TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Inter-pregnAncy Coaching for a Healthy fuTure
Brief Summary: The project focuses on prevention of major pregnancy and birth related complications : pregnancy-induced hypertension (PIH), gestational diabetes mellitus (GDM), caesarean section (CS), and large-for-gestational-age (LGA), i.e. the birth weight of the baby exceeds the 90% percentile of birth weights for the specific pregnancy duration.

The investigators focus on the pre-conception period, i.e. the pre-conception period of the 2nd pregnancy in women with an excessive weight gain during their 1st pregnancy, aiming to decrease the complications rate in their 2nd pregnancy.

Women with an excessive gestational weight gain have obtained the extra weight during a rather short period of time, e.g. 20 kilos in the last 4 or 5 months of their pregnancy. This characteristic distinguishes the target group from the general population with overweight/obesity, in whom the extra weight was acquired during many years and independent from a pregnancy, making a behaviour change more complex.

The coaching intervention combines face-to-face counselling with the use of a mobile App connected to medical devices (scale and pedometer). The app monitors important indicators (weight, eating behaviour, physical activity, mental wellbeing), provides coaching through established behavioral change techniques, and is specifically tailored for women with excessive weight gain during the previous pregnancy.

The goal is to decrease the rate of pregnancy and birth-related adverse outcomes in the next pregnancy by a healthy life style, starting shortly after their 1st delivery and sustained during the next pregnancy.


Options:
A: Percent of children immunized (Up to 12 months of age)
B: Neurodevelopment as measured by the Protocol for Child Monitoring - Infant and Toddler version assessment (12 months of age)
C: Number of Timely Vaccinations Received (Up to 6 months after birth)
D: 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))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cardiovascular Health in Patients With Primary Hyperparathyroidism: Effect of Parathyroidectomy on Cardiovascular Health: A Randomized Controlled Trial
Brief Summary: The aim of this study is to establish whether patients with mild primary hyperparathyroidism (PHPT) have an increased risk of cardiovascular diseases. The primary outcome is to determine whether arterial stiffness and blood pressure will decrease in patients with mild PHPT 3-month after parathyroidectomy (PTX).


Options:
A: N/A
B: Decrease in arterial stiffness after parathyroidectomy (3 month)
C: Total sleep time (Before and After Intervention)
D: Predictive outcome in Quality of Life after parathyroidectomy (after four weeks of calcimimetic treatment and postoperatively)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Glycaemic Response to Oral Nutrition Support During Haemodialysis
Brief Summary: Patients with kidney, or renal, failure require life-saving treatment with regular dialysis. Dialysis is a form of treatment that simulates some kidney functions; to remove harmful waste products and extra water from the blood. Almost one-third of people with kidney failure also have diabetes, as diabetes is one of the leading causes of kidney disease in the United Kingdom, usually due to poor blood sugar control over a long period of time. Malnutrition is common in patients needing dialysis due to kidney failure causing fatigue, taste changes and a build up of waste products, which can reduce appetite. Treatment of malnutrition involves increasing both the energy and protein intake from food and drinks, and milk-drink style specialist nutrition drinks are often given to dialysis patients due to their specific dietary needs. These nutrition drinks can increase blood sugar levels and optimal control for diabetes may be difficult. This research study aims to measure the blood sugar response to a "slow-release" sugar nutrition drink specifically designed for dialysis patients, which may result in a lower blood sugar level, compared to standard nutrition drinks, consumed during a dialysis session. 28 patients with diabetes and having regular dialysis treatment will enrol in the study. Patients will be asked to drink 1 of 3 different nutrition drinks, once a week for 3 weeks during their regular dialysis treatment. Blood sugar levels will be measured from the blood samples taken from the patient's circulation directly before it enters the dialysis machine over 3 hours and the maximum blood sugar reading and total blood sugar response will be measured. Differences between the 3 drinks will be tested statistically. The results will help to advise patients with diabetes and kidney failure on the most suitable type of nutrition drink to consume during dialysis.


Options:
A: Change of physical endurance on bicycle (At months 3 and 15 after inclusion)
B: net muscle protein balance (10 hours)
C: Blood glucose response curve (3 hour)
D: Changes in beat-to-beat systolic blood pressure (Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness Study of a Dialectical Behavioral Treatment for Adolescents With Emotional Instability and Their Families. Comparison of Family Functioning and Cope Strategies in Adolescents With Emotional Instability and Their Families and a Control Group
Brief Summary: Emotional instability disorder (IE) is appreciable since adolescence, and crises (suicidal ideation, self-harm, impulsive acts and brief psychotic episodes) carry a high use of health resources, coupled with the suffering of families who feel helpless and difficulties in handling.

this study is composed of three diferents studies:

. The first study's goal is to determine if there are diferences and, which ones, between family functioning and cope strategies between adolescents with IE and their families, and families of a control group.

