linjc16/ctgov huggingface dataset:
Prevention of Recurrent Hepatitis B After Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Hepatitis B accounts for approximately 5000 deaths per year in the United States. Liver transplantation offers the only hope for patients who develop end-stage liver disease. Early results of liver transplantation for hepatitis B were poor with recurrence rate of 80% and 1-year survival of only 50%. Recent studies found that preventive therapy using hepatitis B immune globulin (HBIG) or antiviral medications such as lamivudine can reduce the recurrence rate to roughly 30% with accompanying improvement in survival. However, HBIG when given as intravenous infusion in high doses is very expensive, while long-term use of lamivudine is associated with drug resistance. Some studies found that preventive therapy using both HBIG and lamivudine may decrease recurrence rate to less than 10% but the dose and duration of HBIG needed when used in combination with lamivudine is not clear. Adefovir, a new antiviral medication, is effective against lamivudine resistant hepatitis B but its role in liver transplantation is uncertain because of the risk of kidney damage. Many studies showed that the risk of recurrent hepatitis B is related to the viral load before transplant. Thus, it may be possible to tailor the preventive therapy according to the risk. The aim of this study is to establish the most cost-effective preventive therapy for recurrent hepatitis B after liver transplantation.

Official Title
-----------------
Prevention of Recurrent Hepatitis B After Liver Transplantation

Conditions
-----------------
Hepatitis B, Cirrhosis, Acute Liver Failure, Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: HBIG, Epivir, Hepsera


Participation Criteria
=================

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 |
| --- |
|Drug: HBIG, Epivir, Hepsera|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of TAP Block on Ventilatory Function Following Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
Abdominal surgery impairs ventilation. Postoperative pain accounts for this impairment. Regional analgesia is known to reduce pain, thus to limit ventilatory impairment. The investigators hypothesized bilateral continuous transverse abdominal plan block would reduce ventilatory impairment following abdominal surgery.

Official Title
-----------------
Assessment of the Ventilatory Effects of Transverse Abdominal Plan Regional Analgesia Following Abdominal Surgery.

Conditions
-----------------
Laparotomy

Intervention / Treatment
-----------------
* Procedure: Regional analgesia infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: laparotomy Exclusion Criteria: below 18, pregnancy, prisoners

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilateral TAP catheter<br>Ultrasonography guided bilateral TAP catheter insertion. | Procedure: Regional analgesia infusion<br> <br> |
| No Intervention: No TAP catheter<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vital capacity |  | 72h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum forced expiratory flow |  | 72h | 
| analgesic consumption |  | 72h | 
| pain | resting pain, assessed using VAS | 72h | 
| diaphragmatic course | using ultrasonography | 72h |
Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Diet Supplementation in Pediatric Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
Pulmonary inflammation is an independent risk factor for disease progression in cystic fibrosis patients (CF). Yet, no effective treatment is known to reduce this detrimental inflammation. Dysbiosis of the gut microbiota has been linked to inflammation in several inflammatory diseases. As children with CF have different faecal microbiota from their healthy siblings, modulating gut microbiota by lactobacillus rhamnosus diet supplementation might be a strategy to target the inflammatory state in CF. Study subjects (CF or healthy control) will receive either placebo or lactobacillus rhamnosus once daily as dietary supplementation for 12 weeks. After a one-week washout phase, they will be switched for another 12 weeks to the other trial arm. Effect on in intestinal and pulmonary inflammation as well as clinical outcome will be studied.

Official Title
-----------------
Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Rhamnosus Diet Supplementation in Pediatric Cystic Fibrosis (MoHuM-1)

Conditions
-----------------
Pulmonary Inflammation, Cystic Fibrosis, Microbiota

Intervention / Treatment
-----------------
* Dietary Supplement: Lactobacillus rhamnosus
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate to severe CF disease Exclusion Criteria: acute gastroenteritis 2 weeks prior to inclusion chronic disease other than CF (except CF associated disorders) oral or parenteral antibiotics 2 weeks prior to inclusion systemic steroids 4 weeks prior to inclusion any probiotic intake

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 20 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>placebo once daily for 12 weeks | Dietary Supplement: Placebo<br> <br> |
| Experimental: Lactobacillus rhamnosus<br>lactobacillus rhamnosus once daily for 12 weeks | Dietary Supplement: Lactobacillus rhamnosus<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline at w12 and w24 in fecal calprotectin levels | Baseline, week 12 change from baseline, week 24 change from week 12 | Baseline, week 12, week 24 | 
| Change from baseline at w12 and w24 in pulmonary calprotectin levels | Baseline, week 12 change from baseline, week 24 change from week 12 | Baseline, w12, w24 |
Retrospective Evaluation of Risk Factors for Lower Outcomes After Vitrectomy With ILM Flap Technique

Study Overview
=================
Brief Summary
-----------------
A retrospective review of medical charts of patients having undergone vitrectomy with ILM Peeling and ILM flap technique for macular hole repair.

