TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Sildenafil to Tadalafil in Pulmonary Arterial Hypertension (SITAR)
Brief Summary: Assess tolerability, transition methods and clinical effects of transition from sildenafil (Revatio) to tadalafil (Adcirca) for treatment of pulmonary arterial hypertension.


Options:
A: Change From Baseline in the Total Distance Walked During 6 Minute Walk Time (6MWT) at Week 12 (Week 12)
B: Reduction of mean PAP and PVR (60 minutes)
C: Safety; Standard safety data; Efficacy; 6-Minute Walk Test; BORG Dyspnoea Score; WHO Functional Class; Quality of Life SF-36 and EQ-5D
D: Describe tolerability of transition from sildenafil to tadalafil for treatment of pulmonary arterial hypertension (PAH). (12/2011)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Study of YM178: A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multi-center Study in Subjects With Symptoms of Overactive Bladder
Brief Summary: This study is to assess the efficacy and safety of YM178 in patients with symptoms of overactive bladder.


Options:
A: N/A
B: Hopkins Verbal Learning Test - Revised (Week 4); Hopkins Verbal Learning Test - Revised (Week 4)
C: Change from baseline in the mean number of micturitions per 24 hours (Within a 12-week treatment period)
D: Change in mean number of micturitions per 24 hrs (Within a 12-week treatment period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Bispectral Index (BIS) Monitoring of Anaesthesia With Propofol and Remifentanyl in Pediatric Patients in Ear Nose and Throat Surgery: Are There Clinical Advantages?
Brief Summary: The objective of the study is to determine wether the use of the Bispectral Index Monitor (BIS) as a method to guide anaesthesia for children in different groups of age, undergoing ear nose and throat surgery anaesthetized with an infusion of Propofol and Remifentanil with an high dose of Remifentanil (0,5-2 mcg/kg/min), can lead to a reduction in the time needed for extubation and in the amount of anesthetics used.


Options:
A: Time to extubation since the interruption in the administration of anaesthetics. (30 minutes-3 hours)
B: Bispectral index (BIS) monitoring in abdominal surgery patients (six months)
C: The incidence of explicit recall of events during the surgical and anesthetic periods. (Three years)
D: The incidence of explicit recall of events during the surgical and anesthetic periods. (30 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intracoronary Injection of Epo During Reperfusion in Patients Hospitalized for First Acute Myocardial Infarct STEMI
Brief Summary: Primary endpoint: Is intracoronary injection of a single dose of darbepoetin alpha, during reperfusion in patients hospitalized for ST segment elevation myocardial infarction (STEMI), able to reduce infarct size ?

In in vivo studies, many experiments evidenced infarct size reduction, due to anti-apoptotic compounds, when given during reperfusion, after cardiac ischemia. In humans, post-conditioning offers such a protection, as the investigators have previously showed (Staat P et al. Post-conditioning the human heart. Circulation. 2005 112(14):2143-8).

Infarct size reduction could lead to a reduced rate of complications (heart failure, rhythmic complications) and finally, morbidity and even mortality. This protection depends on anti-apoptotic properties (Zhao ZQ et al. Inhibition of myocardial injury by ischemic postconditioning during reperfusion: comparison with ischemic preconditioning. Am J Physiology Heart Circ Physiology 2003 Aug; 285(2):H579-88). Many drugs have been proposed to be able to mimic this phenomenon. Among them, many are efficient but toxic in vivo or difficult to manage (insulin, morphin). One of the most promising agent could then be erythropoietin (EPO) (Opie LH et al. Postconditioning for protection of the infarcting heart. Lancet. 2006; 367(9509):456-8). In order to target ischemia-reperfusion injuries, EPO impact is better and better demonstrated (e.g.: Mudalagiri NR. Erythropoietin protects the human myocardium against hypoxia and reoxygenation injury via phosphatidylinositol-3 kinase and ERK1-2 activation. Br J Pharmacol. 2007 Oct 22). The purpose of the study is to test this hypothesis in humans, on the onset of the reperfusion, after myocardial ischemia (acute myocardial infarct). EPO could contribute to protect myocardium against ischemia-reperfusion injury. This impact could rely on anti-apoptotic properties.


