linjc16/ctgov huggingface dataset:
Safety Study of a Chinese Herbal Formula Simotang Oral Liquid for the Treatment of Functional Dyspepsia

Study Overview
=================
Brief Summary
-----------------
Functional dyspepsia (FD) is a common functional gastrointestinal disorder and is steadily becoming a public health problem.Simotang is a classical formula that has been used to treat gastrointestinal disorders for hundreds of years [9] and was approved as an oral liquid drug by the Chinese National Food and Drug Administration in the 1980s.In this study,patients with functional dyspepsia were divided according to the inclusive criteria into treatment group and control group randomly, who were given Simo decoction or Domperidone tablets for 14 days。And then the gastric emptying, Symptoms in plasma were observed before and after treatment in mult-center.

Official Title
-----------------
Phase 2 Study of of a Chinese Herbal Formula Simotang Oral Liquid for the Treatment of Functional Dyspepsia

Conditions
-----------------
Functional Dyspepsia(FD) Was Studied, Effect of Simotang on FD Was Studied

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients met the definition of the Rome III criteria for FD Exclusion Criteria: -

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of gastrointestinal Symptom as efficacy and the Number of Participants with Adverse Events as a Measure of Safety |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chinese version of the Nepean Dyspepsia Index as a Measure of efficacy |  | 30 days |
Nice Human Immunodeficiency Virus (HIV) Cohort

Study Overview
=================
Brief Summary
-----------------
Historically, the database on the HIV was organized within the framework of the medico-economic file of the human immunodeficiency (DMI-2), introduced jointly by the Direction of Hospitals (Mission AIDS) and the INSERM at the end of the 80s. Today this database is fed via the computerized medical record NADIS. Most part of the research works on the theme of the HIV take support on this database (DAD, EuroAIDS, Neuradapt).

Official Title
-----------------
Nice Human Immunodeficiency Virus (HIV) Cohort

Conditions
-----------------
Human Immunodeficiency Virus

Intervention / Treatment
-----------------
* Other: Follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrol consecutive patients with a scheduled visit in the outpatient clinic (regardless of CD4 cell count and ART status). Exclusion Criteria: -

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 |
| --- |
|Other: Follow up|Follow up of treatment, behavior, co-morbidity|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of the clinico-biological signs of the patients | change of the clinico-biological values form the start of the study, mesured every year, to the end of the study | Each Year during 50 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of the various type of adverse events related by type of treatments | Number of patients and laboratory data related to any events occurred such as : Death, Acute myocardial infarction , Ascites, Bone Mass Density , Diabetes mellitus, End Stage Renal Disease , Fibroscan stiffness , Bone fracture , Hepatic encephalopathy , Hepatorenal syndrome Invasive Cardiovascular Procedures , Kidney transplantation , Liver biopsy , Liver decompensation , Liver transplantation Non-AIDS defining malignancies , AIDS defining malignancies, Oesophageal variceal bleeding , Stroke | Each Year during 50 years |
Change Trend of Effluent Eosinophil During Peritoneal Dialysis-Related Peritonitis

Study Overview
=================
Brief Summary
-----------------
A multi-center prospective cohort study will be conducted to explore the change trend of eosinophil in peritoneal dialysis effluent during peritoneal dialysis-associated peritonitis, and to explore the relationship between eosinophil increase, peritonitis severity and antibiotic use. This study will provide evidence for routine eosinophil testing

Detailed Description
-----------------
A multi-center prospective cohort study will be conducted to explore the change trend of eosinophil in peritoneal dialysis effluent during peritoneal dialysis-associated peritonitis, and to explore the relationship between eosinophil increase, peritonitis severity and antibiotic use. In this study, 100 patients with peritoneal dialysis-associated peritonitis who meet the inclusion criteria will be selected. Demographic data, laboratory variables, peritoneal fluid cytology and bacterial culture will be collected within 24 hours of peritonitis (day 1). Peritoneal fluid cytology includes leukocyte classification and eosinophilic leukocyte count will be examined at day 3, 5, 7, 10, 14, 21, 30, 60 and 90 after peritonitis. All patients will be followed up for 90 days, and their peritonitis outcome will be recorded. The primary endpoint is the prevalence of eosinophil increase in peritoneal effluent, which is defined as >100 eosinophils/mm^3, or >10% eosinophils of the total non-erythrocyte count. Secondary end points are peritonitis outcome at month 1 and 3 including transfer to hemodialysis , death.

Official Title
-----------------
Study on the Increasing Proportion and Change Trend of Eosinophil in Peritoneal Fluid During Peritoneal Dialysis-Related Peritonitis

Conditions
-----------------
Peritonitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as peritoneal dialysis-related peritonitis; Age> 14 years Maintenance peritoneal dialysis due to end-stage renal failure ≥3 months Use of lactate glucose dialysate Exclusion Criteria: Those who cannot be followed up regularly Reluctant to join this researcher

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- | --- |
| Prevalence of elevated eosinophils in peritoneal dialysis effluent | eosinophil number >100 /mm3, or the proportion of polynuclear leukocytes >10%. | Feb 18,2021 to December 31,2023 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peritonitis, eosinophil, peritoneal dialysis
Prospective Study Evaluating Dry Eye in Patients Operated on for Ametropia by LASIK Surgery and Treated With REPADROP

Study Overview
=================
Brief Summary
-----------------
LASIK is a refractive surgery technique widely used in France. Postoperatively, the classic treatment after LASIK consists of instilling drops to reduce dry eyes. REPADROP® is an innovative eye drops stimulating corneal innervation. To date no study has quantified the improvement in dry eye syndrome and thus the quality of life of patients using REPADROP®.

