TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Multicenter Trial Testing the Antiproteinuric Effect of Statins Added to Combined ACE-inhibitor and Angiotensin Receptor Antagonist Therapy in Proteinuric, Chronic Nephropathies
Brief Summary: End stage renal disease (ESRD) is rapidly growing worldwide. Patients with ESRD have increased morbidity and mortality mostly because of a dramatic excess of cardiovascular disease. Thus, preventing or limiting the progression of chronic nephropathies, in addition to limit the incidence of ESRD, may also postpone death. Drugs that inhibit the renin angiotensin system, such as Angiotensin-Converting-Enzyme inhibitors (ACEi) and Angiotensin II receptor antagonists (ATA), are reno- and cardio-protective in the long-term. There are data that statins,in addition to limit cardiovascular events may have specific reno-protective properties.

Thus we designed a study aimed to evaluate whether statins associated to ACEi and ATA may have an additional reno-protective effect.

ESPLANADE is a multicenter, prospective, randomized, parallel group study in which, after 2 months treatment with ACEi and ATA, two groups of 90 patients, with or without type 2 diabetes, are randomized to 6 months Fluvastatin (40 or 80 mg/day) treatment YES or NO.Twenty Italian Nephrology Units are involved in the trial. The study is fully coordinated by the Clinical Research Center for Rare Disease Aldo e Cele Daccò, Villa Camozzi, Ranica.


Options:
A: Fractional excretion of sodium (5 days treatment)
B: 24-hour urinary protein excretion rate, at the end of 6 months treatment phase (At 0, 2,3,4,5,6,7,8,9,10 months.)
C: Raw Urine Osmolality value at 12 week follow-up, adjusted for baseline (UOsm in mOsm/Kg) (12 weeks follow-up)
D: Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes. (Assessed at Week 52, Last observation carried forward (LOCF))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Sacral Nerve Stimulation for Anal Incontinence and Bowel Control
Brief Summary: Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with InterStim Therapy to treat fecal incontinence or constipation


Options:
A: Percentage of Participants Who Are Responder50. (6 months after last blinded treatment); Percentage of Participants Who Are Responder25. (12 months after last treatment)
B: FI - number of FI episodes per week and/or number of days with FI per week. Constipation - number of bowel movements per week; &/or decrease defecations requiring straining; &/or decrease defecations where there was incomplete emptying (Annually)
C: Proportion of subjects with an average of 3 or more SCBM per week (12 weeks)
D: Number of incontinence episodes Assess number of incontinence episodes. (Will be assessed every four weeks during a twelve-week period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Restore Claims Characterization Study
Brief Summary: The purpose of this study is to characterize the pain coverage capability of the RESTORE spinal cord stimulation (SCS) and assess health outcomes.


Options:
A: Responder Rate (3 months post-activation)
B: The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.
C: Completion of EQ-5D5L Health questionnaire (1 hour); Numeric Rating Scale (NRS) recording pain severity (1 hour)
D: Pain intensity measured on a weighted NRS according to Jensen and a PGIC for pain measured on a 7-point Likert scale. (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Restore Claims Characterization Study
Brief Summary: The purpose of this study is to characterize the pain coverage capability of the RESTORE spinal cord stimulation (SCS) and assess health outcomes.


Options:
A: Pain intensity according to numeric rating scale (NRS) (3 months after implantation)
B: Change in Visual Analog Scale (VAS) score (Pre-implant visit, up to approximately 2 weeks)
C: Changes in pain (6 months)
D: The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Restore Claims Characterization Study
Brief Summary: The purpose of this study is to characterize the pain coverage capability of the RESTORE spinal cord stimulation (SCS) and assess health outcomes.


Options:
A: The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.
B: Changes in pain (6 months)
C: Responder Rate (3 months post-activation)
D: Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline (90 days post activation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Trial of Acute Normovolemic Hemodilution Compared to Standard Intraoperative Management in Patients Undergoing Major Hepatic Resection and Pancreaticoduodenectomy
Brief Summary: With a major liver or pancreas operation, there is a chance that one will require a transfusion of blood products (either red blood cells or plasma). This may be necessary during the operation or a few days after surgery. The surgeons at Memorial Sloan-Kettering Cancer Center perform a very large number of liver or pancreas resections every year and have pioneered techniques that minimize bleeding during the operation. Even so, liver or pancreas operations such as the one that will be undergone carry a 50% chance of requiring a transfusion. A technique that might lower the need for transfusions is called acute normovolemic hemodilution (ANH). ANH was first introduced over twenty years ago and has been used in many types of operations, including liver or pancreas resection. The studies done on ANH at other hospitals suggest that it may help conserve blood. Researchers at Memorial Sloan-Kettering Cancer Center are conducting a study to determine if ANH is better than the 'standard technique' that is currently used in all patients. The purpose of this study is to find out which of the two techniques is better.

