linjc16/ctgov huggingface dataset:
The Prevalence Survey of ALDH Gene Family in Patients With Peripheral Arterial Occlusive Disease or Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
Aldehyde dehydrogenase 2 (ALDH2) is an important enzyme protecting human from the accumulation of aldehyde, the main metabolites of alcohol. The deficiency of ALDH2 gene results in flush and hang over post drinking and most importantly it has been found associated with the incidence of cancer and post myocardial infarction (MI) heart failure. In the previous studies, ALDH2 decreased the ischemic territory post infarction and using a large scaled interaction of genetic variants and ALDH2 as an instrument, the threats of alcohol consumption on Asians' cardiovascular health was underscored. Furthermore, in a meta-analysis reviewing 12 case-control studies also indicated an increase of 48% risks in patients with ALDH2 deficiency. Notably, the genetic deficiency is most prevalent in Asians. In Taiwan one of every two individuals may be the victim and the high prevalence is counted as the top of the world. However, a large scaled prospective study focusing on the prevalence of ALDH2 deficiency in patients with peripheral artery occlusive disease (PAOD) or acute coronary syndrome （ACS）remains lacking.

Official Title
-----------------
The Prevalence Survey of ALDH Gene Family in Patients With Peripheral Arterial Occlusive Disease or Acute Coronary Syndrome

Conditions
-----------------
Peripheral Artery Occlusive Disease, Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Other: Observational research


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age≧20 y/o Using ankle-brachial index (ABI)< 0.9, angiography, vascular duplex, CAT scan or cardiologists'impression to confirm the diagnosis of PAOD Clinical presentation of claudication diagnosis of ACS Exclusion Criteria: If the patient refuses to be included in this study

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational research|Observational research|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of MALE(major adverse limb events) in peripheral arterial disease and acute coronary disease. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of MACCE(major adverse cardiac and cerebrovascular events) in peripheral arterial disease and acute coronary disease. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral Artery Occlusive Disease or Acute Coronary Syndrome
Phase II Neoadjuvant ER+/PgR + Arimidex +/- Iressa Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.

Official Title
-----------------
Phase II, Placebo Controlled, Parallel Group, Double Blind, Randomised, Multicentre Trial Comparing the Anastrozole (Arimidex®) Placebo Combination to the Anastrozole - ZD1839 (Iressa™) Combination as Neoadjuvant Treatment in Postmenopausal Women With Stage I-IIIB Breast Cancer and Oestrogen Receptor (ER) and/or Progesterone (PgR) Positive Tumours

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

Intervention / Treatment
-----------------
* Drug: Anastrazole
* Drug: Gefitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Measurable (stage I-IIIB) non meta static non inflammatory breast cancer Patients must post menopausal women who in the opinion of investigator would be likely to benefit from endocrine therapy. Postmenopausal patients are defined as: Natural menopause with last menses > 1 year ago, Radiation induced oophorectomy with last menses > 1 year ago, Serum FSH and LH levels clearly in the postmenopausal range for the institution. Bilateral oophorectomy Exclusion Criteria: Other current or previous (to last 5 years) malignancies, other metastases, abnormal blood chemistry, lung/ heart/kidney/liver abnormalities, Hormonal treatment within the last 2 weeks, previous hormonal treatment for invasive cancer
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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Anastrazole|nan|
|Drug: Gefitinib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine and compare changes in proliferation marker at 16 weeks in the treatment groups |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumour response, safety and tolerability, pharmacokinetics, pharmacokinetics and dynamics, oestradiol levels, mastectomy rate. |  |  | 
| Comparison of WHO and RECIST criteria, |  |  | 
| Exploratory biomarker studies involving genomics, metabolomics and proteomics. |  |  |
Treatment of Delirium in the Elderly With Donepezil: a Double-blind, Randomized, Placebo-controlled Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Nowadays features for the diagnosis of delirium are: Disturbance of consciousness (i.e. reduced clarity of environment awareness) with reduced ability to focus, sustain or shift attention; A change in cognition (such as memory deficit, disorientation, language disturbance) or the development of a perceptual disturbance that is not better accounted for by a pre-existing or evolving dementia; The disturbance develops over a short period of time (usually hours to days) and its severity fluctuates during the course of the day; There is evidence from the history, physical examination, or laboratory findings that the disorder is caused by the direct physiological consequences of a general medical condition, substance intoxication or substance withdrawal. Treatment of underlying clinical disease is important to remit the delirium. However, these procedures alone are not enough to remit the delirium early and to prevent sequels. There is a need for a specific and faster strategy to treat the delirium. The investigators want to test the hypothesis that an Anticholinesterase Inhibitor (donepezil) can reduce the duration of the delirium.