* the purpose of the second study is to evaluate the effectivenes of a dialectical behavior therapy for adolescents with IE and their families who are in treatment in the Child Abd Adolescent Mental Heath Service of the Hospital sant Joan de Déu Terres de Lleida. This treatment consist on 2 preliminary sessions with parents and patients and 12 group sessions which purpose is to teach skilss to manage emotions based on dialectical Behavior Therapy.
* finally, the third study is designed to evaluate the effectiveness of a dialectical behavior therapy (DBT) for parents of adolescents with IE who are in treatment in the different network devices of Child and Adolescent Mental Health of the Community of Madrid. Treatment goals are the development of communication skills, validation and crisis management as well as increase understanding and competence of the pathology. The DBT intervention will begin with two individual sessions with parents of patients and 10 theoretical and practical seminars in group format (6-7 families) following the model proposed by Marsha Linehan. The DBT interventions will be added to "standard treatment" that a patient with IE receives in the investigative devices.


Options:
A: Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr (Screening, 6 weeks, 24 weeks)
B: The number of contacts with mental health services appropriate to the patient's needs. (3 months)
C: Change in Autonomous and Controlled Motivation (From baseline until 3 months following the completion of the 1-day intervention (i.e., average of 3 months))
D: Difficulties in Emotional Regulation Scale (DERS). (Hervás 2008) (one year); Automatic Anger and Hostility Thoughts Scale (IPRI) (Magán 2010) (one year); Coping Styles and Strategies Scale (COPE) (Crespo 1997) (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness Study of a Dialectical Behavioral Treatment for Adolescents With Emotional Instability and Their Families. Comparison of Family Functioning and Cope Strategies in Adolescents With Emotional Instability and Their Families and a Control Group
Brief Summary: Emotional instability disorder (IE) is appreciable since adolescence, and crises (suicidal ideation, self-harm, impulsive acts and brief psychotic episodes) carry a high use of health resources, coupled with the suffering of families who feel helpless and difficulties in handling.

this study is composed of three diferents studies:

. The first study's goal is to determine if there are diferences and, which ones, between family functioning and cope strategies between adolescents with IE and their families, and families of a control group.

* the purpose of the second study is to evaluate the effectivenes of a dialectical behavior therapy for adolescents with IE and their families who are in treatment in the Child Abd Adolescent Mental Heath Service of the Hospital sant Joan de Déu Terres de Lleida. This treatment consist on 2 preliminary sessions with parents and patients and 12 group sessions which purpose is to teach skilss to manage emotions based on dialectical Behavior Therapy.
* finally, the third study is designed to evaluate the effectiveness of a dialectical behavior therapy (DBT) for parents of adolescents with IE who are in treatment in the different network devices of Child and Adolescent Mental Health of the Community of Madrid. Treatment goals are the development of communication skills, validation and crisis management as well as increase understanding and competence of the pathology. The DBT intervention will begin with two individual sessions with parents of patients and 10 theoretical and practical seminars in group format (6-7 families) following the model proposed by Marsha Linehan. The DBT interventions will be added to "standard treatment" that a patient with IE receives in the investigative devices.


Options:
A: Difficulties in Emotional Regulation Scale (DERS). (Hervás 2008) (one year); Automatic Anger and Hostility Thoughts Scale (IPRI) (Magán 2010) (one year); Coping Styles and Strategies Scale (COPE) (Crespo 1997) (one year)
B: Parasuicidal behaviour (intermittent)
C: Change in Recovery Assessment Scale (Change from baseline in Recovery Assessment Scale at 12th meeting (6 up to 12 weeks))
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: Effectiveness Study of a Dialectical Behavioral Treatment for Adolescents With Emotional Instability and Their Families. Comparison of Family Functioning and Cope Strategies in Adolescents With Emotional Instability and Their Families and a Control Group
Brief Summary: Emotional instability disorder (IE) is appreciable since adolescence, and crises (suicidal ideation, self-harm, impulsive acts and brief psychotic episodes) carry a high use of health resources, coupled with the suffering of families who feel helpless and difficulties in handling.

this study is composed of three diferents studies:

. The first study's goal is to determine if there are diferences and, which ones, between family functioning and cope strategies between adolescents with IE and their families, and families of a control group.

