TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center Trial Comparing the Efficacy and Safety of GSK573719/GW642444 With GSK573719 and With Tiotropium Over 24 Weeks in Subjects With COPD
Brief Summary: This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when administered once-daily over a 24-week treatment period in subjects with chronic obstructive pulmonary disease (COPD). Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to10 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 26 weeks. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, and clinical laboratory tests.


Options:
A: FEV1 AUC0-3h Response (baseline and 12 weeks); Trough FEV1 Response (Change From Baseline) (baseline and 12 weeks); St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Data From This Individual Study (12 weeks treatment); St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352 (12 weeks treatment)
B: FEV1 AUC0-24 on Day 29 (Day 29)
C: Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 169 (Baseline and Day 169)
D: Trough FEV1 Response (Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center Trial Comparing the Efficacy and Safety of GSK573719/GW642444 With GSK573719 and With Tiotropium Over 24 Weeks in Subjects With COPD
Brief Summary: This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when administered once-daily over a 24-week treatment period in subjects with chronic obstructive pulmonary disease (COPD). Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to10 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 26 weeks. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, and clinical laboratory tests.


Options:
A: Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Throughout the Treatment Period (From the first dose of study medication up to 52 weeks); Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period (From the first dose of study medication up to 52 weeks)
B: Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 169 (Baseline and Day 169)
C: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Treatment Day 85 (Visit 8) (Baseline (BL) and Day 85)
D: Change From Baseline in Trough FEV1 on Day 85 (Baseline (BL) and Day 85)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: CONFUCIUS Study : Impact of a Multifaceted Program to Prevent Postoperative Delirium in the Elderly
Brief Summary: Postoperative delirium is common in the elderly and is associated with a significant increase in mortality, complications, length of hospital stay and admission in long care facility. Several interventions have proved their effectiveness to prevent it but their combination within a multifaceted intervention needs to be assessed using rigorous methodology based on randomized study design. CONFUCIUS trial aims to measure the impact of a multifaceted program on the prevention of postoperative delirium in elderly.


Options:
A: Postoperative delirium rate within 7 days after surgery (7 days after surgery)
B: Incidence of postoperative delirium (During the first 7 days after surgery.)
C: Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method (Postoperative days up to hospital discharge)
D: We will use a composite endpoint by these two instruments: Clinical Dementia Rating Scale (CDR), and the 10 words memory task from the Consortium to Establish a Registry for Alzheimer's Disease battery (CERAD) (4 and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: CONFUCIUS Study : Impact of a Multifaceted Program to Prevent Postoperative Delirium in the Elderly
Brief Summary: Postoperative delirium is common in the elderly and is associated with a significant increase in mortality, complications, length of hospital stay and admission in long care facility. Several interventions have proved their effectiveness to prevent it but their combination within a multifaceted intervention needs to be assessed using rigorous methodology based on randomized study design. CONFUCIUS trial aims to measure the impact of a multifaceted program on the prevention of postoperative delirium in elderly.


Options:
A: Changes in functional status after the intervention (Barthel Index) (Baseline (Hospital Admiission), 1 and 3 months later); Changes in functional status after the intervention (Mini Mental State Evaluation, GDS Yesavage, Trail Making Test) (Baseline (Hospital Admiission) and 1 and 3 months later)
B: We will use a composite endpoint by these two instruments: Clinical Dementia Rating Scale (CDR), and the 10 words memory task from the Consortium to Establish a Registry for Alzheimer's Disease battery (CERAD) (4 and 12 months)
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: Postoperative delirium rate within 7 days after surgery (7 days after surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CONFUCIUS Study : Impact of a Multifaceted Program to Prevent Postoperative Delirium in the Elderly
Brief Summary: Postoperative delirium is common in the elderly and is associated with a significant increase in mortality, complications, length of hospital stay and admission in long care facility. Several interventions have proved their effectiveness to prevent it but their combination within a multifaceted intervention needs to be assessed using rigorous methodology based on randomized study design. CONFUCIUS trial aims to measure the impact of a multifaceted program on the prevention of postoperative delirium in elderly.


Options:
A: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
B: Delirium incidence (% participants) (Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
C: Postoperative delirium rate within 7 days after surgery (7 days after surgery)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The primary objective is to test the hypothesis that the use of the Pressure Right device in combination with ondansetron and dexamethasone would result in a lower incidence of postoperative vomiting (emesis) than the combination of antiemetic therapy alone.


