TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Negative Pressure Wound Therapy for At Risk Surgical Closures
Brief Summary: In this study, the investigators propose using negative pressure wound therapy (NPWT) to aid in wound healing along the lines of closure for lower extremity amputation and complex abdominal wounds. This study is designed to be a prospective, randomized clinical trial to evaluate the effectiveness of NPWT versus accepted standard surgical dressings on these wounds. Study participants will be randomized to one of the two treatment groups (NPWT vs. standard dressing) prior to surgery, and will be followed in the post operative period to monitor the effects on their surgical closures. The experimental group will consist of participants receiving NPWT and will have a Vacuum Assisted Closure (V.A.C., KCI inc.) device placed intra-op along the line of closure. The control group will receive a standard surgical dry sterile dressing. The surgical closures will be assessed after three days of treatment as well as the first outpatient post-op visit and any subsequent visits through the following 6 months. By doing so, the investigators hope to demonstrate the utility of NPWT on difficult, at risk surgical closures. Additionally, the investigators hope to show a difference in clinical outcome of incisions treated by NPWT over our current standard technique.

All patients in the principal and co-investigators practice who are scheduled to undergo lower extremity amputation or complex abdominal closure will be eligible for enrollment in this prospective randomized study. There are no exclusion criteria. Informed consent will be obtained pre-operatively. Data collection will include basic demographic data, disease history, past medical and social history as well key data relating to wound healing (infection, wound dehiscence or breakdown) and hospital course (length of stay, operative complications). The investigators will use simple statistical methods (ANOVA and chi-squared analysis) to compare surgical wound healing between the two populations. The only deviation from current standard of care in these populations includes utilizing a V.A.C. system on the closure line of the experimental group versus the standard dry sterile dressing.


Options:
A: Post-operative Seroma Formation (Two weeks following drain removal)
B: Number of Participants With Wound Complication (Day of surgery to 30 days postoperative); Number of Participants With Classification of Wound Morbidity (Day of Surgery to 30 days postoperative)
C: Number of Participants With Wound Complications (Four weeks after cesarean section)
D: Incisional Dehiscence (last post operative visit, up to 2 years); Post operative infection (last post operative visit, up to 2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Negative Pressure Wound Therapy for At Risk Surgical Closures
Brief Summary: In this study, the investigators propose using negative pressure wound therapy (NPWT) to aid in wound healing along the lines of closure for lower extremity amputation and complex abdominal wounds. This study is designed to be a prospective, randomized clinical trial to evaluate the effectiveness of NPWT versus accepted standard surgical dressings on these wounds. Study participants will be randomized to one of the two treatment groups (NPWT vs. standard dressing) prior to surgery, and will be followed in the post operative period to monitor the effects on their surgical closures. The experimental group will consist of participants receiving NPWT and will have a Vacuum Assisted Closure (V.A.C., KCI inc.) device placed intra-op along the line of closure. The control group will receive a standard surgical dry sterile dressing. The surgical closures will be assessed after three days of treatment as well as the first outpatient post-op visit and any subsequent visits through the following 6 months. By doing so, the investigators hope to demonstrate the utility of NPWT on difficult, at risk surgical closures. Additionally, the investigators hope to show a difference in clinical outcome of incisions treated by NPWT over our current standard technique.

All patients in the principal and co-investigators practice who are scheduled to undergo lower extremity amputation or complex abdominal closure will be eligible for enrollment in this prospective randomized study. There are no exclusion criteria. Informed consent will be obtained pre-operatively. Data collection will include basic demographic data, disease history, past medical and social history as well key data relating to wound healing (infection, wound dehiscence or breakdown) and hospital course (length of stay, operative complications). The investigators will use simple statistical methods (ANOVA and chi-squared analysis) to compare surgical wound healing between the two populations. The only deviation from current standard of care in these populations includes utilizing a V.A.C. system on the closure line of the experimental group versus the standard dry sterile dressing.


Options:
A: Surgical site infection rate (30 days)
B: Number of Participants With Wound Complications (Four weeks after cesarean section)
C: Incisional Dehiscence (last post operative visit, up to 2 years); Post operative infection (last post operative visit, up to 2 years)
D: Surgical Site Infection (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Negative Pressure Wound Therapy for At Risk Surgical Closures
Brief Summary: In this study, the investigators propose using negative pressure wound therapy (NPWT) to aid in wound healing along the lines of closure for lower extremity amputation and complex abdominal wounds. This study is designed to be a prospective, randomized clinical trial to evaluate the effectiveness of NPWT versus accepted standard surgical dressings on these wounds. Study participants will be randomized to one of the two treatment groups (NPWT vs. standard dressing) prior to surgery, and will be followed in the post operative period to monitor the effects on their surgical closures. The experimental group will consist of participants receiving NPWT and will have a Vacuum Assisted Closure (V.A.C., KCI inc.) device placed intra-op along the line of closure. The control group will receive a standard surgical dry sterile dressing. The surgical closures will be assessed after three days of treatment as well as the first outpatient post-op visit and any subsequent visits through the following 6 months. By doing so, the investigators hope to demonstrate the utility of NPWT on difficult, at risk surgical closures. Additionally, the investigators hope to show a difference in clinical outcome of incisions treated by NPWT over our current standard technique.