Detailed Description
-----------------
A retrospective review of medical charts of patients having undergone vitrectomy with ILM Peeling and ILM flap technique for macular hole repair. Pre- and postoperative OCT and visual acuity in the time period up to 6 months after surgery are reviewed and possible risk factors for failed macular hole closure or lower visual acuity outcome after surgery are assessed.

Official Title
-----------------
Retrospective Evaluation of Risk Factors for Lower Outcomes After Vitrectomy With ILM Flap

Conditions
-----------------
Macular Holes

Intervention / Treatment
-----------------
* Other: vitrectomy with ILM peeling and ILM flap technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vitrectomy with ILM peeling and ILM flap technique in the time period form 1.1.2015 to 31.4.2020 Age 18 or older Exclusion Criteria: Age <18

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 105 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: vitrectomy with ILM peeling and ILM flap technique|outcomes after vitrectomy with ILM peeling and ILM flap technique for macukar hole repair are assessed|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | best corrected distance visual acuity | change between visual acuity 2-6 months postoperative to baseline | 
| macular hole closure | closure of the macular hole assesed with OCT | 2-6 months postoperative |
Epidemiology of Human Papillomavirus Infection Among Women Living on the Maroni and the Oyapock Rivers

Study Overview
=================
Brief Summary
-----------------
Cervical cancer is the second most frequent cancer of women in French Guiana. Studies have shown that populations living in remote villages in the interior of the territory have early sexual relations and that multiple sexual partnerships are frequent. Hence, the main objective of the study was to determine the prevalence of HPV in these areas, and the predictive factors and epidemiology of this viral infection. Methods - This multicentric cross sectional study aimed the population of women aged 20 to 65 years, living in the remote villages along the Maroni and Oyapock rivers. Women wishing to participate will be included after being informed of the study team schedule through radio address and key opinion leaders. The search for HPV and cytologic examinations will be performed for each woman. 2 samples will be taken from each woman: one sample will be sent to Fort De France hospital for cytology, and HPV testing; cytologic analyses will be performed using the 2001 Bethesda classification. Another sample will be sent to Pasteur Institute in Cayenne for sequencing and detection of E6 and E7 RNA which are associated with carcinogenesis. HPV infection will be defined by the detection of viral DNA using the GREINER-BIO-ONE kit. Statistical analysis of the results will use STATA software and mapping will use Mapinfo.

Official Title
-----------------
Epidémiologie de l'Infection à Human Papilloma Virus Chez Les Femmes Vivant Sur Les Fleuves Maroni et Oyapock

Conditions
-----------------
Human Papillomavirus Viruses

Intervention / Treatment
-----------------
* Other: Cervico-Vaginal Smears analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged from 20 to 65 living in a common Maroni rivers (Apatou , Grand Santi, Papaichton , Maripasoula and the Native American territory of Upper Maroni) and / or Oyapock ( Saint Georges, Camopi , Three Jumps ) Having already had sexual intercourse Having given after information , consent to the inclusion in the study Exclusion Criteria: Age < 20 or age> 65 years Being pregnant more than 3 months Have had a hysterectomy Denial of participation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Cervico-Vaginal Smears analysis|Cervico-Vaginal Smears analysis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and distribution of Human Papillomaviruses genotypes |  | At the time of inclusion (baseline) |
Inositol Treatment in Different Type of PCOS Phenotype

Study Overview
=================
Brief Summary
-----------------
Evaluation of the efficacy of inositol treatment in women with PCOS in relation to the phenotype (according to the Rotterdam Criteria)

Official Title
-----------------
The Effect of Inositol Treatment in Women With PCOS of Different Phenotype

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Myo-inositol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with PCOS of any phenotype Exclusion Criteria: hormonal treatment (such as contraceptive pill) use of supplements containing myo-inositol severe co-morbidities

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperandrogenic PCOS<br> | Dietary Supplement: Myo-inositol<br>* Myo-inositol (4g/die)<br>|
| Experimental: Non-hyperandrogenic PCOS<br> | Dietary Supplement: Myo-inositol<br>* Myo-inositol (4g/die)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regularization of the menstrual cycle | Number of women with regular/altered menstrual cycle | Change from baseline number of women with irregular menstrual cycle at 4 months |
Validation of Neurokeeper's Algorithm on Patients Undergoing Carotid Endarterectomy

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to validate an EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing Carotid Endarterectomy. The secondary objectives is measure time from ICA clamping to algorithm asymmetry detection, time from clinical deterioration to algorithm asymmetry detection Thi study is a prospective, open label, single arm, self control, single center study. This study will be conducted in 50 subjects according to the inclusions/exclusions criteria.

