linjc16/ctgov huggingface dataset:
Collection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This is an observational study designed to collect follow-up clinical date on subjects who were treated with tofacitinib in 2 completed Phase 2 studies who either discontinued treatment prematurely or did not elect to enroll in long-term extension studies.

Detailed Description
-----------------
Subjects are identified based on whether they received tofacitinib in 2 completed Phase 2 studies who either discontinued treatment prematurely or who did not elect to enroll in long-term extension studies. Subjects are pre-identified

Official Title
-----------------
An Observational Study To Collect Follow-up Clinical Data From Kidney Transplant Recipients Who Received Tofacitinib (CP-690,550) In Completed Phase 2 Studies

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Tofacitinib
* Drug: Tofacitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects have discontinued tofacitinib prior to the planned treatment duration in 2 completed Phase 2 studies; or have not enrolled in long-term extension studies. Exclusion Criteria: No other subjects are eligible for this study

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects from Study A3921009<br> | Drug: Tofacitinib<br>* Subjects who previously took 15 mg BID or 30 mg BID<br>|
| Subjects from Study A3921030<br> | Drug: Tofacitinib<br>* Subjects who previously took 15 mg BID for 3 months then 10 mg BID, or 15 mg BID for 6 months then 10 mg BID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD) | All lymphoproliferative disorders diagnosed locally as PTLD based on histopathology were reported. | Baseline through Month 12 | 
| Number of Participants With Central Nervous System (CNS) Infection | Participants with CNS infection involving the brain or spinal cord, within 12 months after the last dose of tofacitinib were reported. | Baseline through Month 12 | 
| Number of Participants With Graft Failure | Graft failure which occurred within 12 months after the last dose of tofacitinib was reported. Graft failure was defined as graft nephrectomy, re-transplantation, or return to dialysis for greater than or equal to (>=) 6 consecutive weeks. | Baseline through Month 12 | 
| Number of Participants Who Died |  | Baseline through Month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Observational, clinical follow-up data
Health and Nutrition Survey on Shenzhen Children

Study Overview
=================
Brief Summary
-----------------
Master and analyze the nutritional health, growth and development status of primary and secondary school students in Shenzhen, and discover the main nutritional health, growth and development problems and influencing factors. Provide basic data and evidence-based basis for the municipal government and related departments to formulate child health policies and measures.

Official Title
-----------------
Investigation on Nutritional Health and Growth Status of Primary and Middle School Students in Shenzhen, 2021

Conditions
-----------------
Nutrition Disorder, Child, Nutrition Disorders in Adolescence, Nutritional Deficiency, Nutrition, Healthy, Nutritional Stunting, Nutritional and Metabolic Diseases, Nutritional Imbalance, Development, Child, Development, Adolescent, Growth Disorders, Growth; Stunting, Nutritional

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: With signed consent to be a study subject. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | kg | 6 months | 
| Height | cm | 6 months | 
| Blood pressure | mmHg | 6 months | 
| Vitamin concentrations in circulation | measured by EIA, CLIA or LC-MS/MS, nmol/L | 8 months | 
| Mineral concentrations in circulation | measured by ICP-MS, mass/volume | 8 months | 
| Glucose and lipid concentrations in circulation | measured by biochemical analyzer, mmol/L | 6 months |
Restless Leg Syndrome and Severe Preeclampsia

Study Overview
=================
Brief Summary
-----------------
Restless Leg Syndrome is a common but not well recognized central nervous system disorder. It is more prevalent during pregnancy and, if present before pregnancy, can develop an exacerbation of symptoms. In some of the hypothesis trying to explain this syndrome, the physiopathology can also explain hypertensive disorders of pregnancy. So far, no study has been done trying to link both disorders.

Official Title
-----------------
Association Between Restless Leg Syndrome and Severe Preeclampsia. A Case Control Study.

Conditions
-----------------
Restless Leg Syndrome, Severe Preeclampsia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age between 24-34 weeks Severe preeclampsia Exclusion Criteria: Neurological disorders (central nervous system)
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Patients with Severe preeclampsia | |
| Control<br>Patients with normal pregnancies at term | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restless Leg Syndrome | Number of patients with criteris for the diagnosis of Restless Leg Syndrome | 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Restless Leg Syndrome, Severe Preeclampsia
Gastric Volume and Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
Postoperative ileus (POI) is a serious complication after colorectal surgery. One of its most frequent consequences is the replacement of nasogastric tube because of the vomiting. Vomiting is due to the distension of the stomach and information on the evolution of gastric filling after surgery could help to better understand the physiopathology of POI. It could also give indication to help the physician in the management of POI. The ultrasonography has been shown to be a reliable technic to assess the gastric emptying. To date, there is no indication in the literature about the evolution of the gastric filling after colorectal surgery while these information could help to identify patients at risk for POI and to predict the need for POI replacement.

