TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Targeted Brief Intervention for Recent Suicide Attempt Survivors
Brief Summary: Effective, brief, low-cost interventions for individuals who attempt suicide are needed to save lives and achieve the goals of the National Strategy for Suicide Prevention. In response to a National Institute for Mental Health (NIMH) Notice of Interest, this time-sensitive proposal leverages an existing federal investment in Zero Suicide to test the effectiveness of a highly promising new treatment for recent suicide attempt survivors and learn how it works. If hypotheses are supported, the study will provide evidence of a brief, practical, and cost-effective therapy that reduces suicide reattempts in a real-world health setting.


Options:
A: Suicide attempts (Measured at 18 months from Baseline)
B: Reduced Self-harm (3 months)
C: Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr (Screening, 6 weeks, 24 weeks)
D: Time to Suicide Attempt (Up to 18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery
Brief Summary: The risk of urinary tract infection (UTI) following female incontinence surgery ranges between 6-48%. The literature has shown mixed results of the therapeutic efficacy of cranberry extract to prevent UTI in females, with some promising preliminary work in the prevention of UTI's following gynecologic surgery. The researchers will conduct a study of the effect of cranberry extracts on preventing urinary tract infections following mid urethral slings, which are the most common urinary incontinence procedures.


Options:
A: To assess the effects of maternal obesity on the concentrations and adequacy of antimicrobial activity of prophylactically administered antibiotics within tissues (subcutaneous adipose and myometrial) at the time of cesarean delivery. (6 weeks)
B: A change in number of cured patients (Up to 1 year)
C: Urine culture based on type of symptoms (2 weeks)
D: Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence (6 weeks); Incidence of Post-operative UTI in Placebo Group (6 weeks); Incidence of Post-operative UTI in Treatment Group (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata
Brief Summary: The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).


Options:
A: Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 (Baseline and 24 weeks)
B: Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 (Week 36)
C: Treatment success (After six months from onset of treatment)
D: Change in scalp surface area affected over time (24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of the Use of a Polyurethane Foam Multilayer Dressing in the Sacral Area, in Addition to Standard Healthcare, to Prevent the Onset of Pressure Ulcer in Patients at Risk. Multicentric Randomized Controlled Trial
Brief Summary: The aim of the present study was to assess whether the application of a multilayered dressing made of hydrocellular polyurethane foam conformed to the sacral area (MSP) in addition to standard preventive care reduces the rate of pressure ulcer (PU) and their severity in population at risk admitted in acute care Hospital.


Options:
A: rate of pressure injury from nasogastric tube (Each participant will be followed for 18 days)
B: Appearance grade II pressure ulcers (48 months)
C: Number of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion) (Duration of hospital stay, an average of 12.6 (SD +/-12.7) days)
D: Rate of any type of pressure ulcer in the sacral area. (On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Post-partum Non-pharmacologic Pain Management
Brief Summary: This study aims to examine whether use of an abdominal binder for postpartum patients after vaginal delivery can effectively manage their pain and reduce the need for pharmacologic analgesics. The investigators hypothesize that use of an abdominal binder will decrease patient pain as reported on a visual analog scale of one to ten, and will decrease quantity of pain medications given. The study will be conducted at the Berry Women's Center at Miami Valley Hospital. Potential eligible participants will be approached regarding the study on admission to labor and delivery. The investigators will recruit 130 participants that will be randomized to two study arms, standard care and standard care plus abdominal binder with 65 participants in each study arm. Data will be collected prospectively while participants are admitted, and through review of electronic medical records. Potential benefits of this study include investigation of a cost-effective method for pain management that could improve patient comfort and reduce need for medications.


Options:
A: Change in Pain Scores on the numeric rating scale at 3 days (2 hours after delivery time and be continued every 6 hours for 3 days.)
B: Postpartum weight loss (12 months after delivery)
C: Rate of change in of the vas scores before and after using this device (24 months)
D: Patient Reported Average Pain Score (Average score computed from postpartum day 0, postpartum day 1); Number of Patient Using Each Type of Non-narcotic Pain Medications (Number of patients using each type of non-narcotic medication recorded on postpartum day 0 and postpartum day 1); Any Narcotic Pain Medication Use (Any narcotic medication use from postpartum day 0 and postpartum day 1)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Effectiveness of a Self-applied Online Program to Promote Resilience and Coping Skills in University Students in Three Spanish-speaking Countries: Study Protocol for a Randomized Controlled Trial
Brief Summary: This study aims to evaluate the effectiveness and efficiency of this intervention protocol applied to three populations of Spanish-speaking university students (Spain, Argentina and Mexico). The purpose of this paper is to present the protocol designed to carry out the randomised controlled study (RCT).


