TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Stroke Team Remote Evaluation Using a Digital Observation Camera Arizona - The Initial Mayo Clinic Experience
Brief Summary: Noninvasive prospective multi-center study of an interactive 2-way, wireless or site-independent, audiovisual telemedicine system designed for real-time remote examination of acute stroke symptoms and deficits as a basis for treatment consultation and recommendation.

Study aims (1) to determine the impact of a site-independent, remote, telemedicine consultation system on decision making in the Emergency Department, regarding the decision to treat or not to treat with thrombolytics; (2) to assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine versus telephone only; (3) to assess the appropriateness of thrombolytic treatment decisions in telemedicine versus telephone-only consultations; and (4) to assess the completeness of the data collection in telemedicine versus telephone-only consultations.

60 patients in Arizona with acute presentation of stroke symptoms, per bedside practitioner discretion (onset generally less than 12 hours and likely less than 3 hours)

Two arms: Video Camera/Telemedicine (Intervention n = 30) and No Video Camera/Telephone only (Control n = 30)


Options:
A: Fasting Insulin (Baseline); 3 Month Fasting Insulin (3 month); 12 Month Fasting Insulin (12 months); Fasting Glucose (Baseline); 3 Month Fasting Glucose (3 months); 12 Month Fasting Glucose (12 Months)
B: to determine the impact of a site-independent, remote, telemedicine consultation system on decision making in the Emergency Department, regarding the decision to treat or not to treat with thrombolytics (90 days); to assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine versus telephone only (90 days); to assess the appropriateness of thrombolytic treatment decisions in telemedicine versus telephone-only consultations (90 days); to assess the completeness of the data collection in telemedicine versus telephone-only consultations. (90 days)
C: Brief Pain Inventory (Pain) (1 year)
D: Change in HbA1c at 12 months (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Controlled, Parallel, Prospective Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subjects, as Applicable, Compared to That of Episodic Treatment
Brief Summary: To evaluate the effect of secondary prophylaxis as compared to episodic treatment on bleeding frequency (number of bleeds per year) and on joint damage.


Options:
A: Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units) (52 weeks after treatment start for patients on prophylaxis); Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units) (28 weeks after treatment start on on-demand treatment)
B: Bleeding Frequency (Number of Total Bleeds) (After the last enrolled patient has been in the study for 1 year. At the cut-off, the median follow-up duration was 616 days (minimum was 111 days and maximum was 1109 days))
C: Change in Frequency of Spontaneous Bleeding Events Between On-demand and Prophylaxis Treatments (Annualized) (Up to 26 weeks for on-demand regimen, and between 1 and 17 months for prophylaxis regimen.); Number of Subjects Developing Inhibitors Against Factor IX (FIX) (Up to 27.7 months (maximum))
D: Area under the concentration versus time curve from time 0 to the last data point (AUC(0-tlast)) for BAY 94-9027 (Pre-dose to 120 hours after the end of the infusion); Area under the concentration versus time curve from time 0 to the last data point (AUC(0-tlast)) for Adynovi (Pre-dose to 120 hours after the end of the infusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Acute Exacerbation of Chronic Heart Failure: "Hospital at Home" Versus Inpatient Care for Elderly Patients. A Randomized, Controlled Trial.
Brief Summary: Aim of the study was to evaluate the efficacy of hospital-at-home treatment compared with inpatient care in selected elderly patients with acute exacerbation of chronic heart failure (CHF).


Options:
A: NIHSS Stroke Scale, relapse rate (360 days)
B: Mortality, dependence, psychoscial outcome; Mortality, dependence and psychosocial outcome (6 months endpoint)
C: mortality (6 months)
D: Total direct cost of hospitalization, $ (From date of admission to date of discharge, an expected average of 4 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Prevention of Broncho-pulmonary Dysplasia and Neonatal Mortality in Very Preterm Infants Using Low Dose of Hydrocortisone: a Randomized Controlled Trial
Brief Summary: There is increasing evidence linking a fetal and early neonatal systemic inflammatory response syndrome to the subsequent development of bronchopulmonary dysplasia (BPD) and white matter injury (WMI) in very preterm infants. Babies with evidence of adrenal insufficiency early in life may not be able to control the inflammatory response and are thereby more likely to develop BPD than babies who do not show such evidence of inflammation. We designed a randomized controlled trial to test the hypothesis whether very preterm babies at high-risk of BPD, treated with low doses of HC during the first 10 days of life, are more likely to survive without BPD at 36 weeks of post-menstrual age (PMA), compared to babies treated with placebo.


