TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: kühlender Effekt Der Eucerin pH5 Lotion Und Der Eucerin pH5 Lotion Mit Cooling Compound Bei Trockener, Juckender Haut
Brief Summary: Dry skin is a physiological condition and is characterized in contrast to greasy skin by roughness, desquamation and lack of brightness of the skin surface. Subjectively, feelings of tension, burning and itching can occur. The skin reacts more intensive on external and physical noxae. Dry skin is caused by a lack of moisture. This is most common during the winter months, when heating systems dry the air. Bathing with hot water, spending extended periods of time in the hot sun, and the skin's natural aging process also remove moisture and oils from the skin. It is diagnosed through clinical observation. People suffering from dry skin often desire to improve this condition for optical cosmetic reasons and due to the occasional feeling of tension. The aim of this investigation is to observe the improvement (or not) of dry itchy skin by a lotion containing a cooling compound


Options:
A: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 (Week 16); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 (Week 16)
B: Compensate the roughness of the skin Compensate sensory symptoms (4 weeks)
C: Visual Analog Scale (6 weeks)
D: Percentage of Participants Who Achieved Success in Investigator's Static Global Assessment (ISGA) Score at Day 29 (Day 29); Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) (AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36); Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings at Day 8 (Baseline, Day 8); Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 36 (Baseline (Day 1), Day 36); Number of Participants With Clinically Significant Laboratory Values (Baseline up to Day 36); Percentage of Participants With Local Tolerability Symptoms at Baseline (Baseline (Day 1)); Percentage of Participants With Local Tolerability Symptoms at Day 8 (Day 8); Percentage of Participants With Local Tolerability Symptoms at Day 15 (Day 15); Percentage of Participants With Local Tolerability Symptoms at Day 22 (Day 22); Percentage of Participants With Local Tolerability Symptoms at Day 29 (Day 29); Percentage of Participants With Local Tolerability Symptoms at Day 36 (Day 36)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of UFH and LMWH on Osteoprotegerin and RANKL Plasma Levels in Hemodialysis Patients
Brief Summary: A randomised, prospective, cross over study will be done to determine whether the anticoagulation therapy with UFH or LMWH used for hemodialysis sessions modifies osteoprotegerin and RANKL plasma levels.


Options:
A: the composite event rate in death (any cause), myocardial infarction and stroke
B: Primary efficacy outcome (up to 12 days post-surgery)
C: therapy interruption event (through study completion, from start to four hours)
D: Levels of osteoprotegerin after administration of UFH or LMWH used as anticoagulant therapy for hemodialysis (during and after dialysis sessions)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pre-Implantation Genetic Screening in Women Under the Age of 36 With Single-Embryo Transfer
Brief Summary: BACKGROUND: Single-embryo transfer is a well-accepted strategy to avoid multiple pregnancies in an assisted reproductive technology programme. The selection of the embryo with the highest implantation potential is a crucial step. Besides the morphological quality and embryo kinetics up to the blastocyst stage, pre-implantation genetic screening (PGS) of aneuploidy has been advocated as an adjuvant approach by which to select the right embryo for transfer.

METHODS: Couples with a female partner younger than 36 years were randomly assigned to undergo transfer of a single blastocyst in a cycle with or without PGS using fluorescence in situ hybridization for the chromosomes X, Y, 13, 16, 18, 21 and 22.


Options:
A: Sustained Implantation Rate Per Embryo Transferred (Within 1 year)
B: Ongoing Pregnancy (Gestational Age of 20 Weeks)
C: live born delivery rate (at birth of the child)
D: Live birth rate per randomized patient (single embryo transfer vs. 2 embryo transfer) (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Placebo-controlled, Randomised, Double-blind Study to Investigate the Efficacy and Safety of Low Dose Hydrocortisone to Prevent the Development of Septic Shock in Patients With Severe Sepsis
Brief Summary: Severe sepsis is a disease with a high mortality. Development of shock is a most serious complication and increases the risk of death considerably. Application of low dose hydrocortisone is currently recommended only in patients after severe septic shock has been established. Hydrocortisone therapy has a hemodynamic stabilizing effect and may reverse shock, however, the preventive application has not been investigated in a larger study. The study investigates whether low dose hydrocortisone prevents the development of shock in patients with severe sepsis. It is postulated that shock prevention may also affect morbidity and mortality.


