linjc16/ctgov huggingface dataset:
Does Rectus Re-approximation Cause Adhesion After Cesarean Section?

Study Overview
=================
Brief Summary
-----------------
Rectus re-approximation and periton closure are not the obligatory steps during cesarean section. These steps are due to surgeon's preference. However, there is lack of knowledge about the relation of rectus muscle re-approximation and adhesion formation. We are going to study the rectus muscle stiffness by share-wave elastosonography.

Official Title
-----------------
The Evaluation of Rectus Re-approximation in Terms of Adhesion After Cesarean Section by Elastography.

Conditions
-----------------
Obstetric Complication, Muscle Injury

Intervention / Treatment
-----------------
* Procedure: Rectus muscle re-approximation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary cesarean section Exclusion Criteria: Wound infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study group<br>This arm is going to include the patients who are performed rectus reapproximation. | Procedure: Rectus muscle re-approximation<br>* Study group: we are going to re-approximate rectus muscle wirth minimum 3 stiches.<br>|
| No Intervention: Control group<br>This arm is going to include the patients who are not performed rectus reapproximation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rectus muscle stiffness | Share wave elastosonography is going to perform to six different points of rectus muscle. Each points will be 2 cm right or left side of linea alba line in horizontal axis. Two points are on cesarean section incision, next two points 2 cm below the incision and other next two points 2 cm above the incision in vertical axis. Rectus muscle stiffness will show the adhesion formation. | 3 months after cesarean section | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | Operation time in minutes is going to be recorded | During operation | 
| Postoperative pain | VAS scale is going to be used. | 3 months after cesarean section | 
| Postoperative bowel function | It is going to be evaluated by self developed questionnaire. | 3 months after cesarean section | 
| Postoperative bladder function | It is going to be evaluated by self developed questionnaire. | 3 months after cesarean section | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elastography, rectus muscle re-approximation
Tumor Recurrence After Abdominal-perineal Amputation in Squamous Cell Carcinoma of the Anus

Study Overview
=================
Brief Summary
-----------------
Squamous cell carcinoma of the anal canal is a rare cancer with an increasing incidence. It represents 2.5% of digestive cancers and occurs more frequently in immunocompromised persons, in particular HIV positive. It is a cancer that develops essentially locally, with only 5% of metastases at diagnosis. The reference treatment for forms deemed localized after clinico-bio-radiological pre-therapeutic evaluation is radiochemotherapy allowing a 5-year survival rate of about 80%. However, up to 30% of patients fail radiochemotherapy. Failure is defined as persistent disease (non response or progression in 10 to 15% of patients) or relapse (local or metastatic in 10 to 15% of patients). Salvage surgery by abdominoperineal amputation is indicated in this case after elimination of the metastatic character with an overall survival rate at 5 years varying from 23 to 69%. This complex and cumbersome surgery is burdened with significant postoperative morbidity with alteration of the quality of life. Investigators would like to perform a retrospective and prospective study in the Paris Saint-Joseph hospital group to evaluate the interest of abdominoperineal amputation in case of failure of radiochemotherapy in patients with squamous cell carcinoma of the anal canal.

Official Title
-----------------
Tumor Recurrence After Abdominal-perineal Amputation in Squamous Cell Carcinoma of the Anus

Conditions
-----------------
Squamous Cell Carcinoma of the Anal Canal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with abdominoperineal amputation for squamous cell carcinoma of the anus Patient whose age ≥ 18 years French speaking patient Exclusion Criteria: Patient under guardianship or curatorship Patient deprived of liberty Patient under court protection Patient objecting to the use of his data for this research

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 |
| --- | --- | --- |
| Recurrence-free survival after abdominal-perineal amputation in case of failure of radiochemotherapy | This outcome corresponds to the Recurrence-free survival (local, metastatic) after abdominal and perineal amputation in case of failure of radio chemotherapy. | Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival after abdominal-perineal amputation | This outcome corresponds to the number of death. | Year 2 |
Sensing Ventricular Arrhythmias by His Bundle Leads

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine if implantable cardiac device leads implanted in the His bundle are capable of detecting ventricular arrhythmias.

Detailed Description
-----------------
During routine testing of implanted leads, the His bundle lead will be connected to a separate device with all therapies disabled. Testing will be done to see if the His bundle lead can detect ventricular arrhythmias.

