TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases
Brief Summary: Inflammatory bowel disease (IBD) is a chronic, debilitating, relapsing inflammatory disorder affecting the gastrointestinal tract which does not have a medical cure. IBD consists of 2 different forms: Crohn's Disease (CD) and Ulcerative Colitis (UC). In the last 2 decades, Gut Microbial Transplantation (GMT), also known as fecal transplantation, has been used as a treatment option for Clostridium difficile colitis and UC. The literature supports strong evidence for the plausibility of using GMT for patients with IBD associated colitis, especially for patients with UC.

This research will be conducted in the Helen DeVos Children's Hospital (HDVCH) Pediatric gastrointestinal outpatient clinic. A pilot study of ten patients will be conducted to evaluate if GMT improves clinical symptoms in patients with IBD. Patients with IBD colitis (UC and CD with colonic involvement only) will be approached for GMT as a treatment option for their disease. Each subject will undergo 5 sessions (1 session/day, and not necessarily on consecutive days) of GMT within a period of 10 days. Post treatment evaluation will be done at their regularly scheduled clinic follow up.

Healthy donors \>18 years of age will be chosen by the family, inclusive of immediate family members and friends. Donors will be required to complete a screening questionnaire, provide medical history, and undergo blood and stool tests.


Options:
A: Feasibility (Composite Measure) (30 weeks)
B: The primary outcome of the randomized trial will remission of UC with colonic mucosa healing defined as Mayo endoscopy score = 0 at 6 weeks (Subjects will have a sigmoidoscopy, physician assessment and complete a Mayo score and IBDQ questionnaire at baseline, week 3 (no sigmoidoscopy is required), week 6 at exit from the study.)
C: The evaluation of the safety of HBT (13 Weeks post HBT); To determine the cure rate without recurrence of CDI at 13 weeks from the last HBT. (13 Weeks post HBT)
D: Clinical Response (4 weeks following GMT Treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases
Brief Summary: Inflammatory bowel disease (IBD) is a chronic, debilitating, relapsing inflammatory disorder affecting the gastrointestinal tract which does not have a medical cure. IBD consists of 2 different forms: Crohn's Disease (CD) and Ulcerative Colitis (UC). In the last 2 decades, Gut Microbial Transplantation (GMT), also known as fecal transplantation, has been used as a treatment option for Clostridium difficile colitis and UC. The literature supports strong evidence for the plausibility of using GMT for patients with IBD associated colitis, especially for patients with UC.

This research will be conducted in the Helen DeVos Children's Hospital (HDVCH) Pediatric gastrointestinal outpatient clinic. A pilot study of ten patients will be conducted to evaluate if GMT improves clinical symptoms in patients with IBD. Patients with IBD colitis (UC and CD with colonic involvement only) will be approached for GMT as a treatment option for their disease. Each subject will undergo 5 sessions (1 session/day, and not necessarily on consecutive days) of GMT within a period of 10 days. Post treatment evaluation will be done at their regularly scheduled clinic follow up.

Healthy donors \>18 years of age will be chosen by the family, inclusive of immediate family members and friends. Donors will be required to complete a screening questionnaire, provide medical history, and undergo blood and stool tests.


Options:
A: Clinical Response (4 weeks following GMT Treatment)
B: Clinical remission (Up to one year)
C: Recurrence of CDI up to 8 Weeks (Up to Week 8)
D: The primary outcome of the randomized trial is remission of UC defined as a Mayo score < 3 with an endoscopic Mayo score = 0 at the end of the trial Transplant Therapy in Ulcerative Colitis (9 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: This Was a Five-year Seven-site Trial to Study the Cost-effectiveness of a Population Based Disease Management Program for Late Life Depression in Primary Care.
Brief Summary: Purpose: To determine the effectiveness of the Improving Mood-Promoting Access to Collaborative Treatment(IMPACT) collaborative care management program for late-life depression.


