TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb, Randomized, Double-Blind, Multi-Center, Placebo- Controlled, Dose-Optimization, Cross-Over, Analog Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention-Deficit/Hyperactivity Disorder
Brief Summary: The primary objective of this study is to assess the time of onset of Vyvanse compared to placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment scale in children (aged 6-12) diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).


Options:
A: Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment. (Baseline, and the Endpoint (average of weeks 5, 6, 7).)
B: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks (Baseline and 1, 2, 3 and 4 weeks)
C: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks (Baseline and up to 7 weeks)
D: Onset of Effect of Vyvanse (Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 6-Week Clinical Study to Assess the Effect of Inhaled Aclidinium Bromide (LAS34273) 200 ug on Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe COPD
Brief Summary: This study evaluated the effect of inhaled aclidinium bromide on exercise endurance and in reducing resting and dynamic lung hyperinflation in patients with moderate to severe COPD. It was 9 weeks in duration, consisting of; a 2-week run-in period, 6 weeks of double-blind treatment, and a 1-week follow-up phone call. All patients meeting the eligibility criteria were randomized to one of two treatment groups: aclidinium bromide or placebo.


Options:
A: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment (Baseline and Week 24); Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment (Baseline and Week 12)
B: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) (Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks)
C: Trough FEV1 (L) at 28 Weeks on Treatment (Week 28); Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment (Week 12)
D: Change From Baseline in Exercise Endurance Time (ET) (From baseline Week 0 (Visit 4) to Week 6 (Visit 6))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients
Brief Summary: This is a multicenter study designed to compare the effect of exenatide plus a lifestyle modification plan versus placebo plus a lifestyle modification plan on weight loss in non-diabetic, obese subjects.


Options:
A: Change in Body Weight (24 weeks)
B: ß-cell Response Measured by Hyperglycemic Clamp (3-months after medication washout (Month 15)); Insulin Sensitivity, M/I (3-months after a medication washout)
C: Inflammatory Biomarker 1: Plasma hsCRP Concentration (2 months); Inflammatory Biomarker 2: Plasma IL-6 Concentration (2 months); Inflammatory Biomarker 3: Serum D-dimer Concentration (2 months)
D: Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke (Randomization (day 0) up to 2.9 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Neuromuscular Electrical Stimulation for Improving Quadriceps Activation in Women With Medial Tibiofemoral Osteoarthritis
Brief Summary: Patients with knee osteoarthritis (OA) often have decreased thigh muscle strength. This muscle weakness is thought to originate from centers in the brain and spinal cord that restrict recruitment of fibers responsible for muscle contraction. An inability to fully contract muscles surrounding the knee joint impairs patients' abilities to perform activities of daily living (i.e. walking, climbing stairs) and may even contribute to further joint degeneration.

Establishing therapies aimed at increasing muscle strength, restoring normal function, and possibly slowing the processes involved in the development of knee OA is essential in order to enhance the quality of life in the adult population plagued with this degenerative joint condition.

Electrical muscle stimulation applied to the thigh is a promising therapy that has been shown to successfully restore muscle strength, however how long the treatment lasts and its influence on functional outcomes remains unknown. In order for electrical muscle stimulation to be of value it must result in sustained improvements in muscle strength and functional outcomes. Therefore, the purpose of the proposed investigation is to determine if electrical muscle stimulation can restore thigh muscle strength and improve functional outcomes in patients with knee osteoarthritis.


Options:
A: Incremental shuttle walk test (10 weeks)
B: VE/VCO2 slope (Change from Baseline in VE/VCO2 slope at five and ten weeks post EMS.)
C: Change From Baseline in Quadriceps Central Activation Ratio at 12 Weeks (Baseline and 12 weeks post-intervention); Change From Baseline in Quadriceps Strength at 12 Weeks (Baseline and 12 weeks following the intervention)
D: Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score (At hospital discharge)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Randomized Trial of Chemoradiation With or Without Panitumumab in Subjects With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Brief Summary: The addition of chemotherapy to radiotherapy (chemoradiation) has improved outcomes for patients with locally advanced squamous cell carcinoma of the head and neck but additional improvements to treatment regimens are needed. The study is investigating if the addition of a targeted therapy (panitumumab) can improve the efficacy of chemoradiation without adding unmanageable toxicity.


