TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Psychoeducational Group Intervention Conducted by Primary Health Care Nurses in Patients With Depression and Physical Comorbidity
Brief Summary: The primary aim is to evaluate the effectiveness of an intervention based on a psychoeducational program carried out by primary care nurses, to improve the rate of remission and response of depression in patients with physical chronic illness (diabetes, COPD, asthma and / or ischemic heart disease). Secondarily, to assess the cost-effectiveness of the intervention, the effectiveness to improve the control of physical pathology, the impact on quality of life and the feasibility of the intervention.

Methods: a multicentre, randomized clinical trial, with two groups and 1 year follow-up evaluation. Economic evaluation study. We will study 504 patients (252 in each group), over 50 years assigned to 25 primary care teams (PC) from Catalonia (urban, semi-urban and rural) with major depression and with at least one of the diseases: diabetes mellitus type 2, chronic obstructive pulmonary disease, asthma, and / or ischemic heart disease. They will be distributed randomly into two groups. The intervention group will participate in psychoeducational groups: 12 weekly 90-minute sessions led by two nurses from PC, consisting of health education on chronic physical illness and depressive symptoms.

Main measurements: clinical remission of depression and / or response to intervention (Beck depression inventory: BDI-II). Secondary measures: improvement in control of chronic disease (blood test and physical parameters), drug compliance (test Morinsky-Green and number of packaging), quality of life (EQ-5D), medical service utilization (appointments and hospital admissions due to complications) and feasibility of the intervention (satisfaction and compliance). Evaluations will be masked and conducted at 0, 3 and 12 months. At 6 months, patients will receive a call from nurses.


Options:
A: Changes in rate of remission of depression (At 12 months of follow-up)
B: Change in level of objectively measured physical activity (7 Days at baseline, 7 days at 3- and 12- months after baseline)
C: Number of exacerbations (12 months)
D: thoracoabdominal motion (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder
Brief Summary: The investigators hypothesize that implementation of a shared decision making care plan for prophylactic treatment will help therapeutic adherence of bipolar patients. They also anticipate that patients treated according to a shared decision making plan will have an elevated satisfaction of their care, quality of life and functionment, as well as a lower number of relapses


Options:
A: changes in cognitive insight over time (baseline, 3,6 and 12 month)
B: Patient Activation (Baseline, 30days, 90days); Patient Self-Management (Baseline, 30days, 90days); Engagement in mental health care (Six months following last research interview); Retention in mental health treatment (Six months following last research interview)
C: The proportion of residents whose preferences and needs, together with the related actions to meet them, are known, documented and satisfied in their 'life-and-care plans'. (6 months after the SDM interview)
D: Measure the difference of prophylactic treatment compliance between bipolar patients receiving treatment according to standard care versus a shared decision making care plan following a mood episode. (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Transplant Medication Safety Through A Pharmacist-Empowered, Patient-Centered, Mhealth-Based Intervention (TRANSAFE Rx Study)
Brief Summary: TRANSAFE Rx is a 12-month, parallel two-arm, 1:1 randomized controlled clinical trial, involving 136 participants (68 in each arm) measuring the clinical and economic effectiveness of a pharmacist-led intervention, which utilizes an innovative mHealth application to improve medication safety and health outcomes, as compared to usual post-transplant care. The primary goal of the TRANSAFE Rx study is to demonstrate significant reductions in med safety issues leading to reduced healthcare resource utilization in kidney transplantation through a pharmacist-led, mHealth-enabled, intervention. This study will provide detailed and novel information on the incidence, etiologies and outcomes of med errors and adverse drug events in this high-risk population; while also demonstrating the effectiveness of this intervention on reducing the incidence and impact of med safety issues in kidney transplantation.


Options:
A: medication adherence (5 months)
B: Rx Pill Count (1 year - 1.5 years)
C: Number of Medication Errors (1 year); Incidence and Severity of Adverse Drug Events (1 year); Severity of Medication Errors (1 year)
D: The primary objective of this study is to compare tacrolimus formulations (Envarsus XR® versus twice a day tacrolimus) based on the difference in mean Calcineurin Inhibitor-Related Symptoms (CIRS) severity score. (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of the Perineal Physiotherapy in the Prevention and Treatment of Pelvic Floor Dysfunction in Postpartum
Brief Summary: Objective: To find out the effectiveness of pelvic-perineal physiotherapy in prevention and treatment of postpartum pelvic floor dysfunction caused by vaginal delivery.


