TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: When to Remove the Indwelling Catheter After Minimally Invasive Sacrocolpopexy?
Brief Summary: Objectives

The objective of this study is to help identify the best practice regarding the use of indwelling catheter after minimally invasive urogynecologic surgery. Investigators propose a randomized controlled trial comparing the immediate removal of indwelling urethral catheter, after minimally invasive sacrocolpopexy, to the present standard catheter removal on post operative day one. Evidence based catheter management will be helpful to both providers and patients in post-operative decision making.

Specific Aims

Aim 1: To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy results in shorter hospital stay than removal on postoperative day 1.

Aim 2: To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy confers no increased risk of re-catheterization.

Aim 3: To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy decreases the occurrence of urinary tract infection.

Design

A randomized controlled trial comparing the standard overnight indwelling urethral catheterization with removal of catheter immediately post surgery after minimally invasive sacrocolpopexy, at Oregon Health \& Science University.

Outcome measures

Primary outcome measures are hospital stay in hours after completion of surgery and need for re-catheterization. Hospital stay will be counted from the time the patient leaves the operating room to the time she leaves the hospital. To avoid confounding, investigators are only including the first / morning case of the day. For re-catheterization, investigators will evaluate if patient was able to void after completion of surgery. Investigators will compare the post voiding residuals, the need for re-catheterizations and the numbers of patients going home with an indwelling catheter between the two groups. Investigators will also compare the number of urinary tract infections, as documented by urine culture and subsequent treatment, between the two groups.

Study Subjects

Study subjects will be women undergoing minimally invasive sacrocolpopexy. Women will be invited to participate in the study during their preoperative visit. If they agree to participation, this will be noted in their chart. Randomization to group will occur immediately following surgery.


Options:
A: Hospital stay (4 weeks)
B: all cause mortality (one year)
C: Number of Participants With Void Trial Failure Rate (post-operative day, about 4 hours post-surgery)
D: time to micturition (first 24 hours after spinal anesthesia)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Platelet Rich Plasma ( PRP ) Applied During Knee Arthroscopy on Pain, Function and Quality of Life - A RCT With a Follow up of 12 Months
Brief Summary: The purpose of this study is to investigate reduction of pain, gain of function and improvement of life quality by intraoperative applied platelet- rich- plasma ( PRP ) during knee arthroscopy for degeneration and osteoarthritis OA by conducting a randomized- controlled, double-blinded trial ( RCT ) including 58 patients with a follow up of 12 months and pain, assessed by Visual- Analogue Scale (VAS) after 6 months as primary endpoint.


Options:
A: Knee injury and Osteoarthritis Outcome Score - KOOS (2 year follow-up)
B: To compare between the two treatment groups the patients' disease-specific quality of life at 2 years using the Western Ontario McMaster (WOMAC) osteoarthritis index and (2 years)
C: The Lysholm Knee Score (One year); Pain After Exercise (VAS) (One year); WOMET (Western Ontario Meniscal Tear -Disease Specific Quality of Life -Assessment Tool) (One year)
D: pain ( VAS ) (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Botswana Vitamin D Supplementation Study in HIV/AIDS
Brief Summary: The goal is to determine the vit D supplementation dose that safely results in optimal serum vitamin D (25D) concentrations in HIV-infected children and adults living in Botswana. To do this the investigators will test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol (D3) dietary supplement over a 12-week period in 60 children and adults with HIV/AIDS living in Botswana (5.0 to 50.9 yrs), to assess safety as determined by serum calcium and 25D concentrations and efficacy to replete vit D status as determined by achieving a minimum serum 25D concentration of 32 ng/mL (80 nmol/L).


Options:
A: CD4 count (Baseline, 6, 12, 18, and 24 months)
B: To test the efficacy of two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS to replete vit D status (achieving a minimum serum 25D concentration of 32 ng/mL). (12 weeks); To test the safety of two oral doses (4000 vs 7000 IU/d) of cholecalciferol (D3) over a 12-week period in 60 children and adults (5.0 to 50.9 y) with HIV/AIDS as determined by serum calcium. (12 weeks)
C: Change in CD4 percent associated with vitamin D supplementation in HIV-infected children (6 months)
D: Mortality

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Wii-Fit For Balance And Gait In Elderly Veterans
Brief Summary: Falls are a major public health problem. They are the leading cause of injuries and injury-related deaths in those aged over 65 years. Balance and gait abnormalities are major reasons for falls in elderly. Exercise interventions improve gait and balance in the elderly. Despite the many proven benefits of exercise, many older adults in the US remain sedentary. This study targets at improving balance and gait with use of Wii-Fit as an exercise program.


