TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An Innovative Home Stroke Rehabilitation and Monitoring System
Brief Summary: The purpose of this research is to evaluate a therapy delivery system for stroke patients that provide accessible, affordable stroke care. User-friendly home therapy robots and a telerehabilitation system are combined to monitor and provide therapy that is accessible for patients in rural and underserved locations. The robotic-based home therapy intervention will produce significantly greater improvement in upper extremity motor function than Usual and Customary Care enhanced with a (non-robotic) home therapy upper extremity rehabilitation program at the end of 8 weeks of home therapy.


Options:
A: Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment (Baseline to Final Training (6 weeks))
B: Fugl Meyer Assessment Scale (four and one weeks prior to intervention, four weeks after intervention started, at the end of intervention(eight weeks), two months and six months follow-up)
C: Action Research Arm Test (ARAT) (End of treatment at 8 weeks post enrolment)
D: Fugl-Meyer (FM-SEC and FM-WH) (7 months); Motor-Functional Independence Measure (m-FIM) (7 months); Frenchay Arm Test (FA-T) (7 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Innovative Home Stroke Rehabilitation and Monitoring System
Brief Summary: The purpose of this research is to evaluate a therapy delivery system for stroke patients that provide accessible, affordable stroke care. User-friendly home therapy robots and a telerehabilitation system are combined to monitor and provide therapy that is accessible for patients in rural and underserved locations. The robotic-based home therapy intervention will produce significantly greater improvement in upper extremity motor function than Usual and Customary Care enhanced with a (non-robotic) home therapy upper extremity rehabilitation program at the end of 8 weeks of home therapy.


Options:
A: Change in Action Research Arm Test score from baseline (Baseline, after 4 weeks and at 3 months follow-up)
B: Physical activity of the lower and upper extremities (6 months)
C: Action Research Arm Test (ARAT) (End of treatment at 8 weeks post enrolment)
D: Length of outpatient rehab stay (LOS) (From admission to discharge, an expected average of 5 weeks.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Innovative Home Stroke Rehabilitation and Monitoring System
Brief Summary: The purpose of this research is to evaluate a therapy delivery system for stroke patients that provide accessible, affordable stroke care. User-friendly home therapy robots and a telerehabilitation system are combined to monitor and provide therapy that is accessible for patients in rural and underserved locations. The robotic-based home therapy intervention will produce significantly greater improvement in upper extremity motor function than Usual and Customary Care enhanced with a (non-robotic) home therapy upper extremity rehabilitation program at the end of 8 weeks of home therapy.


Options:
A: Movement time (Baseline and change from baseline in movement time at 4 weeks); Motor units (Baseline and change from baseline in motor units at 4 weeks); Elbow extension angle (Baseline and change from baseline in elbow extension angle at 4 weeks); Lateral index (Baseline and change from baseline in lateral index at 4 weeks)
B: Fugl-Meyer Assessment for Motor Recovery (FM) Scale (6, 12, 24 and 36 weeks minus baseline)
C: Action Research Arm Test (ARAT) (End of treatment at 8 weeks post enrolment)
D: Change from Baseline in Fugl-Meyer Scale at 28 weeks. (at inclusion, week 4 and week 28); Change from Baseline in Box and Block Test at 28 weeks. (at inclusion, week 4 and week 28.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Fistulas in Patients With Refractory Perianal Crohn's Disease
Brief Summary: In a dose escalation study we will determine the safety and preliminary efficacy of allogeneic bone marrow mesenchymal stem cells (bmMSCs) in the induction of response for active fistulizing Crohn's Disease (CD).


Options:
A: Safety and efficacy (fistula closure) (12 weeks)
B: Clinical response to MSC: Reduction of Crohn's disease Activity score by 100 points or more at six weeks post start of therapy (Six weeks)
C: Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 (Week 6); Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 (Week 52)
D: Treatment related adverse events (Month 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Lapatinib Versus Lapatinib With Capecitabine as Second-line Treatment in Her2-Overexpressing Metastatic Gastro-Esophageal Cancer: A Randomized Phase II Trial
Brief Summary: Combining Erb inhibitors, such lapatinib, and TS inhibitors, such as capecitabine, may be a beneficial contribution to current treatment paradigms since preclinical data suggest that lapatinib alone can decrease TS mRNA and is synergistic with capecitabine in some cell lines, which may contribute to clinical benefit. The study described in this protocol has been designed to establish the anti-tumor activity of Lapatinib with or without capecitabine in the treatment of Her2 overexpressing metastatic gastric- and gastro-esophageal cancer, and to search for molecular correlates that may be associated with response to this compound.

