linjc16/ctgov huggingface dataset:
Prognostic Value of Transforming Growth Factor-Beta 1 in Normal Pressure Hydrocephalus

Study Overview
=================
Brief Summary
-----------------
Correlation of cerebrospinal fluid levels of transforming growth factor beta-1 with functional improvements after insertion of ventriculoperitoneal shunt for normal pressure hydrocephalus

Detailed Description
-----------------
The goal of this research is to investigate a potential CSF biomarker of NPH as a new tool for both the diagnosis of NPH and prognosis of VPS placement. Transforming growth factor-b1 (TGF-b1) is a signaling molecule involved in three fundamental activities; suppression of cell proliferation, immunosuppression, and deposition of extracellular matrix through promotion of synthesis and inhibition of degradation.8 Previously, TGF-b1 had been implicated in the development of communicating hydrocephalus secondary to pre-term infant intraventricular hemorrhage9 and adult aneurysmal sub-arachnoid hemorrhage.10, 11 Recently, an investigation demonstrated elevated levels of TGF-b1 in patients with shunt-responsive NPH compared to non-NPH patients.12 The specific aims of this research proposal are to: Correlate CSF levels of TGF-b1 with the clinical response of patients diagnosed with NPH to VPS placement. Correlate CSF levels of TGF-b1 with optimal VPS pressure settings.

Official Title
-----------------
Prognostic Value of Transforming Growth Factor-Beta 1 in Normal Pressure Hydrocephalus

Conditions
-----------------
Normal Pressure Hydrocephalus

Intervention / Treatment
-----------------
* Other: CSF collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Normal Pressure Hydrocephalus Exclusion Criteria: Patients not diagnosed with Normal Pressure Hydrocephalus

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| A<br>Patients diagnosed with Normal Pressure Hydrocephalus | Other: CSF collection<br>* CSF collection at time of VPS insertion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TGF beta-1 levels |  | Time of Surgery | 
| Mini-mental status exam |  | Pre-operative, 3 and 12 months post-operatively | 
| Modified barthel index |  | Pre-operative, 3 and 12 months post-operatively | 
| Tinetti mobility assessment |  | Pre-operative, 3 and 12 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Programmable shunt setting |  | Pre-operative, 3 and 12 months post-operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NPH, TGF-beta
Relationship Between Hearing Thresholds, Handicap and Time for Treatment-seeking

Study Overview
=================
Brief Summary
-----------------
Purpose: to investigate the relationship between time for treatment seeking and audiometric data and self-assessment of handicap for patients in a public hearing healthcare service. Methods: Retrospective study. Records of 152 elderly and 48 adults with hearing impairment were analyzed. The ISO audiometric thresholds average (500 to 4000Hz) and high frequencies average (2000 to 6000Hz), the speech recognition thresholds and the total, social and emotional scores from the Hearing Handicap Inventory for the Adults (HHIA) and Elderly (HHIE) were compared with the time between the onset of hearing complaints and the first treatment seeking. Results: The average time for treatment seeking was 7,6 years. No statistical difference was found between ISO and high frequency audiometric average, HHIA/E scores and time for treatment seeking between adults and the elderly. Weak but significant negative correlations were observed between the audiometric data and time for treatment seeking. There was no relationship between the time for treatment seeking and educational, socioeconomic levels and perception of handicap. Conclusions: The search for treatment seems to be multifactorial. Despite technological advances and changes in access to information and treatment time for treatment seeking was similar to that reported 30 years ago.

Official Title
-----------------
Relationship Between Hearing Thresholds, Handicap and Time for Treatment-seeking in a Public Hearing Healthcare Service

Conditions
-----------------
Hearing Impairment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years old. Without experience with hearing aid use. Diagnosed with sensorineural hearing loss. Audiogram data available Exclusion Criteria:

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 |
| --- | --- |
| Hearing impaired elderly<br> | |
| Hearing impaired adults<br> | |

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
-----------------
hearing loss, handicap, counseling
The Value of Black Spots in Diagnosing Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy

Study Overview
=================
Brief Summary
-----------------
The study aims to: Explore the properties of mesenchymal black spots, and to determine the value of mesenchymal black spots in diagnosing gastric intestinal metaplasia by confocal laser endomicroscopy (CLE). Evaluate the incidences of gastric intraepithelial neoplasia and gastric cancer in patients with gastric mesenchymal black spot during CLE imaging.

Detailed Description
-----------------
Gastric intestinal metaplasia (GIM) is confirmed to be a risk factor that may lead to the development of intestinal type gastric cancer. Previous study has shown that confocal laser endomicroscopy promising in the diagnosis of GIM. The investigators have found an elevated incidence of mesenchymal black spots in patients with GIM during previous CLE imaging. This study aims to explore the properties of mesenchymal black spots, and to determine the value of mesenchymal black spots in diagnosing gastric intestinal metaplasia by confocal laser endomicroscopy.

