TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical and Economical Assessment of an Intervention to Reduce Potentially Inappropriate Medication in Polymedicated Elderly Patients
Brief Summary: Objective: To evaluate the clinical and economic impact of the application of an algorithm to improve the adequacy and safety of pharmacotherapy in elderly polymedicated (receiving 8 or more medications), not institutionalized.

Design: randomized, open, multicenter and two branches of parallel intervention clinical trial.

Intervention Study: primary care pharmacist apply the GP-GP algorithm to each drug with the support of STOPP criteria, Beers and / or recommendations CatSalut. The pharmacist submit to doctor his findings and reach a consensus and decide which recommendations will be presented to patient. Control intervention: usual procedure.

Main outcome measures: a) Discontinued medications, changed or changing doses, b) GP consultations, hospital emergency department and hospital admissions for acute illness, c) pharmaceutical expenditure, d) restart medication e) complications underlying diseases. Follow-up control at 1 month (security) and at 3, 6 and 12 months.


Options:
A: Emergency medical visits (12 months after hospital discharge)
B: number of unplanned hospitalizations (6 months)
C: Number of unplanned hospital admissions (Recruitment - 6 months post intervention); Number of A&E attendances (Recruitment - 6 months post intervention); Number of GP consultations (Recruitment - 6 months post intervention)
D: Number of patients with medications discontinued, reduced dose or changed. (baseline, 3, 6 and 12 months); Number of discontinued medications, changed or changing doses. (baseline, 3, 6 and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft
Brief Summary: The study is a 3-arm, parallel-design, randomized, prospective clinical trial.designed to examine histologic wound healing following ridge preservation using cortical bone allograft, cancellous bone allograft, or a combination of both cortical and cancellous bone allograft. This entire protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with a combination of 50% cortical/50% cancellous FDBA. This test group will be compared to two active control groups - one using 100% cortical FDBA and the other using 100% cancellous FDBA. The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome).

Each subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a non-resorbable membrane. Following 18-20 weeks of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.


Options:
A: Hard tissue volumetric changes (4 months); Soft tissue volumetric changes (4 months)
B: % Vital Bone Formation (Histological) (3 months after ridge preservation)
C: % Vital Bone Formation (Histological) (18-20 weeks after ridge preservation)
D: % Vital Bone Formation (Histological) (18-20 weeks after ridge preservation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Study of N91115 to Evaluate Safety and Pharmacokinetics in Patients With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation
Brief Summary: This Phase 1b study in F508del-CFTR homozygous CF patients is being conducted to assess the safety of N91115 as the sole cystic fibrosis transmembrane conductance regulator (CFTR) modulator at doses near the expected therapeutic exposure level in preparation for Phase 2 studies of N91115 added to the CFTR modulator combination lumacaftor/ivacaftor when launched.


Options:
A: Safety and Tolerability assessments as determined by number of subjects with adverse events (AEs) and serious adverse events (SAEs) (from baseline up to Day 50)
B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (Baseline (Day 1) up to end of study (Week 196)); Number of Participants With Clinically Significant Laboratory Abnormalities (Baseline (Day 1) up to end of study (Week 196))
C: Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Baseline through Week 100)
D: Safety assessments based on clinical evaluations, laboratory assessments, and adverse events. (28 Days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Study of N91115 to Evaluate Safety and Pharmacokinetics in Patients With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation
Brief Summary: This Phase 1b study in F508del-CFTR homozygous CF patients is being conducted to assess the safety of N91115 as the sole cystic fibrosis transmembrane conductance regulator (CFTR) modulator at doses near the expected therapeutic exposure level in preparation for Phase 2 studies of N91115 added to the CFTR modulator combination lumacaftor/ivacaftor when launched.


Options:
A: Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24 (Baseline, Through Week 24)
B: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline, Week 16 and 24)
C: Safety assessments based on clinical evaluations, laboratory assessments, and adverse events. (28 Days)
D: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Study of N91115 to Evaluate Safety and Pharmacokinetics in Patients With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation
Brief Summary: This Phase 1b study in F508del-CFTR homozygous CF patients is being conducted to assess the safety of N91115 as the sole cystic fibrosis transmembrane conductance regulator (CFTR) modulator at doses near the expected therapeutic exposure level in preparation for Phase 2 studies of N91115 added to the CFTR modulator combination lumacaftor/ivacaftor when launched.


