TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation the Side Effects of Repeated Bone Marrow Derived Mono Nuclear Stem Cells Transplantation in Patients With Lower Limb Ischemic Ulcer
Brief Summary: Critical limb ischemia (CLI) results from severe occlusive disease that impairs distal limb perfusion to the point where oxygen delivery is no longer adequate to meet the metabolic needs of the tissue, even under resting conditions. The limits of peripheral artery disease (PAD) compensatory mechanisms, such as distal vasodilatation and collateral formation, have been exceeded at this point. PAD is a widespread disease, affecting up to 15% of all adults older than 55 years. Formation of true new blood vessels, or angiogenesis, and development of collateral vessels from preexisting blood vessels, or arteriogenesis, is important in the pathophysiology of vascular disease. By stimulating these processes the investigators might be able to provide an alternative treatment strategy for patients with lower limb ischemia. In response to tissue injury and remodeling, neovascularization usually occurs via the proliferation and migration of progenitor endothelial cells (EPC) from preexisting vasculature. Indeed, recent studies have shown that bone-marrow mononuclear cell (BM-MNC) implantation increases collateral vessel formation in patients with limb ischemia. So the investigators determine to evaluate the efficacy of repeated MNC transplantation in patients with ischemic lower limb.


Options:
A: Therapy Success (6 months)
B: adverse events (6 months); ankle-brachial systolic pressure index (3 mo); transcutaneous oxygen value (mm Torr) (3 mo); quality of life (questionnaires) (3 mo)
C: side effects (3months)
D: Major amputation

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation the Side Effects of Repeated Bone Marrow Derived Mono Nuclear Stem Cells Transplantation in Patients With Lower Limb Ischemic Ulcer
Brief Summary: Critical limb ischemia (CLI) results from severe occlusive disease that impairs distal limb perfusion to the point where oxygen delivery is no longer adequate to meet the metabolic needs of the tissue, even under resting conditions. The limits of peripheral artery disease (PAD) compensatory mechanisms, such as distal vasodilatation and collateral formation, have been exceeded at this point. PAD is a widespread disease, affecting up to 15% of all adults older than 55 years. Formation of true new blood vessels, or angiogenesis, and development of collateral vessels from preexisting blood vessels, or arteriogenesis, is important in the pathophysiology of vascular disease. By stimulating these processes the investigators might be able to provide an alternative treatment strategy for patients with lower limb ischemia. In response to tissue injury and remodeling, neovascularization usually occurs via the proliferation and migration of progenitor endothelial cells (EPC) from preexisting vasculature. Indeed, recent studies have shown that bone-marrow mononuclear cell (BM-MNC) implantation increases collateral vessel formation in patients with limb ischemia. So the investigators determine to evaluate the efficacy of repeated MNC transplantation in patients with ischemic lower limb.


Options:
A: major-amputation-free survival rate (at 6 months)
B: Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months (Baseline, 3 months)
C: adverse events (6 months); ankle-brachial systolic pressure index (3 mo); transcutaneous oxygen value (mm Torr) (3 mo); quality of life (questionnaires) (3 mo)
D: side effects (3months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Electronic Health Records for Addressing Overweight and Obesity in Primary Care
Brief Summary: Overweight and obesity are highly significant clinical and public health issues, affecting more than two-thirds of adults in this country; however, primary care clinicians often do not document overweight or obesity or discuss weight management with their patients. The objectives of the proposed research are to develop and evaluate a set of tools within electronic health records (EHRs) to assist primary care clinicians with the diagnosis and treatment of overweight and obesity and to help patients manage their weight.


Options:
A: Changes in BMI z-score (Measured at Month 12)
B: To investigate the feasibility of replicating a successful hospital based, childhood obesity clinic in primary care using trained primary care staff and undertake a pilot trial. (12 months)
C: weight change over 6 months (Baseline, 6 months); weight change over 12 months (Baseline, 12 months)
D: Change from baseline physical activity at 12 weeks (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma
Brief Summary: This 2-arm, randomized, phase III study will investigate the efficacy and safety of the addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have tumors that express the EGFRvIII protein) to the current standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of brain cancer.