The purpose of the study is to see if ANH lowers the need for the transfusion of blood products during and after liver or pancreas resection.

The second purpose of the study is to see how ANH changes the length of the operation, the length of time one spends in the hospital, and the complication rate after surgery. The researchers will also see if ANH requires any changes in the administration of anesthesia.


Options:
A: Serum alanine aminotransferase (ALT) concentration within 5 days post-operative (pre-operative and every day till 5 days post-operative)
B: Proportion of subjects achieving hemostasis at the Target Bleeding Site (TBS). (Intra-operative)
C: To determine if ANH reduces the requirement for allogeneic red cell transfusions in patients undergoing major hepatic resection or pancreaticoduodenectomy compared to standard intraoperative management (All patients will have their blood checked every 30 minutes during surgery)
D: Hepatocellular Damage Reflected by Liver Fatty-acid Binding Protein (L-FABP) Levels (L-FABP area under curve from start of surgery up until postoperative day 3)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Development and Evaluation of a SlimFast Internet Behavioral Weight Loss Program
Brief Summary: The Internet has been used effectively in behavioral weight loss programs. Most of these programs have involved a therapist who provides email counseling. The purpose of this study was to determine whether a computer-assisted weight loss program could be developed (that would use pre-programmed computer generated messages rather than human generated messages) and whether this program would be as effective as the therapist-assisted weight loss program.


Options:
A: Percent Change From Baseline Weight (Baseline, 2 years)
B: Weight loss at 6 months
C: Anthropometrics (body weight, height, circumferences, total body fat%, blood pressure); Energy intake (Food Frequency Questionnaire); Physical activity level (Physical Activity Scale for the Elderly)
D: Body Weight (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Interactive Technologies to Increase Exercise Behavior
Brief Summary: The purpose of this study is to examine if an individually tailored Internet intervention is more efficacious than an individually tailored print-based intervention and standard Internet intervention for physical activity adoption and maintenance among sedentary adults.


Options:
A: Physical activity level
B: Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps (Baseline, 3, and 9 months); Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day) (Baseline, 3 and 9 months)
C: Physical activity measured by accelerometry. (3 months post-randomisation)
D: Minutes of physical activity per week based on 7-Day Physical Activity Recall Interview.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Interactive Technologies to Increase Exercise Behavior
Brief Summary: The purpose of this study is to examine if an individually tailored Internet intervention is more efficacious than an individually tailored print-based intervention and standard Internet intervention for physical activity adoption and maintenance among sedentary adults.


Options:
A: Self-Reported physical activity (Baseline, 3 months, and 6 months)
B: Absolute level of physical activity: (Assessed at baseline, 6, 12 and 24-month follow-up as kcals/wk expenditure based on survey self-report, validated against activity monitor data in a random sub-sample.); Maintenance of physical activity (Physical activity level relative to baseline assessed at all follow-ups 6, 12, 24 months.)
C: Minutes of physical activity per week based on 7-Day Physical Activity Recall Interview.
D: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Interactive Technologies to Increase Exercise Behavior
Brief Summary: The purpose of this study is to examine if an individually tailored Internet intervention is more efficacious than an individually tailored print-based intervention and standard Internet intervention for physical activity adoption and maintenance among sedentary adults.


Options:
A: Minutes of physical activity per week based on 7-Day Physical Activity Recall Interview.
B: Physical activity measured by accelerometry. (3 months post-randomisation)
C: Physical activity level
D: 7-Day Physical Activity Recall (7-Day PAR) (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The obesity epidemic observed in recent years can be largely attributed to an obesogenic environment that encourages overeating and sedentary lifestyles. Behavioral weight control treatment, the most empirically validated intervention approach, produces initial weight losses of 10%; however, maintenance of initial weight loss and behavior change has not been achieved. These disappointing long-term results may reflect the fact that participants are given only minimal, indirect instruction on how to change their environment to support their new weight-regulating behaviors. While in theory, the behavioral model emphasizes environmental antecedents and consequences of eating and exercise, in practice, only 1 to 2 sessions in standard treatment are dedicated to stimulus control-types of skills. By teaching weight control skills in a contextual vacuum, participants remain vulnerable to the same environmental influences that maintained their unhealthy eating and exercise habits. Given that the majority of eating and exercise is home-based, a logical step in strengthening behavioral treatment and moving toward an ecological model of behavior is to expand the focus of treatment from the individual to the individual plus their home environment. We propose to test the long-term impact of a behavioral weight control program designed to directly modify both the physical and social home environment of weight loss participants. Two hundred overweight and obese men and women will be randomly assigned to either 18 months of standard behavioral treatment (SBT) or 18 months of standard behavioral treatment plus direct modifications to the home environment (SBT+Home). SBT+Home will incorporate many strategies that have shown promise in improving weight loss (e.g., food and exercise equipment provision, spouse involvement) but will be the first to study both physical and social factors within the home simultaneously and will be the longest examination of the home environment conducted to date. Participants and spouses will be assessed at baseline, 6, 12, and 18 months. We hypothesize that by broadening the focus of treatment from the individual to the individual plus their home environment, SBT+Home will produce both better long-term weight loss and better maintenance of initial weight loss and behavior change. This home environmental approach, if successful, has potential applications to the maintenance of other important health behaviors.


