TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients
Brief Summary: This study is meant to assess the effectiveness of idebenone on neurological outcome measures in patients with Friedreich's Ataxia over a 6 months period.


Options:
A: The primary endpoint is time to treatment response and difference in time to response for the two data collection methods - daily patient electronic assessment versus weekly assessments measured in clinic.
B: Change in the International Cooperative Ataxia Rating Scale (ICARS) From Baseline Assessment to Week 24 (baseline and 6 months)
C: Change in Disposition Index of Glucose Regulation, determined by Frequent Sampling IV Glucose Tolerance Test (Baseline, Day 14 and Day 28)
D: To examine the change in the level of oxidative stress by measuring the oxidative marker 8-hydroxy-2-deoxyguanosine from baseline and after 6 months of treatment with placebo or varying doses of idebenone (baseline and after 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Mesh Fixation Technique on Postoperative Pain in Laparoscopic Correction of Incisional and Ventral Abdominal Wall Hernias.
Brief Summary: Method of fixation of the mesh in laparoscopic incisional / ventral hernia repair might influence the degree of postoperative pain.

The study hypothesis is that there is no difference in postoperative pain between different methods to fix the mesh in laparoscopic incisional / ventral hernia repair.


Options:
A: Assessment of postoperative pain (one year)
B: Postoperative pain VAS 0-100 mm (1 year)
C: Postoperative pain recorded in SF-36 (3 weeks after surgery)
D: Overall complication rates at eight weeks and the odds of complications, adjusted for study site, body mass index, and hernia type (Eight (8) weeks post-operatively)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Parallel-group Multi-center Comparative Flexible-dose Trial Of Pregabalin Versus Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures.
Brief Summary: To compare the efficacy of pregabalin and gabapentin, as adjunctive therapy in subjects with partial seizures.


Options:
A: Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period (Baseline to 12-week Treatment Period)
B: Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration (12 week Treatment Period); 50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration (Baseline to 12 week Treatment Period)
C: Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period (From Baseline to 12-week Treatment Period)
D: Percent Change From Baseline in 28-day Seizure Frequency at Week 21. (6 weeks Baseline, 21 weeks through End of MP for 27 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Pilot Trial of Oral Cyclophosphamide Versus Oral Cyclophosphamide With Celecoxib for Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with celecoxib may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well giving cyclophosphamide together with celecoxib works compared to cyclophosphamide alone in treating patients with recurrent or persistent ovarian epithelial, fallopian tube, or primary peritoneal cancer.


Options:
A: Proportion of patients with objective response rate with recurrent endometrial cancer with mutated ARID1A (3 years); Proportion of patients with objective response rate with recurrent ovarian cancer with mutated ARID1A (3 years)
B: Overall Response (Up to 3 years); Time to Treatment Failure (Up to 3 years); Overall Survival (Up to 5 years)
C: To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer (The time frame is 82.5 months (median duration of follow-up)); To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer (The time frame is 82.5 months (median duration of follow-up).)
D: Time to Repeat Paracentesis (TRP) (From Day 1 up to 6 months from randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Pilot Trial of Oral Cyclophosphamide Versus Oral Cyclophosphamide With Celecoxib for Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with celecoxib may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well giving cyclophosphamide together with celecoxib works compared to cyclophosphamide alone in treating patients with recurrent or persistent ovarian epithelial, fallopian tube, or primary peritoneal cancer.


Options:
A: Overall Response (Up to 3 years); Time to Treatment Failure (Up to 3 years); Overall Survival (Up to 5 years)
B: Progression Free Survival (PFS) (every 12 weeks until progression or up to 30 months, thereafter every 6 months)
C: Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) (Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.)
D: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: BOSCOT: A Randomised Control Trial of Cognitive Behavioural Therapy Plus Treatment as Usual Versus Treatment as Usual in the Treatment of Borderline Personality Disorder
Brief Summary: The aim of the study was to investigate if the addition of cognitive behavioural therapy to treatment as usual (CBT plus TAU) in participants with borderline personality disorder would decrease the number of participants with emergency (i.e. unplanned) psychiatric or accident and emergency room contact or episode of deliberate self-harm over twelve months treatment and twelve months follow-up, compared with treatment as usual (TAU). The study also examined whether CBT plus TAU would lead to superior improvement in quality of life, social, cognitive and mental health functioning than TAU alone.


