linjc16/ctgov huggingface dataset:
Bone Quality Lyon Orleans

Study Overview
=================
Brief Summary
-----------------
QUALYOR is a prospective study on the predictive value for fragility fracture of various new techniques assessing bone quality, among postmenopausal women with low bone mass.

Official Title
-----------------
Bone Quality and Improvement of Fracture Risk Prediction

Conditions
-----------------
Osteopenic Women

Intervention / Treatment
-----------------
* Other: Bone quality complementary exams


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 50 or older women post-menopausal since at least one year with osteopenia (T-score between -1.0 and -2.5 (with clinical factor risk) or -3.0 (without clinical factor risk) Exclusion Criteria: corticosteroid therapy > 3 months, at least 7.5mg/day equivalent prednisolon (stopped since at least 1 year) osteoporosis treatment antecedent fragility fracture antecedent on going post-menopausal hormonal treatment clinical signs of hepatic, cardiac or respiratory insufficiency, diseases possibly affecting bone metabolism life expectancy < 4 years, mental or serious illness

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Osteopenic women<br>Women with osteopenia: Bone Mineral Density T-score between -1.0 and -2.5 (for whom with clinical factor risk) or -3.0 (for whom without clinical factor risk) | Other: Bone quality complementary exams<br>* realisation of following exams to evaluate fracture risk in osteopenic women: hip and wrist Dual energy X-ray Absorptiometry (DXA) wrist and shin High-Resolution peripheral Quantitative Computed-Tomography(HR-pQCT) hip Quantitative Computed Tomography (QCT) High Resolution Digital X-Ray of calcaneum using BMA(tm) system low-dose stereoradiography using EOS(tm) system (only for a sub-group of 60 voluntary subjects)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fragility fracture | Appearance of vertebral or non-vertebral fracture during the 4 years follow-up | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis, Fracture, Bone microarchitecture
Paracoracoid Subscapularis Plane Block Versus Iso Block for Shoulder Surgery for Shoulder Surgery

Study Overview
=================
Brief Summary
-----------------
Shoulder surgery is the second orthopedic operation cause post operative pain Interscalene block is the standard block for shoulder surgery but it cause phrenic nerve block and diaphragmatic hemipareses Iso block is the block used to block the brachial plexuses cord and suprascapular nerve And paracoracoid subscapularis block supra scapular nerve in supra scapular fosa and axillary nerve as it curves around humeral head

Detailed Description
-----------------
Two groups Group S for paracoracoid subscapularis block Group I for iso block Twenty patients for para coracoid subscapularis block with ultra sonography 50 mm 22G needle inserted anterior to the fascia and 15ml o.5% bupivicaine injected another twenty patients for iso block a linear probe of ultrasound is placed in the infraclavicular region to identify the cords the needle is inserted 2-3cm superior to the clavicle and advanced in.plane posterior to the clavicle toward the cods and 25ml local anaesthesia is injected

Official Title
-----------------
Paracoracoid Subscapularis Plane Block Versus Infraclavicular and Subomohoid Block for Shoulder Surgery

Conditions
-----------------
Post Operative Pain

Intervention / Treatment
-----------------
* Procedure: Infraclavicular and subomohoid block
* Procedure: Paracoracoid subscapularis plane block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female patient >20year for shoulder surgery American Society of anaesthesiologist physical state 1 to2 Exclusion Criteria: refusal of patient Systemic infection Local infection Neurological or respiratory disease

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Infraclavicular and subomohoid block<br> | Procedure: Infraclavicular and subomohoid block<br>* Its blockade of subscapular nerve in the subscapular fossa and axillary nerve as it curves around humeral And blocking of brachial plexuses cord and supra scapular nerve And blocking of the brachial plexuses cord and supra scapular nerve<br>|
| Active Comparator: Paracoracoid subscapularis plane block<br> | Procedure: Paracoracoid subscapularis plane block<br>* Blocking of suprascapular nerve in supra scapular fossa and axillary nerve as it curves the humeral head<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment by VAS score | the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain | At 48 hours postoperative |
Estrogen Pretreatment Prior to GnRH Antagonist Protocol

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether estrogen pre-treatment can allow retrieval of 2 additional oocytes in GnRH antagonist protocol.

Official Title
-----------------
Interest of a Steroid Pre-treatment Prior to IVF Protocol With Ovarian Stimulation by Recombinant FSH and With LH Surge Blockage by Daily GnRH Antagonist

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: 17beta-estradiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: regular normo-ovulatory cycles (28 to 35 days) age < 38 years, body mass index (BMI) between 18 and 30 first or second IVF/ICSI attempt Exclusion Criteria: high basal levels of serum FSH or E2, less than 5 follicles at the antral follicular count performed on day 3 of a spontaneous cycle, history of high (>20 oocytes) or low (< 5 oocytes) ovarian response in a previous IVF attempt