Options:
A: Safety and Tolerability Based on Adverse Events (AEs) (Up to 14 days after last dose (last dose = Day 28))
B: Number of Participants With Treatment-Emergent Adverse Events (First administration (Day 1) through Follow-up (Day 43))
C: Safety assessments based on clinical evaluations, laboratory assessments, and adverse events. (28 Days)
D: Changes in adverse events (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal laboratory (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal vital signs, ECG or physical examination (at screening and at each study visit up to day 43 which is the final FU visit)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Lifestyle Management of CKD in Obese Diabetic Patients
Brief Summary: The purpose of this randomized clinical trial is to evaluate the efficacy of 3 different technology-supported approaches to engaging 300 individuals with diabetes and concurrent chronic kidney disease in weight loss, dietary sodium restriction, and dietary restriction of inorganic phosphates when compared to usual care. Participants will be randomized to 1 of 4 groups, Usual Care (UC), Social Cognitive Theory-based Group Counseling (SCT), Mobile self-monitoring with tailored feedback and counseling (MONITORING), or a combination of SCT plus MONITORING conditions (COMBINED). Investigators will evaluate the intervention arms primarily in terms of weight reduction, urinary sodium excretion, and serum phosphorus and, secondarily in terms of physical activity, blood pressure, fasting lipids, medication requirements, and pulse wave velocity. Measurements will occur at baseline, 6, and 12 months. The statistical modeling of the baseline, 6 mos and 12 mos outcome variables will be based on logistic generalized linear mixed models (for binary outcomes) linear mixed models (for continuous outcomes), and random effects multinomial models (for outcomes with more than 2 levels, such as changes in medication management). In separate analyses of the intervention arm only, investigators will model self-monitoring adherence and examine possible associations between self-monitoring adherence and outcomes. The mediating effect of self-efficacy on the primary outcomes will be evaluated using structural equation models.


Options:
A: Change in 24-hour urinary creatinine clearance from baseline to final follow-up, measured from 24-hour urinary collection and corresponding serum creatinine measurement at randomisation and final visit. (24 months)
B: Net Change in Urinary Albumin-to-Creatinine Ratio (ACR) (Assessed twice at baseline, once at week 12, and twice at week 24)
C: Weight in kgs will be obtained using a single, calibrated scale (Change from baseline in weight at 6 months); Serum phosphorus will be evaluated from a venipuncture sample (Change from baseline in Serum Phosphourous at 6 months); Urinary sodium will be determined from a time 24-hour urine sample (Change from baseline in Urinary sodium at 6 months); Weight in kgs will be obtained using a single, calibrated scale (Change from baseline in weight at 12 months); Serum phosphorus will be evaluated from a venipuncture sample (Change from baseline in Serum phosphorus at 12 months); Urinary sodium will be determined from a time 24-hour urine sample (Change from baseline in Urinary sodium at 12 months)
D: Office systolic and diastolic BP readings (9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Lifestyle Management of CKD in Obese Diabetic Patients
Brief Summary: The purpose of this randomized clinical trial is to evaluate the efficacy of 3 different technology-supported approaches to engaging 300 individuals with diabetes and concurrent chronic kidney disease in weight loss, dietary sodium restriction, and dietary restriction of inorganic phosphates when compared to usual care. Participants will be randomized to 1 of 4 groups, Usual Care (UC), Social Cognitive Theory-based Group Counseling (SCT), Mobile self-monitoring with tailored feedback and counseling (MONITORING), or a combination of SCT plus MONITORING conditions (COMBINED). Investigators will evaluate the intervention arms primarily in terms of weight reduction, urinary sodium excretion, and serum phosphorus and, secondarily in terms of physical activity, blood pressure, fasting lipids, medication requirements, and pulse wave velocity. Measurements will occur at baseline, 6, and 12 months. The statistical modeling of the baseline, 6 mos and 12 mos outcome variables will be based on logistic generalized linear mixed models (for binary outcomes) linear mixed models (for continuous outcomes), and random effects multinomial models (for outcomes with more than 2 levels, such as changes in medication management). In separate analyses of the intervention arm only, investigators will model self-monitoring adherence and examine possible associations between self-monitoring adherence and outcomes. The mediating effect of self-efficacy on the primary outcomes will be evaluated using structural equation models.


