linjc16/ctgov huggingface dataset:
Bone Density in Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
People with chronic mental disorder such as schizophrenia and alcohol abuse are high risk groups for developing osteoporosis. To evaluate the prevalence of bone mineral density in men patients with schizophrenia with alcohol abuse, the investigators will compare bone mineral density between patient with schizophrenia with and without alcohol abuse.

Detailed Description
-----------------
People with schizophrenia has been known as a high risk groups for developing osteoporosis, because of lack of exercise, poor nutrition and high rate of smoking. Those with alcohol abuse may be higher risk group than one with schizophrenia without alcohol abuse, because they frequently have several medical problems such as liver dysfunction, Vitamin D deficiency, hyperparathyroidism and those medical condition increase risk for developing osteoporosis. Also alcohol itself can increase bone loss too by disturbing bone remodeling and enhancing bone fragility. To compare the prevalence of bone mineral density in patients with schizophrenia with alcohol abuse to those without alcohol problem, we will investigate BMD in large population of Korean patients with those illnesses.

Official Title
-----------------
Bone Mineral Density in the Korean Patients With Chronic Schizophrenia With Alcohol Abuse

Conditions
-----------------
Schizophrenia, Alcohol Abuse

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV diagnosis of schizophrenia Onset of illness more than 5 years. Exclusion Criteria: No severe Medical and endocrinological disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Schizophrenia<br>Chronic schizophrenia with aged 18-80 years | Other: No Intervention<br>* No Intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of bone mineral density |  | cross sectional and prospective | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effects of Smoking and antipsychotic drug on BMD |  | Cross sectional Study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Alcohol Abuse, Bone Density
ERCP Mechanical Simulator (EMS) Practice for Training Endoscopic Sphincterotomy

Study Overview
=================
Brief Summary
-----------------
This randomized-controlled study aims to evaluate the effectiveness of using ERCP mechanical simulator for training endoscopic sphincterotomy.

Detailed Description
-----------------
Usual clinical ERCP training is supervised hands-on practice and the number of procedures is used as a surrogate for trainees' experience. At least 180 cases are required to achieve ERCP competence. A major limitation is lack of suitable patients. Alternative supplemental training includes simulator practice using computer simulators, live animal models, and ex-vivo porcine organ. Our previous study has showed that the mechanical simulator training improves trainees' clinical performance in terms of success of deep CBD cannulation. In this study, we aim to evaluate the usefulness of ERCP mechanical simulator for training endoscopic sphincterotomy.

Official Title
-----------------
ERCP Mechanical Simulator (EMS) Practice for Training Endoscopic Sphincterotomy

Conditions
-----------------
Endoscopic Sphincterotomy

Intervention / Treatment
-----------------
* Other: Simulation and lecture
* Other: Lecture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GI trainees who met the minimum endoscopy training experience Exclusion Criteria: GI trainees with no endoscopy experience

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>Simulation and lecture | Other: Simulation and lecture<br>* Endoscopic sphincterotomy on simulator and lecture<br>|
| Active Comparator: control group<br>Lecture only | Other: Lecture<br>* Lecture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of endoscopic sphincterotomy successfully performed by trainees |  | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in overall performance as measured by sphincterotomy score |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopic Sphincterotomy
Tumor Metabolism of Head and Neck Cancer in Patients Who Underwent Radiation Therapy Measured With F-18-FDG-PET

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to describe the regional and global FDG-kinetics in head and neck cancer during percutaneous radiation therapy.

Conditions
-----------------
Head and Neck Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed head and neck cancer not curable by surgery Karnofsky > 70% Tumor volume and localization allow curative radiotherapy Written consent Exclusion Criteria: Metastases Earlier radiotherapy of head or neck Pregnancy Secondary malignancy excluding dermal carcinoma T1 and Tis-carcinoma of cervix uteri Psychiatric impairment

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?
-----------------
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
-----------------
Radiation therapy, F-18-FDG
Clinical Evaluation of a Test for Monitoring Patients Diagnosed With Chronic Myeloid Leukemia (CML)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to establish the performance of an assay that detects mRNA transcript levels in patients diagnosed with CML. The study is conducted at locations within the United States. Testing is performed on peripheral blood specimens provided by eligible enrolled patients. Results from this study will not be used for patient management decisions.

