TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: FRAGMATIC - A Randomised Phase III Clinical Trial Investigating the Effect of FRAGMin Added to Standard Therapy In Patients With Lung Cancer
Brief Summary: RATIONALE: Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients with lung cancer. It is not yet known whether dalteparin is effective in preventing blood clots in patients with lung cancer.

PURPOSE: This randomized phase III trial is studying how well dalteparin works in preventing blood clots in patients with lung cancer.


Options:
A: Thromboembolic events (during study treatment)
B: Progression free survival (5 years)
C: Number of Participants With Venous Thromboembolic Events (VTE) (16 weeks of treatment)
D: Overall survival

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Adherence to IDDM Regimen in Urban Youth
Brief Summary: The protocol is a randomized clinical trial providing Multisystemic Therapy (MST), an intensive home-based family psychotherapy intervention, to a group of urban adolescents with poorly controlled Type 1 diabetes and their families.


Options:
A: Headache diaries assess headache frequency. (Completed one month prior to first visit, then weekly up to Week 20, then one month prior to Month 3, 6, 9, and 12 Follow-Up Visits.)
B: Metabolic Control: Hemoglobin A1c (HbA1c) (2 years)
C: Adherence (beginning at baseline - week 20)
D: Parent Report Measures (4 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Adherence to IDDM Regimen in Urban Youth
Brief Summary: The protocol is a randomized clinical trial providing Multisystemic Therapy (MST), an intensive home-based family psychotherapy intervention, to a group of urban adolescents with poorly controlled Type 1 diabetes and their families.


Options:
A: ER visits (18 months)
B: Parental asthma-related quality of life (one year); Urgent care events for asthma (One year)
C: Metabolic Control: Hemoglobin A1c (HbA1c) (2 years)
D: Change in FDI (Functional Disability Inventory) Scores at End of Study (Baseline and 6 months (end of study))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Adherence to IDDM Regimen in Urban Youth
Brief Summary: The protocol is a randomized clinical trial providing Multisystemic Therapy (MST), an intensive home-based family psychotherapy intervention, to a group of urban adolescents with poorly controlled Type 1 diabetes and their families.


Options:
A: ER visits (18 months)
B: Metabolic Control: Hemoglobin A1c (HbA1c) (2 years)
C: Parent Report Measures (4 years)
D: Change in FDI (Functional Disability Inventory) Scores at End of Study (Baseline and 6 months (end of study))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Community Trial to Assess the Effect of Nutritional Intervention Models on Medical Outcomes Among Obese Type 2 Diabetic Patients
Brief Summary: Obese patients with type 2 diabetes often fail to loose weight and thus do not succeed in improving their sugar and lipid profiles and remain at high risk for diabetes complications

The study enrolled 259 obese diabetic patients attending HMO clinics in central Israel. Over a 6 month period the participants met with a dietitian every fortnight and attended group lectures every 2 months.

The objective of this intervention was to compare three dietary intervention along with close monitoring of the patients by dietitians, regarding blood lipid and sugar balance as well as weight loss. The three diets are the American Diabetes Association (ADA) diet from 2003; a diet containing low glycemic index carbohydrate otherwise similar to the ADA diet; and a low glycemic index diet with more fat than the other 2 diets with high proportion of mono-unsaturated fatty acids.

Patients were individually randomized to receive one of the three diets. Among the measures obtained every 3 months for the first year and every 6 months thereafter are weight, fasting insulin and glucose, glycosylated hemoglobin, blood and urine chemistry profiles and lipid profile.


Options:
A: Triglyceride level, glycated hemoglobin level, fasting plasma glucose (baseline and every 3 months during year 1, every 6 months therafter)
B: body weight in kilograms as measured by a calibrated scale (0,1,2,3,4,5,and 6 months)
C: Change in body weight at Week 16 (Baseline and 16 Weeks); Change in body weight at Week 40 (16 Weeks and 40 Weeks)
D: Change in body weight (measured at Year 2)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled Trial of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in High-risk Adults in the Critical Care Setting
Brief Summary: Adults admitted to intensive care units are at risk for a variety of complications. Infections due to the fungus called candida are of particular concern. The study will test the possibility that caspofungin, a new therapy for fungal infections, can successfully reduce the rate of candida infections in subjects at risk. It will also test if caspofungin is useful in treating subjects for this disease when diagnosed using a new blood test that is performed twice weekly, permitting earlier diagnosis than current practice standards.


