TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Dialectical Behavior Therapy in Patient With Self Harming Behavior and Traits Within the Spectrum of Borderline Personality Disorder.
Brief Summary: Purpose: The purpose of this study is to investigate the efficacy of Dialectical Behavior Therapy (DBT) versus CAMS (Collaborative Assessment and Management of Suicidality) -informed supportive psychotherapy on the risk of self-harm acts and suicide attempts in patients with self behavior and personality traits within the spectrum of borderline personality disorder.

Hypothesis: The hypothesis is 16 weeks of treatment with Dialectical Behavior Therapy (DBT) after a defined manual has a higher efficacy than CAMS-informed supportive psychotherapy on self-harm acts, suicide attempts, suicidal ideation, depressive symptoms, impulsiveness and consumption of hospital services in patients with symptoms within the spectrum of borderline personality disorder (BDP).

Method: The investigators will include 160 patients in the randomized trial to investigate whether 16 weeks of DBT-treatment as a higher efficacy than CAMS-informed supportive psychotherapy on the risk of self-harm acts and suicide attempts in patients with self-harm behavior and personality traits within the spectrum of borderline personality disorder. The trial will meet strict criteria for high quality randomized trials, and will hopefully help to establish evidence for the treatment of this patient group at higher risk of later suicide. There will be performed follow up interviews after 16 weeks, 28 weeks and 52 weeks.


Options:
A: Repetition of self-harm (Three months); Change scores on the Suicide Behaviors Questionnaire from baseline (Baseline and three months)
B: The Borderline Personality Feature Scale for Children (BPFS-C) (Change from Baseline in BPFS-C at 40 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from Baseline in BPFS-C at 10 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from baseline at 20 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from baseline at 30 weeks)
C: Dissociation Tension Scale (DSS), a reliable and valid self-rating instrument to assess dissociative experiences and inner tension during the last 24 hours (Stiglmayr et al. 2001) (Oct. 1998-Oct 2001)
D: Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts). (Week 0 (baseline), 17, 28, 52.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Dialectical Behavior Therapy in Patient With Self Harming Behavior and Traits Within the Spectrum of Borderline Personality Disorder.
Brief Summary: Purpose: The purpose of this study is to investigate the efficacy of Dialectical Behavior Therapy (DBT) versus CAMS (Collaborative Assessment and Management of Suicidality) -informed supportive psychotherapy on the risk of self-harm acts and suicide attempts in patients with self behavior and personality traits within the spectrum of borderline personality disorder.

Hypothesis: The hypothesis is 16 weeks of treatment with Dialectical Behavior Therapy (DBT) after a defined manual has a higher efficacy than CAMS-informed supportive psychotherapy on self-harm acts, suicide attempts, suicidal ideation, depressive symptoms, impulsiveness and consumption of hospital services in patients with symptoms within the spectrum of borderline personality disorder (BDP).

Method: The investigators will include 160 patients in the randomized trial to investigate whether 16 weeks of DBT-treatment as a higher efficacy than CAMS-informed supportive psychotherapy on the risk of self-harm acts and suicide attempts in patients with self-harm behavior and personality traits within the spectrum of borderline personality disorder. The trial will meet strict criteria for high quality randomized trials, and will hopefully help to establish evidence for the treatment of this patient group at higher risk of later suicide. There will be performed follow up interviews after 16 weeks, 28 weeks and 52 weeks.


Options:
A: Suicidal behaviour (2-year follow-up); Suicidal behaviour (1-year follow-up)
B: Beck scale for suicidal ideation (six months)
C: Persons repeating a suicidal act (One, two and three years)
D: Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts). (Week 0 (baseline), 17, 28, 52.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Trial of the Effectiveness of Two Educational Interventions to Improve Evidence-based Practice Knowledge, Attitudes and Behaviour in Occupational Therapists
Brief Summary: This pragmatic randomised controlled trial (RCT) used a two-group parallel design with matched-pair stratification by type (clinician/manager) and knowledge score. The trial aimed to: 1) determine whether an IE was more effective than a DE for improving EBP knowledge, skills and use at 12 weeks, and 2) to investigate the feasibility of conducting a RCT with occupational therapists in a public health setting. Occupational therapists employed by the Western Cape Department of Health (DOH) form,ed the study population(N=98). Fifty-eight consented to participate and were randomly allocated to either an interactive (IE) or a didactic (DE) educational intervention using coin tossing. Data was collected at baseline and 12 weeks The primary outcome was increased EBP knowledge at 12 weeks shown by an improved total knowledge score. Secondary outcomes were improved attitudes and behaviour. Data were collected at the health facilities where participants were employed. Raters for the audit were blinded but participants and the provider could not be blinded.