All patients will be administered temozolomide, the standard treatment for glioblastoma. Half the patients will be randomly assigned to receive rindopepimut and half the patients will be randomly assigned to receive a control called keyhole limpet hemocyanin.

Patients will be treated in a blinded fashion (neither the patient or the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival.


Options:
A: Median Overall Survival Time (From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.)
B: Overall Survival (OS) (From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.); Progression-free Survival (PFS) (From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.)
C: Overall Survival (During treatment and every three months from end of treatment through end of study or approximately up to 5 years.)
D: Evaluation of the treatment impact on progression-free survival (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma
Brief Summary: This 2-arm, randomized, phase III study will investigate the efficacy and safety of the addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have tumors that express the EGFRvIII protein) to the current standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of brain cancer.

All patients will be administered temozolomide, the standard treatment for glioblastoma. Half the patients will be randomly assigned to receive rindopepimut and half the patients will be randomly assigned to receive a control called keyhole limpet hemocyanin.

Patients will be treated in a blinded fashion (neither the patient or the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival.


Options:
A: median overall survival (1 year)
B: Overall survival (12 months)
C: Overall Survival (During treatment and every three months from end of treatment through end of study or approximately up to 5 years.)
D: Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Identifying and Overcoming Barriers to Diabetes Management in the Elderly: An Intervention Study
Brief Summary: The purpose of this research study is to identify barriers affecting self care in older patients with diabetes and to provide coping strategies for these barriers with help from a care manager (Geriatric Life Specialist) to improve clinical, economical, functional and psychosocial parameters.


Options:
A: HbA1c (12 months)
B: change in hemoglobin A1c (6 and 12 months)
C: Health related quality of life (12 months); HbA1c change over time (participants with T2DM only) (12 months)
D: Change in HbA1c at 12 months (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Identifying and Overcoming Barriers to Diabetes Management in the Elderly: An Intervention Study
Brief Summary: The purpose of this research study is to identify barriers affecting self care in older patients with diabetes and to provide coping strategies for these barriers with help from a care manager (Geriatric Life Specialist) to improve clinical, economical, functional and psychosocial parameters.


Options:
A: Depressive Symptoms (CES-D Score) (Baseline, 12 month FU)
B: Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein (12 months)
C: change in hemoglobin A1c (6 and 12 months)
D: % of patients reaching goal HbA1C (<7) (2 years after enrollment); % of patients with BP goal (<130/80) (Two years after enrollment); % of patients with LDL at goal (<100) (2 years after enrollment); % of patients at goal for all three parameters (HbA1C <7, BP <130/80, LDL <100) (2 years after enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Whole Body Vibration Training on the Exercise Performance in Patients After Lung Transplantation
Brief Summary: Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in patients following lung transplantation. Exercise training has been shown to be a cornerstone of an inpatient rehabilitation program to reduce muscle dysfunction and improve exercise performance. In our study we will investigate the benefit of a whole body vibration training in addition to a standard pulmonary rehabilitation program that includes endurance and strength training. We will include a total of 140 patients (70 patients \< 1 year after lung Transplantation and 70 patients \> 1 year after lung Transplantation). Our hypothesis is that an addtitional whole body vibration training produces a greater benefit to exercise capacity in lung transplantat patients (LTx).


Options:
A: change in 6-minute walking distance (change from baseline to day 21)
B: Change in daily physical activity (Measured for 1 week pre-transplant, measured for 1 week at randomisation (1-2 months post-transplant), 1 week following the 3 month intervention, 1 week at 6 months post randomisation and 1 week at 12 months post-randomisation.)
C: SF-36 Physical and Psychological Component Summary (T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up); Maximum exercise capacity in Watts absolutely and in percentage predicted and anaerobic threshold (T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up); Oxygen uptake per minute and kg body mass [VO2/min/kg/Body weight] absolutely and in percentage predicted (T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up); Duration of exercise in minutes during constant load tests in the range of the anaerobic threshold (T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up)
D: Participation in Physical Activities in Daily Life (One year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect and Cost Evaluation of a Multifaceted Approach Including Audit and Feedback With a Patient-centredness Questionnaire in Fertility Care.
Brief Summary: The purpose of this study is to evaluate the effects and costs of a multifaceted approach on the patient-centredness of fertility care and the quality of life of fertility patients.