Official Title
-----------------
Sensing Ventricular Arrhythmias by His Bundle Leads

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals undergoing routine defibrillation threshold testing of a right ventricular implantable cardioverter defibrillator lead who also have previously placed His bundle lead or who are undergoing placement of a His bundle lead. Exclusion Criteria: Individuals with contraindications to defibrillation threshold testing

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of ventricular arrhythmia from His bundle | During defibrillation threshold testing a lead from the His bundle to an external implantable cardiac device will be used to detect an arrhythmia | 1 hour |
24-hour IOP-lowering Effect of 0.01% Bimatoprost

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the 24-hour IOP-lowering efficacy of 0.01% bimatoprost once daily in patients with glaucoma or ocular hypertension

Detailed Description
-----------------
Objectives To investigate the 24 h effects of bimatoprost 0.01% monotherapy on intraocular pressure (IOP) and ocular perfusion pressure (OPP). Design Prospective, open-label experimental study. Setting Single tertiary ophthalmic clinic. Participants Sixteen patients with diagnosed primary open-angle glaucoma (POAG) or ocular hypertension (ages, 49-77 years). Interventions Baseline data of 24 h IOP in untreated patients were collected in a sleep laboratory. Measurements of IOP were taken using a pneumatonometer every 2 h in the sitting and supine body positions during the 16 h diurnal/wake period and in the supine position during the 8 h nocturnal/sleep period. After baseline measurements were taken, patients were treated with bimatoprost 0.01% one time per day at bedtime for 4 weeks, and then 24 h IOP data were collected under the same laboratory conditions. Primary outcome measure of nocturnal IOP mean under bimatoprost 0.01% treatment was compared with baseline.

Official Title
-----------------
24-hour IOP-lowering Effect of 0.01% Bimatoprost

Conditions
-----------------
Intraocular Pressure, Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: 0.01% bimatoprost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary open-angle glaucoma or ocular hypertension Exclusion Criteria: Women of childbearing potential previous glaucoma surgery presence of other eye disease

Ages Eligible for Study
-----------------
Minimum Age: 40 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: 0.01% bimatoprost<br>bimatoprost 0.01% one time per day at bedtime for 4 weeks. | Drug: 0.01% bimatoprost<br>* 0.01% bimatoprost once in the evening for 4 weeks<br>* Other names: Lumigan 0.01%;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nocturnal Intraocular Pressure (IOP) Change | Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline. | 4 weeks |
Microbiota as Potential Target for Food Allergy

Study Overview
=================
Brief Summary
-----------------
Food allergy (FA) derives from a dysregulation of oral tolerance mechanisms. Studies suggest a crucial role for enteric microflora in oral tolerance development. An altered composition of intestinal microflora results in an unbalanced local and systemic immune response to food allergens. There are qualitative and quantitative differences in gut microbiota composition in children with food allergy. These findings support the concept that specific beneficial bacteria from human intestinal microflora, designated probiotics, could restore intestinal microflora homeostasis and prevent or treat FA.

Official Title
-----------------
Microbiota as Potential Target for Innovative Preventive and Therapeutic Strategies for Food Allergy

Conditions
-----------------
Cow Milk Allergy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with cow's milk allergy age 6-12 months Exclusion Criteria: concomitant chronic systemic diseases congenital cardiac defects active tuberculosis autoimmune diseases immunodeficiency chronic inflammatory bowel diseases celiac disease, cystic fibrosis metabolic diseases malignancy chronic pulmonary diseases malformations of the gastrointestinal tract suspected eosinophilic esophagitis or eosinophilic enterocolitis suspected food-protein-induced enterocolitis syndrome.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 12 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cow milk allergy children<br>Children affected by Immunoglobulin E medited cow milk allergy | |
| healthy control<br>healthy infants | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composition and function gut microbiota in children with cow milk allergy and healthy children |  | Change from baseline at 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composition and function gut microbiota comparing cow milk allergy Italian and cow milk allergy children of other countries |  | Change from baseline at 6 and 12 months | 
| Composition and function gut microbiota comparing healthy Italian and healthy children of other countries |  | Change from baseline at 6 and 12 months |
Wavefront Analisys and Contrast Sensitivity of Spherical and Aspherical Intraocular Lenses

Study Overview
=================
Brief Summary
-----------------
Purpose:To compare visual performance, total and high order wavefront aberrations (coma, spherical aberration and other terms) and contrast sensitivity in eyes implanted with one monofocal aspheric intraocular lens (IOL) and two spherical IOLs (SofPort AO, Soflex,AcrySof®IQ (40 eyes), AcrySof®Natural and AMO®Sensar)

Official Title
-----------------
Wavefront Analisys and Contrast Sensitivity of Spherical and Aspherical

Conditions
-----------------
Cataract, Pseudophakia

Intervention / Treatment
-----------------
* Procedure: phacoemulsification (cataract surgery)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with bilateral visually significant senile cataract, corneal astigmatism less than 2.0 diopters and potential acuity meter (PAM) better than 0.2 LogMar Exclusion Criteria: any other ocular diseases, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities, surgical complications, IOL tilt, decentration (estimated by retro illumination and digital photo) greater than 0.4mm13 or loss of follow-up

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: phacoemulsification (cataract surgery)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks

Study Overview
=================
Brief Summary
-----------------
This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a day or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed dose combination tablet of abacavir 600 mg and lamivudine 300 mg once a day to suppress virus levels of HIV to less than 400 copies/mL of blood. In addition we will study the safety and tolerability of these compounds over the 48 week study period in patients naive to anti-HIV therapy.