Options:
A: Weight loss
B: Body Mass Index (Baseline, 3-, 6- and 15- month follow-up)
C: Parameters of the metabolic syndrome (At baseline, and after 6 and 12 months)
D: Changes in anthropometry (BMI, waist and hip cf) (3 years); Maximal oxygen uptake (VO2max) (3 years); Health-related quality of life (EQ 5D, SF-36) (3 years); Self-reported physical activity (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Parallel Group, Placebo-controlled Trial of the Efficacy and Tolerability of Memantine (20 mg) in Frontotemporal Dementia (FTD) Patients
Brief Summary: The purpose of this trial is to assess the efficacy and tolerability of memantine (anti-excitotoxic, neuroprotective treatment currently used in Alzheimer's disease \[AD\]) in frontotemporal dementia patients after a one-year treatment.


Options:
A: Efficacy of Memantine on Behavioural Symptoms in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the NPI - 12 Items Version Total Score. (Baseline to Week 24); Efficacy of Memantine on Cognition in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the SIB Total Score. (Baseline to Week 24)
B: N/A
C: Change in Neuropsychiatric Inventory (NPI) (Baseline, 26 weeks); Clinical Global Impression of Change (CGIC) (26 Weeks)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Etude Multicentrique Ouverte Randomisée de Phase III Comparant l'Association de VELCADE®-Dexaméthasone à la Chimiothérapie de Type VAD Pour le Traitement Des Patients Porteurs de Myélome Multiple de Novo Jusqu'à l'âge de 65 Ans
Brief Summary: This is an open-label, multi-centre, randomised Phase III study, looking at a series of 480 patients up to the age of 65 with newly diagnosed multiple myeloma (MM) not previously treated. They will receive VAD or Velcade®/dexamethasone combination as induction treatment plus/minus (±) dexamethasone/cyclophosphamide/etoposide/cisplatin (DCEP) followed by autograft as first-line therapy, as the investigators try to compare the complete remission (CR) rate (with negative or positive immunofixation) at the end of their induction treatment.


Options:
A: To compare the CR rate (with negative or positive immunofixation) obtained with VAD or the Velcade®/dexamethasone combination used as induction treatment in patients up to the age of 65 with newly diagnosed MM, at the end of this induction treatment
B: Rate of CR+nCR to induction treatment (63 days after the start day of either TD or VTD as induction therapy)
C: N/A
D: Overall survival (from randomistion) of the 2 groups at 5 years

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Etude Multicentrique Ouverte Randomisée de Phase III Comparant l'Association de VELCADE®-Dexaméthasone à la Chimiothérapie de Type VAD Pour le Traitement Des Patients Porteurs de Myélome Multiple de Novo Jusqu'à l'âge de 65 Ans
Brief Summary: This is an open-label, multi-centre, randomised Phase III study, looking at a series of 480 patients up to the age of 65 with newly diagnosed multiple myeloma (MM) not previously treated. They will receive VAD or Velcade®/dexamethasone combination as induction treatment plus/minus (±) dexamethasone/cyclophosphamide/etoposide/cisplatin (DCEP) followed by autograft as first-line therapy, as the investigators try to compare the complete remission (CR) rate (with negative or positive immunofixation) at the end of their induction treatment.


Options:
A: Evaluate the effect on EFS (an event is defined as either progression or death of any cause without preceding progression) of consolidation treatment with bortezomib after ASCT compared to no consolidation (1 year after randomization of the last patient)
B: To compare the CR rate (with negative or positive immunofixation) obtained with VAD or the Velcade®/dexamethasone combination used as induction treatment in patients up to the age of 65 with newly diagnosed MM, at the end of this induction treatment
C: Best Overall Response Rate (ORR) (A0: Subjects evaluated for disease response on Day 24 of Cycles 2, 4, 6, 9, and 12. Onset of response measured on Day 15 of Cycle 1. A1: Subjects evaluated for disease response on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12 and at End of Study.)
D: Determine whether the V-MPT combination improves progression free survival (PFS) (Approximately 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intracoronary Injection of Autologous Bone Marrow Mononuclear Cells for Severe Myocardial Infarction
Brief Summary: Emerging evidence suggests that stem cells and progenitor cells derived from bone marrow can be used to improve cardiac function in patients after acute myocardial infarction. In this randomised trial, we aim to assess whether intracoronary transfer of autologous bone-marrow cells could improve myocardial viability at 3 and 12 months' follow-up.