Options:
A: Quality of life - Physical Functioning Score (baseline, 12 weeks, 6 months and 15 months)
B: Measured glomerular filtration rate (renal function) using the iohexol clearance method in patients with stages 3-4 chronic kidney disease (0, 6, 12 months)
C: Change in GFR (ml/Min) (baseline and after diuretics administration); Renal Vascular Resistance (mm Hg/[ml/Min]) (baseline and after diuretics administration)
D: Weight in kgs will be obtained using a single, calibrated scale (Change from baseline in weight at 6 months); Serum phosphorus will be evaluated from a venipuncture sample (Change from baseline in Serum Phosphourous at 6 months); Urinary sodium will be determined from a time 24-hour urine sample (Change from baseline in Urinary sodium at 6 months); Weight in kgs will be obtained using a single, calibrated scale (Change from baseline in weight at 12 months); Serum phosphorus will be evaluated from a venipuncture sample (Change from baseline in Serum phosphorus at 12 months); Urinary sodium will be determined from a time 24-hour urine sample (Change from baseline in Urinary sodium at 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Dutch STRIDER (Sildenafil TheRapy In Dismal Prognosis Early-onset Fetal Growth Restriction)
Brief Summary: Rationale: Severe, early-onset fetal growth restriction (FGR) due to placental insufficiency is associated with a high risk of perinatal morbidity with long-lasting sequelae and mortality. Placental insufficiency is the result of abnormal formation and function of the placenta (placentation) with inadequate remodelling of the maternal spiral (uteroplacental) arteries. There is currently no therapy available with demonstrated effectiveness. Evidence suggests Sildenafil citrate improves uteroplacental blood flow, growth, and meaningful outcomes.

Objective: To evaluate the effectiveness of sildenafil (versus placebo) in achieving healthy perinatal survival.

Study design: Multicenter nationwide randomized placebo-controlled clinical trial.

Study population: Women with a singleton pregnancy between 20 and 30 weeks with severe fetal growth restriction of likely placental origin, and with estimated significant likelihood of perinatal death.

Intervention: Sildenafil 25mg or placebo tablet orally three times daily. Main study parameters/endpoints: Perinatal healthy survival, i.e. survival without severe neonatal morbidity at term age.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Taking tablets three times daily. No additional ultrasounds, other than standard clinical protocol, one extra blood sample at inclusion. No risks anticipated, unexpected medication-associated risks can't be excluded on beforehand.


Options:
A: compare the gestational age at delivery (d) between sildenafil- and placebo-treated groups (6 weeks after postpartum)
B: Intact neonatal survival until term age (Term age, up to 20 weeks after randomization)
C: The principal outcome is birth weight at delivery and neonatal morbidity (Crib Score) (6 weeks)
D: Primary endpoint is the time from randomization to delivery.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Wellness Program Implementation: School & Student Toolkits
Brief Summary: The project is designed to evaluate a participatory implementation model in HealthCorps (HC) high schools and to assess outcomes within and across school settings . The behavioral objectives from the 2010 Dietary Guidelines to address obesity in youth include: 1) decreasing sugary beverage intake; 2) increasing frequency of breakfast; 3) increasing vegetable and fruit intake to 2½ cups per day;4) decreasing frequency of fast food meals;5) becoming physically active (goal of 1 hour per day); and 6) reducing sedentary behavior time (\<2 hour day). The study is employing system dynamics modeling (SDM) to assess wellness programming options and to evaluate the program implementation within the context of diverse school ecologies. The RE-AIM evaluation metric (Reach, Effectiveness, Adoption, Implementation, and Maintenance) is used to guide SDM development and validation.

The Specific Aims are:

1. To use PAR (Participatory Action Research) methods to refine the school wellness program model and toolkit components that address institutional/community level program implementation barriers and individual level barriers to achieving healthy lifestyle recommendations.
2. To assess the effectiveness of program components using process evaluation techniques guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) model.
3. To evaluate implementation with system dynamics modeling to facilitate dissemination. The simulation analysis will apply the RE-AIM framework to address: Reach (participation rates), effectiveness (outcomes), adoption (acceptability), implementation (intervention fidelity), and maintenance (sustainability of lifestyle changes by students and programs by schools), in order to facilitate refining the toolkits and training program for dissemination to other school setting and diverse educational venues.