Options:
A: Decrease in Delayed Graft Function
B: mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection (4 days)
C: Magnetic resonance imaging (MRI) determination of infarct size (12 weeks)
D: Infarct Size in the Territory of the Infarct Related Artery (performed 2 to 6 days after study medication administration (first CMR))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Trial of Precursor B Cell Acute Lymphoblastic Leukemia (B-ALL) Treated With Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19
Brief Summary: This study is an investigational approach that uses immune cells, called "T cells", to kill leukemia. These T cells are removed from blood, modified in a laboratory, and then put back in the body. T cells fight infections and can also kill cancer cells in some cases. However, right now T cells are unable to kill the cancer cells. For this reason we will put one gene into the T cells that allows them to recognize and kill the leukemia cells. This gene will be put in the T cells by a weakened virus. The gene will produce proteins in the T cells that help the T cells recognize the leukemia cells and possibly kill them. The doctors have found that T cells modified in this way can cure an ALL-like cancer in mice.

The main goals of this study is to determine the safety and appropriate dose of these modified T cells in patients with ALL. This will be done in a "clinical trial." The dose of modified T-cells will depend on if you have disease present in your bone marrow or not. The patient will also receive chemotherapy before the T cells. We will use normally chemotherapy that is used in patients with leukemia. The chemotherapy is given to reduce leukemia and to allow the T cells to live longer.


Options:
A: To evaluate safety and dose limiting toxicities (DLT) of autologous CD30.CAR-T and establish the recommended Phase dose (Day 0 to 28 for DLT)
B: To evaluate the safety of adoptive transfer of gene-modified autologous CD19-specific T cells in adult patients with B-ALL. (2 years)
C: Dose-limiting toxicity (DLT) (28 days)
D: Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0 (2 years post infusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-Month Study on Diet and Weight Loss in Overweight Adolescents
Brief Summary: Advice to increase water consumption as part of a weight-reducing diet - typically to 8 cups (64 fl oz, \~2 L) per day ("8x8" water recommendation) - is almost ubiquitously recommended by healthcare professionals. Many believe that water promotes weight loss through numerous physiological mechanisms. However, only limited observational data and virtually no experimental data exist regarding the effects of water consumption on body weight. In this study, we propose a randomized controlled pilot study in which two groups of overweight adolescents will receive a standard weight loss regimen, either with (experimental intervention) or without (control intervention) additional advice and support to increase water consumption. We will utilize individual sessions, an innovative text messaging protocol, and motivational telephone calls to promote adherence to the interventions. The purpose of this pilot study is to evaluate feasibility and obtain preliminary efficacy data, to inform design of a future, definitive study.

It is hypothesized that increasing water consumption will improve the efficacy of a standard weight-reducing diet and will lead to decreased consumption of energy-containing beverages, decreased total energy intake, improved diet quality, improved immune status, and improved cardiovascular and diabetes risk factors. This simple behavioral intervention will be feasible and will significantly increase water consumption among participants in the experimental vs. control group.


Options:
A: Body mass index (6 month change)
B: Change in the selection of meal components (Selection of entrees, milk, fruits, and vegetables) (baseline, up to 3 months post-implementation, and up to 7 months post-implementation); Change in the consumption of meal components (consumption of entrees, milk, fruits, and vegetables) (baseline, up to 3 months post-implementation, and up to 7 months post-implementation)
C: Purchase of sugar-sweetened beverages (4 months)
D: Change in percent body fat by DXA scan

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Outlook: An Intervention to Improve Quality of Life in Serious Illness Study
Brief Summary: The purpose of this study is to determine whether discussions of life story, forgiveness, and future goals improve quality of life for patients with serious illness.


Options:
A: QUAL-E - Preparation Sub-scale (Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 56, 64)); QUAL-E Life Completion Sub-scale (Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 55, 64))
B: thoracoabdominal motion (2 years)
C: Patient Health Questionnaire -9 (PHQ-9) (4 month (post treatment), 8 month follow/up, and 12 month follow/up); Beck Anxiety Inventory (BAI) (4 month (post treatment), 8 month follow/up, and 12 month follow/up); Chronic Respiratory Questionnaire_Fatigue (4 month (post treatment), 8 month follow/up, 12 month follow/up); Chronic Respiratory Questionnaire_Mastery (4 month (post treatment), 8 month follow/up, 12 month follow/up); Chronic Respiratory Questionnaire_Dyspnea (4 month (post treatment), 8 month follow/up, 12 month follow/up); Kansas City Cardiomyopathy Questionnaire (KCCQ) (4 month (post treatment), 8 month follow/up, and 12 month follow/up)
D: Hospitalization or Emergency Department Visit for COPD (1 yr); Hospitalization or ED Visit for COPD (Mean Cumulative Frequency) (1 yr)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Third Eye Retroscope Randomized Clinical Evaluation (The "TERRACE" Study)
Brief Summary: The Third Eye® Retroscope® is a device that can be inserted through the instrument channel of a standard colonoscope to provide an additional, retrograde (or backward) view that reveals areas behind folds and flexures in the colon, and might detect additional polyps that cannot be seen with the colonoscope alone.

