linjc16/ctgov huggingface dataset:
Study Comparing Classic Vaginal Hysterectomy to vNOTES Hysterectomy

Study Overview
=================
Brief Summary
-----------------
vNOTES is a new surgical approach that has been used for less than 10 years. Several studies compare it to laparoscopy but none compare it to the classic vaginal route. The aim of the research is to analyze postoperative pain

Official Title
-----------------
Retrospective Study Comparing Classic Vaginal Hysterectomy to vNOTES Hysterectomy

Conditions
-----------------
Hysterotomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult woman (≥18 years old) Woman having undergone a vaginal hysterectomy and by vNOTES at Strasbourg University Hospitals between 01/01/2017 and 05/31/2021 Woman who did not express her opposition to the reuse of her data for the purposes of this research. Exclusion criteria: Woman who expressed her opposition to participating in the study Surgical procedure associated with hysterectomy

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of postoperative pain in patients who have had a vaginal hysterectomy |  | Files analysed retrospectively from January 01, 2017 to May 31, 2021 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hysterotomy, vNOTES, Laparoscopy, Vaginal route
Assessment of Body Image in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Investigate body image of patients with rheumatoid arthritis, correlating with self-esteem, function and quality of life.

Detailed Description
-----------------
Methods: Forty-three RA patients and thirty-nine control patients between 18 and 70 years were evaluated. The RA group was made up of individuals with a diagnosis of RA and the control group was made up of individuals from the community, paired for gender, age and body mass index. The patients were assessed with regard to body image (Body dysmorphic disorder examination (BDDE)), self-esteem (Rosenberg self-esteem scale), function (Health assessment questionnaire (HAQ)) and quality of life (Short form-36 (SF-36)).

Official Title
-----------------
Body Image in Patients With Rheumatoid Arthritis

Conditions
-----------------
Body Image, Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The RA group included patients between 18 and 70 years of age, of either gender, with an established diagnosis of RA based ACR criteria and belonging to functional classes I, II and III. The control group was made up of individuals from the community paired for gender, age and body mass index with RA group. Exclusion Criteria: Individuals with fibromyalgia, neurological disease, psychiatric disorders or other severe co-morbidity were excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Rheumatoid Arthritis group1<br>This group had patients with rheumatoid arthritis | |
| 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Dysmorphic Disorder Examination |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form - 36 |  | baseline | 
| Health assessment questionnaire |  | baseline | 
| Rosenberg self-esteem scale |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Body image, Rheumatoid Arthritis
Targeted Interventions for Successful Transition and Transfer of Adolescents With Inborn Errors of Metabolism to Adult Services

Study Overview
=================
Brief Summary
-----------------
Main aims of this project are To assess the baseline status-quo of transition and fitness for transfer in terms of information about the adult centre and team, organisational and practical skills (blood sampling and sending, how to make an appointment etc.), disease- and treatment-related knowledge, health-related quality of life (HrQoL), and self-efficacy in adolescnets with inborn errors of metabolism. Biochemical or physical parameters as appropriate for the respective diseases from 12 months before are documented. To provide targeted, structured intervention modules (using available and, if necessary, adapted materials). To measure the effects of these interventions on information about adult services short-term (within a month) and to re-assess all other baseline status-quo parameters long-term (6 and 12 months later). Psychological assessments will be complemented by biochemical or physical parameters as appropriate for the respective diseases and indicative for transition success.

Official Title
-----------------
Fit for Transfer: Targeted Interventions for Successful Transition and Transfer of Adolescents With Inborn Errors of Metabolism to Adult Metabolic Services

Conditions
-----------------
Transition, Inborn Errors of Metabolism

Intervention / Treatment
-----------------
* Behavioral: Behavioral


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Patients with an inborn error of metabolism in the care of a specialized metabolic care unit requiring specialized adult metabolic care at least 14 years old with a disease for which at least one biochemical and / or physical parameter disease marker is well established . Exclusion Criteria: Patients - with insufficient knowledge of the German with cognitive impairment to a degree that consent, and participation would be impossible in an end-of-life situation with a disease for which no biochemical and / or physical parameter disease marker is well established

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 25 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Training<br>Patient education, empowerment, and information | Behavioral: Behavioral<br>* Patient education, information and empowerment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease knowledge | interview, semistructured | change from baseline to 1 month |
Remission Rate of Newly Diagnosed Type 2 Diabetes Outpatients Treated With Short-term Intensive Insulin Therapy

Study Overview
=================
Brief Summary
-----------------
To evaluate the long-term remission rate of short-term intensive insulin (STII) therapy in newly diagnosed type 2 diabetes outpatients and investigate the predictors contributing to the remission rate.

