TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2B Study of Tenecteplase (TNK) in Acute Ischemic Stroke (TNK-S2B)
Brief Summary: The purpose of this study is to determine which of 3 different doses of tenecteplase (TNK) is better for treating stroke patients and if TNK offers an advantage over currently available treatment with tissue plasminogen activator (tPA).


Options:
A: National Institutes of Health Stroke Scale (NIHSS) (Change from Baseline to day 90); Modified Rankin Scale (MRS) (Day 90); Barthel Index (BI) score of 75-100. (Day 90)
B: Functional Handicap (Modified Rankin Score) (3 months)
C: To assess whether local intra-arterial (LIA) recombinant tissue plasminogen activator rt-PA, as compared to intravenous (IV) rt-PA, increases survival free of disability (modified Rankin score of 0 or 1) . (3 months)
D: To assess whether IA thrombolysis, as compared to IV rt-PA, increases survival free of disability (modified Rankin score of zero or 1) at 3 months. (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Zinc as Adjuvant Therapy in the Treatment of Severe Pneumonia in Nepalese Children at the Kanti Children's Hospital
Brief Summary: The aim of this study is to assess whether zinc given as adjuvant therapy to standard antibiotic treatment in children hospitalized for severe pneumonia reduces the duration of the severe illness and risk of treatment failure. A randomized double blind placebo controlled clinical trial will be conducted at the Kanti Hospital.


Options:
A: Preventive effect of zinc therapy on diarrhoea during the subsequent three month 14 days of enrollment; Assess the acceptability of zinc therapy during diarrhoea in young children.
B: change in mean serum zinc level; Number of episodes of ALRI per child ALRI free days per child per year; (six months)
C: Time to cessation of severe pneumonia (Within 2 weeks after enrollment); The period starting from enrolment to the beginning of a 24-hour consecutive period of absence of lower chest indrawing, of hypoxia and of any danger signs. (Recovery from pneumonia within 2 weeks)
D: Age; Sex; Weight; Body Mass index; Duration of diarrhoea before admission; Stool volume; Dehydration status

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Danish Osteoporosis Prevention Study
Brief Summary: Hypothesis: Use of hormone replacement therapy (HRT) decreases the incidence of fractures in early postmenopausal women.

The project was initiated in 1990, and the inclusion ended in 1993. A total of 2,016 early postmenopausal women were divided into two groups: The first group accepted randomisation to HRT or not, and the second group was allowed to choose HRT or not.

The study was not blinded. Main measurements were fracture risk over 20 years, changes in bone mineral density over 20 years, and side effects, mainly breast cancer.


Options:
A: N/A
B: rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)
C: N/A
D: Fracture; Bone mineral density

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Danish Osteoporosis Prevention Study
Brief Summary: Hypothesis: Use of hormone replacement therapy (HRT) decreases the incidence of fractures in early postmenopausal women.

The project was initiated in 1990, and the inclusion ended in 1993. A total of 2,016 early postmenopausal women were divided into two groups: The first group accepted randomisation to HRT or not, and the second group was allowed to choose HRT or not.

The study was not blinded. Main measurements were fracture risk over 20 years, changes in bone mineral density over 20 years, and side effects, mainly breast cancer.


Options:
A: Fracture; Bone mineral density
B: All-cause dementia and Mild Cognitive Impairment (Measured once a year)
C: rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Galantamine Versus Placebo in Childhood Autism
Brief Summary: Autism is a severe neurodevelopmental disorder that affects up to 16 in 10,000 individuals. It is a pervasive developmental disorder affecting social, communicative, and compulsive/repetitive behaviors characterized by stereotypic complex hand and body movements, craving for sameness, and narrow repetitive interests. Autism severely impacts both the affected individual and family members.

The proposed study is designed to assess the efficacy of treatment with Galantamine vs. placebo in childhood/adolescent autism fulfilling DSM-IV and Autism Diagnostic Interview (ADI) criteria. We therefore hypothesize:

1. Galantamine will be superior to placebo in the acute treatment of global autism.
2. Galantamine will be superior to placebo in improving functional ability.
3. Galantamine will be superior to placebo in improving language function.
4. Galantamine will be superior to placebo improving irritable and hyperactive behavior.
5. Galantamine will be superior to placebo in improving social deficits.


Options:
A: The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score. (Throughout the study)
B: Autism Diagnostic Observation Schedule-Generic (ADOS-G)- Change from Baseline to Final Visit; Clinical Global Impression Improvement (CGI)- Change from Baseline to Final Visit; Aberrant Behavior Checklist (ABC) (hyperactivity/irritability sections)- Change from Baseline to Final Visit; Vineland Adaptive Behavior Scale- Change from Baseline to Final Visit; MacArthur Communicative Development Inventory (MCDI)- Change from Baseline to Final Visit; Conners' Parent Rating Scale-Revised: Long form (CPRS-R:L)- Change from Baseline to Final Visit
C: Number of Participants Reporting Improvement on the Clinical Global Impression (Baseline to end of study (week 15)); Change in Aberrant Behaviors as Measured by the Aberrant Behavior Checklist Scores (Baseline and End of Study (week 15))
D: Aberrant Behavior Checklist - Social Withdrawal Subscale (Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Study of Early vs. Delayed Goal Enteral Nutrition in Mechanically Ventilated Patients
Brief Summary: This study tests the hypothesis that initial trophic enteral feedings will increase the time alive and free of mechanical ventilation as compared to initial goal enteral feedings in patients who are mechanically ventilated.


