TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Double-dummy, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Brief Summary: This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.


Options:
A: Percentage reduction of treated areas from baseline (4 weeks)
B: Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks (12 weeks); Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1 (12 weeks)
C: Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . (12 wks); Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 (12 wks)
D: Change from baseline in PPSI total score at Week 16. (Baseline to Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase III Study of a Treatment Driven by Early PET Response Compared to a Treatment Not Monitored by Early PET in Patients With Ann Arbor Stage III-IV or High Risk IIB Hodgkin Lymphoma
Brief Summary: All study treatments have proven efficacy in the treatment in Hodgkin lymphoma (HL). It is hoped that patients will achieve a good response to both induction therapies consisting either of 4 cycles of BEACOPPesc (Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Procarbazine, and Prednisone) or 2 cycles of BEACOPPesc plus 2 cycles of ABVD (Adriamycine, Bléomycine, Vinblastine, Décarbazine).

The use of F-FDG Position Emission Tomography performed after 2 cycles of chemotherapy (PET2) in the experimental arm will help to stratify patients in order to restrict the BEACOPPesc therapy continuation to those patients who achieved only a partial response after 2 BEACOPPesc regimen and to allow a conventional dose ABVD chemotherapy strategy for PET2 negative patients. For all patients included in the trial the achievement of a good response to induction treatment will be checked after four cycles of induction treatment including a centrally reviewed PET assessment

Patients will be randomized after verification of eligibility and before the start of the protocol treatment.Patients will be randomly assigned to the standard treatment arm not monitored by early PET, or the experimental treatment arm driven by the PET2 result.


Options:
A: Progression-free survival
B: Progression free survival (PFS) (5 years)
C: Progression Free Survival (5 years)
D: Progression free survival (5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase III Study of a Treatment Driven by Early PET Response Compared to a Treatment Not Monitored by Early PET in Patients With Ann Arbor Stage III-IV or High Risk IIB Hodgkin Lymphoma
Brief Summary: All study treatments have proven efficacy in the treatment in Hodgkin lymphoma (HL). It is hoped that patients will achieve a good response to both induction therapies consisting either of 4 cycles of BEACOPPesc (Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Procarbazine, and Prednisone) or 2 cycles of BEACOPPesc plus 2 cycles of ABVD (Adriamycine, Bléomycine, Vinblastine, Décarbazine).

The use of F-FDG Position Emission Tomography performed after 2 cycles of chemotherapy (PET2) in the experimental arm will help to stratify patients in order to restrict the BEACOPPesc therapy continuation to those patients who achieved only a partial response after 2 BEACOPPesc regimen and to allow a conventional dose ABVD chemotherapy strategy for PET2 negative patients. For all patients included in the trial the achievement of a good response to induction treatment will be checked after four cycles of induction treatment including a centrally reviewed PET assessment

Patients will be randomized after verification of eligibility and before the start of the protocol treatment.Patients will be randomly assigned to the standard treatment arm not monitored by early PET, or the experimental treatment arm driven by the PET2 result.


Options:
A: Response (24 weeks)
B: 3-year progression-free survival (3 years)
C: Progression free survival (5 years)
D: Progression free survival (PFS) (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multiprofessional Impact on Body Composition, Central and Peripheric Adiposity, Lipid Profile, Hormonal Regulation, Lung, Sleep and Humor Disorders in Adolescents
Brief Summary: Obese adolescents are submitted to a multiprofessional weight loss program, which is formed by doctors, nutritionists, physiotherapists, psychologists,and physiologists. The volunteers have intervention 3 times a week during one year, where they practice exercises, have nutrition and psychology counseling, and physiotherapy orientation. Once a month they have an appointment with the doctor. The hypothesis of this study is that a multiprofessional therapy is able to improve anthropometric and biochemical parameters, and also the quality of life of obese adolescents.