Options:
A: Total Cerebral Volume as Measured by Volumetric Brain MRI (38 weeks postmenstrual age (PMA))
B: dichotomous variable: survival without BPD at 36 weeks PMA. (add 8 to12)
C: Enrollment and completion of 60 infants (1 year)
D: Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD) (From day of randomization to 36 weeks post menstrual age); Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI) (From day of randomization to 22-26 months corrected age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Prevention of Broncho-pulmonary Dysplasia and Neonatal Mortality in Very Preterm Infants Using Low Dose of Hydrocortisone: a Randomized Controlled Trial
Brief Summary: There is increasing evidence linking a fetal and early neonatal systemic inflammatory response syndrome to the subsequent development of bronchopulmonary dysplasia (BPD) and white matter injury (WMI) in very preterm infants. Babies with evidence of adrenal insufficiency early in life may not be able to control the inflammatory response and are thereby more likely to develop BPD than babies who do not show such evidence of inflammation. We designed a randomized controlled trial to test the hypothesis whether very preterm babies at high-risk of BPD, treated with low doses of HC during the first 10 days of life, are more likely to survive without BPD at 36 weeks of post-menstrual age (PMA), compared to babies treated with placebo.


Options:
A: dichotomous variable: survival without BPD at 36 weeks PMA. (add 8 to12)
B: Successful rate in closing PDA of ibuprofen administered at high or standard dose. (Between 84 and 96 hours of life)
C: closure of PDA (6 days)
D: Composite of mortality, and/or NEC, and/or BPD (At a postmenstrual age of 36 completed weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center Phase II Study to Evaluate Tumor Response to Ipilimumab (BMS-734016) Monotherapy in Subjects With Melanoma Brain Metastases
Brief Summary: To assess the response of melanoma with brain metastases to ipilimumab treatment while maintaining acceptable tolerability.


Options:
A: Objective Response Rate (ORR) (From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 months)); Overall Survival (OS) (Up to 96 months)
B: Relapse-free survival (RFS) (Up to 1 year)
C: Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria (From Day 1, first dose to end of Week 12)
D: Overall Survival (OS) (Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention Through Acitivity in Kindergarten Trial
Brief Summary: Objectives: The PAKT project shall evaluate the effects of an exercise intervention in kindergarten combined with an educational training of parents and kindergarten teachers on behavior and health status of children.

Study design: Baseline measurements were performed on more than 700 kindergarten children aged 43-67 months in May to July 2007. The kindergartens are located in and around Wuerzburg in Germany. Kindergartens were then randomized in an intervention (21 kindergartens) and a control (20 kindergartens) group. The intervention group offers a daily exercise class lasting at least 30 min. Parents and teachers of the children in the intervention program receive educational training. In addition, the children have activity homework involving the entire family. The control kindergartens keep their routine. Follow-up measurements of physical activity (actigraph), motor skills, body mass index, skinfold thickness, and blood pressure take place in January/February 2008, June/July 2008, and September/October 2008. The number of accidents in and outside of the kindergartens and the number of children missing the kindergarten due to infections are monitored continuously.

Use of results: If the PAKT program should proof effective, the results will be published in scientific journals and made public using the press. With the help of the GEK, the program will then be implemented nationwide in kindergartens.


Options:
A: Change in Fruit and Vegetable Consumption at School Lunch (assessed 4 times each 9-month school year; once prior to intervention beginning (i.e., September), approximately 10 weeks and then 20 weeks later, and finally once after the intervention ends (i.e., May).); Change in Student Activity Level (assessed 3 times over 1 year; initially prior to the intervention beginning (i.e., September), a 2nd time once the intervention ends (i.e., May), and then again at the beginning of the following school year (i.e., September))
B: Change in BMI z-score (Baseline (0 months) and 9 months)
C: Develop/evaluate effectiveness of a community-based intervention targets children of the Pacific Region who are overweight in order to slow and prevent further weight gain (for children to "grow into their weight") (Feb 2008 - Feb 2012)
D: Physical activity (baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention); motor skills (baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Supplementation With Zinc and Other Micronutrients on the Health and Development of African Children
Brief Summary: The purpose of this study is to determine to what extent supplementation with zinc and other micronutrients are efficacious in preventing malaria in young Tanzanian children.


