TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Quetiapine Prolong and Escitalopram on the Hypothalamic-pituitary-adrenocortical (HPA)-Axis Activity in Depressed Patients
Brief Summary: In former studies of the investigators research group the investigators could also demonstrate acute inhibitory effects of the antidepressant mirtazapine on ACTH and cortisol release in normal controls (Schüle et al. 2002), most likely mediated via antagonism at central 5-HT2- and H1-receptors. In contrast to mirtazapine, serotonin or norepinephrine reuptake inhibiting antidepressants acutely stimulate ACTH and cortisol secretion (Schüle 2007). The investigators also performed a study in depressed patients who were treated either with mirtazapine or with reboxetine using serial dexamethasone/CRH tests (week 0, 1, and 5) as a parameter for HPA axis activity. Mirtazapine, but not the norepinephrine reuptake inhibitor reboxetine was able to significantly reduce HPA axis activity already within one week (Schüle et al. 2006). Mirtazapine is known to have an earlier onset of antidepressant action than do SSRIs such as sertraline (Behnke et al. 2003) or antidepressants with dual mechanism of action such as venlafaxine (Benkert et al. 2006), possibly due to its rapid inhibition of HPA axis activity in unipolar depressed patients.

Since mirtazapine and quetiapine have similar effects on the HPA system in healthy male volunteers (i.e. inhibition of ACTH and cortisol secretion), a rapid attenuation of HPA axis activity is also expected during quetiapine XR treatment in depressed patients.

Therefore, in the present study the investigators goal is to investigate whether quetiapine fumarate XR at a dosage of 300 mg per day has an impact on HPA axis activity in unipolar depressed patients, as measured by serial dexamethasone/CRH tests (week 0, 1, and 5) and salivary cortisol profiles and whether putative effects of quetiapine XR on the HPA system are related to its antidepressant efficacy.


Options:
A: Overall Response Rate (ORR) (6 weeks)
B: depressive symptoms (3 to 28 days)
C: serial dexamethasone/CRH tests (week 0, 1, and 5)
D: Hot Flash Symptom Severity Score (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Periconceptional Iron Supplementation on Iron and Folate Indicators Among Pregnant and Non-pregnant Women in Rural Bangladesh.
Brief Summary: The investigators hypothesize that periconceptional iron supplementation to married, nulliparous women in rural Bangladesh will significantly reduce anemia and improve hemoglobin concentrations before and during pregnancy.


Options:
A: Frequency of Consumption of the Calcium Vehicle (Change from Baseline in Consumption of the Calcium Vehicle at day 22)
B: Hemoglobin (February 2007-February 2008)
C: The primary outcome is a comparison of area under the curve (AUC) for change in serum iron for each intervention adjusted for diurnal variation. The use of AUC will provide a single outcome for each participant. (3 weeks)
D: Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness. (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Periconceptional Iron Supplementation on Iron and Folate Indicators Among Pregnant and Non-pregnant Women in Rural Bangladesh.
Brief Summary: The investigators hypothesize that periconceptional iron supplementation to married, nulliparous women in rural Bangladesh will significantly reduce anemia and improve hemoglobin concentrations before and during pregnancy.


Options:
A: Birth weight; 3-month infant mortality
B: Hemoglobin (February 2007-February 2008)
C: Heme and Non-Heme Iron Absorption (two-weeks post dosing (3rd trimester for pregnant subjects)); Heme and Non-Heme Transfer to Fetus (Delivery)
D: Hematologic status at 6 months of age; Iron status at 6 months of age

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Periconceptional Iron Supplementation on Iron and Folate Indicators Among Pregnant and Non-pregnant Women in Rural Bangladesh.
Brief Summary: The investigators hypothesize that periconceptional iron supplementation to married, nulliparous women in rural Bangladesh will significantly reduce anemia and improve hemoglobin concentrations before and during pregnancy.


Options:
A: 1 or more adenomas (For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8)
B: Birth weight; 3-month infant mortality
C: Hemoglobin (February 2007-February 2008)
D: Recurrent colorectal adenoma (May 1996-March 2004)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Periconceptional Iron Supplementation on Iron and Folate Indicators Among Pregnant and Non-pregnant Women in Rural Bangladesh.
Brief Summary: The investigators hypothesize that periconceptional iron supplementation to married, nulliparous women in rural Bangladesh will significantly reduce anemia and improve hemoglobin concentrations before and during pregnancy.


