TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi Protocol Investigation to Compare the Effects of Intra-dialytic Exercise on Physiological Changes and Toxin Removal in Maintenance Hemodialysis Patients
Brief Summary: Hemodialysis is a life-saving treatment for end stage renal disease patients. The chief aims of hemodialysis are solute and fluid removal. Solute removal is associated with outcome of dialysis patients. Intra-dialytic exercise has been found to improve the toxin removal and it is suggested that exercise increases the cardiac output, thus increases the blood flow to lower extremities. This leads to increased toxin removal from low blood flow regions. On the other hand, exercise can possibly dilate the vasculature and decrease the compartmental resistance. In this study, the investigators aim to investigate the exercise induced physiological changes which enhances the toxin removal. This information combined with patient specific mathematical models will encourage clinicians to opt for Optimal intra-dialytic exercise protocol. On the other hand, Hemodiafiltration is widely accepted renal replacement therapy for improved toxin removal. Hence, we intend to compare the toxin removal outcome for standalone Hemodiafiltration and intra-dialytic exercise in conventional hemodialysis.


Options:
A: Number of patients who correct the state of protein energy wasting in intervention group compared to a control group (at 6 months)
B: Quantify toxin removal (6 months)
C: Effects of aerobic training during hemodialysis on exercise tolerance and VO2 kinetics in end stage renal disease patients (3 months)
D: IRLS severity scale (24 and 48 wks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Randomized Open Label Study of Neo-Adjuvant Degarelix vs. LHRH Agonist in Prostate Cancer Patients Prior to Radical Prostatectomy
Brief Summary: To assess the effect of neo-adjuvant GnRH antagonist, degarelix, versus LHRH agonist on intratumoral levels of androgens.


Options:
A: Intratumoral androgen levels (Week 12)
B: Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) (After treatment of 12 weeks compared to Baseline); Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set) (After treatment of 12 weeks compared to Baseline)
C: Cumulative castration rate of treatment in terms of serum testosterone level (Up to one year of the treatment)
D: Median and Between Participant Variability of Time to Prostate-specific Antigen (PSA) >4 ng/mL During the First Cycle of Intermittent Androgen Deprivation (IAD) After 7 Monthly Injections of Degarelix Induction Treatment (Up to 24 months after end of induction period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Mindfulness-based Cognitive Therapy (MBCT) on Chronic Pain in Women Treated for Breast Cancer
Brief Summary: A recent epidemiologic survey has indicated that approx. 42% of Danish women treated for breast cancer experience negative sequelae in the form of pain following treatment. Chronic pain is known to be associated with impaired social and emotional functioning, and thus presents a particular concern.

Mindfulness-based intervention is among the complementary, psychological treatments, which cancer patients commonly seek out in relation to the course of their illness. Despite the popularity of mindfulness-based intervention among cancer patients, no studies have so far investigated the effect of mindfulness-based intervention on chronic pain in breast cancer patients. While no studies so far have focused on pain, there is evidence to suggest that mindfulness-based intervention is associated with improved psychosocial adaption to cancer. Furthermore, non-cancer research suggests that mindfulness-based intervention is associated with reduced pain experiences.

The aim of this project is to investigate the effect of Mindfulness-Based Cognitive Therapy (MBCT) on chronic pain in breast cancer patients. Women who have completed their treatment for breast cancer and who experience chronic pain, will be randomized to an intervention group (MBCT) or a treatment-as-usual control group. All participants will be assessed at the same time points, i.e. before the intervention (baseline), and three times after the intervention/control condition, with the last follow-up 6 months after the intervention. In addition, a number of potential moderators and mediators of the outcome will be explored. For example, recent studies indicate that adult attachment style may constitute an important moderator and/or mediator in the development of pain, and preliminary research has suggested that attachment style may moderate the effect of mindfulness-based intervention.

The results will provide valuable new knowledge about the potential of MBCT as a treatment strategy for chronic pain in breast cancer patients, will contribute to the clarification of underlying mechanisms in the experience of and coping with pain, which could help the development of more effective, individualized interventions.


Options:
A: Pain (From baseline until 6 months)
B: The efficacy of Mindfulness Based Stress Reduction on mood disorders (up to 5 years follow up)
C: Overall Survival (OS) (From date of randomization until date of death from any cause, assessed up to data cutoff date of 12 Mar 2012, or up to approximately 6 years); Progression Free Survival (PFS) (From date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date of 12 Mar 2012 or up to approximately 6 years)
D: Hot flash frequency and intensity (Baseline, 8 weeks, 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Mindfulness-based Cognitive Therapy (MBCT) on Chronic Pain in Women Treated for Breast Cancer
Brief Summary: A recent epidemiologic survey has indicated that approx. 42% of Danish women treated for breast cancer experience negative sequelae in the form of pain following treatment. Chronic pain is known to be associated with impaired social and emotional functioning, and thus presents a particular concern.