Official Title
-----------------
Treatment of Delirium in the Elderly With Donepezil: a Double-blind, Randomized, Placebo-controlled Clinical Trial

Conditions
-----------------
Elderly, Delirium of Unknown (Axis III) Etiology, Intensive Care (ICU) Myopathy

Intervention / Treatment
-----------------
* Drug: Donepezil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 60 year old Delirium according to the CAM-ICU (Confusion Assessment Method for Intensive Care Unit) informed consent (legal representatives) Exclusion Criteria: unable to swallow pills previous allergy to donepezil Atrioventricular block of 2nd and 3nd degree

Ages Eligible for Study
-----------------
Minimum Age: 60 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: donepezil<br>Donepezil 5mg/day during 2 weeks | Drug: Donepezil<br>* 5 mg PO a day, during 2 weeks<br>|
| Placebo Comparator: placebo<br>placebo comparator to donepezil (double blind) | Drug: Donepezil<br>* 5 mg PO a day, during 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of the duration of delirium in elderly patients treated with donepezil |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of delirium (as measured by the DSR-98-R) may influence the response to donepezil |  | 2 weeks |
Metabolism Des LAM

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators study the prognostic role of oxidative stress metabolism and iron in Acute myeloid leukemia.

Detailed Description
-----------------
Primary goal of this study is to Evaluate the characteristics of regulatory networks of iron and redox balance in leukemic cells, to study the correlations between the prognosis of AML patients (in terms of response to induction chemotherapy and survival i) and metabolism of these markers. Secondary ones areto assess the impact of induction therapy on markers of oxidative stress and to correlate biological iron and redox metabolism with the molecular status of patients (eg Flt3/IDH/CEBPA/NPM...). Eligibility criteria are patients at diagnostic of de novo acute myeloid leukemia (promyelocytic excluded) aged from 18 to 100 years.

Official Title
-----------------
Rôle Pronostique Des métabolismes du Stress Oxydatif et du Fer Dans Les Leucémies Aiguës Myéloblastiques

Conditions
-----------------
Iron, Acute Myeloid Leukemia, Diagnosis, Oxydative Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: de novo acute myeloid leukemic patient from 18 years to 99 years at diagnosis Exclusion Criteria: age under 18 years promelocytic leukemia secondary leukemia

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| overall survival Event-free survival Response to induction chemotherapy, overalll survival, event-free survival |  | five years after the inclusion |
Study of Mechanisms of Anovulation in Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
We previously hypothesized that the excess of Anti-Mullerian Hormone (AMH) at the level of ovarian selectable follicles could be involved in the follicular arrest of Polycystic Ovary Syndrome (PCOS), mainly through inhibition of FSH effect on aromatase expression.In this study, we plan to investigate whether a drop in the serum AMH level would be concomitant to the appearance of a dominant follicle induced by administration of mild amounts of exogenous FSH in women with PCOS.

Detailed Description
-----------------
Women with PCOS (Rotterdam definition) whom anovulation is resistant to clomiphene citrate will receive recombinant FSH using the low-dose step-up protocol during only one cycle. Serum levels of estradiol, AMH, LH, FSH, inhibin B and ultrasound (U/S) parameters will be assessed twice a week until 3 days after appearance of > 1 dominant follicle(s).The starting dose of recFSH will be 50 IU/day. In the absence of criteria for dominance (see below) after 14 days at 50 IU/day, recFSH dose will be increased by 25 IU/day every 7 days until dominance is achieved. Dominance will be defined by the appearance of at least one follicle >10 mm growing at least 2 mm/day and serum E2> 100 pg/L. Ultrsound examination will performed with a 7-MHz transvaginal transducer (Sonoline Elegra, Siemens), in real time, according to a standardized protocol.Serum AMH levels will be assessed using the second-generation enzyme immunoassay AMH-EIA.

Official Title
-----------------
Dynamic Changes in the Serum Anti-Müllerian Hormone Level During Low-Dose recFSH Administration Further Support Its Role in the Anovulation of Polycystic Ovary Syndrome

Conditions
-----------------
Anovulation

Intervention / Treatment
-----------------
* Drug: usual administration of exogenous recombinant FSH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal sperm analysis in the partners and normal hysterosalpingography in all patients PCOS defined by Rotterdam criteria resistance to clomiphene citrate, i.e. no ovulation at 150 mg/day or no pregnancy after 6 ovulatory cycles informed consent before inclusion Exclusion Criteria: on-going pregnancy age<18 or >40 yr. unability to understand the treatment protocol other medications any co-existent morbid condition contra-indicating a pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: usual administration of exogenous recombinant FSH|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
-----------------
FSH, Polycystic Ovary Syndrome, Follicular Arrest, Anti-Mullerian Hormone
Refinement and Assessment of New Magnetic Resonance Imaging (MRI) Technologies for Vascular, Abdominal, and Pelvic Exams

Study Overview
=================
Brief Summary
-----------------
This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies designed to improve MRI examinations of the vascular structures, abdomen, and pelvis regions.