All patients in the principal and co-investigators practice who are scheduled to undergo lower extremity amputation or complex abdominal closure will be eligible for enrollment in this prospective randomized study. There are no exclusion criteria. Informed consent will be obtained pre-operatively. Data collection will include basic demographic data, disease history, past medical and social history as well key data relating to wound healing (infection, wound dehiscence or breakdown) and hospital course (length of stay, operative complications). The investigators will use simple statistical methods (ANOVA and chi-squared analysis) to compare surgical wound healing between the two populations. The only deviation from current standard of care in these populations includes utilizing a V.A.C. system on the closure line of the experimental group versus the standard dry sterile dressing.


Options:
A: Change from baseline ASEPSIS score of wound healing at 6 weeks. (Baseline and 6 weeks)
B: Incisional Dehiscence (last post operative visit, up to 2 years); Post operative infection (last post operative visit, up to 2 years)
C: Number of Participants With Superficial or Deep Surgical Site Infections (SSIs) (30 days postoperatively)
D: Number of participants with seroma (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (ASCEND Trial)
Brief Summary: PIPF-016 (ASCEND) is a Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. The study objectives are to confirm the treatment effect of pirfenidone compared with placebo on change in percent predicted forced vital capacity (%FVC) in patients with idiopathic pulmonary fibrosis (IPF), and to confirm the safety of treatment with pirfenidone compared with placebo in patients with IPF.


Options:
A: Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks. (52 weeks)
B: Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52 (52 weeks)
C: Daily activity assessed by time (in minutes) spent in moderate activity (superior to 2,5 MET) (12 months)
D: Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks (52 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (ASCEND Trial)
Brief Summary: PIPF-016 (ASCEND) is a Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. The study objectives are to confirm the treatment effect of pirfenidone compared with placebo on change in percent predicted forced vital capacity (%FVC) in patients with idiopathic pulmonary fibrosis (IPF), and to confirm the safety of treatment with pirfenidone compared with placebo in patients with IPF.


Options:
A: Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value (Measured at study Baseline and Months 3, 6, 12, 15, 18, 21, and 24)
B: Absolute Change in Percent Predicted Forced Vital Capacity (FVC) (From baseline up to 72 weeks)
C: Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52 (52 weeks)
D: Overall Change in Forced Vital Capacity (Measured as the estimated change from baseline to Week 60)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Median Effective Dose (ED50) of Paracetamol and Morphine for Postoperative Patients: A Study of Interaction.
Brief Summary: The aim of our study is to define the median effective analgesic doses (ED50) of paracetamol, morphine, and their combination and determination the nature of their interaction administered IV for postoperative pain after moderate painful surgery using up-and-down and isobolographic methods.


Options:
A: Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 1 g IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.) (Baseline to 24 hrs)
B: ED50s of Paracetamol, morphine and their combination (participants will be followed for the duration of hospital stay, an expected average of 8 weeks)
C: Postoperative pain (24 hours)
D: Change from pain intensity until postoperative 6 hours (Pain intensity recorded until postoperative 6 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Directional AthErectomy Followed by a PaclItaxel-Coated BallooN to InhibiT RestenosIs and Maintain Vessel PatEncy: A Pilot Study of Anti-Restenosis Treatment
Brief Summary: The DEFINITIVE AR study is a prospective, multi-center, randomized pilot study evaluating the use of either the TurboHawk™ or SilverHawk® plaque excision systems followed by treatment with the Cotavance™ drug-eluting balloon catheter versus the Cotavance balloon catheter alone in patients with peripheral arterial disease.


Options:
A: Safety: Freedom from death at 30 days post-procedure. Effectiveness: Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure. (30 Day, 6 Month, and 12 Month)
B: The primary endpoint will be primary patency of the treated site at 6 months. Primary patency is defined as <50% loss of luminal diameter at the treated site on CT arteriography (CTA) without re-intervention in the interim. (6 months)
C: Target Lesion Percent Stenosis (1 year)
D: In-stent late lumen loss (9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Renal Denervation on Blood Pressure and Clinical Course of Obstructive Sleep Apnea in Patients With Resistant Hypertension
Brief Summary: The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of resistant hypertension coexisting with obstructive sleep apnea.


