TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Depressive Symptoms in Breast Cancer Patients: Comparison of Cognitive Therapy and Bright Light Therapy
Brief Summary: Depressive symptoms are highly frequent among cancer patients. These symptoms significantly impair quality of life (e.g., hopelessness, greater risk of suicidal behaviours) and may even affect patients' prognosis (e.g., through decreased adherence to cancer treatments). Cognitive therapy (CT) is an established treatment for depression in the general population, but its efficacy has not yet been investigated in non-metastatic cancer patients. Furthermore, because the accessibility to CT is very limited in routine cancer care and because many patients are reluctant to use pharmacological treatment, they often turn to alternative treatments such as bright light therapy (BLT), but empirical data on its efficacy are needed before its use can be recommended. Goal 1: To assess at post-treatment, as compared to a waiting-list control condition, the effect of bright light therapy (BLT) and cognitive therapy (CT): (1a) in reducing depressive symptoms; and (1b) in improving subjective and objective sleep parameters, in reducing fatigue and anxiety and in increasing patients' functioning and quality of life. Goal 2: To compare at post-treatment and at 3- and 6-month follow-ups the effect of BLT and CT : (2a) in reducing depressive symptoms; and (2b) in improving subjective and objective parameters of sleep, in reducing fatigue and anxiety and in increasing patients' functioning and quality of life. It is hypothesized that, As compared to control patients after their waiting period, both BLT and CT groups will have significantly greater improvement of all symptoms at post-treatment. However, as compared to BLT patients, CT patients will show greater improvements of all symptoms at post-treatment and at 3- and 6-month follow-ups. This study will provide empirical data on the efficacy of two approaches for treating depressive symptoms in cancer patients in order to better inform the scientific community, health care providers, and patients on the most effective depression treatments to implement in cancer care.


Options:
A: Psychological:mood, stress, post-traumatic growth, social support, quality of life, spirituality; Physical:cortisol levels (stress hormone)
B: Changes in depressive symptoms (Pre-treatment (at recruitment; about 2 weeks before starting the experimental condition of 8 weeks), post-treatment (immediately after the experimental condition of 8 weeks), 3-month follow-up and 6-month follow-up)
C: SCL-90r Depression and anxiety subscales (baseline - 12 months)
D: To assess whether MBSR favorably influences psychological status (anxiety, perceived stress, depression), quality of life, and immune status (among post-treatment breast cancer survivors) (6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Psychoeducation to Sick-listed Individuals With Mental Health Problems
Brief Summary: In Denmark, it is estimated that 35-45% of all sick leave registered citizens are on sick leave due to psychiatric sufferings. Mental health conditions are of great consequence not only to the sick-listed individual but also to his/her family and to society in general and in socioeconomic terms.

The aim of this project is to systematically compare psychoeducation with the various standard offers to sick listed individuals with mental health conditions provided by job centers in four municipalities.

Psychoeducation is employed within the psychiatric healthcare system and is defined as a group based treatment by means of educating participants about psychiatric conditions. In the present project, the employed psychoeducation focuses on psyche and work life, and its purpose is to impart knowledge about psychiatric conditions in order to provide the sick listed individuals with qualifications to understand, and, thereby, improve their own situation. Among others, there will be information about the symptoms of various psychiatric conditions, diagnoses, and treatment options. Furthermore, the participants will learn about specific, useful, cognitive tools in regards to the barriers and difficulties they might experience when reentering the work force and leave sickness absence behind.

The project is designed as a randomized clinical trial in which the participants are offered either 1) psychoeducation as well as the standard offer to sick listed individuals provided by the municipality in which the individual lives or 2) the participants are offered merely the standard offer to sick listed individuals provided by the municipality.

The target group consists of recently sick listed individuals with mental health issues - whether diagnosed or not. The individuals must be inhabitants of the municipalities of Struer, Lemvig, Skive, and Holstebro.

The outcome measure is the determined as the duration of the sickness absence, the severity of the psychiatric condition, self-reported health, and 'locus of control´. These outcome measurements are assessed at baseline and after 3 and 6 months.


