TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: AID-trial:A Randomized Clinical Trial Comparing the Effect on Repeated Self-harm of Assertive Intervention and Standard Treatment After Deliberate Self-harm
Brief Summary: Background

Previous suicide attempts is a high-risk factor with a repetition rate between 12-30 percent. Compliance with after treatment is often poor. A systematic review by Hawton, 1999 states a lack of evidence on psychosocial interventions due to selections bias or statistical power.

Objective

The aim is to investigate if assertive outreach, incorporating hands-on guidance and motivational support of compliance with follow-up treatment after suicide attempts is able to reduce the frequency of non-fatal and fatal suicide acts in a one-year follow-up period.

Method and Design

A randomized, controlled intervention trial in a prospective design. The patients included will be randomized to either standard treatment (n = 120) or intervention treatment (N = 120), representing 6 - 8 assertive outreach contacts with a research nurse after suicide attempts or deliberate self-harm. The outreach contacts are thought of as supporting and guiding home visits towards compliance with after care or follow-up treatment Inclusion criteria Males and females, aged 12 years or older with a recent suicide attempt or act of deliberate self-harm, living independently and not diagnosed with severe mental illness (psychosis, severe dementia)

Outcome

The primary outcome measure is repeated fatal suicidal act (fatal or non fatal)assessed by the Danish Cause of Death Register and the rate of repeated suicide attempts/deliberate self-harm registered in the medical records by the collaborating wards and units in their routine procedure of treating people applying for help in relation to suicidal behavior.


Options:
A: USCD Performance-Based Skills Assessment (2009)
B: Repeated fatal or non fatal suicidal act (one year)
C: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)
D: Psychotic symptoms at one and two year follow-up; Negative symptoms at one and two year follow-up

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: AID-trial:A Randomized Clinical Trial Comparing the Effect on Repeated Self-harm of Assertive Intervention and Standard Treatment After Deliberate Self-harm
Brief Summary: Background

Previous suicide attempts is a high-risk factor with a repetition rate between 12-30 percent. Compliance with after treatment is often poor. A systematic review by Hawton, 1999 states a lack of evidence on psychosocial interventions due to selections bias or statistical power.

Objective

The aim is to investigate if assertive outreach, incorporating hands-on guidance and motivational support of compliance with follow-up treatment after suicide attempts is able to reduce the frequency of non-fatal and fatal suicide acts in a one-year follow-up period.

Method and Design

A randomized, controlled intervention trial in a prospective design. The patients included will be randomized to either standard treatment (n = 120) or intervention treatment (N = 120), representing 6 - 8 assertive outreach contacts with a research nurse after suicide attempts or deliberate self-harm. The outreach contacts are thought of as supporting and guiding home visits towards compliance with after care or follow-up treatment Inclusion criteria Males and females, aged 12 years or older with a recent suicide attempt or act of deliberate self-harm, living independently and not diagnosed with severe mental illness (psychosis, severe dementia)

Outcome

The primary outcome measure is repeated fatal suicidal act (fatal or non fatal)assessed by the Danish Cause of Death Register and the rate of repeated suicide attempts/deliberate self-harm registered in the medical records by the collaborating wards and units in their routine procedure of treating people applying for help in relation to suicidal behavior.


Options:
A: Number of suicide re-attempters (six months)
B: Repeated fatal or non fatal suicidal act (one year)
C: Suicidal thoughts or attempts (Measured at Year 2)
D: Persons repeating a suicidal act (One, two and three years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label Phase III Intergroup Study: Effect of Adding Bevacizumab to Cross Over Fluoropyrimidine Based Chemotherapy (CTx) in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line Standard CTx/Bevacizumab Combination
Brief Summary: This study will evaluate the efficacy and safety of adding bevacizumab to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus bevacizumab. Participants will receive chemotherapy alone, or in combination with bevacizumab. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after stopping chemotherapy.


