linjc16/ctgov huggingface dataset:
Pompe Gene Therapy- Screening for Eligibility

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine eligibility for the future clinical trial of gene therapy in adults with late-onset Pompe disease. This screening protocol will enroll up to 20 adults patients (>=18 yo) with late-onset Pompe disease. Study assessments include review of medical history, vital signs, physical examination, muscle function testing, lung function testing, blood and urine collection, serum pregnancy test and ECG. The study results will be collected to perform descriptive statistical analysis and used to determine eligibility for the proposed clinical trial of gene therapy in the future.

Official Title
-----------------
Screening for Eligibility to Participate in a Clinical Trial of Gene Therapy for Late-onset Pompe Disease

Conditions
-----------------
Pompe Disease (Late-onset)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Diagnosis of Pompe disease by blood or skin fibroblast GAA assay and two pathogenic variants in the GAA gene. Age: at least 18 years at enrollment. Subjects are capable of giving written consent. Receiving ERT at a stable dose for at least 104 weeks. Exclusion Criteria Any condition that would interfere with participation in the study as determined by the principal investigator. Pregnancy or nursing mothers. History of active hepatitis B, hepatitis C, or cirrhosis Receiving any investigational agent.

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 |
| --- | --- | --- |
| Eligibility for gene therapy. | The purpose of this study is to determine eligibility for the proposed clinical trial of gene therapy in adults with late-onset Pompe disease. Eligibility is measure by a composite score of blood tests, Electrocardiogram, Pulmonary Function Tests, and Muscle Status Testing. | Up to 2 days |
Weissella Cibaria JW15 Consumption and NK Cell Activity

Study Overview
=================
Brief Summary
-----------------
A The aim of this study was to investigate the impact of consuming Weissella cibaria (W. cibaria) JW15 supplementation isolated from Kimchi, Korea traditional fermented food, on natural killer (NK) cell activity and circulating levels of cytokines and immunoglobulin (Ig).

Detailed Description
-----------------
A randomized, double-blinded, placebo-controlled study was conducted on 100 nondiabetic subjects. Over an eight-week testing period, the probiotic group consumed 4 capsules (300 mg/capsule) containing 1 x 10^10 colony-forming units (cfu) of W. cibaria JW15 each day, whereas the placebo group consumed the same product without a probiotic.

Official Title
-----------------
Weissella Cibaria JW15 Consumption and NK Cell Activity

Conditions
-----------------
Immune Function

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo
* Dietary Supplement: Probiotic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nondiabetic (fasting serum glucose concentration < 126 mg/dL) Subjects with 4,000-8,000 leukocyte counts Exclusion Criteria: Constant consumption of any probiotic products Taking medicine related to inflammation within one month before screening Allergy to probiotics Lactose intolerance Diabetes History/presence of significant metabolic disease Acute or chronic disease requiring treatment Taking any medications

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>4 capsules (300 mg/capsule) containing 52% crystalline cellulose and 46% lactose in identical-looking with test product | Dietary Supplement: Placebo<br>* 4 capsules (300 mg/capsule) containing 52% crystalline cellulose and 46% lactose in identical-looking with test product<br>|
| Experimental: Probiotic<br>4 capsules (300 mg/capsule) containing each capsule 1.0 x 10^10 colony-forming units (cfu) of Weissella cibaria JW15, twice a day | Dietary Supplement: Probiotic<br>* 4 capsules (300 mg/capsule) containing each capsule 1.0 x 10^10 colony-forming units (cfu) of Weissella cibaria JW15, twice a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural killer cell activity at baseline | Natural killer cell activity (%) | Baseline | 
| Natural killer cell activity at 8-week follow up | Natural killer cell activity (%) | 8-week follow up |
Left Ventricular Dysfunction in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
Left ventricular dysfunction is common in the critically ill. The aim of this study is to assess the incidence and prognosis of left ventricular dysfunction in critically ill patients.

Detailed Description
-----------------
Left ventricular dysfunction is common in the critically ill. A number of conditions can cause left ventricular dysfunction including myocardial infarction, septic cardiomyopathy, post resuscitation syndrome, takotsubo syndrome etc. A number of studies have assessed cardiac dysfunction in specific conditions (e.g. sepsis, cardiac arrest) but only a few studies have assessed cardiac dysfunction in a general ICU-population. The study will focus on diagnostics of the different types of cardiomyopathy and differentiating between ischemic and non-ischemic left ventricular dysfunction in a general ICU population. The aim of this study is to assess the incidence and prognosis of the different types of left ventricular dysfunction in critically ill patients. Our hypothesis is that left ventricular dysfunction is common in the critically ill and is associated with an increased risk of short-term death.

Official Title
-----------------
Left Ventricular Dysfunction in Critically Ill Patients

Conditions
-----------------
Left Ventricular Dysfunction, Critically Ill, Acute Coronary Syndrome, Cardiomyopathies, Takotsubo Cardiomyopathy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted within 24 hours to the ICU Dysfunction of at least one organ system, defined as at least +1 point in SOFA-score. Exclusion Criteria -

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Echocardiography|Echocardiography for assessment of left ventricular dysfunction|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | All cause mortality after admission to the ICU | 30 days |
Study of the Efficience of Chewing-gum to Reduce the Duration of Postoperative Ileus

Study Overview
=================
Brief Summary
-----------------
Postoperative ileus (POI) is a serious complication after surgery. While it complicates all type of surgery, it is more frequent after abdominal surgery (especially bowel or colorectal surgery). Many studies aim to reduce the occurence of POI without efficiency. The aim of this study is to assess the efficiency of the vagal stimulation, by the mean of chewing, to reduce the duration of POI.

Official Title
-----------------
Efficiency of Chewing-gum to Reduce the Duration Postoperative Ileus: a Randomized Controlled Study

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

Intervention / Treatment
-----------------
* Behavioral: chewing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing colorectal surgery or small bowel surgery elective or in emergency open surgery or laparoscopy diagnosis of POI indication of fasting or nasogastric tube placement Exclusion Criteria: contra-indication of chewing pregnancy

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chewing gum<br>POI patients are asked to chew 20 minutes x2/ day | Behavioral: chewing<br>* patients are asked to chew chewing gum X 3/ day<br>|
| No Intervention: No chewing<br>POI patients receive no intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficiency of chewing gum in reducing the duration of POI. POI is defined by the criteria of Vather from the postoperative day 1 up to day 30 | The duration of POI is the time between the first day of meeting the criteria of Vather to the day of recovery of tolerance of solid food and of exoneration of stool and/or flatus (GI-3 recovery). Patients will be asked to report in their diary the day of tolerance of solid food and of exoneration of stool and/or flatus (GI-3 recovery) after the diagnosis of POI | collected each day until the end of the POI, assessed up to day 21 |
Study on Heart Rate Variability in Cardiac Transplant Recipients With Exercise and After Exercise Training

Study Overview
=================
Brief Summary
-----------------
The purpose of the study was to investigate the changes on heart rate variability, exercise capacity, activities of daily living, and quality of life after aerobic exercise training in cardiac transplant recipients.

Official Title
-----------------
Study on Heart Rate Variability in Cardiac Transplant Recipients With Exercise and After Exercise Training

Conditions
-----------------
Cardiac Transplant Disorder

Intervention / Treatment
-----------------
* Behavioral: Exercise training
* Behavioral: usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart transplant recipients with stable post operation condition Age between 20-70 years No acute or severe chronic rejection Exclusion Criteria: Any condition that might affect exercise performance

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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: exercise group<br>exercise training | Behavioral: Exercise training<br>* exercise training<br>|
| Active Comparator: Control<br>usual care | Behavioral: usual care<br>* received usual medical care after heart transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability | R-R interval difference | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity | oxygen consumption | 8 weeks | 
| Quality of life | This outcome measures how good life the patients have | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac transplant recipients, Heart rate variability, Exercise training
Evaluation of the Threshold for the Interpretation of the Results of a Method for the Blood Determination of Phosphatidyléthanol

Study Overview
=================
Brief Summary
-----------------
For an analytical validation of the method for the determination of blood hosphatidylethathanol, it is necessary to: to compare the results of chronic and excessive ethanol patients with the cut-off proposed in the literature. Also assess the stability of phosphatidylethanol in total blood collected, and in blotted dried blood stains (DBS), depending on temperature (ambient temperature and +4°C)

Official Title
-----------------
Evaluation of the Threshold for the Interpretation of the Results of a Method for the Blood Determination of Phosphatidyléthanol

Conditions
-----------------
Alcohol Abuse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Person with alcohol consumption ≥ 40g/day (women) and ≥ 60g/day (men) according to WHO criteria Person hospitalized for a hospital withdrawal in the addiction service of Lille's hospital, without other distinctions. Exclusion Criteria: Patient opposing the use of their personal data in the study Patient subject to protective measures (guardianship or curatorship) Person deprived of liberty

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 |
| --- | --- | --- |
| Frequency of patients with a Peth concentration greater than 200 µg/L |  | at the end of study (at 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the concentration of Peth in blood in ambiant temperature | descrease expressed as a percentage of the initial concentration, in the primary blood tube (citrate tube) and stored at room temperature, | between T0 and 96h and the end of study (at 6 months) | 
| the concentration of Peth in blood at 4°C | ecrease expressed as a percentage of the initial concentration, in the primary blood tube (citrate tube) and at 4°C. | between T0 and 96h and the end of study (at 6 months) | 
| the concentration of Peth in blood in DBS | decrease expressed as a percentage of the initial concentration, in the Dried Blood Spot (DBS) | between T0 and 4 weeks and the end of study (at 6 months) |
Study of MDX-010 in Stage IV Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This Phase II study is designed to treat patients who have been diagnosed with Stage IV Breast Cancer, which has progressed despite treatment with primary therapies, including hormonal therapy, chemotherapy, and antibody therapy. Thirty-three patients will be treated with the monoclonal antibody MDX-010. The initial antitumor activity profile of MDX-010 will be determined, as well as identification of the induction of any antitumor immunity following the MDX-010 treatment.