Thirty participants were allocated to receive the IE and 28 the DE. Twenty-five participants in the IE and 21 in the DE completed the trial and were included in the 12 week analysis. Results revealed no significant difference between the groups in the primary knowledge outcome at 12 weeks. Examination of within-group changes revealed significant improvements in knowledge in both groups (IE: T=4.0, p\<0.001; DE: T=12.0, p=0.002), but the IE also showed a significant increase in behaviour (T=64.5, p=0.044) and attitudes on one sub-scale (T=33.0, p=0.039). As the study was powered at 43%, it may have failed to detect significant differences at 12 weeks. Conducting a high-quality RCT was feasible and the risk of bias was assessed as low. The OTEBP trial adds strength to the existing evidence that both didactic and interactive educational interventions can improve knowledge, but it seems that interactive interventions may be more effective for changing behaviour. High-quality pragmatic trials can feasibly be conducted within the public health service


Options:
A: HbA1c (Last measurement within 12 months before - and 15 months after nurse participation in the course)
B: Episiotomies; Oxytocin use in third stage of labor
C: Rate of Inappropriate transthoracic echocardiograms (12 months)
D: Shortened Fresno Test of Competence in Evidence-based Practice (SAFT) (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial to Determine Outcome and Cost Effectiveness of Case Management of Patients Suffering From Chronic Obstructive Pulmonary Disease (COPD) in a Danish Setting
Brief Summary: This randomized controlled trial (RCT) will examine a nurse case management model for patients suffering from chronic obstructive pulmonary disease (COPD) in a Danish municipality, and is performed in order to evaluate the use of case management as a tool in achieving integrated, quality and cost-effective care for this group of patients.

The main objectives are to evaluate how case management influences on hospital admissions, mortality, quality of life and self care, as well as to compare costs and cost-effectiveness of case management vs. usual care.


Options:
A: COPD hospitalization rates (1 year (study inclusion - 12 months of follow-up))
B: Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score (9 months); Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF) (9 months)
C: Evaluation of effects (T1: Initial evaluation; T2: after three months; T3: one year after T1)
D: Change in the strength of the quadriceps over the 6-week electrostimulation program. (6 to 8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial to Determine Outcome and Cost Effectiveness of Case Management of Patients Suffering From Chronic Obstructive Pulmonary Disease (COPD) in a Danish Setting
Brief Summary: This randomized controlled trial (RCT) will examine a nurse case management model for patients suffering from chronic obstructive pulmonary disease (COPD) in a Danish municipality, and is performed in order to evaluate the use of case management as a tool in achieving integrated, quality and cost-effective care for this group of patients.

The main objectives are to evaluate how case management influences on hospital admissions, mortality, quality of life and self care, as well as to compare costs and cost-effectiveness of case management vs. usual care.


Options:
A: Improvement tolerance capacity (4 months and 6 months)
B: COPD hospitalization rates (1 year (study inclusion - 12 months of follow-up))
C: Combined number of hospitalizations and emergency department presentations (Two years)
D: Self-Reported Respiratory-Specific Quality of Life (four months from randomization); Self-Reported Respiratory-Specific Quality of Life (twelve months from randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 14 Day, Multi-center, Randomized, Double Blinded, Placebo-controlled, Parallel Group, Fixed Dose, Phase III Clinical Trial to Assess the Efficacy and Safety of TRK-820 in Treating Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis
Brief Summary: The purpose of this study is to determine whether nalfurafine hydrochloride is effective and safe in the treatment for conventional-treatment-resistant pruritus in patients receiving hemodialysis.


Options:
A: Change from Baseline in Detailed score proposed by Duo for pruritus (Change from Baseline in Detailed score at 1months)
B: Change in pruritus degree measured by VAS(Visual Analogue Scale) score (4 weeks (2 weeks measurement with only conventional treatment + 2 weeks measurement with conventional treatment & investigational products))
C: Severity of Pruritis (Baseline and end of study (up to 12 weeks))
D: Primary efficacy endpoint is the change in worst itching intensity from baseline, compared to that in the last two weeks of the double blind, placebo controlled, randomized withdrawal period. (11 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Rationalisation of Polypharmacy in the Elderly by the RASP Instrument (Rationalisation of Home Medication by an Adjusted STOPP-list in Older Patients): a Prospective, Clinical Trial.
Brief Summary: The aim of this study is to determine whether a clinical pharmacist using the RASP list (RASP = Rationalisation of home medication by an adjusted STOPP-list in older patients; STOPP = Screening Tool of Older Persons' potentially inappropriate Prescriptions) can optimise the drug use in elderly inpatients.