Options:
A: Overall Survival (Every 8 weeks, up to 12 months after the last participant was randomized or until the target number of events (deaths) was met, whichever was later. (Overall survival data was collected till 24 Jan 2014 which was date of observation of the 571st death))
B: Overall Survival: Time From Randomization to Death From Any Cause (within 6.5 years)
C: Overall Survival (OS) (From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years))
D: Overall survival (5-year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-label Phase III Intergroup Study: Effect of Adding Bevacizumab to Cross Over Fluoropyrimidine Based Chemotherapy (CTx) in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line Standard CTx/Bevacizumab Combination
Brief Summary: This study will evaluate the efficacy and safety of adding bevacizumab to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus bevacizumab. Participants will receive chemotherapy alone, or in combination with bevacizumab. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after stopping chemotherapy.


Options:
A: Overall Survival: Time From Randomization to Death From Any Cause (within 6.5 years)
B: Overall Survival (From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.)
C: Incidence of Adverse events; Changes in Lab values; Incidence of HAHA formation
D: Progression free survival (every course for first three courses, then every other course)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind Cross Over Clinical Trial to Determine Colchicine Efficacy in Behcet's Disease
Brief Summary: Colchicine was first used in Behcet's Disease (BD), in 1977. There are controversial reports of the efficacy of Colchicine in BD. For some experts the unresponsiveness of some patients could be explained by genetic difference between the Silk Road BD and sporadic BD from other parts of the world.

To test this hypothesis (the inefficacy of colchicine in the Silk Road BD), we designed a randomized double-blind controlled crossover study in Iran, which is in the middle of the Silk Road, and has the second highest prevalence of BD in the world.


Options:
A: Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence (3 months)
B: Recurrence rate at 18 months
C: Iranian Behcet's Disease Dynamic Activity Measurement (IBDDAM) (8 months)
D: Postpericardiotomy syndrome (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
Brief Summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.


Options:
A: Median Percent Change in Primary Generalized Tonic Clonic Seizure Frequency (PGTC) Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to Baseline (Prerandomization) - (for Core Study) (Baseline (4 or 8 weeks), Titration (4 weeks), and Maintenance (13 weeks)); 50% Responder Rate for Primary Generalized Tonic Clonic Seizure During Maintenance - LOCF - (for Core Study) (Baseline (4 or 8 weeks) and Maintenance (13 weeks)); 50% Responder Rate in Primary Generalized Tonic-Clonic Seizure Frequency Per 28 Days Relative to the Core Study Prerandomization Phase - (for Extension Phase) (Week 1 of perampanel treatment to date of last dose of perampanel in the Extension Phase)
B: Change From Baseline to Week 19 in Cognition Drug Research (CDR) System Global Cognition Score (Core Study) (Baseline (Visit 2/Week 0 Evaluation) and Week 19 LOCF (last observation carried forward))
C: Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases) (Baseline (Pre-randomization) through Week 19)
D: Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases) (Baseline (Pre-randomization) through Week 19)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Subjects With Type 2 Diabetes. A 26-week, Randomised, Open-label, Active Comparator, Three-armed, Parallel-group, Multi-centre, Multinational Trial With a 52-week Extension
Brief Summary: This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone.

The trial has been extended by 52 weeks. The extension will consist of two 26-week periods:

1. Week 27-52 after randomisation

   - All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen.
2. Week 53-78 after randomisation

   * Subjects receiving sitagliptin at the end of week 52 after randomisation will discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and increased to 1.2 mg/day or 1.8 mg/day in weekly intervals.
   * Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after randomisation will continue the treatment at unchanged dose and dosing regimen. Trial completion is planned for June 2010.


