linjc16/ctgov huggingface dataset:
Measurement of Cerebral Flow Using Transfontanellar Doppler in Infants Under Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
Transfontanellar Doppler can measure the velocity at both the carotid artery and the anterior cerebral artery during cardiopulmonary bypass in congenital heart disease patients. This study can provide reference value of appropriate cerebral blood flow velocity during pediatric cardiac surgery.

Official Title
-----------------
Intraoperative Trans-fontanel Cerebral Ultrasonography in Infants During Pediatric Cardiac Surgery Under Cardiopulmonary Bypass

Conditions
-----------------
Cardiopulmonary Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the patients less than 1 year of age undergo congenital heart surgery with cardiopulmonary bypass written informed consent is obtained from their guardians in accordance with the requirements of the local ethics committee Exclusion Criteria: synostosis skull abnormality or fracture epidural hematoma, scalp hematoma

Ages Eligible for Study
-----------------
Maximum Age: 1 Year

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 |
| --- | --- | --- |
| cerebral blood flow velocity | during cardiac surgery | 6hour |
Scoliosis Survey to Development Treatment Decision Tool

Study Overview
=================
Brief Summary
-----------------
This is a survey to help understand the influences related to the decision for Adolescent Idiopathic Scoliosis treatment (observation vs. bracing vs. surgery). The investigator then plans to create a decision aid to help families when making a decision about the treatment choice being presented to them.

Detailed Description
-----------------
This survey is designed to help understand the factors that families consider to help make treatment decisions related to Adolescent Idiopathic Scoliosis (AIS). The surveys will then be used to help create a shared decision making tool to help families better understand the treatment options and optimize clinical conversations surrounding AIS treatment.

Official Title
-----------------
Your Scoliosis Journey: A Survey for Patients Treated for Scoliosis and Their Families

Conditions
-----------------
Scoliosis; Adolescence

Intervention / Treatment
-----------------
* Other: Survey for Patients Treated for Scoliosis and ther Families


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject (and/or parent of subject) who has previously been treated for Adolescent Idiopathic Scoliosis (AIS) Exclusion Criteria: Age less than or equal to 12 years

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Survey for Patients Treated for Scoliosis and ther Families|Your Scoliosis Journey: A Survey for Patients Treated for Scoliosis and ther Families|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects who completed the survey | Number of subjects who completed the survey | Baseline, approximately 3 years |
Autoreactivity Threshold Analysis in Lupus and Immune Thrombocytopenia (Checkpoints ITP and SLE)

Study Overview
=================
Brief Summary
-----------------
The aim of this proposal is to test if anti-BAFF antibody can restore a normal threshold of tolerance in patients in two auto-immune diseases along the RITUX-PLUS study in immune thrombocytopenia, and along the Believe study in SLE. This work would help to conclude whether or not the 'double hit' therapy may help to reset the immune system toward a more tolerogenic profile. The aim is to compare the polyreactivity and autoreactivity, of immature (central tolerance) and naïve B cells (peripheral tolerance) in the peripheral blood along the RITUX-PLUS STUDY and the BLISS BELIEVE study after treatment (B-cell reconstitution time).

Official Title
-----------------
Tolerance Checkpoints Upon the B-cell Depletion Plus BAFF Blockade Strategy in Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE) (Checkpoints ITP and SLE)

Conditions
-----------------
Immune Thrombocytopenia (ITP), Systemic Lupus Erythematosus (SLE)

Intervention / Treatment
-----------------
* Other: Bliss-Believe


Participation Criteria
=================
Eligibility Criteria
-----------------
There are no specific inclusion and exclusion criteria for this study. The inclusion and exclusion criteria are those of patients enrolled in the RITUX-PLUS (NCT03154385) and BLISS BELIEVE studies (NCT03312907) including the following inclusion criteria: individuals are affiliated to social security individuals not be placed under judicial protection, guardianship or curatoship

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bliss-Believe<br>Patients included in the BLISS-BELIEVE study (NCT03312907). | Other: Bliss-Believe<br>* The samples from the blood samples carried out within the framework of Bliss Believe will be collected for a biological collection. Only one sample of patients included in BLISS BELIEVE STUDY will be obtained during a standard of care visit. It will be 21ml of blood.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of polyreactive and autoreactive cells in immature and naïve B cells subsets in the peripheral blood | Number of polyreactive and autoreactive cells in immature (central tolerance) and naïve B cells (peripheral tolerance) subsets in the peripheral blood along the RITUX-PLUS and the BLISS BELIEVE studies after treatment (reconstitution time). | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rituximab
A Large Multi-Center Database of Women Who Have Had and Are Going to Have Surgical Correction of Their Pelvic Organ Prolapse Using the Gynecare Prolift System

Study Overview
=================
Brief Summary
-----------------
retrospective and prospective data collection for a database. Patients will have had or are going to have a repair of their pelvic organ prolapse using the Gynecare mesh Prolift System

Official Title
-----------------
A Large Multi-Center Database of Women Who Have Had and Are Going to Have Surgical Correction of Their Pelvic Organ Prolapse Using the Gynecare Prolift System

Conditions
-----------------
Pelvic Organ Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women recieving surgery for their pelvic organ prolapse using the Gynecare mesh kit called Prolift Exclusion Criteria: none
Sexes Eligible for Study
-----------------
Female

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
-----------------
Gynecare Prolift, Pelvic organ prolapse, forming a large database of women who have recieve Gynecare prolift system
Pilot Study to Determine Feasibility of Benign and Malignant Skin Lesion Detection.

