linjc16/ctgov huggingface dataset:
Spine Quantitative Computed Tomography (QCT)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare healthy children to children who have a chronic illness called Juvenile Idiopathic Arthritis (JIA). JIA is a childhood disease that causes swollen joints that are often stiff and painful. JIA affects about 1 in 1,000 children age 16 and younger.

Detailed Description
-----------------
Children with chronic illnesses are at risk for bone fragility due to inflammation, glucocorticoid therapy, physical activity limitation, malnutrition, and pubertal delay. The impact of low bone mass during childhood may be immediate, resulting in childhood fractures, or delayed, due to suboptimal peak bone mass attainment.

Official Title
-----------------
Spine Quantitative Computed Tomography (QCT) for the Assessment of Osteoporosis on Children

Conditions
-----------------
Juvenile Idiopathic Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: for JIA patients: subjects age 5-21 Drawn from Dr. Burnham's prospective cohort study of bone health in 101 children with arthritis. for Control patients: subjects age 5-21 Controls will be a 50% male/female Exclusion Criteria: for JIA patients: Subjects with JIA will be excluded if they have conditions or drug exposure unrelated to JIA and known to impact growth or bone health. for Control patients: Chronic disease or syndrome known to affect growth or bone health, prematurity (<37 weeks gestation), or use of any medication known to affect growth.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No treatment<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lumbar spine volumetric Bone Mineral Density (vBMD) and vertebral size will vary according to sex, age and pubertal stage. |  | same day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children with JIA will have lower vertebral stiffness and strength, compared with controls. |  | same day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Juvenile Idiopathic Arthritis, JIA, Arthritis, Osteoporosis, Osteoporosis in Children
Xeloda Vs Monitoring in Advanced Colorectal Cancer Responsive to Chemotherapy

Study Overview
=================
Brief Summary
-----------------
To compare maintenance chemotherapy with Xeloda to control after best response with first line chemotherapy in advanced colorectal cancer. Main endpoint is progression free survival. A total of 300 patients will be included.

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Procedure: Monitoring
* Procedure: Xeloda


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with metastatic colorectal cancer (confirmed histologically) with objective response or stabilization after at least 6 cycles of first line chemotherapy (treatment of choice is selected freely by the investigator according to the recommendations and consensus in force), The interval between completion of first line chemotherapy and randomization should not exceed 4 weeks Age>18 years ECOG status 0 to 2 Biological criteria prior to any chemotherapy: Neutrophils>1.5 109 g/l, platelets>100 109/l, haemoglobin>10 g/dl, Creatininaemia<150 mol/l, bilirubinaemia<2x normal level Signed informed consent Life expectancy > 3 months Exclusion Criteria: Metastatic colorectal cancer treated with more than one modality of first line chemotherapy (including oral fluoropyrimidines) Tumour progression after first line chemotherapy or before randomization Other tumour pathology Symptomatic cerebral metastases Any severe uncontrolled disease in addition to colorectal cancer (in particular decompensated cardiac failure (LVEF<50%) or coronary insufficiency) Lack of integrity of the upper GI tract: malabsorption syndrome or major surgery of the stomach or the small intestine Severe renal impairment (creatinine clearance < 30 ml/min) Severe psychiatric disorder (other than controlled depressive syndrome) Patient participating in another experiment Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Monitoring|nan|
|Procedure: Xeloda|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Opioid Rotation From Morphine to Methadone in Treatment of Non-malignant Pain

Study Overview
=================
Brief Summary
-----------------
Patients with non-malignant pain are switched from morphine to methadone with a nine-months' follow-up.

Detailed Description
-----------------
Twelve patients with poor pain control or unacceptable side effects during treatment with morphine were switched to methadone and followed for nine months in this open prospective study. Primary outcomes were patient preference for opioid and pain control while physical, cognitive and role functioning were secondary outcomes. The morphine dose was decreased by 1/3 daily and was replaced with an equianalgesic dose of methadone over a three-day period. During switching and a one-week dose titration period, patients were given additional methadone if required. During dose titration one patient experienced sedation requiring naloxone. Four patients were switched back to morphine due to poor pain control, drowsiness or sweating. Seven patients preferred long-term (>nine months) treatment with methadone and reported reduced pain and improved functioning while cognition was not improved. This study brings novel information on the long-term consequences for pain control, health-related quality of life and cognitive functioning with a switch from morphine to methadone in the treatment of chronic non-malignant pain.

Official Title
-----------------
Opioid Switching From Oral Slow Release Morphine to Oral Methadone May Improve Pain Control in Chronic Non-malignant Pain: a Nine-month Follow-up Study.