Options:
A: Daily Depression (Change in daily depression assessed daily for seven days during week 2 and week 16 of the study.); Depression I (Change in depression over 4-month period.); Depression II (Change in depression over 4-month period.); Daily Social Connection (Change in daily social connection assessed daily for seven days during week 2 and week 16 of the study.); Daily Belonging (Change in loneliness over 4-month period.); Loneliness (Change in loneliness over 4-month period.)
B: level of depression (Baseline to 3 months)
C: Change in Stress (baseline, 8wks (post-intervention),12-month follow-up)
D: Connor-Davidson's Resilience Scale (CDRISC; Connor and Davidson, 2003) (Up to 3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Effectiveness of a Self-applied Online Program to Promote Resilience and Coping Skills in University Students in Three Spanish-speaking Countries: Study Protocol for a Randomized Controlled Trial
Brief Summary: This study aims to evaluate the effectiveness and efficiency of this intervention protocol applied to three populations of Spanish-speaking university students (Spain, Argentina and Mexico). The purpose of this paper is to present the protocol designed to carry out the randomised controlled study (RCT).


Options:
A: Connor-Davidson's Resilience Scale (CDRISC; Connor and Davidson, 2003) (Up to 3 months)
B: smoking cessation: 7-day point prevalence abstinence (6 months)
C: Number of Participants Who Stopped Smoking by 6 Month Post Treatment (6 months)
D: Degree of occupational stress (Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)); Degree of occupational stress (Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)); Degree of burnout (Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)); Degree of Self-Compassion (Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Effectiveness of a Self-applied Online Program to Promote Resilience and Coping Skills in University Students in Three Spanish-speaking Countries: Study Protocol for a Randomized Controlled Trial
Brief Summary: This study aims to evaluate the effectiveness and efficiency of this intervention protocol applied to three populations of Spanish-speaking university students (Spain, Argentina and Mexico). The purpose of this paper is to present the protocol designed to carry out the randomised controlled study (RCT).


Options:
A: Connor-Davidson's Resilience Scale (CDRISC; Connor and Davidson, 2003) (Up to 3 months)
B: Self-harm as measured by the self-harm sub scale of the Risk-taking and Self-harm Inventory for Adolescents (Vrouva et al, 2010) (12 weeks); Self-harm and related hospital use as reported in National Health Service patient records (12 weeks)
C: assessing change in number of suicide attempts/self-harming acts (baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment)
D: Drop-out (1 year); Suicidality (Suicide Attempts) (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: ETDRS Panretinal Photocoagulation (PRP) Combined With Intravitreal Ranibizumab (IVR) Versus Retinal Photocoagulation Targeted to Ischemic Retina Combined With IVR for the Treatment of Proliferative Diabetic Retinopathy
Brief Summary: Purpose: To compare panretinal photocoagulation (PRP) as described in ETDRS Study combined with intravitreal injection of ranibizumab (IVR) (ETDRS-PRP group) and retinal photocoagulation targeted to ischemic retina combined with IVR (ISQ-RP group) in patients with proliferative diabetic retinopathy (PDR).

Design: Randomized prospective clinical trial. Methods: Patients with PDR were assigned to receive either PRP plus IVR (20 eyes) or retinal photocoagulation targeted to ischemic areas plus IVR (20 eyes). ETDRS best-corrected visual acuity (BCVA), central subfield macular thickness (CSFT) measured by optical coherence tomography (OCT) were performed at baseline and every 4 weeks through week 48. Area of fluorescein leakage from active new vessels (FLA) was measured every 12 weeks. Full-field electroretinography (ERG) was recorded at baseline and after 3 months.


Options:
A: Fluorescein leakage area of active new vessels (FLA) (48 weeks)
B: Mean Change in Visual Acuity From Baseline (2-years)
C: Functional Macular Evaluation (24 weeks)
D: E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) (24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Oxytocin Antagonists on Implantation Success Rates of Frozen-thawed Embryo Transfer
Brief Summary: Uterine contraction has a negative impact on implantation and pregnancy rates. Inhibition of oxytocin receptors decreases uterine contraction frequency both on pregnant and non-pregnant women. Atosiban has been studied as an oxytocin antagonist to decrease uterine contraction frequency in order to increase implantation and pregnancy rates in assisted reproduction. Previous studies have studied 37,5mg total dose which was used both before and during embryo transfer, and found atosiban to be effective in increasing implantation and pregnancy rates. We aim to use a single dose of 6,75mg atosiban before embryo transfer, in order to decrease the dose and cost and possibly introduce a simpler protocol. Our study will also be the first randomized clinical study which investigates the effect of atosiban on frozen-thawed embryo transfer cycles.