Study Overview
=================
Brief Summary
-----------------
In this study a fluorescent contrast dye is applied to a suspicious skin lesion. Images are acquired and processed. The information is used to develop a prediction model for the presence of malignant transformation in the skin.

Detailed Description
-----------------
Images acquired in the study are used for the development of a software analysis program.

Official Title
-----------------
Pilot Study to Asses the Identification of Melanoma in Skin Lesions.

Conditions
-----------------
Skin Lesions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over the age of 18 Individual is scheduled for a skin biopsy in toto The lesion is pigmented or non pigmented Lesions may be under suspicion for basal cell carcinoma, squamous cell carcinoma, actinic keratosis, nevi, melanoma, seborrheic keratosis. The lesion is accessible to the imaging device Exclusion Criteria: The patient has sensitive skin and easily breaks out in rash The lesion is within 1 cm of the eye The lesion is on mucosal surfaces (e.g., lips, genitals) Pregnant females Taking medications that pigments the skin

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 |
| --- | --- |
| Individuals undergoing skin excision.<br>Skin lesions are under suspicion for skin cancer. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between imaging and pathology. | Patients are imaged and then undergo a biopsy. Images are used to develop a software predicting model based on pathology. Sensitivity and specificity parameters are calculated. No long term follow up is required since the biopsy is performed on the skin imaged. The follow up required is for the pathology for the skin excised. | No long term follow up is necessary. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute response | The acute dermal response to the imaging procedure is evaluated. | up to 1 day |
Safety Study of BMS-823778 in Subjects With Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C)

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Parallel-Group, Randomized, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of BMS-823778 in Non-Diabetic Subjects With Primary Hypercholesterolemia on a Stable Dose of Statin Therapy With or Without Ezetimibe

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: BMS-823778
* Drug: BMS-823778
* Drug: BMS-823778
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypercholesterolemia Currently taking a stable daily dose of statin therapy Serum triglyceride level < 500mg/dl Exclusion Criteria: History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study Congestive heart failure Diabetes mellitus Active liver disease Impaired renal function Hepatitis C, B and HIV This list is not inclusive; additional information is provided in the protocol

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-823778 (2 mg)<br> | Drug: BMS-823778<br>* Capsules, Oral, 2 mg, once daily, 28 days<br>|
| Experimental: BMS-823778 (10 mg)<br> | Drug: BMS-823778<br>* Capsules, Oral, 10 mg, once daily, 28 days<br>|
| Experimental: BMS-823778 (20 mg)<br> | Drug: BMS-823778<br>* Capsules, Oral, 20 mg, once daily, 28 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Capsules, Oral, 0 mg, once daily, 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lowering of LDL-C |  | Within 28 days following dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (measuring trough concentrations) |  | On days 7, 14, and 28 | 
| Pharmacodynamic effects of BMS-823778 on Total cholesterol, HDL-C, Triglycerides, non-HDL-C, free fatty acids, Apolipoprotein fractions, HPA axis marker and free testosterone and sex hormone binding globulin (SHBG) |  | Within 28 days following dosing |
Prehabilitation and Rehabilitation for Patients With Oesophageal Cancer

Study Overview
=================
Brief Summary
-----------------
Patients with oesophageal cancer selected for oncological and surgical treatment with curative intent are offered supervised physiotherapy and home-based training before and after surgery.

Detailed Description
-----------------
Patients with loco-regional oesophageal cancer who will receive neoadjuvant chemotherapy or chemoradiotherapy followed by surgery and sometimes adjuvant chemotherapy are eligible to be enrolled in the trial. Study treatment is supervised group training twice weekly and home-based training three times weekly during neoadjuvant treatment and after surgery.

