linjc16/ctgov huggingface dataset:
Interest of HI-RTE Elasticity in Obstetric

Study Overview
=================
Brief Summary
-----------------
In obstetric, the investigators can't predict accurately with current means (BISHOP score, traditional cervix ultrasonography and fibronectin) the childbirth time and delay. If ultrasonography can determine the length, the cervix opening, it can't define its flexibility. Indeed, the conventional cervix ultrasonography can't inform us about the consistency of the uterine cervix. The elastography (elasticity imagery) is an innovating technology. It is a new technology currently used as part of breast cancer estimate. This diagnosis mean use the ultrasonography to measure the tissues answer under pressure. Its contribution in obstetric must be estimated to improve patients minimum fare. The main target of the investigators study is to estimate the interest of the measure of cervix elasticity degree by elastography in prediction of premature birth within a population of pregnant women

Conditions
-----------------
Premature Birth

Intervention / Treatment
-----------------
* Other: The elastography (elasticity imagery)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unique(only) or multiple pregnancy about is the term presenting an intra Utérine pregnancy in the 1st quarter · Signed lit(enlightened) consent · Patient of more than 18 years old Exclusion Criteria: Suspicion of pregnancy extra utérine, hémodynamique unstable, important métrorragies, maternal diabetes, arterial high blood pressure impossibility to receive the consent lit(enlightened) by the patient · patient old under age 18

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: The elastography (elasticity imagery)|This diagnosis mean use the ultrasonography to measure the tissues answer under pressure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The elastography (elasticity imagery) |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
estimate the interest of the measure of cervix elasticity degree by elastography in prediction of premature birth within a population of pregnant women
Observational Follow-up Study of REGATTA

Study Overview
=================
Brief Summary
-----------------
Observational follow-up study of patients included in the clinical trial REGATTA.

Detailed Description
-----------------
A follow-up telephone interview of the participants of the clinical trial REGATTA exploring the occurrence of urinary tract infections, pyelonephritis within a follow-up period of three months after inclusion.

Official Title
-----------------
Observational Study of Patients With Uncomplicated Urinary Tract Infection Treated With Antibiotics or Herbal Medicinal Product

Conditions
-----------------
Urinary Tract Infections

Intervention / Treatment
-----------------
* Drug: Arctuvan
* Drug: Placebo to Fosfomycin
* Drug: Fosfomycin
* Drug: Placebo to Arctuvan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participants of the clinical trial REGATTA informed consent to participate in the observational study REGATTA II Exclusion Criteria: - no informed consent granted

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women treated with the herbal drug Uva Ursi<br>Patients of the clinical trial REGATTA (NCT03151603) who have been randomized in the Uva Ursi arm. | Drug: Arctuvan<br>* application of a herbal drug in the clinical trial REGATTA (NCT03151603)<br>Drug: Placebo to Fosfomycin<br>* application of Placebo to Fosfomycin in the clinical trial REGATTA (NCT03151603)<br>|
| Women treated with antibiotics<br>Patients of the clinical trial REGATTA (NCT03151603) who have been randomized in the fosfomycin arm. | Drug: Fosfomycin<br>* application of an antibiotic drug in the clinical trial REGATTA (NCT03151603)<br>Drug: Placebo to Arctuvan<br>* application of Placebo to Arctuvan in the clinical trial REGATTA (NCT03151603)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of urinary tract infections | number of urinary tract infection within 3 months after inclusion in REGATTA | 3 months after inclusion in REGATTA | 
| number of pyelonephritis | number of pyelonephritis within 3 months after inclusion in REGATTA | 3 months after inclusion in REGATTA | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
herbal treatment, antibiotics, uncomplicated urinary tract infection
Efficacy and Safety of DHEA for Myotonic Dystrophy

Study Overview
=================
Brief Summary
-----------------
To test the efficacy and safety of two doses of dehydroepiandrosterone (DHEA) in adults with myotonic dystrophy

Detailed Description
-----------------
Myotonic dystrophy is an inherited disorder that affects 1 per 8000 adults. The disease is characterize by muscular dystrophy, myotonia, cardiac disorders, cognitive function impairment, hypersomnia, hair loss, endocrine disorders. Recent small studies suggested that DHEA treatment may improve muscle strength in adults with myotonic dystrophy. Thus, the current study aims at investigating the safety and efficacy of a prolonged treatment with DHEA in adults with myotonic dystrophy.