Options:
A: Falls rate (6 months post intervention)
B: MoCA (2 years); SPPB (2 years); NPI (2 years); CSDD (2 years); DQOL (2 years); (I)ADL (2 years)
C: Berg Balance Scale (8 weeks)
D: Feasibility - recruitment (relative) (Through recruitment completion, an average of 12 weeks.); Feasibility - recruitment (absolute) (Through recruitment completion, an average of 12 weeks.); Feasibility - adherence (Through recruitment completion, an average of 12 weeks.); Feasibility - compliance (Through recruitment completion, an average of 12 weeks.); Feasibility - attrition (Through recruitment completion, an average of 12 weeks.); Usability (System Usability is assessed in the Exergame Group at week 6 of the study intervention.); Acceptance - enjoyment (Through recruitment completion, an average of 12 weeks.); Acceptance - motivation (Through recruitment completion, an average of 12 weeks.); Acceptance - perceived usefulness (Through recruitment completion, an average of 12 weeks.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Losartan and Spironolactone on Residual Renal Function Preservation in Peritoneal Dialysis Patients
Brief Summary: Aldosterone blockade is useful in preserving residual renal function in patients on PD.The long term efficacy of dual blockade of the RAAS is better than monotherapy.


Options:
A: Safety - Number of Participants With Serum Potassium >6.5 mEq/L (0 - 40 weeks); Safety - Participants With Serious Hypotension (0 - 40 weeks); Study Drug Tolerability (0 - 36 weeks); Efficacy - Change in Mitral Annular E' Velocity (Baseline to 36 weeks); Feasibility of Conducting a Full-scale Mortality-powered Trial (0 - 40 weeks)
B: residual renal function of peritoneal dialysis patients (From date of randomization until the date of dropping out of the study or death from any cause, whichever came first, assessed up to 12 months.)
C: Change in coronary Flow Reserve (PET) (Between baseline and 9 months); Change in left ventricular diastolic function (Between baseline and 9 months)
D: cardio- and cerebrovascular events

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-Controlled Study of an Herbal Tea to Support Lactation
Brief Summary: The overall aims of this project are to 1) determine the quality of life effects of a combination herbal galactagogue tea in lactating women, and 2) measure changes in maternal blood concentration of oxytocin, prolactin, and milk production. The defined outcome measures will include quality of life measures in the breastfeeding woman and basic infant health. If the tea proves safe and effective, then it can provide a proven all-natural and organic supplement for increasing lactation in women. This in turn will increase quality of life for both the infant and the mother.


Options:
A: Quality of life (4 weeks); Quality of life (4 weeks); Quality of life (4 weeks); Quality of life (4 weeks)
B: Peak Change in Milk Output (baseline and 4 weeks post-intervention)
C: success of continuing breastfeeding; amount of supplementation used
D: a.successful initiation of lactation as determined by lactogenesis II markers, maternal perception and timing c.timing of successful establishment of lactogenesis II (within the first two weeks postpartum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness Interventions and Chronic Symptoms
Brief Summary: The primary objective of this study to determine the feasibility and acceptability of a mindfulness intervention for adolescents with juvenile fibromyalgia/ chronic widespread pain and other similar chronic symptoms.


Options:
A: Change in Functional Disability (Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
B: PATIENT-RATED LOW BACK PAIN (3 and 12 months)
C: Change in Level of Adherence in Subjects (Objective Measure) (Baseline, 3 months, 6 months); Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ (Baseline, 3 months, 6 months); Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky (Baseline, 3 months, 6 months); Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement (Baseline, 3 months, 6 months)
D: Feasibility and retention (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a "Fast Track" Respiratory Therapy Clinic for Patients With Suspected Severe Sleep-Disordered Breathing
Brief Summary: Access to medical care for patients with breathing disorders during sleep is a major problem for Canadians. Recently, there has been increasing interest in how health care providers who are not physicians can help to improve access to medical care for these patients, but it is unclear whether patients with severe sleep-disordered breathing who receive care from these non-physician providers have the same response to treatment as patients who receive care from physicians. Since these severe have a high risk of developing cardiac and respiratory complications and of being hospitalized, an initiative to improve access such as the use of non-physician providers could be of great benefit to individual patients and the health care system.

