TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two-Part Pilot Study of Dosing, Safety and Efficacy of Varenicline Initiated During an Acute Smoke-free Hospitalization and Continued Post-Hospitalization
Brief Summary: This Investigator Initiated Research Award (IIR Award #WS981308) is a two-part pilot study that aims to examine acceptability and feasibility of varenicline use during an acute (72-hr) smoke-free hospitalization (Part 1) and 4-weeks post-hospitalization (Part 2).


Options:
A: Percentage of Smokers With Delivery of Brief Interventions and/or Referral to Treatment (within a week of the index dental encounter)
B: Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 (12 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 (24 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 (52 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 (64 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 (104 weeks following treatment initiation)
C: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)
D: Smoking Behavior (Nine weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two-Part Pilot Study of Dosing, Safety and Efficacy of Varenicline Initiated During an Acute Smoke-free Hospitalization and Continued Post-Hospitalization
Brief Summary: This Investigator Initiated Research Award (IIR Award #WS981308) is a two-part pilot study that aims to examine acceptability and feasibility of varenicline use during an acute (72-hr) smoke-free hospitalization (Part 1) and 4-weeks post-hospitalization (Part 2).


Options:
A: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)
B: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)
C: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
D: Rating of urges to smoke 1-week after the target quit (1 week)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Walnuts on Endothelial Function in Overweight Adults With at Least One Factor of Metabolic Syndrome: A Randomized, Controlled, Cross-Over Trial
Brief Summary: The purpose of this study is to examine the effects of walnut consumption on endothelial function and lipid markers in overweight patients with at least one factor of metabolic syndrome as compared to the control group.


Options:
A: Changes from baseline in circulating levels of glucose and insulin according to the intervention arm (Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm)
B: The primary outcome measure is HDL-C (12 weeks and 24 weeks)
C: Endothelial function (8 weeks)
D: Body mass index (BMI); Glycated Haemoglobin (HbA1c); Triglycerides; Dietary intake as measured by 3-day weighed diet records; All measures to be compared at end of study (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Fortified Dietary Supplement for Pregnant Women on Maternal and Newborn Outcomes in Kampong Chhnang Province, Cambodia
Brief Summary: The study will evaluate the effects of a nutrition supplement for pregnant women on birth weight and other outcomes. The hypothesis is pregnant women who consume a daily fortified food supplement will produce babies with a higher mean birth weight than those who do not.


Options:
A: Mean birth weight (9 months)
B: Haemoglobin; Plasma Ferritin; Plasma Transferrin receptor
C: Hemoglobin (Start of study (T=0), End of study (T=4months))
D: Linear growth velocity (6 to 18 months of age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Fortified Dietary Supplement for Pregnant Women on Maternal and Newborn Outcomes in Kampong Chhnang Province, Cambodia
Brief Summary: The study will evaluate the effects of a nutrition supplement for pregnant women on birth weight and other outcomes. The hypothesis is pregnant women who consume a daily fortified food supplement will produce babies with a higher mean birth weight than those who do not.


Options:
A: Proportion recovered from moderate acute malnutrition (MAM) (up to 40 weeks); Maternal change in mid-upper arm circumference (MUAC) (up to 40 weeks); infant birth weight (up to 40 weeks); infant birth length (up to 40 weeks); premature delivery (up to 36 weeks)
B: Mean birth weight (9 months)
C: red blood cell folate concentration at three time points (baseline, 8th week, 16th week)
D: 1 or more adenomas (For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Fortified Dietary Supplement for Pregnant Women on Maternal and Newborn Outcomes in Kampong Chhnang Province, Cambodia
Brief Summary: The study will evaluate the effects of a nutrition supplement for pregnant women on birth weight and other outcomes. The hypothesis is pregnant women who consume a daily fortified food supplement will produce babies with a higher mean birth weight than those who do not.


Options:
A: Subjective well-being (baseline and 4 weeks)
B: Mean birth weight (9 months)
C: Vitamin A in the entire body (4 months)
D: Anthropometry (6 months); Micronutrient status (6 months); Cognition (6 months); absentism (6 months); morbidity (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Randomised Study of Nasal Oxygen Treatment for Pain Relief During Percutaneous Coronary Interventions
Brief Summary: Nasal oxygen is widely used as pain relief against ischemic pain during Percutaneous Coronary Intervention (PCI). However, to our knowledge no randomised clinical trials have tested this. In contrast, oxygen causes coronary artery vasoconstriction in man. Furthermore, a recent Cochrane meta-analysis has shown no evidence of beneficial effect of oxygen for patients with acute myocardial infarction (with normal blood saturation. The investigators therefore wanted to examine if oxygen reduces ischemic pain during PCI for stable angina or NSTEMI.