Options:
A: The effect of aerobic exercise on: Intrahepatic fat content (3 years)
B: Body composition (six months)
C: Change in intrahepatic triglyceride content (6 weeks)
D: Non-alcoholic Fatty Liver Disease Ultrasonography Score (Six months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improvement of Antibiotic Prescription in Outpatient Care: a Cluster-randomised Intervention Study Using a Sentinel Surveillance Network of Physicians
Brief Summary: Antimicrobial resistance has become a world-wide problem and antibiotic consumption is a major driving force for the development of resistance. Thus optimization of antibiotic prescription and reduction of unnecessary antimicrobial treatment are essential in the prevention and reduction of antimicrobial resistance rates.

The goal of this study is the improvement of antibiotic prescription in outpatient care. The study will take place within a Swiss-wide sentinel surveillance network of physicians. The participating physicians will be randomised in a control and intervention group. The intervention group will receive therapeutic guidelines for the treatment of upper and lower respiratory tract infections and lower urinary tract infection as well as regular feed-backs on the prescription pattern of the sentinel physicians during the past months. Sentinel physicians will collect information about each antibiotic prescription, its indication and characteristics of the patient.

Our hypothesis is that the prescription pattern in the intervention group will be optimised and unnecessary antibiotic therapy will be reduced compared to the control group.


Options:
A: Percentage of prescriptions of penicillin for respiratory tract infections (Two years); Percentage of prescriptions of TMP/SMX for lower urinary tract infections in adults (Two years)
B: Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge (6 months post-discharge from hospitalization following COPD exacerbation)
C: PROMIS-29 v2 (24 months)
D: Hospital admissions per patient (maximum 2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: "Spot Sign" Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy: SPOTLIGHT
Brief Summary: This clinical trial will enroll 110 patients from approximately 15 Canadian stroke centres. Patients coming to the emergency department with bleeding in the brain not due to trauma or other known causes who can be treated within 6 hours of onset will undergo CT angiography using standard CT scanners ("CAT scan"). Those with a "spot sign", a type of marker on the CT scan that shows the brain is still bleeding, will be randomly assigned to a single injection of "factor 7"(a blood clotting drug used in hemophilia) or placebo (inactive saline); patients without a spot sign will not be treated. The researchers will look at how much bleeding happens after the treatments are administered, as well as clinical outcomes such as death and disability. The researchers think that factor 7 will cause the bleeding to stop faster and possibly decrease death and disability.


Options:
A: Number of eligible patients who received allocated treatment (90 days); Rate of eligible patients randomised (18 months); Proportion of eligible patients and randomised (18 months); Proportion of participants followed up at 90 days (90 days); Proportion of patients with full outcome data available, and reasons for non-availability (90 days); Proportion of eligible patients approached (18 months); Adherence to intervention (18 months)
B: ICH size (24 hours)
C: Hematoma expansion (up to 27 hours)
D: Number of Study Subjects With Life-threatening Thromboembolic Complications (through day 4 after completion of study drug administration); Number of Subjects With Hematoma Growth Among Spot Sign Positive Subjects at 24 Hours. (From baseline to 24 hours); The Sensitivity of the Spot Sign for Predicting Hematoma Growth (Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours.); The Specificity of the Spot Sign for Predicting Hematoma Growth (Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Parallel, Open-Label, Randomized Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of PSI-7977 in Combination With BMS-790052 With or Without Ribavirin in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotypes 1, 2, or 3
Brief Summary: The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment


Options:
A: Safety and tolerability: Adverse events, ECG, laboratory parameters (approximately 3 years); Pharmacokinetics: Cmax, AUC, Cmin, Tmax, Cl, T1/2 (Days 3-9); Antiviral activity: HCV RNA (COBAS Taqman HCV Test) (from baseline to Day 28)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate (12 weeks after last dose of study drug)
C: Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12) (Follow-up Week 12)
D: Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs (12 weeks after first dose); Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA (Week 4); Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA (Week 12); Phase 2b only: Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA (at follow-up Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Parallel, Open-Label, Randomized Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of PSI-7977 in Combination With BMS-790052 With or Without Ribavirin in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotypes 1, 2, or 3
Brief Summary: The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment


Options:
A: Percentage of Participants Achieving Sustained Virologic Response (SVR)12 (Posttreatment Week 12); Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug (Baseline to Week 12)
B: Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12) (Follow-up Week 12)
C: Sustained Virologic Response (SVR) Rate (At Follow-up Week (FW) 24)
D: Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) (Post-treatment Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Parallel, Open-Label, Randomized Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of PSI-7977 in Combination With BMS-790052 With or Without Ribavirin in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotypes 1, 2, or 3
Brief Summary: The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment


Options:
A: Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) (At follow-up Week 12)
B: Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12) (Follow-up Week 12)
C: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing (24 weeks after the completion of study drug dosing (up to Week 72))
D: Percentage of Participants Achieving RVR (Week 4); Number of Participants Experiencing an Adverse Event (AE) (Up to Day 42); Number of Participants Discontinuing From Study Therapy Due to AEs (Day 1 to Day 28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel With Suicidal Behaviors: A Multi-Site Randomized Controlled Trial
Brief Summary: This study will implement and empirically evaluate the efficacy of a cognitive behavioral intervention program, titled, Post Admission Cognitive Therapy(PACT), for military service members and beneficiaries \[with Veterans expected to be added\] admitted for inpatient care due to severe suicide ideation and/or a recent suicide attempt.


Options:
A: Remission From Major Depressive Episode in Intent to Treat Sample (Up to 12 Weeks); Remission From Major Depressive Episode Among Participants Who Completed the Intervention (Measured at Weeks 10 and 12)
B: Change in Beck Scale for Suicide Ideation Score (Baseline, Week 10, Post-treatment Months 6 and 12); Change in Suicide Attempt Index (Baseline, Week 10, Post-treatment Months 6 and 12); Change in Index of Spouse Abuse Score (Baseline, Week 10, Post-treatment Months 6 and 12)
C: 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.)
D: Repeat Suicide Attempts (1, 3, 6, and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel With Suicidal Behaviors: A Multi-Site Randomized Controlled Trial
Brief Summary: This study will implement and empirically evaluate the efficacy of a cognitive behavioral intervention program, titled, Post Admission Cognitive Therapy(PACT), for military service members and beneficiaries \[with Veterans expected to be added\] admitted for inpatient care due to severe suicide ideation and/or a recent suicide attempt.


Options:
A: Repeat Suicide Attempts (1, 3, 6, and 12 months)
B: Clinical changes after 16 sessions of Dialectical Behavioral Therapy. (4 months); Neural changes after 16 sessions of Dialectical Behavioral Therapy. (4 months); Neuropsychological changes after 16 sessions of Dialectical Behavioral Therapy. (4 months)
C: Change in BHS Scores (Baseline, 6 weeks, and 12 weeks)
D: Change in Autonomous and Controlled Motivation (From baseline until 3 months following the completion of the 1-day intervention (i.e., average of 3 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel With Suicidal Behaviors: A Multi-Site Randomized Controlled Trial
Brief Summary: This study will implement and empirically evaluate the efficacy of a cognitive behavioral intervention program, titled, Post Admission Cognitive Therapy(PACT), for military service members and beneficiaries \[with Veterans expected to be added\] admitted for inpatient care due to severe suicide ideation and/or a recent suicide attempt.