Options:
A: Overall Response Rate (ORR) (Up to 36 months); Response to Treatment (Up to 36 months)
B: Number of Participants (Par.) With Complete Response (CR), as Assessed by Independent Radiological Review (From the date of randomization until 6 months post chemoradiation treatment, assessed for a median time of 13 months)
C: Disease Free Survival (DFS) (Up to 5 years)
D: Local Regional Control Rate at 2 Years (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Acute Intravenous Magnesium Loading on Pulmonary Function Parameters and Maximal Exercise Capacity of Patients With Chronic Obstructive Pulmonary Disease in Stable Clinical Conditions.
Brief Summary: Dietary magnesium (Mg) intake has been shown to be independently related to lung function, airway reactivity, and respiratory symptoms in the general population. Inhaled Mg and IV Mg administration have been shown to promote bronchodilation and to improve lung function in asthmatic patients. Some studies have suggested that COPD patients exhibit decreased body levels of Mg. The purpose of the present study was to investigate the effects of acute IV Mg loading on parameters of respiratory function and maximal exercise capacity of stable COPD patients.The study hypothesis is that Mg administration will be associated to improvements on airflow and vasodilation leading to improvements of pulmonary function and exercise performance.


Options:
A: All cause mortality at 3 years
B: Identifying new patient subtypes and endpoints for COPD (3 years)
C: lung oxygenation (over a period of 6-8 hours, from the time of induction of general anesthesia until time of patients discharge from the PACU.)
D: Measurements of forced vital capacity (FVC), forced expiratory volume (FEV1), functional residual capacity (FRC),maximal respiratory pressures,maximal oxygen consumption and maximal work load. (Immediatly after the end of IV infusion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of a Real Time Continuous Glucose Monitoring System (RT-CGMS) in Type 1 Diabetes Patients on Continuous Intraperitoneal Insulin Infusion (CIPII. A Feasibility Study
Brief Summary: To investigate the effectiveness and safety of a Real Time Continuous Glucose Monitoring System (RT-CGMS in a population of patients with type 1 diabetes mellitus treated with insulin through an implanted pump.


Options:
A: Difference in HbA1C From Baseline and 6 Months (Baseline and 6 months)
B: Daily time spent in the hypoglycemic glucose range during continuous glucose measurement with and without real time access to glucose values and glucose alarms (during the 48 hours of using blind vs. unblind continuous glucose monitoring)
C: Clinical effectiveness: percentage of time spent in euglycaemia (3-6 days)
D: Change in A1c From Baseline to 52 Weeks (Baseline and 52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine
Brief Summary: Primary objective is to determine if antibody responses to HPV types 16 \& 18 are non-inferior after a 2-dose paediatric regimen as compared to a 3-dose adult regimen of Q-HPV vaccination, with responses measured at Month 7.


Options:
A: Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs) (Within 14 days of first three doses of vaccination); Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs) Attributed to Study Treatment (Within 14 days of first three doses of vaccination); Percent of Participants With Human Papillomavirus (HPV) Type-Specific Seroconversion (At week 28 after beginning the vaccination series); Serum Anti-HPV Antibody Titers (cLIA) (Arm A week 0, 28, 72, 96, 97, 100; Arm B week 0, 28, 72, 96, 97, 100, 124.)
B: Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies (One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).); Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms (Within 7 days (Day 0-6) after vaccination.); Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms (Within 7 days (Day 0-6) after vaccination.)
C: N/A
D: Primary Objective Part 1 (Measured after Month 7); Primary Objective Part 2 (At 18, 24 and 36mths post dose 1); Primary Objective Part 2 (Measured at 36 mths)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine
Brief Summary: Primary objective is to determine if antibody responses to HPV types 16 \& 18 are non-inferior after a 2-dose paediatric regimen as compared to a 3-dose adult regimen of Q-HPV vaccination, with responses measured at Month 7.


