TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Oral Azithromycin (500 Mg OD) as a Supplement to Standard Care for Adult Patients With Acute Exacerbations of Asthma
Brief Summary: Acute attacks (exacerbations) of asthma are common and cause a great deal of suffering in asthmatic patients. Current treatments for asthma attacks are not completely effective and new and better treatments are needed. Viruses often cause asthma attacks and bacterial lung infections have also been associated with asthma attacks. However, the role for bacteria is uncertain. Current asthma guidelines for doctors treating asthma exacerbations do not recommend the routine use of antibiotics. The investigators would like to investigate whether or not azithromycin, which is a safe and well tolerated antibiotic (an antibacterial) that has been used for many years in the treatment of respiratory disease, might be of benefit in asthma attacks. As there is some evidence that azithromycin has anti-viral properties this may add to its benefits (antibiotics don't usually affect viruses). By looking at the effect of azithromycin on asthma attacks this will help us to show whether or not azithromycin should be recommended during an acute asthma attack in addition to the usual care that is provided to these patients as it may help them recover quicker from the exacerbation. The investigators will also be able to look at why azithromycin may be effective - if it is having an anti-bacterial and/or anti-viral effect.


Options:
A: Prevalence of Bronchiolitis Obliterans Syndrome (BOS) (2 years post-transplant); Overall Survival (2 years post-transplant)
B: Time Until First Occurrence of Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (Measured monthly through 13 months)
C: Proportion of Participants With Severe Asthma Exacerbations (from baseline to week 26)
D: Diary card summary symptom score (10 days after randomisation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Psychodynamic Motivation and Training Program (PMT) as Secondary Prevention in Patients With Stable Coronary Heart Disease
Brief Summary: The purpose of this study is to examine the effectiveness of a Psychodynamic Motivation and Training Program (PMT) for the improvement of physical fitness in patients with stable coronary heart disease as compared to advice in exercise training or treatment as usual.


Options:
A: Change in individual anaerobic threshold according to lactate kinetics during spiroergometry (6 months)
B: Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via: (Baseline, 6 and 12 months)
C: Total steps (last 30 days of intervention)
D: cardiovascular mortality; non fatal re-MI; angina requiring hospitalization; urgent revascularization procedures; hospitalization for heart failure; non fatal stroke

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Electronic Daily Self-monitoring of Subjective and Objective Symptoms in Bipolar Disorder - The MONARCA Project (MONitoring, treAtment and pRediCtion of bipolAr Disorder Episodes)
Brief Summary: Bipolar disorder is associated with a high risk of relapse and hospitalisation and many patients do not recover to previous psychosocial function. Major reasons for poor outcome are delayed intervention for prodromal depressive and manic episodes as well as decreased adherence with treatment. Recently, electronic self monitoring of affective symptoms using cell phones to prompt patients to respond to weekly text messages has been suggested as an easy and cheap way to identify early signs of affective episodes. Nevertheless, so far the electronic devises has been rather simple not including a bi-directional feed back loop between patients and providers and without electronic data on "objective" measures of the affective psychopathology. As part of an ongoing EU research program a software program for online electronic self-monitoring using a cell phone is being developed including an interactive feed back loop between patients, relatives and clinicians. Electronic self-monitoring includes subjective items such as mood, irritability, sleep duration, activity, alcohol consumption, medication intake and objective items of speech duration (on the cell phone), social activity (numbers of calls and SMS'es at the cell phone) and physical activity (acceleration of the cell phone). The present PhD. study will in a randomized controlled single blind trial including 60 patients with bipolar disorder allocated to using the active cell phone program (intervention group) or to using a cell phone to usual communication (control group) during a 6 months study period.

If the cell phone self-monitoring system is proved effective in preventing mood symptoms and improving psychosocial functioning,quality of life etc. in the present study there might be basis for extending the use of the system to treatment of patients with bipolar disorder in clinical practice in general.