Options:
A: Depressive symptoms reduction (Measured at months 6 and 12)
B: Generic Mental Health-Related Quality of Life (Measured 8 months post-CABG)
C: Change in Mental Health-related Quality of Life From Baseline to 24 Weeks (Baseline, 24 weeks)
D: Severity of depression symptoms

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Time Required to Remain Sitting After Spinal Anesthesia for 50% of Patients to Not Experience Hypotension
Brief Summary: Hypotension is extremely common after induction of spinal anesthesia for cesarean delivery. Anesthetic blockade of the sympathetic outflow of the spinal cord causes vasodilation, and is one cause of this hypotension. The higher the spread of the blockade will result in a higher incidence of hypotension. Injected hyperbaric medication has about 15 minutes to spread within the intrathecal space before it will be taken up by the nerve roots. The time that a patient remains in one position after medication injection will affect the spread of the resultant anesthetic block. A patient who is left sitting for a longer period of time after injection of hyperbaric medication will have a lower level of block than someone who is placed supine immediately. In this study, the investigators wish to use up down sequential analysis to determine the time period a patient should remain seated after intrathecal injection of hyperbaric bupivacaine that will result in a 50% rate of hypotension.


Options:
A: Early Profound Fetal Bradycardia (Within 30 minutes of combined spinal epidural (CSE) placement)
B: The time required to remain sitting after spinal anesthesia (start with 3 minutes after completion of spinal then we ll go up or down)
C: Incidence of hypotension (Time between induction of spinal anesthesia until delivery)
D: Frontal lobe cerebral oxygenation (Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour); Foetal heartrate (Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Time Required to Remain Sitting After Spinal Anesthesia for 50% of Patients to Not Experience Hypotension
Brief Summary: Hypotension is extremely common after induction of spinal anesthesia for cesarean delivery. Anesthetic blockade of the sympathetic outflow of the spinal cord causes vasodilation, and is one cause of this hypotension. The higher the spread of the blockade will result in a higher incidence of hypotension. Injected hyperbaric medication has about 15 minutes to spread within the intrathecal space before it will be taken up by the nerve roots. The time that a patient remains in one position after medication injection will affect the spread of the resultant anesthetic block. A patient who is left sitting for a longer period of time after injection of hyperbaric medication will have a lower level of block than someone who is placed supine immediately. In this study, the investigators wish to use up down sequential analysis to determine the time period a patient should remain seated after intrathecal injection of hyperbaric bupivacaine that will result in a 50% rate of hypotension.


Options:
A: Frontal lobe cerebral oxygenation (Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour); Foetal heartrate (Participants will be followed for the time in the operation theatre of the hospital stay, an expected average of 1 hour)
B: The time required to remain sitting after spinal anesthesia (start with 3 minutes after completion of spinal then we ll go up or down)
C: Early Profound Fetal Bradycardia (Within 30 minutes of combined spinal epidural (CSE) placement)
D: Number of Participants with Adverse Events as a Measure of Safety and Tolerability" (day 1)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Maternal Analgesia for Procedural Pain in Preterm Neonates: Does It Remain Efficacious?
Brief Summary: Mothers can provide pain relief to their newborns, even in the context of intensive neonatal care. There is a recent accumulation of data, being analyzed by ourselves in a Cochrane review, that mothers holding their infants in a bare-chested skin-to-skin position, known as Kangaroo Mother Care (KMC), is effective in diminishing pain response during a single painful procedure. While evidence is compelling, leading to recommendations for its use, to date there is not a single study on the repeated efficacy to reduce pain. Current guidelines recommend sweet taste for minor painful procedures. Although there is some controversy about its continued use in this population based on one study with negative neurodevelopmental outcomes as well as its potential interaction with dopaminergic development, oral sucrose (sweet taste) remains efficacious in decreasing pain response over several weeks. The combination of KMC and sucrose is marginally more potent, but again, long term use remains unstudied.

AIMS. To test the repeated efficacy in diminishing pain from heel lance of KMC compared to usual care (sucrose), and of KMC in combination with sucrose by examining each condition at least three times during NICU stay. A secondary aim is to compare these interventions on neurodevelopment at discharge from the NICU.


Options:
A: Painful response as assessed by PIPP Scale (Pre procedure,Intra procedure,post 30 sec,post 1 min,post 2 minutes)
B: Premature Infant Pain Profile (two hours)
C: Pain measured on PIPP (Premature Infant Pain Profile) scale (4 week to complete)
D: Premature Infant Pain Profile (PIPP) (At the moment of painful procedure)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Breastfeeding Promotion RCT and Child Metabolic Syndrome
Brief Summary: The overall goal of the PROBIT study is to investigate the influence of a randomized breastfeeding promotion intervention designed to increase the duration and exclusivity of breastfeeding ("the breastfeeding promotion intervention") on the development of maternal and child health outcomes. The hypothesis is that randomization to the intervention will be associated with lower child adiposity, lower risk of asthma and atopy, improved lung function, and improved cognitive outcomes.