Options:
A: Efficiency of the 3 programs (One year)
B: Change in Sickness leave 1 year after inclusion (At 12 months after baseline)
C: length of sickness absence (6 months after randomization)
D: Return to work from sick leave (Up to 1,5 years post intervention completion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: NORADRENALINE VERSUS TERLIPRESSIN IN THE TREATMENT OF TYPE 2 HEPATORENAL SYNDROME:A RANDOMIZED STUDY
Brief Summary: Various vasoconstrictors have shown promising results in the management of type 1 hepatorenal syndrome (HRS). However, there are very few studies on vasopressors in the management of type 2 HRS. Terlipressin has been used commonly; however it is costly and not available in some countries. In the present study, the investigators evaluated safety and efficacy of terlipressin and noradrenaline in the treatment of type 2 HRS


Options:
A: Treatment Success (Day 14)
B: Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal (within 14 days)
C: The primary end point of the study was serum creatinine less than 1.5 mg (15 days)
D: Renal function at the beginning and at the end of therapy (two weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: NORADRENALINE VERSUS TERLIPRESSIN IN THE TREATMENT OF TYPE 2 HEPATORENAL SYNDROME:A RANDOMIZED STUDY
Brief Summary: Various vasoconstrictors have shown promising results in the management of type 1 hepatorenal syndrome (HRS). However, there are very few studies on vasopressors in the management of type 2 HRS. Terlipressin has been used commonly; however it is costly and not available in some countries. In the present study, the investigators evaluated safety and efficacy of terlipressin and noradrenaline in the treatment of type 2 HRS


Options:
A: The primary end point of the study was serum creatinine less than 1.5 mg (15 days)
B: Percentage of Participants With Confirmed Hepatorenal Syndrome (HRS) Reversal (within 14 days)
C: Treatment Success (Day 14)
D: Renal function at the beginning and at the end of therapy (two weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre Randomised Double Blinded Phase III Trial of the Effect of Standard Issue Red Blood Cell Blood Units on Mortality Compared to Freshest Available Red Blood Cell Units
Brief Summary: In Australia, blood for transfusion has a "use by" date of 42 days after collection. The actual age of blood given to patients depends on what is available at the time and the rate of usage. During the last decade, it has been reported that blood transfusion in patients admitted to intensive care was associated with an independent increase of mortality. Some research suggests that transfusion of fresher blood might help patients in the intensive care unit to reach a better recovery. This project will test whether patients who receive 'fresher' blood do better than patients who receive 'standard issue' blood.


Options:
A: Microcirculatory Flow Index (MFI) before and after blood transfusion. (One hour after the end of blood transfusion compared with before blood transfusion)
B: Mortality at Day 90 (90 Day)
C: Primary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery. (30 days post surgery.); Effect of RBC Age on Occurrence of Mortality or Multisystem Organ Failure Events (30 days post surgery); Effect of RBC Age on Occurrence of Neurologic Events (30 days post surgery.); Effect of RBC Age on Occurrence of Pulmonary Events. (30 days post surgery.); Effect of RBC Age on Occurrence of Renal Failure (30 days post surgery.); Effect of RBC Age on Occurrence of Infection Events (30 days post surgery.); Effect of RBC Age on Occurrence of Atrial Fibrillation (30 days post surgery.); Effect of RBC Age on Occurrence of Asystole (30 days post surgery.); Effect of RBC Age on Occurrence of Gastrointestinal Events (30 days post surgery.); Effect of RBC Age on Occurrence of Any Reoperation (30 days post surgery.); Effect of RBC Age on Occurrence of Vascular Events (30 days post surgery.)
D: The Effects of Storage-related RBC Changes on Acetylcholine-stimulated (NO-mediated) Forearm Blood Flow. (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre Randomised Double Blinded Phase III Trial of the Effect of Standard Issue Red Blood Cell Blood Units on Mortality Compared to Freshest Available Red Blood Cell Units
Brief Summary: In Australia, blood for transfusion has a "use by" date of 42 days after collection. The actual age of blood given to patients depends on what is available at the time and the rate of usage. During the last decade, it has been reported that blood transfusion in patients admitted to intensive care was associated with an independent increase of mortality. Some research suggests that transfusion of fresher blood might help patients in the intensive care unit to reach a better recovery. This project will test whether patients who receive 'fresher' blood do better than patients who receive 'standard issue' blood.