Options:
A: Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events. (From baseline to 1 month post-procedure (6 months for new renal artery stenosis)); Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (From baseline to 3 months post-procedure)
B: Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring from baseline (3 months post-randomization)
C: Blood Pressure Reduction (3 months)
D: Solo Cohort - Mean Difference in Average Daytime Ambulatory Systolic BP (from baseline to 2 months post procedure); Trio Cohort - Median Change in Daytime Ambulatory Systolic BP (from baseline to 2 months post procedure)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Development of a Yoga Intervention for Symptoms Related to Severe Visual Impairment
Brief Summary: This study aims to provide novel information on the feasibility of yoga interventions for secondary symptoms related to severe vision loss, such as sleep disturbances, negative mood states, fall risk and balance. This information will be important for determining safe, cost-effective and reliable practices for the benefits of yoga as an alternative means for improved health and well-being. A yoga intervention that is integrative and evidence-based will benefit the blind population through effective treatments and prevention of secondary symptoms as well as serve to inform rehabilitation specialists, educators, and clinicians in the future.


Options:
A: Depression (4 months)
B: Participant enrollment, recruitment and retention. (Ongoing for18 months after start of recruitment.)
C: Static Balance (Week 0 and Week 8.)
D: activities of daily life (subscale of the Groningen Activity Restriction Scale (GARS)) (5 and 17 weeks); distance activities and mobility (subscales of the Visual Functioning Questionnaire (VFQ)) (5 and 17 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects on Cytokines, Immunoglobulins, Antibodies, Sphingomyelinase and PAF Hydrolysis Capacity in the Maternal Milk After Probiotic VSL#3 Administration in the Last Four Weeks of Gestation and First Month of Lactation
Brief Summary: The newborn immune system is influenced by maternal immunity through both placenta and breastfeeding.

There exists a close interaction between the mother and the baby during gestation and lactation. Maternal milk contains a number of factors that protect the newborn against infections including 1) cytokines and their receptors which are also thought to play a role in the protection against allergies; 2) oligosaccharides with low molecular weight and 3) probiotic bacteria that contribute to the development of the newborn immune system.

Probiotics have a potent immunogenic activity as well as an immunoprotective potential in maternal milk after administration of probiotics during pregnancy and breastfeeding. In addition probiotics are supposed to play a role in the increased production of sphingomyelinase.


Options:
A: Spontaneous premature birth (<37, <35, <32 weeks of pregnancy) (24 weeks)
B: Gestational weight gain (week 36-37 of pregnancy); Change in glucose levels (Oral glucose tolerance test) (baseline (week 14-20) and 27-30 of pregnancy)
C: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)
D: Effect of VSL#3 probiotic administration on breast milk (2 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Technology Enhanced Delivery of Treatment for Early Conduct Problems
Brief Summary: This study aimed to examine if technology could enhance the treatment engagement and outcomes of low income parents of 3 to 8 children with externalizing problems.


Options:
A: rates of pregnancy and out-of-wedlock child birth (At age 19); educational achievement, including graduation from high school and participation in various types of post-high school education (At age 19); participation in the work force, including enrollment in the armed services (At age 19); use of welfare (At age 19); use of substances (cigarettes, alcohol, and illegal drugs) (At age 19); involvement with the criminal justice system (arrests, convictions, incarcerations, etc.) (At age 19)
B: CHild Behaviour Checklist (to measure change from baseline) (Measure change from baseline at 6 & 12 months)
C: Engagement (Participants will be followed for the duration of treatment, an expected average of 10 weeks)
D: Retention (Baseline to Post-Intervention (average 8 to 12 weeks)); Mean % Sessions Attended as Scheduled (Baseline to Post-Intervention (average 8 to 12 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week, Randomised, Multi-centre, Parallel Group Study to Investigate the Safety and Efficacy of BI 10773 (10 mg or 25 mg Administered Orally Once Daily) as add-on Therapy to an Oral Antidiabetic Drug (Sulfonylurea, Biguanide, Thiazolidinedione, Alpha Glucosidase Inhibitor, DPP-IV Inhibitor, or Glinide) in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
Brief Summary: The objective of the study is to investigate the long-term safety and efficacy of BI 10773 given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2 diabetes mellitus with insufficient glycaemic control.