Options:
A: Postoperative nausea and vomiting (Postperative nauea and vomiting are registred regularly 0-48 hours postperatively.)
B: Postoperative nausea and vomiting (24 hours)
C: N/A
D: Postoperative nausea and vomiting

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Using an Electronic Personal Health Record to Empower Patients With Hypertension
Brief Summary: Project Summary:

An electronic personal health record (ePHR) could maximize patient/clinician collaboration and consequently improve patient self-management and related health outcomes. The purpose of the proposed project is to examine the feasibility, acceptability, and impact of an ePHR that has been modified using a patient- and family-centered approach and incorporates the experiences, perspectives, and insights of patients and family members actually using the system. Comparison of patients with the ePHR intervention to a group of "care as usual" patients will be performed. The investigators Specific Aims are: (1) To improve the application of patient- and family-centered care elements in an existing ePHR, based on feedback from a pilot study of patients and their families. The modified ePHR will be tested in a pilot group of patients with hypertension and their families. (2) To implement and test the effectiveness of the modified ePHR with patients being treated for hypertension by a team of physicians, mid-level practitioners, nurse clinicians, and support staff in two ambulatory settings. Outcome measures will include patient activation and perception of care, quantifiable biological markers, patient-physician communication, and congruence of treatment with guidelines, particularly medication management; (3) To monitor the shift in provider and support staff awareness and incorporation of patient- and family-centered care as a result of implementation of the ePHR using questionnaires and focus groups. If successful, this ePHR could be implemented in additional locations in the Southeast.


Options:
A: Comparison of change in diabetes quality of care between intervention and usual care group. (6 months follow-up)
B: Change in Patient Activation Measure (Admission to Unit and 3-5 days after)
C: Improvement in Self-Administered Psoriasis Area and Severity Index (SA-PASI) (12 months)
D: Systolic blood pressure (9 months); Diastolic blood pressure (9 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Using an Electronic Personal Health Record to Empower Patients With Hypertension
Brief Summary: Project Summary:

An electronic personal health record (ePHR) could maximize patient/clinician collaboration and consequently improve patient self-management and related health outcomes. The purpose of the proposed project is to examine the feasibility, acceptability, and impact of an ePHR that has been modified using a patient- and family-centered approach and incorporates the experiences, perspectives, and insights of patients and family members actually using the system. Comparison of patients with the ePHR intervention to a group of "care as usual" patients will be performed. The investigators Specific Aims are: (1) To improve the application of patient- and family-centered care elements in an existing ePHR, based on feedback from a pilot study of patients and their families. The modified ePHR will be tested in a pilot group of patients with hypertension and their families. (2) To implement and test the effectiveness of the modified ePHR with patients being treated for hypertension by a team of physicians, mid-level practitioners, nurse clinicians, and support staff in two ambulatory settings. Outcome measures will include patient activation and perception of care, quantifiable biological markers, patient-physician communication, and congruence of treatment with guidelines, particularly medication management; (3) To monitor the shift in provider and support staff awareness and incorporation of patient- and family-centered care as a result of implementation of the ePHR using questionnaires and focus groups. If successful, this ePHR could be implemented in additional locations in the Southeast.


Options:
A: Change in serum LDL-cholesterol level (at 6 months post disclosure of CAD risk)
B: Systolic blood pressure (9 months); Diastolic blood pressure (9 months)
C: Understanding (Directly proceeding the clinical encounter); Decisional Conflict (Directly proceeding the clinical visit); Treatment Action, adherence (Directly proceeding the clinical encounter, 6 months after the clinical encounter)
D: Proportion of patients reporting a decision for "immediate antibiotics." (After index consultation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Folic Acid and B Vitamins for Secondary Prevention of Stroke : A Double-blinded Randomized Controlled Trial
Brief Summary: The CSSPT study is a multi-center, randomized, double blinded, placebo-controlled secondary stroke prevention trial in China to determine whether the addition of folic acid and vitamin supplements will reduce recurrent stroke events and other combined incidence of recurrent vascular events and vascular death.


Options:
A: Recurrent stroke (3 years); Myocardial infarction (3 years); Death due to other vascular causes (3 years)
B: Change in mean carotid intima-media thickness; Change in maximum carotid intima-media thickness
C: Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes (The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).)
D: Change in Clinical Dementia Rating Scale (CDR) (Change from baseline in CDR at month 9, 18, 27)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Folic Acid and B Vitamins for Secondary Prevention of Stroke : A Double-blinded Randomized Controlled Trial
Brief Summary: The CSSPT study is a multi-center, randomized, double blinded, placebo-controlled secondary stroke prevention trial in China to determine whether the addition of folic acid and vitamin supplements will reduce recurrent stroke events and other combined incidence of recurrent vascular events and vascular death.


Options:
A: Major fatal and non fatal ischemic cardiovascular events; Cancer any kind except for basal cell skin carcinoma
B: Recurrent stroke (3 years); Myocardial infarction (3 years); Death due to other vascular causes (3 years)
C: Prostate cancer (Ongoing); Total cancer (Ongoing); Major cardiovascular events (Ongoing)
D: Development of Advanced AMD in People at Moderate to High Risk for Progression. (5 years of follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Bilateral Bispectral Index Monitoring During and After Electroconvulsive Therapy Compared With Magnetic Seizure Therapy for Treatment-resistant Depression
Brief Summary: Electroconvulsive therapy (ECT) has been shown to be an effective treatment for patients suffering from depression, who do not respond to medical treatment. However it is often dismissed by patients, who feel uncomfortably about the application of electric shocks to their heads. In 2000, magnetic seizure therapy (MST) has been introduced which uses magnetism instead of electricity to evoke convulsions. MST seems to be as effective as ECT in terms of its antidepressant potency but may be associated with less severe cognitive side effects.