* the purpose of the second study is to evaluate the effectivenes of a dialectical behavior therapy for adolescents with IE and their families who are in treatment in the Child Abd Adolescent Mental Heath Service of the Hospital sant Joan de Déu Terres de Lleida. This treatment consist on 2 preliminary sessions with parents and patients and 12 group sessions which purpose is to teach skilss to manage emotions based on dialectical Behavior Therapy.
* finally, the third study is designed to evaluate the effectiveness of a dialectical behavior therapy (DBT) for parents of adolescents with IE who are in treatment in the different network devices of Child and Adolescent Mental Health of the Community of Madrid. Treatment goals are the development of communication skills, validation and crisis management as well as increase understanding and competence of the pathology. The DBT intervention will begin with two individual sessions with parents of patients and 10 theoretical and practical seminars in group format (6-7 families) following the model proposed by Marsha Linehan. The DBT interventions will be added to "standard treatment" that a patient with IE receives in the investigative devices.


Options:
A: Suicidal thoughts or attempts (Measured at Year 2)
B: MHS heavy use (2 years)
C: Difficulties in Emotional Regulation Scale (DERS). (Hervás 2008) (one year); Automatic Anger and Hostility Thoughts Scale (IPRI) (Magán 2010) (one year); Coping Styles and Strategies Scale (COPE) (Crespo 1997) (one year)
D: Change in level of stress per Perceived Stress Scale (PSS) (Baseline and at 2 months (immediately post-intervention))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness Study of a Dialectical Behavioral Treatment for Adolescents With Emotional Instability and Their Families. Comparison of Family Functioning and Cope Strategies in Adolescents With Emotional Instability and Their Families and a Control Group
Brief Summary: Emotional instability disorder (IE) is appreciable since adolescence, and crises (suicidal ideation, self-harm, impulsive acts and brief psychotic episodes) carry a high use of health resources, coupled with the suffering of families who feel helpless and difficulties in handling.

this study is composed of three diferents studies:

. The first study's goal is to determine if there are diferences and, which ones, between family functioning and cope strategies between adolescents with IE and their families, and families of a control group.

* the purpose of the second study is to evaluate the effectivenes of a dialectical behavior therapy for adolescents with IE and their families who are in treatment in the Child Abd Adolescent Mental Heath Service of the Hospital sant Joan de Déu Terres de Lleida. This treatment consist on 2 preliminary sessions with parents and patients and 12 group sessions which purpose is to teach skilss to manage emotions based on dialectical Behavior Therapy.
* finally, the third study is designed to evaluate the effectiveness of a dialectical behavior therapy (DBT) for parents of adolescents with IE who are in treatment in the different network devices of Child and Adolescent Mental Health of the Community of Madrid. Treatment goals are the development of communication skills, validation and crisis management as well as increase understanding and competence of the pathology. The DBT intervention will begin with two individual sessions with parents of patients and 10 theoretical and practical seminars in group format (6-7 families) following the model proposed by Marsha Linehan. The DBT interventions will be added to "standard treatment" that a patient with IE receives in the investigative devices.


Options:
A: Clinical Global Impression (CGI): Improvement (1-7): score 3 ( a little better) associated with a hopelessness scale score < 8 (this means that the suicide risk is low)
B: Difficulties in Emotional Regulation Scale (DERS). (Hervás 2008) (one year); Automatic Anger and Hostility Thoughts Scale (IPRI) (Magán 2010) (one year); Coping Styles and Strategies Scale (COPE) (Crespo 1997) (one year)
C: episodes of parasuicide, alcohol intoxication, institutional care (12 months)
D: EPs during BART (Baseline (Day 0), Day 5, Day 12 and Day 30 post-tDCS)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Addressing Heightened Levels of Aggression in Traumatized Offenders With Psychotherapeutic Means: A Randomized Controlled Trial in Eastern DR Congo
Brief Summary: Heightened levels of aggression are fuelling violent incidents at all levels, especially in post-war regions. Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET) aims to address trauma symptoms along with reactive and instrumental/appetitive aggression to encounter the downward cycle of perpetration and enforce a sustainable (re-)integration into civil life. In the present study, the investigators provide an adapted version of FORNET to former combatants in the North Kivu, Eastern DR Congo. Structured baseline, 3 and 6 month follow up interviews will be administered to assess the main outcome measures recent violent acts and appetitive aggression.


Options:
A: Percent of Participants Who Develop Major Depression and Anxiety Disorders (One year); General Health Questionnaire (GHQ) Scores (One year)
B: Appetitive aggression (sumscore; 0-60 indicating higher levels) (Change from baseline to 3-5 and 6-9 months post treatment); Current violent behavior (sumscore; 0-96 indicating more acts) (Change from baseline to 3-5 and 6-9 months post treatment)
C: Changes in thyroid morphology and thyroid function tests in morbidly obese patients following significant weight loss after bariatric surgery (> 3 month or when relevant weight loss has been achieved)
D: Change in COVID-19 knowledge (Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey); Change in COVID-19 protective behaviors (Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey); Change in depressive symptoms (Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey); Change in anxiety symptoms (Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Addressing Heightened Levels of Aggression in Traumatized Offenders With Psychotherapeutic Means: A Randomized Controlled Trial in Eastern DR Congo
Brief Summary: Heightened levels of aggression are fuelling violent incidents at all levels, especially in post-war regions. Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET) aims to address trauma symptoms along with reactive and instrumental/appetitive aggression to encounter the downward cycle of perpetration and enforce a sustainable (re-)integration into civil life. In the present study, the investigators provide an adapted version of FORNET to former combatants in the North Kivu, Eastern DR Congo. Structured baseline, 3 and 6 month follow up interviews will be administered to assess the main outcome measures recent violent acts and appetitive aggression.