Options:
A: 1 or more adenomas (For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8)
B: Use of Emergency Contraception (7 months); Use of Folate supplements (7 months)
C: Recurrent colorectal adenoma (May 1996-March 2004)
D: Hemoglobin (February 2007-February 2008)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Aerobic Exercise on Asthma Morbidity
Brief Summary: Asthma is a chronic disorder of the airways primarily driven by increased airway inflammation, and is an escalating medical problem in Canada. For example, between 1994 and 2001 there was a 40% increase in the number of Canadians who had asthma. Not only is the prevalence of asthma increasing but there has been a rapid rise in the number of asthma events and costs associated with asthma and poor asthma control. It has been estimated that the global cost of caring for asthma exceeds that of AIDS/HIV and tuberculosis combined. These increases have occurred in spite of the development of clear asthma management guidelines. There is evidence to suggest that aerobic exercise, e.g., running or cycling, may improve asthma symptoms and control in children. However, there are currently no studies that have systematically assessed the effects of exercise on asthma control or symptoms in adults. The current proposed study will assess the effects of aerobic exercise in sedentary patients with poorly controlled asthma. In addition to usual medical care, 52 patients will participate in a supervised aerobic exercise program. The program will consist of 3 X 1hr sessions of supervised exercise per week for 12 weeks. Another 52 patients will only maintain usual medical care. The asthma control, quality of life, and inflammatory profile will be evaluated at baseline and following the 12 weeks of treatment. The investigators believe that: (1) The exercise intervention will significant improve asthma control and asthma quality of life; (2) The exercise intervention will result in significant improvements in inflammatory profiles; and (3) These changes in the inflammatory profile will be directly related to the improvements in asthma control and quality of life.


Options:
A: Maximum oxygen uptake (One year)
B: Asthma control Questionnaire (Juniper) (Within 1 week of completion of the intervention (i.e., after 12 weeks))
C: Clinical Control (Before and after 3 months of intervention)
D: Bronchial hyperresponsiveness (Before and after 3 months of intervetion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Remote Ischemic Preconditioning on Cognitive Function After Off-Pump Coronary Artery Bypass Graft
Brief Summary: The aim of this study is to evaluate the effects of remote ischemic preconditioning on cognitive function in patients undergoing off-pump coronary artery bypass graft.


Options:
A: The primary outcome measure is postoperative neurocognitive dysfunction. (Preoperative, 1 week and 3 months after surgery)
B: Composite structural and functional neurological outcome (7 days)
C: cognitive function (preoperative, 1 week and 6 months after surgery)
D: Mitochondrial respiration (1 hour)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of VX-770 in Subjects Aged 12 Years and Older With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of ivacaftor in participants with cystic fibrosis (CF) who were aged 12 years or older and were homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic adenosine monophosphate (AMP)-dependent protein kinase A (PKA) activation.


Options:
A: Part A : Absolute Change From Part A Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 16 (Part A baseline through Week 16)
B: Number of Participants With Treatment Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) in Ivacaftor Arm (Day 1 up to Week 108 (Study 112))
C: Safety and Tolerability Based on Adverse Events (AEs) (Up to 14 days after last dose (last dose = Day 28))
D: Sweat Chloride Concentration (14 +/- 2 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery
Brief Summary: This is a comparison, at this VA Hospital, of standard operating room management in colorectal surgery to a more rigid management using an additional five previously tested treatments to determine if this changes the rate of post operative wound infections.


Options:
A: Surgical Site Infections (30 days (exact 30 days after the Operation date))
B: Surgical site infection incidence (30 days after surgery)
C: %/type Surgical wound infections rated per infection classifications of NNIS/CDC (with in 30 days post-op)
D: anastomotic leakage and/or abscess (30 days postoperatively)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery
Brief Summary: This is a comparison, at this VA Hospital, of standard operating room management in colorectal surgery to a more rigid management using an additional five previously tested treatments to determine if this changes the rate of post operative wound infections.