Options:
A: Febrile malaria episodes (60 weeks)
B: - To measure the impact of zinc and vitamin A on the duration of diarrheal illness (Weekly home visits for 6 months)
C: Changes in Maternal Serum B12 Concentration From 1st to 3rd Trimester (from 1st to 3rd trimester)
D: IQ score (Aug 2007-Jan 2008)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: IV vs. IA tPA (Activase) in Acute Ischemic Stroke With CTA Evidence of Major Vessel Occlusion
Brief Summary: Stroke is the third leading cause of death in the United States, responsible for 158,488 deaths in 1998 (American Heart Association). Nationwide, each year, an estimated 600,000 to 750,000 people suffer a new or recurrent stroke. Cerebral infarction comprises 80% of all strokes and is the result of a complex series of cellular metabolic events that occur rapidly after interruption of blood flow to a region of the brain. The extent of the brain damage is dependent on the duration and severity of the cerebral ischemia. Acute thrombus formation or migration is the principal cause of blood flow interruption in at least 75% of cerebral infarctions. In several animal models of focal cerebral ischemia, restoration of cerebral blood flow within two to six hours after initial occlusion has been associated with smaller volumes of cerebral infarction and improved functional outcome. An effective way of dissolving the thrombus is by administration of recombinant tissue plasminogen activator or Activase (Alteplase, rt-PA), which promotes the proteolytic action of plasmin from plasminogen at the site of a clot. In this study, the drug, Activase, will be administered in subjects with acute ischemic stroke (AIS) intravenously (IV) or by local intra-arterial (IA) injection. The use of the intravenous administration within 3 hours of stroke symptom onset is FDA approved whereas the intra-arterial administration, despite evidence of potential benefit, is not currently FDA approved. Although not FDA approved, this study will evaluate the effectiveness of IA thrombolysis with Activase, used in AIS because of its higher rate of recanalization , potential expansion of the time window out to 6 hours, and lower doses of thrombolytic agent used compared with systemic or intravenous Activase. The study is designed to test the feasibility and provide preliminary safety data regarding the relative benefits and risks of IA Activase as compared to IV Activase when administered per the NINDS rt-PA stroke study protocol, i.e. randomized within 3 hours of onset of symptoms of ischemic stroke then treated within 3 hours in the IV Activase arm and within 4 hours in the IA Activase arm.


Options:
A: Shift in the mRS score, defined by a proportional odds model. (90 days)
B: 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)
C: The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90 (Day 90)
D: Feasibility of enrolling 12 subjects with major vessel occlusion within 1 year and random 1:1 assignment to treatment with IV (N=6) and IA (N=6) IA Activase using the following criteria: Time to clinical and radiological assessments (3 years); Time to IA Activase treatment (3 years); Preliminary safety assessment: 24 hour symptomatic ICH (3 years); Resources utilized and risk-benefit of IA Activase treatment. (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label Trial of the Efficacy and Safety of Chronic Administration of the Fixed Dose Combination of Telmisartan 40mg + Amlodipine 10mg or Fixed Dose Combination of Telmisartan 80mg + Amlodipine 10mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension
Brief Summary: The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10) during open-label treatment for at least six months.

An additional objective is to assess the efficacy and safety of concomitant administration of either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of hypertension.

The primary endpoint is the proportion of patients achieving DBP control (defined as mean seated DBP \< 90 mmHg at trough i.e. approximately 24 hours after last dose of study treatment) at six months of treatment or at last trough observation during the treatment period (i.e. last trough observation carried forward).


Options:
A: Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12 (Baseline, Month 12)
B: Trough Seated Diastolic Blood Pressure (DBP) Control (End of study (34 weeks or last value on treatment))
C: Reduction in blood Pressure (12 weeks); reduction in Heart Rate (12 weeks); modify lipids (12 weeks)
D: Proportion of patients receiving AAS, an ACE inhibitor and a statin among those without contraindications to any of these drugs Adherence to treatment measured by: Morinsky-Green test and Pill accountability. (18 months); Adherence to treatment measured by the Morisky-Green questionnaire (18 months); Treatment adherence measured by: Morisky-Green test: (Good adherence score 16-20) at 1 and 9 months. (18 months); Treatment adherence measured by: Pill counts at 1-4-9 months. (Good adherence 80-110% PC) (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Voriconazole vs IV Low Dose Amphotericin B for Primary Antifungal Prophylaxis in Pediatric Acute Leukemia Induction:A Prospective, Randomized, Clinical Trial.
Brief Summary: Hypothesis:Oral Voriconazole will be as effective as intravenous Amphotericin B as antifungal prophylaxis in induction of acute leukemia (ALL, AML) in pediatric patients, with less toxicity and more convenience.