Options:
A: Chest pain measured with VAS (1 h)
B: all-cause mortality (day 28)
C: Death (Day 28)
D: 1-year all-cause mortality (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Randomised Study of Nasal Oxygen Treatment for Pain Relief During Percutaneous Coronary Interventions
Brief Summary: Nasal oxygen is widely used as pain relief against ischemic pain during Percutaneous Coronary Intervention (PCI). However, to our knowledge no randomised clinical trials have tested this. In contrast, oxygen causes coronary artery vasoconstriction in man. Furthermore, a recent Cochrane meta-analysis has shown no evidence of beneficial effect of oxygen for patients with acute myocardial infarction (with normal blood saturation. The investigators therefore wanted to examine if oxygen reduces ischemic pain during PCI for stable angina or NSTEMI.


Options:
A: all-cause mortality (day 28)
B: Myocardial Infarct Size (At 72 hours post infarct)
C: Chest pain measured with VAS (1 h)
D: Neuron-specific enolase (NSE) serum concentration (48 hour after cardiac arrest)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Randomised Study of Nasal Oxygen Treatment for Pain Relief During Percutaneous Coronary Interventions
Brief Summary: Nasal oxygen is widely used as pain relief against ischemic pain during Percutaneous Coronary Intervention (PCI). However, to our knowledge no randomised clinical trials have tested this. In contrast, oxygen causes coronary artery vasoconstriction in man. Furthermore, a recent Cochrane meta-analysis has shown no evidence of beneficial effect of oxygen for patients with acute myocardial infarction (with normal blood saturation. The investigators therefore wanted to examine if oxygen reduces ischemic pain during PCI for stable angina or NSTEMI.


Options:
A: A single SPECT scan will be used to determine whether or not the treatment results in a significant reduction in infarct size in the treatment group. The scan is performed 14 days post-event. (14 +/- 7 days); Safety will be determined by comparing 30-day MACE (Major Adverse Cardiac Events) rates, where MACE is comprised by the combined incidence of death, stroke, repeat MI, and target vessel revascularization. (30 days)
B: Myocardial Infarct Size (At 72 hours post infarct)
C: Chest pain measured with VAS (1 h)
D: 1-year all-cause mortality (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cocinar Para su Salud! (Cook for Your Life!): Implementing Dietary Change Among Hispanic Breast Cancer Survivors
Brief Summary: The primary objectives of this study are to determine the effect of the dietary intervention (Cocinar para su salud! Program) vs. control (standard written nutrition education materials for cancer survivors) in Hispanic breast cancer survivors with early stage breast cancer on 1) daily servings of fruit and vegetable intake from baseline to 6 months; and 2) percent energy from fat and fat-related dietary habits from baseline to 6 months.


Options:
A: Nutrition Behavior and Knowledge, measured by Likert scale (Change from baseline at three months, and 12 months)
B: Primary Outcome Measures Described Below (December 2011)
C: improvement in insulin resistance measured by HOMA index (6 months)
D: Change in Daily Servings of Fruits and Vegetables (Baseline and 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Open-Label, Dose Titration, Safety and Efficacy Study of FG-4592 for the Correction of Anemia in Newly Initiated Dialysis Patients Not on Erythropoiesis-Stimulating Agent Treatment
Brief Summary: The purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with end-stage renal disease who recently started dialysis.


Options:
A: Mean Change in Hemoglobin From Baseline and Over the Evaluation Period (Mean Over Week 24 and 28) (Baseline (Day 1) and Week 24 to Week 28)
B: Mean Hb (Hemoglobin) level (From week 30 to 36); Change in hemoglobin level from baseline to the average during the evaluation period (Baseline and week 30 to 36)
C: Maximum Change From Baseline in Hb During Weeks 3-13 (Baseline, Weeks 3-13)
D: Mean Hb (Hemoglobin) level (From week 30 to 36); Change in hemoglobin level from baseline to the average during the evaluation period (Baseline and week 30 to 36)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Comparison of OSHO Induction vs. the German AML Intergroup Standard, Randomised Comparison of AraC/Mtx vs. Flu/AraC/Mtx in Pts Without CR After One Induction Cycle and Randomized Comparison of One vs. Two Consolidation Therapies.
Brief Summary: This protocol is part of the German AML Intergroup Trial, where the OSHO study arm is compared to the common German standard arm after randomization in a 9:1 ratio. The hypothesis involves primarily dosing and application of AraC for induction. It is expected that CR rates and as a consequence also LFS are higher in protocols using higher AraC compared to lower doses and that LFS might be superior in the study specific arm compared to the golden standard published several years ago. In the standard arm, AraC 100mg/m2/day is given as continuous infusion over 7 days. Daunorubicin is given as 60 mg/m2/day over a two hours infusion on days 3, 4 und 5. On day 22 a second induction course is applied. After reaching CR, three cycles of AraC 3 g/m2 over three hours bid are infused on day 1, 3 und 5. In contrast the OSHO arm consists of induction therapy with IDA 12 mg/m\*2 over 20-30-min-iv on day 1 - 3 and AraC 2 x 1 g/m\*2 bid over 3-h-iv on days 1+3+5+7.