Options:
A: Septic shock (14 days)
B: Number of patients who do not receive any more catecholamine 4 days after the beginning of the shock
C: rate of hospital acquired pneumonia (day-28)
D: Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria (28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Tranexamic Acid in Reducing Perioperative Bleeding in Patients Undergoing Radical Prostatectomy. A Randomized Controlled Double-blind Study.
Brief Summary: This prospective randomized double-blind placebo vs control study aims at verifying the efficacy of tranexamic acid administration in reducing perioperative bleeding in patients undergoing open radical prostatectomy. Two recent meta-analysis confirmed that tranexamic acid administration does not increase mortality, myocardial infarction, deep venous thrombosis, pulmonary embolism, stroke and renal failure.

200 patients undergoing open radical prostatectomy will be enrolled. Patients will receive a slow endovenous infusion of 500 mg of tranexamic acid before surgical incision, followed by 250 mg/h of tranexamic acid by continuous infusion.

Patients belonging to the control group will receive the same volume of saline infusions.


Options:
A: The change in urine NGAL/Cr value (2 hours preoperative and 2 hours postoperatively)
B: The primary outcome is death from haemorrhage (within 5 days of randomisation)
C: Analgesic demand (Postoperative 24 hours); Stone clearance (3 months)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Extension of the 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis
Brief Summary: This study was an extension study of NCT00537082. This study was designed to evaluate the efficacy and safety of long-term administration of 0.5 mg or 1.25 mg of fingolimod (FTY720) to relapsing multiple sclerosis.


Options:
A: Percentage of Patients Free of Gd-enhanced T1 Weighted Magnetic Resonance Imaging (MRI) Lesions (Months 6, 9, 12, 18, 24, 36, and 48)
B: Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint (up to 36 months after the last patient was randomized)
C: Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6 (Baseline, Month 6)
D: Estimated Annualized Aggregate Relapse Rate (ARR) (Baseline to end of study (Month 24))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparing Study of the Smoking Cessation Program NIX Individual and the Self-Help Program Fimpa Dig Fri
Brief Summary: Aim: to assess relative effectiveness of a high and a low intensity intervention for smoking cessation support in a dental clinic setting.

Method: 300 smokers were randomly assigned to support with either low (LTI) or high treatment intensity (HTI).

Main outcome measures were self-reported point-prevalence and continuous abstinence (≥183 days).


Options:
A: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
B: Point prevalence abstinence
C: Smoking abstinence (one year)
D: sustained smoking abstinence (during the study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparing Study of the Smoking Cessation Program NIX Individual and the Self-Help Program Fimpa Dig Fri
Brief Summary: Aim: to assess relative effectiveness of a high and a low intensity intervention for smoking cessation support in a dental clinic setting.

Method: 300 smokers were randomly assigned to support with either low (LTI) or high treatment intensity (HTI).

Main outcome measures were self-reported point-prevalence and continuous abstinence (≥183 days).


Options:
A: being a smoker (29 years)
B: To assess the primary outcome of provider adherence to tobacco use treatment guidelines, we will conduct patient exit interviews with 80 smokers pre and post-intervention at each of the 18 study sites (2880 smokers pre and post). (prior to and approximately 12 months following each site's enrollment in the study); Compare the effectiveness of the three intervention arms on provider behavior for aiding patient's tobacco cessation (June 2013-June 2017)
C: Point prevalence abstinence
D: Our primary outcome measures are patient-reported provider delivered tobacco screening and tobacco cessation advice. (Baseline, 8-months post-intervention, and 24-months post-intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparing Study of the Smoking Cessation Program NIX Individual and the Self-Help Program Fimpa Dig Fri
Brief Summary: Aim: to assess relative effectiveness of a high and a low intensity intervention for smoking cessation support in a dental clinic setting.

Method: 300 smokers were randomly assigned to support with either low (LTI) or high treatment intensity (HTI).

Main outcome measures were self-reported point-prevalence and continuous abstinence (≥183 days).


