment (Initial Therapy or Restart) (Virological failure was assessed from randomization through the entire study duration of 4.8 years.)
C: HIV PCR (1 month)
D: Virologic suppression at 6 months after randomization

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylactic Cognitive Therapy for Depression.
Brief Summary: This study determined the effectiveness of continuation phase cognitive therapy versus antidepressant medication in preventing relapse of depression in people with recurrent depression.


Options:
A: Depressive Relapse or MDD (Measured at month 8); Depressive Relapse/Recurrence or MDD (Measured at month 20); Depressive Relapse/Recurrence or MDD (Measured at month 32)
B: Hamilton Rating Scale for Depression (Change from Baseline in HAM-D at 8 weeks)
C: N/A
D: Depressive symptoms as measured by the HRSD (24-item Hamilton Rating Scale of Depression) (20 weeks after randomization (after acute treatment phase))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Stepped Care for Affective Disorders and Musculoskeletal Pain
Brief Summary: This study will evaluate the effectiveness of a stepped care approach in treating depression and reducing pain.


Options:
A: Pain, physical functioning, coping efficacy, positive and negative emotional affect, and depression (6 months after treatment)
B: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year
C: Brief Pain Inventory Interference (Measured at Year 1); HSCL-20 Depression Severity (Measured at Year 1)
D: Pain VAS

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Stepped Care for Affective Disorders and Musculoskeletal Pain
Brief Summary: This study will evaluate the effectiveness of a stepped care approach in treating depression and reducing pain.


Options:
A: To determine if a culturally focused psychiatric (CFP) consultation service can improve depressive symptoms and increase diagnosis and treatment of depression in Asian American and Latino American primary care patients at MGH. (6 months after baseline assessment)
B: 20-Item Symptom Checklist Depression Scale (Measured at baseline and after 6 months of treatment)
C: Brief Pain Inventory Interference (Measured at Year 1); HSCL-20 Depression Severity (Measured at Year 1)
D: Quick Inventory of Depressive Symptomatology - Clinician Administered (QIDS-C) (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Prevention of Osteoporosis in Premenopausal and Newly Postmenopausal (Up to 8 Years) Women With Breast Cancer Following Chemotherapy (REBBeCA Study)
Brief Summary: The purpose of this study is to evaluate the effectiveness of once weekly risedronate in the prevention and treatment of bone loss in premenopausal and newly menopausal women with breast cancer who have received chemotherapy.

The hypothesis is that bisphosphonate therapy will prevent bone loss at clinically relevant sites, such as the hip and spine. The investigators also hypothesize that there will be a correlation between biochemical markers of bone turnover and changes in bone mineral density.


Options:
A: That bone loss, as determined through BMD every six months, will be prevented at clinically relevant sites, such as the hip & spine, through the use of bisphosphonate therapy in study subjects. (24 months)
B: Increase in apoptotic index between diagnostic core biopsy and repeat core biopsy taken on day 5 (Repeat biopsy on day 5 (+/- day 21))
C: sCTX values (baseline, 1 week post treatment, week 4, week 8, week 12)
D: Evaluate the impact of Zometa (zoledronic acid) on the clearance of bone marrow micrometastases (Prior to therapy initiation, after completion of neoadjuvant chemotherapy, and 12-15 months from registration); Evaluate the protective effect of Zometa (zoledronic acid) on chemotherapy-induced loss of bone mineral density (Prior to therapy initiation and 12-15 months from registration)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #519 - Integrating Practice Guidelines for Smoking Cessation Into Mental Health Care for PTSD (SCP)
Brief Summary: The primary study objective is to conduct a prospective, randomized controlled clinical trial that compares the effectiveness of two approaches for delivering smoking cessation treatment for veterans with posttraumatic stress disorder (PTSD). An approach where smoking cessation treatment is integrated into mental health care for PTSD and delivered by mental health providers (experimental condition) will be compared to specialized smoking cessation clinic referral (VA's usual standard of care).