Conditions
-----------------
Type2 Diabetes

Intervention / Treatment
-----------------
* Drug: Novolin 30R;Pioglitazone;Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed, insulin-naive type 2 diabetes outpatients Diabetes duration less than 1 year Exclusion Criteria: Various acute complications Hepatic transaminase >2.5x normal reference value (glutamic-pyruvic transminase>100U/L, glutamic-oxalacetic transaminase > 100U/L) Abnormal renal functions (serum cretinine>the normal reference value) Cardiac insufficiency (America NYHA caediac function >3) Type 1 diabetes mellitus Ongoing hormone therapy Women in gestation and lactation Patients with other endocrine disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 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: Novolin 30R;Pioglitazone;Metformin<br>Drugs: Insulin (Novolin 30R) monotherapy or combined with one or two oral drugs (metformin 0.5 mg tid and pioglitazone hydrochloride 15 mg qd). | Drug: Novolin 30R;Pioglitazone;Metformin<br>* Insulin (Novolin 30R) was titrated according to the level of blood glucose until reached euglycemia (FPG≤6.1mmol/L and/or P2hBG≤8.0mmol/L and/or HbA1c ≤6.5%). After glucose was well controlled within these targets for 4 weeks, insulin dosage was gradually decreased until discontinued; Pioglitazone hydrochloride was discontinued if the glucose was well controlled at the 6th week after the cessation of insulin; Metformin was the last drug that to be discontinued if the glucose was still well controlled at the 4th week after the cessation of pioglitazone.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prolonged-remission rate | hyperglycemia below diagnostic thresholds for diabetes without active pharmacologic therapy or ongoing procedures of 5 years' duration. | 5 years | 
| partial-remission rate | hyperglycemia below diagnostic thresholds for diabetes without active pharmacologic therapy or ongoing procedures of more than 3 months' duration, and less than 5 years. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, remission, short-term intensive insulin therapy
Study for the Treatment of Ulcerative Colitis With Adacolumn (Companion to US Study 512-04-205)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis.

Detailed Description
-----------------
Study Type: Interventional Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study.

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Device: Adacolumn Apheresis System


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

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

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 |
| --- |
|Device: Adacolumn Apheresis System|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcomes: Effectiveness will be primarily evaluated at Week 12 by disease activity index (DAI) score; Safety will be evaluated by determining the frequency and severity of adverse events. |  |  |
Icotinib as the Adjunctive Treatment After Surgery in Stage I-IIIB Lung Adenocarcinoma Patients With EGFR Gene Mutation

Study Overview
=================
Brief Summary
-----------------
This is a randomized ,opened, prospective controlled trial of clinical effectiveness for Icotinib as the adjunctive treatment after surgery in stage I-IIIB lung adenocarcinoma patients with epidermal growth factor receptor gene mutation

Detailed Description
-----------------
In this trial the investigators will enlist 100 patients who accepted surgery and with epidermal growth factor receptor gene mutation,these patients will be divided into 2 groups (chemotherapy group and Icotinib group),compare the PFS,RFS,OS after 5 years follow up

Official Title
-----------------
A Randomized ,Opened, Prospective Controlled Trial of Clinical Effectiveness for Icotinib as the Adjunctive Treatment After Surgery in Stage I-IIIB Lung Adenocarcinoma Patients With Epidermal Growth Factor Receptor Gene Mutation

Conditions
-----------------
Neoplasms, Therapy-Associated

Intervention / Treatment
-----------------
* Drug: Icotinib
* Drug: chemotherapy (Carboplatin and Docetaxel)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-75 years old Lung adenocarcinoma patients with epidermal growth factor receptor gene mutation,stage I-IIIB after surgery The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2 Exclusion Criteria: Mismatch conditions above Have used other anti-cancer therapy drug before the trial and may influence the outcome

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: chemotherapy<br>Carboplatin,350mg/m2,1/3weeks Docetaxel,75mg/m2,1/3weeks | Drug: Icotinib<br>* compared with chemotherapy,which is better for lung adenocarcinoma patients with epidermal growth factor receptor gene mutation after surgery<br>* Other names: Conmana;Drug: chemotherapy (Carboplatin and Docetaxel)<br>* as control group,compared with Icotinib<br>* Other names: Carboplatin and Docetaxel;|
| Experimental: Icotinib<br>Icotinib, 125mg,3/D,2years | Drug: Icotinib<br>* compared with chemotherapy,which is better for lung adenocarcinoma patients with epidermal growth factor receptor gene mutation after surgery<br>* Other names: Conmana;Drug: chemotherapy (Carboplatin and Docetaxel)<br>* as control group,compared with Icotinib<br>* Other names: Carboplatin and Docetaxel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free Survival |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 6 months |
Efficacy Study of Magnetic Resonance (MR) Guided Focused Ultrasound in the Treatment of Large Fibroids

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether ablation of uterine fibroids with MR guided focused ultrasound following 3 months pre-treatment with Gonadotrophin releasing analogues will allow the effective use of this therapy in women with larger fibroids.