Options:
A: Quit Attempt(s) (Any time within 26 weeks)
B: smoking cessation (6-months)
C: Smoking abstinence (2 years)
D: Point prevalence abstinence

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparing Study of the Smoking Cessation Program NIX Individual and the Self-Help Program Fimpa Dig Fri
Brief Summary: Aim: to assess relative effectiveness of a high and a low intensity intervention for smoking cessation support in a dental clinic setting.

Method: 300 smokers were randomly assigned to support with either low (LTI) or high treatment intensity (HTI).

Main outcome measures were self-reported point-prevalence and continuous abstinence (≥183 days).


Options:
A: Long term abstinence (one year)
B: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)
C: Point prevalence abstinence
D: Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial Assessing the Effectiveness of a Pharmacist-Delivered Program for Smoking Cessation
Brief Summary: This randomized trial compared the effectiveness of a three session pharmacist-delivered group program for smoking versus one 5 to 10 minute standard care session delivered over the telephone on 7-day point prevalence quit rates. Participants in both groups were offered their choice of bupropion IR or nicotine patch at no cost. At 6 months after the established quit date, self-reported cessation was biochemically verified using tests for urinary cotinine.


Options:
A: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)
B: The primary outcome variable for the study was biochemically verified 7-day point prevalence smoking cessation at 6 months, defined as having smoked no cigarettes - not even a puff - for the previous 7 days. (6 months)
C: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
D: 6 Month Self-reported Abstinence From Smoking (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial Assessing the Effectiveness of a Pharmacist-Delivered Program for Smoking Cessation
Brief Summary: This randomized trial compared the effectiveness of a three session pharmacist-delivered group program for smoking versus one 5 to 10 minute standard care session delivered over the telephone on 7-day point prevalence quit rates. Participants in both groups were offered their choice of bupropion IR or nicotine patch at no cost. At 6 months after the established quit date, self-reported cessation was biochemically verified using tests for urinary cotinine.


Options:
A: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)
B: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)
C: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)
D: The primary outcome variable for the study was biochemically verified 7-day point prevalence smoking cessation at 6 months, defined as having smoked no cigarettes - not even a puff - for the previous 7 days. (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study
Brief Summary: The purpose of this study is to evaluate efficacy and safety of Polyunsaturated Fatty Acid for the prevention of Posttraumatic Stress Disorder (PTSD) in patients with accidental injuries.


Options:
A: Reduction in Pain (between pre-treatment EMS assessment (baseline) and at 30-minutes post-treatment)
B: Total score of Clinician-Administrated PTSD Scale (Three month)
C: The primary outcome is symptom severity at the end of the trial .This will be determined using the Clinician Administered PTSD Scale (CAPS), a scale with established reliability and good psychometric properties. (13 months)
D: Oxygenation (PO2/FIO2 ratio) (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique
Brief Summary: Recent studies indicate that infusing 300 milliliters of water (in lieu of air) into the rectum and left colon through the colonoscope as it is being inserted during a colonoscopy examination can allow easier endoscope advancement. This method may prevent stretching of the colon, and ultimately reduce pain induced during colonoscopy. Improvements in patient comfort and cooperation, may increase the efficiency and success rate of complete colonoscopy. The purpose of the study is to test the efficacy of the water immersion technique in patients colonoscopy.


Options:
A: Increments of medications used for sedation (duration of procedure)
B: Cecal intubation success rate (up to ten months)
C: Proportion of Patients Without Pain (up to 12 months)
D: Colonoscopy Success With Minimal Sedation (At the time of the procedure)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Analyses and Long-term Follow-up in the Two Norwegian Homocysteine-Lowering B-Vitamin Trials NORVIT and WENBIT
Brief Summary: Two large homocysteine-lowering B-vitamin intervention trials have been performed in Norway during the period 1998 to 2005, NORVIT and WENBIT. The main objective in these trials was to study the clinical effects of homocysteine-lowering therapy with folic acid and vitamin B12 in patients with established coronary artery disease. Follow-up was terminated for NORVIT on Marc 31st 2004 and for WENBIT October 5th 2005, and none of the two trials proved any protective effect of the B-vitamin intervention on cardiovascular outcomes.

There is so far no data on possible long-term effects following years of such B-vitamin treatment.

Thus, the main objective of the combinded NORVIT-WENBIT study will will be to evaluate the long-term effect of the B-vitamin intervention on incident life-style diseases including cardiovascular disease, diabetes, osteoporotic fractures and cancer.