Detailed Description
-----------------
This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies such as new hardware or software designed to improve MRI examinations of the vascular structures, abdomen, and pelvis regions. Software and hardware are always being improved, new machines replace old machines, software is updated and improved as well as devices used to produce better MRI images.

Official Title
-----------------
Refinement and Assessment of New Magnetic Resonance Imaging (MRI) Technologies for Vascular, Abdominal, and Pelvic Exams

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Procedure: MRI Magnetic Resonance Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or non-pregnant female patient 18 years or older any ethnic background presenting to MRI for a clinically-ordered chest MRI exam. Exclusion Criteria: Patients, who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator. Pregnant patients or patients who are lactating. A patient who is claustrophobic

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New MRI techniques<br>New hardware or software technologies designed to improve MRI (Magnetic Resonance Imaging) exams. | Procedure: MRI Magnetic Resonance Imaging<br>* MRI<br>* Other names: Magnetic Resonance Imaging;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of new software in MRI vascular imaging | New software technology will be utilized to enhance MRI imaging of the vascular regions of the body. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vascular MRI, Abdominal MRI, Pelvic MRI, Breast MRI, Magnetic Resonance Imaging (MRI)
PRINTO (the Paediatric Rheumatology International Trials Organisation)

Study Overview
=================
Brief Summary
-----------------
A comparison of outcome in children with JIA who are in remission on MTX, when MTX is then stopped for either 6 or 12 months

Conditions
-----------------
Juvenile Idiopathic Arthritis

Intervention / Treatment
-----------------
* Drug: methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any child with JIA who has gone into remission using methotrexate

Ages Eligible for Study
-----------------
Maximum Age: 16 Years

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

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A New 3D Geometrical Modelisation of Adolescent Idiopathic Scoliosis and Conception of a Personal Brace

Study Overview
=================
Brief Summary
-----------------
Adolescent idiopathic scoliosis (AIS) involves complex tridimensional deformities of the spine. In case of progressive curve deformity, the use of spinal bracing remains the standard non operative treatment of moderate AIS. Most of the time, the different types of braces don't take into account the individual biomechanical properties of each patient's spine. Actually, it is essential to better understand the effect of the loads applied on the trunk and on the spine, and a 3D geometrical modelisation of these components is essential. Many studies have been publishing concerning the use of radiographs for the geometrical reconstruction of the spine, and more recently the EOS system. But even then, it is still necessary to obtain an important number of geometrical data and discretisation is still a long procedure.

Official Title
-----------------
A New 3D Geometrical Modelisation of Adolescent Idiopathic Scoliosis and Conception of a Personal Brace

Conditions
-----------------
Scoliosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 12 years Pre menarchial for the girls Risser 0 et Risser 3 on X rays. Radiologic classification of spine maturity (ossification of the iliac crests). Five stages. Cobb angle ≥25° and < 40° Information to the parents and child, and signed approval Exclusion Criteria: No idiopathic scoliosis Previous brace treatment Immediate indication for surgery Previous thoracic surgery

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 15 Years

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

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 |
| --- | --- | --- |
| Photographs of the back and spine radiographs for making a corset | The torso shape reconstruction is realized thanks to the system Model Maker(Proteor®) on adolescent idiopathic patients. Model Maker allows to reconstruct the external shape of the human body from about 20 images steaming from a standard digital camera.The spine reconstruction is has for her obtained by means of a software interface, from tow standard clinical X-rays in the digital format (frontal and sagittal) and images were used by Model Maker for the external shape reconstruction. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recording of pressure from the brace | The recording of pressure from the brace is done through a web of pressure positioned in the brace. It is a structure teck scan (Expert-Seat, Ergoresearch Inc) containing polymeric pressure sensors. The pressure exerted by the brace on the trunk is registered in different positions (standing, lying). | 3 years |
Study to Evaluate Safety of Brimonidine/Timolol Fixed Combination in Glaucoma or Ocular Hypertension Patients

Study Overview
=================
Brief Summary
-----------------
This study evaluates the safety of brimonidine/timolol fixed combination in glaucoma or ocular hypertension patients

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution
* Drug: Concurrent brimonidine 0.2% and 0.5% timolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of ocular hypertension or glaucoma Patient requires IOP-lowering therapy in both eyes Exclusion Criteria: Uncontrolled medical conditions Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy

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: 1<br>Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution | Drug: Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution<br>* Brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution 1 drop instilled in each eye two times daily (morning and evening)<br>* Other names: COMBIGAN™;|
| Active Comparator: 2<br>Concurrent Brimonidine 0.2% and 0.5% Timolol | Drug: Concurrent brimonidine 0.2% and 0.5% timolol<br>* Brimonidine 0.2%, 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and timolol 0.5% timolol, 1 drop instilled in each eye twice daily (morning and evening) and vehicle of brimonidine combination ophthalmic solution 1 drop instilled in each eye (morning, afternoon and/or evening)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | Day 10 |