Options:
A: Suicide re-attempt rate reduction using the Columbia Suicide Severity Rating Scale (C-SSRS) (At 2 years after the intervention)
B: The primary outcome will be the composite outcome of the number of in-patient psychiatric hospitalisations, the number of A& E contacts, and the number of suicidal acts. (At both 12 and 24 months post randomisation.)
C: Time to Suicide Attempt (Up to 18 months)
D: Repeat Suicide Attempts (1, 2, and 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: BOSCOT: A Randomised Control Trial of Cognitive Behavioural Therapy Plus Treatment as Usual Versus Treatment as Usual in the Treatment of Borderline Personality Disorder
Brief Summary: The aim of the study was to investigate if the addition of cognitive behavioural therapy to treatment as usual (CBT plus TAU) in participants with borderline personality disorder would decrease the number of participants with emergency (i.e. unplanned) psychiatric or accident and emergency room contact or episode of deliberate self-harm over twelve months treatment and twelve months follow-up, compared with treatment as usual (TAU). The study also examined whether CBT plus TAU would lead to superior improvement in quality of life, social, cognitive and mental health functioning than TAU alone.


Options:
A: Clinical Global Impression (CGI): Improvement (1-7): score 3 ( a little better) associated with a hopelessness scale score < 8 (this means that the suicide risk is low)
B: Change in severity of borderline personality disorder assessed with the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview (Assessed at baseline, and at 8, 16 and 24 months post-randomization)
C: Functioning Assessment Scale Test (FAST) (up to three years)
D: The primary outcome will be the composite outcome of the number of in-patient psychiatric hospitalisations, the number of A& E contacts, and the number of suicidal acts. (At both 12 and 24 months post randomisation.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: BOSCOT: A Randomised Control Trial of Cognitive Behavioural Therapy Plus Treatment as Usual Versus Treatment as Usual in the Treatment of Borderline Personality Disorder
Brief Summary: The aim of the study was to investigate if the addition of cognitive behavioural therapy to treatment as usual (CBT plus TAU) in participants with borderline personality disorder would decrease the number of participants with emergency (i.e. unplanned) psychiatric or accident and emergency room contact or episode of deliberate self-harm over twelve months treatment and twelve months follow-up, compared with treatment as usual (TAU). The study also examined whether CBT plus TAU would lead to superior improvement in quality of life, social, cognitive and mental health functioning than TAU alone.


Options:
A: MHS heavy use (2 years)
B: Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS) (26 weeks)
C: CAPS-5 (Clinician Administered PTSD Scale) (12 months)
D: The primary outcome will be the composite outcome of the number of in-patient psychiatric hospitalisations, the number of A& E contacts, and the number of suicidal acts. (At both 12 and 24 months post randomisation.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: BOSCOT: A Randomised Control Trial of Cognitive Behavioural Therapy Plus Treatment as Usual Versus Treatment as Usual in the Treatment of Borderline Personality Disorder
Brief Summary: The aim of the study was to investigate if the addition of cognitive behavioural therapy to treatment as usual (CBT plus TAU) in participants with borderline personality disorder would decrease the number of participants with emergency (i.e. unplanned) psychiatric or accident and emergency room contact or episode of deliberate self-harm over twelve months treatment and twelve months follow-up, compared with treatment as usual (TAU). The study also examined whether CBT plus TAU would lead to superior improvement in quality of life, social, cognitive and mental health functioning than TAU alone.


Options:
A: CGI scale for use in borderline personality disorder (CGI-BPD) (12 weeks)
B: Borderline Symptom Checklist (BSL-23) (Changes in scores of BSL-23 before treatment, and at 4, 8, 12 months after starting the treatment)
C: Parasuicidal behaviour (intermittent)
D: The primary outcome will be the composite outcome of the number of in-patient psychiatric hospitalisations, the number of A& E contacts, and the number of suicidal acts. (At both 12 and 24 months post randomisation.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4
Brief Summary: The purpose of this study is to evaluate the absolute (versus placebo) and relative (one vaccine compared to the other) efficacies of the live attenuated and inactivated influenza vaccines in preventing laboratory confirmed symptomatic influenza caused by circulating strains whether similar or dissimilar to strains included in the vaccines.