Secondary study objectives are to (a) compare the cost outcomes and cost-effectiveness of IC versus USC, (b) identify treatment process variables that explain (mediate) observed differences in smoking abstinence rates for the two study conditions, and (c) determine whether cessation from smoking is associated with worsening of symptoms of PTSD and/or depression.


Options:
A: Bioverified 12-Month Prolonged Abstinence Between 6 and 18 Months Postrandomization (between 6 and 18 months)
B: Patient report (Within 3 days of the dental encounter)
C: Rates of clinician delivering cessation assistance other than advice as assessed by parent surveys at baseline and 12 months after clinic visit; Rates of 7-day abstinence as confirmed biochemically at 12 months after clinic visit
D: Self reported abstinence confirmed by an expired air carbon monoxide concentration of 10 parts per millions or less; Point prevalence at the end of intervention, 1 and 2 years after the beginning of intervention; Continuous abstinence rate for 1 year; Change of stage in the smoking cessation process

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial Comparing Surveillance and Selective Surgical Treatment for Abdominal Aortic Aneurysms Less Than 5.5 cm in Diameter Versus Early Endovascular Treatment
Brief Summary: Objective of the present study is to compare endovascular repair versus surveillance and, eventually delay treatment in patients with small abdominal aortic aneurysms (AAA), with respect to patient survival, AAA rupture and AAA related death risks.


Options:
A: all cause mortality at 3 years (3 years)
B: Death and major adverse events (4 years)
C: Number of Subjects That Experienced Rupture or Aneurysm Related Death (3 years)
D: All-cause Mortality (Participants were followed for the duration of the study, up to 9 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial Comparing Surveillance and Selective Surgical Treatment for Abdominal Aortic Aneurysms Less Than 5.5 cm in Diameter Versus Early Endovascular Treatment
Brief Summary: Objective of the present study is to compare endovascular repair versus surveillance and, eventually delay treatment in patients with small abdominal aortic aneurysms (AAA), with respect to patient survival, AAA rupture and AAA related death risks.


Options:
A: Death and major adverse events (4 years)
B: all cause mortality at 3 years (3 years)
C: All-cause Mortality (Participants were followed for the duration of the study, up to 9 years)
D: combined operative mortality and morbidity (5-8 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial Comparing Surveillance and Selective Surgical Treatment for Abdominal Aortic Aneurysms Less Than 5.5 cm in Diameter Versus Early Endovascular Treatment
Brief Summary: Objective of the present study is to compare endovascular repair versus surveillance and, eventually delay treatment in patients with small abdominal aortic aneurysms (AAA), with respect to patient survival, AAA rupture and AAA related death risks.


Options:
A: combined operative mortality and morbidity (5-8 years)
B: Mortality at 30 days after the treatment(endovascular repair versus conventional repair) (30 days after the treatment)
C: all cause mortality at 3 years (3 years)
D: Death and major adverse events (4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial Comparing Surveillance and Selective Surgical Treatment for Abdominal Aortic Aneurysms Less Than 5.5 cm in Diameter Versus Early Endovascular Treatment
Brief Summary: Objective of the present study is to compare endovascular repair versus surveillance and, eventually delay treatment in patients with small abdominal aortic aneurysms (AAA), with respect to patient survival, AAA rupture and AAA related death risks.


Options:
A: combined operative mortality and morbidity (5-8 years)
B: All-cause Mortality (Participants were followed for the duration of the study, up to 9 years)
C: Number of Subjects That Experienced Rupture or Aneurysm Related Death (3 years)
D: all cause mortality at 3 years (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Active-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
Brief Summary: The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.