Options:
A: Evaluation of subjective cure (At the end of 3 months of supervised treatment)
B: Change from baseline in average number of urinations per patient per day at Week 12
C: Change in life impact of pelvic floor dysfunction (5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.); Change in symptoms and quality of life (5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), , 3 months, 6 months and 12 months after the intervention.); Change in pelvic floor muscle strength (5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), , 3 months, 6 months and 12 months after the intervention.); Change in pelvic floor muscle characteristics (5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.); Change in pelvic floor muscle strength (5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.)
D: UI reduction (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: "Clinical Trial Randomized, Controlled, Parallel-group and Open About the Use of"TELEMEDICINE"in the Management of the Maintenance of a Respiratory Rehabilitation Program Phase in Patients With Chronic Respiratory Diseases"
Brief Summary: Respiratory rehabilitation (RR) has been shown to provide benefits in patients with Chronic Obstructive Pulmonary Disease (COPD) with a degree of evidence A.

These benefits are primarily focused on an increase in the capacity of effort for activities of daily living and in an improvement in the quality of life related to health (HRQOL) a constant to the RR critique is the fact that the benefits achieved with programmes are lost in a progressive and constant way once the patient completes the treatment and lost contact with the team.

The introduction of new technologies in different fields of medicine has been a new approach when it comes to the management of various diseases and treatments in chronic patients. In the case of the RR telemedicine provides a new tool.

COPD disease very prevalent and chronic it is generator of a high economic cost. The possibility of universalizing the rehabilitation treatment would involve a potential savings in this population group ,another potential benefit is as translational trial as part of the development of a new technology and its possible application to clinical practice.

General objective: to determine whether a program of TeleRehabilitation (TeleRR)- Respiratory Rehabilitation Maintenance (RRm) after an intensive initial program of RR, is a useful intervention against the current usual strategy (intensive program of RR and a recommendation of not protected maintenance program).

Method: clinical trial , open, randomized, multicenter, parallel group, and focus of superiority with a strategy of Telerehabilitation program respiratory of maintenance after an intensive RR for 8 weeks in patients diagnosed with grade moderately - severe stable COPD (Bode 3-7).


Options:
A: Effectiveness of an Tele Respiratory Rehabiltation program (TeleRehab) in the maintenance of benefits after an intensive respiratory rehabilitation program evaluated through the 6 m Walking test and health quality questionnaires after 12 months (One Year)
B: Improvement in physical activity (1 month)
C: Exercise behavior (3 & 6 Months)
D: change from baseline in Modified Medical Research Council dyspnea score (12 weeks); change from baseline in COPD Assessment Test(CAT) score (12 weeks); change from baseline in real distance walked for 6 minutes (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: "Clinical Trial Randomized, Controlled, Parallel-group and Open About the Use of"TELEMEDICINE"in the Management of the Maintenance of a Respiratory Rehabilitation Program Phase in Patients With Chronic Respiratory Diseases"
Brief Summary: Respiratory rehabilitation (RR) has been shown to provide benefits in patients with Chronic Obstructive Pulmonary Disease (COPD) with a degree of evidence A.

These benefits are primarily focused on an increase in the capacity of effort for activities of daily living and in an improvement in the quality of life related to health (HRQOL) a constant to the RR critique is the fact that the benefits achieved with programmes are lost in a progressive and constant way once the patient completes the treatment and lost contact with the team.

The introduction of new technologies in different fields of medicine has been a new approach when it comes to the management of various diseases and treatments in chronic patients. In the case of the RR telemedicine provides a new tool.

COPD disease very prevalent and chronic it is generator of a high economic cost. The possibility of universalizing the rehabilitation treatment would involve a potential savings in this population group ,another potential benefit is as translational trial as part of the development of a new technology and its possible application to clinical practice.

General objective: to determine whether a program of TeleRehabilitation (TeleRR)- Respiratory Rehabilitation Maintenance (RRm) after an intensive initial program of RR, is a useful intervention against the current usual strategy (intensive program of RR and a recommendation of not protected maintenance program).

