TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Hyperinvasive Approach to out-of Hospital Cardiac Arrest Using Mechanical Chest Compression Device, Prehospital Intraarrest Cooling, Extracorporeal Life Support and Early Invasive Assessment Compared to Standard of Care. A Randomized Parallel Groups Comparative Study. "Prague OHCA Study"
Brief Summary: Prague out-of Hospital Cardiac Arrest (OHCA) study is a prospective randomized multicenter clinical study comparing use of prehospital intraarrest hypothermia, mechanical chest compression device, extracorporeal life support (ECLS) and early invasive investigation and treatment (coronary angiography/percutaneous coronary intervention \[PCI\]; pulmonary angiography/percutaneous embolectomy; aortography) in all patients with OHCA of presumed cardiac origin compared to standard of care. It is hypothesized, that above stated "hyperinvasive" approach might improve outcome of out-of hospital cardiac arrest victims.


Options:
A: Ventilator free days within 28 days after enrollment (28 days)
B: Achievement of VT reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values obtained at VT of 6 mL/kg. (maximum 28 days)
C: Composite endpoint of survival with good neurological outcome (CPC 1-2). (6 months)
D: Survival (Approximately 25 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Hyperinvasive Approach to out-of Hospital Cardiac Arrest Using Mechanical Chest Compression Device, Prehospital Intraarrest Cooling, Extracorporeal Life Support and Early Invasive Assessment Compared to Standard of Care. A Randomized Parallel Groups Comparative Study. "Prague OHCA Study"
Brief Summary: Prague out-of Hospital Cardiac Arrest (OHCA) study is a prospective randomized multicenter clinical study comparing use of prehospital intraarrest hypothermia, mechanical chest compression device, extracorporeal life support (ECLS) and early invasive investigation and treatment (coronary angiography/percutaneous coronary intervention \[PCI\]; pulmonary angiography/percutaneous embolectomy; aortography) in all patients with OHCA of presumed cardiac origin compared to standard of care. It is hypothesized, that above stated "hyperinvasive" approach might improve outcome of out-of hospital cardiac arrest victims.


Options:
A: Achieve Return of Spontaneous Circulation (ROSC) (1-hour after arrest); Survived to Hospital Discharge (30 days after arrest); Survived Neurologically-Intact (30-days after arrest)
B: Neurologically intact survival (CPC-cerebral performance categories scale 1-2) (90 days after cardiac arrest)
C: Composite endpoint of survival with good neurological outcome (CPC 1-2). (6 months)
D: Number Alive at Hospital Discharge (at hospital discharge)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational diabetes in high risk pregnant women.


Options:
A: Maternal Weight Change (baseline to 2 weeks post partum)
B: Birth weight as assessed by z-scores (At birth)
C: OGTT
D: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Comparative Study of Efficacy and Safety of Combined Deferiprone (DFP) and Deferasirox Versus DFP and Desferrioxamine (DFO) Therapy in Diseases With Severe Iron Overload
Brief Summary: Interventional Allocation: Randomized Endpoint Classification: Safety/Efficacy Study of combined chelation therapy Masking: Open Label Primary Purpose: Treatment of transfusional iron overload

Primary Outcome Measures:

• The primary outcome measure is to assess efficacy in lowering serum ferritin level(the change in serum ferritin compared to baseline) with combining DFP and deferasirox compared to combined DFP and DFO in conditions with severe chronic iron overload; showing an up-trend of SF over previous 12 months on single chelator.

Secondary Outcome Measures:

• The secondary outcome measure is to determine the number of patients who will develop adverse events in order to assess safety upon administering the drugs in combination (DFP and DFX) compared to the combination of DFO and DFP.


Options:
A: The prevalence and incidence of complications specific to thalassemia and its treatment among participants (Measured throughout the duration of the study)
B: to assess efficacy of combining DFP and deferasirox compared to combined DFP and DFO in decreasing the serum ferritin level in conditions with severe chronic iron overload. (12 months)
C: difference between multiple observations of the serum ferritin concentrations (five-year treatment)
D: Percentage of Successfully Chelated Patients (at baseline and after 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Comparative Study of Efficacy and Safety of Combined Deferiprone (DFP) and Deferasirox Versus DFP and Desferrioxamine (DFO) Therapy in Diseases With Severe Iron Overload
Brief Summary: Interventional Allocation: Randomized Endpoint Classification: Safety/Efficacy Study of combined chelation therapy Masking: Open Label Primary Purpose: Treatment of transfusional iron overload

Primary Outcome Measures:

• The primary outcome measure is to assess efficacy in lowering serum ferritin level(the change in serum ferritin compared to baseline) with combining DFP and deferasirox compared to combined DFP and DFO in conditions with severe chronic iron overload; showing an up-trend of SF over previous 12 months on single chelator.