Options:
A: Ongoing pregnancy with fetal heart beat at 10 weeks (10 weeks post ET day)
B: Pregnancy rates (1 year)
C: live birth rate (9 months)
D: implantation rate (16 days from eggretrieval)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Oxytocin Antagonists on Implantation Success Rates of Frozen-thawed Embryo Transfer
Brief Summary: Uterine contraction has a negative impact on implantation and pregnancy rates. Inhibition of oxytocin receptors decreases uterine contraction frequency both on pregnant and non-pregnant women. Atosiban has been studied as an oxytocin antagonist to decrease uterine contraction frequency in order to increase implantation and pregnancy rates in assisted reproduction. Previous studies have studied 37,5mg total dose which was used both before and during embryo transfer, and found atosiban to be effective in increasing implantation and pregnancy rates. We aim to use a single dose of 6,75mg atosiban before embryo transfer, in order to decrease the dose and cost and possibly introduce a simpler protocol. Our study will also be the first randomized clinical study which investigates the effect of atosiban on frozen-thawed embryo transfer cycles.


Options:
A: implantation rate (16 days from eggretrieval)
B: Number of mature(MII) oocyte (Day1(from the day of oocyte retrieval to fertilization confirmation))
C: Clinical pregnancy rate (4 weeks after embryo transfer)
D: Pregnancy rates (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Exercise Rehabilitation Regimes in Combination With Changes in Dialysis Procedures in Aspects Related to Quality of Life and Health in End Stage Renal Disease Patients
Brief Summary: Despite the tremendous advances in dialysis technology, hemodialysis (HD) is a significant challenge for dialysis patients and quality of their lives\[2\]. Research has shown for years that dialysate fluid temperature and especially the typical dialysis (TD) temperature at (37°C) are complicated by hemodynamic instability which leading to an increased risk of heat-induced hypotension causing patient discomfort and increased mortality.

Cold dialysis (CD) is defined as the reduction of dialysis fluid temperature to 35-36°C, approximately 1°C below the typical dialysate temperature which ranges between 37-38°C. A number of studies have reported beneficial effects of CD on maintaining hemodynamic stability, minimizes hypotension and exerts a protective effect over major organs including the heart and brain. In addition, current evidence showed the protective effect of CD in cardiac performance during the dialysis session. As the investigators know until today cardiovascular mortality is an important issue for nephrologists that care for ESRD patients, however, many other benefits have been observed on patients' overall health and quality of life levels by used of CD.

The above-mentioned benefits of CD in the hemodynamic stability and the general quality of life of the patients are highlighted even further due to the ever-increasing adoption of intradialytic exercise programs. It has been well established that intradialytic exercise leads to benefits of physiological, functional, and psychological deterioration, which commonly accrues as a consequence of biological aging, catabolic illness, and a sedentary lifestyle, factors that may all contribute to the progressive decline of vitality and quality of life commonly observed in ESRD patients.

However, despite a strong rationale for the implementation of intradialytic exercise programs and the aforementioned benefits of CD, the separate and combined effects of these protocols in aspects related to quality of life and health in ESRD patients have not been investigated to date.

The aim of the current clinical study was to assess the effect of exercise rehabilitation regimes in combination with changes in dialysate temperature in aspects related to quality of life and health in end-stage renal disease patients receiving hemodialysis.


Options:
A: The % of target ultrafiltration achieved (1 year)
B: Change in Body Heat Storage (Changes from baseline at 7 months); Change in Insulin Resistance (Changes from baseline at 7 months); Change in Muscle Size (Changes from baseline at 7 months)
C: a composite of mortality with the change over 12 months in left ventricular mass (12 months); a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite. (12 months)
D: Levels of Fatigue (9 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrated Care Pathway for Hip Fractures in a Subacute Rehabilitation Setting
Brief Summary: The effectiveness of integrated care pathways for hip fractures in sub-acute rehabilitation settings is not known. The study objective was to assess if a hip fracture integrated care pathway at a sub-acute rehabilitation facility would result in better functional outcomes, shorter length of stay and fewer institutionalisations. A randomised controlled trial on an integrated care pathway was conducted for hip fracture patients in a sub-acute rehabilitation setting. The study supports the use of integrated care pathways in sub-acute rehabilitation settings to reduce length of stay whilst achieving the same functional gains.