Method: clinical trial , open, randomized, multicenter, parallel group, and focus of superiority with a strategy of Telerehabilitation program respiratory of maintenance after an intensive RR for 8 weeks in patients diagnosed with grade moderately - severe stable COPD (Bode 3-7).


Options:
A: Change in physical activity levels (1 week before, 1 week after, 3 and 6 months after the PR program)
B: The primary endpoint will be change from baseline in the dyspnoea domain of the Chronic Respiratory Questionnaire (CRQ). (14 Months)
C: Effectiveness of an Tele Respiratory Rehabiltation program (TeleRehab) in the maintenance of benefits after an intensive respiratory rehabilitation program evaluated through the 6 m Walking test and health quality questionnaires after 12 months (One Year)
D: Exercise behavior (3 & 6 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: GASTROKE- the Effect of General Anesthesia Versus Sedation for Patients With Acute Ischemic STROKE Undergoing Endovascular Treatment on Three Month Morbidity and Mortality: a Feasibility Study.
Brief Summary: After a stroke caused by a blockage (clot) in a blood vessel in the brain, patients may have the clot removed by threading a catheter from the groin up to the affected area of the brain. An anesthesiologist is involved in the patient's care during this procedure to maximize patient safety and procedural efficiency. The options for anesthesia for this procedure are general anesthesia (where the patient is unconscious) or sedation (where the patient is in a relaxed, calm, sleepy condition). Currently, it is unclear which of these anesthetic options contributes to the best patient outcome. The investigators would like to investigate whether or not one method of anesthesia (general or sedation) is better to use than the other when removing the clot.


Options:
A: Randomization potential (20 weeks)
B: modified Rankin scale (mRS) 0-1 (favourable outcome) at Day 90 (at day 90)
C: Growth of DWI lesion (48-72 hours)
D: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-masked, Placebo-controlled Evaluation of Netarsudil for Prevention of Corticosteroid-induced Intraocular Pressure Elevation
Brief Summary: Cornea transplant recipients who are using topical corticosteroids long-term to prevent transplant rejection will be randomized to use netarsudil or placebo.


Options:
A: Intraocular Pressure (from date of randomization until the date of first documented intraocular pressure elevation exceeding defined threshold up to 9 months)
B: Intraocular Pressure (IOP) (Primary efficacy endpoint measured for 3 months (data collected at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90))
C: Intraocular Pressure (IOP) (3 months)
D: Intraocular Pressure (IOP) (29 Days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Eucrisa for Atopic Dermatitis: Measuring and Improving Adherence to Topical Eucrisa in Patients With Atopic Dermatitis
Brief Summary: Patients with mild to moderate atopic dermatitis will be asked to participate in helping the study team determine how well the medication works for atopic dermatitis. Participants will not be told that adherence will be monitored. Patients will be dispensed topical crisaborole 2% ointment (Eucrisa®) in a medication tube fitted with a Medication Event Monitoring System (MEMS) cap if they agree to participate. This cap records dates and times the bottle is opened and this data can be downloaded and tabulated with the associated software.

Investigators and subjects will be blinded to the adherence data until the final treatment (12 month) session. The study subjects will be randomized to two groups. After baseline visit, both groups will come for a follow-up visit at 1 month, 3 months, 6 months, and 12 months. The intervention group will also be asked to complete an online treatment response survey designed to improve adherence at weekly intervals for 6 weeks, then monthly thereafter.

The study will consist of a 12-month Treatment Phase. Study subjects will be instructed to apply the medication twice daily (morning and evening) to all of their AD lesions. They will be instructed to apply the smallest amount of study medication possible that is sufficient to cover all lesions. These instructions are standard-of-care for patients with AD.

Subjects will be asked to bring their medication tubes with them at each visit. At each visit, the study coordinator will weigh the medication tube and download the MEMS cap data. Disclosure of the adherence monitoring will occur at the 12 month visit (or end of treatment), at which time the results of the subject's adherence behavior will be used to supply individualized treatment options for each subject (feedback session).

At each visit, drug tubes will be measured for weight to determine the amount of study medication used. This data will be correlated with the extent of BSA involved and the response of the disease. The MEMS caps will be downloaded at each visit.