Patients who participate as subjects in the study will undergo two complete colonoscopy procedures, a standard colonoscopy and a colonoscopy in which a Third Eye Retroscope is used along with the same colonoscope. Half of the patients will have the standard colonoscopy first followed by the Third Eye colonoscopy, and the other half will have the Third Eye procedure first.

Results from the two groups will be analyzed and compared to determine the effectiveness of the Third Eye Retroscope for detecting additional adenomas and other polyps compared with the standard colonoscope alone.


Options:
A: 1. Compare the miss rate of standard white light imaging compared to NBI for detection of colon polyps with NBI (2 years)
B: Correlation of adenoma detection rate with case volume of endoscopists (18 months)
C: Detection Rates for Adenomas and for Total Polyps (Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.)
D: polyp detection rate (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation
Brief Summary: The objective of this application is to identify a pharmacologic agent which helps couples in whom the female partner ovulates regularly successfully obtain their goal of delivering a healthy child, whose use will result in low rates of multiple gestations. The central hypothesis is that, in infertile ovulatory women undergoing ovarian stimulation (OS) and intrauterine insemination (IUI), the use of aromatase inhibitors (AI) will stimulate the ovaries sufficiently to produce no reduction in the rate of pregnancy, while significantly reducing the numbers of multiple gestational pregnancies that result from stimulation with clomiphene citrate (CC) or follicle stimulating hormone (FSH). The rationale for the proposed research is that reduction of multiple pregnancy rates could significantly reduce maternal and neonatal morbidity and mortality, as well as the cost of healthcare for these individuals and society.


Options:
A: Pituitary Response to GnRH (Peak hormone level within 2 hours post GnRH doses); Effect of Estrogen on Pituitary Response to GnRH (Peak hormone level within 2 hours post GnRH doses)
B: Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH. (Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks)
C: Live Birth (1 year)
D: Implantation Rate,Chemical pregnancy rate, Clinical pregnancy rate (One year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation
Brief Summary: The objective of this application is to identify a pharmacologic agent which helps couples in whom the female partner ovulates regularly successfully obtain their goal of delivering a healthy child, whose use will result in low rates of multiple gestations. The central hypothesis is that, in infertile ovulatory women undergoing ovarian stimulation (OS) and intrauterine insemination (IUI), the use of aromatase inhibitors (AI) will stimulate the ovaries sufficiently to produce no reduction in the rate of pregnancy, while significantly reducing the numbers of multiple gestational pregnancies that result from stimulation with clomiphene citrate (CC) or follicle stimulating hormone (FSH). The rationale for the proposed research is that reduction of multiple pregnancy rates could significantly reduce maternal and neonatal morbidity and mortality, as well as the cost of healthcare for these individuals and society.


Options:
A: Clinical pregnancy rate per cycle (6-7 weeks gestation)
B: Clinical pregnancy rate (5 weeks after intrauterine insemination)
C: Number of mature follicles in the study and control group.
D: Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH. (Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation
Brief Summary: The objective of this application is to identify a pharmacologic agent which helps couples in whom the female partner ovulates regularly successfully obtain their goal of delivering a healthy child, whose use will result in low rates of multiple gestations. The central hypothesis is that, in infertile ovulatory women undergoing ovarian stimulation (OS) and intrauterine insemination (IUI), the use of aromatase inhibitors (AI) will stimulate the ovaries sufficiently to produce no reduction in the rate of pregnancy, while significantly reducing the numbers of multiple gestational pregnancies that result from stimulation with clomiphene citrate (CC) or follicle stimulating hormone (FSH). The rationale for the proposed research is that reduction of multiple pregnancy rates could significantly reduce maternal and neonatal morbidity and mortality, as well as the cost of healthcare for these individuals and society.