Mindfulness-based intervention is among the complementary, psychological treatments, which cancer patients commonly seek out in relation to the course of their illness. Despite the popularity of mindfulness-based intervention among cancer patients, no studies have so far investigated the effect of mindfulness-based intervention on chronic pain in breast cancer patients. While no studies so far have focused on pain, there is evidence to suggest that mindfulness-based intervention is associated with improved psychosocial adaption to cancer. Furthermore, non-cancer research suggests that mindfulness-based intervention is associated with reduced pain experiences.

The aim of this project is to investigate the effect of Mindfulness-Based Cognitive Therapy (MBCT) on chronic pain in breast cancer patients. Women who have completed their treatment for breast cancer and who experience chronic pain, will be randomized to an intervention group (MBCT) or a treatment-as-usual control group. All participants will be assessed at the same time points, i.e. before the intervention (baseline), and three times after the intervention/control condition, with the last follow-up 6 months after the intervention. In addition, a number of potential moderators and mediators of the outcome will be explored. For example, recent studies indicate that adult attachment style may constitute an important moderator and/or mediator in the development of pain, and preliminary research has suggested that attachment style may moderate the effect of mindfulness-based intervention.

The results will provide valuable new knowledge about the potential of MBCT as a treatment strategy for chronic pain in breast cancer patients, will contribute to the clarification of underlying mechanisms in the experience of and coping with pain, which could help the development of more effective, individualized interventions.


Options:
A: To assess whether MBSR favorably influences psychological status (anxiety, perceived stress, depression), quality of life, and immune status (among post-treatment breast cancer survivors) (6 weeks)
B: Pain (From baseline until 6 months)
C: Hospital Anxiety and Depression Scale (change from baseline to one month post-intervention)
D: Oral morbidity (Up to two years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Urgent vs. Early Endoscopy in High Risk Patients With UGIB
Brief Summary: Acute upper gastrointestinal bleeding (UGIB) is one of the commonest medical emergencies. The condition accounts for 150 per 100,000 populations. A National United Kingdom reported a crude overall mortality rate of 10%. While bleeding stops spontaneously in majority of patients at their presentation, there remains a subgroup of patients who continue to bleed or develop recurrent bleeding. In these patients, the mortality increases manifolds. If these high-risk patients can be identified, early interventions may improve their outcomes.

Several prognostic indices are in use for the purpose of patient stratification. They include the Rockall, Glasgow-Blatchford (GBS) and the Baylor scores. The Rockall score is a composite score which incorporates clinical parameters as well as findings during endoscopy which was derived to predict mortality. The GBS is a pre-endoscopy or a clinical score for the prediction for the need of further intervention loosely defined as the need for transfusion, endoscopy or surgery. It has been shown to be accurate in identifying low risk patients for early discharge.


Options:
A: Bleeding free probability in 30 days after randomization (30 days)
B: Mortality (30 days)
C: number of participants who presents and confirmed endoscopically as recurrent upper gastro-intestinal bleeding (30 days)
D: The primary end point was to determine the effect of erythromycin on gastric cleansing and thereby quality of endoscopic visualization, reflecting the ease with which the procedure was performed in a clear stomach. (For upto 45 minutes from start to end of endoscopy)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Surgical Intervention Study Between Adenotonsillectomy and Adenotonsillotomy in Children With Obstructive Sleep Apnea Syndrome
Brief Summary: Non-inferiority hypothesis; adenotonsillotomy is equally good as adenotonsillectomy in treating obstructive sleep apnea syndrome (OSAS) in children after one, three and ten years.


Options:
A: Difference between the three arms regarding serum IL1 beta, TNF alpha, IL2, IL6. (12 months)
B: Changes in polysomnographic parameter AHI (Apnea Hypopnea Index) (One, three and ten years)
C: Absolute percentage difference between groups of patients having pharyngitis with delayed recovery time defined by symptoms and blood sample values (crp, procalcitonin) (5 months follow up)
D: microbiologically confirmed streptococcal pharyngitis episodes

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact Evaluation of a Social Franchise Model Implemented by Alive & Thrive for Improving Infant and Young Child Feeding and Child Nutrition in Rural Vietnam
Brief Summary: Alive \& Thrive is an initiative that aims to improve infant and young child feeding practices and reduce childhood stunting. In Vietnam, Alive \& Thrive's primary intervention is implemented through a social franchise linked with the government's health system. The impact evaluation is conducted using a cluster-randomized design in which 20 commune health centers (CHC) were assigned to the social franchise model, and 20 CHC were assigned to routine government services. Repeated cross-sectional baseline and endline surveys will be used to assess the public health impact of this intervention. The baseline was in 2010 and an endline survey in the same communities will be conducted in 2014. Mixed methods process evaluation will be conducted in 2011, 2012 and 2013 to study the pathways through which the program impact is achieved.