Official Title
-----------------
Phase 4 Study of Magnetic Resonance Guided Focused Ultrasound Surgery Following Gonadotrophin Releasing Hormone Agonist Treatment for Symptomatic Uterine Fibroids

Conditions
-----------------
Uterine Fibroids

Intervention / Treatment
-----------------
* Procedure: Magnetic Resonance Guided Focused Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has given consent Willing and able to attend all visits Minimum age 18 with no desire for future fertility Uterine fibroid > 300 cc on MRI Normal cervical smear Screening symptom score >21 Pre or peri-menopausal Fibroids being device accessible Exclusion Criteria: Pregnancy Previous GNRH treatment HRT use Hormonal Contraception Patient on dialysis Haematocrit <25 ASA score > 2 Severe cerebrovascular disease Anticoagulated Active pelvic infection or history of PID Weight> 250 lbs Any contra-indication to MR imaging Intolerance to MRI contrast agent Unable to remain in prone positions for 3hours IUCD Abdominal scarring in beam pathway Breast feeding Non-perfused fibroid on contrast enhanced images

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Magnetic Resonance Guided Focused Ultrasound|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom improvement as judged by validated disease specific questionnaire |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fibroid and uterine volume. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnetic Resonance Guided Focused Ultrasound, Gonadotrophin Releasing Hormone Agonist, Uterine Fibroids
Comparison Between 2L Coolprep® and Combination of 1L Coolprep® and Bisacodyl as Bowel Preparation

Study Overview
=================
Brief Summary
-----------------
comparison of the use of Colyte® (ascorbic acid mixed polyethylene glycol solution) in two-liter versus one-liter volume and pretreatment with bisacodyl for colonoscopy preparation.

Official Title
-----------------
Comparison Between 2L Coolprep® and Combination of 1L Coolprep® and Bisacodyl as Bowel Preparation for Colonoscopy

Conditions
-----------------
Healthy Person, Bowel Preparation Before Colonoscopy

Intervention / Treatment
-----------------
* Drug: 2L Coolprep®
* Drug: 1L Coolprep® and Bisacodyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: willing to consent/undergo necessary procedures between the age of 20 and 75 years healthy persons planning to have a colonoscopy Exclusion Criteria: history of abdominal surgery except appendectomy inflammatory bowel disease clinically or laboratory-confirmed ileus (both functional and mechanical) malignancy clinically severe cerebrovascular, cardiovascular, kidney, liver or hematologic disease dementia, cognitive impairment the use of prokinetics, antispasmodics, antidiarrheal drugs, laxatives or neuroleptics in 2 weeks known sensitivity to the agents used Pregnancy, Lactating woman

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2L Coolprep®<br> | Drug: 2L Coolprep®<br>* * Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g<br>* Other names: 2L Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea);|
| Experimental: 1L Coolprep® and Bisacodyl<br> | Drug: 1L Coolprep® and Bisacodyl<br>* Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea) * Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g Dulcolax-S® (Boehringer Ingelheim ,Seoul, Korea) * composition /1 tablet : Bisacodyl 5mg, docusate sodium 16.75mg<br>* Other names: 2. Dulcolax-S® (Boehringer Ingelheim ,Seoul, Korea) : 4 tablet;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel cleansing scale | using SNUH scale | on the day of the colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel cleansing scale of Right/Transverse/Left colon | also using SNUH scale | on the day of the colonoscopy |
Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized, multi-center pilot study of isolated, displaced neck fractures of the fifth metacarpal. The patients are randomly assigned to osteosynthesis with antegrade intramedullary splinting or conservative treatment.

Detailed Description
-----------------
The aim of this study is to provide criteria for treatment decisions in patients with isolated, displaced neck fractures of the fifth metacarpal. The primary outcome criterion is the functional status measured by the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcome criteria are pain, range of motion (ROM), grip strength, and radiological parameters.

Official Title
-----------------
Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal

Conditions
-----------------
Fifth Metacarpal Neck Fracture

Intervention / Treatment
-----------------
* Procedure: antegrade intramedullary splinting
* Procedure: conservative treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: displaced neck fracture of the fifth metacarpal (at least 30° angulation) isolated injury age between 18 and 75 years informed consent Exclusion Criteria: rotational displacement open fracture injury older than one week treatment other than within this study other relevant injuries of the upper extremities other injury or disease of the hand pregnancy missing informed consent incompliance coagulopathy allergy to metallic implants Patients who have participated in any other device or drug clinical trial within the previous month

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>antegrade intramedullary splinting | Procedure: antegrade intramedullary splinting<br>* antegrade intramedullary splinting with 2 to 3 small K-wires<br>|
| Active Comparator: B<br>conservative treatment | Procedure: conservative treatment<br>* conservative treatment with 2-finger splint for one week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability of the Arm, Shoulder and Hand (DASH) questionnaire |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neck fracture of the fifth metacarpal, displacement, antegrade intramedullary splinting, conservative treatment