Options:
A: Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104 (Baseline and Week 104)
B: HbA1c (after 26 weeks of treatment)
C: HbA1c Change From Baseline at Week 18 (Interim Analysis) (Baseline and week 18); HbA1c Change From Baseline at Week 18 (Final Analysis) (Baseline and week 18)
D: Number of Patients With Drug Related Adverse Events (After the first drug intake until 7 days after the last treatment administration, up to 383 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Early (4 Days) Versus Standard Drainage Removal of the Abdominal Cavity After Pancreaticoduodenectomy- - A Randomized Multicenter Study
Brief Summary: Around two thousand pancreaticoduodenectomy (PD) are performed each year in France. This intervention is associated with a high rate of postoperative complications including:

* pancreatic fistulas (PF);
* surgical site infections (intra-abdominal abscess, wound infection);
* delayed gastric emptying (gastroparesis);
* and hemorrhage.

The incidence of SSI (superficial and deep) is about 35% and seems influenced by the prolonged intra-abdominal drainage. For several years, there has been a global trend to reduce the use of abdominal drainage after abdominal surgery. Several randomized clinical trials have shown that prophylactic drainage does not decrease the incidence of postoperative complications during elective hepatectomy, colectomy, and cholecystectomy and could increase the number of SSI. However, the role of prophylactic drainage after PD is so far unclear.

The aim of this prospective randomized multicenter study is to evaluate the influence of early (4 days) versus standard (10 to 15 days, depending on the staff clinical practice) drainage removal of the abdominal cavity after PD, on the rate of SSI.

Materials and Methods: The technique of PD is left at the discretion of the operator as well as the prescription of analogues of somatostatin. Drainage of the abdominal cavity is made of one or two round silicone close suction drains or open multichannel silicone drains placed in the vicinity of the pancreatic and biliary anastomosis. Shall be excluded patients operated on for chronic pancreatitis and patients who underwent preoperative radiotherapy. The 3rd postoperative day, a fistula is sought clinically, biologically and on CT-scanner images. In case of pancreatic fistula, the patient is excluded from randomization and drainage of the abdominal cavity is left in place depending on the different teams' practice. Patients without fistula are randomized to either drainage removal 4 days after surgery (D4) or standard drainage.


Options:
A: 60-day ≥ Grade II Complication Rate (60 days)
B: Surgical Site Infection at D30 (30 days after surgical intervention)
C: Rate of clinically relevant postoperative pancreatic fistula (POPF) (Up to 60 days after Surgery)
D: Abdominal Complications (1 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Hand in Hand. Psychological Intervention for Breast Cancer Patients and Their Partners. A Randomised, Controlled Trial.
Brief Summary: This study evaluates the effect of a psychological intervention to breast cancer patients and their partners compared to a control group receiving usual care


Options:
A: Change in Quality of Life (Baseline, 3 and 6 months)
B: Caregiver Quality of Life Index - Cancer (4 weeks); Perceived Stress Scale (4 weeks); Hospital Anxiety and Depression Scale (4 weeks); Basic Psychological Needs Scale (4 weeks); Healthcare Climate Questionnaire (4 weeks); Perceived Competence Scale (4 weeks); Interpersonal Support Evaluation List (4 weeks); Benefit Finding (4 weeks); Satisfaction and Feedback Questionnaire (4 weeks)
C: Change in the mean score of distress (Hospital Anxiety Depression Scale) (Baseline, after 3, 6 and 9 months); Change in the mean score of distress (Psychological distress scale used in the Quebec Health Survey) (Baseline, after, 3, 6 and 9 months)
D: Change in Impact of Event Scale (IES) (Baseline, 2 weeks post-intervention, 10 months follow-up); Change in The Hospital Anxiety and Depression Scale (HADS) (Baseline, 2 weeks post-intervention, 10 months follow-up); Change in The Profile of Mood States - Short Form (POMS-SF) (Baseline, 2 weeks post-intervention, 10 months follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: MASTER: MGUARD for Acute ST Elevation Reperfusion
Brief Summary: The goal of this study is to demonstrate the superiority of the MGuard™ stent over commercially-approved bare-metal (BMS) /drug-eluting stents (DES) in achieving better myocardial reperfusion in primary angioplasty for the treatment of acute ST-elevation myocardial infarction (STEMI).


Options:
A: Ischemia Driven Target Lesion Failure (TLF) (1 year)
B: The primary end point for the trial was the binary restonis at one year angiographic follow-up
C: The incidence of complete ST segment resolution (defined as ≥70% ST 1. The incidence of complete ST segment resolution (60 to 90 minutes after the last angiogram)
D: In segment Late Lumen Loss (6 months post index procedure)

Answer: C