Official Title
-----------------
Phase 3 Study of Oral Dehydroepiandrosterone (DHEA) in Adults With Myotonic Dystrophy

Conditions
-----------------
Myotonic Dystrophy

Intervention / Treatment
-----------------
* Drug: dehydroepiandrosterone 100 and 400 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Myotonic dystrophy (genetically proven) MDRS score of 3 or 4 Exclusion Criteria: Age <18 years or >70 years Pregnancy or breastfeeding Poor compliance to treatment and follow up Inclusion in any other clinical trial Severe cardiac disease: acute myocardial infarction in the preceding 6 months, unstable heart failure, uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg after 10 minutes of rest in the lying position), severe arteritis, any past history of thrombose or embolic event, any past history of symptomatic arrhythmia) Chronic renal failure Chronic liver disease Long term mechanical ventilation Any ongoing cancer Any underlying endocrine disorders Impaired swallowing Previous treatment with DHEA

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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

| Intervention/Treatment |
| --- |
|Drug: dehydroepiandrosterone 100 and 400 mg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in a Muscle Strength Score between randomization and study week 12 |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of myotonia |  | 3 months | 
| Appeal score |  | 3 months | 
| Epworth score |  | 3 months | 
| Forced vital capacity |  | 3 months | 
| arterial blood gas |  | 3 months | 
| changes in EKG and echocardiography |  | 3 months | 
| tolerance |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myotonic dystrophy, hypersomnia, dehydroepiandrosterone
Lithotripsy for the Treatment of Gallstones

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness and safety of using the Medstone lithotripter to treat single non-calcified gallstones from 4 to 20 mm in diameter.

Detailed Description
-----------------
This study is a randomized, single-masked controlled trial in which the combination therapy of lithotripsy and the bile acid drug Actigall is compared to monotherapy with only Actigall. The primary objectives are, 1) To determine whether the use of the Medstone STS Lithotripter system in combination with the orally administered drug Actigall is more effective (as measured by percentages of stone free patients 6 months after randomization) in reducing single non-calcified radiolucent gallstones (from 4 to 20mm in diameter) than use of Actigall alone, and 2) To demonstrate that use of the Medstone lithotripsy system is safe (as measured by incidence of adverse events) for the intended purpose, when operated according to its labeling.

Official Title
-----------------
Biliary Lithotripsy in Combination With Actigall Versus Actigall Monotherapy for the Treatment of Symptomatic Cholesterol Gallstones

Conditions
-----------------
Cholelithiasis

Intervention / Treatment
-----------------
* Device: Extracorporeal Shock Wave Lithotripsy
* Drug: ursodiol


Participation Criteria
=================
Eligibility Criteria
-----------------
History of biliary pain Evidence of a single noncalcified, radiolucent gallstone between 4 and 20 mm (inclusive) diameter HIDA scan demonstrating patency of cystic bile duct No cardiac pacemaker No allergy to radioopaque dye, iodine, bile acids No spontaneous or iatrogenic bleeding disorder No current or prior bile duct obstruction, cholangitis, pancreatitis, or cholecystitis Not pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Extracorporeal Shock Wave Lithotripsy|nan|
|Drug: ursodiol|nan|

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
-----------------
Gallstones, Gallstone, Biliary stones, Gallbladder stones, Gallbladder, Lithotripsy, Cholelithiasis, ESWL, Shock wave, Shock waves, shockwaves, shockwave
Effect of Sildenafil on Endothelial Function