Options:
A: Referral for Kidney Transplantation (One Year)
B: Change from baseline in the level of patient-centredness at one year (one year)
C: Change in uptake of shared decision-making from the patients' perspective (All clinics: baseline, 8 months, 16 months, 24 months)
D: At set time points the following will be measured: Recovery from depression Patient quality of life 1 year before and after: Clinic depression treatment utilization and costs

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Phase I Dose Finding Safety Study of a Thrombopoietin-receptor Agonist, Eltrombopag, in Patients With Myelodysplastic Syndrome Treated With Azacitidine
Brief Summary: Patients with Myelodysplastic Syndromes (MDS) often suffer from low platelet levels which may lead to bleeding complications. Treatment with cytotoxic agents can decrease the platelet levels further. Eltrombopag is a relatively new drug that increases the platelet level in the blood by working directly on the bone marrow. It is available for treatment of the disease Immunological Thrombocytopenic Purpura (ITP). In this study patients with MDS and low platelet levels that are treated with the cytotoxic agent Azacitidine will also receive Eltrombopag. The administration of Eltrombopag to MDS patients treated with Azacitidine may result in less dose reductions and less treatment delays for Azacitidine and may reduce the need for thrombocyte transfusions and lower the risk of bleeding complications.

This is a phase I study, meaning that our major goal is to investigate the safety and tolerability for Eltrombopag in this patient group. It will also generate a basis for a phase II-III-study.


Options:
A: The Portion of Drug Responders as Defined by Hematologic Improvements (12-16 weeks)
B: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period (up to 20 weeks))
C: Safety and tolerability parameters (week 26)
D: Response to Drug Based on Platelet Count at the End of Therapy (21 days and/or 42 days of therapy, 15 and 30 days after the end of therapy)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects
Brief Summary: The purpose of this study is to determine the effect of theobromine on blood lipid parameters in healthy subjects. Secondary objectives are to determine the effect of cocoa and an interaction effect of cocoa and theobromine on blood lipid parameters.

Hypothesis: theobromine has a positive effect on blood lipid parameters.


Options:
A: Endothelial function (change in flow mediated dilatation between first treatment at day 0 and after last treatment at day 14)
B: Changes in systolic and diastolic blood pressure (8 weeks)
C: Augmentation index (Changes in augmentation index at 1 week, according to glycemic index of the breakfast)
D: Blood lipids (after 4 weeks intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy Of Multiparametric Telemonitoring On Respiratory Outcomes In Elderly People With Chronic Obstructive Pulmonary Disease.
Brief Summary: Chronic obstructive pulmonary disease (COPD) determines an important risk of disability and disease-related need of care. Selected interventions were able to reduce the number and the severity of exacerbations. Telemedicine has also been proposed for this purpose. Current evidences, however, are scant. The investigators present a randomized, parallel-group trial of a multiparametric remote monitoring system to test its ability to improve early exacerbation detection rates and impact on clinical outcomes.


Options:
A: The reduction of systolic blood pressure in the nurse administered intervention will be 5 mm hg lower than those patients randomized to an education control group over 12 months of follow-up (12 months)
B: Rate of Heart Failure Related (HFR) Hospitalizations (6 months); Freedom From a Device/System-related Complication (DSRC). (6 months); Freedom From Pressure Sensor Failure (6 months)
C: Hemoglobin A1c Levels (5 years); Blood Pressure Levels (5 years); Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol (5 years)
D: Respiratory Events (9 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy Of Multiparametric Telemonitoring On Respiratory Outcomes In Elderly People With Chronic Obstructive Pulmonary Disease.
Brief Summary: Chronic obstructive pulmonary disease (COPD) determines an important risk of disability and disease-related need of care. Selected interventions were able to reduce the number and the severity of exacerbations. Telemedicine has also been proposed for this purpose. Current evidences, however, are scant. The investigators present a randomized, parallel-group trial of a multiparametric remote monitoring system to test its ability to improve early exacerbation detection rates and impact on clinical outcomes.