Options:
A: Differences in Hamilton Depression Rating Scale (HAM-D17) score and Young Mania Rating Scale (YMRS) score during the entire 6 months study period. (Measured on all participants included one time a month for six months)
B: The primary outcome is feasibility/acceptability of the process of e-screening (vs 'usual' screening). (10 months)
C: Adherence to the trial (6 months); Adherence to the intervention arms (6 months)
D: Depressive symptoms (Pre-, post-monitoring, 6-week follow up & 6 month follow-up); Emotional Self Awareness (Pre-, post-, 6-weeks post- and 6-months post-test)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Alcohol Exposed Pregnancy Risk
Brief Summary: The EARLY Randomized Controlled Trial (RCT) will test the finalized EARLY preventive intervention against one comparison and one control condition. Because prevention of Alcohol-exposed pregnancy (AEP) will be achieved whether woman change drinking OR contraception, the primary endpoints will be rates of risky drinking and ineffective contraception at six-month follow-up, in addition to dichotomously defined "successful outcome" that will be observed whenever a woman has sufficiently altered one or both of the behaviors that placed her at risk of Alcohol-Exposed Pregnancy (AEP). The goal is to identify a transferable intervention that effectively reduces behaviors that put women at risk for AEP and alcohol-related birth defects including FASD.


Options:
A: Change in alcohol consumption Score as assessed by the AUDIT-C tool . (6 months)
B: Drinks per drinking day (6 months); Rate of effective contraception (6 months)
C: Discontinuation of consumption of prescription drugs (one year); Reduction of consumption of prescription drugs (one year); Utilization of formal help (one year)
D: Drug use (Six Months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Alcohol Exposed Pregnancy Risk
Brief Summary: The EARLY Randomized Controlled Trial (RCT) will test the finalized EARLY preventive intervention against one comparison and one control condition. Because prevention of Alcohol-exposed pregnancy (AEP) will be achieved whether woman change drinking OR contraception, the primary endpoints will be rates of risky drinking and ineffective contraception at six-month follow-up, in addition to dichotomously defined "successful outcome" that will be observed whenever a woman has sufficiently altered one or both of the behaviors that placed her at risk of Alcohol-Exposed Pregnancy (AEP). The goal is to identify a transferable intervention that effectively reduces behaviors that put women at risk for AEP and alcohol-related birth defects including FASD.


Options:
A: Drinks per drinking day (6 months); Rate of effective contraception (6 months)
B: Reduction of 25% in self reported alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the intervention group. In the control group we expect that 10% will reduce their consumption equivalent. (6 and 12 months)
C: Effectiveness of brief intervention for decreasing problem drinking and partner violence (Weekly for 3 months; then 6 and 12 months)
D: Change in the number of drinks per week and the number of drinks per drinking day (Baseline, 3 months & 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Alcohol Exposed Pregnancy Risk
Brief Summary: The EARLY Randomized Controlled Trial (RCT) will test the finalized EARLY preventive intervention against one comparison and one control condition. Because prevention of Alcohol-exposed pregnancy (AEP) will be achieved whether woman change drinking OR contraception, the primary endpoints will be rates of risky drinking and ineffective contraception at six-month follow-up, in addition to dichotomously defined "successful outcome" that will be observed whenever a woman has sufficiently altered one or both of the behaviors that placed her at risk of Alcohol-Exposed Pregnancy (AEP). The goal is to identify a transferable intervention that effectively reduces behaviors that put women at risk for AEP and alcohol-related birth defects including FASD.


Options:
A: contraception (past 3 months)
B: Measurement of contraceptive adherence (12 months); Measurement of dual method use (12 months); Measurement of pregnancy rates and sexually transmitted diseases (STDs) (12 months)
C: Drinks per drinking day (6 months); Rate of effective contraception (6 months)
D: Re-infection with a non-viral sexually transmitted infection (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Diagnosis of Pancreatic Cysts: Endoscopic Ultrasound With Fine Needle Aspiration (EUS/FNA), Direct Visualization, and Confocal Laser-induced Endomicroscopy-A Pilot Study
Brief Summary: The purpose of this study is to assess the yield of combination modalities in the diagnosis of pancreatic cysts using EUS/FNA, Fiber optics (direct visualization probe), and prototype needle based confocal laser-induced endomicroscopy miniprobe (nCLE).


Options:
A: Assess the yield of combination modalities in the diagnosis of pancreatic cysts using EUS/FNA, Fiber optics (direct visualization probe), and prototype needle based confocal laser-induced endomicroscopy miniprobe (nCLE) (From the date of imaging until follow up for 6 months to two years.)
B: Compare the degree of cytologic quality in specimen obtained by EUS-FNA with or without suction, pushing the stylet or injecting air. (within 6 months)
C: Value of endoscopic ultrasound elastography for the differential diagnoses of pancreatic masses. (18 months)
D: Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts (Within 6 months after the end of Follow-up period); Descriptive criteria in nCLE sequences for the characterization of pancreatic masses and lymph nodes (Within one year after the end of the follow-up period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The investigators conducted a pilot study including 17 patients with liver cirrhosis showing that a moderate exercise programme during three months increased thigh circumference,exercise tolerance and quality of life without adverse effects. The present study aim to more accurately evaluate the effect of exercise on muscle mass, effort tolerance and inflammatory response in patients with cirrhosis. This study will include 30 patients with compensated liver cirrhosis that will be randomized into two groups: exercise group and control group. Evaluation of muscle mass, effort tolerance, inflammatory response and quality of life will be made at the beginning and at the end of the study.