Conditions
-----------------
Non-malignant Chronic Pain

Intervention / Treatment
-----------------
* Drug: Methadone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-70 years of age non-malignant chronic pain morphine use Exclusion Criteria: addiction kidney disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: switch from morphine to methadon<br> | Drug: Methadone<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain |  | 9 months |
Finding Ideal Blood Culture Volume in NICU

Study Overview
=================
Brief Summary
-----------------
The investigators want to assess the effectivity of different sample volumes in blood cultures.

Detailed Description
-----------------
The investigators intend to compare yield of 0.5ml sample x2 vs 0.25 ml samples x2 (aerobic and anaerobic media for each volume) taken from the sample taken from the same site and time. Time to positivity will also be compared, as well as possible contamination rates.

Official Title
-----------------
Finding Ideal Blood Culture Volume in NICU

Conditions
-----------------
Ideal Sample Volume for Blood Cultures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected sepsis Exclusion Criteria: Need for extra puncture in order to withdraw enough blood for the second set of cultures. Urgent need for antibiotic without time for cultures.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive blood cultures of each group |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to positivity for each group |  | 2 years | 
| Suspected contamination rate |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neonatal sepsis
Study of Prognostic Factors in Patients Admitted to ICU for Stroke

Study Overview
=================
Brief Summary
-----------------
Outcome of stroke patients admitted to the intensive care unit the intensive care unit (ICU) is poor and haemorrhagic stroke, fixed dilated pupil(s) and GCS <10 are associated with increased mortality and poor functional outcome. However little is known about the impact of clinical events occuring during the ICU stay (ventilator acquired pneumoniae, shock, dysglycemia....). The objective of this study was to determine the mortality rate and the functional outcomes of stroke patients admitted to ICU and to identify predictors of poor outcome in this population.

Official Title
-----------------
Study of Prognostic Factors in Patients Admitted to ICU for Stroke

Conditions
-----------------
Stroke, Critically Ill

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute stroke ICU admission for acute stroke 1 organ dysfunction : coma, shock, respiratory failure Exclusion Criteria: refuse participation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | through ICU hospitalization, an average of one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality | At 90 days | 
| Functional outcome: Modified Rankin Score | Modified Rankin Score (0: no symptoms at all; 6: dead) | at hospitalization discharge, an average of three months |
The Effect of Tympanostomy Tube Insertion on Sleep in Children With Chronic Otitis Media With Effusion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the prevalence of sleep disturbances in children with Chronic Otitis Media with Effusion (COME) and the effect of tympanostomy tube insertion (TTI) on sleep disturbances.

Detailed Description
-----------------
Comparison of sleep disturbances will be between infants with Chronic Otitis Media with Effusion (COME) who will be referred for tympanostomy tube insertion (TTI) (study group) and healthy infants that were recruited from the community well-baby clinics (control group). To evaluate sleep patterns, parents of the study group will complete two validated sleep questionnaires assessing the infant's typical sleep patterns based on parental reports. A week before TTI and 1 week to 1 month after the surgery, sleep will be evaluate by actigraph for a week long.

Official Title
-----------------
The Effect of Tympanostomy Tube Insertion on Sleep in Children With Chronic Otitis Media With Effusion

Conditions
-----------------
Chronic Otitis Media With Effusion, Sleep Disturbances

Intervention / Treatment
-----------------
* Device: Actigraphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 6-36 months Referred for tympanostomy tube insertion as a treatment for COME. Exclusion Criteria: Snoring and sleep disordered breathing (SDB) Chronic medical condition referred for TTI and adenoidectomy/tonsillectomy

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 36 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Infants with COME who will be referred for TTI will undergo actigraphy for 7 consecutive nights prior to TTI and for 7 consecutive nights 4-6 weeks following TTI. | Device: Actigraphy<br>* Actigraphy will be conducted for each participant for 7 consecutive nights prior to TTI and for 7 consecutive nights 4-6 weeks following TTI.<br>|
| Healthy infants<br>Healthy infants that were recruited from the community well-baby clinics. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actigraphy measurements |  | Up to two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OSA-18 questionnaire score |  | Up to two years | 
| Brief Infant Sleep Questionnaire (BISQ) score |  | Up to two years |
Branched-chain Amino Acids, and Resistance Exercise on Skeletal Muscle Signaling Pathways

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the effects of leucine and branched-chain amino acids supplementation on skeletal muscle remodeling signaling pathways induced by resistance exercise.