Options:
A: survival to 28 days without proven fungal infection (a fungal infection occurring within 48 hours after inclusion will be considered available for inclusion) (28 days follow-up)
B: Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria. (Within 7 days after end of therapy)
C: course of the colonization index over time. (AT 15 day from ICU admission)
D: Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients. (Participants were followed until ICU discharge, an average of 17 days); Safety and Tolerability of Preemptive Anidulafungin (weekly until ICU discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Incidence of Cardiac Complications in Patients With Cardiac Siderosis During 1 Year Follow-up and the Normal T2* Ranges in LVF, MI and Normal Population.
Brief Summary: The purpose of this study is to provide accurate prognostic data linking cardiac complications to myocardial T2\* values (A measure of iron levels in the heart using MRI)in patients predisposed to heart iron overload.


Options:
A: Myocardial T2* values (msec) (6 and 12 months)
B: Area Under the Curve of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Half-Life of Deferasirox (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Clearance/Bioavailability of Deferasirox in Patients With Poor Response to Deferasirox Compared to Patients With Good Response After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.)
C: Change From Baseline in Liver Iron Concentration (LIC) at 96 Weeks (Baseline and 96 weeks)
D: Heart Failure (1yr); Arrhythmia (1yr)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Incidence of Cardiac Complications in Patients With Cardiac Siderosis During 1 Year Follow-up and the Normal T2* Ranges in LVF, MI and Normal Population.
Brief Summary: The purpose of this study is to provide accurate prognostic data linking cardiac complications to myocardial T2\* values (A measure of iron levels in the heart using MRI)in patients predisposed to heart iron overload.


Options:
A: Heart Failure (1yr); Arrhythmia (1yr)
B: Efficacy of amlodipine in retarding rate of myocardial iron deposition (Assessed by change in T2* times) (At baseline, and then at 6 months and 12 months from the start of the study)
C: Change From Baseline in Liver Iron Concentration (LIC) at 96 Weeks (Baseline and 96 weeks)
D: Area Under the Curve of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Half-Life of Deferasirox (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Clearance/Bioavailability of Deferasirox in Patients With Poor Response to Deferasirox Compared to Patients With Good Response After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Double-blind Controlled Phase III Study to Compare the Efficacy and Safety of Intravenous Iron Carboxymaltose (Ferinject®) With Placebo in Patients With Chronic Heart Failure and Iron Deficiency
Brief Summary: This study is designed to evaluate the efficacy of Ferinject® in improving symptoms of CHF in patients with iron deficiency. Analyses will focus both on subjective and objective measures. Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.


Options:
A: Change in Peak VO2 (mL/kg/min) from baseline to Week 24 (Week 24)
B: Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy (24 weeks)
C: Incidence of severe adverse drug reactions (ADRs) (Immediate - during infusion)
D: Change in pulmonary artery systolic pressure (One week (SLR arm) and one month (CMS arm))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Double-blind Controlled Phase III Study to Compare the Efficacy and Safety of Intravenous Iron Carboxymaltose (Ferinject®) With Placebo in Patients With Chronic Heart Failure and Iron Deficiency
Brief Summary: This study is designed to evaluate the efficacy of Ferinject® in improving symptoms of CHF in patients with iron deficiency. Analyses will focus both on subjective and objective measures. Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.


Options:
A: Hematocrit (Day 7, Day 14, Day 21, Day 28); Serum Iron Concentration (Day 7, Day 14, Day 21, Day 28); Serum Ferritin Concentration (Day 7, Day 14, Day 21, Day 28); Erythrocyte Zinc Protoporphyrin Concentration (Day 7, Day 14, Day 21, Day 28)
B: Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy (24 weeks)
C: The primary endpoint of the IRON-HF study is to assess the impact of iron supplementation alone (IV or PO) on changes in oxygen maximal consumption (peak VO2) assessed by ergospirometry over a 3-month follow-up period.
D: Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL (Any time between baseline and the end of study or time to intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Double-blind Controlled Phase III Study to Compare the Efficacy and Safety of Intravenous Iron Carboxymaltose (Ferinject®) With Placebo in Patients With Chronic Heart Failure and Iron Deficiency
Brief Summary: This study is designed to evaluate the efficacy of Ferinject® in improving symptoms of CHF in patients with iron deficiency. Analyses will focus both on subjective and objective measures. Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.