A secondary object will be the identification of risk phenotypes or genotypes, and if such risk associations are midified by the B-vitamin intervention


Options:
A: fractures (4 years)
B: Possible effects of B-vitamin treatment on risk of developing cancer during the trial periods (completed by 2004 and 2005) and during post-trial follow-up. (1998-2014)
C: Cardiovascular disease; Cancer
D: all-type cancer (excluding non-melanoma skin cancers) (4 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group Trial Comparing Casodex 150mg Once Daily With Placebo in Patients With Non-Metastatic Prostate Cancer.
Brief Summary: The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.


Options:
A: Quality of life (using Rand 36-Item Health Survey SF-36) (3 monthly for 1 year)
B: Time to clinical progression (Throughout study period); Tolerability in terms of adverse events and laboratory parameters (Throughout study period)
C: Survival (Throughout study period); Time to clinical progression (Throughout study period)
D: Time to clinical progression (Throughout study period); Overall patient survival (Throughout study period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group Trial Comparing Casodex 150mg Once Daily With Placebo in Patients With Non-Metastatic Prostate Cancer.
Brief Summary: The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.


Options:
A: Survival (Throughout study period); Time to clinical progression (Throughout study period)
B: Time to clinical progression (Throughout study period); Tolerability in terms of adverse events and laboratory parameters (Throughout study period)
C: Disease-free survival; Survival; Toxicity/morbidity of treatment,; Locoregional remission rate; Time to treatment failure
D: Death from any cause at 8 years

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder
Brief Summary: The purpose of this study is to determine the efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder.


Options:
A: Change From Baseline in MADRS Total Score After 8 Weeks of Treatment. (Baseline and Week 8)
B: Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 8 (Baseline and Week 8)
C: Change From Baseline in MADRS Total Score at Week 8 (Baseline and Week 8)
D: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (Baseline and Week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of the Efficacy of Omega-3 Fatty Acids Supplementation, Multi-domain Intervention or Their Combination on the Change of Cognitive Functions in Frail Elderly Subjects
Brief Summary: Epidemiological and fundamental research carried out in recent years has highlighted the role played by omega-3 fatty acids in the process of cognitive decline that accompanies advancing age and Alzheimer's disease. In addition, it has been recognized for some years, following several convergent studies on the prevention of cognitive decline, that nutrition, physical exercise, cognitive training and social activities play a significant role in the maintenance of cognitive faculties. At present, there are a number of epidemiological arguments in favour of a protective role of each of these factors taken in isolation. It can be postulated that a multi-domain intervention may potentiate the protective role of omega-3 fatty acids.

The main objective of this study is to assess the efficacy of isolated supplementation with omega-3 fatty acid, an isolated multi-domain intervention (nutrition, physical exercise, cognitive stimulation, social activities), or their combination on the change of cognitive functions in frail elderly subjects aged of 70 years and older over 3 years.

Secondary objectives:

* To assess the efficacy of each treatment strategy on the change of functional capacities and the prevention of dependency,
* To study the long-term safety and tolerability of V0137,
* To study compliance and adhesion to the multi-domain intervention programme,

Ancillary studies :

To assess the impact of an intervention program on brain metabolism in FDG PET (MAPT-NI : : impact of multidomain intervention on brain metabolism (FDG-PET))

* To evaluate the impact of preventive strategies (Omega-3 treatment and multidomain intervention ) of MAPT study on brain atrophy (MRI),
* To evaluate the presence and density of ß-amyloid in MAPT subjects using AV45 PET scans (MAPT AV45),
* To determine if sleep disorders at early stage of Alzheimer 's disease could be predictive of cognitive decline and used as diagnosis tools (Mapt SLEEP)
* To evaluate the impact of omega-3 fatty acids on the body composition measured by DXA scans (MAPT-DXA)


Options:
A: Change in cognitive function at 36 months determined by a composite score (sum of Z-score of 4 tests: FCRST test (free recall + total recall) score, MMSE orientation score, Wais-R score (Digit Substitution Symbol test), and the Category Naming Test score (Baseline, 6, 12, 24, 36 months)
B: All strokes (fatal and non-fatal) (Duration of trial)
C: N/A
D: Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death (6 years)

Answer: A