linjc16/ctgov huggingface dataset:
Hypertension and Diabetes Mellitus Community Management Center(HAD-COME) Project

Study Overview
=================
Brief Summary
-----------------
To develop and implement quality improvement programs for the treatment and management of hypertension and diabetes,and preventing and controlling hypertension and diabetes-related diseases in Chinese community. This program will use data collection, analysis, feedback, and process improvement to extend the use of evidence-based guidelines throughout the healthcare system and improve patient care of hypertension and diabetes in Chinese community.

Detailed Description
-----------------
The aim of this project was to improving care for hypertension and diabetes mellitus in Chinese community. Study population including subjects who are hypertension and/or diabetes mellitus, of any race or ethnicity, any age.

Official Title
-----------------
Establishment of Hypertension and Diabetes Mellitus Community Management Center(HAD-COME) Project

Conditions
-----------------
Hypertension, Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: No special intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In accordance with the diagnosis of essential hypertension; In accordance with the diagnosis of type 2 diabetes mellitus. Exclusion Criteria: Non-type 2 diabetes patients Secondary hypertension Non-hypertensive patients Type 1 diabetes or other types of diabetes
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No special intervention|No special intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of community hypertension patients receiving treatment as Chinese guideline recommended | Proportion of community hypertension patients receiving treatment as Chinese guideline recommended at the time of enrollment | at the time of enrollment | 
| Proportion of community diabetes mellitus patients receiving treatment as Chinese guideline recommended | Proportion of community diabetes mellitus patients receiving treatment as Chinese guideline recommended at the time of enrollment | at the time of enrollment |
Objective Study in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Primary Objectives To test the feasibility, in patients with active rheumatoid arthritis, of using an 'aggressive' treatment algorithm to bring a short term treatment objective (STO) within the normal or an arbitrarily defined 'desirable' range. To determine whether patients with active rheumatoid arthritis randomly allocated to a particular STO show a reduced rate of Magnetic resonance imaging damage progression at two years compared to those randomly allocated to usual care. Secondary Objectives To establish the relationship between achieving a given STO or combination of STOs and damage progression. To identify the characteristics of responders and non-responders with respect to STO achievement and predictors of greater and lesser degrees of damage progression.

Official Title
-----------------
Objective Study in Rheumatoid Arthritis

Conditions
-----------------
Arthritis, Rheumatoid

Intervention / Treatment
-----------------
* Drug: LEFLUNOMIDE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rheumatoid Arthritis as defined by the American College of Rhemuatology criteria and either Active disease: ≥6/28 swollen joints or Erythrocyte sedimantation or C-Reactive Protein > normal Disease duration ≤ 15 yrs Any therapy Females of child-bearing potential must be adequate contraception Exclusion Criteria: Frailty, limiting co-morbidity Obesity limiting ability to have MRI Geographical difficulty preventing follow-up and visits Women at risk of becoming pregnant The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LEFLUNOMIDE|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long Term Objective (damage) is the MRI which will be undertaken at baseline, 12 months and 24 months. |  |  | 
| The Short Term Objectives are: swollen joint count - target:(28) ≤ 2 joints |  |  | 
| C-Reactive Protein - target: within the normal range (provided elevation is not due clinically to an intercurrent event) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test |  |  |
Parotid-sparing IMRT for Nasopharyngeal Cancer

Study Overview
=================
Brief Summary
-----------------
In the treatment of nasopharyngeal cancers, to determine the incidence of high grade (≥G2) subjective xerostomia at 1 year.

Detailed Description
-----------------
The purpose of this study was to determine the feasibility in delivering induction chemotherapy and concomitant chemotherapy with IMRT in the treatment of locally advanced nasopharyngeal cancers and to determine the incidence of high grade (≥G2) subjective xerostomia at 1 year.

Official Title
-----------------
Phase II Study of Parotid Sparing IMRT for Nasopharyngeal Cancer

Conditions
-----------------
Nasopharyngeal Cancers, Intensity Modulated Radiotherapy With Chemotherapy

Intervention / Treatment
-----------------
* Radiation: Intensity modulated radiotherapy with chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nasopharyngeal cancers Exclusion Criteria: Patients <16 years old or with a previous malignancy other than non-melanomatous skin cancer were excluded

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Nasopharyngeal cancers<br>Intensitiy modulated radiotherapy with chemotherapy | Radiation: Intensity modulated radiotherapy with chemotherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of ≥G2 xerostomia at 1 year using the subjective component LENTSOMA |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute radiation toxicities |  | 0-3 months | 
| Late radiation toxicities |  | 3-24 months | 
| loco-regional disease-free survival (LRDFS), progression-free survival (PFS) and overall survival (OS) |  | 2 years | 
| chemotherapy compliance and toxicities |  | 0-12 weeks |
3D Echo Evaluation of the Ventricles in Sclero Associated Severe PAH

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to document the left and right ventricular function in patients with sclerodermia associated pulmonal arterial hypertension via 3D echocardiography. The results of this study should help to generate hypothesis for further future studies. The primary hypothesis is that the increased use of modern image guided methods could provide essential aspects for the follow up.