Options:
A: Exclusive breastfeeding among children 0-6 months of age (4 years); Child heights and weights (children 24-60 months of age) (4 years); Complementary feeding for children 6-23.9 months of age (4 years)
B: Changes in degree of exclusivility of Breastfeeding (1st, 3st and 6th month postpartum)
C: Breastfeeding intensity at 1,3, and 6 months (1,3, and 6 months after birth of the baby)
D: Exclusive breastfeeding (at six month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact Evaluation of a Social Franchise Model Implemented by Alive & Thrive for Improving Infant and Young Child Feeding and Child Nutrition in Rural Vietnam
Brief Summary: Alive \& Thrive is an initiative that aims to improve infant and young child feeding practices and reduce childhood stunting. In Vietnam, Alive \& Thrive's primary intervention is implemented through a social franchise linked with the government's health system. The impact evaluation is conducted using a cluster-randomized design in which 20 commune health centers (CHC) were assigned to the social franchise model, and 20 CHC were assigned to routine government services. Repeated cross-sectional baseline and endline surveys will be used to assess the public health impact of this intervention. The baseline was in 2010 and an endline survey in the same communities will be conducted in 2014. Mixed methods process evaluation will be conducted in 2011, 2012 and 2013 to study the pathways through which the program impact is achieved.


Options:
A: Stunting-reduction in stunted children in intervention group (2 Years)
B: Exclusive breastfeeding (EBF) among children 0-6 months of age (4 years after baseline); Child anthropometry (height, weight) among children 24-48 months of age (4 years after baseline); Complementary feeding among children 6-23.9 months of age (4 years after baseline); Anemia among children 6-23.9 months (4 years after baseline)
C: Hemoglobin (Start of study (T=0), End of study (T=4months))
D: Exclusive breastfeeding among children 0-6 months of age (4 years); Child heights and weights (children 24-60 months of age) (4 years); Complementary feeding for children 6-23.9 months of age (4 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact Evaluation of a Social Franchise Model Implemented by Alive & Thrive for Improving Infant and Young Child Feeding and Child Nutrition in Rural Vietnam
Brief Summary: Alive \& Thrive is an initiative that aims to improve infant and young child feeding practices and reduce childhood stunting. In Vietnam, Alive \& Thrive's primary intervention is implemented through a social franchise linked with the government's health system. The impact evaluation is conducted using a cluster-randomized design in which 20 commune health centers (CHC) were assigned to the social franchise model, and 20 CHC were assigned to routine government services. Repeated cross-sectional baseline and endline surveys will be used to assess the public health impact of this intervention. The baseline was in 2010 and an endline survey in the same communities will be conducted in 2014. Mixed methods process evaluation will be conducted in 2011, 2012 and 2013 to study the pathways through which the program impact is achieved.


Options:
A: Neonatal mortality rate (deaths within 28 days of birth)
B: Exclusive breastfeeding among children 0-6 months of age (4 years); Child heights and weights (children 24-60 months of age) (4 years); Complementary feeding for children 6-23.9 months of age (4 years)
C: Complications detected (3 days after delivery); Successful referrals (10 days after delivery (survey and administrative records)); Care Seeking Behavior around complications and well baby check-up (10 days after delivery (survey)); Knowledge of danger signs (10 days after delivery (survey)); Breastfeeding (10 days and 9 weeks after delivery (survey))
D: perinatal mortality (Jan 1999-Dec 2003)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Preference, Acceptability, and Palatability of Alternative Delivery Vehicles for Prenatal Calcium Supplementation Among Pregnant Women in Bangladesh
Brief Summary: The SickKids-led research team is currently developing a prenatal micronutrient powder that will contain calcium, iron, and folic acid with different absorption characteristics. Once the powder is developed, it can be incorporated into various oral delivery vehicles. The overall effectiveness of a micronutrient program is highly dependent on the acceptance and regular consumption of supplements (i.e., adherence) by the targeted users. This is a study of the preference, acceptability, and palatability of 4 alternative delivery vehicles for the innovative prenatal multiple micronutrient supplement: traditional tablets, oral disintegrating tablets, unflavoured powder with a suspension agent, and flavoured powder with a suspension agent. This study will be conducted in Dhaka, Bangladesh. This study hypothesizes that that the formulation of the delivery vehicle will impact preference, acceptability, and palatability.