Options:
A: Surgical site infection (2 weeks)
B: Myocardial Infarct Size (At 72 hours post infarct)
C: %/type Surgical wound infections rated per infection classifications of NNIS/CDC (with in 30 days post-op)
D: surgical wound infection (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Double-blinded Randomized Controlled Evaluation of MVA85A/AERAS-485 for Safety, Immunogenicity and Prevention of Tuberculosis in BCG-vaccinated, HIV-negative Infants
Brief Summary: This was a Phase II double-blinded randomized controlled evaluation of safety, immunogenicity and efficacy of MVA85A/AERAS-485 in Bacillus Calmette-Guérin (BCG) vaccinated infants without tuberculosis or HIV infection. This study planned to enroll 2784 infants (126 to 182 days of age) who received study vaccine or control and were followed for 15 - 36 months. The study was conducted at a single site in South Africa.


Options:
A: All-cause mortality 12 weeks after inclusion (12 weeks)
B: Tuberculosis diagnostic algorithm (3 years)
C: All-cause Mortality (6 months post-HAART initiation)
D: To Evaluate the Safety Profile of MVA85A/AERAS-485 in Bacillus Calmette-Guerin (BCG) -Vaccinated, HIV-negative Infants. (AEs recorded 28 days post-vaccination; SAEs recorded for entire study period.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Double-blinded Randomized Controlled Evaluation of MVA85A/AERAS-485 for Safety, Immunogenicity and Prevention of Tuberculosis in BCG-vaccinated, HIV-negative Infants
Brief Summary: This was a Phase II double-blinded randomized controlled evaluation of safety, immunogenicity and efficacy of MVA85A/AERAS-485 in Bacillus Calmette-Guérin (BCG) vaccinated infants without tuberculosis or HIV infection. This study planned to enroll 2784 infants (126 to 182 days of age) who received study vaccine or control and were followed for 15 - 36 months. The study was conducted at a single site in South Africa.


Options:
A: To Evaluate the Safety Profile of MVA85A/AERAS-485 in Bacillus Calmette-Guerin (BCG) -Vaccinated, HIV-negative Infants. (AEs recorded 28 days post-vaccination; SAEs recorded for entire study period.)
B: Safety evaluation through actively and passively collected data on adverse events (Up to 24 weeks)
C: The occurance and severity of local and systemic side effects will be monitored. Vital signs and local reactions will be monitored at 30 and 60 minutes after each mmunisation (and after 7 days).; Blood will be taken at: the screening visit, prior to the BCG vaccination, 1 and 4 weeks after the BCG vaccination, and also at 1,4, 8, 12 and 24 weeks after the MVA85A vaccination.
D: Safety of MVA85A (Six months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercising Together: An Intervention for Prostate Cancer Survivors and Spouses
Brief Summary: The purpose of this study is to explore the benefits of "Exercising Together"-a partnered strength training program for married couples coping with prostate cancer- on the physical and emotional health of prostate cancer survivors and their spouse and on marital quality.


Options:
A: Falls (Baseline up to 12 months)
B: Physical function (baseline, 3, 6 months)
C: Mean change in quality of life from baseline to week 12 (12 weeks)
D: Specific aim 1: To determine whether there are any changes in lymphedema in breast cancer survivors who participate in a one-year randomized exercise intervention of twice-weekly strength training, as compared to a non-exercising group. (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group Efficacy and Safety Study of Linagliptin (5 mg), Administered Orally Once Daily for at Least 52 Weeks in Type 2 Diabetic Patients in Combination With Basal Insulin Therapy
Brief Summary: The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.


Options:
A: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
B: Change from baseline in HbA1c at 24 weeks
C: Change From Baseline in HbA1c After 24 Weeks (Baseline and 24 weeks)
D: HbA1c at each visit (28 Weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group Efficacy and Safety Study of Linagliptin (5 mg), Administered Orally Once Daily for at Least 52 Weeks in Type 2 Diabetic Patients in Combination With Basal Insulin Therapy
Brief Summary: The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.


Options:
A: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
B: Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) (Baseline , Week 24)
C: 5-year Composite Endpoint of All-cause Mortality, Non-fatal Myocardial Infarction, and Stroke (Measured at Year 5)
D: Change From Baseline in HbA1c After 24 Weeks (Baseline and 24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Arthralgia and Medication Adherence in Women With Early Stage Breast Cancer Taking Aromatase Inhibitors: The Breast Cancer Adjuvant Therapy (BCAT) Longitudinal Cohort Study.
Brief Summary: RATIONALE: Gathering information over time about joint pain and stiffness from postmenopausal women with early-stage breast cancer who are receiving aromatase inhibitors may help doctors plan treatment and help patients live more comfortably.