Options:
A: Hospital Readmission (12 months)
B: Respiratory Events (9 months)
C: Health-Related quality of life (12 months)
D: Total cost of hospitalization, $ (Day of admission to day of discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind Randomized Controlled Trial of Phenylephrine for the Prevention of Spinal Induced Hypotension in Obese Parturients
Brief Summary: Previous research regarding the use of phenylephrine has excluded obese subjects (BMI \>35). This subgroup of patients represents a large portion of the obstetric patient population locally and nationally. It is unclear whether previous research should be extrapolated to the obese patient population. This study is being done to compare the incidence of hypotension, intraoperative nausea and vomiting, and neonatal acidosis between obese patients who receive a prophylactic phenylephrine infusion versus those who receive phenylephrine boluses for the treatment of established hypotension. This study will help us determine whether using a phenylephrine infusion or a phenylephrine bolus is the best way to prevent/treat spinal induced hypotension during cesarean deliveries in obese patients.


Options:
A: Intraoperative Nausea and Vomiting (Intraoperatively)
B: Intraoperative blood loss (mL) (20 minutes); Postoperative Hemoglobin (gm/L) (20 minutes)
C: Incidence of Nausea and Vomiting (intraoperative 2-3 hours); Incidence of Nausea and Vomiting (2 hrs postoperative); Incidence of Nausea and Vomiting (24hrs postoperative)
D: Intra-operative nausea (intra-operative)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma
Brief Summary: The clinical benefits of sunitinib and sorafenib have been demonstrated in patients with cytokine-refractory metastatic renal cell carcinoma. Sunitinib has also been shown to improve progression free survival and overall survival in a comparative study with interferon-alpha. When sunitinib is used as first-line molecular-targeted therapy, switching to sorafenib is one of the treatment options after disease progression. Reversely, when sorafenib is used as first-line molecular-targeted therapy, sunitinib is used as second-line therapy. The goal of cancer treatment is cure, and if cure is not possible, it is to prolong survival. In this study, sunitinib or sorafenib will be administered as first-line molecular-targeted therapy and treatment switched to the other test drug, sorafenib or sunitinib, when disease progression is detected to assess which treatment sequence produces longer progression free survival and offers a better safety profile (causing fewer adverse events). The purpose of this trial is to compare progression free survival of first line sunitinib versus sorafenib, and that of two treatment sequences, i.e. sunitinib followed by sorafenib versus sorafenib followed by sunitinib.


Options:
A: Progression-free Survival (PFS) (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks (up to approximately 5 years))
B: Progression Free Survival (PFS) (Randomization to Measured Progressive Disease or Date of Death From Any Cause (Up to 67 Months))
C: Progression free survival in first-line treatment (Time of progression in first line treatment)
D: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Using Technology to Prevent Obesity Among African American Girls
Brief Summary: The purpose of this project is to reduce health disparities in obesity risk among 8-10 year old African American girls using a culturally sensitive and developmentally appropriate internet-based program with no face-to-face interaction. This study will conduct an outcome evaluation to test short and longer term effects on obesity risk.


Options:
A: Body mass index percentile (6 months)
B: changes in body mass index throughout the intervention
C: Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex (Baseline, 24 months); Change in Waist Circumference (Baseline, 78 months); Prevalence of Acanthosis Nigricans (Baseline, 24 months); Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex (Baseline, 78 months); Change in Waist Circumference (Baseline, 24 months); Prevalence of Acanthosis Nigricans (Baseline, 78 months)
D: For adults: body weight loss maintenance (6 Month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Detection and Intervention on Mild/Moderate Chronic Obstructive Pulmonary Disease by Traditional Chinese Medicine Treatment and Application
Brief Summary: The purpose of this study is to compare the exercise capacity and pulmonary function test parameters of Chronic Obstructive Pulmonary Disease (COPD) patients who underwent usual care with and without pulmonary daoyin therapy of China in community.


Options:
A: "Quality of care process" (one year)
B: Change in the strength of the quadriceps over the 6-week electrostimulation program. (6 to 8 weeks)
C: Re-hospitalizations (During the 30days after discharge)
D: 6 Minutes Walking Distance Test ( 6MWD) (Change from Baseline in 6MWD at month 3 of the treatment phase); Forced expiratory volume in one second, FEV1 (Change from Baseline in FEV1 at month 3 of the treatment phase)

Answer: D