The majority of patients with metastatic gastric and gastro-esophageal cancer undergo first-line combined chemotherapy (e.g. platin derivates and fluoropyrimidines, sometimes combined to a taxane), but the role of second-line chemotherapy has not yet been defined. Therefore, progression during or shortly after first-line chemotherapy is a medical condition no standard medical approach exists. The overexpression of EGFR and Her2 in gastric and gastroesophageal cancer make these indications prime candidate for treatment with the dual ErbB1/2 tyrosine kinase inhibitor (TKI) Lapatinib.


Options:
A: Progression free survival (PFS), as measured by RECIST per local review (Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study.)
B: Failure-free survival (six months)
C: Progression Free Survival (PFS) (22 months)
D: Objective response rate (ORR) (about 10 month (until progression))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Lapatinib Versus Lapatinib With Capecitabine as Second-line Treatment in Her2-Overexpressing Metastatic Gastro-Esophageal Cancer: A Randomized Phase II Trial
Brief Summary: Combining Erb inhibitors, such lapatinib, and TS inhibitors, such as capecitabine, may be a beneficial contribution to current treatment paradigms since preclinical data suggest that lapatinib alone can decrease TS mRNA and is synergistic with capecitabine in some cell lines, which may contribute to clinical benefit. The study described in this protocol has been designed to establish the anti-tumor activity of Lapatinib with or without capecitabine in the treatment of Her2 overexpressing metastatic gastric- and gastro-esophageal cancer, and to search for molecular correlates that may be associated with response to this compound.

The majority of patients with metastatic gastric and gastro-esophageal cancer undergo first-line combined chemotherapy (e.g. platin derivates and fluoropyrimidines, sometimes combined to a taxane), but the role of second-line chemotherapy has not yet been defined. Therefore, progression during or shortly after first-line chemotherapy is a medical condition no standard medical approach exists. The overexpression of EGFR and Her2 in gastric and gastroesophageal cancer make these indications prime candidate for treatment with the dual ErbB1/2 tyrosine kinase inhibitor (TKI) Lapatinib.


Options:
A: overall survival
B: Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma (Up to 2 years post-treatment)
C: Objective response rate (ORR) (about 10 month (until progression))
D: Overall Survival (From Baseline until death from any cause (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.4 [0-42] months vs. 25.0 [0-41] months; Final Analysis: 46.1 [0-70] months vs. 44.4 [0-68] months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)
Brief Summary: The purpose of this study is to compare the efficacy and safety of intravenous iron therapy with oral iron therapy in patients with cancer and chemotherapy induced anaemia.


Options:
A: Progression-free Survival (PFS) Rate at 3 Years (Assessed every 3 months until progression up to 4 years and 8 months)
B: Change in Hb Concentration (Baseline week 4)
C: Incidence of at least one RBC transfusion from week 5 to End of Treatment Period (EOTP) (from week 5 to EOTP)
D: Hb response rate (up to week 15)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Five Year Follow-up of Internet-based Cognitive Behaviour Therapy for Social Anxiety Disorder
Brief Summary: Social anxiety disorder (SAD) is one of the most prevalent anxiety disorders in the western world. Cognitive behavioural therapy (CBT) is the psychological treatment that has the largest empirical support. However, the availability to CBT is very limited in Sweden due to lack of therapists with proper training. Therefore it is important to evaluate alternative forms of treatment that are more time efficient. One of these methods is Internet based self-help therapy, which has proven to be an effective treatment for social anxiety disorder.

In this study, the investigators aim to conduct a follow-up assessment five years after completed Internet-based CBT. Participants received treatment within the context of a randomised controlled trial conducted in 2005. Thus, in the present study there will be no treatment interventions, only assessment.