Detailed Description
-----------------
The 3D echocardiography could provide early and detailed information about the changes in the left and right ventricle. The prediction of sclerodermia associated pulmonary arterial hypertension (PAH) is rather adverse, so it makes sense to evaluate relevant changes of the left-ventricular longitudinal strain soon to adapt the PAH specific therapy accordingly.

Official Title
-----------------
3D Echo Evaluation of the Ventricles in Sclero Associated Severe PAH (EVA 3D Pilot Study)

Conditions
-----------------
Pulmonary Arterial Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >17 pulmonary arterial hypertension (PAH) associated with WHO group 1 who start a parenteral prostanoid-therapy written informed consent prostanoid naive no change of the PAH specific therapy within 3 weeks of the recruitment to the study Exclusion Criteria: pregnancy and lactation period Women of child bearing potential who do not use an effective and secure method for birth control severe chronic kidney insufficiency (glomerular filtration rate <30), which will remain for more than 3 months liver-insufficiency Child C life expectancy shorter than the course of the study (for example because of malignant disease

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 |
| --- | --- |
| no treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the left ventricular longitudinal strain | echocardiography | day 90 (+/- 7 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wall thickness | echocardiography | 90 days (+/- 7 days) | 
| left ventricular ejection fracture | echocardiography | 90 days (+/- 7 Days) | 
| left ventricular stroke volume | echocardiography | 90 days (+/- 7 days) | 
| Tricuspid Annular Plane Systolic Excursion (TAPSE) | echocardiography | 90 days (+/- 7 days) | 
| right ventricular fractional area change | echocardiography | 90 (+/- 7 days) |
Interaction Study SLV337/Simvastatin

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of multiple doses of SLV337 on the pharmacokinetics of simvastatin and simvastatin acid when co-administered in healthy male subjects

Official Title
-----------------
A Drug Interaction Study to Investigate the Effects of SLV337 on the Pharmacokinetics of Simvastatin and Simvastatin Acid in Healthy Male Volunteers

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Simvastatin- SLV337 SD beta- SLV337 SD alpha - SLV337 MD beta- SLV337 SD beta+ Simvastatin
* Drug: Simvastatin - SLV337 SD alpha - SLV337 SD beta - SLV337 MD beta - SLV337 SD beta+ Simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteers with Body Mass Index 18.0-28.0 kg/m2 Exclusion Criteria: Clinically relevant medical history

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Drug: Simvastatin- SLV337 SD beta- SLV337 SD alpha - SLV337 MD beta- SLV337 SD beta+ Simvastatin<br>* Single dose of 40 mg simvastatin tablet, single dose of 1400 mg SLV337 beta capsule, single dose of 1400 mg SLV337 alpha capsule, multiple dose over 12 days of 1400 mg/day SLV337 beta capsule including a single dose of 40 mg simvastatin tablet before the last dosing day<br>|
| Other: 2<br> | Drug: Simvastatin - SLV337 SD alpha - SLV337 SD beta - SLV337 MD beta - SLV337 SD beta+ Simvastatin<br>* Single dose of 40 mg simvastatin tablet, single dose of 1400 mg SLV337 alpha capsule, single dose of 1400 mg SLV337 beta capsule, multiple dose over 12 days of 1400 mg/day SLV337 beta capsule including a single dose of 40 mg simvastatin tablet before the last dosing day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simvastatin and simvastatin acid: Cmax, tmax, AUC0-t, AUC, lz, and t1/2, as well as CL/F and Vz/F for simvastatin only |  | 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SLV337 and its acylglucuronide metabolite: Cmax, tmax, AUC0-24, AUC0-t, CL/F (SLV337 only) on Days 1 and 13, as well as AUC, lz, t1/2 and Vz/F (SLV337 only) on Day 1 |  | 20 days | 
| Safety and tolerability assessments including adverse events, clinical laboratory tests, electrocardiogram (ECG) and vital signs |  | During the duration of study participation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interaction SLV337 and simvastatin, Type 2 diabetes mellitus
E-learning to Prevent Drug Errors in Anesthesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to assess the efficiency of an e-learning in order to put into practice some preventive measures to avoid medication errors during anesthesia.