A previous phase II study of the OSHO has shown high CR in patients with relapsed AML using MitoFlag. In this study we asked the question if MitoFlag is superior to IdaAraC in newly diagnosed AML patients without CR after the first induction chemotherapy. Therefore patients are randomized to receive either MitoFlag or IdaAraC and the difference in CR rates evaluated.

It is still unclear if two consolidation therapies are needed before allogeneic or autologous stem cell transplantation. This question is being addressed in the second part of the OSHO study, where patients are randomized to receive either one or two consolidation therapies.

In this study all patients with AML and an age of 18-60 years except M3 are entered


Options:
A: Efficacy and toxicity of FLAG-Ida as second induction course in high risk patients.; Efficacy and toxicity of high-dose cytarabin/daunorubicin (HD-Ara-C/DNR) based late consolidation therapy vs. autologous peripheral blood stem cell transplantation in standard risk patients.
B: Remission rate, Remission duration,Relapse-free survival, Overall survival, Event-free survival (12-18months)
C: overall survival; relapse-free survival
D: Event free survival (after 5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Managing the Dysexecutive Syndrome Following Traumatic Brain Injury: An Ecologically Valid Rehabilitation Approach
Brief Summary: Successful community participation following acquired brain injury (ABI) continues to be an elusive goal for patients, clinicians and researchers. Our pilot work shows that community dwelling survivors of ABI can significantly improve performance on self-identified real- world performance problems and that they can transfer this learning to improve goals not trained in the treatment sessions. We will compare two types of rehabilitation intervention using a randomized controlled trial. We will also interview survivors, their significant others and clinicians regarding their experiences with each intervention to help us discover what works best.


Options:
A: change in number of care goals met (one year)
B: N/A
C: Change in walking activity from admission to discharge from rehabilitation (Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks)); Change in control of walking (Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks))
D: Change in performance on COPM (pre, post, 3 month follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Managing the Dysexecutive Syndrome Following Traumatic Brain Injury: An Ecologically Valid Rehabilitation Approach
Brief Summary: Successful community participation following acquired brain injury (ABI) continues to be an elusive goal for patients, clinicians and researchers. Our pilot work shows that community dwelling survivors of ABI can significantly improve performance on self-identified real- world performance problems and that they can transfer this learning to improve goals not trained in the treatment sessions. We will compare two types of rehabilitation intervention using a randomized controlled trial. We will also interview survivors, their significant others and clinicians regarding their experiences with each intervention to help us discover what works best.


Options:
A: Social Functioning: Total Social Behavior (6 weeks)
B: Change scores of Montreal Cognitive Assessment (MoCA) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Wechsler Memory Scale - Third Edition (WMS-III) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Useful Field of View (UFOV) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop Color-Word test (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
C: Change in performance on COPM (pre, post, 3 month follow-up)
D: Change in Rivermead Mobility index (Baseline, 6 months, 9 months); Change in Timed Up and Go Test (Baseline, 6 months, 9 months); Change in Modified Patient Specific Functional Scale (Baseline, 6 months, 9 months); Change in Physical Activity Diary (Baseline, 6 months, 9 months); Change in Physical activity - 7-day accelerometry (Baseline, 6 months, 9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: High Dose Dexamethasone as Pain Treatment After Arthroscopic Shoulder Surgery: A Randomised, Blinded Clinical Trial
Brief Summary: The purpose of this study is to determine if a dose of 40 mg dexamethasone is more effective as pain treatment than the currently used dose of 8 mg after arthroscopic shoulder surgery.