The objectives of this project are:

1. to determine whether patients with severe breathing disorders during sleep have the same response to treatment when cared for by non-physician health care providers (respiratory therapists) as they do when cared for by physicians;
2. to determine the effects of non-physician health care provider treatment to patient access;
3. to determine health care utilization and related costs associated with non-physician health care provider treatment.


Options:
A: Ambulatory blood pressure monitoring (Change from Baseline in Blood Pressure at 6 months)
B: Adherence to positive airway pressure (PAP) therapy (3 months after treatment initiation)
C: Rate of adherence to recommended home OSA evaluation and treatment after intervention exposure (12 Months)
D: Effect of intensive intervention on CPAP adherence (24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To ensure minimal cervical motion during the intubation of trauma patients is important for the prevention of cervical spine injury (CSI) or further deterioration of existing CSI.

Intubation is required to secure the airway in patient during an anesthesia management or a mechanical ventilation at intensive care units. Laryngoscopes are the assisting tools for intubations. The most widely used laryngoscope type is one with a Macintosh blade. However, various types of laryngoscopes have been developed to be used for in case of difficult intubations, the intubation of the patients with head and neck trauma, or the intubation attempts carried out by inexperienced individuals. Truview EVO2® and Airtraq® are newly developed laryngoscopes, integrated with an optical view system.

The Truphatek TruView EVO2® (Truphatek International Ltd, Netanya, Israel) is a recently introduced, easy viewing type of laryngoscope, modified from the blades of Macintosh type laryngoscopes, having an angle of 46° at the end of blade and including a camera system that magnifies the image.

The Airtraq® laryngoscope (ATQ; King Medical Systems, Newark, DE) is also a newly developed type of laryngoscope, including optical imaging system. There is a channel on the device for the placement of the endotracheal tube. Endotracheal tube is inserted into the channel before the laryngoscopy. It has been reported that Airtraq is a novel single use laryngoscope which provides glottis display without any deviation in the normal position of the oral, pharyngeal or the tracheal axes.

In the literature, there are many studies comparing the effects of these newly developed laryngoscopes on cervical motions in different scenarios with cadavers and normal patients. However, in these studies, individual vertebral motion was reported during the placement of the tube, while the angulation of the head and neck and the difficulty of the intubations were not clear.

In this study our first hypothesis was cervical motion during endotracheal intubation in Truview EVO2® and Airtraq® types of laryngoscopes is lesser than Macintosh. The second one was the endotracheal intubation time is similar to the Macintosh that is used more often.


Options:
A: Maximum cervical spine motion (degree) (During tracheal intubation time, an expected average of 90 seconds)
B: Required dose of opioid to counteract nociceptive stimulation (1 hour)
C: First Pass Success in Patients Undergoing Emergency Intubation, Intubated With Either Direct Larynogoscopy or Video Laryngoscopy Using a C-MAC Device. (During intubation procedure up to 1 hour); Time to Intubation (From the time the first device entered the patients mouth until successful intubation up to 1 hour)
D: CERVICAL MOTIONS (January 2011 and December 2012)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: To ensure minimal cervical motion during the intubation of trauma patients is important for the prevention of cervical spine injury (CSI) or further deterioration of existing CSI.

Intubation is required to secure the airway in patient during an anesthesia management or a mechanical ventilation at intensive care units. Laryngoscopes are the assisting tools for intubations. The most widely used laryngoscope type is one with a Macintosh blade. However, various types of laryngoscopes have been developed to be used for in case of difficult intubations, the intubation of the patients with head and neck trauma, or the intubation attempts carried out by inexperienced individuals. Truview EVO2® and Airtraq® are newly developed laryngoscopes, integrated with an optical view system.

The Truphatek TruView EVO2® (Truphatek International Ltd, Netanya, Israel) is a recently introduced, easy viewing type of laryngoscope, modified from the blades of Macintosh type laryngoscopes, having an angle of 46° at the end of blade and including a camera system that magnifies the image.

The Airtraq® laryngoscope (ATQ; King Medical Systems, Newark, DE) is also a newly developed type of laryngoscope, including optical imaging system. There is a channel on the device for the placement of the endotracheal tube. Endotracheal tube is inserted into the channel before the laryngoscopy. It has been reported that Airtraq is a novel single use laryngoscope which provides glottis display without any deviation in the normal position of the oral, pharyngeal or the tracheal axes.

In the literature, there are many studies comparing the effects of these newly developed laryngoscopes on cervical motions in different scenarios with cadavers and normal patients. However, in these studies, individual vertebral motion was reported during the placement of the tube, while the angulation of the head and neck and the difficulty of the intubations were not clear.