Options:
A: 1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality (2 weeks, 4 weeks, 12 weeks, 90 days)
B: Number of severe complications (grade 3 or more) (up to 1 month after the last day of hospitalization)
C: Mortality at Day 90 (90 Day)
D: We will test the hypothesis that the transfusion of red cells of lesser storage age, (5 days or less) will produce less changes of pulmonary function and immune activation than will transfusion of red cells of conventional storage age (median 21 days). (At the end of the transfusion as compared to the beginning of the transfusion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre Randomised Double Blinded Phase III Trial of the Effect of Standard Issue Red Blood Cell Blood Units on Mortality Compared to Freshest Available Red Blood Cell Units
Brief Summary: In Australia, blood for transfusion has a "use by" date of 42 days after collection. The actual age of blood given to patients depends on what is available at the time and the rate of usage. During the last decade, it has been reported that blood transfusion in patients admitted to intensive care was associated with an independent increase of mortality. Some research suggests that transfusion of fresher blood might help patients in the intensive care unit to reach a better recovery. This project will test whether patients who receive 'fresher' blood do better than patients who receive 'standard issue' blood.


Options:
A: Incidence of death or major neurodevelopmental impairment (24 months of age corrected for prematurity)
B: Myocardial Injury (Upto 60 days)
C: Overall adherence to the transfusion strategies defined as adherence to the transfusion strategies in 90% of patients in more than 90% of their days in hospital. (Day of surgery through to hospital discharge.)
D: Mortality at Day 90 (90 Day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Safety of REGN668 Administered Concomitantly With Topical Corticosteroids to Patients With Moderate-to-Severe Atopic Dermatitis
Brief Summary: The purpose of this study was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to-severe atopic dermatitis (AD).


Options:
A: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) (Baseline up to end of study (up to Day 85))
B: Percent Change From Baseline in the Eczema Area Severity Index Score (EASI) to Week 16 (Baseline to Week 16)
C: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) (Baseline up to the end of study (up to Day 78))
D: Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16 (Baseline to Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 4 Study of Optimal Dose of Haloperidol
Brief Summary: Low-dose haloperidol is known to be effective for the treatment of postoperative nausea and vomiting (PONV). However, precise dose-response studies have not been completed, especially in patients at high risk for PONV who require combination therapy. This study sought to identify the optimal dose of haloperidol that could be combined with dexamethasone without adverse effects in high-risk PONV patients receiving intravenous patient-controlled anesthesia (IV PCA) after gynecological laparoscopic surgery.


Options:
A: Prevention of PONV in the 24 hours following end of surgery; Tolerability
B: Cumulative usage of morphine 0-48 hours postoperatively (0-48 hours postoperatively)
C: Rates of vomiting and retching (after surgery)
D: Incidence of Postoperative Nausea and Vomiting (postoperative 24 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Age-dependent Effects of Flavanol Metabolism and Absorption on Vascular Status After Acute and Chronic Application.
Brief Summary: Epidemiological studies suggest that certain foods rich in flavanols, including cocoa products, red wine, and tea, are associated with decreased cardiovascular mortality and morbidity. Dietary interventional studies have corroborated this finding and showed that flavanols can acutely and after sustained ingestion improve surrogate markers of cardiovascular risk including endothelial function. Endothelial dysfunction is the key event in the development and progression of cardiovascular disease. Aging is the major non-modifiable cardiovascular risk factor associated with progressive decline in endothelial function, vascular stiffening and increase in blood pressure. We hypothesize that flavanols can counteract age-dependent vascular changes by interacting with key mechanisms, most prominently endothelial function.


Options:
A: Change in cardiovascular disease risk indictaors - including carotid intima-media thickness (CIMT), total plaque volume (TPV) (at the carotid bifurcation), pulse wave velocity (PWV) and biomarkers of risk in blood samples . (6 months - 1 year)
B: endothelial function (acute (2 hours), chronic (2 and 4 weeks))
C: Endothelial function (change in flow mediated dilatation between first treatment at day 0 and after last treatment at day 14)
D: Augmentation index (Changes in augmentation index at 1 week, according to glycemic index of the breakfast)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Double-Randomization, Placebo-Controlled Study of the Efficacy of Intravenous Esketamine in Adult Subjects With Treatment-Resistant Depression
Brief Summary: The purpose of this study is to assess the efficacy of esketamine compared with placebo in improving symptoms of depression in patients with treatment resistant depression.


