TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Liraglutide Effect and Action in Diabetes (LEAD-1): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride Versus Glimepiride Monotherapy Versus Glimepiride and Rosiglitazone Combination Therapy in Subjects With Type 2 Diabetes.
Brief Summary: This trial is conducted globally (the United States of America excepted). This trial is designed to show the effect of treatment with liraglutide when added to existing glimepiride therapy and to compare this to both glimepiride monotherapy and to rosiglitazone as add-on therapy to glimepiride.


Options:
A: HbA1c (after 26 weeks of treatment)
B: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26); Change in Glycosylated A1c (HbA1c) at Week 104 (week 0, week 104)
C: HbA1c (after 26 weeks of treatment)
D: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16 (Baseline and Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The type of hemodialysis access and preservation of this access greatly influences the quality of life and survival of patients undergoing hemodialysis. The Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines for vascular access recommend the primary placement of native or autogenous hemodialysis fistulas in preference to polytetrafluoroethylene (PTFE) grafts and central venous catheters because the former form of access has fewer complications and a longer durability. However, autogenous hemodialysis fistulas, like polytetrafluoroethylene grafts, are also subject to dysfunction and eventual failure. Endovascular angioplasty has become an accepted alternative treatment to surgical revision for hemodialysis access-related venous stenoses and occlusions. However, the patency rates in the follow-up period are low because of the high frequency of restenosis due to intimal hyperplasia. Since 1988, noncovered stents have been used to improve fistula patency. In the central veins, bare stents demonstrate better patency rates than percutaneous transluminal angioplasty (PTA) alone. Neointimal hyperplasia is the major reason for restenosis following stent placement. The cephalic vein forms the outflow conduit for radiocephalic and brachiocephalic autogenous fistulas. It has recently been suggested that a focal area of the cephalic vein is prone to developing hemodynamically significant stenosis, in what is now termed the cephalic arch. This is the perpendicular portion of the cephalic vein in the region of the deltopectoral groove before its junction with the axillary vein. To overcome the problem of restenosis due to intimal hyperplasia in the cephalic arch the investigators used the insertion of a stent-graft as an alternative approach. In this study they investigated the use of a PTFE-covered nitinol stent-graft (Fluency, Bard) versus a Luminex (Bard) stent.


Options:
A: Technical success (1 minute after the final balloon angioplasty); Primary patency (1 year)
B: N/A
C: N/A
D: Percent of Participants With Treatment Area Primary Patency (TAPP) (6 month follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Liraglutide Effect and Action in Diabetes (LEAD-2): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Metformin Versus Metformin Monotherapy Versus Metformin and Glimepiride Combination Therapy in Subjects With Type 2 Diabetes
Brief Summary: This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).


Options:
A: Absolute Change in the Endothelial Progenitor Cell (EPC) Number (V0, V2 (month 4), V4 (12 month))
B: The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment. (Baseline and 104 weeks)
C: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26); Change in Glycosylated A1c (HbA1c) at Week 104 (week 0, week 104)
D: HbA1c Change From Baseline at Week 52 (Baseline and week 52); HbA1c Change From Baseline at Week 104 (Baseline and week 104)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Liraglutide Effect and Action in Diabetes (LEAD-2): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Metformin Versus Metformin Monotherapy Versus Metformin and Glimepiride Combination Therapy in Subjects With Type 2 Diabetes
Brief Summary: This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).


Options:
A: N/A
B: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
C: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26); Change in Glycosylated A1c (HbA1c) at Week 104 (week 0, week 104)
D: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Liraglutide Effect and Action in Diabetes (LEAD-2): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Metformin Versus Metformin Monotherapy Versus Metformin and Glimepiride Combination Therapy in Subjects With Type 2 Diabetes
Brief Summary: This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).


Options:
A: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26); Change in Glycosylated A1c (HbA1c) at Week 104 (week 0, week 104)
B: Change in HbA1c From Baseline to Week 26 (Day 1, Week 26)
C: To assess the pharmacokinetics of exenatide (Three day-long (8 hour) assessments over a 5-week period); To assess the pharmacodynamics of exenatide (Three day-long (8 hour) assessments over a 5-week period); Number of adverse events (Visit 2 through Visit 4)
D: Percentage of patients withdrawn because of gastrointestinal effects (Week 9)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Asthma Clinical Research Network (ACRN) Trial - Macrolides in Asthma (MIA)
Brief Summary: Asthma can be caused by a variety of factors, including tobacco smoke, allergens, and respiratory airway infections. Many people use inhaled corticosteroid medications to treat their symptoms. These medications, however, are not effective for everyone. Clarithromycin is an antibiotic that may effectively treat asthma in these individuals. This study will evaluate the effectiveness of clarithromycin at controlling asthma symptoms.