Official Title
-----------------
The Value of Mesenchymal Black Spots in Diagnosing Gastric Intestinal Metaplasia by Confocal Laser Endomicroscopy

Conditions
-----------------
Gastric Intestinal Metaplasia

Intervention / Treatment
-----------------
* Procedure: CLE examination for upper gastrointestinal tract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will include male or female aged between 18 and 80 years with indications for upper-endoscopy , but without any disease of heart, liver or kidney. Exclusion Criteria: Patients who are allergic to fluorescein sodium Patients who are unwilling to sign or give the informed consent form Patients with impaired cardiac, liver or renal function Patients with coagulopathy Patients with pregnancy or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Consecutive patients for CLE examination<br> | Procedure: CLE examination for upper gastrointestinal tract<br>* Routine upper GI endoscopy plus targeted CLE examination<br>* Other names: confocal endomicroscopy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of black spots in diagnosis of gastric intestinal metaplasia |  | up to six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric Intestinal Metaplasia, Confocal Laser Endomicroscopy
Prospective Study of 3 Phone Assistance Strategies to Achieve a Continuous Cardiac Massage

Study Overview
=================
Brief Summary
-----------------
This study must evaluate the benefit of a continuous audio guidance on the effectiveness of MCE directed by a volunteer. The evaluation of the MCE for this study is based on both quantitative criteria (based on the recommendations ERC 2010) frequency depth of chest compressions. This study compares two methods of continuous audio guide (one arm with an audio continuous guidance method by the regulator and second arm with an audio continuous guidance method by the controller relayed by an audio) to a method of incentive MCE based on a unique set made by the regulator(control arm).

Official Title
-----------------
Prospective Study of 3 Phone Assistance Strategies to Achieve a Continuous Cardiac Massage During Training in Non-hospital Cardiac Cases.

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Other: Therapeutic and preventive strategies
* Other: Therapeutic and preventive strategies
* Other: Therapeutic and preventive strategies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Healthy volunteers from the general population understanding the French language. Exclusion Criteria: major physical disability; do not speak French first aid training under one year

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single set (control Arm)<br>method of external cardiac massage incentive based on a single set. Intervention : Therapeutic and preventive strategies | Other: Therapeutic and preventive strategies<br>* Single set (control Arm)<br>|
| Experimental: Controller<br>Audio continuous guidance method by the controller. Intervention : Therapeutic and preventive strategies | Other: Therapeutic and preventive strategies<br>* Controller<br>|
| Experimental: Audio<br>Audio continuous guidance method by the controller relayed by an audio. Intervention : Therapeutic and preventive strategies | Other: Therapeutic and preventive strategies<br>* Audio<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency and depth of chest compressions |  | at the end of the simulation (10 minutes) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
external cardiac massage, medical hotline,
Cytokine Kinetics Test to Assess the Presence or Absence of Tolerance in Organ Transplant

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to determine if there is clinical correlation between the CKT and transplant recipients who are known to be on minimal or no immunosuppression (presumed tolerant) and those who are on conventional amounts of immunosuppression and have either experienced rejection (presumed hyper-responsive to donor) or have not experienced rejection (unknown responsive state).

Official Title
-----------------
Cytokine Kinetics Assay to Assess the Presence or Absence of Tolerance in Organ Transplant Recipients

Conditions
-----------------
Kidney Transplantation, Liver Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney or liver transplant recipients for whom donor cells are available Exclusion Criteria: HcT <32%
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 |
| --- | --- |
| 1<br>Subjects on mimimal or no immunosuppression and no rejection history | |
| 2<br>Subjects who have had rejection on conventional immunosuppression | |
| 3<br>Subjects who have not had acute or chronic rejection who are on conventional immunosuppression | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between cytokine kinetics test and clinical status of subject |  | 1 year |
Environmental Exposures, Genetics, and Exhaled Nitric Oxide in Pediatric Asthma

Study Overview
=================
Brief Summary
-----------------
Asthma is one of the most common childhood diseases. It is chronic and often severely disabling. The amount of nitric oxide that is exhaled while breathing increases with airway inflammation, a symptom of asthma. This study will examine the results from a previous study, the Cincinnati Asthma Prevention (CAP) study, to evaluate the effects of environmental and genetic factors on exhaled nitric oxide (eNO) levels and to determine the relationship between eNO and asthma severity.

Detailed Description
-----------------
Nitric oxide is a naturally occurring gas that plays a role in many body functions. Levels of eNO increase with airway inflammation, a symptom of asthma. Researchers have proposed using eNO as a noninvasive measure to guide physicians in the treatment and medical management of asthma in children. However, more information about eNO is needed before this can happen. This study will perform a secondary analysis of the results from its parent study, the CAP study, which evaluated the effectiveness of preventing asthma in children who had been exposed to environmental tobacco smoke. This study will not enroll any new participants. Previously collected data from the CAP study will be reevaluated in this study to determine the longitudinal effects of environmental and genetic factors on eNO levels. In addition, the data will be evaluated to determine the relationship between eNO levels and asthma severity. No new data will be collected in this study.