Options:
A: Risk of blood transfusion or death (From randomisation until 30-days following the index operation); Blood transfusion rate (including repeat transfusions) (From randomisation until 30-days following the index operation)
B: Haemoglobin and Hematocrit values (2 years)
C: Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy (24 weeks)
D: Change in peak VO2 from baseline to week 18

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Inpatient, Phase 2, Double-blind, Placebo-Controlled Dose Ranging Study of LY2140023 in Patients With DSM-IV Schizophrenia
Brief Summary: The purpose of this study is to test the hypothesis that 1 or more dose levels of LY2140023 given orally to patients with schizophrenia twice daily for 4 weeks will have significantly greater effect than placebo.


Options:
A: A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in overall schizophrenia population (baseline, up to 7 weeks of treatment); A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in a genetic subgroup of schizophrenia patients (baseline, up to 7 weeks of treatment)
B: Change From Baseline to Week 6 in the PANSS Total Score (Baseline to Week 6)
C: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline, Week 6)
D: Positive and Negative Syndrome Scale (PANSS) total score (over 4 weeks of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Inpatient, Phase 2, Double-blind, Placebo-Controlled Dose Ranging Study of LY2140023 in Patients With DSM-IV Schizophrenia
Brief Summary: The purpose of this study is to test the hypothesis that 1 or more dose levels of LY2140023 given orally to patients with schizophrenia twice daily for 4 weeks will have significantly greater effect than placebo.


Options:
A: Clinical Utility Index (CUI) (Baseline through Week 6)
B: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline, Week 6)
C: A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in overall schizophrenia population (baseline, up to 7 weeks of treatment); A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in a genetic subgroup of schizophrenia patients (baseline, up to 7 weeks of treatment)
D: Positive and Negative Syndrome Scale (PANSS) total score (over 4 weeks of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: New Physiopathogenics Mechanisms Susceptible of Pharmacological Developments (Insulin Resistance and Atherosclerosis)
Brief Summary: The study aims to evaluate IFG, IGT or unknown type 2 diabetes mellitus in new classes at high risk to develop alterations of glucose metabolism and definition of new pathogenic mechanisms of insulin resistance and atherosclerosis.

The following classes of subjects at high risk will be considered:First degree relatives of patients with type 2 diabetes mellitus, patients with cardiovascular disease and stroke, patients with heart valve disease. age will be \> 30 years, both gender.


Options:
A: The proportion of patients who reach normal levels of all glycaemic parameters. (Month 24 of the intervention)
B: Reduction in incidence of diabetes at 3 years (3 years from entry into the study)
C: Incidence of CHD and other lifestyle related diseases after ten years (2012)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Blood Pressure in Colorado
Brief Summary: We will improve hypertension control in Colorado by implementing a population-based intervention using interactive voice response (IVR) technology that will be delivered to patients in three healthcare systems across Colorado (Denver Health and Hospitals \[DH\], VA Colorado Healthcare System \[VA\], and Kaiser Permanente of Colorado \[KPCO\]). Together, these organizations serve over 1 million Coloradans. The IVR-based hypertension program will: 1) reach out to more patients using fewer resources than a traditional patient visit approach, 2) implement evidence based guidelines for therapy, 3) facilitate patients' acquisition of medications by allowing them to order and receive medications at home, and 4) enhance medication adherence using tailored educational and motivational messages.

HYPOTHESES:

1. A sizable population of patients is at high risk for further cardiovascular morbidity and mortality, based on uncontrolled hypertension.
2. An IVR-centered intervention among patients with diagnosed but uncontrolled hypertension is feasible.
3. An IVR-centered intervention plus usual care for these patients improves BP control, compared to usual care alone.


Options:
A: Completion of a Fecal Occult Blood Test (FOBT) (within 6 months of randomization)
B: Change from baseline in depression outcome at 6-months (6-months from enrollment)
C: Usual Gait Speed (Baseline); Usual Gait Speed (3 month); Usual Gait Speed (12-month); Rapid Gait Speed (Baseline); Rapid Gait Speed (3-month); Rapid Gait Speed (12-month)
D: We will assess the primary measures of effectiveness (control of blood pressure) in the clinic at baseline and 6 months, for both the usual care plus IVR arm and usual care arm alone. (6 months of follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Buprenorphine for the Treatment of Neonatal Abstinence Syndrome
Brief Summary: Neonatal abstinence syndrome is a disease that affects children who were exposed to opioid drugs prior to birth. Commonly used treatments at present include morphine or tincture of opium. Buprenorphine is a drug used in adults to treat narcotic dependence, but has not been used for Neonatal Abstinence Syndrome. This trial is designed to see if the use of sublingual (under the tongue) buprenorphine is able to be used safely and easily in newborns with the neonatal abstinence syndrome. Secondary goals will be to see if treatment with buprenorphine is associated shorter stays in the hospital and fewer days of treatment than the use of standard therapy. Another secondary goal will be to understand buprenorphine concentration in the blood of babies treated with the drug (this is called "pharmacokinetics").