Control of anaesthesia during seizure therapy is demanding since light anesthesia might be associated with awareness, whereas deep anesthesia impedes the antidepressant effect of the convulsion. Therefore, Bispectral index (BIS) monitoring is frequently used to tailor anaesthesia for ECT, however little is known about BIS following MST.

The investigators hypothesize that in comparing MST with ECT, (a) patients show a faster increase in BIS and that (b)less left-right differences occur in BIS.


Options:
A: Hamilton Rating Scale for Depression, 24-Item (HRSD-24) (baseline (pre-treatment) and post-treatment)
B: Clinical improvement (Hamilton Rating Scale for Depression) (After each treatment and at followups up to 3 months after the treatment course)
C: MADRS (2 weeks)
D: Recovery Time (same day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of the Use of Universal Glove and Gowning on Healthcare Associated Infection Rates and Antibiotic Resistant Bacteria
Brief Summary: This study will test if doctors, nurses and other people who take care of patients in hospitals wearing gloves and gown for all contact with patients in an intensive care unit (ICU) will:

* Decrease the chance of patients getting an infection while in the hospital
* Decrease the chance of patients picking up bacteria as a result of being in the hospital
* Decrease the time a patient spends in the ICU or in the hospital
* Increase the frequency of adverse events

The study will also look at whether making doctors, nurses and other people who take care of patients wear gloves and gown for all contact with patients will decrease the amount of time healthcare workers spend with patients.

This study will gather information by comparing what happens in ICUs that continue to do what they were doing before the study with what happens in ICUs that require healthcare workers to wear gloves and gown for all contact with patients.

This study will provide information that will help to make being in the hospital safer for all patients.


Options:
A: Number of ICU Patients Who Acquire VRE or MRSA (9 months)
B: N/A
C: Number of Subjects With Single Negative Polymerase Chain Reaction (PCR) Result and 3 Negative Culture Assays (1 year); Completion of Screening Protocol in Both Trial Arms (1 year); Discontinuation of Contact Precautions in Both Trial Arms (1 year)
D: Bacterial colony counts and the frequency with which methicillin-resistant Staphylococcus aureus was found over time (8 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I/II Study of Cellular Immunotherapy Using Central Memory-Enriched CD8+ T Cells Lentivirally Transduced to Express A CD19-Specific Chimeric Immunoreceptor Following Peripheral Blood Stem Cell Transplantation for Patients With High-Risk Intermediate Grade B-Lineage Non-Hodgkin Lymphoma
Brief Summary: This phase I/II trial studies the side effects and best dose of genetically engineered lymphocyte therapy and to see how well it works after peripheral blood stem cell transplant (PBSCT) in treating patients with high-risk, intermediate-grade, B-cell non-Hodgkin lymphoma (NHL). Genetically engineered lymphocyte therapy may stimulate the immune system in different ways and stop cancer cells from growing. Giving rituximab together with chemotherapy before a PBSCT stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim (G-CSF), or plerixafor helps stem cells move from the bone marrow to the blood so they can be collected and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving genetically engineered lymphocyte therapy after PBSCT may be an effective treatment for NHL.


Options:
A: Number of Participants With Dose Limiting Toxicities (DLTs) (Within 28 days of T-cell infusion); Woodchuck Hepatitis Virus Post-transcriptional Regulatory Element (WPRE) Detection Above Background (28 days post T cell infusion); Number of Days of Quantifiable CD19 CAR Post T-cell Infusion (28 days post T cell infusion)
B: Frequency, relatedness, severity and duration of treatment emergent and treatment related adverse events (35 days); Number of first cycle dose limiting toxicities (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) (up to 1 year)
C: Overall response rate (12 weeks); Overall Survival (6 months,1 year, 2 years); Progression-free Survival (12 weeks,6 months,1 year, 2 years); Event-free Survival (12 weeks,6 months,1 year, 2 years)
D: Safety as assessed by dose limiting toxicities (DLTs) (28 days); Determination of maximum tolerated dose and proposed recommended Phase 2 dose (24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: HepZero:Heparin Free Dialysis With Evodial: A Prospective Multicenter, Open, Randomized, Controlled Clinical Study With Parallel Groups
Brief Summary: The study hypothesis is that with Evodial in patients requiring heparin free dialysis, the heparin free treatment can be performed easily (without saline flushes or blood predilution) and is at least not inferior and maybe superior to the standard care heparin free treatment in terms of clotting.


Options:
A: Clotting of the dialysis session (During first dialysis session_Dialysis duration: 4 hours)
B: Assess the safety of the factor Xa inhibitor apixaban versus a vitamin-K antagonist phenprocoumon in patients with NVAF and ESKD on hemodialysis. (1-60 months)
C: clinical patency of the hemodialysis extracorporeal circuit (4 hours)
D: Number of open fibres in the dialyzer (17 weeks)

Answer: A