Official Title
-----------------
Ultrasonographic Evaluation of the Evolution of the Gastric Volume After Colorectal

Conditions
-----------------
Postoperative Ileus

Intervention / Treatment
-----------------
* Diagnostic Test: ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient undergoing colorectal resection whatever the surgical access Exclusion Criteria: contra-indication to ultrasonography performance history of gastrectomy

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gastric antrum measurement<br> | Diagnostic Test: ultrasonography<br>* Ultrasonography of the stomach is performed to measure the diameter of the antrum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diameter of the gastric antrum |  | immediately before the procedure and each postoperative day up to discharge (mean 7 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative ileus |  | in the morning up to 30 postoperative days | 
| Postoperative quality of life: GIQLI | GIQLI | before discharge | 
| postoperative morbidity | Dindo Clavien Scale (from 1 (minor) to 5 (death)) | within 30 postoperative days |
Response Prediction After GKS in Patients With Vestibular Schwannoma Using DCE MR Imaging

Study Overview
=================
Brief Summary
-----------------
Response Prediction after Gamma Knife Surgery (GKS) in Patients with Vestibular Schwannoma using Dynamic Contrast-Enhanced (DCE) MR Imaging

Detailed Description
-----------------
The purpose of this study was to evaluate the response of Gamma Knife Surgery to Ktrans, Ve, and Vp, which are indicators of permeability map obtained from dynamic contrast enhanced (DCE) MRI in patients with vestibular schwannoma .

Official Title
-----------------
Response Prediction After Gamma Knife Surgery (GKS) in Patients With Vestibular Schwannoma Using Dynamic Contrast-Enhanced (DCE) MR Imaging

Conditions
-----------------
Vestibular Schwannoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with vestibular schwannoma, who underwent gamma knife surgery and pre-op dynamic contrast enhanced (DCE) MRI Patients with vestibular schwannoma, who received consent Exclusion Criteria: In addition to the vestibular schwannoma, if the brain has other underlying or systemic disease During the observation period, other treatments were performed other than gamma knife surgery If patients have a contraindication to MRI (eg, pacemaker, cochlear implants, hemodynamically unstable) Concomitant use of gadolinium MRI contrast agents (eg, renal insufficiency [glomerular filtration rate <30 ML / min]), or if there was a side effect when using a contrast medium. Adults with impaired ability to cope If the images and medical records required for this study are not available or are not appropriate

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Tumor size change before and after surgery |  | pre-op, Immediately after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In patients who underwent gamma knife surgery, the magnitude of tumor size change before and after surgery |  | through study completion, an average of 1 year |
Neurohormonal Parameters in Hypertrophic Cardiomyopathies

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to demonstrate that changes in plasma levels of circulating neurohormones (mainly BNP and NT-proBNP), measured at rest and post-exercise correlate with exercise functional limitation (assessed by exercise peak VO2) and exercise ultrasonic parameters (as left ventricular filling, obstruction, and mitral regurgitation)

Detailed Description
-----------------
The secondary purposes are to study the kinetics of secretions of natriuretic peptides, and their relationships with extent of MRI myocardial fibrosis with the degree of exercise functional limitation.

Official Title
-----------------
Evaluation at Rest and Exercise of Clinical, Ultrasonic and Neurohormonal Parameters in Hypertrophic Cardiomyopathies

Conditions
-----------------
1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy, 2- Obstructive Hypertrophic Cardiomyopathy, 3- Non Obstructive Hypertrophic Cardiomyopathy

Intervention / Treatment
-----------------
* Other: blood sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Age 18 to 75 years Primary (sarcomeric) hypertrophic cardiomyopathy, obstructive or non obstructive, with studies of exercise peak oxygen consumption and cardiac MRI with gadolinium late-enhancement Informed consent Patient with a social insurance Patient at rest - Age 18 to 75 years Primary (sarcomeric) hypertrophic cardiomyopathy, obstructive or non obstructive Informed consent Patient with a social insurance Exclusion Criteria: - Insufficient echogenicity Permanent atrial fibrillation Complete BBB on the ECG LVEF < 35 % Previous septal ablation (surgical or percutaneous) Simultaneous participation to another biomedical research If exercise needed: contraindication to exercise : hemodynamic instability, uncontrolled high blood pressure (>220/120 mmHg), severe aortic stenosis Inability to exercise (muscular, pulmonary, elderly patient)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: single group - consecutive patients<br> | Other: blood sample collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasmatic Neurohormonal measures: BNP - NT ProBNP - Troponine |  | Day 1 at rest and during exercise | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
1- Hypertrophic cardiomyopathy, 2- BNP, 3- NT-proBNP, 4- Neurohormons
Evaluation of Dysphagia by 6-chnnel Surface Electromyography

Study Overview
=================
Brief Summary
-----------------
The natural process of aging affects a few very specific timing parameters such as swallow reaction time and hyoid one movement velocity. Many swallow timing and bolus transit parameters appear to be unaffected by aging. We want to know the changes of kinematic variables according to the aging process. First hypothesis: There are probably be a protection mechanism that blocks functional loss progressing to kinematic abnormality. Muscle activation sequence change (i.e duration or amplitude) of the oropharyngeal muscles play an important role. Second hypothesis: Age-related differences in muscle activation patterns will also appear differently depending on the characteristics of swallowed food.