Official Title
-----------------
Prehabilitation and Rehabilitation for Patients With Oesophageal Cancer

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Other: Physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histopathologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma in the oesophagus or cardia (Siewert I or II), cT1 N+ or cT2-4a any N, M0, according to the 8th version of the AJCC TNM classification. Assessed at a multidisciplinary conference to be suitable for curatively intended oncological and surgical treatment. Age > 18 years. Performance status ECOG 0-2. Patient has provided written informed consent. Exclusion Criteria: Previous radiotherapy in the thorax (except for tangential field radiotherapy for breast cancer). Inability to understand written and spoken instructions and to comply with protocol requirements.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physiotherapy<br> | Other: Physiotherapy<br>* Supervised physiotherapy one hour twice weekly and 20 minutes three times weekly during 14- 17 weeks before surgery during neoadjuvant chemotherapy or chemoradiotherapy and during eight weeks after surgery (sometimes during adjuvant chemotherapy)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to exercise sessions. | Percentage of sessions completed out of number of sessions planned | Up to 40 weeks | 
| Un-planned interruptions in the prehabilitation/rehabilitation programme | Percentage of patients having an unplanned interruption of ten days or more of the supervised prehabilitation/rehabilitation programme | Up to 40 weeks |
Prophylactic Antibiotic After Perineal Tear

Study Overview
=================
Brief Summary
-----------------
Current World Health Organization guidelines recommend routine antibiotic prophylaxis for women with perineal tear 3rd and 4th degree but not for 2nd degree because of insufficient evidence of effectiveness. The investigators aimed to investigate whether antibiotic prophylaxis prevented maternal infection after the first and second perineal tear after vaginal birth.

Detailed Description
-----------------
The PATPET trial is a randomized, controlled trial done at tertiary hospital obstetric units in Israel. Women who had first and second-degree tear (or after episiotomy) after delivery at 37 weeks or greater gestation, with no indication for ongoing prescription of antibiotics in the post-partum period and no contraindications to prophylactic Cefamezin (cefazolin), were randomly assigned (1:1) to receive a single intravenous dose of prophylactic antibiotic or not.

Official Title
-----------------
Prophylactic Antibiotic Treatment for Perineal Tear After Delivery: a Randomized Controlled Trial

Conditions
-----------------
Puerperal Infection

Intervention / Treatment
-----------------
* Drug: Cefazolin (Cefamezin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-45 perineal tear 2nd and 1st degree( episiotomy) Exclusion Criteria: 3rd and 4 th degree perineal tear antibiotic indication during delivery cesarian section delivery

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parturition
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prophylactic antibiotic treatment<br>Will be given Cefamezin antibiotic within 6 hours of delivery | Drug: Cefazolin (Cefamezin)<br>* Cefamezin 2 gr within 6 hour of delivery<br>|
| No Intervention: No intervention<br>Will not get antibiotic prophylactics | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with a fever after delivery | Maternal fever above 38 C (Celsius) | 6 weeks of delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Way of delivery | Type of delivery- vacuum-assisted delivery vs. vaginally | 6 weeks of delivery |
Effects of Prednisolone and Infliximab on the Regulation of Urea Synthesis in Active Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
Loss of total mass of muscles (catabolism) is a serious clinical problem in patients with active inflammatory bowel disease (IBD). The investigators have earlier shown that the liver plays an important role in this stress-catabolism by increasing the production of urea during the inflammatory process. The purpose of this study is to examine the effect of the anti-inflammatory drugs prednisolone and infliximab on the regulation of the urea synthesis in patients with active ulcerative colitis and Crohn's disease.

Official Title
-----------------
Effects of Prednisolone and Infliximab on the Regulation of Urea Synthesis in Patients With Active Ulcerative Colitis and Crohn's Disease

Conditions
-----------------
Inflammatory Bowel Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe active inflammatory bowel disease Exclusion Criteria: Viral or bacterial infections Other chronical inflammatory diseases Cancer Other catabolic diseases Treatment with prednisolone or infliximab within the last 8 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Active inflammatory bowel disease<br>Patients with moderate to severe active inflammatory bowel disease (ulcerative colitis and Crohn's disease) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Hepatic Nitrogen Clearance |  | Before and one week after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and biochemical measures of inflammation |  | Before and one week after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammation, Urea synthesis, Catabolism, Nitrogen balance
Treatment of Acute Asthma in ER With Combination of Systemic Steroids and Inhaled Steroids

Study Overview
=================
Brief Summary
-----------------
We assume that the combination of systemic steroids and inhaled steroid in the first hour of treatment in the ER will decrease the admission rate and improve faster the pulmonary function. 120 patients refferd to the ER due to asthma attack aged 18-60 with PFR < 60% 0o predicted will participate in the study after giving informed consent. The usual treatment in the ER is inhalation of Beta 2 short acting and I.V solumedrol 120 mg . The study group will recieve in addition 3 inhalation of Budesonide 1000 microgram each during the first hour. The controlled group will recieve Nacl 0.9% PFR will be followed 0 30 60 120 min.

Detailed Description
-----------------
Primary end points- PFT improvment and admission rate.

Conditions
-----------------
Asthma Exacerbation

Intervention / Treatment
-----------------
* Drug: inhalation of corticosteroids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asthmatic patients aged 18-60 with PFR < 60% of predicted Exclusion Criteria: Patients with other chronic diseases cardiac renal hepatic etc will be excluded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: inhalation of corticosteroids|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFT improvment |  |  | 
| Admission rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dyspnea, Cough