Official Title
-----------------
Prospective Study Evaluating Dry Eye in Patients Operated on for Ametropia by LASIK Surgery and Treated With REPADROP

Conditions
-----------------
Ametropia

Intervention / Treatment
-----------------
* Other: Describe the evolution of dry eye between 1 month and 3 months post-LASIK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 Planned bilateral LASIK surgery Use of Repadrop as postoperative eye drops Patient agreement to participate Exclusion Criteria: History of corneal pathology Diabetes History of treatment with REPADROP® or CACICOL® or NGF® (other eye drops which are no longer available on the market to date but which would also improve corneal healing) Ongoing treatment with topical cyclosporine Presence of punctal plugs Adults who are the subject of a legal protection measure (guardianship, curators) Pregnant or breastfeeding women

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 |
| --- |
|Other: Describe the evolution of dry eye between 1 month and 3 months post-LASIK|Dry eye will be assessed through the OSDI (Ocular Surface Disease Index) questionnaire. The questionnaire will be dispensed during consultations by an orthoptist or an intern/junior doctor, at 1 month and at 3 months post-LASIK.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in OSDI (Ocular Surface Disease Index) score | Variation in OSDI (Ocular Surface Disease Index) score between 1 month and 3 months post-LASIK. The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability. | 3 Months |
Integrated Rehabilitation Program for Fractures

Study Overview
=================
Brief Summary
-----------------
The recovery of range of motion and muscle power after surgical intervention of the fracture will mostly affect patient's daily activities. So postoperative rehabilitation program will play the important role. Correct and effective physical therapy will reduce the functional impairment of limbs after long term casting or surgical fixation, and accelerate to recover the independent daily activities. There is no consensus between immediate or delay and the duration of continue physical therapy will improve the shoulder function、muscle power and degree of satisfaction( physiological function、social function、mental health、 pain、 general health status ) after surgical fixation of fractures. This study will evaluate the patients of the fracture that including of the humeral neck fracture, vertebral fracture, distal radial fracture and hip fractures after surgical fixation, to see the difference of fracture healing time, function recovery and pain sensation after intervention of physical therapy at different time point. From this study, we hope to discriminate the timing of intervention and duration of physical therapy which is the key factors for postoperative prognosis of fractures fixation, and to set up the perfect rehabilitation program in ChangHua Christian Hospital. The results of this study will improve the discomfort of fracture patient's recovery or reduce the complications rate, and set up the standard treatment policy of our hospital , also was the model of other hospitals.

Conditions
-----------------
Humeral Neck Fracture, Vertebral Fracture, Distal Radial Fracture, Hip Fractures

Intervention / Treatment
-----------------
* Behavioral: physical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with humeral neck fracture, vertebral fracture, distal radial fracture or hip fractures after surgical fixation Exclusion Criteria: no
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: Physical therapy<br> | Behavioral: physical therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain degree | use Visual Analog Scale (VAS) to measure the pain condition after surgical fixation and 1 month | 1 month after surgical fixation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in range of motion at the fracture area | to access the range of motion in the elbow, wrist, hip, and knee joint, and the muscle power of upper limb and lower limb | 1 month after surgical fixation |
An Open-Label Interaction Study to Look at the Effects of Brivaracetam on Phenytoin When Taken Together in 15 Adult Patients With Epilepsy.

Study Overview
=================
Brief Summary
-----------------
The primary objective of this Phase I study in 15 adult subjects suffering from epilepsy and chronically treated with phenytoin monotherapy is to evaluate the effect of steady-state ucb 34714 administration on the steady-state plasma levels of phenytoin.

Official Title
-----------------
A Multi-Center, Open-Label, Unilateral Interaction Study of Ucb 34714 on Stable Phenytoin Monotherapy During a 45 Day b.i.d. Administration Period in 15 Adult Subjects Suffering From Epilepsy