Options:
A: adolescent alcohol use and binge drinking (any, number of days, number of related problems) (change from baseline to 6 months (prior 3 months)); adolescent suicidal ideation and behavior (severity of suicidal ideation and presence of any suicidal ideation or suicidal behavior) (change from baseline to 6 months (prior month to 6 months)); adolescent HIV risk behavior (any sexual behavior, number of sexual partners, number of unprotected sexual acts) (change from baseline to 6 months (prior 3 months)); adolescent marijuana use (any use, number of days, related problems) (change from baseline to 6 months (prior 3 months)); adolescent alcohol use and binge drinking (any, number of days, number of related problems) (change from baseline to 12 months (prior 3 months)); adolescent suicidal ideation and behavior (severity of suicidal ideation and presence of any suicidal ideation or suicidal behavior) (change from baseline to 12 months (prior month to 6 months)); adolescent HIV risk behavior (any sexual behavior, number of sexual partners, number of unprotected sexual acts) (change from baseline to 12 months (prior 3 months)); adolescent marijuana use (any use, number of days, related problems) (change from baseline to 12 months (prior 3 months))
B: Repeat Suicide Attempts (1, 3, 6, and 12 months)
C: Beck scale for suicidal ideation (six months)
D: The number of contacts with mental health services appropriate to the patient's needs. (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Albumin Administration in Septic Cirrhotic Patients With Child > 8 Unrelated to Spontaneous Bacterial Peritonitis on Renal Function and Survival: A Multicenter Randomized Controlled Trial Comparing Use and Non-use of Human Albumin (Vialebex ®)
Brief Summary: Patients with cirrhosis present an increased susceptibility to bacterial infections. Spontaneous bacterial peritonitis (SBP) is the most frequent infection and induces severe circulatory dysfunction associated with renal failure in about 30% of cases. Renal failure is a reliable surrogate marker of in-hospital mortality in patients with SBP or with non-SBP infections. Albumin, as an adjuvant to antibiotherapy reduces significantly the rate of renal failure, in-hospital mortality, and overall mortality (Sort P, et al. NEJM 1999). However, little is known regarding the effect of albumin administration in patients with non-SBP infections. Two recent prospective studies demonstrated that non-SBP infections are associated with impairment of the effective circulating volume and precipitate renal failure whatever the presence of ascites.

The aim of this randomized clinical trial is to evaluate the effects of albumin, associated with appropriate antibiotic therapy, on occurrence or deterioration of renal failure and survival in septic (SIRS criteria required) cirrhotic patients with non-SBP infections and presenting with a Child-Pugh score \> 8.


Options:
A: Mortality (18 months)
B: renin-angiotensin-aldosterone activation (4-6 days)
C: Renal failure rate (at 3 months)
D: Mortality or dialysis-dependency (90 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Fibrinogen Concentrate as Initial Treatment for Postpartum Haemorrhage - A Randomised Clinically Controlled Trial
Brief Summary: Severe maternal bleeding is a serious complication of birth and causes 125.000 deaths worldwide each year. The investigators aim to investigate if early treatment with fibrinogen concentrate versus saline can reduce the incidence of blood transfusion in women with postpartum haemorrhage.

A low level of fibrinogen has been associated with increased blood loss and transfusion requirements in different clinical settings including obstetrical bleeding. Early up-front treatment with fibrinogen may reduce incidence of transfusion by securing optimal haemostatic capacity in women with postpartum haemorrhage.

The investigators plan to enrol 245 patients on four hospitals in the Capital Region of Denmark during a two year period.

As safety measure the investigators plan to use TEG®/Functional Fibrinogen/Rapid-TEG as haemostatic monitoring of all participants during the trial: Baseline test is taken at inclusion before administration of fibrinogen concentrate/placebo. Further tests are taken immediately after intervention, 4 hours and 24 hours after. Baseline test is blinded to the providers of treatment - the rest is clinically available.


Options:
A: Incidense of transfusion with allogenic blood products (During hospital stay or until 6 weeks postintervention)
B: Death in hospital within four weeks of injury (causes of death will be described to assess whether deaths were due to haemorrhage or vascular occlusion). (Death, discharge or four weeks post randomisation whichever occurs first.)
C: Blood loss greater than or equal to 500 mls after enrolment (Blood loss measured for minimum of 1 hour or until active bleeding ceased)
D: Need for additional treatment after initial PPH study treatment (all additional interventions recorded following initial uterotonic treatment)

Answer: A