Options:
A: Global Left Ventricular Ejection Fraction change (6 months)
B: Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year) (after 3 months and 1 year of treatment)
C: The primary objective is to demonstrate the safety of autologous cardiosphere-derived stem cells administered by intra-coronary infusion in patients with ischemic left ventricular dysfunction and a recent myocardial infarction. (6 months)
D: change of left ventricular ejection fraction measured by cardiac MRI (6, 12, and 24month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Obesity in Underserved Rural Settings (TOURS)
Brief Summary: To test the effectiveness of interventions designed to promote long-term weight management of obese women in medically underserved rural counties.


Options:
A: Change in Weight (Baseline to 30 months)
B: Change in Body Weight. (one year)
C: Percent Change From Baseline Weight (Baseline, 2 years)
D: Anthropometrics (body weight, height, circumferences, total body fat%, blood pressure); Energy intake (Food Frequency Questionnaire); Physical activity level (Physical Activity Scale for the Elderly)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Adherence to Blood Pressure Guidelines
Brief Summary: The purpose of this study is to evaluate the impact of physician/pharmacist collaborative teams on hypertension guideline adherence for patients with uncontrolled hypertension in six family medicine practice sites in Iowa.


Options:
A: HbA1c (6 months)
B: Multiple CVD risk factor control targets (42 months after randomization)
C: Insulin Prescription Rate - the Number of Insulin-eligible Patients Per 12 Months Who Are Prescribed Insulin in Each Family Physician (FP) Practice (12 months)
D: Adherence to hypertension guidelines (Measured for two 6 month periods: the first is prior to the participant's enrollment in the study and the second is while the participant is enrolled in the study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Adherence to Blood Pressure Guidelines
Brief Summary: The purpose of this study is to evaluate the impact of physician/pharmacist collaborative teams on hypertension guideline adherence for patients with uncontrolled hypertension in six family medicine practice sites in Iowa.


Options:
A: Adherence to hypertension guidelines (Measured for two 6 month periods: the first is prior to the participant's enrollment in the study and the second is while the participant is enrolled in the study)
B: The number of patients that complete recommended laboratory monitoring within one week and twenty five days after intervention.; The study will evaluate the time to completion of the recommended labs.; The study will also evaluate PCP and patient experiences with the interventions in order to refine the interventions in the future.
C: Blood pressure control (Measured by zero blood pressure measurements at baseline and 2, 4, 6, 8, and 9 months)
D: Medication adherence; Exacerbation of heart failure; Health-related quality of life

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Collaborative Management of Hypertension
Brief Summary: The purpose of this study is to test whether blood pressure control can be improved by physician education and feedback provided through the development of physician/pharmacist collaborative teams.


Options:
A: Blood pressure control (Measured by zero blood pressure measurements at baseline and 2, 4, 6, 8, and 9 months)
B: Metabolic Syndrome (MetS) (Baseline)
C: Evaluate the effect of the pharmaceutical intervention on the disease control, treatment adherence and patient knowledge of his/her medication using the MEF, treatment adherence and patient knowledge of the medication indicators. (First a Pilot in 3 months and then the final study in 6 months)
D: Systolic Blood Pressure (SBP) (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Collaborative Management of Hypertension
Brief Summary: The purpose of this study is to test whether blood pressure control can be improved by physician education and feedback provided through the development of physician/pharmacist collaborative teams.


Options:
A: Combined outcome of BP<130/80 mmHG, HgbA1C<8%, and LDL<100mg/dl at 1 year; the primary analysis will compare the intervention to usual care with respect to the percentage of diabetic individuals achieving all three therapeutic goals (one year)
B: Change in Systolic Blood Pressure (6 months prior to 6 months after the intervention period)
C: Blood Pressure Control (Baseline, 6 months, 12 months, 18 months); Mean Systolic Blood Pressure (Baseline, 6 months, 12 months, 18 months, 54 months); Mean Diastolic Blood Pressure (Baseline, 6 months, 12 months, 18 months, 54 months)
D: Blood pressure control (Measured by zero blood pressure measurements at baseline and 2, 4, 6, 8, and 9 months)

Answer: D