Options:
A: To assess the pharmacokinetics of exenatide (Three day-long (8 hour) assessments over a 5-week period); To assess the pharmacodynamics of exenatide (Three day-long (8 hour) assessments over a 5-week period); Number of adverse events (Visit 2 through Visit 4)
B: Change in HbA1c From Baseline to Week 26 (Baseline, Week 26)
C: HbA1c (after 26 weeks of treatment)
D: Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26 (Week 0, Week 26); Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Week 0, Week 52); Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78 (Week 0, Week 78); Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78 (Week 52, Week 78)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin Compared With the Addition of Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin
Brief Summary: A study to see if better control of type 2 diabetes can occur in patients taking a stable dose of metformin when they are also provided either sitagliptin or glimepiride. This study will also see if this treatment is safe and tolerable.


Options:
A: Change in HbA1c From Baseline to Week 26 (Day 1 (Baseline) and Week 26)
B: HbA1c Change From Baseline at Week 18 (Interim Analysis) (Baseline and week 18); HbA1c Change From Baseline at Week 18 (Final Analysis) (Baseline and week 18)
C: Change From Baseline in HbA1c at Week 30 (Week 0 to Week 30)
D: Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment (after 24 weeks of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Haemocomplettan® P in Patients Experiencing Acute Bleeding While Undergoing Aortic Replacement Surgery
Brief Summary: The primary purpose is to show that administration of Haemocomplettan® P significantly reduces the amount of blood products needed during aortic surgery.


Options:
A: efficacy endpoint (the volumes of allogeneic blood products, volumes of cumulative drainage within 24 h and 48 h and 5 days (from the time of fibrinogen concentrate administration until the 5th postoperative day)
B: Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects. (From administration of Haemocomplettan® P until 24 hours later)
C: Total units of allogeneic blood products (Up to 24 hours after investigational medicinal product (IMP) administration)
D: fibrinogen concentration (clauss) (45 minutes after the admission on day 1 after trauma)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Haemocomplettan® P in Patients Experiencing Acute Bleeding While Undergoing Aortic Replacement Surgery
Brief Summary: The primary purpose is to show that administration of Haemocomplettan® P significantly reduces the amount of blood products needed during aortic surgery.


Options:
A: Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects. (From administration of Haemocomplettan® P until 24 hours later)
B: Multiple Organ Failure (MOF) (Variable until 24h on ICU at the end of the IMP-administration)
C: Incidense of transfusion with allogenic blood products (During hospital stay or until 6 weeks postintervention)
D: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Haemocomplettan® P in Patients Experiencing Acute Bleeding While Undergoing Aortic Replacement Surgery
Brief Summary: The primary purpose is to show that administration of Haemocomplettan® P significantly reduces the amount of blood products needed during aortic surgery.


Options:
A: major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) (30 days)
B: Proportion of Subjects Achieving Hemostasis by Five Minutes After Treatment Start at the TBS (From start of treatment until 5 minutes after treatment start)
C: Blood loss (milliliters) (intraoperative (from skin incision to skin closure))
D: Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects. (From administration of Haemocomplettan® P until 24 hours later)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (Agalsidase Beta) in Treatment-Naïve Male Pediatric Patients With Fabry Disease Without Severe Symptoms
Brief Summary: The purpose of this study was to determine whether 2 alternative dosing regimens of Fabrazyme (Agalsidase beta) (1.0 mg/kg every 4 weeks or 0.5 mg/kg every 2 weeks) were effective in treatment-naïve pediatric participants without severe symptoms. Participants were to be treated for 5 years.


Options:
A: Skin Globotriaosylceramide (GL-3) Clearance From Superficial Skin Capillary Endothelium (Baseline, Week 52, Week 156 and Week 260)
B: Globotriaosylceramide (GL-3) Clearance in Capillary Endothelium in the Skin (Baseline, Week 24 and Week 48)
C: Patients Who Experienced At Least One Adverse Event (AE) (362 weeks)
D: Number of Participants Experiencing a Clinically Significant Renal, Cardiac or Cerebrovascular Event and/or Death in Fabrazyme (Agalsidase Beta) Patients as Compared to Placebo Patients (up to 35 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 4 Study of Losartan in Hypertensive Men and Women With Obstructive Sleep Apnea Before and After Continuous Positive Airway Pressure (CPAP) Treatment
Brief Summary: Obstructive sleep apnea (OSA) is a highly prevalent condition in hypertensive patients. The renin-angiotension-aldosterone-system (RAAS) has a central role in blood pressure control. An angiotensin-II-antagonist, Losartan, is an effective antihypertensive drug. However, some patients respond to this drug worse than the others, and it is a clinical praxis to either increase the dosage and/or add another drug. There is limited data regarding the impact of antihypertensive drugs in OSA patients, i.e., whether or not OSA may constitute the subgroup of therapy-resistent hypertensive patients. In the literature, there is no data, either, whether or not CPAP treatment may have an additive blood pressure lowering impact in this certain subgroup.


