linjc16/ctgov huggingface dataset:
Open Wedge High Tibia Osteotomy

Study Overview
=================
Brief Summary
-----------------
The aim of this RCT is to show, that in a patient group receiving COLLOSS E combined with TomoFix for medical open wedge high tibial osteotomy, the onset of bone healing is earlier in time, compared to patients receiving TomoFix without COLLOSS E.

Detailed Description
-----------------
The healing effect should be demonstrated by using MRI pictures during the entire FU's in order to demonstrate the differences if COLLOSS E is applied or not.

Official Title
-----------------
Comparison of Open Wedge High Tibia Osteotomy Surgeries Using Colloss E and Tomofix and Tomofix Only, Regarding the Bone Healing

Conditions
-----------------
High Tibia Osteotomy

Intervention / Treatment
-----------------
* Device: COLLOSS E
* Device: TomoFix Plate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult and active patient Varus malalignment of the leg Intact lateral joint compartment Physiological age-appropriate ROM in hip, knee and ankle of affected leg Exclusion Criteria: BMI>35 Drug or alcohol abuse Known equine protein allergy or immunological anormalities Immunosuppressive treatment Systemic or severe local inflammation or infections History of active malignancy or systemic disease Impossible to obtain informed consent Legal incompetence Pregnant and nursing women Patients before, during or one year after radio- or chemotherapy Patients with metal or metal implants near vulnerable structures Patients with pacemakers or other implanted devices

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: COLLOSS E|nan|
|Device: TomoFix Plate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of the osteotomy gap volume filled with bone healing tissue as determined on the MRI at 2 and 6 weeks postoperatively |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone union |  |  | 
| Complication rate |  |  | 
| Pain asset on the VAS |  |  | 
| Deviation planing angle |  |  | 
| Immuno reaction on equine proteins |  |  | 
| Range of motion |  |  | 
| Ligament stability |  |  | 
| Time to pain free walking |  |  | 
| WOMAC osteoarthritis index |  |  | 
| SF36 Index |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tibia osteotomy, Bone healing, Bone filler, Equine Protein, COLLOSS E, TomoFix
National Survey on Hypertension

Study Overview
=================
Brief Summary
-----------------
Describe the clinical characteristics of hypertensive patients aged of 75 years and older seen in general practitioner consultation according to their renal damage

Official Title
-----------------
Profile of Hypertensive Patients Aged of 75 Years and Older Seen in General Practitioner According to Their Renal Damage.

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 75 years or older With a diagnosis of Hypertension treated or not, seen in general practitioner consultation Who has given his/her consent to participate to the study. Exclusion Criteria: Patient who participated to a clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 75 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 |
| --- | --- | --- |
| Describe the clinical characteristics of hypertensive patients aged of 75 years and older seen in general practitioner consultation according to their renal damage |  | once | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertensive patients aged of 75 years and older, renal damage, Clinical characteristics of hypertensive patients aged of 75 years and older seen in general practitioner consultation according to their renal damage
Inhaled Heparin for Hospitalised COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
This meta-trial is a prospective collaborative individual participant data meta-analysis of randomised controlled trials and early phase studies. Individual studies will be conducted in multiple countries, including Australia, the UK, the USA, Ireland, Argentina, Brazil and Egypt. Adult patients admitted to the hospital with confirmed SARS-CoV-2 infection, who do not require immediate mechanical ventilation, will be randomised to inhaled nebulised heparin or standard care for up to 21 days or until the patient has no respiratory symptoms. All studies will collect a minimum core dataset. The primary outcome for the meta-trial is the proportion of patients who receive invasive mechanical ventilation censored at day 28. Individual studies may have specific outcome measures in addition to the core set.

Official Title
-----------------
INHALEd Unfractionated HEParin for the Treatment of Hospitalised Patients With COVID-19 Meta-trial

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Drug: Unfractionated heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to hospital with COVID-19 No immediate requirement for mechanical ventilation (points 3-5 on the WHO ordinal scale) Age equal to or greater than 18 Able to provide informed consent Exclusion Criteria: Pregnant women Known allergy to Heparin Participant in another clinical trial that is not approved for joint enrollment. APTT> 120 seconds, not due to anticoagulant therapy. Platelet count <20 x 109 per L Lung bleeding. Uncontrolled bleeding Advanced neurological impairment Advanced oncological 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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhaled heparin<br>Inhaled nebulised unfractionated heparin in addition to standard care Dose 25,000 IU every 6 hours for up to 21 days | Drug: Unfractionated heparin<br>* Inhaled nebulised 6 hourly<br>|
| No Intervention: Standard care<br>Standard care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation rate | Proportion of patients requiring invasive mechanical ventilation | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHO ordinal scale COVID19 | Number of patients showing 1 or 2 point worsening on the ordinal scale | Day 7 | 
| Oxygenation | Daily ratio of partial pressure of oxygen to FiO2 (PaO2/FiO2) | Day 7 |
No Routine CXR After Bronchoscopy