Options:
A: Improvement in QOL questionnaires (3 months); Lack of deterioration in portal hypertension (3 months)
B: HVPG change (4 months)
C: Change in peak exercise pulmonary oxygen uptake (peak VO2) (Baseline (day 1) and Study End (8 weeks))
D: Increase in muscle mass (Basal and three months); Change in Effort tolerance (Basal and three months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized Open Label Study of MM-121 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Platinum Resistant/ Refractory Advanced Ovarian Cancers
Brief Summary: To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone


Options:
A: Number of Participants With the Indicated Tumor Response at 12 Weeks From First Dose (Week 12); Percentage of Participants Who Remained Progression-free 12 Weeks After Randomization (Week 12 after randomization.)
B: Objective Response (Complete Partial, Stable and Progression) (06.16.2005 to 10.05.2009); Median Response Duration (Weeks) (1 week to 96 weeks)
C: Overall survival as measured by Kaplan Meier every 3 months for 2 years, every 6 months for 3 years, and then annually
D: Progression Free Survival (Time from first dose to date of progression, the longest time frame of 3.9 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Blinded Placebo Controlled Trial of Hydrocortisone in Critically Ill Patients With Septic Shock
Brief Summary: The purpose of this study is to find out whether adult patients admitted to the Intensive Care Unit with septic shock who are given hydrocortisone compared to placebo (a dummy solution), will have an improved rate of survival 90 days later.

Septic shock is the result of an infection, which triggers a complex response by the body (the inflammatory response) that causes a decrease in blood pressure and subsequently one or more organ systems to fail when blood supply to these organs is reduced. This may result in poor recovery and death. About a quarter of the people who suffer septic shock that is not rapidly reversed, will die.

When patients are admitted to Intensive Care with sepsis and/or septic shock they receive a number of therapies. These include fluids given through a drip, antibiotics, drugs to boost your blood pressure and other organ systems.

In addition to these therapies, steroids (hydrocortisone) are sometimes administered. Whether steroids are useful or not in the treatment of severe infections has been studied for more than 50 years. Previous research has suggested that the use of low dose steroid may have shortterm benefits in improving the circulation. However, there is no agreement amongst doctors around the world about whether treatment with or without low dose steroids improves the overall recovery and survival in patients with septic shock. This study would allow doctors to make informed decisions about whether the addition of low dose steroid therapy is better for patients with septic shock in intensive care.

The study will include 3800 intensive care patients who have septic shock. Each enrolled patient will be randomised to receive either Hydrocortisone 200mg or placebo daily for 7 days as a continuous intravenous infusion while in intensive care. The patient will be followed for 90 days. If the patient is discharged prior to 90 days a telephone call will be made for the followup information. At six months the patient will be contacted again for completion of a quality of life questionnaire.


Options:
A: All cause mortality at 90 days after randomisation (90 days after randomisation)
B: Duration of mechanical ventilation (0-28 days)
C: Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria (28 days)
D: rate of hospital acquired pneumonia (day-28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Eyelid Warming Technology for Relief of Meibomian Gland Dysfunction in an Asian Population
Brief Summary: Meibomian gland dysfunction (MGD), an extremely common clinical condition (seen in more than half of some Asian populations), affects the lipid producing meibomian glands in the eyelids. One function of the glandular secretions is to reduce evaporation of the tear film. In MGD the meibomian glands may become blocked for various reasons. The consequential retention and stasis of the secretion increases immune response as well as scarring response. This eventually results in an abnormal tear film and dry eye symptoms.

The current standard treatments include warm moist compresses, regular lid hygiene, oral antibiotics, topical antibiotic ointments and Omega 3 supplementation. Heating for an extended duration is important because it relieves the occlusion of blocked meibomian glands. However, improvised methods of heating are cumbersome and inefficient requiring repeated measures, often leading to lack of compliance. Today, there is a wider range of commercially available devices that help to unblock meibomian glands and relief dry eye symptoms. These devices may improve MGD treatment dramatically, but have not been tested in the warm climate of Singapore, and are not readily available.

