TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Surgical Ablation Versus No Surgical Ablation for Patients With Persistent or Longstanding Persistent Atrial Fibrillation (AF) Undergoing Mitral Valve Surgery
Brief Summary: The purpose of the research is to determine whether treating atrial fibrillation with surgical ablation during scheduled mitral valve surgery is better than mitral valve surgery by itself without the surgical ablation. Surgical ablation of atrial fibrillation is a technique used by surgeons to deaden atrial heart tissue and block electrical signals that may be causing your heart to beat irregularly. There are no new procedures being tested in this study; both mitral valve surgery and surgical ablation are used regularly in patients who have mitral valve problems and atrial fibrillation, although no surgical ablation devices have been approved by the Food and Drug Administration for the treatment of atrial fibrillation. What is not known with certainty, is whether patients with atrial fibrillation who are having planned mitral valve surgery would do better if they also had surgical ablation rather than medication alone to treat their atrial fibrillation.


Options:
A: At 3rd, 6th and 12th month's follow-up, to evaluate the rhythm status by ECG and 24-hour Holter and cardiac hemodynamic status by transthoracic echocardiography (1 year)
B: Quality of life and maintenance of sinus rhythm at 1 year will be considered as primary end points. (Baseline, 3, 6, and 12 months after operation)
C: The primary outcome endpoint was the presence of SR at 12 months
D: Freedom From Atrial Fibrillation (Measured at Month 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study PMA112509, a Phase I/II Study of Eltrombopag in Thrombocytopenic Subjects With Advanced Myelodysplastic Syndrome (MDS) or Secondary Acute Myeloid Leukemia After MDS (sAML/MDS)
Brief Summary: This study will evaluate the safety and tolerability of eltrombopag in the treatment of low platelet counts in adult subjects with advanced myelodysplastic syndrome (MDS), secondary acute myeloid leukemia after MDS (sAML/MDS), or de novo AML that are relapsed, refractory or ineligible to receive azacitidine, decitabine, intensive chemotherapy or autologous/allogeneic stem cell transplantation. This is a placebo-controlled study in which patients will receive study medication daily for 6 months, during which time the dose of study medication may be adjusted based upon individual platelet counts and bone marrow blast counts. All subjects will receive best standard of care (platelet transfusions, mild chemotherapy, cytokines, valproic acid, all-trans retinoic acid, ESAs or G-CSF) in addition to study medication. Subjects taking placebo may be allowed to crossover to eltrombopag treatment if a clinically and statistically significant improvement in bone marrow blast counts is seen in subjects treated with eltrombopag.


Options:
A: Safety and tolerability parameters including non-hematological laboratory Grade 3/Grade 4 toxicities, change in bone marrow blast counts from baseline and adverse events reporting. (Approximately 46 months)
B: Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First (measured ongoing from dosing until day 7 or discharge, whichever came first)
C: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period through interim follow-up visit (up to 16 weeks))
D: How Many WAS Patients Will Achieve Platelet Counts Above 50,000/ul. (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study PMA112509, a Phase I/II Study of Eltrombopag in Thrombocytopenic Subjects With Advanced Myelodysplastic Syndrome (MDS) or Secondary Acute Myeloid Leukemia After MDS (sAML/MDS)
Brief Summary: This study will evaluate the safety and tolerability of eltrombopag in the treatment of low platelet counts in adult subjects with advanced myelodysplastic syndrome (MDS), secondary acute myeloid leukemia after MDS (sAML/MDS), or de novo AML that are relapsed, refractory or ineligible to receive azacitidine, decitabine, intensive chemotherapy or autologous/allogeneic stem cell transplantation. This is a placebo-controlled study in which patients will receive study medication daily for 6 months, during which time the dose of study medication may be adjusted based upon individual platelet counts and bone marrow blast counts. All subjects will receive best standard of care (platelet transfusions, mild chemotherapy, cytokines, valproic acid, all-trans retinoic acid, ESAs or G-CSF) in addition to study medication. Subjects taking placebo may be allowed to crossover to eltrombopag treatment if a clinically and statistically significant improvement in bone marrow blast counts is seen in subjects treated with eltrombopag.