Detailed Description
-----------------
A Phase IIIB, Randomized, Open-Label, Multicenter Study of the Safety and Efficacy of GW433908 (700mg BID) plus ritonavir (100mg BID) Versus Lopinavir/ritonavir (400mg/100mg BID) when Administered in Combination with the Abacavir/Lamivudine (600mg/300mg) Fixed-Dose Combination Tablet QD in Antiretroviral-Naive HIV-1 Infected Adults Over 48 Weeks

Official Title
-----------------
See Detailed Description

Conditions
-----------------
HIV Infection, Infection, Human Immunodeficiency Virus

Intervention / Treatment
-----------------
* Drug: LEXIVA (GW433908)
* Drug: Ritonavir
* Drug: KALETRA
* Drug: EPIVIR
* Drug: Ziagen
* Drug: Abacavir/Lamivudine
* Drug: Fosamprenavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infected subjects that are naive to anti-HIV therapy. History of a positive HIV test. At least 1000 copies/mL of HIV in their blood as screening. Exclusion Criteria: Active HIV-related diseases. Taking other investigational drugs. Pregnant or breastfeeding females. Not be suitable to participate per investigator opinion.

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

| Intervention/Treatment |
| --- |
|Drug: LEXIVA (GW433908)|nan|
|Drug: Ritonavir|nan|
|Drug: KALETRA|nan|
|Drug: EPIVIR|nan|
|Drug: Ziagen|nan|
|Drug: Abacavir/Lamivudine|nan|
|Drug: Fosamprenavir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with plasma HIV-1 RNA <400 copies/mL at Week 48. Proportion of subjects who permanently discontinue randomized treatment due to adverse events. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with plasma HIV-1 RNA <400 copies/mL at Week 48. Proportion of subjects who permanently discontinue randomized treatment due to adverse events. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ritonavir, abacavir, HIV, lopinavir, lamivudine, fosamprenavir, Epzicom
Bone Mineral Content in Healthy Children

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to determine the effects of early diet on bone health.

Official Title
-----------------
Bone Mineral Content in Healthy Children

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

Intervention / Treatment
-----------------
* Device: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current or past participation in the Beginnings study (IRB#07180) Age 5-7 years Exclusion Criteria: Growth or bone disorders Non-removal metal on participant Any other conditions that may affect the outcome of interest as determined by the PI.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 7 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 |
| --- | --- |
| No grouping<br> | Device: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone health assessed by pQCT and DXA |  | 5-7 years |
Preliminary Study of Safety and Efficacy of Policosanol

Study Overview
=================
Brief Summary
-----------------
Lay Language Summary: High cholesterol levels are common in persons with HIV infection. However, conventional cholesterol-lowering medications may have harmful side effects when given to HIV-infected persons. Therefore, we plan to evaluate the safety and effectiveness of policosanol, a dietary supplement derived from sugar cane that has cholesterol-lowering properties, to lower cholesterol levels in persons with HIV infection. We hypothesize that policosanol will lower levels of LDL cholesterol (bad cholesterol) and raise levels of HDL cholesterol (good cholesterol).

Detailed Description
-----------------
As per Brief Summary

Official Title
-----------------
Preliminary Study of Safety and Efficacy of Policosanol

Conditions
-----------------
Dyslipidemia, HIV Infections

Intervention / Treatment
-----------------
* Drug: Policosanol
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CD4 count > 250 Plasma HIV RNA < 50,000 Currently receiving HAART age 18-60 total cholesterol between 200-240 or triglycerides between 150-400 or LDL cholesterol > 160 Exclusion Criteria: kidney or liver disease current use of lipid-lowering drugs pregnancy lactation -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Policosanol<br>20 mg daily of policosanol | Drug: Policosanol<br>* 20 mg of policosanol in capsular form daily<br>|
| Placebo Comparator: Placebo<br>20 mg of microcrystalline cellulose daily | Dietary Supplement: Placebo<br>* Two capsules of 10 mg of microcrystalline cellulose daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL Cholesterol | Low density lipoprotein cholesterol | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglycerides |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, lipids, dyslipidemia, policosanol, treatment experienced