Options:
A: Diary card summary symptom score (10 days after randomisation)
B: Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population (Baseline to Week 52); Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population (Baseline, Week 12)
C: Changes in proportions of macrolide-resistant streptococcal (MRS) carriage in the oropharynx
D: Juniper Asthma Control Questionnaire (ACQ) Results (Measured every four weeks during the 16-week treatment period, with the change (week 16 minus baseline) as the primary outcome)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial to Investigate the Efficacy and the Safety of Thrice-Daily NN2000-Mix70 (NovoRapid 70 Mix) Compared to Twice-Daily NN-X14Mix30 (NovoRapid 30 Mix) in Subjects With Type 2 Diabetes Mellitus
Brief Summary: This trial is conducted in Japan. This a clinical trial to study the efficacy and safety of three times a day BIAsp-70 compared to two times a day BIAsp-30 in subjects with type 2 diabetes.


Options:
A: Mean Blood Glucose Concentration (hospital stay days 2-10)
B: Hemoglobin A1C (HbA1C) (After 16 weeks of treatment)
C: Relative risk of major maternal hypoglycaemia (after 24 hours)
D: HbA1c (After 16 weeks treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: CRISTAL: Colloids Compared to Crystalloids in Fluid Resuscitation of Critically Ill Patients: A Multinational Randomised Controlled Trial
Brief Summary: Background: Two recent systematic reviews of the literature and meta-analyses have suggested that colloids administration might be deleterious in critically ill patients.

Objective: To compare the effects on hospital mortality of crystalloids and colloids when given for fluid resuscitation in critically ill patients.

Setting: Adult intensive care units (ICUs) in several European countries.

Study design: A multinational, randomised, controlled trial performed on two parallel groups.

Intervention: Any type of crystalloids (control group) versus any type of colloids (including albumin).

Patients: All patients above the legal age of consent and hospitalised in an intensive care unit, who need fluid resuscitation (according to the physician). Pregnant women, moribund patients, brain dead patients, and patients who have a known allergy to colloids or severe head injury or major burns (\> 20% of body surface) or dehydration will not be included.

Primary endpoint: 28-day mortality.

Hypothesis: Assuming a hospital mortality rate of 20% in the crystalloids group, a 0.05 type I error, 3010 patients are needed to show a difference between the 2 groups of 5% with a 90% probability (two-sided test).


Options:
A: mortality rate at the 28th day after randomization, with a further control at 90th day. (mortality at 28th and 90th day after randomization)
B: 28 Day Survival (28 days from time of Emergency Department (ED) arrival)
C: Mortality or dialysis-dependency (90 days)
D: 28-day mortality (Day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Concerta in Treating ADHD in Mothers of Children With ADHD
Brief Summary: This study involves a 7 week dose-response trial of Concerta™ methylphenidate for mothers of children with ADHD who have ADHD themselves. The aim of this study is to assess the efficacy of Concerta™ in improving adult ADHD symptoms and impairments (primary outcome), as well as observed and reported parenting (secondary outcome). The researchers hypothesize that Concerta™ will significantly decrease mothers ADHD symptoms and impairment, as well as improve observed and reported parenting


Options:
A: Adult ADHD symptoms (Conners Adult ADHD Rating Scale); Impairment ratings (CGI); Side Effects (Pittsburgh Side Effect Scale)
B: Number of Participants With Adverse Events, Serious Adverse Events and Deaths. (Week 40 - Week 66)
C: Wender Reimherr Adult Attention Deficit Disorder Scale (Double-blind endpoints during MTS and placebo arms)
D: Monitoring adverse events, blood pressure, pulse, and weight throughout the study; ECG at Screening, Baseline, 1 week after upward dose titration, Months 3, 6, 9, 12 or Early Termination; Laboratory tests Screening, Month 6, Month 12 or Early Termination

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A New Approach to Office Hysteroscopy Compared With Traditional Hysteroscopy
Brief Summary: This randomized clinical trial compares two methods of diagnostic hysteroscopy: vaginoscopic hysteroscopy vs. traditional method. Pain intensity was estimated using a visual analogue scale (VAS), and patient satisfaction was evaluated. These endpoints were compared by treatment assignment. Vaginoscopic hysteroscopy was associated with significantly lower VAS scores, indicating reduced experience of pain in this treatment group; however, this was not associated with improved patient satisfaction.