Options:
A: Prevention of possible, probable or proven fungal infection. (Completion of Induction Chemotherapy or successful recovery of ANC > 1000/mm3)
B: The proportion of patients treated with at least 1 course of empiric antifungal therapy as per protocol definition at 26 weeks following randomisation (26 weeks of follow-up)
C: Efficacy of PCR technique for detection of Aspergillus DNA versus the standard technique for the determination of galactomannan Antigen (AGA) in serum (18-20 months)
D: Calculation of sensitivity, Specificity, positive predictive value, negative predictive value and diagnostic odds ratio (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of PET Scan on the Curative Strategy of Colo-rectal Cancers : A Randomized Study
Brief Summary: The risk of recurrence in stage III and IV of colorectal cancers (CRC) is high during the three years following the tumoral resection with curative aim. Therefore, a prolonged follow-up and an intense monitoring are recommended to detect these recurrences precociously. Nevertheless, current consensual morphological and biological examinations are not very contributory, of difficult interpretation and expensive. The metabolic imagery in tomoscintigraphy by emission of positron coupled with the scanner, called PET-TDM, allows to identify more specifically recurrences, analyzes the whole body, detects hepatic metastasis more precociously and give some benefice for early diagnosis of lymph nodes recurrence. The principle purpose of this study is to evaluate if the systematic follow-up per PET-TDM allows detecting more often recurrences accessible to a curative surgery. We make the hypothesis that the systematic practice of PET- tomodensitometry (TDM) during the follow-up of CRC allows to decrease non curative recurrences appearance during the 3 years follow-up after a curative surgery.


Options:
A: Subscale quality of life of the questionnaire: EORTC QLQ C30 (After each treatment completion, during follow up; first year every 3 months, second year every 6 months)
B: Percentage of patients with a non removable recurrence (at the end of the study)
C: Patient in receipt of a complete survivorship care plan (16 weeks)
D: Overall and cancer-specific mortality (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of PET Scan on the Curative Strategy of Colo-rectal Cancers : A Randomized Study
Brief Summary: The risk of recurrence in stage III and IV of colorectal cancers (CRC) is high during the three years following the tumoral resection with curative aim. Therefore, a prolonged follow-up and an intense monitoring are recommended to detect these recurrences precociously. Nevertheless, current consensual morphological and biological examinations are not very contributory, of difficult interpretation and expensive. The metabolic imagery in tomoscintigraphy by emission of positron coupled with the scanner, called PET-TDM, allows to identify more specifically recurrences, analyzes the whole body, detects hepatic metastasis more precociously and give some benefice for early diagnosis of lymph nodes recurrence. The principle purpose of this study is to evaluate if the systematic follow-up per PET-TDM allows detecting more often recurrences accessible to a curative surgery. We make the hypothesis that the systematic practice of PET- tomodensitometry (TDM) during the follow-up of CRC allows to decrease non curative recurrences appearance during the 3 years follow-up after a curative surgery.


Options:
A: Overall Survival (OS) (5-year OS); Health Related Quality of Life (Yearly assessment over 5 years)
B: Percentage of patients with a non removable recurrence (at the end of the study)
C: Difference in unmet supportive care needs between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline); Difference in continuity of care between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline); Difference in quality of life between intervention and control group (2 to 3 weeks after baseline; 8 to 10 weeks after baseline)
D: Overall survival rate (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week Treatment, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Indacaterol (150 μg o.d.) in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: This study was designed to provide 12 weeks efficacy and safety data of the 150 μg once-daily (od) dose of indacaterol in chronic obstructive pulmonary disease (COPD).


Options:
A: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)
B: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85) (End of treatment (Week 12 + 1 day, Day 85))
C: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of Treatment (Week 12) (From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84))
D: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85) (24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85))

Answer: D