Options:
A: Comparison of Antibody Response to HPV Type 16 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. (25 months); Comparison of Antibody Response to HPV Type 18 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. (25 months)
B: Primary Objective Part 1 (Measured after Month 7); Primary Objective Part 2 (At 18, 24 and 36mths post dose 1); Primary Objective Part 2 (Measured at 36 mths)
C: Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (Test of Hypothesis) (From Day 1 until >=30 cases accumulate, up to Month 54 in the base study); Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (End-of-study Update) (Up to Month 54 in the base study); Base Study: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58 (4 weeks postdose 3 in the base study); Base Study: Percentage of Participants With One or More Adverse Event (Up to Month 7 (low- and high-dose V503) or up to Month 54 (mid-dose V503 and Gardasil)); Base Study: Percentage of Participants With One or More Injection-site Adverse Event (Up to Day 5 after any vaccination); Base Study: Percentage of Participants With One or More Non-injection-site (Systemic) Adverse Event (Up to Day 15 after any vaccination); Base Study: Percentage of Participants With One or More Vaccine-related Adverse Event (Up to Month 7 (low- and high-dose V503) or up to Month 54 (mid-dose V503 and Gardasil)); Base Study: Percentage of Participants With Study Medication Withdrawn Due to an Adverse Event (Up to Month 6)
D: Occurrence, intensity and relationship to vaccination of any solicited local or general symptoms (Within 7 days after each vaccine dose)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study on the Effect of Parathyroidectomy on Sleep
Brief Summary: Primary hyperparathyroidism (PHPT) is an endocrine disorder that disrupts calcium metabolism and has a broad range of clinical manifestations. With respect to the nonclassic, subjective symptoms that have been reported to be associated with PHPT, such as sleep disturbance, neurocognitive dysfunction, mood disturbance, fatigue, and decreased quality of life, there is a lack of objective data on the extent to which these symptoms are affected by parathyroidectomy.

There have been reports of improvements in sleep in patients following parathyroidectomy, but these have been based solely on subjective sleep surveys. To date, there are no published studies on objective sleep evaluations of patients with PHPT. The overall goals of this protocol are to ascertain the feasibility of performing sleep studies on patients with PHPT, and to obtain pilot data on the effects of parathyroidectomy on those sleep studies.

It is hypothesized that it will be feasible to evaluate sleep parameters in patients with PHPT in the M. D. Anderson Sleep Center. Towards testing this hypothesis, the specific aims are:

Specific Aim 1: To assess the feasibility of using nocturnal polysomnography (PSG) to evaluate the primary outcome measure of total sleep time.

Specific Aim 2: To assess the feasibility of using nocturnal polysomnography (PSG) to evaluate the secondary outcome measures of sleep architecture, arousal index, sleep efficiency, wake after sleep onset, and sleep onset latency in patients with PHPT.

Specific Aim 3: To assess the feasibility of evaluating the secondary outcome measures of subjective sleepiness as tested with the Epworth Sleepiness Scale (ESS), and of sleep quality as tested with the Brief Sleep Disturbance Scale (BSDS) in patients with PHPT.

Specific Aim 4: To assess the feasibility using a randomized "wait-list"-control design to assess the effects of parathyroidectomy on sleep measures obtained with nocturnal PSG.


Options:
A: Decrease in arterial stiffness after parathyroidectomy (3 month)
B: postoperative parathyroid hormone level (3 months); ambulatory blood pressure (one year)
C: Total sleep time (Before and After Intervention)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb, Long-Term, Open-Label, Multi-Center, Extension Study Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary: To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17 years diagnosed withADHD


Options:
A: N/A
B: Systolic Blood Pressure (Baseline and 6 months); Diastolic Blood Pressure (Baseline and 6 months); Pulse Rate (Baseline and 6 months); Electrocardiogram Results (QTcF Interval) (Baseline and 6 months); Post Sleep Questionnaire (PSQ) Quality of Sleep (6 months); Weight (Baseline and 6 months); Dermal Reactions (6 months)
C: Total score on the Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase.
D: Efficacy outcome was change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T) (at 16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb, Long-Term, Open-Label, Multi-Center, Extension Study Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary: To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17 years diagnosed withADHD


Options:
A: N/A
B: ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) (Measured at baseline Week 4 and Week 8)
C: Systolic Blood Pressure (Baseline and 6 months); Diastolic Blood Pressure (Baseline and 6 months); Pulse Rate (Baseline and 6 months); Electrocardiogram Results (QTcF Interval) (Baseline and 6 months); Post Sleep Questionnaire (PSQ) Quality of Sleep (6 months); Weight (Baseline and 6 months); Dermal Reactions (6 months)
D: NCBRF-TIQ D-Total Score (Measured at baseline and Weeks 3, 4, 5, 6, 7, 8, 9)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb, Long-Term, Open-Label, Multi-Center, Extension Study Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary: To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17 years diagnosed withADHD


