linjc16/ctgov huggingface dataset:
Characterization of the Digestive Functions and the Enteric Nervous System in Obesity. Investigations of Relationships With Metabolism Disorders (EnteroNeurObesity)

Study Overview
=================
Brief Summary
-----------------
60 patients scheduled for bariatric surgery will be included into 3 categories (20 patients with non complicated obesity, 20 patients with metabolic syndrome and 20 patients with a type 2 diabetes or hypertension). 20 volunteers will be enrolled as normal referents. The patients and the volunteers will have a classical pre-operative check-up (fibroscopy, oesophageal pHmetry and manometry) and extra investigations as isotopic gastric empty exam, lactulose oro-caecal transit exam, intestinal permeability test calculated by lactulose-manitol ratio urinary excretion. Intestinal and colonic biopsies will be also provided for studying permeability. For only patients, samples from the gastric resection will be provided for analysing the enteric nervous system and motricity.

Official Title
-----------------
Characterization of the Digestive Functions and the Enteric Nervous System in Obesity. Investigations of Relationships With Metabolism Disorders(EnteroNeurObesity)

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Digestive functions investigations


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients: Patients must be aged between 18 and 65 years old with a BMI>40kg/m2 for non complicated patients or with a metabolic syndrome and with a BMI>35kg/m2 for patients with type 2 diabetes or hypertension. They must be eligible for bariatric surgery. Patients with a type 1 diabetes, neurologic or neuro-degenerative disease will be excluded. Volunteers: Volunteers must be aged between 18 and 65 years old with a BMI between 20 and 25kg/m2 Men and women are eligible.

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

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

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

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 |
| --- | --- |
| No Intervention: Digestive functions investigations<br>Results from digestive functions investigations will be compared between patients eligible for bariatric surgery (BMI>40kg/m2) and volunteers (BMI between 20 and 25kg/m2). | Other: Digestive functions investigations<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T1/2 solids (on the kinetic of isotopic gastric empty exam) | This evaluation will be obtained before bariatric surgery for patients and at any time before end of study for volunteers. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients eligible for bariatric surgery (BMI>40kg/m2)
BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and efficacy of formulation BLI1100 to its vehicle in the treatment of moderate-severe acne vulgaris.

Official Title
-----------------
A Randomized, Controlled Evaluation of the Safety and Efficacy of a Topical Treatment for Moderate-Severe Facial Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: BLI1100
* Drug: Vehicle cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Qualifying Investigator's Global Assessment severity score Qualifying number of non-inflammatory lesions Qualifying number of inflammatory lesions Exclusion Criteria: Facial hair (beard), excessive scarring, sunburn or other disfigurement that may obscure the accurate assessment of acne grade Using medications that are reported to exacerbate acne Any clinically relevant finding at their baseline physical examination or dermatological medical history such as severe systemic diseases or diseases of the facial skin Have a known hypersensitivity or previous allergic reaction to any of the components Patients who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 45 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLI1100<br>BLI1100 topical cream | Drug: BLI1100<br>* BLI110 topical cream<br>|
| Placebo Comparator: Vehicle cream<br>Vehicle topical cream | Drug: Vehicle cream<br>* Vehicle topical cream<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent reduction of total acne lesion counts |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Assessment | Rating of overall facial acne on a 4 point scale (0=clear to 4=severe) performed by a blinded investigator. | 12 | 
| Change in serum chemistry |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
moderate to severe facial acne vulgaris
Impact of Peritoneal Closure and Retroperitoneal Drainage on Patients Who Underwent Laparotomic Retroperitoneal Lymph Node Dissection

Study Overview
=================
Brief Summary
-----------------
To elucidate whether peritoneal closure and retroperitoneal drainage can benefit clinical outcome of early gynecologic cancer patients who underwent retroperitoneal lymph node dissection.

Detailed Description
-----------------
To elucidate whether peritoneal closure and retroperitoneal drainage can benefit clinical outcome of early gynecologic cancer patients who underwent retroperitoneal lymph node dissection by reviewing the medical records of patients who underwent retroperitoneal lymph node dissection for stage I or II gynecological cancer in Far Eastern Memorial Hospital, January 2011 December 2017.

