linjc16/ctgov huggingface dataset:
The Potential Biochemical Diagnosis Criteria and Therapeutic Effect Indexes: Sex Hormone Binding Globulin Levels and Free Androgen Index in Blood of Patients With Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
To explore whether Free androgen index（FAI）can be regarded as biochemically diagnostic indexes of high androgen hormone in blood of patients with Polycentric ovary syndrome（PCOS）. Also to explore whether Sex hormone-binding globulin（SHBG） and FAI can be seen as therapeutic effect indicatrixes of women with PCOS.

Conditions
-----------------
The Investigators Collected 534 PCOS Patients as the Case Group,and 580 Infertile Women With Normal Ovulatory Cycle of the Control Group;, At the Same Time, the Investigators Continuedly Collect Cases to October 2012, and Totally Collected 579 Patients With PCOS Altogether;, 534 Patients in the Cases Group and 580 Women in the Control Group Received no Measures, While 579 Patients Received Drugs;, The Investigators Monitored Basic Indexes in Blood of All the Subjects in This Suvey,and Also Monitored Indexes of 579 Patients After Treatment.

Intervention / Treatment
-----------------
* Drug: Diane-35;metformin;Clomiphene citrate; Human menopausal gonadotropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The clinical diagnosis criteria for PCOS by European Society of Human Reproduction and Embryology, and Rotterdam working group of American Society for Reproductive Medicine (ESHRE /ASRM ) Exclusion Criteria: hyperprolactinemia and other endocrine diseases such as high androgen hormone in blood, namely Cushing's syndrome, congenital adrenal hyperplasia ( CAH ), ovarian or adrenal tumor and so on

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 43 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 |
| --- | --- |
| the case group<br> | |
| the control group<br> | |
| the treatment group<br>Patients of the treatment group recieved drugs,then we observed drugs' treatment effect. | Drug: Diane-35;metformin;Clomiphene citrate; Human menopausal gonadotropin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The potentially biochemical diagnosis criteria and therapeutic effect evaluation indexes: Sex hormone binding globulin levels and free androgen index in blood of patients with polycystic ovary syndrome |  | after 5 weeks of ovulation treatment |
Medium Calorie Parenteral Nutrition on Patients With Gastrointestinal Cancer Undergoing Surgery

Study Overview
=================
Brief Summary
-----------------
aimed at investigating the efficacy, safety, and clinical outcome of Medium-Calorie or standard-calorie total parenteral nutrition (TPN) for patients with gastrointestinal cancer undergoing surgery

Detailed Description
-----------------
biochemistry data Various inflammation-related cytokines clinical outcome hospital stay

Official Title
-----------------
Assessment the Effect of Medium-Calorie TPN on Patients With Gastrointestinal Cancer Undergoing Surgery

Conditions
-----------------
Colorectal Neoplasms

Intervention / Treatment
-----------------
* Dietary Supplement: Total Parenteral Nutrition (TPN)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients considered for major surgery for colorectal cancer Expected requirement for post operative PN or TPN of at least for 7 days Age >18 Hemodynamically stable Written Informed Consent Exclusion Criteria: Hemodynamic failure of any organ Renal insufficiency Patients with severe liver dysfunction Albumin < 3g/dL DM with poor blood sugar control

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medium calorie<br> | Dietary Supplement: Total Parenteral Nutrition (TPN)<br>* Medium calorie ,Nonprotein calories 20 Kcal/Kg/day,Protein 1g/Kg,Fat emulsion 0.5 g/kg/day D1-D6 post OP standard calorie, Nonprotein calories 30 Kcal/Kg/day,Protein 1.5 g/Kg,Fat emulsion 50g/day D1-D6 post OP<br>|
| Experimental: standard calorie<br> | Dietary Supplement: Total Parenteral Nutrition (TPN)<br>* Medium calorie ,Nonprotein calories 20 Kcal/Kg/day,Protein 1g/Kg,Fat emulsion 0.5 g/kg/day D1-D6 post OP standard calorie, Nonprotein calories 30 Kcal/Kg/day,Protein 1.5 g/Kg,Fat emulsion 50g/day D1-D6 post OP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biochemistry data; Various inflammation-related cytokines ; |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical outcome(hospital stay..) |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
parenteral nutrition, medium-calorie, standard calorie
Evaluation of Corneal Endothelial Changes After Uneventful Phacoemulsification in Diabetic and Non-diabetic Patients in Relation to the Level of Glcosylated Hemoglobin Level