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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: Estrogen pre-treatment<br> | Drug: 17beta-estradiol<br>* Pretreatment with 17beta-estradiol (Provames®, Aventis, Paris, France) was administered daily (2 mg twice a day) during the cycle preceding the IVF/ICSI cycle, starting 7 days before the predicted onset of menses and administered up until to the following Thursday after the occurrence of menses.<br>|
| No Intervention: Control<br>The control group did not receive any pre-treatment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of retrieved oocytes |  | at the ovarian puncture, 36 hours post HCG administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate |  | at pregnancy test and at 6 Week US examination | 
| delivery rate |  | 9 months later | 
| number of obtained embryos |  | 2 days after in vitro fertilization | 
| duration of FSH administration | number of days of administration | at the end of ovarian stimulation usually after a mean of 12 days of administration | 
| Total FSH dose | daily dose x number of days of administration | at the end of ovarian stimulation usually after a mean of 12 days of administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Assisted reproductive treatment, GnRH antagonist, Estrogen pre-treatment, Ovarian stimulation
Mental Health and Academic Performance in COVID-19

Study Overview
=================
Brief Summary
-----------------
This study aims to identify the preference of the class modalities (classroom or online) in undergraduate and graduate students. Additionally, to explore if the presence of any mental state alterations such as depression or anxiety due to the COVID-19 pandemic can alter their perception of academic performance.

Official Title
-----------------
dePression, Anxiety, aNd acaDemic pErforMance In Covid-19: PANDEMIC Study.

Conditions
-----------------
Depression, Anxiety

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years Students of any undergraduate or graduate course who are attending their semester online Exclusion Criteria: Students who are not attending an online course Students who are not registered in a university undergraduate or graduate course.

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: Survey|The investigators will use the Spanish language validated version of the Academic Self-Concept Scale (ASCS), the Patient Health Questionnaire-9 (PHQ-9) depression screening scale, and the General Anxiety Disorder-7 (GAD-7) screening scale. Additionally, the sample will be asked about their gender, age, preference of teaching modality, and finally, if the participants have perceived a change in their performance or any change in their grades.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Academic Self-Concept Scale Score | This scale will explore the effort and confidence of the participants. The minimum score for each facet is 10, and the maximum score is 70. | up to 3 months | 
| PHQ-9 Score | This inventory will be used to identify the presence and intensity of depressive disorders. The minimum score is 0, and the maximum score is 27. | up to 3 months | 
| GAD-7 Score | This questionnaire will be used to evaluate the presence and intensity of anxiety disorders. The minimum score is 0, and the maximum score is 21. | up to 3 months | 
| Preference of teaching method | Students' preference of classroom or online classes. | up to 3 months | 
| Self perceived academic performance | Students' perception of changes in their academic performance: got better, worse, or stayed the same. | up to 3 months | 
| Academic grades changes | Students' perception of changes in their grades: got better, worse, or stayed the same. | up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Depression, Anxiety, Public health, Academic performance
The Use of Drugs to Improve Kidney Function in Patients With Liver and Kidney Dysfunction

Study Overview
=================
Brief Summary
-----------------
We will address the hypothesis that refractory ascites and Type 2 hepatorenal syndrome are mediated in part by diminished circulatory volume and that treatment with midodrine, octreotide and albumin can improve renal and patient outcomes by restoring effective circulating volume and systemic perfusion. Our primary objective is to assess change in creatinine clearance using inulin. We will enroll 15 patients with Type 2 hepatorenal syndrome or refractory ascites once inclusion and exclusion criteria are satisfied. They will be treated for 1 month with octreotide LAR, albumin and midodrine. Renal, serum and neurohormonal parameters will be measured before, during, and after initiation of drug and compared.

Official Title
-----------------
The Use of Midodrine, Octreotide and Albumin in Refractory Ascites

Conditions
-----------------
Type 2 Hepatorenal Syndrome, Refractory Ascites

Intervention / Treatment
-----------------
* Drug: Midodrine, albumin, octreotide LAR
* Drug: midodrine, octreotide, albumin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhosis (biopsy or compatible clinical (ascites, varices), laboratory (low albumin, elevated bilirubin, elevated INR) and radiologic data (nodular appearing liver on ultrasound)). Type 2 hepatorenal syndrome and/or refractory ascites Exclusion Criteria: Secondary causes of renal dysfunction (proteinuria >500 mg/day, active urinary sediment, abnormal renal ultrasound, nephrotoxic medications) Bacterial infection (positive blood, urine or ascites cultures) within the past 2 weeks Gastrointestinal hemorrhage or encephalopathy within the past 2 weeks Age <18 Transvenous intrahepatic portosystemic stent shunt (TIPS) Hepatocellular carcinoma beyond the Milan criteria

Ages Eligible for Study
-----------------
Minimum Age: 19 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Midodrine, albumin, octreotide LAR<br> <br> Drug: midodrine, octreotide, albumin<br>* midodrine up to 12.5 mg tid, octreotide LAR 20 mg im once, albumin 150 mg q weekly<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in renal function (creatinine) |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ascites control |  | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatorenal syndrome, Refractory ascites, Midodrine, Octreotide, Albumin, Cirrhosis
An Extension Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-off. This Study is Not Recruiting in the United States

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of the long-term treatment of entacapone in patients with Parkinson's disease with end-of-dose wearing-off. This study is not recruiting patients in the United States.