Official Title
-----------------
Effects of Leucine, Branched-chain Amino Acids, and Resistance Exercise on Skeletal Muscle Remodelling Signaling Pathways: a Randomized, Double-blind, and Placebo-controlled Study

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Leucine supplementation
* Dietary Supplement: BCAA supplementation
* Dietary Supplement: Alanine supplementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sedentaries Must be able to exercise Must be able to swallow tablets Exclusion Criteria: Use of nutritional supplements Use of anti-inflammatory drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Leucine<br> | Dietary Supplement: Leucine supplementation<br>* 1 bout of resistance exercise and supplementation of 4.0 g of leucine + 5.6 g of alanine<br>|
| Experimental: BCAA<br> | Dietary Supplement: BCAA supplementation<br>* 1 bout of resistance exercise and supplementation of 4.0 g of leucine + 2.8 g of isoleucine + 2.8 g of valine<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Alanine supplementation<br>* 1 bout of resistance exercise and supplementation of 9.6 g of alanine<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein synthesis | Phosphorylation of proteins involved in protein synthesis | 1 hour | 
| Protein degradation | Expression of protein involved in proteolytic pathway | 1 hour | 
| Inflammation | Expression of systemic and muscular cytokines | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
leucine supplementation, BCCA supplementation, resistance exercise-induced muscle remodeling
Pre-approval Single-patient Expanded Access for Elranatamab (PF-06863135)

Study Overview
=================
Brief Summary
-----------------
Provide pre-approval single-patient Expanded Access (Compassionate Use) of elranatamab for patients with relapsed/refractory multiple myeloma

Detailed Description
-----------------
In Expanded Access, treating physicians are the Sponsors Expanded Access requests from treating physicians should be directed to www.pfizercares.com Availability will depend on location.

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Elranatamab


Participation Criteria
=================
Eligibility Criteria
-----------------
Must have relapsed/refractory multiple myeloma (RRMM) and be refractory to at least one immunomodulatory drug, one proteasome inhibitor and one anti-CD38 antibody. Must have evidence of disease progression after last therapy. Must have exhausted all available treatment options accessible as local standard of care and not be eligible for participation in any ongoing clinical trial. Additional eligibility criteria may be required.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Elranatamab|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
refractory, relapsed
Endoscopic Vacuum Therapy for Transmural Defects in the Upper Gastrointestinal Tract

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to learn about the best indications and techniques regarding endoscopic vacuum therapy (EVT) in patients with a transmural defect in the upper gastrointestinal (GI) tract (e.g. anastomotic leakage, Boerhaave syndrome, iatrogenic perforation, other). The main questions it aims to answer are: What is the success rate of EVT for transmural defects in the upper GI tract? What are the best indications for EVT in the upper GI tract? (e.g. etiology, patient characteristics, defect characteristics) What are the best techniques for EVT in the upper GI tract? (e.g. EsoSponge, VACStent, vacuum pressure, intraluminal/intracavitary) Participants will be asked for informed consent to retrospectively and prospectively collect data on EVT.

Official Title
-----------------
Endoscopic Vacuum Therapy for Anastomotic Leakage After Upper Gastrointestinal Surgery / Endoscopic Vacuum Therapy for Esophageal Perforation: A Multicenter Retrospective Cohort Study

Conditions
-----------------
Endoscopic Vacuum Therapy, Anastomotic Leak, Esophageal Perforation, Esophageal Perforation, Traumatic, EsoSponge, VACStent

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treated with EVT for anastomotic leakage after esophago-gastric surgery Signed informed consent form 18 years or older Exclusion Criteria: No signed informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anastomotic leakage after gastrointestinal surgery<br>No interventions will be administered, as this is an observational study. | Other: Observational<br>* Collection of data from electronic health record<br>|
| Esophageal perforation (Boerhaave syndrome, iatrogenic, trauma, other)<br>No interventions will be administered, as this is an observational study. | Other: Observational<br>* Collection of data from electronic health record<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate |  | 1-3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 1-3 years | 
| Adverse events |  | 1-3 years | 
| Treatment specifics | Including number of EVT-related endoscopies, number of used sponges/VACStents | 1-3 years | 
| Treatment specifics | Including days between exchanges, duration of treatment in days, hospital stay in days, ICU stay in days | 1-3 years |
Pre-Market Algorithm Validation Study

Study Overview
=================
Brief Summary
-----------------
The study sponsor has developed a patented medical device called Seipher Wellness. This is a non-invasive medical device that assesses heart health based on established cardiac parameters; timing events of the cardiac cycle. These are specific parameters captured and analyzed by the device. A ratio of two specific timing parameters provides an assessment of the subject's overall heart health. The aim of this study is to validate the device algorithm across a range of subjects.

Official Title
-----------------
Pre-Market Algorithm Validation Study

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: Seipher Wellness


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older able to understand the informed consent document willing to participate ambulatory volunteers Exclusion Criteria: individuals with visible scar(s) or deformity in the test area of the chest non-ambulatory subjects enrolled in another concurrent study or trial exercised excessively within the last 4 hours unwilling to sign informed consent female subjects who are pregnant, suspected or planning to become pregnant or breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seipher Wellness<br> | Device: Seipher Wellness<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Time Intervals (STI) value |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seipher Wellness, algorithm, secure samples of SGC waveform, volunteers, validation, heart health algorithm