Detailed Description
-----------------
Before the study, the investigators selected 15 preventive measures to avoid medication errors during anesthesia. These measures were learned to the entire anesthesia team (nurse, resident and anesthesiologist) during conventional meetings. An initial evaluation of the application of these measures will be carried out before the introduction of e-learning. This assessment will be conducted by nurses without the knowledge of the anesthetic team evaluated. After this initial evaluation, e-learning will be broadcast on the hospital intranet. Then a second evaluation of the application of the preventive measures will be carried out 6 month and 1 year after the introduction of e-learning.

Official Title
-----------------
Evaluation of an E-learning to Prevent Drug Errors in Anesthesia.

Conditions
-----------------
Medical Errors : Drugs Errors During Anesthesia

Intervention / Treatment
-----------------
* Other: Elearning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: patient undergoing regional and/or general anesthesia Exclusion criteria: only sedation

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Elearning|Elearning|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of application of the preventive measures after versus before the use of an e-learning. | Percentage of application of the preventive measures after versus before the use of an e-learning. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the application of each of the 15 preventive measureaccording to various clinical parameters | Evaluation of the application of each of the 15 preventive measures according to the clinical parameters of the patients followed (age of the patient, physical state of the ASA, type of surgery, type of anesthesia, period of the day or of the week, surgery of Emergency or elective.)emergency or elective surgery. In each completed questionnaire, these clinical parameters are noted.) | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
medical error in anesthesia, drug error in anesthesia
The Effect of Physiotherapy on Cervicogenic Somatic Tinnitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether physiotherapy is effective in the treatment of a group of tinnitus patients with neck complaints.

Official Title
-----------------
Evaluation of the Effect of Cervical Spine Treatment in Tinnitus Patients

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Other: physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe chronic non-fluctuating subjective cervicogenic somatic tinnitus, which has been stable for at least three months, combined with neck complaints Exclusion Criteria: objective tinnitus subjective tinnitus with etiologies, such as hearing loss or Meniere's disease, severe depression (> 19 on the Beck depression questionnaire) progressive middle ear pathology intracranial pathology traumatic cervical spine injury tumors cervical spine surgery any cervical spine condition in which physical therapy treatment is contra- indicated received physical therapy treatment directed to the cervical spine in the past 2 months

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: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate therapy<br>Physiotherapy protocol | Other: physiotherapy<br> <br> |
| Placebo Comparator: waiting list<br>Physiotherapy protocol | Other: physiotherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tinnitus Functional Index |  | pre treatment, post treatment, 6 and 12 months follow up |
J-Pouch vs Side-to-End Anastomosis After Hand-Assisted Laparoscopic Low Anterior Resection for Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
Current study aims to analyze the outcomes of j-pouch and side-to-end anastomosis in rectal cancer patients treated with laparoscopic hand-assisted low anterior resection

Official Title
-----------------
J-Pouch vs Side-to-End Anastomosis After Hand-Assisted Laparoscopic Low Anterior Resection for Rectal Cancer: Short and Long-Term Outcomes of a Prospective Randomized Trial

Conditions
-----------------
Quality of Life, Fecal Incontinence, Postoperative Complications

Intervention / Treatment
-----------------
* Device: Linear cutter-Circular stapler
* Device: Circular stapler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with rectal cancer which is located up to 12 cm from the dentate line observed with a rigid rectosigmoidoscope Exclusion Criteria: refusal of the patient to participate pregnancy, previous radiation therapy, those have cancers other than adenocarcinoma, those planned to have local excision or abdominoperineal resection
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Linear cutter-Circular stapler J pouch<br>J pouch anal anastomosis after laparoscopic low anterior resection | Device: Linear cutter-Circular stapler<br>* a 5 to 6 cm-long colonic pouch will be created with a 80 mm linear cutting-closing stapler. The anastomosis of j-pouch will be routinely strengthened with 3:0 vicryl sutures. Then, a pouch to anal anastomosis will be performed<br>|
| Active Comparator: Circular stapler Side-to-end anastomosis<br>side to end coloanal anastomosis after laparoscopic low anterior resection | Device: Circular stapler<br>* a 5 to 6 cm-long colonic segment will be left at the distal part and a side-to-end anastomosis will be performed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form 36 Quality of life Questionnaire |  | Change from baseline scores at 4th, 8th and 12th months after stoma reversal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications |  | 30 days postoperatively | 
| Functional outcome measured with Fecal Incontinence Severity Index |  | Change from baseline scores at 4th, 8th and 12th months after stoma reversal | 
| Functional outcome measured with Sexual Health Inventory |  | Change from baseline scores at 4th, 8th and 12th months after stoma reversal | 
| Functional outcome measured with Overactive Bladder validated 8 scale |  | Change from baseline scores at 4th, 8th and 12th months after stoma reversal |