Study Overview
=================
Brief Summary
-----------------
We are investigating the chronic effect of daily assumption of Viagra on the blood vessels function in patients with impotence. The study will include 2 groups: 1- patients with multiple risk factors, e.g. hypertension 2- patients with no cardiovascular risk factors

Detailed Description
-----------------
We are investigating the chronic effect of daily assumption of Viagra on the blood vessels function in patients with impotence. The study will include 2 groups: 1- patients with multiple risk factors, e.g. hypertension 2- patients with no cardiovascular risk factors

Official Title
-----------------
Effect of Sildenafil on Endothelial Function

Conditions
-----------------
Impotence

Intervention / Treatment
-----------------
* Drug: Viagra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 40-70 impotence with and without hypertension, Hypercholesteremia or DM Exclusion Criteria: CHF: NYHA > II Stable angina: CCS > II Nitrate treatment

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of endothelial function following Viagra treatment, according to platismographia. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
impotence, endothelial function, autonomic nervous system
A Questionnaire Survey for Biliary Tract Cancers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is: To evaluate risk factors for cancers of the biliary tract by registering new patients and their counterparts in a multi-center program Development of programs by creating a multi-center biliary tract cancer registration system

Official Title
-----------------
A Questionnaire Survey Study for Establishment of Surveillance and Prevention Through the Analysis of Epidemiologic Risk Factors in Patients With Biliary Tract Cancers

Conditions
-----------------
Biliary Tract Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study population : Newly diagnosis of biliary tract cancers - Pathological or Radiological or other clinical diagnosis of biliary tract cancers Informed consent Control : with no previous cancer diagnosis Informed consent Exclusion Criteria: Previous diagnosis of bile duct cancer with resection operation, endoscopic resection, chemotherapy or radiation therapy Prior diagnosis of other cancer in 5 years or ongoing cancer treatment Patients' refusal

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Newly diagnosed as bile duct cancer | |
| Control group<br>No history of cancer in previous 5 years | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and percentage of cases and controls who complete each part of the study | Information is obtained by a questionnaire, laboratory findings, image data, physiological parameter. | 5 years |
Quality of Life for Subjects Receiving Androgen Deprivation Therapy and Have a Doubling in PSA of Either Less Than or Greater Than 1 Year

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if there is a difference in quality of life (as measured by FACT-P) in patients treated with androgen deprivation therapy (ADT) for biochemical failure (PSA recurrence) following surgery or radiation for prostate cancer depending on when ADT is initiated.

Official Title
-----------------
An Open-Label, Phase ll Trial Comparing FACT-P Scores For Subjects Who Are Indicated To Receive Androgen Deprivation Therapy And Have A Doubling In PSA Post Curative Therapy Of Either Less Than Or Greater Than One Year

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Received therapy of curative intent (surgery or radiotherapy) Have a rising PSA which has doubled from a nadir value. Histologically proven prostate cancer requiring androgen deprivation therapy for at least 12 months Written informed consent to participate in the trial. Exclusion Criteria: Known hypersensitivity to Zoladex, Casodex, ar any component of these products Prior treatment with LHRH agonist or anti-androgens in the past 12 months Any concomitant condition that would make it undesirable, in the physician's opinion, for the subject to participate in the trial or would jeopardize compliance with the protocol.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Patients who have been identified as having a doubling in PSA from nadir of greater than one year | |
| B<br>Patients who have been identified as having a doubling in PSA from nadir of less than one year. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant difference in FACT-P scores after 12 months between the 2 groups |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA response |  | 12 months | 
| To evaluate the ease of use of FACT-P to measure Quality of Life |  | 12 months | 
| QOL, side effect profile and evaluate the safety and tolerability of Androgen Deprivation Therapy |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life, Androgen Deprivation Therapy, Goserelin
Periperal Blood Lymphocytes During Prostate RT

Study Overview
=================
Brief Summary
-----------------
Right now it is not possible to predict which patients are going to react more to RT. Many things could affect patient's response to radiation. One of the factors is whether the person can repair damage to the genetic material (DNA/RNA) caused by the RT. There is some evidence that a certain protein called Gamma H2AX is involved in DNA damage and repair and this can be used to predict the sensitivity of individual patients. The investigators will be studying this protein: Gamma H2AX) in the blood samples of prostate cancer patients exposed to both computed tomography (CT) scan and RT treatment. This will help us to understand why different individuals show differences in side effects following RT.