Study Overview
=================
Brief Summary
-----------------
Evaluation of corneal endothelial changes after uneventful phacoemulsification in diabetic and non-diabetic patients using specular biomicroscopy in relation to the level of glcosylated hemoglobin level

Detailed Description
-----------------
86 patients will be divided into two equal groups of diabetic and non-diabetic patients will undergo phacoemulsification of cataract will be evaluated thier endocelium before surgery and 3 weeks after surgery to detect the effect of level of glcosylated hemoglobin on the endothelial changes after uneventful phacoemulsification

Official Title
-----------------
Evaluation of Corneal Endothelial Changes After Uneventful Phacoemulsification in Diabetic and Non-diabetic Patients in Relation to the Level of Glcosylated Hemoglobin Level

Conditions
-----------------
Corneal Endothelial Changes After Phacoemulsification

Intervention / Treatment
-----------------
* Device: Specular biomicroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetics and non-diabetic patients undergo cataract surgery Age between 50-60 years old Corrected distance visual acuity<0.4 Gender: both genders. Exclusion Criteria: Chronic Ocular diseases (glaucoma,uveitis, amblyopia, strabismus,keratoconus, corneal opacity). corneal dystrophy History of previous keratitis or viral corneal infection. Corneal dystrophy Ocular trauma. Previous ocular surgery. Complicated cataract surgery

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diabetic patient<br>Patient with diabetes will undergo cataract surgery | Device: Specular biomicroscopy<br>* Specular microscopy will be done before and 3 weeks after cataract surgery<br>|
| Active Comparator: Non diabetic patients<br>Healthy non diabetic patients will undergo cataract surgery | Device: Specular biomicroscopy<br>* Specular microscopy will be done before and 3 weeks after cataract surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defferentiate patients into diabetic and non-diabetic patients according to the endothelial changes after uneventful phacoemulsification | Detect effect of glycosylated hemoglobin level after uneventful phacoemulsification in diabetic and non-diabetic patients | 6 monthes |
Diclofenac vs Dexamethasone in Combined Surgery

Study Overview
=================
Brief Summary
-----------------
To study the effect of Diclofenac drops or Dexamethasone drops on combined surgery of trabeculectomy and cataract surgery.

Official Title
-----------------
Evaluation the Effect of Diclofenac Drops vs Dexamethasone Drops in Trabeculectomy and Cataract Surgery

Conditions
-----------------
Glaucoma, Cataract

Intervention / Treatment
-----------------
* Drug: diclofenac drops
* Drug: dexamethasone sodium phosphate 0.1% eye drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for combines surgery of trabeculectomy and cataract surgery Exclusion Criteria: severe complicated surgery like vitreal loss, expulsive hemorrhage, endophthalmitis

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1diclofenac drops treatment<br>four times a day for 3 months | Drug: diclofenac drops<br>* one drop 4 times a day for 3 months<br>|
| Active Comparator: 2dexamethasone drops<br> | Drug: dexamethasone sodium phosphate 0.1% eye drops<br>* for first week after the operation : one drop 6 times a day. Then tapering by reducing one drop for a week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraocular pressure |  | year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of antiglaucoma medications |  | year |
Metoclopramide Use in Very Low Birth Weight Newborns

Study Overview
=================
Brief Summary
-----------------
During the first 7 days of life very small babies will receive the drug metoclopramide or a salt solution through an intravenous line. They will also begin to receive a very small amount of breast milk or formula within the first 72 hours of life, in addition toother nourishment that is provided by an intravenous line, according to standard hospital procedure. We think that the babies who receive the medication may reach full oral feeds than babies who receive the salt solution.