Official Title
-----------------
A Phase II Study of MDX-010 in Patients With Stage IV Adenocarcinoma of the Breast

Conditions
-----------------
Breast Cancer, Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: MDX-010


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide written informed consent diagnosed with Stage IV adenocarcinoma that has progressed despite previous therapy at least 18 years of age measurable disease defined by RECIST must discontinue any alternative therapy used to treat breast cancer at least 4 weeks prior to enrollment and agree to not use such therapies during the duration of the study (patients may continue to receive tamoxifen, bisphosphate therapy and trastuzumab) prior radiation must be completed at least 4 weeks prior to enrollment ECOG performance status of 0-2 Negative pregnancy test Screening lab values must be met Exclusion Criteria: must be disease free from other cancers for at least 5 years symptomatic or untreated brain metastases active or history of autoimmune disease active HIV, HTLV, HBV or HCV infection concurrent medical condition requiring the use of systemic corticosteroids, must be discontinued at least 4 weeks prior to enrollment prior therapy with anti-CTLA-4 antibody significant organ compromise, uncontrolled heart, liver, lung, or renal disease or other serious illness pregnancy or nursing

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MDX-010|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
-----------------
Breast Cancer, Stage IV adenocarcinoma of the breast
Safety and Efficacy of URS Stents in the Treatment of Ureteral Stricture

Study Overview
=================
Brief Summary
-----------------
A prospective observational study aimed to assess the efficacy and safety of Allium ureteral stent long-term indwelling in the treatment of ureteral stricture.

Official Title
-----------------
Prospective Observational Study for Assessment of the Efficacy and Safety of Allium Ureteral Stent Long-term Indwelling in the Treatment of Ureteral Stricture

Conditions
-----------------
Ureteral Stricture

Intervention / Treatment
-----------------
* Device: URS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Benign diseases: UPJ, ischemic injury caused by surgical separation, endoscopic surgery injury, heat injury by laser lithotripsy, infection (chronic inflammation, tuberculosis), peri-ureteral fibrosis caused by endometriosis, ureteral anastomotic stenosis after renal transplantation, ureteral fistula, multiple polyps; Malignant diseases: ureteral anastomotic stricture after urinary diversion, stricture caused by compression of abdominal and/or pelvic tumors, stricture caused by urinary tract tumors, stricture caused by radiotherapy for colon or cervical cancer, ureteral fistula Exclusion Criteria: Combine with hypertonic neurogenic bladder (except for patients with long-term indwelling catheter) Colon resection surgery patients -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: URS|URS is a permanent ureteral stent made of nitinol and covered by a polymer, that is indicated to open strictures in the ureter. Study patients who has strictures in the ureter, will be implanted with the URS for long term opening of the stricture.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency rate | Number of patients evaluated with hydronephrosis | Up to 36 months | 
| Indwelling time | Number of months of the implant in the ureter | Up to 36 months | 
| Device related serious adverse events | Number of device related serious adverse events | Up to 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ureteral, ureteral stent, ureteral stricture
Circulating Endothelium Progenitor Cells and Endogenous Oestrogen in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the number of circulating EPC is different between healthy women and men.

Detailed Description
-----------------
Study design: Open pilot study in health volunteers in the Hospital Saint-ANTOINE's Clinical Investigation Centre (CIC). Recruitment and course of the study: The subjects will be recruited among the CIC's pool of healthy volunteers. Volunteer people will then have biological and clinical baseline examinations. If they match the inclusion criteria, an appointment will be taken for the blood sample intend for the characterization of the EPC and hormonal plasma levels evaluation. The participation will not exceed 2 months. Young women will have to come between the 9th and the 11th day after the beginning of menses). A total of 150 ml of peripheral blood will be collected. The study will last 18 months.

Official Title
-----------------
Impact of Endogenous Sexual Hormones (Oestrogens and Testosterone) on the Endothelium Circulatory on Rolling at the Young and Old Healthy Volunteer.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 19 and 25 kg/m² non menopausal women : age 18 to 40 years, regular menstrual cycles no hormone therapy as contraceptives postmenopausal women : age above 55 years old amenorrhoea since 5 years at least no hormone therapy since at least 3 month Exclusion Criteria: no medical insurance inclusion in another study smoking, Statins treatment, uncontrolled diabetes or hypertension and personal history of cardiovascular disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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 |
| --- | --- |
| 1<br>Non menopausal women | |
| 2<br>age matched men | |
| 3<br>Menopausal women | |
| 4<br>age matched men | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of endothelial progenitor cells by cytometry |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the number of EPC in young women to older men and menopausal women. To evaluate the correlation between the number of EPC and 17 b-estradiol plasma level. |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endothelial progenitor cells, estrogen, menopause, cardiovascular risk