Options:
A: The primary objective of safety and tolerability of GHB01L1 administered as single dose intranasal aerosol will be evaluated by clinical signs and symptoms as well as laboratory tests. (Beginning with signing Informed Consent through 30 days after study end)
B: Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza (one influenza season - 2007-2008)
C: Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age; local and systemic reactions within 2 weeks of vaccination
D: Safety of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine by estimating the incidence of reported Adverse Events, Serious Adverse Events or Adverse Events of Special Interest in a cohort of actively monitored vaccinated subjects (Within 3 weeks and 6 weeks after vaccine administration)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-national, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse. (CALYPSO)
Brief Summary: Multi-national, randomized, phase III, GCIG Intergroup study comparing pegylated liposomal Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in patients with epithelial ovarian cancer in late relapse. (CALYPSO)


Options:
A: overall survival (overall)
B: To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin (Once 244 planned pts. received at least 2 cycles of study treatment(s))
C: Progression-free Survival (Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month))
D: Number of Participants With Dose Limiting Toxicities of Cediranib Maleate in Combination With Olaparib (Phase I) (At 28 days); The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Metastatic Triple-negative Breast Cancer (Phase I) (At 28 Days); Progression-free Survival (PFS) at the Maximum Tolerated Dose/Recommended Phase 2 Dose of Cediranib Maleate With Olaparib Compared to That of Olaparib Alone (Phase II) (Time from start of treatment to time of objective disease progression, assessed up to 5 years); The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib Tablet Formulation in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer (Phase I-T). (At 28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Interferon-gamma With Interferon Alpha and Ribavirin for Hepatitis C Patients Who Are Non-responders to Interferon Alpha Plus Ribavirin
Brief Summary: When administered simultaneously, interferon-alpha 2b + interferon-gamma result in dramatic antiviral synergy.Ribavirin has shown to enhance interferon-gamma levels in patients with chronic hepatitis C treated with interferon-alpha. Enhancement of immune responses, especially those related to type-1 T helper cell activity, may contribute to better efficacy in combining ribavirin with IFN-alpha for treatment of chronic hepatitis C. The aim of the present study is to evaluate the efficacy and safety of a triple regimen, a combination treatment with Interferon gamma, Interferon alfa-2b plus Ribavirin in patients who have not previously responded to interferon alpha in combination of ribavirin.


Options:
A: Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) (Post-treatment Week 24); Percentage of Participants Who Experienced Adverse Events (Baseline (Day 1) to post-treatment Day 30)
B: Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population. (At Follow-up Week 24)
C: Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment (24 weeks after last planned dose of study treatment (up to Week 72))
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Extrapulmonary Interventional Ventilatory Support for Lung Protection in Severe Acute Respiratory Distress - a Prospective Randomized Multi Centre Study
Brief Summary: A prospective, randomized study will be performed investigating the effects of a pumpless extracorporeal interventional lung assist \[iLA\] on the implementation of a lung-protective ventilatory strategy in patients with acute respiratory distress syndrome \[ARDS\] with a PaO2/FiO2 ratio \< 200. The duration of ventilation, intensive care and hospital stay and in-hospital mortality will be investigated.


Options:
A: 30-day survival rate with favorable neurological status (30 days)
B: All-cause Mortality (Day 30)
C: Ventilator free days within 28 days after enrollment (28 days)
D: Left ventricular ejection fraction (LVEF) on day 30 (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Swiss Dark Chocolate on Endothelial and Baroreceptor Function and Markers of Inflammation in Patients With Chronic Heart Failure
Brief Summary: The aim of the present study is to investigate whether in patients with chronic heart failure endothelial dysfunction and baroreceptor function is altered by ingestion of a flavonoid-rich dark chocolate in comparison to placebo chocolate (Nestlé Placebo Chocolate) on top of standard medication.