Options:
A: Sudden cardiac death (12 months)
B: Number of ventilator-free days (VFD) (Measured at Day 28); Mortality before hospital discharge, with unassisted breathing (Measured at Days 60 and 90)
C: Ventilator-free days (day 28)
D: Number of ventilator-free days (VFD) (Measured at Day 28); Mortality before hospital discharge, with unassisted breathing (Measured at Days 60 and 90)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 2 Diabetic Patients With Retinopathy.
Brief Summary: The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normoalbuminuric type 2 diabetic patients with retinopathy.

The secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic retinopathy (PDR) and beneficially influences the rate change in urinary albumin excretion rate (UAER).

This study is part of the DIRECT Programme also including a primary prevention study of diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 1 diabetes. The primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.


Options:
A: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
B: N/A
C: Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale. (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
D: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 2 Diabetic Patients With Retinopathy.
Brief Summary: The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normoalbuminuric type 2 diabetic patients with retinopathy.

The secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic retinopathy (PDR) and beneficially influences the rate change in urinary albumin excretion rate (UAER).

This study is part of the DIRECT Programme also including a primary prevention study of diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 1 diabetes. The primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.


Options:
A: Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale. (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
B: Relative risk of major maternal hypoglycaemia (after 24 hours)
C: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
D: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 2 Diabetic Patients With Retinopathy.
Brief Summary: The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normoalbuminuric type 2 diabetic patients with retinopathy.

The secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic retinopathy (PDR) and beneficially influences the rate change in urinary albumin excretion rate (UAER).

This study is part of the DIRECT Programme also including a primary prevention study of diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 1 diabetes. The primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.


Options:
A: To recruit 285 type 1 DM Pts without HTN, diabetic nephropathy, or microalbuminuria into a 5-year study to determine the effect of inhibition RAS with either losartan or enalapril. (5 year); To obtain two percutaneous renal biopsies from each patient, five years apart. (5 year)
B: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
C: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
D: Basement membrane thickness; Mesangial expansion

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 2 Diabetic Patients With Retinopathy.
Brief Summary: The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normoalbuminuric type 2 diabetic patients with retinopathy.

The secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic retinopathy (PDR) and beneficially influences the rate change in urinary albumin excretion rate (UAER).

This study is part of the DIRECT Programme also including a primary prevention study of diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 1 diabetes. The primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.


Options:
A: A composite of fatal and non-fatal cardiovascular events: Cerebrovascular events (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, stroke of undetermined etiology and transient ischemic attack) (36 Months); Coronary events (sudden death, myocardial infarction, angina pectoris, asymptomatic myocardial ischemia) (36 Months); Heart failure (36 Months); Vascular events (aortic aneurysm, aortic dissection, and arteriosclerotic diseases) (36 Months); Diabetic complications (nephropathy, retinopathy and neuropathy) (36 Months); Renal dysfunction (doubling of serum creatinine, end stage renal diseases) (36 Months); All cause mortality (36 Months)
B: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
C: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
D: To contribute to the ADDITION-Europe study, to assess screening and intensive treatment on 5 year cardiovascular outcomes (At end of study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 2 Diabetic Patients With Retinopathy.
Brief Summary: The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normoalbuminuric type 2 diabetic patients with retinopathy.

The secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic retinopathy (PDR) and beneficially influences the rate change in urinary albumin excretion rate (UAER).

This study is part of the DIRECT Programme also including a primary prevention study of diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 1 diabetes. The primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.


Options:
A: To recruit 285 type 1 DM Pts without HTN, diabetic nephropathy, or microalbuminuria into a 5-year study to determine the effect of inhibition RAS with either losartan or enalapril. (5 year); To obtain two percutaneous renal biopsies from each patient, five years apart. (5 year)
B: Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy (Measured at Year 4)
C: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
D: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Randomised, Open-Label, Parallel-Group, Phase III Post-Marketing Clinical Study to Compare the Overall Survival Between Gefitinib and Docetaxel in Patients With Advanced or Metastatic (Stage IIIB/IV), or Recurrent Non-Small Cell Lung Cancer, Who Have Failed One or Two Chemotherapy Regimens
Brief Summary: In this study, among the patients with non-small cell lung cancer, those with metastasis or recurrence and previous treatment with chemotherapy will receive gefitinib or docetaxel, and we will compare the effectiveness and safety of gefitinib with docetaxel.


Options:
A: Determine the overall survival with these treatments as the primary outcome.
B: Progression Free Survival (PFS) (Randomization to the first date of measured PD or death up to 37.32 months)
C: Progression Free Survival (PFS) (Randomization to Progressive Disease or Death Due to Any Cause (Up to 58.78 Months))
D: Progression free survival (PFS) (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: DIRECT: DIabetic Retinopathy Candesartan Trials. Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 1 Diabetic Patients With Retinopathy.
Brief Summary: The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic patients with retinopathy.

The secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic retinopathy (PDR) and beneficially influences the rate of change in urinary albumin excretion rate (UAER).

This study is part of the DIRECT Programme also including a primary prevention study of diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 2 diabetes. The primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.


Options:
A: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
B: Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale. (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
C: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: DIRECT: DIabetic Retinopathy Candesartan Trials. Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 1 Diabetic Patients With Retinopathy.
Brief Summary: The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic patients with retinopathy.

The secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic retinopathy (PDR) and beneficially influences the rate of change in urinary albumin excretion rate (UAER).

This study is part of the DIRECT Programme also including a primary prevention study of diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 2 diabetes. The primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.


Options:
A: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
B: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
C: Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale. (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
D: Glycosylated Haemoglobin (HbA1c) for Full Analysis Set (Pregnant Subjects) at GW 36 (At gestational week (GW) 36); Glycosylated Haemoglobin (HbA1c) for Per Protocol Analysis Set (Pregnant Subjects) at GW 36 (At gestational week (GW) 36)

Answer: B