Options:
A: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 of Double- Blind Induction Phase- Mixed- Effects Model Using Repeated Measures (MMRM) Analysis (Baseline up to Day 28 of Double-blind Induction Phase); Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis (Baseline up to Double-blind Endpoint (Day 28))
B: Change from Day 1 (baseline) to Day 2 in the Montgomery Asberg Depression Rating Scale (MADRS) total score in the double-blind treatment phase (Day 1 (baseline), Day 2)
C: Change in depressive symptoms (After 4th treatment)
D: To give evidence of an antidepressant effect versus placebo, given together with another antidepressant confirmed by change in the MADRS total score (Baseline to week 3)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Lumbar Segmental Stabilization and TENS in Lumbar Disc Herniation: a Randomized Clinical Trial
Brief Summary: The purpose of this study was to compare the efficacy of method Lumbar Segmental Stabilization and transcutaneous electrical nerve stimulation (TENS) on pain, functional disability and ability to activate the transversus abdominis (TrA) of individuals with chronic back pain caused by disc herniation.


Options:
A: Pain intensity (Six weeks after randomization); Disability (Six weeks after randomization)
B: Timed Get-Up-And Go (Change from baseline to 12-week follow-up); PROMIS Health Assessment Questionnaire (Change from baseline to 12-week follow-up)
C: Pain. (8 weeks)
D: Change of self-reported pain on 100mm Visual Analogue Scale (VAS) (Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)); Change of functional status recorded with the Oswestry Disability Index (ODI) (Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Parallel Open Label Comparison Between 7 and 14 Day Primaquine Combined With 3-day Dihydroartemisinin-piperaquine or 3-day Chloroquine Regimens for Radical Cure of Plasmodium Vivax
Brief Summary: In Southeast Asia, Plasmodium vivax (Pv) infection reaches 50-80% and bears a greater burden of disease than Plasmodium falciparum (Pf). As control over Pf improves, Pv will assume increasingly larger percentages of malaria prevalence. The chronicity of Pv, due to the latent liver stage (hypnozoite) not eradicated by chloroquine, causes recurring disability and compounds the economic burden of those with symptomatic disease. The only widely available treatment for hypnozoites is primaquine, which, because of challenges with tolerability, safety in G6PD deficient persons, and compliance, is not commonly prescribed for the treatment of Pv. Currently, chloroquine is used for the treatment of the blood stages of Pv, however, there are concerns about increasing parasite resistance. Alternative treatments, such as artesunate, should be considered in the future of the treatment of blood stage Pv. The use of primaquine in the treatment of hypnozoites (radical cure) should be emphasized so that transmission of Pv can be controlled.

This study aims to determine the optimal primaquine regimen for radical cure of Plasmodium vivax. Chloroquine is currently the standard of treatment for Plasmodium vivax. Chloroquine may have synergistic effects when used with primaquine and due to its long half-life may delay the first relapse of vivax malaria. In contrast, artesunate does not have documented interactions with primaquine and has a very short half-life, thus, presumably will have no impact on first relapse. Combining primaquine with these two anti-malarials may lead to an alternative regimen for Pv infection and changing the primaquine dosing regimen may lead to a more practical and efficacious therapy.


Options:
A: Primary Efficacy Variable: Proportion with relapse(s) of P. vivax in 12 months of follow-up. (2004-March 2007)
B: Incidence rate (per person-year) of symptomatic recurrent P. vivax (12 months)
C: Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate (28 Days)
D: Recurrence of P. vivax (52 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-blind and Open Label, 4 Year Extension Study of Subcutaneous Secukinumab in Prefilled Syringes, Assessing Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Treated With Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen
Brief Summary: CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used.


Options:
A: Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in Psoriasis Area and Severity Index (PASI) at Week 16 (Week 0 and Week 16)
B: Long-term Safety and Tolerability of Secukinumab (Week 268)
C: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 (Week 12); Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status (Week 12)
D: Aortic Vascular Inflammation as Measured by FDG-PET/CT (baseline, 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-blind and Open Label, 4 Year Extension Study of Subcutaneous Secukinumab in Prefilled Syringes, Assessing Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Treated With Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen
Brief Summary: CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used.


Options:
A: Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20]) (Week 24)
B: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) (Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) (Week 16)
C: Long-term Safety and Tolerability of Secukinumab (Week 268)
D: Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12 (Week 12)

Answer: C