Moreover, we will evaluate the effect of chocolate on oxidative stress, platelet adhesion as well as systemic inflammatory response such as C-reactive protein and pro-inflammatory cytokines in patients with chronic heart failure.


Options:
A: changes in systolic and diastolic blood pressure
B: Change in cardiovascular disease risk indictaors - including carotid intima-media thickness (CIMT), total plaque volume (TPV) (at the carotid bifurcation), pulse wave velocity (PWV) and biomarkers of risk in blood samples . (6 months - 1 year)
C: Change in blood pressure (Baseline (day 0) and 14, 28, 42 and 56 days after intervention); Change in platelet function (Baseline and 14, 28, 42 and 56 days after intervention); Change in metabolic parameters in blood (Baseline (day 0) and 14, 28, 42 and 56 days after intervention)
D: endothelial function (acute (2 hours), chronic (2 and 4 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of Optimised Surgical Recovery: the Potential Synergy Between Enhanced Gastrointestinal Motility and Oral Nutritional/ Metabolic Support
Brief Summary: Factors which delay recovery following uncomplicated abdominal surgery include uncontrolled pain, intolerance of diet and poor mobility. Enhanced recovery after Surgery (ERAS) programmes are perioperative care pathways that address systematically these issues (i.e. improved dynamic pain relief, optimised nutritional care and enforced mobilisation) to promote a faster recovery and a shorter stay. The key treatments that improve outcome within an ERAS programme are not known. Moreover there are few acceptable, objective endpoints to assess key outcome variables such as return of GI function. This randomised trial will assess the potential synergy between early recovery of GI function (laxation) and early postoperative oral nutritional support(with associated preoperative preconditioning using carbohydrate/fluid loading). The main overall outcome targets being improved recovery of gastrointestinal function, postoperative nutritional status and physical function. It will validate the use of a novel, objective technique to measure gastric motility (surrogate for GI function). Such refinement of ERAS should result in shorter hospital stay and better use of limited health care resource.


Options:
A: Recovery of gastrointestinal function: Time to pass flatus/stool (hours following the end of surgery) (Number of hours post surgery)
B: Insulin sensitivity (baseline and postoperatively)
C: insulin resistance (Homa-IR will be assessed in two time points: baseline (2-3 h before operatio) and 24h after operation)
D: Morbidity and mortality after open infrarenal aortic aneurysm repair (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of Optimised Surgical Recovery: the Potential Synergy Between Enhanced Gastrointestinal Motility and Oral Nutritional/ Metabolic Support
Brief Summary: Factors which delay recovery following uncomplicated abdominal surgery include uncontrolled pain, intolerance of diet and poor mobility. Enhanced recovery after Surgery (ERAS) programmes are perioperative care pathways that address systematically these issues (i.e. improved dynamic pain relief, optimised nutritional care and enforced mobilisation) to promote a faster recovery and a shorter stay. The key treatments that improve outcome within an ERAS programme are not known. Moreover there are few acceptable, objective endpoints to assess key outcome variables such as return of GI function. This randomised trial will assess the potential synergy between early recovery of GI function (laxation) and early postoperative oral nutritional support(with associated preoperative preconditioning using carbohydrate/fluid loading). The main overall outcome targets being improved recovery of gastrointestinal function, postoperative nutritional status and physical function. It will validate the use of a novel, objective technique to measure gastric motility (surrogate for GI function). Such refinement of ERAS should result in shorter hospital stay and better use of limited health care resource.


Options:
A: Safety parameters reflecting pathophysiological functions of the liver (day -1, 0, 1, and 7); Gastrointestinal tolerance (day 0 before and 6-8h after surgery); Metabolic parameters in serum, liver and muscle tissue (on day -1, 0, 1, and 7)
B: To study the benefit of branched-chain amino acids enriched nutrient-mixture by analyzing a variety of clinical parameter, including laboratory data, the duration of hospitalization after the surgery. (3-6 months)
C: Recovery of gastrointestinal function: Time to pass flatus/stool (hours following the end of surgery) (Number of hours post surgery)
D: Factor V at day 3 after surgery (day 3)

Answer: C