Options:
A: Ambulatory blood pressure monitoring (Change from Baseline in Blood Pressure at 6 months)
B: proportion using CPAP within 48-hours of stroke onset (72 hours)
C: 24 h blood pressure (mean blood pressure; mmHg) (Changes from Baseline in 24 h BP at 6 and 12 weeks, respectively)
D: cognitive functioning; reports of daytime sleepiness; reports of quality of sleep (three weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Randomized Double-Blind Placebo and Active Comparator Controlled Parallel-group, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MBX-8025 in Moderately Obese Hyperlipidemic Patients With/Out Concomitant Atorvastatin"
Brief Summary: A Multicenter Randomized, Double-Blind, Placebo-Controlled Study to evaluate the efficacy, safety and tolerability of MBX-8025, a novel PPAR-d agonist to treat hyperlipidemia, insulin resistance and obesity in overweight, hyperlipidemic patients, both as monotherapy and in combination with Atorvastatin

Total participation for each patient is approximately 16-17 weeks, which may include up to a 2 week screening period, 5 week run-in period, 8 week treatment period, and 2 week follow-up. During the run-in period patients taking statins, statin combination or Zetia will undergo a 'washout'. All patients will be instructed to follow a weight-maintenance diet (i.e., their same diet prior to entering the study). They will be asked to defer initiating any weight loss diets or meaningful changes in their activity level until after they have completed the study. Once randomized into the double blind study, patients will visit the clinic every two weeks thereafter until the end of the study. At the end of the 8-week treatment phase, the double-blind study medication will be discontinued. Patients will attend a follow up visit two weeks after their final dose for safety evaluation.


Options:
A: The change of LDL-C (Baseline to 12 weeks)
B: Low density Lipoprotein cholesterol level - reaching internationally recognised LDL cholesterol goal levels. (16 weeks)
C: Lipid levels will be measured in patients with hyperlipidemia to assess the benefits of the investigational drug (8 week treatment period)
D: Time of Atrial Fibrillation Recurrence (Upon recurrence, up to 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation and the Natural History of HIV-Associated Emphysema
Brief Summary: People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema.


Options:
A: Intervention effect on Flow-mediated dilatation (FMD) assessed via ultrasound (%FMD). (6 months following quit day.)
B: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)
C: Maximum Nicotine Concentration in Blood (180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period)); Concentration of Carboxyhemoglobin in Blood (Baseline and 8 days); Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours (Baseline and 8 days); Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours (Baseline and 8 days); Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours (Baseline and 8 days)
D: Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12. (Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation and the Natural History of HIV-Associated Emphysema
Brief Summary: People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema.


Options:
A: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)
B: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)
C: Self- Reported 7-day Abstinence (6 Months); Carbon Monoxide (CO)-Confirmed 7-day Abstinence (6-Months); Rates of Smoking Cessation Continuous From First Quit Day to 6 Months (6-Months); Self-reported 7-day Abstinence (12 Months); CO-confirmed 7-day Abstinence (12 Months)
D: Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation and the Natural History of HIV-Associated Emphysema
Brief Summary: People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema.


Options:
A: Cigarette use (8 weeks)
B: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)
C: Percent Compliance With Chantix (Months 1, 2, 3)
D: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12

Answer: B