PURPOSE: This observational epidemiologic cohort is designed to study arthralgia, patient-reported outcomes, and medication adherence in postmenopausal women with early-stage breast cancer who are receiving aromatase inhibitors.


Options:
A: Week 12 Brief Pain Inventory (BPI) Worst Pain/Stiffness Score (12 weeks post-registration)
B: Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item (Day 1 of Week 1 to Day 1 of Week 6)
C: To evaluate patient willingness to use STAR (Symptom Tracking and Reporting for Patients), an Internet-based system for cancer patients to self-report common toxicity symptoms, performance status, and quality of life. (conclusion of study); To evaluate the impact of STAR on clinical outcomes (2 years)
D: Arthralgia incidence, defined as proportion of the baseline population (those who have taken ≥ 9 doses of aromatase inhibitor [AI]) in which new or worsening joint pain or stiffness is observed at 1, 3, and 12 months after beginning AI therapy (12 months); Time to onset of arthralgia (continuous variable in weeks) among baseline population (12 months); Arthralgia point prevalence, defined as proportion of the baseline population with a score of ≥ 2 on any one dimension of the outcome measure at 1, 3, and 12 months after beginning AI therapy (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Compare Efficacy and Safety Between Quetiapine and Haloperidol in Treatment Delirium
Brief Summary: The purpose of this study is to determine whether quetiapine, and haloperidol are effective and safe in the treatment psychiatric symptoms in patients with delirium.


Options:
A: Days alive and free of delirium and coma (delirium and coma free days) (enrollment to day 21)
B: decrease in delirium rating scale and clinical global improvement (7 days)
C: Ventilator-free hours (7 days following randomisation)
D: Time from the commencement of treatment to extubation (days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Community Intervention Trial for Smoking Cessation With Intensive Advice in Diabetic Patients in Primary Health Care
Brief Summary: This study addresses an important problem in public health, smoking in diabetics. The morbidity and mortality observed in diabetics is linked to macro and microvascular problems. The consumption of tobacco has a multiplying effect on these vascular problems in diabetics. This study aims to evaluate the effectiveness of an intensive intervention in tobacco addiction in diabetic patients in primary care.


Options:
A: smoking cessation (date of surgery)
B: Smoking abstinence: Self reported abstinence (6 or more months without smoking) confirmed by an expired air carbon monoxide concentration of 6 parts per millions or less (12 months after initiation of study)
C: Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards. (6 months from participant's quit date)
D: 7-day point prevalence abstinence from smoking (6 months after enrollment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of SIS Mesh for Anterior Repair: A Pilot Study
Brief Summary: Prolapse occurs when pelvic organs drop down and cause a bulging of the tissues. An "anterior wall prolapse" occurs when the front of the vagina loses its support, and the bladder drops down and rotates into the vaginal opening. The bladder can cause a bulge out of the vagina.

One of the treatment options available is to repair the anterior wall surgically. The goals of surgery are to return the anatomy to its usual position, ensuring that all the pelvic floor organs (bladder, vagina and rectum) can function properly. The ideal surgical repair would also be long lasting.

Two surgical options are routinely performed in Calgary for repair of an anterior compartment prolapse. One option involves fixing the organs back in place using sutures. The other option uses sutures plus a mesh made of small intestine submucosa (SIS) that is already licensed for use in Canada. The SIS mesh is slowly absorbed after it is placed in the pelvic area. The investigators do not know which of these two options is the best surgical procedure. Both may have different advantages that would result in better results. This study is designed to try and find out if one of these procedures is better, and if a larger study may be needed.


Options:
A: Recurrence of anterior vaginal wall prolapse
B: Anatomical success rates 1 year after surgery to correct pelvic organ prolapse with the Avaulta synthetic mesh kit (1 year post operatively)
C: Recurrent Stage II or Greater Anterior Vaginal Prolapse (three years)
D: Objective assessment of prolapse. "Cure" is defined as point Ba (on POP-Q) of -1 or above (i.e., more negative) (12 months postoperatively)

Answer: D