Study Overview
=================
Brief Summary
-----------------
Most pulmonologist request a routine chest-x-ray after bronchoscopy with transbronchial biopasie to exclude pneumothorax. We published a study in CHEST showing that routine chest-ray might not be necessary. We would like to conduct a propsective study to validate the results of the CHEST-study. Before and after the procedure follwing information will be collected: Age, Sex, Indication for procedure, number of biopsies and segment of biopsie, Saturation, Physical examination, Symptoms suggestive of pneumothorax. If there is no aggravation of the symptoms and/or physical examination after the procedure, as compared to before, routine chest-x-ray will NOT be done. A phone will be made 24 to 48 hours following the procedure to the patient.

Official Title
-----------------
Is Routine Chest-X-Ray Necessary After Bronchoscpy With Thransbronchial Biopsie? A Prospective Study

Conditions
-----------------
Pneumothorax

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with bronchoscopy and transbronchial biopsie Exclusion Criteria: No informed consent given

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones

Study Overview
=================
Brief Summary
-----------------
to assess safety, efficacy of Flexible ureteroscopy (FURS) holmium:YAG laser lithotripsy (LL) compared to extracorporeal shockwave lithotripsy (ESWL) in management of lower calyceal stones (LC) stones.

Detailed Description
-----------------
to assess stone free rate, number of sessions and complications of flexible ureteroscopy holmium:YAG laser lithotripsy compared to extracorporeal shockwave lithotripsy in the management of lower calyceal stones less than 2 cm in size.

Official Title
-----------------
Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones: A Prospective Randomized Study

Conditions
-----------------
Renal Stones

Intervention / Treatment
-----------------
* Procedure: Ureteroscopy
* Procedure: Shockwave lithotripsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unilateral radiopaque stone(s) < 2 cm located in the lower calyx. Exclusion Criteria: Bleeding tendency distal obstruction Anomalies of the urinary tract Solitary kidney

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Active Comparator: Ureteroscopy<br>Intervention: Flexible ureteroscopy for removal of lower calyceal stones using holmium:YAG laser lithotripsy | Procedure: Ureteroscopy<br>* In Group A patients, Karl Storz Flex-X 7.5, FURS with a 365 µm laser fiber.<br>* Other names: Flexible Ureteroscopy;|
| Active Comparator: Shockwave lithotripsy<br>Intervention: Shockwave lithotripsy for lithotripsy of lower calyceal stones using Siemens Lithostar Lithotriptor | Procedure: Shockwave lithotripsy<br>* In Group B patients, a Siemens Lithostar Lithotriptor<br>* Other names: ESWL;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone free rate | no stone fragments or having fragments <3mm | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Bleeding Infection Pain obstruction renal or ureteric injury UTI Fever | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal stones, lower calyx, Ureteroscopy, Shockwave lithotripsy, Holmium laser, Adult, Kidney
Rates DMBT1 ( Glycoprotein) in Sputum of CF Patients With Pseudomonas Aeruginosa

Study Overview
=================
Brief Summary
-----------------
Rates of DMBT1 (Glycoprotein like) in Sputum of CF Patients with or without may be different according to their Pseudomonas Aeruginosa chronic colonization status. The aim of this study is to compare rates of DMBT1 (Glycoprotein like) in Sputum of CF patients with or without a Pseudomonas Aeruginosa chronic colonization.

Detailed Description
-----------------
Rates of DMBT1 (Deleted in Malignant Brain Tumor 1) will be compared between 2 groups of 30 CF patients : group 1 : with Pseudomonas Aeruginosa chronic colonization and group 2 30 CF patients without Pseudomonas Aeruginosa chronic colonization.

Official Title
-----------------
Comparison of Rates DMBT1 ( Glycoprotein) in Sputum of CF Patients Colonized Patients Between Chronic and Non-chronic Patients Colonized With Pseudomonas Aeruginosa

Conditions
-----------------
Malignant Brain Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CF patient 6 years Availability of sputum Signed Informed consent Exclusion Criteria: Cardiac insufficiency Anti-inflammatory drugs on going Oral corticosteroid therapy Inhaled corticosteroids during the two weeks before inclusion, Patient awaiting lung transplantation Patient with a past history of heart/lung transplantation Patient with a sputum examination positive for : atypical mycobacteria, Burkholderia cepacia, Stenotrophomonas maltophilia, Patient chronically colonized with multiresistant Pseudomonas aeruginosa Orkambi© or Kalydeco© therapy Change of the CF treatment during the last 4 weeks +/- 2 days before inclusion : corticosteroid, pancreatic extracts, antisecretory drugs...