Detailed Description
-----------------
Clinically stable, premature babies (birth weight between 500 and 1,250g) will be randomized to receive metoclopramide (0.1 mg/kg IV q8h)or an equal volume of placebo for 7 days.A transition feeding schedule will begin within the first 72 hours of life. The time to full feeds for the 2 groups will be analyzed.

Official Title
-----------------
The Effect of Metoclopramide on Feeding in Very Low Birthweight Newborns : a Randomized, Double Blind, Placebo Controlled Pilot Study and a Proposal for a Multicentre Trial

Conditions
-----------------
Infant, Premature

Intervention / Treatment
-----------------
* Drug: Metoclopramide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: birth weight 500 to 1,250g clinically stable no contraindications to initiating minimal enteral feeding Exclusion Criteria: birth weight > 1,250g clinically unstable any major congenital anomaly significant GI pathology severe IUGR cholestasis

Ages Eligible for Study
-----------------
Minimum Age: 72 Hours
Maximum Age: 7 Days

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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days required to attainment of full feeds. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight at full enteral feeds (g). |  |  | 
| Weight at discharge (g). |  |  | 
| Duration of TPN (days). |  |  | 
| Length of stay(days). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metoclopramide, feeding, very low birthweightnewborn
Stopping Cardiovascular Treatments and Mortality in a MICU

Study Overview
=================
Brief Summary
-----------------
Cardiovascular treatments should not be interrupted following hospital admission, in order to decrease patients' morbidity. However, following ICU admission, such treatments are frequently interrupted and/or modified. The question of the study is to investigate wether such treatment interruption might be responsible for prognosis modifications.

Detailed Description
-----------------
Cardiovascular treatments should not be interrupted following hospital admission, in order to decrease patients' morbidity. However, following ICU admission, such treatments are frequently interrupted and/or modified. Few studies have investigated the outcome impact of medications interruption and/or modifications following hospital admission. We did consider that it might be interesting to study whether treatment continuation, interruption, and/or re-introduction following ICU admission may modify patients' outcome either in the ICU or following hospital discharge (at 3,6 and 12 months).

Official Title
-----------------
Impact on Mortality of Cardiovascular Treatments Interruption in a Medical Intensive Care Unit

Conditions
-----------------
Critical Care, Medication, Cardiovascular Diseases, Outcome, Fatal

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with cardiovascular treatment prior to ICU admission Exclusion Criteria: Data unavailability Consent withdrawal following information

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observation|No intervention will be performed|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU Mortality | Patients mortality will be assessed at the end of the ICU stay (two months) | 2 months following ICU Discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital mortality | Patients mortality will be assessed at the end of the hospitalisation stay (two months) | 2 months following Hospital Discharge | 
| Mortality at Month 3 following discharge |  | 3-months following discharge | 
| Mortality at Month 6 following discharge |  | 6-months following discharge | 
| Mortality at Month 12 (1-year) following discharge |  | 12-months following discharge |
Efficacy of SEROQUEL in Selective Serotonin Reuptake Inhibitors (SSRI)-Resistant Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
An open-label, non-comparative, multi-centre, phase II prospective trial to assess the efficacy of Quetiapine fumarate augmentation of selective serotonin reuptake inhibitors (SSRIs) in SSRI-resistant major depressive disorder.

Official Title
-----------------
An Open-Label, Non-Comparative, Multi-Centre, Phase II Prospective Trial to Assess the Efficacy of Quetiapine Fumarate Augmentation of Selective Serotonin Reuptake Inhibitors (SSRIs) in SSRI-Resistant Major Depressive Disorder.