Options:
A: To determine the major erythroid response rate after 6 courses, assessed according to IWG 2000 criteria (after 6 courses of treatment in the respective treatment arm)
B: Incidence of adverse events (throughout study)
C: Occurrences of red blood cell transfusion (from study day 29 (week 5) to week 17)
D: Incidence of at least one RBC transfusion from week 5 to End of Treatment Period (EOTP) (from week 5 to EOTP)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phytoestrogens and Progression of Atherosclerosis
Brief Summary: The purpose of this study is to determine whether soy supplementation can reduce hardening of the arteries and cognitive decline in postmenopausal women.


Options:
A: Self report daily diary of frequency and intensity of vasomotor symptoms at BL, 3, 6 and 12 months.; Wiklund Menopause Symptom Checklist at BL, 3, 6 and 12 months.
B: Bone mineral density (One year and two years)
C: Progression of Subclinical Atherosclerosis (Baseline x 2 and then every 6 months, up to 2.5 years)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Repaglinide Versus Metformin Treatment in Combination With Insulin Biasp30 (Novologmix 70/30) Predinner on Glycemic and Non-Glycemic Cardiovascular Risk-Factors in Non-Obese Patients With Type-2-Diabetes With Unsatisfactory Glycaemic Control With Oral Hypoglycaemic Agents
Brief Summary: Aim:

The United Kingdom Prospective Diabetes Study (UKPDS) showed a reduction in cardiovascular events in obese patients with type-2-diabetes treated with metformin compared with other hypoglycaemic treatments with no difference in glycemic control between treatments. Non-obese patients with type-2-diabetes are usually treated with insulin-secretagogues or insulin when diet fails. Since non-obese patients with type-2-diabetes also carry a high risk of cardiovascular events, the use of metformin for this sub-group of patients might be more beneficial. Moreover, when insulin-treatment is initiated ongoing oral hypoglycaemic agents (OHA) are often continued, but in non-obese patients with type-2 diabetes little evidence exist for choosing the optimal class of OHA to be combined with insulin. The aim of the project is therefore to investigate the effect of metformin vs. an insulin-secretagogue (repaglinide) in combination with insulin on glycemic control and non-glycemic cardiovascular risk-factors in non-obese patients with type-2-diabetes, uncontrolled on diet alone.

Methodology:

Single-center, double-blind, double-dummy, randomized, parallel study involving 100 non-obese (BMI 27 kg/m2 or lower) patients with type-2-diabetes investigating the effect of treatment with metformin vs. repaglinide each in combination with biphasic insulin (Insulin-aspart 30/70, BIAsp30) for a period of 12 months.


Options:
A: Glycemic control (HbA1c).
B: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
C: Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in overall study population (Baseline and every study visit up to 24 weeks); Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in Chinese study population (Baseline and every study visit up to 24 weeks)
D: To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight).

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: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)
B: Decisional quality (knowledge, decisional conflict, and satisfaction) (Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter)
C: Cardiac Medication Use (3 and 12 months)
D: Blood Pressure and Hemaglobin A1c

Answer: D
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: Physical activity measured with an accelerometer, pedometer en the International Physical Activity Questionnaire (IPAQ) (At baseline, after the intervention (at 6 months) and one year after baseline); Health parameters: systolic and diastolic blood pressure, resting heart rate, waist circumference, weight, height (At baseline, after the intervention (at 6 months) and one year after baseline); Blood samples taken to determine:HBA1C, glucose, insulin, leptin, c-peptide, IGF-1, total cholesterol, HDL-c, LDL-C, triglycerides, APo-B, high sensitive C-reactive protein, vrij-t, DHEAS Oestradiol, Shbg, LH, FSH (At baseline, after the intervention (six months) and one year after baseline); Dexa scan (At baseline, after the intervention (six months) and one year after baseline)
C: Change From Baseline in Glycosylated Hemoglobin (%) (Baseline to 12 months)
D: Glucose control (HbA1c levels) (Baseline, 3 months and 6 months)

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: Blood Pressure and Hemaglobin A1c
B: HbA1c (3 months)
C: Comparison of HbA1c mean between the 3 groups (at 6 months)
D: change of infarct size between baseline and day 6 (day 6)

Answer: A