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| group 1<br>CF patients with Pseudomonas aeruginosa chronic colonization. | |
| group 2<br>CF patients without a Pseudomonas aeruginosa chronic colonization. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure glycoprotein-like DMBT1 by Elisa | DMBT1 in mg DMBT1 / mg of total protein measured by BCA (BiCinchoninic acid Assay) present in each sputum | at 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure MUC5B by Elisa | MUCB in mg / mg of total protein measured by BCA present in each sputum | at 1 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malignant Brain Tumor, patient sputum
Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
Efficacy duration of triamcinolone acetonide (steroid) for treatment of diabetic macular edema. Furthermore, dosage dependency of triamcinolone acetonide comparing a high dosage versus a low dosage.

Detailed Description
-----------------
Patients with diabetic retinopathy suffer from visual acuity loss caused by diabetic macular edema. Intravitreal injected Triamcinolone Acetonide (steroid) reduces macular edema and increases visual acuity. The duration of its effect is however limited. Therefore, several injections are necessary. In this study a dosage dependency of triamcinolone acetonide (high dosage vs low dosage) is performed. The primary outcome parameters are the number of treatments and the efficacy of each injection.

Official Title
-----------------
Dosage Dependency of Intravitreal Triamcinolone Acetonide for Treatment of Diabetic Macular Edema

Conditions
-----------------
Diabetic Retinopathy, Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: Intravitreal injection (triamcinolone acetonide)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic macular edema and visual acuity between 20/200 and 20/40 age over 18 years Exclusion Criteria: recent treatment with laser photocoagulation or intravitreal drugs

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intravitreal injection (triamcinolone acetonide)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity, no of treatments, duration of efficacy |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraocular pressure, retinal thickness |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetic macular edema, triamcinolone acetonide, intravitreal, steroid
Study on the Evolution of Genes Mutation Related With Gastrointestinal Stromal Tumors

Study Overview
=================
Brief Summary
-----------------
Mutations of tumor-related genes are dynamic. Gastrointestinal stromal tumor cells often are obviously more invasive in case of recurrence. The great majority of relapses may be associated with secondary mutation in the GIST related genes. Full gene sequences of c-KIT、PDGFRA and DOG1, which is extracted from the specimen cells of repeated surgical resection or biopsy tissue in GIST patients with postoperative recurrence, are analyzed with the screening-sequencing approach, in order to investigate the characteristics and variations associated with the different gene mutations of c-KIT、PDGFRA and DOG1 in GIST patients and be likely to find out the evolutionary pattern, try to learn the facts about the effect of tyrosine kinase inhibitors on the GIST related genes, make a survey of any association of c-KIT、PDGFRA and DOG1 gene mutations and provide the basis for seeking molecular marker of GIST for monitoring course of disease, and offer a theoretical basis and new therapeutic strategies for application of clinical treatment.

Conditions
-----------------
Full Gene Sequences of c-KIT、PDGFRA and DOG1 Are Analyzed With the Screening-sequencing Approach, Investigate the Characteristics and Variations Associated With the Different Gene Mutations of c-KIT、PDGFRA and DOG1 in GIST Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with Gist at the Department of Gastrointestinal and Glands Surgery of the First Affiliated Hospital of Guangxi Medical University in China. Exclusion Criteria: patients with hepatitis and tuberculosis
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gist,c-KIT,PDGFRA,DOG1,mutation
Impact of Parent's Presence in Neonatology

Study Overview
=================
Brief Summary
-----------------
Every year 75000 new-born babies are hospitalized in neonatology yard in France with about 60000 born prematurely. Studies showed that parents presence is good for the baby development , decrease the stress due to hospitalization.It's also efficient for the attachment between the baby and parents. Although the team try to settle a good atmosphere to establish this link and let parents take their position,it seems that the time taken to stay with the baby is less moreover the night. The aim of the study is to evaluate the time of presence to find tools to increase this time in the neonatotology yard

Official Title
-----------------
Impact of Parent's Presence in Neonatology

Conditions
-----------------
Newborn; Vitality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: every newborn baby hospitalized in neonatology yard Exclusion Criteria: no french speaking parents duration of hospitalization less than 1 week.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 7 Days

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 |
| --- | --- | --- |
| number of hours spent with the newborn baby the night. |  | Day 5 |