Options:
A: Montebello Rehabilitation Factor Score (MRFS) (1 day At discharge); Montebello Rehabilitation Factor Score (MRFS) (At 6 months); Montebello Rehabilitation Factor Score (MRFS) (At 1 year); Proportions of patients achieving pre-morbid ambulatory status (1 day At discharge); Proportions of patients achieving pre-morbid ambulatory status (At 6 months); Proportions of patients achieving pre-morbid ambulatory status (At 1 year); Length of stay in hospital (1 day At discharge); Percentage of patients admitted to nursing home (Up to 1 year after discharge)
B: Quality of life (1 year)
C: Major Adverse Events related to treatment / residential status / immobilization (From surgery up to 1 year follow-up)
D: Relational Coordination (For average period of 3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial
Brief Summary: Improving adherence to inhaled corticosteroids (ICS) medication in urban minority pediatric populations is a clinical and population health priority. Financial incentives have been shown as a compelling method to engage a high-risk asthma population in regular ICS use, but whether and how adherence can be maintained and lead to sustained high adherence trajectories is unknown.


Options:
A: Adherence rate (at three months)
B: Change from Baseline Asthma Control to 3 Month Asthma Control (Post-Refinement Baseline, 3 Months); Change from Baseline Asthma Control to 3 Month Asthma Control (Post-Refinement Baseline, 4 Months)
C: Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) (6 months)
D: Change in asthma control from baseline at 3 months (3 months); Change in asthma control from baseline at 6 months (6 months); Change in asthma control from baseline at 9 months (9 months); Change in asthma control from baseline at 12 months (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: SMART 2.0: Social Mobile Approaches to Reducing weighT in Young Adults
Brief Summary: The SMART 2.0 study is a 24-month trial designed to evaluate the impact of the intervention with technology and personal health coaching or with technology alone on objectively measured weight among overweight young adults in a university setting over 24 months compared to a control group. The investigators hypothesize that both interventions will significantly improve weight compared to the control group, and the group receiving personal health coaching will experience the greatest improvement.


Options:
A: Change in Weight (Baseline, 24 months)
B: Change in weight (12 weeks)
C: Weight (Measured at Assessment Visits) and Pain Intensity and Pain Related Disability (NRS-I) (baseline, 3, 6, 9, and 12 months)
D: Change in BMI. We have set a target of BMI maintenance among those randomized to the intervention condition. (6, 12 and 18 months post baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Efficacy of Topical Hydrocortisone 0.335% (Softacort®) in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation
Brief Summary: Dry eye disease (DED) is a highly prevalent ocular condition and induces a significant burden to the affected patients. Regardless of the underlying etiology, DED is associated with increased inflammation of the entire ocular surface including the adnexa, conjunctiva and cornea. As such, there is evidence from in vitro, animal and clinical studies that this inflammatory response of the ocular surface plays a pathophysiological key role in the development of DED. The Dry Eye Workshop 2007 (DEWS) therefore suggests the use of anti-inflammatory drugs such as corticosteroids, cyclosporine or others when topical lubricants alone are not sufficient. Recently, Softacort® eye drops containing 0.335% hydrocortisone have gained marketing authorization for the treatment of ocular surface inflammation. This formulation offers several advantages that make them potentially interesting for the treatment of DED. First, the formulation is preservative-free, which is of special importance in patients with DED, since it has been shown that preservatives are detrimental for the ocular surface. Further, hydrocortisone has the advantage that in comparison to other glucocorticoid derivatives, it features poor solubility. This means that corneal penetration is low, which is a desired effect in the treatment of ocular surface inflammation. Because of the poor penetration through thecornea, elevation of intraocular pressure and cataract formation, which are common side effect of corticosteroid treatment, have not been observed with Softacort® to date, also favoring the use of this agent in DED. The aim of the present study is to investigate whether treatment with Softacort® improves ocular surface inflammation as well as clinical signs and symptoms associated with DED in patients who are already taking topical lubricants for at least three months.


Options:
A: Ocular Surface Disease Questionnnaire Results; Lissamine green staining; Fluorescein Staining; Schirmer testing
B: Changes of inflammatory cytokines in the tears of moderate and severe MGD (1 second before using topical loteprednol etabonate, after 1 month, and after 2 months of using topical loteprednol etabonate)
C: Bulbar Conjunctival Hyperemia (Visit 6 (Day 29)); Ocular Discomfort (Visit 6 (Day 29))
D: Conjunctival hyperemia (5 minutes)

Answer: D