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: Brivaracetam (ucb34714)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Well-characterized epileptic syndrome according to the ILAE classification. Patients currently treated with stable phenytoin monotherapy for at least three months and with at least one plasma measurement of pheyntoin within the target range (7 - 23 µg/ml) during the screening period. Exclusion Criteria: History of status epilepticus in the last year. Subjects taking any drug that may significantly influence the metabolism of ucb 34714 (CYP2C or CYP3A potent inducers/inhibitors) except if the dose has been stable at least three months before entry into the study and will be kept stable for the entire trial duration. Subjects with a creatinine clearance of ≤50 mL/min.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Brivaracetam (ucb34714)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the effect of steady-state ucb 34714 administration on the steady-state plasma levels of phenytoin. |  |  | 
| Blood samples for PK calculations collected at different time points, on Visit 2 and Visit 7, for determination of phenytoin plasma concentrations (Phenytoin levels at pre-dose, 1, 2, 4, 6, 8, 12 (24 if PHT od) hours at V2 and V7) |  |  | 
| The drug interaction on phenytoin will be assessed by comparison of AUCτ and Cmax between Visit 2 (phenytoin alone) and Visit 7 (combination of ucb 34714 and phenytoin). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| information on the tolerability and safety of the simultaneous administration of ucb 34714 and phenytoin in epilepsy patients. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
partial onset seizures, phenytoin, dilatin, brivaracetam, interaction
Quality Control of Cardiopulmonary Exercise Equipment

Study Overview
=================
Brief Summary
-----------------
This study is designed to make sure exercise equipment used by the National Heart, Lung, and Blood Institute is working properly. Healthy volunteers will be requested to use P-CCMB cardiopulmonary exercise equipment (treadmills and exercise bicycles) two times a month to ensure the machines are functioning properly.

Detailed Description
-----------------
Proper functioning of recently acquired P-CCMB cardiopulmonary exercise equipment will be verified by testing healthy volunteers. In addition, quality control will be verified by performing monthly testing of healthy volunteers as biologic standards.

Official Title
-----------------
Quality Control of P-CCMB Cardiopulmonary Exercise Equipment

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

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION: Healthy research volunteers who are between 21 and 65 years. EXCLUSION: Patients with a history of ischemic or valvular heart disease. Patients with history of chronic pulmonary disease. Pregnant women.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bicycle, Treadmill, Lung Function, Physiology, Quality Control, Normal Volunteers
The Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the visualization rates of the ampulla of Vater using forward- viewing endoscopes with or without cap attached to the distal end in the same patient.

Detailed Description
-----------------
The complete visualization of the ampulla of Vater for the detection of ampullary neoplastic lesions is technically challenging with a forward-viewing endoscope. There are limited data in the relevant literature regarding the effectiveness of the Cap assisted forward viewing endoscope for accurate evaluation of the ampulla de Vater. Therefore, the aim of this study is to compare the visualization rates of the ampulla of Vater using forward-viewing endoscopes with or without cap attached to the distal end in the same patient.

Official Title
-----------------
The Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater

Conditions
-----------------
Ampulla of Vater Intestinal-Type Adenoma

Intervention / Treatment
-----------------
* Device: Cap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cap-assisted endoscopy Referral to endoscopic examination of ampulla of Vater Exclusion Criteria: Patients with surgically modified anatomy. Obstruction of the upper gastrointestinal tract. Contra-indication for endoscopy. Absence of informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cap-assisted endoscopy<br>forward-viewing endoscope with a Cap attached at the tip | Device: Cap<br>* Cap-assisted endoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visualization rates of the ampulla of Vater |  | Up to 30 minutes during gastrointestinal endoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of complications for both groups. |  | Up to 3 hours after upper endoscopy | 
| Additional time required for Cap-assisted endoscopy |  | Up to 30 minutes during upper endoscopy | 
| Need for additional sedation required for the Cap-assisted endoscopy. |  | Up to 30 minutes during upper endoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopy, Ampulla of Vater, Duodenoscopy
Nonoperative Management Protocol in Patients With Blunt Splenic Injuries

Study Overview
=================
Brief Summary
-----------------
This study was designed to explore the adverse events and associated risk factors before and after protocol-based NOM of BSI over a 12-year period in our institution.

Detailed Description
-----------------
The nonoperative management (NOM) protocol with angioembolization (AE) presents a trend in dealing with trauma patients with blunt splenic injury (BSI). This study was designed to explore the adverse events and associated risk factors before and after protocol-based NOM of BSI over a 12-year period.

Official Title
-----------------
Is Strict Adherence to the Nonoperative Management Protocol Associated With Better Outcome in Patients With Blunt Splenic Injuries

Conditions
-----------------
Blunt Injuries

Intervention / Treatment
-----------------
* Other: Patient before cohort (2005-2010)
* Other: Patient after cohort (2011-2016)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult trauma patients with blunt splenic injury who were admitted from 2005 to 2016. Exclusion Criteria: Patients younger than 16 years Patients who died in the emergency department

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 100 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 |
| --- | --- |
| Nonoperative management protocol with angioembolization<br>The nonoperative management (NOM) protocol with angioembolization (AE) presents a trend in dealing with trauma patients with blunt splenic injury (BSI). This study was designed to explore the adverse events and associated risk factors before and after protocol-based NOM of BSI over a 12-year period. | Other: Patient before cohort (2005-2010)<br>* The NOM protocol with AE was recognized and accepted after our previous study reported in 2004.<br>Other: Patient after cohort (2011-2016)<br>* The protocol of NOM became more aggressively and strictly adhered to since 2011.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The numbers of associated complications and mortality | The primary outcome of interest in this study would be the associated complications and mortality. | up to 6 months |