Options:
A: Adherence to topical Therapy (12 months)
B: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Day 29 (Baseline, Day 29); Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) (Baseline up to Day 60); Percentage of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters (Baseline up to Day 29); Percentage of Participants With Clinically Significant Changes From Baseline in Vital Signs (Baseline up to Day 29)
C: VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8 (Baseline to Week 8)
D: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4 (Baseline (pre-dose on Day 1) and Week 4)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: mHealth-Assisted Conditional Cash Transfers to Improve Timeliness of Childhood Vaccinations
Brief Summary: Vaccination is a cost-effective strategy for conferring immunity against a host of preventable diseases, however, rates of timely childhood vaccinations remain inadequate in resource-limited settings. We propose to evaluate the feasibility and efficacy of mHealth-assisted conditional cash transfers as a means of overcoming individual barriers to timely vaccinations. The study will form the basis for a pragmatic randomized controlled trial of the efficacy and cost-effectiveness of mHealth reminders and conditional cash transfers for improving rates of timely vaccinations among young children.


Options:
A: Neurodevelopment as measured by the Protocol for Child Monitoring - Infant and Toddler version assessment (12 months of age)
B: prevalence of participants with at least one of the following four complications: pregnancy-induced hypertension, gestational diabetes mellitus, caesarean section, large-for-gestational age baby (at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks))
C: Number of Timely Vaccinations Received (Up to 6 months after birth)
D: Percent of children immunized (Up to 12 months of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Individual, Acceptance and Commitment Therapy (ACT) in Smoking Cessation for People With Schizophrenia: a Randomized Controlled Trial
Brief Summary: The purpose of this study is to evaluate the efficacy of using Acceptance and commitment therapy for smoking cessation for schizophrenic patients.


Options:
A: Smoking Abstinence (24 weeks post quit day)
B: Self-report of not having smoked for the past 7 days (At 6th month after the initial intervention)
C: Smoking behavior (6 months)
D: Smoking abstinence (7 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Evaluation of Pulse: A Mobile Health App and Teen Pregnancy Prevention Program
Brief Summary: This study uses a randomized controlled design to evaluate the efficacy of a new mobile app, Pulse, in reducing the incidence of unprotected sex among young women. Pulse is a web-based mobile health application that can be accessed through mobile smartphones and computers. Pulse was designed to increase highly effective birth control use and reproductive and sexual health care utilization, and ultimately decrease teen pregnancy. The sample is comprised of women with the following characteristics at study enrollment: aged 18-20, not pregnant or trying to become pregnant, has daily access to a smartphone, currently living in the United States or a U.S. territory, and speaks either English or Spanish. Most of the sample (at least 70%) will be women who identify as Black and/or Latina. The evaluation team plans to enroll up to 1,300 participants over a one-year enrollment period using social media, including Facebook, Instagram, and Twitter.

Users access Pulse autonomously, on their own terms, and in their own time and place. The app consists of 6 sections and includes 3 hours of unique content. It does not require the user to follow a specific sequence of content viewed; however, all users will receive a monetary incentive after registering with the apps. Youth randomized to the intervention condition are given access to Pulse indefinitely and receive daily text messages related to sexual health for 6 weeks. Control participants are directed to a free general health/fitness web-based mobile application, also called Pulse, and receive text messages related to general health for 6 weeks. The control and treatment apps look and feel similar aesthetically but contain different content. Participants in both the intervention and comparison groups receive a baseline survey and a 6-week follow-up survey. Participants will also receive incentives once they complete the baseline and post-intervention survey. Both surveys are conducted online via an electronic survey platform. This study is being conducted as a Rigorous Evaluation of New or Innovative Approaches to Prevent Teen Pregnancy funded by the U.S. Department of Health and Human Services' Office of Adolescent Health.


Options:
A: Acceptability of at least one method of effective contraception (4 months)
B: Initiation of highly effective contraception, as defined by the World Health Organization. (3 months after initial enrollment)
C: Rate of Enrollment (Month 12); Acceptability of the mHealth application (Month 12)
D: Unprotected sex, no contraceptive (6-week post-baseline (in the past 6 weeks)); Unprotected sex, no highly effective contraceptive (6-week post-baseline (in the past 6 weeks))

Answer: D