Options:
A: Number of actually stopped or adjusted drugs (Patients will be followed for the duration of hospital stay, an expected average of 14 days.)
B: Body balance. (at 6 weeks)
C: The outcome measure will be rate of patients falls per 1000 patient days (1/2009-6/2009)
D: fall-related injury (Study duration = 18 months. Outcome measured for each patient for duration of stay in ward (approx. 30 days).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Rationalisation of Polypharmacy in the Elderly by the RASP Instrument (Rationalisation of Home Medication by an Adjusted STOPP-list in Older Patients): a Prospective, Clinical Trial.
Brief Summary: The aim of this study is to determine whether a clinical pharmacist using the RASP list (RASP = Rationalisation of home medication by an adjusted STOPP-list in older patients; STOPP = Screening Tool of Older Persons' potentially inappropriate Prescriptions) can optimise the drug use in elderly inpatients.


Options:
A: Improvement of drug prescribing (Participants will be followed for the duration of hospital stay, an expected average of 12 days)
B: Number of patients with at least one preventable medication error (Day 1 (medical prescription at hospital admission)); Number of patients with at least one preventable medication error (Phase 2 (maximum 105 days))
C: Number of actually stopped or adjusted drugs (Patients will be followed for the duration of hospital stay, an expected average of 14 days.)
D: The primary outcome measure will be the "improvement" of prescribing for efficacious therapies in patients with a chronic cardiovascular disease within six months of the intervention.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Rationalisation of Polypharmacy in the Elderly by the RASP Instrument (Rationalisation of Home Medication by an Adjusted STOPP-list in Older Patients): a Prospective, Clinical Trial.
Brief Summary: The aim of this study is to determine whether a clinical pharmacist using the RASP list (RASP = Rationalisation of home medication by an adjusted STOPP-list in older patients; STOPP = Screening Tool of Older Persons' potentially inappropriate Prescriptions) can optimise the drug use in elderly inpatients.


Options:
A: Number of actually stopped or adjusted drugs (Patients will be followed for the duration of hospital stay, an expected average of 14 days.)
B: Number of Patients Readmitted Because of Drug Related Reasons (Six months follow-up)
C: Days outside hospital until an eventual first readmission (12 months after hospital discharge)
D: Drug Related Problems (DRP) (Participants will be followed for the duration of hospital stay, an expected average of 10 days); Mortality (6-month after inclusion); Average length of the hospital stay (Participants will be followed for the duration of hospital stay, an expected average of 10 days); Readmissions (6-month after inclusion); Average cost of hospital stay (Participants will be followed for the duration of hospital stay, an expected average of 10 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-week, Multinational, Multi-centre, Open-Labelled, Randomised, Parallel, Efficacy and Safety Comparison of Insulin Degludec and Insulin Detemir in Children and Adolescents 1 to Less Than 18 Years With Type 1 Diabetes Mellitus on a Basal-bolus Regimen With Insulin Aspart as Bolus Insulin, Followed by a 26-week Extension Investigating Long Term Safety (BEGIN™: Young 1)
Brief Summary: This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of this trial is to investigate the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus.


Options:
A: Glycosylated Haemoglobin A1c (HbA1c) (after 52 weeks of treatment)
B: Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory) (Week 0, week 26)
C: 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)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Home Non Invasive Ventilation (NIV) Treatment for COPD-patients After a NIV-treated Exacerbation
Brief Summary: Background: In chronic obstructive pulmonary disease, the prognosis for patients who have survived an episode of acute hypercapnic respiratory failure due to an exacerbation is poor. Despite being shown to improve survival and quality-of-life in stable patients with chronic hypercapnic respiratory failure, long-term noninvasive ventilation is controversial in unstable patients with frequent exacerbations, complicated by acute hypercapnic respiratory failure. In an uncontrolled group of patients with previous episodes of acute hypercapnic respiratory failure, treated with noninvasive ventilation, we have been able to reduce mortality and the number of repeat respiratory failure and readmissions by continuing the acute noninvasive ventilatory therapy as a long-term therapy.

Methods: Multi-center open label randomized controlled trial of 150 patients having survived an admission with noninvasive ventilatory treatment of acute hypercapnic respiratory failure due chronic obstructive pulmonary disease. The included patients are randomized to usual care or to continuing the acute noninvasive ventilation as a long-term therapy, both with a one-year follow-up period.

End points: The primary endpoint is one-year mortality; secondary endpoints are time to death or repeat acute hypercapnic respiratory failure, number of readmissions and repeat acute hypercapnic respiratory failure, exacerbations, dyspnea, quality of life, sleep quality, lung function, and arterial gases.