The current study aims to test the efficacy of treatment for devices that utilize A) warm moisture (Blephasteam) and B) warmth (EyeGiene) in patients suffering from meibomian gland dysfunction. Patients will be asked to use Blephasteam and EyeGiene for a period of 4 weeks. The study will monitor patients for changes in tear film and lipid composition, as well as changes in the anatomy of meibomian glands. Additionally, dry eye symptoms will be documented in form of questionnaires. If the newer methods of managing MGD are found to be efficacious and safe, these treatment measures can be made available to patients in Singapore.


Options:
A: Tear Break-Up Time (1 month); Meibomian Gland Secretion Score (1 month)
B: Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12 (Baseline, Month 12)
C: Dry Eye Symptoms (Week 4)
D: Change of Dry Eye Symptoms (after 3 month compared to baseline value)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients
Brief Summary: This study is to define the optimal method of prophylaxis for patients with gastrectomy in Korea and the investigators hypothesized only mechanical method would be enough for preventing VTE on perioperative period.


Options:
A: incidence of VTE (up to 30 days after operation)
B: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event (12 months)
C: Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism) (20 days)
D: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6- or 12-month study treatment period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients
Brief Summary: This study is to define the optimal method of prophylaxis for patients with gastrectomy in Korea and the investigators hypothesized only mechanical method would be enough for preventing VTE on perioperative period.


Options:
A: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event (12 months)
B: incidence of VTE (up to 30 days after operation)
C: Incidence of NCI CTC Toxicity III°/IV° and severe bleedings (minimum of 3 months)
D: Recurrent venous thromboembolism (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients
Brief Summary: This study is to define the optimal method of prophylaxis for patients with gastrectomy in Korea and the investigators hypothesized only mechanical method would be enough for preventing VTE on perioperative period.


Options:
A: Time From Randomization to First Occurrence of Composite of All Symptomatic Venous Thromboembolism (VTE) and VTE Related Death Adjudicated by Clinical Event Committee (CEC) (Up to Day 45); Event Rate Based on Time From Randomization to the First Occurrence of Major Bleeding Adjudicated by CEC (From randomization to 2 days after the last dose (Day 45))
B: incidence of VTE (up to 30 days after operation)
C: Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) Through Day 35 (Up to Day 35); Number of Participants With AEs Resulting in Study Intervention Discontinuation Through Day 35 (Up to Day 35); Number of Participants With Serious Adverse Events Through Day 35 (Up to Day 35); Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale Through Day 28 (Up to Day 28)
D: Hierarchical composite endpoint composed of mortality, number of days alive, number of days in the hospital and number of days with oxygen therapy at the end of 30 days. (In 30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients
Brief Summary: This study is to define the optimal method of prophylaxis for patients with gastrectomy in Korea and the investigators hypothesized only mechanical method would be enough for preventing VTE on perioperative period.


Options:
A: Number of Patients With Asymptomatic Venous Thrombosis of Lower Limbs as Detected by Duplex Ultrasound (time of discharge from the hospital or death, up to 45 days)
B: Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes (Treatment period : up to day 36+/-6)
C: incidence of VTE (up to 30 days after operation)
D: Proximal deep vein thrombosis(DVT) diagnosed by compression ultrasound (28 days from randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients
Brief Summary: This study is to define the optimal method of prophylaxis for patients with gastrectomy in Korea and the investigators hypothesized only mechanical method would be enough for preventing VTE on perioperative period.


Options:
A: Hierarchical composite endpoint composed of mortality, number of days alive, number of days in the hospital and number of days with oxygen therapy at the end of 30 days. (In 30 days)
B: Mean daily PaO2 to FiO2 ratio (10 days)
C: Venous or Arterial Thrombotic Events: Full-dose Anticoagulation Versus Standard-dose Prophylactic Anticoagulation (28 days or until hospital discharge, whichever earlier); Venous or Arterial Thrombotic Events: Anti-platelet Therapy Versus No Anti-platelet Therapy (28 days or until hospital discharge, whichever earlier)
D: incidence of VTE (up to 30 days after operation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients
Brief Summary: This study is to define the optimal method of prophylaxis for patients with gastrectomy in Korea and the investigators hypothesized only mechanical method would be enough for preventing VTE on perioperative period.


Options:
A: incidence of VTE (up to 30 days after operation)
B: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)
C: Percentage of Participants Who Experience Venous Thromboembolism Event (VTE) or All-cause Death (From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first)
D: Composite end-point represented by the time in days from randomisation to the first occurrence of VTE (6 months)

Answer: A