Official Title
-----------------
A Pilot Study of Gamma H2AX DNA Repair Foci Kinetics in Peripheral Blood Lymphocytes During Prostate Cancer Radiotherapy

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intermediate-risk prostate cancer patients (T1/T2N0M0 with either GS < 7 and PSA between 10-20 ng/ml or GS 7 and PSA less than 20 ng/ml). Planned for radical RT to the prostate with IMRT planning (79Gy/39fractions or 60 Gy/20 fractions). No contraindications to diagnostic CT scanning. Prostate volumes will be less than 80 cc to control the planning dose volume histogram (DVH) as much as possible in terms of rectal and bladder volumes. No known DNA repair disorders (e.g. family history of AT, BRCA1/2 or Li Fraumeni syndrome) or contraindications to radical pelvic RT. Exclusion Criteria: Inability to provide informed consent. Patient having contraindications to diagnostic CT scan. Patients who have unobtainable data regarding previous therapy and their clinical outcome. Patients should not have any diagnostic X-rays or CAT scans 2 weeks prior to their enrollment into the study.

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

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

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 |
| --- | --- | --- |
| Gamma H2AX in peripheral blood lymphocytes. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gamma H2AX following RT planning (CT scan). |  | 1 year | 
| Gamma H2AX during RT |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer
Clinical and Radiological Results of Osteochondral Repair Using MaioRegen in Knee and Ankle Surgery

Study Overview
=================
Brief Summary
-----------------
Osteochondral lesions in knee and ankle are injuries commonly seen in young patients. MaioRegen fleece is a cartilage substitute which can be used in circumscribed defects. This prospective study follows patients treated with MaioRegen implants from pre-surgery until 24 months post-surgery.

Official Title
-----------------
Clinical and Radiological Results of Osteochondral Repair Using MaioRegen in Knee and Ankle Surgery

Conditions
-----------------
Osteochondral Lesion of Talus, Degenerative Lesion of Articular Cartilage of Knee

Intervention / Treatment
-----------------
* Device: implantation of MaioRegen fleece into osteochondral lesion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: single osteochondral lesion in knee/ankle (2-4 sq cm) Exclusion Criteria: multiple osteochondral lesions pre-existing injuries/arthropathies

Ages Eligible for Study
-----------------
Minimum Age: 16 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: osteochondral lesions in knee/ankle<br>patients with traumatic and atraumatic osteochondral lesions in knee/ankle, implantation of MaioRegen fleece into osteochondral lesion | Device: implantation of MaioRegen fleece into osteochondral lesion<br>* arthroscopic localization of lesion, arthroscopic guided mini-arthrotomy and implantation of defect sized MaioRegen fleece<br>* Other names: MaioRegen Fin-Ceramica Faenza S.p.A.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI imaging - gap between cartilage-implant surface in mm | ingrowth of fleece into the cartilage | 18 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical outcome measurement | Lysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot&Ankle Disability Index | pre-surgery | 
| clinical outcome measurement | Lysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot&Ankle Disability Index | 6 months post-surgery | 
| clinical outcome measurement | Lysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot&Ankle Disability Index | 12 months post-surgery | 
| clinical outcome measurement | Lysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot&Ankle Disability Index | 18 months post-surgery | 
| clinical outcome measurement | Lysholm Knee Score Cincinatti Knee Scale IKDC Knee Score AOFAS Hindfoot Score Foot&Ankle Disability Index | 24 months post-surgery |