In this study our first hypothesis was cervical motion during endotracheal intubation in Truview EVO2® and Airtraq® types of laryngoscopes is lesser than Macintosh. The second one was the endotracheal intubation time is similar to the Macintosh that is used more often.


Options:
A: risk of failure on the first attempt of endotracheal intubation
B: Time to intubation (seconds) (Immediate)
C: Intubation Time (At intubation)
D: CERVICAL MOTIONS (January 2011 and December 2012)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Technology to Enhance Treatment for Early Conduct Problems in Low Income Families
Brief Summary: This study aims to the test the efficacy and cost effectiveness of new service delivery methods to enhance the reach and impact of the standard of care treatment, Behavioral Parent Training (BPT), for early onset disruptive behavior disorders.


Options:
A: Engagement (Participants will be followed for the duration of treatment, an expected average of 10 weeks)
B: CHild Behaviour Checklist (to measure change from baseline) (Measure change from baseline at 6 & 12 months)
C: 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)
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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Intervention to Feedback 'Early' Non-Adherence Data to ImproveCardiovascular Disease Risk Factor Outcomes in Patients With Diabetes
Brief Summary: This multisite pragmatic clinical trial was designed to assess the effectiveness of a single scripted telephone call to diabetes patients who (a) were currently above recommended clinical goals for glucose, blood pressure, or lipids, and (b) had recently been prescribed a new medication for that specific clinical domain. The goals of the intervention were to improve primary adherence and persistence to the newly prescribed medication and to improve control of glucose, blood pressure, and lipids.


Options:
A: The change in mean daytime systolic BP from baseline to the last (12-month) visit on 24-hour ambulatory. (1 year)
B: 60 day Medication Adherence (60 days); 120 day medication adherence (120 days)
C: Glowcap bottle openings/Medication Adherence (6 months)
D: Net change in systolic (SBP) and diastolic BP (DBP) from baseline to month 18 between the intervention and control groups among hypertensive study participants. (Baseline and 18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Intervention to Feedback 'Early' Non-Adherence Data to ImproveCardiovascular Disease Risk Factor Outcomes in Patients With Diabetes
Brief Summary: This multisite pragmatic clinical trial was designed to assess the effectiveness of a single scripted telephone call to diabetes patients who (a) were currently above recommended clinical goals for glucose, blood pressure, or lipids, and (b) had recently been prescribed a new medication for that specific clinical domain. The goals of the intervention were to improve primary adherence and persistence to the newly prescribed medication and to improve control of glucose, blood pressure, and lipids.


Options:
A: 60 day Medication Adherence (60 days); 120 day medication adherence (120 days)
B: The proportion of subjects who attain the LDL-C levels set as targets by the Guidelines for Management of Dyslipidaemias and CVR (24 months)
C: Estimated Percentage of Participants in Blood Pressure Control at Baseline (Baseline); Estimated Percentage of Participants in Blood Pressure Control at 6 Months (6month); Estimated Percentage of Participants in Blood Pressure Control at 12 Months (12 month); Estimated Percentage of Participants in Blood Pressure Control at 18 Months (18 month); Blood Pressure Averages Systolic & Diastolic (Baseline); Blood Pressure Averages Systolic & Diastolic (12-month)
D: Adherence to ART and HIV RNA suppression (6,12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Insulin Degludec on Risk of Symptomatic Nocturnal Hypoglycaemia in Subjects With Type 1 Diabetes and High Risk of Nocturnal Severe Hypoglycaemia
Brief Summary: The purpose of this study is to determine whether insulin degludec compared to insulin glargine can reduce the risk of symptomatic nocturnal hypoglycaemia in subjects with the greatest potential benefit from optimised insulin treatment, which are patients with type 1 diabetes and high risk of nocturnal severe hypoglycaemia.


Options:
A: Symptomatic nocturnal hypoglycaemia (9 months (3-12) of each treatment period)
B: Glycosylated Haemoglobin A1c (HbA1c) (after 52 weeks of treatment)
C: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment (Week 0, Week 26); Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes (Week 0 to Week 53 + 7 days follow up); Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes (Week 0 to Week 53 + 7 days follow up); Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) (Week 0 to Week 53 + 7 days of follow up)
D: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment (Week 0, Week 52); Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) (Week 0 to Week 104 + 7 days follow up); Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes (Week 0 to Week 104 + 7 days follow up); Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin (Week 0, Week 106)

Answer: A