Options:
A: Pain 6 hours postoperatively (6 hours postoperatively); Pain 3 hours postoperatively (3 hours postoperatively); Pain 24 hours postoperatively (24 hours postoperatively); Pain (2-7 days postoperatively)
B: Pain score by numeric rating scale (At 8 hours postoperatively)
C: Prevention of PONV in the 24 hours following end of surgery; Tolerability (24 hours)
D: • Proportion of patients with Complete Response (no nausea, no vomiting, no retching, and no use of rescue medication) during the first 24 hours after surgery (1-24 hours post-operatively)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: High Dose Dexamethasone as Pain Treatment After Arthroscopic Shoulder Surgery: A Randomised, Blinded Clinical Trial
Brief Summary: The purpose of this study is to determine if a dose of 40 mg dexamethasone is more effective as pain treatment than the currently used dose of 8 mg after arthroscopic shoulder surgery.


Options:
A: Surgical wound infection (30 days)
B: Pain score by numeric rating scale (At 8 hours postoperatively)
C: Major Perioperative Morbidity (30 day after surgery)
D: pain during coughing (day 1)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: High Dose Dexamethasone as Pain Treatment After Arthroscopic Shoulder Surgery: A Randomised, Blinded Clinical Trial
Brief Summary: The purpose of this study is to determine if a dose of 40 mg dexamethasone is more effective as pain treatment than the currently used dose of 8 mg after arthroscopic shoulder surgery.


Options:
A: Painscore during mobilization (2-24 hours after extubation time.)
B: Pain score by numeric rating scale (At 8 hours postoperatively)
C: Postoperative nausea and vomiting (PONV) (24-32 hours postoperative)
D: Nausea (0-72 hours postoperative)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Interventions for Chronic Diseases: Effect of Patient Values and Effectiveness Information on Patients' Choice of Therapy, Adherence to Therapy and Satisfaction With Therapy
Brief Summary: Few studies have explored how specific formats of effectiveness information effect on real patients' decisions. We only know little about what kind of format would be the optimal to help patients make well-informed real-life decisions corresponding to their preferences.

The trial is developed in a clinical randomised design to study risk communication in the shared decision making between general practitioners (GP) and their patients in primary prevention with of cholesterol lowering drug. Endpoints are effect of GPs' information about treatment effectiveness and their patients' values on patients' tendency to accept and adhere to the treatment as well as their feeling of content with the choice made. GPs are randomised to inform about risk and treatment effectiveness by means of either absolute risk reduction (ARR) or Prolongation of Life (POL). Afterwards patients are invited to answer questionnaires concerning their content with decisions and reflections. Patients' redemption of prescriptions during the following week and the first year are recorded through an electronic database.

57 GPs and 248 patients have been enrolled in the trial.


Options:
A: Participant-reported most important attribute from survey (1 day)
B: Hemoglobin A1c (6 months)
C: Patient knowledge (Immediately after patient visit)
D: Patient's satisfaction and confidence with the information given. (Within two weeks after receiving the information and after 3 months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Interventions for Chronic Diseases: Effect of Patient Values and Effectiveness Information on Patients' Choice of Therapy, Adherence to Therapy and Satisfaction With Therapy
Brief Summary: Few studies have explored how specific formats of effectiveness information effect on real patients' decisions. We only know little about what kind of format would be the optimal to help patients make well-informed real-life decisions corresponding to their preferences.

The trial is developed in a clinical randomised design to study risk communication in the shared decision making between general practitioners (GP) and their patients in primary prevention with of cholesterol lowering drug. Endpoints are effect of GPs' information about treatment effectiveness and their patients' values on patients' tendency to accept and adhere to the treatment as well as their feeling of content with the choice made. GPs are randomised to inform about risk and treatment effectiveness by means of either absolute risk reduction (ARR) or Prolongation of Life (POL). Afterwards patients are invited to answer questionnaires concerning their content with decisions and reflections. Patients' redemption of prescriptions during the following week and the first year are recorded through an electronic database.

57 GPs and 248 patients have been enrolled in the trial.


Options:
A: Mean change in systolic Blood Pressure (BP) (Baseline to 12 months)
B: Feasibility of subject recruitment; feasibility of delivery of the CHD intervention and surveys in a busy practice setting; feasibility of measuring study outcomes (Measured at the end of the study period (approximately 2 years))
C: Patient's satisfaction and confidence with the information given. (Within two weeks after receiving the information and after 3 months.)
D: Impact of personalized risk information (baseline); Impact of personalized risk information (3 month)

Answer: C