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Quetiapine fumarate (Seroquel)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inform consent Male and female, age between 18 and 65 years. Naïve to any atypical antipsychotic A diagnosis of major depressive disorder Exclusion Criteria: No use of fluvoxamine Patients with a history of bipolar I or II disorder Diagnosis of psychotic major depression disorder

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

| Intervention/Treatment |
| --- |
|Drug: Quetiapine fumarate (Seroquel)|300 mg, PO, 100 mg morning, 200 mg evening, 4 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Montgomery-Asberg Depression Scale (MADRS) score |  | Visit 1 - > 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Brief psychiatric Rating Scale (BPRS) scoreThe Clinical Global impression (CGI) scorePatient reported outcomes (PROs) |  | Visit 1 - > 5 (1 week between each visit) | 
| Sheehan Disability Scale (SDS) score |  | Visit 1 - > 5 (1 week between each visit) | 
| The Symptom Checklist 90 Revisred (SCL-90-R) score |  | Visit 1 - > 5 (1 week between each visit) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
considered, entry, into, the study, SSRI, Seroquel, Quetiapine, fumarate, antipsychotic
Computed Tomography Coronary Angiography (CTCA) and Coronary Flow in Stenosis Analysis

Study Overview
=================
Brief Summary
-----------------
The investigators' rationale was to evaluate whether a 64-slice CT scanner allows accurate measurement of computed tomographic changes in coronary artery flow profiles and whether CT flow measurements are suitable for classifying the significance and hemodynamic relevance of a stenosis and thereby supplement as a functional parameter for morphological stenosis analysis.

Detailed Description
-----------------
A total of 50 patients prospectively underwent computed tomography coronary angiography (CTCA) in a multidetector CT scanner (Brilliance 64, Philips) ± 1 day before or after invasive coronary angiography (ICA). Immediately thereafter, 2 radiologists reviewed the imaging data to detect any vessel segments with morphology poorly evaluable by CTCA. A locally constant cyclical measurement was acquired in these coronary arteries in breath-hold technique during the passage of a 50ml bolus of contrast media. For analysis, time-density curves of the bolus passage were registered in the coronary artery and the aorta (internal reference), the up-slopes were determined and correlated with each other. The results were compared with the ICA findings.

Official Title
-----------------
CT Coronary Angiography: Coronary Flow Quantification Supplements Morphological Stenosis Analysis

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically known or presumed CAD Age > 50 years Hospitalization for invasive coronary angiography Sinus rhythm Written informed consent by the patient to participate in the study after comprehensive presentation of the facts Exclusion Criteria: Age <= 50 years Contraindications to contrast media administration (medical history of iodine allergy, nephropathy, latent or manifest hyperthyroidism) Arrhythmias Dyspnea at rest, acute unstable angina pectoris, acute myocardial infarction Pregnancy Implanted pacemaker Unwillingness of patient to consent to the study

Ages Eligible for Study
-----------------
Minimum Age: 51 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery, stenosis
Neuromuscular Ultrasound in ALS

Study Overview
=================
Brief Summary
-----------------
Amyotrophic Lateral Sclerosis (ALS) is a progressive fatal neurodegenerative disease affecting motor neurons. Early diagnosis is essential for the success of clinical trials and objective biomarkers are needed for monitoring disease progression. Nerve and muscle ultrasound may provide this information. This study will collect pilot data to evaluate the value of muscle and nerve ultrasound to identify and monitor disease progression in ALS.

Official Title
-----------------
Ultrasonography in Amyotrophic Lateral Sclerosis as a Predictor of Disease Progression and Tool in Diagnosis: a Pilot Study

Conditions
-----------------
ALS

Intervention / Treatment
-----------------
* Other: Ultrasound of nerve and muscle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects referred to the electromyography laboratory for ALS. Exclusion Criteria: Patients with known comorbid myopathy or neuropathy will be excluded from the study. Patients unable to provide their own consent will be excluded.

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 |
| --- | --- |
| Control Group<br>No intervention to be performed. | |
| Ultrasound Group<br>All will receive nerve and muscle ultrasound. | Other: Ultrasound of nerve and muscle<br>* Ultrasound of 6 muscles and 2 nerves will be performed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormalities at onset: Ultrasound vs. Electromyography | Ultrasound measures will be compared to electromyography measures at the patient's initial assessment. The number of abnormal muscles will be counted using each technique and analyzed to determine if one test is superior. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound Predicting Outcome at 1 year | The initial ultrasound measures and patient outcomes, as measured by standard validated scales, will be assessed at periodic intervals for one year. Analysis will be performed to determine if ultrasound measures can predict the clinical course. | 1.5 years |