Options:
A: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period (up to 20 weeks))
B: Daily hemostatic assessments will be conducted to determine presence of WHO Grade 2 bleeding or greater.
C: Safety and tolerability parameters including non-hematological laboratory Grade 3/Grade 4 toxicities, change in bone marrow blast counts from baseline and adverse events reporting. (Approximately 46 months)
D: Change in baseline platelet count from the first day of the second cycle of chemotherapy to the lowest count observed (nadir) during the cycle(21 days) (throughout entire study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study PMA112509, a Phase I/II Study of Eltrombopag in Thrombocytopenic Subjects With Advanced Myelodysplastic Syndrome (MDS) or Secondary Acute Myeloid Leukemia After MDS (sAML/MDS)
Brief Summary: This study will evaluate the safety and tolerability of eltrombopag in the treatment of low platelet counts in adult subjects with advanced myelodysplastic syndrome (MDS), secondary acute myeloid leukemia after MDS (sAML/MDS), or de novo AML that are relapsed, refractory or ineligible to receive azacitidine, decitabine, intensive chemotherapy or autologous/allogeneic stem cell transplantation. This is a placebo-controlled study in which patients will receive study medication daily for 6 months, during which time the dose of study medication may be adjusted based upon individual platelet counts and bone marrow blast counts. All subjects will receive best standard of care (platelet transfusions, mild chemotherapy, cytokines, valproic acid, all-trans retinoic acid, ESAs or G-CSF) in addition to study medication. Subjects taking placebo may be allowed to crossover to eltrombopag treatment if a clinically and statistically significant improvement in bone marrow blast counts is seen in subjects treated with eltrombopag.


Options:
A: Safety and tolerability parameters including non-hematological laboratory Grade 3/Grade 4 toxicities, change in bone marrow blast counts from baseline and adverse events reporting. (Approximately 46 months)
B: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period through interim follow-up visit (up to 16 weeks))
C: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period (up to 20 weeks))
D: Participants Who Achieved Red Blood Cell (RBC) -Transfusion Independence (Up to 2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Controlled Outcome Evaluations of a Daily Physical Activity Intervention for Individuals With Type 2 Diabetes
Brief Summary: The intervention consists of an individual counseling session, telephone counseling (7 calls), given by a psychologist, and a pedometer. The intervention is based on cognitive behavioral therapy, the Diabetes Prevention Program, the first Step Program and Motivational Interviewing. The taxonomy of behavior change techniques is also taken into account. The duration of the intervention is six months. The individual session takes place one week after the baseline measurements, together with the participants' follow-up appointment with their endocrinologist. The individual session takes place at the endocrinology department and is expected to last approximately 30 minutes. In addition to the session, the participants of the intervention group receive a pedometer and a pedometer diary for six months. Participants of the intervention group also receive telephone counseling from the psychologist during 24 weeks. They receive a call every two weeks for four weeks and then every four weeks for the next 20 weeks, good for a total of seven counseling calls. The calls are expected to last approximately 20 minutes. The Control Group has no intervention at all and receive their usual care.


Options:
A: The percentage of participants reaching target control of HbA1c (7.0), and blood pressure (<140/80) and cholesterol (<4 mmol/l), (18 months)
B: Hemoglobin A1c Levels (5 years); Blood Pressure Levels (5 years); Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol (5 years)
C: Glycemic relapse: increase in HbA1c by 1% over baseline and >8%
D: Physical activity measured with an accelerometer, pedometer en the International Physical Activity Questionnaire (IPAQ) (At baseline, after the intervention (at 6 months) and one year after baseline); Health parameters: systolic and diastolic blood pressure, resting heart rate, waist circumference, weight, height (At baseline, after the intervention (at 6 months) and one year after baseline); Blood samples taken to determine:HBA1C, glucose, insulin, leptin, c-peptide, IGF-1, total cholesterol, HDL-c, LDL-C, triglycerides, APo-B, high sensitive C-reactive protein, vrij-t, DHEAS Oestradiol, Shbg, LH, FSH (At baseline, after the intervention (six months) and one year after baseline); Dexa scan (At baseline, after the intervention (six months) and one year after baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I Study of Eltrombopag for Promoting Thrombopoiesis in Patients Undergoing Stem Cell Transplantation After Total Body Irradiation
Brief Summary: Patients who undergo total body irradiation (TBI) for stem cell transplantation have prolonged periods of low counts of specific blood cells called platelets. These low platelets counts can cause bleeding and infection. Thus far, no drug is available for use to speed the recovery of platelets, and therefore transfusions are often necessary.

The purpose of this study is to test the safety of a drug called eltrombopag in patients who have received TBI. The investigators want to find out what effects, good or bad, it has on people with low platelet counts due to treatment with TBI. The investigators will also be testing how well eltrombopag may work at different doses and determine if this drug speeds up the recovery of the platelets.