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: Neurokeeper stroke detector


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old. Primary Carotid Endarterectomy under local anesthesia in symptomatic or asymptomatic patients. Exclusion Criteria: General anesthesia Selective carotid artery shunting. Previous major hemispheric stroke. Any known major hemispheric lesion. Significant movement disorder. Local skull or skin affliction which prevents electrodes application. Any known condition which in the opinion of the investigator may interfere with the protocol implementation.

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 |
| --- | --- |
| Patients undergoing cartoid endarterectomy surgery<br> | Device: Neurokeeper stroke detector<br>* Electrophisoloigcal monitoring<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological detrioration detection | The primary objective of the study is to validate an EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing Carotid Endarterectomy. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from deterioration to detection | The secondary objectives is measure time from ICA clamping to algorithm asymmetry detection, time from clinical deterioration to algorithm asymmetry detection |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke
Day Case Colectomy: Optimizing Short Stay-surgery.

Study Overview
=================
Brief Summary
-----------------
HRV measurement of patients recovering from laparoscopic colorectal resection for any pathology.

Detailed Description
-----------------
Patients scheduled for colorectal surgery are recruited to the study. HRV parameters including e.g. RMSSD are evaluated before and after surgery. The effect of surgery and possible complications associated with it on parameters and relationship with specific adverse effects caused by complications are evaluated.

Official Title
-----------------
Day Case Colectomy: Optimizing Short Stay-surgery.

Conditions
-----------------
Monitoring, Physiologic

Intervention / Treatment
-----------------
* Device: PulseOn


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Colorectal resection for any pathology Exclusion Criteria: • Arrhytmias likely to cause problems with HRV measurements

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?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colorectal Surgery Patients<br> | Device: PulseOn<br>* Postoperative HRV measurement<br>* Other names: Emfit QS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate Variability (HRV) change | Reliability of HRV parameters | 3 days |
Hospital Acquired and Community Acquired MRSA in GI Lab

Study Overview
=================
Brief Summary
-----------------
Hospital acquired and community acquired methicillin resistant staph aureus (MRSA) has become an important health issue for in recent years. Up to two thirds of patients that are hospitalized may be colonized with MRSA. The prevalence in the community is also on the rise and affects the young and healthy. It is unclear what the true prevalence of MRSA is in our own hospital and outpatient setting. This information would be relevant to how healthcare staff adhere to contact and universal precautions. : The purpose of this study is to determine the prevalence of MRSA in patients that have gastrointestinal endoscopy and endoscopic ultrasound.

Official Title
-----------------
Hospital Acquired and Community Acquired Methicillin Resistant Staph Aureus in the Outpatient Gastrointestinal Lab: A Prospective Study of Prevalence

Conditions
-----------------
Hospital Acquired MRSA, Community Acquired MRSA

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol. Subjects must provide signed written informed consent. Exclusion Criteria: Inability to provide written informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective of this prospective study is to identify the prevalence of MRSA in patients that use the Indiana University GI lab. |  | less than one year |
Remineralization of Caries Affected Dentin

Study Overview
=================
Brief Summary
-----------------
Remineralization of carious affected dentin

Detailed Description
-----------------
Remineralization of Carious affected dentin by using Pulpine alone and combination of Pulpine with Polyamidoamine Dendrimer.

Official Title
-----------------
Effect of Pulpine and Combination of Pulpine With Polyamidoamine Dendrimer on Remineralization of Carious Affected Human Dentin

Conditions
-----------------
Deep Caries

Intervention / Treatment
-----------------
* Other: Pulpine with Polyamidoamine Dendrimer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of at least one class one carious posterior teeth in both left and right side. Absence of spontaneous pain, Mobility and tenderness on percussion. Radiographically, the preoperative inclusion criteria are, no internal or external resorption and no widening of the periodontal membrane space. Exclusion Criteria: Patients with poor oral Hygiene. Evidence of Rampant Caries. Teeth with periodontal involvement. Poor general health condition.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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
Interventional Model Description: split mouth design
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination of pulpine with Polyamidoamine Dendrimer<br>Removal of Caries infected dentin from the walls and floor of the cavity and then apply polyamidoamine Denrimer for 30 secs ,then washed out of the cavity followed by placement of Pulpine over affected Dentin. | Other: Pulpine with Polyamidoamine Dendrimer<br>* Removal of infected dentin in class I Cavities followed by application of Polyamidoamine Denrimer on caries affected Dentin that is washed out of the cavity after 30 secs then finally place Pulpine .<br>|
| Active Comparator: Pulpine<br>Removal of Caries infected dentin from the walls and the floor of the cavity followed by application of Pulpine over affected Dentin. | Other: Pulpine with Polyamidoamine Dendrimer<br>* Removal of infected dentin in class I Cavities followed by application of Polyamidoamine Denrimer on caries affected Dentin that is washed out of the cavity after 30 secs then finally place Pulpine .<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remineralization & increase dentin density that is measured by using Vista Scan Radiography. | Vista scan Radiography used to measure pixel grey value after 6 months. | 6 months |