Options:
A: Infant Feeding Questionnaire (4 weeks)
B: Frequency of exclusive and total breastfeeding (First year)
C: Gastrointestinal tract infection (12 months of age)
D: Any breastfeeding (yes/no) at 3 months (Three months); Exclusive breastfeeding (yes/no) at 3 months (Three months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Breastfeeding Promotion RCT and Child Metabolic Syndrome
Brief Summary: The overall goal of the PROBIT study is to investigate the influence of a randomized breastfeeding promotion intervention designed to increase the duration and exclusivity of breastfeeding ("the breastfeeding promotion intervention") on the development of maternal and child health outcomes. The hypothesis is that randomization to the intervention will be associated with lower child adiposity, lower risk of asthma and atopy, improved lung function, and improved cognitive outcomes.


Options:
A: Study the effect of a standard two-encounter postnatal lactation counseling protocol on the initiation and maintenance of exclusive breastfeeding in mothers
B: Gastrointestinal tract infection (12 months of age)
C: Breastfeeding at 3 months and at 6 months (3 months and six months)
D: Percent of infants breastfed exclusively (4 weeks of age); Daily volume of formula supplement received by mixed feeders (at 4 weeks of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Complementary Food Supplements For Reducing Childhood Undernutrition: The JiVitA-4 Study
Brief Summary: The purpose of this study is to test the impact on child growth of three specially formulated complementary food supplements vs. Plumpy'Doz, a previously tested, commercially available complementary food, and vs. a control group that receives no food. All groups will receive nutrition education related to infant and young child feeding. This will be a cluster-randomised trial in children 6-18 months old in rural Rangpur and Gaibandha in Bangladesh.


Options:
A: Change in Child Physical Activity (Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.); Change in Child Dietary Intake (Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.)
B: Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE (6 weeks)
C: Stunting in Children at 18 mo (18 months of age)
D: fasting blood glucose (Baseline to 10 months postpartum); weight (body mass index) (Baseline to 10 months postpartum)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Complementary Food Supplements For Reducing Childhood Undernutrition: The JiVitA-4 Study
Brief Summary: The purpose of this study is to test the impact on child growth of three specially formulated complementary food supplements vs. Plumpy'Doz, a previously tested, commercially available complementary food, and vs. a control group that receives no food. All groups will receive nutrition education related to infant and young child feeding. This will be a cluster-randomised trial in children 6-18 months old in rural Rangpur and Gaibandha in Bangladesh.


Options:
A: body mass index (three years)
B: Change in fruit, vegetable, whole grain in the lunch sack from baseline to 6 weeks, 22 weeks, and 28 weeks (Baseline, 6 weeks, 22 weeks, 28 weeks)
C: Stunting in Children at 18 mo (18 months of age)
D: BMI z-score (via measured weight and height) of preschooler (~2 years post baseline)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Complementary Food Supplements For Reducing Childhood Undernutrition: The JiVitA-4 Study
Brief Summary: The purpose of this study is to test the impact on child growth of three specially formulated complementary food supplements vs. Plumpy'Doz, a previously tested, commercially available complementary food, and vs. a control group that receives no food. All groups will receive nutrition education related to infant and young child feeding. This will be a cluster-randomised trial in children 6-18 months old in rural Rangpur and Gaibandha in Bangladesh.


Options:
A: Stunting in Children at 18 mo (18 months of age)
B: Child percent body fat after the 8-month intervention period, controlling for baseline percent body fat. Percent body fat will be calculated using Dezenberg's equation which takes into account child height, weight, gender, race, and tricep skinfolds. (baseline, 8 months and 14 months)
C: Maintenance of a Child's Body Mass Index as a result of the intervention (up to two years)
D: Child anthropometry (Baseline. Up to 12 months. Up to 24 months.); Child food intake (Baseline. Up to 12 months. Up to 24 months.); Child health (Baseline. Up to 12 months. Up to 24 months.); Distribution of food intake within the household (Baseline. Up to 12 months. Up to 24 months.); Household food security (Baseline. Up to 12 months. Up to 24 months.); Maternal nutrition knowledge (Baseline. Up to 12 months. Up to 24 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Complementary Food Supplements For Reducing Childhood Undernutrition: The JiVitA-4 Study
Brief Summary: The purpose of this study is to test the impact on child growth of three specially formulated complementary food supplements vs. Plumpy'Doz, a previously tested, commercially available complementary food, and vs. a control group that receives no food. All groups will receive nutrition education related to infant and young child feeding. This will be a cluster-randomised trial in children 6-18 months old in rural Rangpur and Gaibandha in Bangladesh.