Options:
A: second diagnostic hysteroscopy (postoperation three to four months)
B: Visual analogue scale for pain; Patient satisfaction
C: Ongoing pregnancy (18 months)
D: The time taken for polyp removal (at the time of surgery (day 1 intraoperatively))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Function and Effect of Exercise Therapy in Patients With Osteoarthritis of the Hip. A Randomized Controlled Trial.
Brief Summary: Aims:

1. Evaluate the effect of an exercise therapy program and patient education, versus patient education only, on hip function among patients with radiologically verified hip OA
2. To identify biomechanical differences during gait, one-leg standing , and two-legged-raise analysis in patients with hip OA following either exercise therapy and patient education program, or a patient education program only.

Main Hypothesis:

Significant improved hip function (WOMAC) will be demonstrated in patients with hip osteoarthritis (OA) (radiographically verified hip OA) following a patient education program and a 12 week exercise therapy program, compared to those only going through a patient education program.

Material and Methods:

110 patients with radiographically verified hip OA will be included in the randomized controlled trial; they will be randomized into:

1. Patient Education, or
2. Patient Education in addition to a supervised exercise program.

The main outcome is:

The Disease Specific WOMAC-Index.

Secondary outcome measures are:

SF-36v2 (quality of life),PASE (activity score), Self-efficacy for pain, muscle strength tests, gait analysis (biomechanical analysis),6 minutes walking test, Åstrand's bike test, range of motion.

Status:

The PhD student is accepted at the University of Oslo,and the study has so far included 17 subjects.

The study will be carried out:

NAR-Orthopedic Centre, Ullevaal University Hospital in collaboration with Diakonhjemmet Hospital and University of Delaware.

The study is included in our research program for active rehabilitation.


Options:
A: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year
B: Knee function, as measured by the ERGOS machine (Measured at baseline and Months 9 and 24)
C: EQ5D (At baseline and at follow-up after 6 months); Arthritis self-efficacy scale (At baseline and at follow up after 6 months); One-leg rising from sitting to standing (At baseline and at follow up after 6 months); Grip Ability Test (At baseline and at follow up after 6 months)
D: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (0, 4, 10, 16 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Function and Effect of Exercise Therapy in Patients With Osteoarthritis of the Hip. A Randomized Controlled Trial.
Brief Summary: Aims:

1. Evaluate the effect of an exercise therapy program and patient education, versus patient education only, on hip function among patients with radiologically verified hip OA
2. To identify biomechanical differences during gait, one-leg standing , and two-legged-raise analysis in patients with hip OA following either exercise therapy and patient education program, or a patient education program only.

Main Hypothesis:

Significant improved hip function (WOMAC) will be demonstrated in patients with hip osteoarthritis (OA) (radiographically verified hip OA) following a patient education program and a 12 week exercise therapy program, compared to those only going through a patient education program.

Material and Methods:

110 patients with radiographically verified hip OA will be included in the randomized controlled trial; they will be randomized into:

1. Patient Education, or
2. Patient Education in addition to a supervised exercise program.

The main outcome is:

The Disease Specific WOMAC-Index.

Secondary outcome measures are:

SF-36v2 (quality of life),PASE (activity score), Self-efficacy for pain, muscle strength tests, gait analysis (biomechanical analysis),6 minutes walking test, Åstrand's bike test, range of motion.

Status:

The PhD student is accepted at the University of Oslo,and the study has so far included 17 subjects.

The study will be carried out:

NAR-Orthopedic Centre, Ullevaal University Hospital in collaboration with Diakonhjemmet Hospital and University of Delaware.

The study is included in our research program for active rehabilitation.