Detailed Description
-----------------
The purpose of this study is to evaluate the safety and efficacy of the long-term treatment of entacapone in patients with Parkinson's disease with end-of-dose wearing-off.

Official Title
-----------------
An Extension Study to Phase IIb Dose-finding Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-off

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Entacapone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Attended the Phase IIb study Able to fill out the patient diary Exclusion Criteria: Serious heart, pulmonary, renal, hepatic or gastrointestinal disease Dementia symptoms Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Entacapone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events during the long term treatment (maximum 3 years) |  |  | 
| Blood pressure at every 12 weeks |  |  | 
| Laboratory test at every 16 weeks |  |  | 
| ECG at every 16 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| On time based on patient diary (up to 104 weeks) |  |  | 
| UPDRS score at every 16 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, end-of -dose wearing-off, entacapone
Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.

Study Overview
=================
Brief Summary
-----------------
This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil.

Official Title
-----------------
An Open Label Crossover Study In Healthy Older Male Subjects To Evaluate The Pharmacokinetics And Safety Of Sildenafil Following Fasted Administration Of An Orally Disintegrating Tablet Formulation Of Sildenafil Administered With Or Without Water Relative To Viagra® Oral Tablet With Water

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Sildenafil Tablet
* Drug: Sildenafil ODT
* Drug: Sildenafil ODT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Otherwise healthy male subjects age 45 years or older with or without erectile dysfunction. Body Mass Index (BMI) of 17.5 to 32.5 kg/m2. Signed and dated informed consent document. Exclusion Criteria: Evidence or history of clinically significant abnormalities Have baseline orthostatic hypotension Positive drug screen, excessive alcohol and tobacco use

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment A<br>Viagra 50 mg tablet, administered with approximately 240 mL water under fasted conditions | Drug: Sildenafil Tablet<br>* Tablet, 50 mg, Single Dose<br>|
| Experimental: Treatment B<br>Sildenafil ODT tablet 50 mg, administered without water under fasted conditions | Drug: Sildenafil ODT<br>* Orally Disintegrating Tablet, 50 mg, Single Dose<br>|
| Experimental: Treatment C<br>Sildenafil ODT tablet 50 mg, administered with water under fasted conditions. | Drug: Sildenafil ODT<br>* Orally Disintegrating Tablet, 50 mg, Single Dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(0-t) of sildenafil. |  | Up to 1 month | 
| Cmax of sildenafil. |  | Up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(0-inf) of sildenafil, if data permits. |  | Up to 1 month | 
| Half-life of sildenafil, if data permits. |  | Up to 1 month | 
| Tmax of sildenafil. |  | Up to 1 month | 
| Number of patients with adverse events. |  | Up to 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bioequivalence Oral Dissolving Tablet
Determination of Predictive Genetic Markers of Toxicity After Hypofractionated Radiotherapy in Breast Cancer Patients Post-Conservative Surgery

Study Overview
=================
Brief Summary
-----------------
The single shot partial breast irradiation (SSPBI) trial was designed as a prospective Phase II single-arm study. The use of a single dose tumor bed is expected to be very effective in terms of tumor control, but it could increase the incidence of radiation induced erythema. Therefore, the investigators assumed that a decreased DNA repair capability, as well as a reduced detoxification of the damage caused by oxidative stress could explain the increased acute toxicity, i.e. a higher incidence of erythema after a single dose. For this reason the investigators decided to investigate SNPs of genes involved in antioxidant and DNA damage repair pathways such as GST, XRCC1, XRCC3 and RAD51. The investigators assumed an erythema rate of 20% and 54% in patient groups at low and high risk, respectively, (groups were identified based on the absence/presence of the above polymorphisms alone or in combination), thus the minimum sample size was 56 patients with α=0.05, 2-tailed test and a power of the study of 80%.

Official Title
-----------------
Determination of Predictive Genetic Markers of Toxicity After Hypofractionated Radiotherapy in Breast Cancer Patients Post-Conservative Surgery

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 48 years old with a life expectancy of at least 5 years Post-menopausal status Histologically proven, non lobular, adenocarcinoma of the breast Primary tumours ≤ 3 cm Negative surgical margins (≥ 2 mm) Negative sentinel nodes or < 4 positive axillary nodes No extra-capsular extension No previous radiotherapy Exclusion Criteria: multicentric disease extended intraductal component (EIC > 25%) Paget's disease lobular adenocarcinoma distant metastases All the above criteria allow to identify patients at low risk of local recurrence.

Ages Eligible for Study
-----------------
Minimum Age: 48 Years
Maximum Age: 90 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 |
| --- | --- |
| BC patients after SSPBI<br>breast cancer (BC) patients following single shot partial breast irradiation (SSPBI) after breast conservative surgery | |

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
-----------------
toxicity after single shot partial breast irradiation (SSPBI)