Options:
A: Key Behaviors (12 months)
B: Percent Body Fat (Baseline and One year)
C: Weight in Kilograms (Baseline, 12 weeks); Weight z Score (Baseline, 12 weeks); BMI Calculated as "Weight (kg) / Height (m^2)" (Baseline, 12 weeks); BMI z Score (Baseline, 12 weeks); Body Fat Percentage as Determined by Siri Formula From Skinfold Thicknesses (Baseline, 12 weeks)
D: Blood pressure (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
Brief Summary: This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).


Options:
A: Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16 (Baseline to Week 16)
B: Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 12. (Baseline to Week 12)
C: Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16 (Week 16)
D: Percent Change From Baseline in the Eczema Area Severity Index Score (EASI) to Week 16 (Baseline to Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
Brief Summary: This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).


Options:
A: Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16 (Week 16)
B: Percentage of Participants Who Achieved Success in Investigator's Static Global Assessment (ISGA) Score at Day 29 (Day 29); Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) (AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36); Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings at Day 8 (Baseline, Day 8); Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 36 (Baseline (Day 1), Day 36); Number of Participants With Clinically Significant Laboratory Values (Baseline up to Day 36); Percentage of Participants With Local Tolerability Symptoms at Baseline (Baseline (Day 1)); Percentage of Participants With Local Tolerability Symptoms at Day 8 (Day 8); Percentage of Participants With Local Tolerability Symptoms at Day 15 (Day 15); Percentage of Participants With Local Tolerability Symptoms at Day 22 (Day 22); Percentage of Participants With Local Tolerability Symptoms at Day 29 (Day 29); Percentage of Participants With Local Tolerability Symptoms at Day 36 (Day 36)
C: Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12 (Baseline (Day 1) and Week 12); Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12 (Week 12)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Permanent Versus Delayed-absorbable Monofilament Suture for Vaginal Graft Attachment During Minimally-invasive Total Hysterectomy and Sacrocolpopexy: A Randomized Clinical Trial
Brief Summary: Primary Aim:

The primary aim of this randomized controlled trial (RCT) is to compare vaginal mesh and suture exposure rates in women undergoing robotic total hysterectomy and sacrocolpopexy with a light-weight polypropylene mesh (Upsylon™ y-mesh) using permanent (polytetrafluoroethylene, Gore-Tex) versus delayed absorbable monofilament (2-0 polydioxanone, PDS) sutures through 1-year.

Secondary Aims:

1. To compare the 1-year composite success rate (leading edge of prolapse is at or above the hymen and apex has descended less than 1/3 of the vaginal length, no subjective feeling of bulge; and no retreatment for pelvic organ prolapse (POP) or vaginal mesh exposure) of permanent versus delayed absorbable sutures for mesh graft attachment during robotic total hysterectomy and sacrocolpopexy.
2. To evaluate adverse outcomes in each group


Options:
A: anatomic outcomes,graft-related complications between the two materials, changes in pelvic organ prolapse-related quality of life,subjective changes in sexual function,changes in bowel function and the prolapse related pain present after sacral colpopexy (One year)
B: Primary outcome: operative time from incision to closure. (Primary outcome: will be obtained immediately at the end of each procedure.)
C: Number of Participants With Vaginal Mesh or Suture Exposure (1 year)
D: Surgical Success (24 months); Anatomic Failure (24 months); Urinary Distress Inventory at 6 Months (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tranexamic Acid in Knee Joint Surgery - a Randomised Controlled Trial
Brief Summary: Total knee joint replacement surgery can lead to significant blood loss, which can affect recovery after surgery. Tranexamic acid (TXA) is a medication which stops the breakdown of blood clots and therefore prevents blood loss. The optimal use of TXA remains a point of debate. Growing interest in the topical application of TXA (directly into the surgical wound) has been suggested as an alternative way of administering TXA, and may demonstrate similar effectiveness as when it is given intravenously. Therefore, this multicentred, randomized controlled trial, aims to investigate the safety and effectiveness of both topical and intravenous administrations of TXA in total knee joint surgery. The investigators predict that both routes of administration will demonstrate similar results when compared to placebo.


Options:
A: Blood Loss (Post operative day 3)
B: Number of Patients Managed With Blood Transfusion (daily during hospital stay (an expected average of 4 days))
C: The volume of postoperative blood loss in the drain (48 hours after the operation); Changes from baseline hemoglobin concentrations (48 hours after the operation); unit of blood transfusion (48 hours after the operation)
D: Death in hospital within four weeks of injury (causes of death will be described to assess whether deaths were due to haemorrhage or vascular occlusion). (Death, discharge or four weeks post randomisation whichever occurs first.)

Answer: A