Options:
A: Absolute Value of OA Symptoms at 8 Weeks (8 weeks); Absolute Value of OA Pain at 8 Weeks (8 weeks)
B: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (0, 4, 10, 16 months)
C: Change in the Western Ontario and McMaster University Index (WOMAC) Pain Subscale Between Baseline and 12 Weeks (between baseline and 12 weeks.)
D: Self-reported pain and function (WOMAC)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of a Psychoeducational Group Program for Unipolar Depression in Adults in Norway
Brief Summary: The purpose of the study is to test the efficacy of a psychoeducational group program on unipolar depression


Options:
A: Remission (Measured at Week 6 or 22)
B: BeckDepression Inventory : A questionnaire with 23 items to measure symptoms of depression
C: Hamilton Depression Rating Scale (HAMD-17) (Baseline, 4, 8, 24, 36, 52 week)
D: Hamilton Rating Scale for Depression (Change from Baseline in HAM-D at 8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer-Based Therapy for Mild Cognitive Impairment
Brief Summary: The purpose of this study is to determine the neuropsychological and neurophysiological impacts of a computer-based training program designed to improve the cognitive performance of patients with mild cognitive impairment (MCI).


Options:
A: Global cognitive functioning (26 weeks)
B: STROOP-Negative Priming (Change from Baseline Stroop-Negative Priming task at 15 weeks and 30 weeks); ODDBALL (Change from Baseline oddball task at 15 weeks and 30 weeks); N-BACK (Change from Baseline N-back task at 15 weeks and 30 weeks); CORSI BLOCK (Participants with non-action video-game training, change from baseline Corsi block task at 15 weeks and 30 weeks)
C: Change in Global Cognition Assessed Using the ADASCog(13 and Plus Modalities). (baseline and at 20 weeks (after interventions finalised))
D: The study investigates changes in a neuropsychological assessment battery pre-randomization; and upon the completion of training.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer-Based Therapy for Mild Cognitive Impairment
Brief Summary: The purpose of this study is to determine the neuropsychological and neurophysiological impacts of a computer-based training program designed to improve the cognitive performance of patients with mild cognitive impairment (MCI).


Options:
A: the change in cortical thickness between the baseline and the post-intervention assessment. (between the baseline and the post-intervention assessment (12 week training))
B: Change in cognitive function summary score (12 weeks)
C: The study investigates changes in a neuropsychological assessment battery pre-randomization; and upon the completion of training.
D: Change scores of Montreal Cognitive Assessment (MoCA) (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Timed up and go (TUG) test (baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer-Based Therapy for Mild Cognitive Impairment
Brief Summary: The purpose of this study is to determine the neuropsychological and neurophysiological impacts of a computer-based training program designed to improve the cognitive performance of patients with mild cognitive impairment (MCI).


Options:
A: Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. (2 years)
B: The study investigates changes in a neuropsychological assessment battery pre-randomization; and upon the completion of training.
C: cognition: MMSE, ADAS-cog. (month 0, 6, 12)
D: Changes in Cognitive Abilities of Memory From Baseline to Year 10 (Up to 10 years); Changes in Cognitive Abilities of Reasoning From Baseline to Year 10 (Up to 10 years); Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10 (Up to 10 years); Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10 (Up to 10 years); Changes in Everyday Problem Solving From Baseline to Year 10 (Up to 10 years); Changes in Everyday Speed of Processing From Baseline to Year 10 (Up to 10 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer-Based Therapy for Mild Cognitive Impairment
Brief Summary: The purpose of this study is to determine the neuropsychological and neurophysiological impacts of a computer-based training program designed to improve the cognitive performance of patients with mild cognitive impairment (MCI).


Options:
A: overall cognition (2 Monhths)
B: Composite Cognitive Function in Z-scores (i.e. Which Converts Raw Data to Standard Deviation (SD) Units: [Score-mean]/SD]). This Composite is Formed by Averaging the Z-scores From Individual Tests. (Changes from baseline at 4 months in z-scores.)
C: Useful Field of View Test (12 months)
D: The study investigates changes in a neuropsychological assessment battery pre-randomization; and upon the completion of training.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial II of Lung Protection With Azithromycin in the Preterm Infant
Brief Summary: The hypothesis of this study is that administration of azithromycin to ventilated premature infants will decrease the incidence and severity of BPD.

The purpose of this study is to determine if Azithromycin treatment is beneficial for prevention of bronchopulmonary dysplasia in preterm infants.


Options:
A: 24 Hour Sputum Volume (Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24))
B: Prevalence of Bronchiolitis Obliterans Syndrome (BOS) (2 years post-transplant); Overall Survival (2 years post-transplant)
C: All-cause Mortality Rate in Children Aged 1-60 Months (24 Months); All-cause Mortality Rate in Children Aged 1-60 Months (36 months)
D: Incidence of Bronchopulmonary Dysplasia (BPD) (diagnosis of BPD at 36wks corrected gestational age)

Answer: D