Options:
A: Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR (Baseline to Month-2)
B: Systolic Blood Pressure (Baseline and 6 months); Diastolic Blood Pressure (Baseline and 6 months); Pulse Rate (Baseline and 6 months); Electrocardiogram Results (QTcF Interval) (Baseline and 6 months); Post Sleep Questionnaire (PSQ) Quality of Sleep (6 months); Weight (Baseline and 6 months); Dermal Reactions (6 months)
C: CGI -S - ADHD rating scale (Father) (Change from Screening at 8 weeks.); Conners Adult ADHD Rating Scale - Self Report (Father) (Change from Screening at 8 weeks.); Conners Other Report (about Father) (Change from Screening at 8 weeks); Barkley Functional Impairment Rating Scale (Father) (Change from Screening at 8 weeks.); Conners Parent (completed by parent about child) (Change form Screening at 8 weeks.); Conners Teacher Rating Scale (completed by teacher about child) (Change from Screening at 8 weeks.)
D: Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8 (Baseline, 8 weeks); Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8 in Stimulant Naive Methylphenidate Group (Baseline, 8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study for the Prevention of Ascites (SPA): Comparison of Fixed Doses of SR121463B Versus Placebo in the Reduction of Recurrence of Cirrhotic Ascites
Brief Summary: The primary objective is to determine the optimal dose or range of doses of SR121463B for the reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone.

The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites, over a 12-week treatment period.

This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).


Options:
A: Incidence of overcorrection rate at any given period (up to 48 hours)
B: Number and time of recurrences of therapeutic paracenteses (up to 12 weeks)
C: Time to repeat therapeutic paracentesis (12 weeks)
D: Dyspnea Improvement Measured by Likert Scale at 8 and 24 Hours (8 and 24 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Exploratory Study of INT-747 in Patients With Type 2 Diabetes Mellitus and Presumed Nonalcoholic Fatty Liver Disease
Brief Summary: The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following:

* The safety and tolerability of multiple doses of INT 747;
* The effects of 2 dose levels (25 mg and 50 mg) of INT 747 on insulin resistance and glucose homeostasis;
* Effects of INT-747 on hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function and inflammation, and;
* Trough concentrations of INT-747 and its metabolites, glyco 6-ethyl chenodeoxycholic acid (6-EDCA) and tauro 6-ECDCA.


Options:
A: Insulin Resistance and Glucose Homeostasis (baseline and 6 weeks)
B: Alaninaminotransferase(ALT) (12 weeks)
C: Grade of steatosis as judged by repeat biopsy (6 mo)
D: The primary endpoint is weight loss leading to improvement in the global necroinflammatory and fibrosis scores on liver biopsies. A change of one point in the necroinflammatory grade or fibrosis stage will be considered statistically significant.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: SR121463B in Cirrhotic Ascites Treatment With Hyponatraemia: A Placebo-Controlled, Dose-Comparison Study
Brief Summary: The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites and the correction of hyponatraemia when used concomitantly with a standard dose regimen of spironolactone.

The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.

This Hypo\~CAT study is followed by a single-blind, placebo-controlled, one-year long-term safety extension (Expo\~CAT). The first extension is followed by another long-term study (PASCCAL-1).


Options:
A: EFFICACY:Serum Sodium; SAFETY:Physical examination, vital signs, adverse events, electrocardiogram, hematology, serum chemistry; PHARMACOKINETICS:Plasma SR121463B concentrations
B: change in body weight, change in serum sodium (within 14 days)
C: The change of average daily Area Under the Curve (AUC) of serum sodium by day 4 and 7 comparing with baseline serum sodium level within the double-blind therapy period. (4 and 7 days)
D: To evaluate the short term efficacy and safety of tolvaptan in subjects hospitalized for worsening heart failure who have volume overload and one of the following: renal insufficiency, or hyponatremia or inadequate response to diuretic therapy. (8 and 16 hours)

Answer: B