Options:
A: Live birth rate
B: Clinical pregnancy (within 6 calendar months of randomisation)
C: Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH. (Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks)
D: The main outcome was change in body weight. (Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of 2 Doses of Aclidinium Bromide Compared With Placebo for 12 Weeks in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease Followed by a 40-Week Evaluation of the Higher Aclidinium Bromide Dose
Brief Summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of aclidinium bromide doses compared with placebo in the treatment of moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week run-in period followed by a 12-week double-blind, placebo-controlled treatment period. This will be followed by an open-label 40-week treatment period and a 2-week follow up phone call. All patients will receive the higher Aclidinium Bromide during the 40-week open label treatment period.


Options:
A: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks) (1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Day 85); Trough FEV1 Response at Day 85 (12 Weeks) (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h and - 10 mins prior to study drug at Day 85.)
B: Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1) (Change from baseline (Week 0) to Week 12); Part B: Morning Predose (Trough) FEV1 (Change from baseline (Week 0) to 52 Weeks)
C: Rate of healthcare utilisation based exacerbations of COPD
D: 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))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of 2 Doses of Aclidinium Bromide Compared With Placebo for 12 Weeks in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease Followed by a 40-Week Evaluation of the Higher Aclidinium Bromide Dose
Brief Summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of aclidinium bromide doses compared with placebo in the treatment of moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week run-in period followed by a 12-week double-blind, placebo-controlled treatment period. This will be followed by an open-label 40-week treatment period and a 2-week follow up phone call. All patients will receive the higher Aclidinium Bromide during the 40-week open label treatment period.


Options:
A: Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1) (Change from baseline (Week 0) to Week 12); Part B: Morning Predose (Trough) FEV1 (Change from baseline (Week 0) to 52 Weeks)
B: Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment. (Day 15)
C: Trough FEV1 (L) at 28 Weeks on Treatment (Week 28); Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment (Week 12)
D: Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1) (Change from Baseline to 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of the National Taiwan University Hospital Elder Life Program
Brief Summary: The aim is to replicate, develop, and pilot test a model of care for the prevention and management of functional decline of older patients during hospitalization.


Options:
A: Postoperative delirium rate within 7 days after surgery (7 days after surgery)
B: Reduction in the incidence of Post-Operative Delirium (%) (Post-Operative Period (Day 0 through Day 7 or Discharge, whichever comes first))
C: Functional status:Barthel Index. (through study completion, an average of 3 months); Mini-Nutritional Assessment scores (MNA) (through study completion, an average of 3 months); Mini Mental State Examination scores (MMSE) (through study completion, an average of 3 months); Frailty rates and transition between frailty states (through study completion, an average of 3 months); Postoperative delirium incidence rate [Confusion Assessment Method (CAM)] (through study completion, an average of 3 months); Postoperative bowel dysmotility (through study completion, an average of 3 months)
D: Return to Baseline Physical Function Based on the Barthel Index (Change From 2 Weeks Prior to Admission and Changes at Admission, Discharge, and 2 and 6 Months Post-discharge). (Change from 2 weeks prior to admission to changes at admission, discharge, and 2 and 6 months post-discharge); Caregiver Preparedness (Discharge and 2 and 6 months post-discharge)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of the National Taiwan University Hospital Elder Life Program
Brief Summary: The aim is to replicate, develop, and pilot test a model of care for the prevention and management of functional decline of older patients during hospitalization.


Options:
A: postoperative delirium (2 MONTHS)
B: Functional status:Barthel Index. (through study completion, an average of 3 months); Mini-Nutritional Assessment scores (MNA) (through study completion, an average of 3 months); Mini Mental State Examination scores (MMSE) (through study completion, an average of 3 months); Frailty rates and transition between frailty states (through study completion, an average of 3 months); Postoperative delirium incidence rate [Confusion Assessment Method (CAM)] (through study completion, an average of 3 months); Postoperative bowel dysmotility (through study completion, an average of 3 months)
C: Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Enrollment (Enrollment was assessed after enrollment was completed.); Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Adherence (To be evaluated at the conclusion of the study. Adherence was assessed in 3 separate periods: pre hospital, in hospital, and post discharge (typically at the 4 week follow up clinic visit).)
D: Participant Reduced Symptom Burden (From Baseline to 4 Days Later (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion))

Answer: B