Options:
A: Infant weight for height (One year after study entry)
B: Vitamin D plasma concentrations (12 months)
C: Stunting in Children at 18 mo (18 months of age)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Complementary Food Supplements For Reducing Childhood Undernutrition: The JiVitA-4 Study
Brief Summary: The purpose of this study is to test the impact on child growth of three specially formulated complementary food supplements vs. Plumpy'Doz, a previously tested, commercially available complementary food, and vs. a control group that receives no food. All groups will receive nutrition education related to infant and young child feeding. This will be a cluster-randomised trial in children 6-18 months old in rural Rangpur and Gaibandha in Bangladesh.


Options:
A: Increase physical activity (2010); Increase the intake of fiber (2010); Decrease fat intake (2010); Decrease television and other screen time (2010); Decrease obesity (2010)
B: Provision of flesh-food or vitamin A-rich food (Change from baseline to 5 months)
C: Stunting in Children at 18 mo (18 months of age)
D: BMI z score (24 months (end of intervention)); BMI z score (60 months of age (followup at 5 years of age)); BMI z score (Follow-up at 11 years of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Behavioral Therapy for Anxiety Disorders in Adolescents With Autism
Brief Summary: Due to the considerable prevalence of anxiety in youth with autism spectrum disorders, this study seeks to establish the efficacy of a modified cognitive behavioral therapy protocol in 50 adolescents versus other available treatment options.


Options:
A: Change from Baseline in anxiety severity on the Hamilton Anxiety Scale after 16 weeks of treatment. (After 16 weeks of treatment)
B: Score on anxiety diagnostic interview after treatment or waitlist (post-treatment); Score on anxiety rating scale after treatment or waitlist (post-treatment)
C: Pediatric Anxiety Rating Scale (After an average of 16 weeks (Post-treatment))
D: Change in Repetitive Behavior Scale (RBS_SCR) (Assessment occurred at baseline and 2 weeks following end of treatment, as well as at follow-up (6 months following the cessation of treatment)); Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) (Assessment occurred at baseline and 2 weeks following end of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Behavioral Therapy for Anxiety Disorders in Adolescents With Autism
Brief Summary: Due to the considerable prevalence of anxiety in youth with autism spectrum disorders, this study seeks to establish the efficacy of a modified cognitive behavioral therapy protocol in 50 adolescents versus other available treatment options.


Options:
A: Pediatric Anxiety Rating Scale (After an average of 16 weeks (Post-treatment))
B: Changes in dental anxiety (3 months and 12 months from baseline)
C: DSM-IV criteria for Separation Anxiety Disorder (December 2009); Global Success Rating (GSR) (December 2009); Separation Anxiety Inventory for Children (SAI) (December 2009)
D: Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP). (Change from baseline interview results at 14 weeks); Anxiety Disorders Interview Schedule for DSM-IV: Parent & Child interview schedule (ADIS/CP). (Change from baseline interview results at 3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Evaluation Of NCLE in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas
Brief Summary: This study focuses on three different lesions: pancreatic cysts, lymph nodes near the gastrointestinal tract and pancreatic masses.

On one hand, the results obtained during previous studies are more advanced for the assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have already been performed, and an interpretation criteria classification exists. On the other hand, results for pancreatic masses and Lymph nodes are less developed.

The study therefore comprises two sub-studies, one on the pancreatic cysts, and another on pancreatic masses and lymph nodes.

1. Cysts The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows better characterization of pancreatic cysts and improves appropriate therapeutic decision-making.

   For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could impact patient management by :
   * Ruling out malignancy for patients with benign appearing nCLE images.
   * Characterizing more malignant tumors in the pancreas.
2. Pancreatic masses and Lymph nodes The primary hypothesis of the study is that in vivo imaging of lymph-nodes near the gastrointestinal tract and pancreatic masses during EUS-FNA procedures is feasible and that descriptive criteria can be defined to further differentiate the different types of lesions.


Options:
A: Value of endoscopic ultrasound elastography for the differential diagnoses of pancreatic masses. (18 months)
B: number of passes (up to 12 months)
C: Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts (Within 6 months after the end of Follow-up period); Descriptive criteria in nCLE sequences for the characterization of pancreatic masses and lymph nodes (Within one year after the end of the follow-up period)
D: Compare the degree of cytologic quality in specimen obtained by EUS-FNA with or without suction, pushing the stylet or injecting air. (within 6 months)

Answer: C