Options:
A: Measure of social anxiety and avoidance - Liebowitz Social Anxiety Scale (LSAS) (5-year follow-up)
B: Panic Disorder Severity Scale (PDSS) (Pre, post at 6-month follow-up)
C: Panic Disorder Severity Scale (PDSS) (Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment)
D: Leibowitz Social Anxiety Scale - Self Report (LSAS-SR) (pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)); Social Phobia Inventory (SPIN) (pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Five Year Follow-up of Internet-based Cognitive Behaviour Therapy for Social Anxiety Disorder
Brief Summary: Social anxiety disorder (SAD) is one of the most prevalent anxiety disorders in the western world. Cognitive behavioural therapy (CBT) is the psychological treatment that has the largest empirical support. However, the availability to CBT is very limited in Sweden due to lack of therapists with proper training. Therefore it is important to evaluate alternative forms of treatment that are more time efficient. One of these methods is Internet based self-help therapy, which has proven to be an effective treatment for social anxiety disorder.

In this study, the investigators aim to conduct a follow-up assessment five years after completed Internet-based CBT. Participants received treatment within the context of a randomised controlled trial conducted in 2005. Thus, in the present study there will be no treatment interventions, only assessment.


Options:
A: Measure of social anxiety and avoidance - Liebowitz Social Anxiety Scale (LSAS) (5-year follow-up)
B: Liebowitz Social Anxiety Scale (LSAS)
C: Leibowitz Social Anxiety Scale - Self Report (LSAS-SR) (pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)); Social Phobia Inventory (SPIN) (pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37))
D: Panic Disorder Severity Scale (PDSS) (Pre, post at 6-month follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nutrition and Physical Activity in Patients With Cerebrovascular Disease
Brief Summary: The study will provide evidence of eating habits and physical activity in cerebrovascular patients in Luxembourg and of the degree to which these habits may be changed acutely (after one month) and in the long run (after 4 months) by intensive counselling. Furthermore the influence of intensive counselling and of the consumption of red wine on cerebrovascular risk factors, cognition, and on surrogate parameters for stroke will be assessed.


Options:
A: Adherence to alcohol intake and MRI examinations (6 months)
B: Vascular function (Measured at weeks 4 and 12)
C: Blood Pressure (2 hours after consuming beverage)
D: Differences in mean systolic blood pressure in the two diet/sport arms (4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Nutrition and Physical Activity in Patients With Cerebrovascular Disease
Brief Summary: The study will provide evidence of eating habits and physical activity in cerebrovascular patients in Luxembourg and of the degree to which these habits may be changed acutely (after one month) and in the long run (after 4 months) by intensive counselling. Furthermore the influence of intensive counselling and of the consumption of red wine on cerebrovascular risk factors, cognition, and on surrogate parameters for stroke will be assessed.


Options:
A: Differences in mean systolic blood pressure in the two diet/sport arms (4 months)
B: Cardiovascular mortality (From entry into the study (baseline: 2002-2006) through study completion); All-cause mortality (From entry into the study (baseline: 2002-2006) through study completion); Major cardiovascular events (From entry into the study (baseline: 2002-2006) until November 2009)
C: Survival free of atrial fibrillation (12 months)
D: All-cause mortality (from enrollment to 1252 deaths in R2 arm); All cause mortality or hospitalizations for any reason (from enrollment to 1252 deaths)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nutrition and Physical Activity in Patients With Cerebrovascular Disease
Brief Summary: The study will provide evidence of eating habits and physical activity in cerebrovascular patients in Luxembourg and of the degree to which these habits may be changed acutely (after one month) and in the long run (after 4 months) by intensive counselling. Furthermore the influence of intensive counselling and of the consumption of red wine on cerebrovascular risk factors, cognition, and on surrogate parameters for stroke will be assessed.


Options:
A: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)
B: Survival free of atrial fibrillation (12 months)
C: Sudden cardiac death (12 months)
D: Differences in mean systolic blood pressure in the two diet/sport arms (4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Acetazolamide and Furosemide on Obesity-induced Glomerular Hyperfiltration
Brief Summary: Background:

Obesity is associated with a high prevalence of chronic kidney disease.The glomerular hyperfiltration associated with obesity may play a role in the pathogenesis of obesity associated chronic kidney disease. Attenuation of hyperfiltration by pharmacological means may slow down the development and progression of chronic renal failure. The investigators have previously shown that acetazolamide, a proximally acting diuretic that activates tubuloglomerular feedback(TGF) by increasing solute delivery to the Macula DENSA, abates glomerular hyperfiltration. The present study was designed to test the hypothesis that this decrease in hyperfiltration is specific to acetazolamide and not due to a non specific diuretic effect. The aim of the present study is to compare the effects of furosemide and acetazolamide on glomerular hemodynamics in subjects with severe obesity.