Options:
A: Evaluate the relative bioavailability of a PfOS formulation relative to the commercial eltrombopag 25 mg tablet formulation in healthy adult subjects. (72 hours x 2 periods); Evaluate the effect of a high calcium, moderate fat and calorie meal on the pharmacokinetics of a single oral 25 mg dose of eltrombopag PfOS in healthy adult subjects when eltrombopag is administered concurrently, two hours before, or two hours afte (72 hours x 3 periods)
B: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period through interim follow-up visit (up to 16 weeks))
C: Maximum Tolerated Dose (MTD) of Eltrombopag (1.5 years)
D: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period (up to 20 weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: NWP06 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)- A Laboratory Classroom Study
Brief Summary: The objective of this study was to establish that an optimal dose of Quillivant XR oral suspension would result in a significant reduction in signs and symptoms of ADHD compared to placebo treatment in pediatric patients ages 6-12 years with ADHD.


Options:
A: Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted) (Hour 4 of the of the Lab School Day during Double-Blind Assessment Period); Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct) (Hour 4 of the Lab School Day During the Double-Blind Assessment Period)
B: N/A
C: SKAMP deportment rating scale (Week 8)
D: Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at Hour 4 Post-Dose (Hour 4 post-dose)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: NWP06 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)- A Laboratory Classroom Study
Brief Summary: The objective of this study was to establish that an optimal dose of Quillivant XR oral suspension would result in a significant reduction in signs and symptoms of ADHD compared to placebo treatment in pediatric patients ages 6-12 years with ADHD.


Options:
A: Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at Hour 4 Post-Dose (Hour 4 post-dose)
B: Score on ADHD Rating Scale at 4 weeks (30 days)
C: Psychopathology: improvement on PANSS positive scale (PANSS 'Positive and Negative Syndrome Scale') (12 weeks)
D: Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score (Week 12); Clinical Global Impression - Severity (CGI-S) Score (Week 12); Clinical Global Impression - Improvement (CGI-I) Score (Week 12); Learning Skill Test (LST) Total Score (Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: NWP06 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)- A Laboratory Classroom Study
Brief Summary: The objective of this study was to establish that an optimal dose of Quillivant XR oral suspension would result in a significant reduction in signs and symptoms of ADHD compared to placebo treatment in pediatric patients ages 6-12 years with ADHD.


Options:
A: Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day. (Baseline and 4 weeks); Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM. (Baseline and 4 weeks)
B: Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points (0.75 up to 13 hours post-dose)
C: Efficacy outcome was change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T) (at 16 weeks)
D: Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at Hour 4 Post-Dose (Hour 4 post-dose)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Port Access Cholecystectomy Versus Standard Laparoscopic Cholecystectomy - Randomized Study
Brief Summary: Background:

Single port access surgery is a rapidly progressing surgical approach which allows performance of standard laparoscopic surgery through a single transparietal port instead of multiple port accesses.

Objective:

Demonstrate the validity of Single port access (SPA) cholecystectomy compared to multiple ports laparoscopic cholecystectomy.

Hypothesis:

SPA cholecystectomy is associated with decreased parietal and body image trauma compare to multiple ports laparoscopic cholecystectomy. SPA cholecystectomy should be associated with better cosmetic results, may improve postoperative recovery due to lower parietal pain. SPA cholecystectomy may also be associated with decreased rate of parietal complications as lower numbers of transparietal port are placed.

Methods:

All patients offered cholecystectomy, either SPA or multiport cholecystectomy, included in the study will have recognized biliary pathology for which formal indication cholecystectomy are recognized internationally.

Surgical technique, either for SPA cholecystectomy or for multiple ports cholecystectomy, will be the same except, that one surgical technique is achieved through a single transparietal port and the other through multiple ports.

Randomization will be performed before surgeries after patients have given their informed consent to the study.

No specific test or cost will be necessitated by the study. Patients will be informed orally and will receive a short study summary, allowing them to give an informed consent.