Official Title
-----------------
Environmental Exposures, NOS Genes, and Exhaled Nitric Oxide in Pediatric Asthma

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participated in the Cincinnati Asthma Prevention Study Diagnosis of asthma Lives with someone that smokes at least 5 cigarettes a day Exclusion Criteria: No additional neuromuscular or respiratory disorder that may interfere with safe participation in the parent study Does not have electricity Plans to move within 1 year of entry into the parent study

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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 |
| --- | --- | --- |
| Effects of environmental and genetic factors on exhaled nitric oxide (eNO) levels and the relationship between eNO and asthma severity |  | Measured through the use of data previously collected in the Cincinnati Asthma Prevention (CAP) study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exhaled Nitric Oxide, Asthma, Tobacco Smoke, Allergen
Sampling Biomarkers in Meniscus Injury to the Knee

Study Overview
=================
Brief Summary
-----------------
The diagnosis of clinically-significant meniscal tears of the knee remains challenging, and it is unknown why only some injuries become painful. The limitations of diagnostic magnetic resonance imaging result in arthroscopy that is not always beneficial. Elucidation of biochemical pathways underlying pain in this condition may aid patient selection for surgery and provide pharmacotherapeutic targets. Cytokines may be involved in pain following meniscus injury and diagnostic cytokine assay may help physicians differentiate patients that may benefit from arthroscopy from those that may not.

Detailed Description
-----------------
Lavage of the operative and contralateral knee for comparison was performed under anesthesia prior to arthroscopy by the infusion of sterile saline into the knee joint followed by the immediate withdrawal into the syringe. Sixteen asymptomatic control subjects also contributed knee samples. The concentrations of 17 inflammatory cytokines/chemokines were measured using a multiplexed immunoassay panel. Pre-operative magnetic resonance imaging findings and cytokine assay results were compared to gold-standard intraoperative findings.

Official Title
-----------------
Diagnostic Utility of Cytokine Biomarkers in the Evaluation of Acute Knee Pain

Conditions
-----------------
Cartilage Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with knee pain < 6 months with acute onset who had failed conservative treatment and elected for arthroscopic management. Indications for surgery included the presence of mechanical symptoms on history, a physical examination positive for McMurray's maneuver or joint line tenderness or both32, absence of severe joint space narrowing on plain radiography1 33, and the presence of grade III signal changes on MRI35 in an anatomic location consistent with the history and physical examination. Exclusion Criteria: Less than 18 years old. Recent (within three months) intra-articular corticosteroid injection and past or current medical history of autoimmune disease (i.e. rheumatoid arthritis). In addition, no patients involved in a worker's compensation claim or personal injury litigation were enrolled in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
AVTX-801 D-galactose Supplementation in SLC35A2-CDG

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, open-label, withdrawal and treatment study assessing the efficacy, safety, and tolerability of CERC-801 in subjects with SLC35A2-CDG.

Official Title
-----------------
Evaluation of Efficacy and Safety of D-galactose Supplementation in SLC35A2-CDG, a Disorder of Hypogalactosylation

Conditions
-----------------
SLC35A2-CDG - Solute Carrier Family 35 Member A2 Congenital Disorder of Glycosylation

Intervention / Treatment
-----------------
* Drug: AVTX-801
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Molecular diagnosis of SLC35A2-CDG A parent or legal guardian must be available and willing to provide consent on behalf of minor subjects or adult subjects who are unable to give informed consent due to developmental disabilities. Exclusion Criteria Aldolase-B deficiency Galactosemia Hemolytic uremic syndrome Hemoglobin < 7 mg/dL Previously experienced severe AEs from oral galactose (severe diarrhea, vomiting, constipation, galactosuria, or increased liver glycogen storage) Other history of galactose intolerance as determined by the investigator Currently treated with ketogenic diet Current enrollment in another trial involving investigational compounds Dietary D-galactose supplementation Use of investigational compounds Pregnancy
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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Main study arm - AVTX-801<br>subjects will wash out from food grade D-galactose then be put on medical grade D-galactose | Drug: AVTX-801<br>* Medical grade D-galactose<br>* Other names: D-Galactose;|
| Placebo Comparator: Placebo<br>placebo crossover | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the composite score of the Nijmegen Pediatric CDG Rating Scale | Changes in the composite Nijmegen Pediatric CDG Rating Scale (NPCRS) score from post washout baseline to 12 months | 12 months | 
| Change in Alanine aminotransferase level | • Change in the key clinical laboratory parameters alanine aminotransferase [ALT], aspartate aminotransferase [AST]) from post-washout baseline to 12 months | 12 months | 
| Change in Aspartate aminotransferase level | • Change in the key clinical laboratory parameters alanine aminotransferase [ALT], aspartate aminotransferase [AST]) from post-washout baseline to 12 months | 12 months |