Detailed Description
-----------------
Inclusion criteria Inclusion criteria of healthy older adults : Age > 60, without dysphagia, comorbidity Inclusion criteria of young control group : Age < 60, without dysphagia, comorbidity No prior history of swallowing difficulty or history of central nervous system disease, and none were taking medication that are known to affect swallowing. Surface EMG was performed at bilateral suprahyoid, thyrohyoid, sternothyroid and pharyngeal constrictors. The latency of activation and termination was checked.

Official Title
-----------------
Evaluation of Dysphagia by 6-chnnel Surface Electromyography and Preliminary Study for Design 6-channel Electrical Stimulation

Conditions
-----------------
Deglutition Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria of old group Age > 60, without dysphagia, comorbidity Inclusion Criteria of young control group Age < 60, without dysphagia, comorbidity

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Young normal group<br>normal participants below 60 years | |
| Old normal group<br>normal participants above 60 years | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Latency | the latency of muscular activation | once at study, when patient enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration | the contractile duration of evaluated muscles | once at study, when patient enrolled | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
deglutition disorders, electromyography
Treatment of APAP Toxicity With IV and Oral NAC 2008-2011

Study Overview
=================
Brief Summary
-----------------
Retrospective chart review of patients who receive N-acetylcysteine for Acetaminophen(APAP) toxicity to assess length of oral vs. IV treatment and the effect of a Clinical Pharmacology and Toxicology division in the management of APAP ingestions.

Official Title
-----------------
Treatment of Acetaminophen Toxicity With Intravenous vs. Oral N-acetylcysteine: A Retrospective Review

Conditions
-----------------
Acetaminophen Toxicity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to CHMCA between June 1, 2008 to June 30, 2011 Qualifying ICD-9 diagnosis code for the following APAP overdose situations: poisoning, accidental, suicide attempt, therapeutic use, assault, and undetermined (965.4, E850.4, E950.0, E935.4, E962.0, E980.0) Serum APAP concentration above the possible hepatotoxic line on the Rumack-Matthew's nomogram if obtained > 4 hours post ingestion Between ages 0-21 years on date of admission Acute APAP ingestion Exclusion Criteria: Serum APAP concentrations not actually documented Did not receive the oral or IV NAC treatment Preexisting liver disease such as cirrhosis or hepatitis C Patient > 21 years of age on the date of admission Chronic APAP ingestion

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 21 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oral NAC<br>Patients receiving oral NAC treatment after an acute acetaminophen ingestion. | |
| IV NAC<br>Patients receiving IV NAC after an acute Acetaminophen ingestion. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of NAC treatment in hours | Length of NAC treatment (in hours) for both IV and PO formulations used in patients with APAP toxicity | Retrospective data collection for patient's hospital admission, max estimated 5days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacology & Toxicology consults | Documenting whether or not a pharmacology & toxicology consult was obtained during the patient's hospital admission for APAP toxicity | Retrospective data collection for length of patient's hospital admission, max estimated 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acetaminophen Toxicity, Acetaminophen Overdose, N-acetylcysteine, Liver Toxicity
Effect of Three Non-drug Intervention in Treatment of Children With Overweight

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effect of three different non-pharmacological interventions (usually practiced in ambulatory care of Childhood Obesity (AmO), physical activity program (IFSP) and diet therapy adjusted estimate by indirect calorimetry) on the percentage of body fat and basal metabolism of children and Overweight and obesity in the metropolitan region of Porto Alegre (RS).

Official Title
-----------------
EFFECT OF THREE NON-DRUG INTERVENTION IN TREATMENT OF CHILDREN WITH OVERWEIGHT

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: physical activities, dietician counseling and behavioral changes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 8 to 15 years old with overweight (Z-score BMI +1 e +2) and obesity (Z-score BMI > +2) Exclusion Criteria: chronic diseases

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 15 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dietetic counseling<br> | Behavioral: physical activities, dietician counseling and behavioral changes<br>* One arm receive an schedule for physical activities. One arm receive a diet prescription. One arm receive general guidance on diet, physical activity and behavioral changes<br>|
| Experimental: physical activities<br> | Behavioral: physical activities, dietician counseling and behavioral changes<br>* One arm receive an schedule for physical activities. One arm receive a diet prescription. One arm receive general guidance on diet, physical activity and behavioral changes<br>|
| Experimental: Lifestyle counseling<br> | Behavioral: physical activities, dietician counseling and behavioral changes<br>* One arm receive an schedule for physical activities. One arm receive a diet prescription. One arm receive general guidance on diet, physical activity and behavioral changes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in percentage body fat and basal metabolism after 1 year of randomization |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity