linjc16/ctgov huggingface dataset:
Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
Probiotics have been proposed for the treatment of dyslipidemia. the investigators aimed to evaluate efficacy, tolerability and safety of a new symbiotic formulation containing a combination of probiotic and prebiotics and amine in the treatment of children affected by familial hypercholesterolemia (FH).

Detailed Description
-----------------
FH subjects, aged 6-12 years, consecutively observed a Tertiary Center for Pediatric Nutrition were randomly allocated to two groups of intervention for 6 months: active group, received a low saturated fats diet plus the symbiotic (2.5×109cfu, bid) for 6 months; control group, received low saturated fats diet alone. All children received written indications for low saturated fats diet. The plasmatic lipid profile was assessed by peripheral blood sampling at T0 and T1.

Official Title
-----------------
Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia

Conditions
-----------------
Dyslipidemia, Familial Hypercholesterolemia

Intervention / Treatment
-----------------
* Dietary Supplement: Lactobacillus paracasei B21060
* Other: low satured diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged ≥ 6 and ≤ 12 years. Diagnosis of hypercholesterolemia (LDL cholesterol> 140 mg / dl) Each patient must have shown resistance to dietary therapy lasting at least 6-12 months. Exclusion Criteria: Age <6 or> 12 years. Patients undergoing drug treatment for hypercholesterolemia. Any medical condition that may interfere with participation in this study Participation in clinical trials still in progress. Taking pre / probiotics for more than 7 days in the 6 months prior to enrollment

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: diet plus Lactobacillus paracasei B21060<br>low saturated fats diet plus the symbiotic (2.5×109cfu, bid) | Dietary Supplement: Lactobacillus paracasei B21060<br>* combination of probiotic (Lactobacillus paracasei B21060) and prebiotics (arabinogalactans, xyloooligosaccarides) and amine (L-glutamine)<br>Other: low satured diet<br> <br> |
| Placebo Comparator: low saturated fats diet<br>low saturated fats diet | Other: low satured diet<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of LDL cholesterol after 6 months of treatment wiyh symbiotic |  | The plasmatic lipid profile was assessed by peripheral blood sampling at enrollment and after 6 months. |
Chest Pain Unit II Register

Study Overview
=================
Brief Summary
-----------------
Multicentric, prospective, non-interventional observational study with two parts: A register of quality assurance within the recertification of clinics An extended register with scientific protocol.

Detailed Description
-----------------
Quality assurance As a quality-assuring basic register, the CPU II register checks the extent to which certified Chest Pain Units fulfill the criteria published by the DGK. In particular, the following quality dimensions are evaluated: Indication quality Diagnostic quality Therapeutic quality Structural quality / networking Platform for projects with a scientific focus The CPU II register and the infrastructure provided are a platform for further projects with scientific questions (scientific protocol = WP): WP: Clinical history after CPU (PCI data / discharge / 12-month FUP) in patients with leading cardiac diagnosis

Official Title
-----------------
Chest Pain Unit II Register - CPU II Register

Conditions
-----------------
Chest Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CPU patient > 18 years Written consent of the patient Exclusion Criteria: Denied consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Fulfillment of DGK criteria | Quality assurance: Fulfillment of the recertification criteria of the german society for cardiology | 12 months | 
| Clinical progress after CPU | Scientific protocol: Documentation of the clinical progress after CPU | 12 months |
Prospective Registry of Patients With Isolated Severe Tricuspid Regurgitation

Study Overview
=================
Brief Summary
-----------------
Prospective registry for patients with severe isolated tricuspid regurgitation (TR) without significant left-sided valvular or myocardial diseases. Aim: To evaluate clinical course and prognostic factors of patients with severe isolated TR.

Detailed Description
-----------------
Inclusion criteria Severe isolated TR for more than 6 months Exclusion criteria Severe mitral and aortic valvular heart disease Age equals to or more than 75 years Malignancy or serious comorbidity with life expectancy < 5years Acute or subacute infective endocarditis requiring antibiotics therapy Untreated hyperthyroidism Constrictive pericarditis Unclosed significant atrial septal defect Previous tricuspid valve surgery Significant coronary artery disease Cardiomyopathy Pregnancy Severe resting pulmonary hypertension(TR Vmax >4.0 m/s)

Conditions
-----------------
Tricuspid Regurgitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Severe isolated TR for more than 6 months Exclusion criteria Severe mitral and aortic valvular heart disease Age equals to or more than 75 years Malignancy or serious comorbidity with life expectancy < 5years Acute or subacute infective endocarditis requiring antibiotics therapy Untreated hyperthyroidism Constrictive pericarditis Unclosed significant atrial septal defect Previous tricuspid valve surgery Significant coronary artery disease Cardiomyopathy Pregnancy Severe resting pulmonary hypertension(TR Vmax >4.0 m/s)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| all cause death |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization of cardiovascular causes |  | 5 years | 
| tricuspid valve surgery |  | 5 years | 
| stroke |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clinical course and prognostic factors in patients with severe isolated TR
Self Screening Tool for Crohn's Perianal Fistula

Study Overview
=================
Brief Summary
-----------------
This study aims to develop a self-screening tool for Crohn's perianal fistula.

Official Title
-----------------
Development and Validation of Patient Self-screening and Monitoring Tool for Crohn's Perianal Fistula

Conditions
-----------------
Crohn Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Crohn's disease Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Perianal fistula | perianal fistula rate confirmed by MRI | 1 day |
Antenatal Detection by Array CGH Genomic Rearrangements Unbalanced Front Uninsulated Thick Neck or a Combination of Two Signs of Ultrasound Calling Normal Karyotype

Study Overview
=================
Brief Summary
-----------------
This is the first study with a real diagnostic and prognostic focus in prenatal. In addition to this innovative aspect, the identification of cryptic imbalances in fetuses with malformative syndrome would be an invaluable resource for the identification of new genes involved in development, as is already the case for postnatal studies. This research aims to: to test the feasibility of this protocol, ie the practical application of this new technology in the context of prenatal diagnosis, demonstrate and evaluate the possible involvement of cryptic chromosomal abnormalities in fetuses with a thick neck associated with other malformations and recruited on the strict criteria mentioned above, assist in the diagnosis of these fetuses and genetic information for their families, identify new regions of the genome potentially involved in the occurrence of congenital malformations.

Official Title
-----------------
Antenatal Detection by Array CGH Genomic Rearrangements Unbalanced Front Uninsulated Thick Neck or a Combination of Two Signs of Ultrasound Calling Normal Karyotype

Conditions
-----------------
Abnormality of the Neck, Fetus; Abnormal, Affecting Management of Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a karyotype performed from a trophoblast biopsy or an amniotic fluid puncture is normal or apparently balanced. The fetuses included in the study should have one of the following two criteria: 1) Thick bone (greater than 99th percentile, between week 11 and week 13 of amenorrhoea plus 6 days, correlated to a cranio-caudal length measured between 45 and 84 mm) detected in the first trimester of pregnancy associated with One or more echographic sign (s). 2) At least two ultrasound call signs involving the following organs (heart, kidney, brain, limbs, digestive tract, face) or intrauterine growth retardation (less than 3rd percentile) associated with one of these Signs of appeal. Exclusion Criteria: The parturientes in emergency situation, Benefiting from a legal protection (guardianship / curatorship)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| Number of patient with Ultrasound call signs (thick neck and / or any other organ concerned) |  | During the first trimester of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGH-array analysis | CGH-array result: normal, deletion or duplication, de novo or inherited, size, type and number of genes involved | During the first trimester of pregnancy |
RNA-Loaded Dendritic Cell Cancer Vaccine

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of administering a dendritic cell vaccine to patients with metastatic renal cell carcinoma.

Official Title
-----------------
A Phase I/II Study To Examine The Safety, Feasibility, Immunological Response, And Measures Of Clinical Antitumor Activity After Administering Unselected, Autologous, Amplified Tumor Total RNA-Transfected, Dendritic Cell Vaccine (MB-002) To Patients With Metastatic Renal Cell Carcinoma

Conditions
-----------------
Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Biological: MB-002


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a new diagnosis of metastatic renal cell carcinoma; Must be at least 18 years or older; Have a scheduled unilateral nephrectomy; ECOG of 0 or 1; Free of brain metastases by CT or MRI; Normal renal function in contralateral kidney; Male or non-pregnant/non-lactating female on appropriate birth control methods while on study; Clinically acceptable screening results. No immunosuppressive therapy not limited to corticosteroids (including topical steroids or steroid containing inhalers), azathioprine cyclosporine two months prior to study entry; No active autoimmune disease

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MB-002-003<br> | Biological: MB-002<br>* Dendritic Cell Immunotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the safety of multiple administrations of MB-002 in patients with newly diagnosed, metastatic renal cell carcinoma. |  | From registration until disease progression or withdrawal from study | 
| To measure clinical antitumor activity including objective tumor response and an estimate of time to tumor progression (or progression-free interval). |  | From registration until disease progression or withdrawal from study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney cancer, Renal cancer
Evaluation of EverOn™ System in Medical / Surgical Ward

Study Overview
=================
Brief Summary
-----------------
The EverOn™ system developed by EarlySense, Ltd., the sponsor of this study, is intended to assist hospitals to better address and improve recognition and response to changes in a patient's condition. The system, monitors the patient while in bed consists of a contact-free sensor that is placed under the bed mattress and identifies respiratory and heart rates, degree of patient's movement or agitation while in bed as well as patient's actual exit out of the bed. The EverOn system does not require a physical contact with the patient, eliminating the need for any direct contact electrodes, leads, cuffs or nasal cannulae.

Official Title
-----------------
Evaluation of EarlySense EverOn™ System in Medical / Surgical Ward

Conditions
-----------------
Post Operative Patient, Patients Requiring PCA, Respiratory Patients, Patients in Risk of Fall

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 18 years. Patients not monitored continuously by telemetry, vital sign monitor or oximetry. Patients not requiring special mattresses (e.g. airflow). The patient or a legal guardian is ready to sign the Informed Consent. Exclusion Criteria: Patients that at the judgment of the staff in the evaluating unit, are not able to communicate coherently and respond to nurses' questions. Patients monitored continuously by telemetry, vital sign monitor or oximetry. Patients requiring special mattresses.

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?
-----------------
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
-----------------
heart and respiratory monitoring
Treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) With 3, 4 DAP

Study Overview
=================
Brief Summary
-----------------
Lambert Eaton Myasthenic Syndrome (LEMS) is rare neurological disorder that results in muscle weakness and limited reflex activity. More than half of LEMS cases are associated with a malignancy, usually small cell lung cancer, and tend to progress more quickly than cases not coupled with malignant cells. 3,4diaminopyridine (3,4DAP)is a drug that has been demonstrated to be effective in treating the weakness associated with LEMS as it increases strength and improves autonomic symptoms in LEMS patients. It is not currently approved by the FDA for use in the United States. The investigators plan to use 3,4DAP to treat patients with LEMS here at the Columbia University MDA/ALS Research Center.