Official Title
-----------------
Impact of Peritoneal Closure and Retroperitoneal Drainage on Patients Who Underwent Laparotomic Retroperitoneal Lymph Node Dissection for Early Gynecological Cancer

Conditions
-----------------
Lymphocele, Gynecologic Cancer

Intervention / Treatment
-----------------
* Procedure: Peritoneal closure
* Procedure: Retroperitoneal drainage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage I or stage II gynecologic cancer (including cervical cancer, endometrial cancer, ovarian cancer, and fallopian tube cancer) Underwent laparotomic gynecologic oncologic surgery, including retroperitoneal lymphadenectomy. Exclusion Criteria: nil

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Peritoneal closure|Peritoneal closure after pelvic lymph node dissection for early gynecologic cancer|
|Procedure: Retroperitoneal drainage|Retroperitoneal drainage after pelvic lymph node dissection for early gynecologic cancer|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors predicting lymphocele occurrence | To find independent factors that can predict lymphocele occurrence in patients who underwent laparotomic gynecologic oncologic surgery | 10 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors predicting surgical complication | To find independent factors that can predict occurrence of surgical complication in patients who underwent laparotomic gynecologic oncologic surgery | 10 years |
SSNB in Hemiplegic Shoulder Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare suprascapular nerve block with therapeutic ultrasound in stroke patients who have shoulder pain in weak side.

Detailed Description
-----------------
Shoulder pain is a common complication after a cerebrovascular accident.Hemiplegic shoulder pain has been shown to affect stroke outcome in a negative way.It interferes with recovery after stroke:it can cause distress and reduced activities and can markedly hinder rehabilitation.Suprascapular nerve block has been shown to be effective as an analgesic for different indications such as shoulder capsulitis.The purpose of this study was to evaluate the effectiveness of this technique conjunction with a rehabilitation program to reduce shoulder pain in hemiplegic patients.

Official Title
-----------------
Suprascapular Nerve Block in Hemiplegic Shoulder Pain.

Conditions
-----------------
Shoulder Pain, Stroke

Intervention / Treatment
-----------------
* Drug: 1% xylocaine
* Other: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stroke patients who develope shoulder pain at weak limb. Good conscious and able to access pain score. No history of drug reaction with xylocaine No history of fracture,tumor or blood tendency. Willing to enrolled to study and signs inform consent. Exclusion Criteria: Patients who do not meet the inclusion criteria.
Sexes Eligible for Study
-----------------
Female

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Suprascapular nerve block | Drug: 1% xylocaine<br>* 10 cc. of 1%xylocaine, once a week<br>* Other names: suprascapular nerve block;|
| Experimental: B<br>therapeutic ultrasound | Other: ultrasound<br>* ultrasound at shoulder area about 10 mins.<br>* Other names: therapeutic ultrasound;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score of pain |  | 4 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion of the shoulder joint |  | 4 weeks after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
suprascapular nerve block, shoulder pain, hemiplegia
The Influence of Health Information in Stretch Break Program Participant's Lifestyle

Study Overview
=================
Brief Summary
-----------------
Objective: To verify the influence of information passed during anthropometric assessment would have in physical exercise (PhE) and eating habits of 14 participants (female=11; 51,07+-8,17 years) from the Stretch Break Program of Federal University of Paraíba (SBP of FUPb). Methods: The research was a descriptive cross-sectional quantitative and qualitative approach. Were applied, between March and May of 2010, anthropometric evaluation and semi-structured interviews. During the evaluation were provided information and guidance on health.

Official Title
-----------------
The Influence of Health Information in Stretch Break Program Participant's Lifestyle: a Quantitative and Qualitative Study

Conditions
-----------------
Health Behavior

Intervention / Treatment
-----------------
* Behavioral: Information passed on anthropometric assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FUPb white collar workers of either gender Exclusion Criteria: Anyone who did not complete anthropometric measurements

Ages Eligible for Study
-----------------
Minimum Age: 28 Years
Maximum Age: 63 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br>Information passed on anthropometric assessment | Behavioral: Information passed on anthropometric assessment<br>* Information passed on worker's anthropometric assessment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric evaluation | Height (cm) was measured with a stadiometer (Sanny), body weight (kg) was measured using a digital scale (TechLine), circumference (cm) was measured (Sanny) at the midpoint between lower costal margin and the superior iliac crest and blood pressure (mmHg) was measured with a sphygmomanometer and a stethoscope (Premium). Direct measurement assessed body mass index, waist-to-height-ratio and blood pressure classification (determined by highest blood pressure category - systolic blood pressure or diastolic blood pressure). | Up to 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Information, Lifestyle, Occupational Health
A Phase I Open Label Dose Escalation Study for the Safety and Tolerability of AZD2171 in Solid Tumors in Japan

Study Overview
=================
Brief Summary
-----------------
A Phase I open label dose escalation study to assess the safety and tolerability of AZD2171 following single and multiple oral doses in patients in Japan with advanced solid malignancies. In addition there will be an expanded cohort multi-centre study phase with NSCLC patient and CRC patients

Official Title
-----------------
A Phase I Open Label Dose Escalation Study for the Safety and Tolerability of AZD2171 Following Single and Multiple Oral Doses in Patients in Japan With Advanced Solid Malignancies