Options:
A: Change in Infant Movement between Mattress ON and Mattress OFF (control) (Single sessions throughout course of hospitalization. Each session may last up to 24 hours.); Change in Infant Breathing between Mattress ON and Mattress OFF (control) (Single sessions throughout course of hospitalization. Each session may last up to 24 hours.); Change in Infant Heart Rate between Mattress ON and Mattress OFF(control) (Single sessions throughout course of hospitalization. Each session may last up to 24 hours.)
B: Heart Rate (up to 2 weeks); Respiratory Rate (up to 2 weeks); O2 sats (up to 2 weeks); Activity level (up to 2 weeks); Sleep category (up to 2 weeks); Feeding (sucking and absorption) category (up to 2 weeks); Neonatal Abstinence Scoring (NAS) (up to 2 weeks)
C: Days of Treatment With Opioid Medication (From date of randomization until the date of last opioid dose or date of death from any cause, whichever came first, assessed up to 12 months)
D: Sublingual Buprenorphine safety and tolerability in the neonate (Index hospitalization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Activity as an Aid for Smoking Cessation: a Randomized Controlled Trial
Brief Summary: Including a tailored moderate-intensity physical activity intervention in a standard smoking cessation treatment program (pharmaceutical treatment and counseling) increases the chances of quitting and reduces nicotine withdrawal symptoms, negative moods, stress, and weight gain.


Options:
A: TC/HDL ratio (one year)
B: Smoking Cue Reactivity on Quit Day (4-weeks)
C: smoking cessation (12 months)
D: Salivary Cotinine (12 months posttreatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Activity as an Aid for Smoking Cessation: a Randomized Controlled Trial
Brief Summary: Including a tailored moderate-intensity physical activity intervention in a standard smoking cessation treatment program (pharmaceutical treatment and counseling) increases the chances of quitting and reduces nicotine withdrawal symptoms, negative moods, stress, and weight gain.


Options:
A: To compare 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation, and to evaluate continuous abstinence from smoking for 12 weeks after the treatment period.
B: Evaluation of smoking cessation verified by expired air carbon monoxide (12 weeks after baseline)
C: Smoking Abstinence (12 months)
D: smoking cessation (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Study of the Efficacy of Analytic Oriented Group Psychotherapy for Psychiatric Outpatients
Brief Summary: A primary goal of this study is to investigate the significance of treatment duration, by comparing change after group psychotherapy of varying lengths. A secondary goal is to investigate the predictive value of selected patient variables on outcome: personality pathology, quality of object relations, presence of personality disorder, degree of initial disturbance, and education. One hundred and twenty patients from 5-6 different study sites (consisting of one coordinator and 3 therapists) will be included. Exclusion criteria are psychosis, substance abuse, and organically based symptoms. Patients are interviewed before treatment and one year after termination, and self-rated outcome measures are filled in at 3-month intervals during treatment and at termination. After an initial evaluation, patients are randomized to one of two manualized psychodynamic group psychotherapies with different treatment lengths (20 and 80 sessions). Each therapist will conduct both a short- and a long-term group, and sessions are taped in order to check treatment integrity.


Options:
A: Changes in Stages of Change Questionnaire, which measures motivation (3 months); Changes in Reasons for Living Inventory (3 months); Changes in State Hope Scale (3 months); Changes in Interpersonal Needs Questionnaire, which measures constructs of thwarted belongingness and perceived burdensomeness. (3 months); Changes in Beck Scale for Suicide Ideation (3 months); Suicide Attempt Self-Injury Count (3 months)
B: scl-90-R, IIP-C, GAF (before and after therapy,follow-up and every 3 months during therapy)
C: Change in frequency of self-harm (suicidal and non-suicidal) behaviours over time as measured by the Suicide Attempt Self-Injury Interview (SASII) (Administered pre-treatment and every three months until 24 months)
D: Change on the severity of borderline personality disorder measured by Borderline Personality Symptom List (BSL-23). (Baseline and up to 12 months after inclusion.)

Answer: B