Methods:

A randomized double-blind crossover controlled design will be used. Fifteen obese subjects and ten subjects with normal body weight will participate in the study. Obese subjects will undergo measurement of glomerular filtration rate (GFR)(inulin clearance), renal plasma flow (RPF) (p-aminohippuric acid clearance), filtration fraction, fractional excretion of lithium (FE LI) and blood pressure, before and after intravenous administration of furosemide 2 mg. and acetazolamide 5 mg/kg BW. Ten subjects with normal body weight will undergo measurement of renal function without administration of diuretics.


Options:
A: Percentage change of 24-hour proteinuria (6 months)
B: Change in GFR (ml/Min) (baseline and after diuretics administration); Renal Vascular Resistance (mm Hg/[ml/Min]) (baseline and after diuretics administration)
C: Difference in Tacrolimus Exposure (AUC-0-24)) in Obese Patients Who Received an Initial TAC -ER Dose of 0.15 mg/kg Using aBW Versus IBW (Days 1-14)
D: Time-to-first event of the composite endpoint (Approximately 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Retrospective Epidemiological Study to Map Out Patients With Chronic Obstructive Pulmonary Disease (COPD) and Describe COPD Health Care in Real-Life Primary Care During the First Ten Years of the 21th Century
Brief Summary: The aim of this study is to describe COPD health care and to assess demographics, concurrent diseases and mortality and the use of pharmaceuticals for a chronic obstructive pulmonary disease (COPD) population in real life in primary care during the last ten years.


Options:
A: Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean (From the start of the double blinded study medication until Visit 11 (Week 52)/Early Withdrawal)
B: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
C: Describe the development of COPD health care structure in primary care. (Data will be extracted from the medical records on one occassion, covering a period of one decade.)
D: Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean (From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Follow-up Protocol to Collect the Outcome and Safety of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Study P06029 (Phase 3; Protocol No. P06031)
Brief Summary: The purpose of this follow-up study is to collect the outcome and safety of FTET cycles after the embryos are cryopreserved in P06029 (NCT01144416). P06029 was a study in which a single injection of corifollitropin alfa (SCH 900962) was compared with daily recombinant follicle stimulating hormone (recFSH) injections in women aged 35 to 42 years undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).


Options:
A: Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate) (Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years))
B: Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) (7 weeks gestation)
C: live birth rate (10 months for group A, 12 months for group B)
D: Implantation rate (8 weeks after replacement)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Follow-up Protocol to Collect the Outcome and Safety of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Study P06029 (Phase 3; Protocol No. P06031)
Brief Summary: The purpose of this follow-up study is to collect the outcome and safety of FTET cycles after the embryos are cryopreserved in P06029 (NCT01144416). P06029 was a study in which a single injection of corifollitropin alfa (SCH 900962) was compared with daily recombinant follicle stimulating hormone (recFSH) injections in women aged 35 to 42 years undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).


Options:
A: live birth rate (10 months for group A, 12 months for group B)
B: Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) (7 weeks gestation)
C: Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate) (Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years))
D: implantation rate (4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy of Varenicline Tartrate for Alcohol Dependence in Very Heavy Drinkers
Brief Summary: The primary objective of this study is to assess the efficacy of varenicline in reducing the proportion of heavy drinking days during the last 8 weeks of treatment in subjects with alcohol dependence confirmed by Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR) criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks for women (designated as "very heavy" drinkers).


Options:
A: Success rates and safety at week 24 in the varenicline vs placebo. Success rates will be defined as the Continuous Quit Rate since last visit. Maintain abstinence during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. (week 24)
B: Weekly Percentage of Heavy Drinking Days (Weeks 2-13*)
C: 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (Week 11)
D: Continuous abstinence from smoking (Six months post-quit date)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Double Blind, Placebo Controlled Trial to Assess the Efficacy of Varenicline Tartrate for Alcohol Dependence in Very Heavy Drinkers
Brief Summary: The primary objective of this study is to assess the efficacy of varenicline in reducing the proportion of heavy drinking days during the last 8 weeks of treatment in subjects with alcohol dependence confirmed by Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR) criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks for women (designated as "very heavy" drinkers).


Options:
A: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
B: 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (Week 11)
C: Weekly Percentage of Heavy Drinking Days (Weeks 2-13*)
D: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)

Answer: C