Conditions
-----------------
Advanced Solid Tumor

Intervention / Treatment
-----------------
* Drug: AZD2171


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: advanced solid tumors life expectancy is 12 weeks or longer Exclusion Criteria: patient with uncontrolled brain metastases patient with inappropriate laboratory test values patient with poorly controlled hypertension

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AZD2171|oral tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  | Assessed at each visit for 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy, PK |  | Assessed at each visit for 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Japan, Phase I, solid tumor, AZD2171
Evaluation of Methods for Diagnosis of Cytomegalovirus Pneumonia in Mechanically Ventilated Patient

Study Overview
=================
Brief Summary
-----------------
Viral infections are only recently been investigated in patients on mechanical ventilation (MV) in ICU. It is especially the progress in the direct detection of these pathogens that allowed intensivists to try to assess objectively the impact of viruses in their patients. This is of course of viral infections Community (influenza virus, rhinovirus ...), but some viruses also occur under mechanical ventilation in immunocompetent adults. This is called viral infection nosocomial whose Herpesviridae are the most frequent and best studied. This replication Herpesviridae in ICU patients is usually a reactivation as primary infection. This reactivation is explained by the fact that after a few days of mechanical ventilation appears immunoparalysis, which can make the bed of bacterial or viral infection.Several studies have compared the pp65 antigenemia for quantitative PCR in immmunodéprimés patients. For example, in transplant patients (solid organs), the sensitivity of antigenemia was 91%, Quantitative PCR of 95.6% while the specificity was 57% and 81.6% respectively. No work, however, has to date compared these techniques in the intensive care patient. In a subject shortly epidemiological study, the sensitivity of the quantitative PCR performed on the LBA is 80%, when compared to antigenemia. Moreover this same study shows that half of the positive PCR on the BAL are not accompanied by a positive antigenemia, suggesting that PCR may be more sensitive than antigenemia. This exam has never been validated to date in intensive care. Finally, no work has so far evaluated the diagnostic performance of quantitative PCR performed on BAL

Conditions
-----------------
CMV Reactivation Diagnosis in ICU Patient

Intervention / Treatment
-----------------
* Biological: blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient in ICU with ventilator-associated pneumonia suspicion Exclusion Criteria: ICU pateint undergoing invasive ventilation for less than 48 hour

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 |
| --- |
|Biological: blood draw|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of CMV positive reactivation in ICU patient for sensitivity of quantitative PCR ( qPCR ) on LBA and CMV in whole blood compared with pp65 antigenemia. |  | 1 day |
Dextenza for Post-operative Treatment of Pterygium

Study Overview
=================
Brief Summary
-----------------
DEXTENZA for the Treatment of Post-Surgical Pain and Inflammation Compared to Standard of Care Topical Cortico-steroid Treatment in Patients who Undergo Bilateral Pterygium Surgery

Detailed Description
-----------------
In patients who undergo bilateral pterygium surgery, eyes will be randomized to receive either DEXTENZA at baseline, Month 1 and Month 2 or prednisolone x 3 months. Both eyes will receive antibiotic drops four times per day for two weeks and Maxitrol ointment at bedtime for two weeks following surgery.

Official Title
-----------------
DEXTENZA for the Treatment of Post-Surgical Pain and Inflammation ComparEd to StandaRd of Care Topical Cortico-Steroid Treatment In PatientS Who Undergo BilaTeral Pterygium Surgery PERSIST Study

Conditions
-----------------
Pterygium of Both Eyes

Intervention / Treatment
-----------------
* Drug: Intracanalicular Dexamethasone, (0.4 mg) Insert
* Drug: Prednisolone Acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with bilateral pterygium - Exclusion Criteria: none -

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
Intervention Model: Single Group Assignment
Interventional Model Description: In patients who undergo bilateral pterygium surgery, eyes will be randomized to receive either DEXTENZA at baseline, Month 1 and Month 2 or prednisolone x 3 months. Both eyes will receive antibiotic drops four times per day for two weeks and Maxitrol ointment at bedtime for two weeks following surgery.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pterygium patients<br>patients with bilateral pterytium | Drug: Intracanalicular Dexamethasone, (0.4 mg) Insert<br>* To determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo bilateral pterygium surgery.<br>* Other names: Dextenza;Drug: Prednisolone Acetate<br>* To reduce post-surgical pain and inflammation in patients who undergo bilateral pterygium surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient pain level follow pterygium removal | measurement of pain following pterygium removal using the validated Numeric Pain Rating Scale to assess pain, which ranges from 0 to 10 with higher values indicating more severe pain. | 2 months | 
| inflammation | measurement of ocular surface inflammation using the standard 1+ - 4+ rating scale commonly used in ophthalmology with 4+ indicating the most inflammation. | 2 months |