Options:
A: Change in Difficulties in Emotion Regulation (baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment)); Change in General Health (baseline, after 14 weeks (= post-treatment), 3-months-follow-up (3 months after the treatment))
B: Appetitive aggression (sumscore; 0-60 indicating higher levels) (Change from baseline to 3-5 and 6-9 months post treatment); Current violent behavior (sumscore; 0-96 indicating more acts) (Change from baseline to 3-5 and 6-9 months post treatment)
C: Parenting practices (One month and six months post-intervention)
D: Post Traumatic Stress Disorder- Reaction Index (RI) (Baseline and Follow-up within one month of treatment completion. For controls follow up was 4 months post baseline.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Topical Tranexamic Acid (TXA) in Hip Fractures, A Double-Blind, Randomized Controlled Trial
Brief Summary: Mechanisms by which to reduce exposure to allogeneic blood are of financial and clinical benefit in the hip fracture population. Tranexamic acid (TXA) is an inexpensive medication with low complication risk. Its use in the hip fracture population is unproven. The purpose of this study is to evaluate the efficacy and safety of topical tranexamic acid in reduction of peri-operative blood loss in hip fracture surgery.


Options:
A: number of patients receiving the transfusion of at least one unit of allogeneic red blood cell (between the begining of surgery (day 1) and the eighth post-operative day (day 8))
B: Proportion of patients who received a blood transfusion during their hospital stay following surgery (From the day of surgery until hospital discharge (or until day 30 if patient is still hospitalized).)
C: Change in hemoglobin (1 day and 3 days post-surgery)
D: Intraoperative blood loss (End of surgery (last suture))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: iTRACC (Improving Technology-Assisted Recording of Asthma Control in Children)
Brief Summary: The goal of this study is to determine whether a sensor-enabled, clinically integrated, mobile health asthma program can improve asthma outcomes among 4-17 year old children with moderate-to-severe asthma.


Options:
A: Asthma Control Test (ACT) (12 month follow-up assessment); Frequency of Urgent Health Utilization (the 12 month study period); 12 Month Rate of Medication Use (Over a 12 month study period); Frequency of Asthma-related Hospitalizations (the 12 month study period)
B: Change in baseline asthma self efficacy after 3 weeks (participants will be followed for an average of 4 weeks, with this measure collect at the beginning of the period and after 3 weeks of reminders.)
C: Emergency Department Visit (12 months)
D: Recorded Medication Adherence (26 weeks); Self-reported Medication Adherence (6-months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Pilot Study of Home Monitoring in Adults With Cystic Fibrosis (HOMECF)
Brief Summary: Cystic fibrosis (CF) is the most common fatal inherited condition in Caucasians, causing recurrent chest infections and premature death due to lung failure. When patients develop chest infections their symptoms usually slowly worsen over the course of several days to weeks. Due to this gradual onset, patients often seek medical attention several days or weeks after symptoms start to worsen. The Investigators believe that if they were able to monitor patients more closely they could diagnose and treat chest infections earlier and consequently improve health outcomes.

The HOMECF study aims to investigate whether home monitoring is beneficial for adults with CF. 100 subjects will be randomly allocated, 50 to receive home monitoring and 50 to receive routine clinical care for 12 months. Subjects receiving home monitoring will measure their lung function and symptoms twice weekly and this data will be transmitted to the medical team by means of a modified mobile phone.

the Investigators hypothesize that home monitoring will allow them to diagnose chest infections at an earlier stage and reduce hospital inpatient days. They will also assess the subjects' experience of receiving home monitoring, the impact on body weight and lung function and and conduct a full health economic analysis to assess value for money. They will also ask subjects to collect a urine sample once weekly to allow us to measure urinary levels of inflammatory markers.

Subjects will be recruited at the West Midlands Adult CF Centre in Birmingham. The research team are well placed to carry out the study because it is a large regional adult CF centre with an excellent record of conducting clinical research.


Options:
A: Health related self-efficacy (8 months)
B: Change in FEV1 (12 months)
C: Number of inpatient hospital days in the home monitoring group compared to the routine clinical care group (up to 12 months)
D: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))

Answer: C