Secondary Outcome Measures:

• The secondary outcome measure is to determine the number of patients who will develop adverse events in order to assess safety upon administering the drugs in combination (DFP and DFX) compared to the combination of DFO and DFP.


Options:
A: difference between multiple observations of the serum ferritin concentrations (five-year treatment)
B: to assess efficacy of combining DFP and deferasirox compared to combined DFP and DFO in decreasing the serum ferritin level in conditions with severe chronic iron overload. (12 months)
C: To evaluate if fixed starting doses of ICL670, based on transfusion history and subsequent dose titration can provide clinically acceptable chelation as measured by serum ferritin (at baseline and at 52 weeks)
D: The prevalence and incidence of complications specific to thalassemia and its treatment among participants (Measured throughout the duration of the study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Comparative Study of Efficacy and Safety of Combined Deferiprone (DFP) and Deferasirox Versus DFP and Desferrioxamine (DFO) Therapy in Diseases With Severe Iron Overload
Brief Summary: Interventional Allocation: Randomized Endpoint Classification: Safety/Efficacy Study of combined chelation therapy Masking: Open Label Primary Purpose: Treatment of transfusional iron overload

Primary Outcome Measures:

• The primary outcome measure is to assess efficacy in lowering serum ferritin level(the change in serum ferritin compared to baseline) with combining DFP and deferasirox compared to combined DFP and DFO in conditions with severe chronic iron overload; showing an up-trend of SF over previous 12 months on single chelator.

Secondary Outcome Measures:

• The secondary outcome measure is to determine the number of patients who will develop adverse events in order to assess safety upon administering the drugs in combination (DFP and DFX) compared to the combination of DFO and DFP.


Options:
A: to assess efficacy of combining DFP and deferasirox compared to combined DFP and DFO in decreasing the serum ferritin level in conditions with severe chronic iron overload. (12 months)
B: Core Study: Change in Liver Iron Concentration (LIC) From Baseline to Week 52 (Baseline, Week 52); Extension Study: Percentage of Participants Reaching a Liver Iron Concentration (LIC) < 5 mg Fe/g dw From Core Baseline to End of Extension Study (Core Baseline to End of Extension Study (up to 24 months))
C: The primary outcome measure is to assess the safety and tolerability of combining DFO and deferasirox in thalassemia subjects with translation iron overload. (34 days)
D: To evaluate if fixed starting doses of ICL670, based on transfusion history and subsequent dose titration can provide clinically acceptable chelation as measured by serum ferritin (at baseline and at 52 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Web-based Self-management Exercise and Diet Intervention Program With Tailored Motivation and Action Planning for Breast Cancer Survivors: A Randomized Controlled Trial
Brief Summary: Life style interventions that promote exercise and a healthy diet, which have the potential to improve health-related quality of life (HRQOL), may be particularly appropriate for cancer survivors. The previous studies suggested that a key strategy to implement sustainable healthy behavior and improve health was providing appropriate feedback and promoting self-efficacy. Web-based program enables to provide the feedback in a timely manner on a daily basis, to continue the healthy behaviors.

Therefore, the investigators developed a web-based, stage-matched Exercise and Diet Planning program, and whether the program can promote significantly greater changes in behavioral outcomes \[goal of exercise (energy expenditure of aerobic exercise ≥ 12.5 kcal/kg/week) and diet (intake of vegetables ≥ 5 serv/day and intake of fruit ≥ 1 serv/day)\], stage of changes for exercise and diet, psychosocial outcomes (HRQOL, fatigue, anxiety and depression) and self-efficacy in implementing goal of exercise and diet among breast cancer survivors in Korea was examined.

Hypotheses were following:

1. Survivors of a group participating in a web-based, stage-matched Exercise and Diet Planning program (hereinafter called the 'intervention group') will show a more advanced stage of change for exercise and diet compared to survivors in the control group.
2. The intervention group will show a higher proportion of attaining goal of exercise (or higher level of energy expenditure of aerobic exercise) compared to the control group.
3. The intervention group will show a higher proportion of attaining goal of diet (or higher level of diet quality) compared to the control group.
4. The intervention group will show a better HRQOL level compared to the control group.
5. The intervention group will show a better self-efficacy level compared to the control group.
6. The intervention group will show a lower fatigue level compared to the control group.
7. The intervention group will show less anxiety compared to the control group.
8. The intervention group will show less depression compared to the control group.