Endpoints:

* Morbidity
* Body image and Cosmetic results
* Post-operative pain (opioid sparing effect)
* Operative time
* Hospital stay


Options:
A: Post-operative pain scores (visual analogue pain scale from 0-10)assessed on post-operative day 1 and at the post-operative follow up visit in clinic. The mean pain scores will be compared using student's t-test. (3-6 weeks)
B: Cosmesis, body image and quality of life scale (at 1 month)
C: SILS cholecystectomy, except the invisible scar, has significantly less abdominal and shoulder pain scores
D: Parietal complications after surgery (infection and hernia) (One year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Interventions to Improve Warfarin Adherence
Brief Summary: The purpose of this research study is to see if a lottery which provides the opportunity to win money, a reminder system using a "Med-eMonitor", or the combination of both might be useful in helping patients to achieve better control of their anticoagulation therapy. Selection for the arms of the study is randomized by the study computer. Some will participate in the daily lottery only, some with the reminder system only, some with the reminder system and the daily lottery, and some with neither the lottery nor the reminder system.


Options:
A: Improved Warfarin Adherence/% Timeout of Target INR Range (six months)
B: N/A
C: Percentage Changed in Adherence Score (Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores); Number of Symptom-free Days (Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores)
D: Primary outcome: heart failure hospitalizations, time to death or hospitalization

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pacific Kids DASH for Health
Brief Summary: The increasing prevalence of childhood overweight has been found to be related to decreased levels of physical activity (PA) and increased energy content of the diet. Childhood offers an opportunity to develop and support health-promoting behaviors. Pacific Kids DASH for Health (PacDASH) is a community-based intervention that links food, PA, and health, and targets overweight children in Hawaii with a goal of preventing further weight gain. Components of the intervention include a food and PA prescription delivered by physicians at community-based health centers complemented with a toolbox of activities, behaviorally tailored messages, and PacDASH educational materials. This project will extend and apply the nationally recommended DASH eating pattern to children and the growing population of Asians and Pacific Islanders. The investigators will incorporate culturally preferred foods, recipes, and PA messages that meet DASH and other national guidelines. The approach will target child food behaviors and social and environmental cues that are important to making healthy food and PA choices and will provide steps to behavior change. Farmers markets at participating health centers are a support resource for activities. Providing access to, coupons for, and guidance about selecting and preparing fresh fruits and vegetables at a convenient health center farmers market will support increased intake of nutrient-rich foods among these children who are overweight and at risk for obesity.

Pacific Islanders are among the world's most obese populations while Asians, although of relatively low body mass index (BMI), carry much of their body fat in the upper body and exhibit greater health risk at the same BMI. Through this project, the investigators hope to learn more about body size and composition in children of the Pacific Region for whom there are few national data. In addition, evaluate the effectiveness of a community-based intervention within a health care system on managing overweight in children.


Options:
A: increased physical activity (4 months)
B: Body mass index (BMI) at 1 year.
C: Change from baseline in weekly time in moderate-to-vigorous physical activity at 4 months (baseline and after 4-months of intervention); Change from baseline in the daily time using TV/computer/video games at 4 months (baseline and after 4-months of intervention)
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Warm Water Irrigation Versus Standard Air Insufflation for Unsedated Colonoscopy: a Randomized Controlled Trial
Brief Summary: Unsedated colonoscopy is characterized by lower costs, recovery time and incidence of drug-related side effects, although it may be painful for the patient. Based on recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of water irrigation versus air insufflation during the insertion phase of colonoscopy might increase the global tolerability of the examination and the proportion of patients undergoing complete colonoscopy without sedation.


Options:
A: number of patients undergoing complete unsedated colonoscopy (6 months)
B: Number of Patients Undergoing Complete Unsedated Colonoscopy (6-9 months)
C: Primary outcome - success of cecal intubation without sedation (1 year)
D: Increments of medications used for sedation (duration of procedure)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy
Brief Summary: The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following robot-assisted endoscopic thyroidectomy compared to placebo. The primary outcome will be acute postoperative pain, measured by a verbal numerical rating score (VNRS) and total analgesic consumption during postoperative 48 hours. The secondary outcome will be the incidence of chronic pain and hypoesthesia in the anterior chest at 3 months after operation.


Options:
A: Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively. (1, 6, 24 & 48 hours); The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. (1, 6, 24 & 48 hours); Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively (1, 6, 24 & 48 hours)
B: VAS and McGill PRI(R)2 scores for phantom and stump pain are recorded 48 and 24 hours before, and 4 and 10 days, 1 and 6 months after amputation. Phantom and stump pain intensity are the endpoints of the study. (six months)
C: Average Pain Score at Rest (48 hours); Average Pain Score With Coughing the First Morning Following Surgery (First morning following surgery); Average Pain Score With Coughing on Second Morning After Surgery (Second morning after surgery)
D: occurrence of chronic pain (3 months)

Answer: A