Official Title
-----------------
Treatment of Lambert-Eaton Myasthenic Syndrome and Congenital Myasthenic Syndromes With 3, 4-Diaminopyridine

Conditions
-----------------
Lambert Eaton Myasthenic Syndrome (LEMS)

Intervention / Treatment
-----------------
* Drug: 3,4-diaminopyridine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be diagnosed with LEMS or a type of CMS likely to respond to 3, 4-DAP. If female of childbearing age, have negative pregnancy test, and be willing to practice and effective form of birth control during the study. Tested and found by ECG not to have a prolonged QTc syndrome. Agrees to have a second ECG at the time of peak drug effect. Has understood and signed the Informed Consent. Exclusion Criteria: Is known to have a sensitivity to 3, 4-DAP. Has a history of past or current seizures or of severe asthma, or has an epileptiform EEG. Is believed by the investigator to be unable to comply with the protocol. Is unable to give informed consent. No patient will be excluded based on race, ethnicity, gender, or HIV status

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 |
| --- |
|Drug: 3,4-diaminopyridine|Treatment will begin with 5mg three times a day or less.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Relationship and Sexual Satisfaction of Stoma Patients

Study Overview
=================
Brief Summary
-----------------
Anonymous questionnaire regarding relationship and sexual satisfaction as well as quality of life of stoma patients.

Detailed Description
-----------------
With an anonymous questionnaire relationship, sexual and life satisfaction of stoma patients are investigated. The questionnaire will be made public by support groups and stoma nurses. Analysis of data and publication of sexual and relationship satisfaction of stoma patients.

Official Title
-----------------
Relationship and Sexual Satisfaction of Stoma Patients

Conditions
-----------------
Satisfaction, Patient, Stoma Ileostomy, Stoma Colostomy

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ileostomy or Colostomy Exclusion Criteria: Disease affecting sexual functioning Disease affecting daily life

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| ileostomy<br>Patients with ileostomy | Other: Questionnaire<br>* Questionnaire regarding relationship and sexual satisfaction<br>|
| colostomy<br>Patients with colostomy | Other: Questionnaire<br>* Questionnaire regarding relationship and sexual satisfaction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sexual satisfaction | Questionnaire regarding sexual satisfaction of participants, multiple choice answers. | September 2022 | 
| relationship satisfaction | Questionnaire regarding relationship satisfaction of participants, multiple choice answers. | September 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfaction influences | Questionnaire with multiple choice answers to possible influences of satisfaction | September 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sexual satisfaction, stoma patients, relationship satisfaction
A New Track Ablation Device for Liver Biopsy: A Feasibility Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness and safety of a new biopsy track ablation device for liver biopsy.

Detailed Description
-----------------
Background: Percutaneous biopsy for hepatic masses has a potential risk of bleeding and peritoneal tumor seeding. A new device for biopsy track ablation has been invented to reduce the risk of bleeding and peritoneal tumor seeding. Method: Routine percutaneous biopsy for hepatic masses is performed. Immediate after obtaining tissue, biopsy needle track is ablated with a new biopsy tract ablator. Immediate (with ultrasound) and 24 hours (with CT scan) after procedure, occurrence of complications is evaluated.

Official Title
-----------------
A New Track Ablation Device for Liver Biopsy: A Feasibility Study

Conditions
-----------------
Liver Neoplasms

Intervention / Treatment
-----------------
* Device: Biopsy Track Ablator (STARmed, Goyang, Korea)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with a hepatic mass on CT scan or MRI patients who are referred for percutaneous biopsy of a hepatic mass patients with normal range of platelet count and coagulation test Exclusion Criteria: pregnant women patients with ascites Uncooperative patients

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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: Ablation<br>Intervention: ablation of biopsy needle track with a new device | Device: Biopsy Track Ablator (STARmed, Goyang, Korea)<br>* After percutaneous ultrasound guided biopsy for hepatic masses is performed, biopsy track is ablated with a new track ablation device.<br>* Other names: Ultrasound (Logig E9, GE Healthcare);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with complications | If procedure-related complications are suspected clinically, appropriate tests such as CT scan or Ultrasound are performed and complications are evaluated. If procedure-related complications are not suspected, non-contrast CT scan is performed at 24 hours after procedure and complications are evaluated. | within 24 hours after procedure |