Options:
A: Frequency of Consumption of the Calcium Vehicle (Change from Baseline in Consumption of the Calcium Vehicle at day 22)
B: Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness. (2 years)
C: Perinatal mortality, i.e., the number of stillbirths (fetal deaths of 28 weeks or more of gestation) and the number of deaths within the first 0-6 days of life per 1000 births (live births and stillbirths) (20 weeks gestation to 6 days postpartum)
D: Hemoglobin (February 2007-February 2008)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma:a Randomized, Double-blind, Multicenter, Controlled Clinical Trial.
Brief Summary: To evaluate the efficacy and safety of a fixed-dose, single-capsule budesonide(400µg)-formoterol(12µg) combination, in comparison with budesonide alone, both delivered via a dry powder inhaler, in 181 patients with uncontrolled asthma.This was Randomized, double-blind, multicenter, phase III, parallel clinical trial.


Options:
A: Change in evening PEF (Daily throughout the 12 week treatment period)
B: The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1. (Measured during the last 12 weeks of each 16-week treatment period)
C: Change in Forced Expiratory Volume in 1 s(FEV-1) from Baseline (Week 0) to Week 12. (Week 0 and 12 visits); Discontinuation due to lack of efficacy. (Whole duration of study)
D: Evaluation of the efficacy and safety of a fixed-dose, single capsule budesonide-formoterol combination in comparison with budesonide alone in patients with uncontrolled asthma (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma:a Randomized, Double-blind, Multicenter, Controlled Clinical Trial.
Brief Summary: To evaluate the efficacy and safety of a fixed-dose, single-capsule budesonide(400µg)-formoterol(12µg) combination, in comparison with budesonide alone, both delivered via a dry powder inhaler, in 181 patients with uncontrolled asthma.This was Randomized, double-blind, multicenter, phase III, parallel clinical trial.


Options:
A: To demonstrate the efficacy in terms of the Formoterol fumarate component of SKP FlutiForm HFA pMDI (250/10ug) compared to SKP Fluticasone HFA pMDI (250ug), on the change in FEV1 from morning pre-dose at Baseline (Week 0) to 2 hours post-dose at Week 12. (Week 0 and 12 visits)
B: Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period (Baseline to 12 weeks)
C: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Week 12)
D: Evaluation of the efficacy and safety of a fixed-dose, single capsule budesonide-formoterol combination in comparison with budesonide alone in patients with uncontrolled asthma (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma:a Randomized, Double-blind, Multicenter, Controlled Clinical Trial.
Brief Summary: To evaluate the efficacy and safety of a fixed-dose, single-capsule budesonide(400µg)-formoterol(12µg) combination, in comparison with budesonide alone, both delivered via a dry powder inhaler, in 181 patients with uncontrolled asthma.This was Randomized, double-blind, multicenter, phase III, parallel clinical trial.


Options:
A: Difference in mean FEV1 between the two groups at 1, 5, 10, 30, 60 minutes (60 min)
B: Asthma control assessed by asthma exacerbations (Continuosly throughout the treatment period)
C: Evaluation of the efficacy and safety of a fixed-dose, single capsule budesonide-formoterol combination in comparison with budesonide alone in patients with uncontrolled asthma (12 weeks)
D: Change in PD20 histamine

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma:a Randomized, Double-blind, Multicenter, Controlled Clinical Trial.
Brief Summary: To evaluate the efficacy and safety of a fixed-dose, single-capsule budesonide(400µg)-formoterol(12µg) combination, in comparison with budesonide alone, both delivered via a dry powder inhaler, in 181 patients with uncontrolled asthma.This was Randomized, double-blind, multicenter, phase III, parallel clinical trial.


Options:
A: Evaluation of the efficacy and safety of a fixed-dose, single capsule budesonide-formoterol combination in comparison with budesonide alone in patients with uncontrolled asthma (12 weeks)
B: Change in Forced Expiratory volume in 1 s (FEV-1) from morning predose at Baseline (Week 0) to predose at Week 12 (Week 0 and 12)
C: Change in Forced Expiratory Volume in 1 s(FEV-1) from Baseline (Week 0) to Week 12. (Week 0 and 12 visits); Discontinuation due to lack of efficacy. (Whole duration of study)
D: Change in Forced Expiratory Volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy (Week 0 and 12 visits)

Answer: A