Options:
A: Health related quality of life measured by the Chronic Respiratory Questionnaire
B: Acute hypercapnic respiratory failure episode (up to 102 weeks)
C: Time to death or repeat AHRF with need of NIV (1 year)
D: Identifying new patient subtypes and endpoints for COPD (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Single-Arm, Multi-Center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE)
Brief Summary: The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used in conjunction with recombinant tissue plasminogen activator (t-PA) as a treatment for acute PE will decrease the ratio of right ventricle (RV) to left ventricle (LV) diameter within 48 =/- 6 hours in participants with massive or submassive PE.


Options:
A: Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy (Baseline, within 48 +/- 6 hours of initiation of therapy); Number of Participants With Major Bleeding (From start of study drug infusion up to 72 hours)
B: Right Ventricle/Left Ventricle (RV:LV) Ratio (from baseline to 48 hours); Major Adverse Event Rate (within 48 hours)
C: Reduction of RV/LV Ratio (24 hours); Major Bleeding and Intracranial Bleeding at 30 Days. (30 days)
D: Incidence of chronic thromboembolic pulmonary hypertension (within 3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet and Exercise in Type 2 Diabetes - a Randomized Controlled Trial
Brief Summary: The investigators investigate if combined progressive aerobic training and resistance training improve metabolic control and fat mass in patients with type 2 diabetes who are eating a modified paleolithic diet. The investigators randomize 40 participants to two groups: 1) Modified paleolithic diet and exercise under observation 3 sessions/week, 2) Modified paleolithic diet and general advice about exercise.

The investigators primary hypothesis is that in patients with type 2 diabetes decreases fat mass more with progressive exercise under observation and a modified paleolithic diet than with general advice about exercise and a modified paleolithic diet.


Options:
A: Fat mass (Baseline - 12 weeks)
B: Dietary intake (6 month)
C: Change in Hemoglobin A1C (A1C) (Baseline, 12 weeks and 24 weeks)
D: Changes in body weight; Weight loss maintenance efficacy (>5% and >10%); Body composition (whole body DEXA-scanning); Drop-out rate; Glucose metabolism (Oral Glucose Tolerance Test); Endothelium function (flow-mediated vasodilatation, FMD)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet and Exercise in Type 2 Diabetes - a Randomized Controlled Trial
Brief Summary: The investigators investigate if combined progressive aerobic training and resistance training improve metabolic control and fat mass in patients with type 2 diabetes who are eating a modified paleolithic diet. The investigators randomize 40 participants to two groups: 1) Modified paleolithic diet and exercise under observation 3 sessions/week, 2) Modified paleolithic diet and general advice about exercise.

The investigators primary hypothesis is that in patients with type 2 diabetes decreases fat mass more with progressive exercise under observation and a modified paleolithic diet than with general advice about exercise and a modified paleolithic diet.


Options:
A: Body weight reduction (Month 6)
B: Breast Cancer Recurrence (Lifetime)
C: Change in Hemoglobin A1C (A1C) (Baseline, 12 weeks and 24 weeks)
D: Fat mass (Baseline - 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Stress, Ongoing Self Monitoring and Ischemic Heart Disease Rehabilitation, a Randomized Controlled Trial (SongHeart)
Brief Summary: The purpose of the study is to examine if bio feedback guided stress management by daily measurement of pressure pain sensitivity followed by acupressure reduces signs of depression and number clinical stress signs and increases quality of life in patients with stable, ischemic heart disease


Options:
A: Self-rated sleep quality score measured by Insomnia Severity Index questionnaire (Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.); Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy (Baseline, 1-week posttreatment, and 4-week posttreatment.); Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by subjective measures using sleep log. (Baseline, weekly during the treatment course, 1-week and 4-week posttreatment.)
B: Self-rated sleep quality score changes from baseline to 5-week posttreatment measured by Insomnia Severity Index questionnaire (Baseline, 1-week and 5-week posttreatment.)
C: N/A
D: MDI depression score (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring in COPD
Brief Summary: The purpose of this study is to evaluate whether the introduction of large-scale telemonitoring of patients with COPD produces benefits in terms of improved health-related quality of life and reduced access to hospital facilities. In addition, the trial evaluates the economic and organisational impact of the new services, and examine their acceptability by patients and health professionals.


Options:
A: 30 day readmission rate (30 days)
B: Re-hospitalizations (During the 30days after discharge)
C: Number of hospitalizations (2011)
D: Health-Related quality of life (12 months)

Answer: D