Options:
A: Changes in estrone, estradiol and adiposity levels (Up to 12 months)
B: Change from baseline in numbers of goal behaviors at 3 months (Baseline (pre-treatment) and after 12 weeks of intervention (post-treatment))
C: physical activity (baseline and 3 months); muscle strength (baseline and 3 months); fatigue (baseline and 3 months); sleep dysfunction (baseline and 3 months)
D: Patient rated physical functioning (at 8 weeks and 24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Web-based Self-management Exercise and Diet Intervention Program With Tailored Motivation and Action Planning for Breast Cancer Survivors: A Randomized Controlled Trial
Brief Summary: Life style interventions that promote exercise and a healthy diet, which have the potential to improve health-related quality of life (HRQOL), may be particularly appropriate for cancer survivors. The previous studies suggested that a key strategy to implement sustainable healthy behavior and improve health was providing appropriate feedback and promoting self-efficacy. Web-based program enables to provide the feedback in a timely manner on a daily basis, to continue the healthy behaviors.

Therefore, the investigators developed a web-based, stage-matched Exercise and Diet Planning program, and whether the program can promote significantly greater changes in behavioral outcomes \[goal of exercise (energy expenditure of aerobic exercise ≥ 12.5 kcal/kg/week) and diet (intake of vegetables ≥ 5 serv/day and intake of fruit ≥ 1 serv/day)\], stage of changes for exercise and diet, psychosocial outcomes (HRQOL, fatigue, anxiety and depression) and self-efficacy in implementing goal of exercise and diet among breast cancer survivors in Korea was examined.

Hypotheses were following:

1. Survivors of a group participating in a web-based, stage-matched Exercise and Diet Planning program (hereinafter called the 'intervention group') will show a more advanced stage of change for exercise and diet compared to survivors in the control group.
2. The intervention group will show a higher proportion of attaining goal of exercise (or higher level of energy expenditure of aerobic exercise) compared to the control group.
3. The intervention group will show a higher proportion of attaining goal of diet (or higher level of diet quality) compared to the control group.
4. The intervention group will show a better HRQOL level compared to the control group.
5. The intervention group will show a better self-efficacy level compared to the control group.
6. The intervention group will show a lower fatigue level compared to the control group.
7. The intervention group will show less anxiety compared to the control group.
8. The intervention group will show less depression compared to the control group.


Options:
A: Change in skeletal muscle area (cm2) between individualized nutritional counselling versus usual nutritional care (During 9 weeks of first line chemotherapy)
B: Change from baseline in numbers of goal behaviors at 3 months (Baseline (pre-treatment) and after 12 weeks of intervention (post-treatment))
C: Fatigue in Breast Cancer Survivors (12 weeks)
D: Weight loss maintenance (6 - 18 months)

Answer: B
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: Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts). (Week 0 (baseline), 17, 28, 52.)
B: Changes in scores on Beck's Scale for Suicide Ideation (BSSI) (From baseline to 6 and 12 months after patient is included in the study)
C: Clinical Global Improvement Scale (0, 1, 5, 10 week)
D: Reduction of dissociative symptoms (End of 3rd week treatment of naltrexon)

Answer: A
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: 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: Borderline Symptoms (6 weeks)
C: Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts). (Week 0 (baseline), 17, 28, 52.)
D: 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)

Answer: C
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: Change from Baseline Adult Suicide Ideation Questionnaire score at 6 and 12 months (Baseline, 6 month and 12 month follow up)
B: Suicidal Attempts (Months 1, 3, 6, 12, 18, and 24)
C: The number of contacts with mental health services appropriate to the patient's needs. (3 months)
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: Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts). (Week 0 (baseline), 17, 28, 52.)
B: The primary outcome will be the composite outcome of the number of in-patient psychiatric hospitalisations, the number of A& E contacts, and the number of suicidal acts. (At both 12 and 24 months post randomisation.)
C: Change in severity of borderline personality disorder assessed with the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview (Assessed at baseline, and at 8, 16 and 24 months post-randomization)
D: Number of days with hospital admission (Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively)

Answer: A