Official Title
-----------------
Clinical Evaluation of the Xpert BCR-ABL Ultra Assay on the GeneXpert Instrument Systems

Conditions
-----------------
Leukemia, Myelogenous, Chronic

Intervention / Treatment
-----------------
* Device: Xpert BCR-ABL Ultra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prospective specimens: Patient is at least 18 years of age Patient has provided documented informed consent as required by the reviewing IRB. Experimental Bill of Rights will also be documented for all subjects enrolled in applicable states. Patient has been diagnosed with CML. Patient consents to provide at least 12 mL of peripheral blood for study purposes frozen specimens: Specimen is from a subject diagnosed with CML Specimen meets the manufacturer's criteria to support testing by both diagnostic assays Exclusion Criteria: prospective specimens: Patient is considered to be of insufficient health to supply the required volume of peripheral blood by his/her health care provider Patient has been previously enrolled frozen specimens: • Specimen previously enrolled

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Enrollment<br>Initial enrollment of patients with history of CML | Device: Xpert BCR-ABL Ultra<br>* Semi-quantitation of BCR-ABL transcript in patients that have been previously diagnosed with CML<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Method comparison to an on-market molecular diagnostic assay | Comparison of Xpert to an on-market test for the quantitation of BCR-ABL | Baseline = testing upon enrollment |
Evaluation of Novel Lung Function Parameters in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
Current guideline-based criteria defining COPD do not meet the challenges set by the complex pathophysiology of the disease. The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and therapeutic monitoring of COPD.

Official Title
-----------------
Evaluation of Novel Lung Function Parameters in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
-----------------
COPD, Obstructive Ventilation Disorder, Pulmonary Emphysema

Intervention / Treatment
-----------------
* Device: impulse oscillometry
* Device: multiple breath washout test
* Device: body plethysmography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: known or suspected COPD known or suspected obstructive ventilation disorder pulmonary healthy controls Exclusion Criteria: pregnancy inability to participate

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 |
| --- | --- |
| COPD<br>Patients with known or suspected COPD Patients with known or suspected obstructive ventilation disorder | Device: impulse oscillometry<br> <br> Device: multiple breath washout test<br> <br> Device: body plethysmography<br> <br> |
| pulmonary healthy controls<br>Patients without known or suspected pulmonary disease | Device: impulse oscillometry<br> <br> Device: multiple breath washout test<br> <br> Device: body plethysmography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung clearance index (LCI) as determined by multiple breath washout |  | 30 minutes | 
| airway resistance and reactance (R5, X5, R-D5-20) as determined by impulse oscillometry |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| repeatability of lung clearance index (LCI) |  | 30 minutes |
Effects of Implementing a High Potassium Diet in Heart Failure Patients

Study Overview
=================
Brief Summary
-----------------
This study evaluates the safety and physiologic effects of increasing dietary potassium intake in individuals with heart failure.

Official Title
-----------------
Safety and Physiologic Effects of Implementing a High Potassium Diet in Heart Failure Patients

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: High potassium diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients classified as having HF, both systolic and diastolic. New York Heart Association class II-III symptoms. Treatment with an beta blocker, ACE inhibitor, or angiotensin receptor blocker without any adjustment over the previous month Intake at baseline of ≤ 3 servings of fruits and vegetables per day. Servings defined by Health Canada's food guide. Exclusion Criteria: Patients with an episode of decompensated heart failure, acute coronary syndrome, or revascularization within the previous 3 months of study inclusion. Patients receiving insulin therapy Glomerular filtration rate < 40mL/min/1.73 m2 Pregnancy and lactation (women of childbearing potential will be included but will have to have a negative pregnancy test prior to inclusion). Inability to provide informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High potassium diet group<br>Individuals in this arm were asked to increase dietary potassium intake over a 4 week period. This was achieved through an increase in consumption of fruits and vegetables. | Other: High potassium diet<br>* An increase in consumption of high potassium fruits and vegetables<br>|
| No Intervention: Usual diet group<br>Individuals in this group were asked to continue habitual dietary intake | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum potassium concentration |  | 10 days and 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Potassium, Nutrition
Special Survey on Parkinson's Disease Patients Treated Long-term Use of Pramipexole

Study Overview
=================
Brief Summary
-----------------
The survey is conducted to collect safety and effectiveness information on the use of Pramipexole for long time of period in daily clinical settings in Japan.

Official Title
-----------------
Pramipexole Special Survey on Long-Term Use

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Parkinson's disease Exclusion Criteria: Patients should have been treated according to the Japanese insert slip
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 |
| --- | --- | --- |
| Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events | The aim of this Post Marketing Surveillance (PMS) was to obtain long-term safety data with treatment of pramipexole in Parkinson's disease (PD) patients. Therefore these items were considered as a safety evaluation. | during 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Improvement | Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable). | 18 months | 
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score | Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement. | Baseline and at 18 months (or at the time of discontinuation) | 
| Change From Baseline in Modified Hoehn & Yahr Rating Scale | A severity of PD symptom are assessed by Modified Hoehn & Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst). | Baseline and at 18 months (or at the time of discontinuation) |
Danazol Treatment in Endometriosis Women Before IVF

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether pre-treatment with danazol for at least 4 months before controlled ovarian hyperstimulation for IVF cycles improves pregnancy rate.

Detailed Description
-----------------
Endometriosis is a chronic benign disease defined by the presence of endometrial tissue outside the uterine cavity, affecting women in their reproductive age. This disease is clinically characterized by infertility pelvic pain and the presence of ovarian cysts, endometriomas, and affects the about 10% of women. Women with endometriosis when undergo IVF show lower pregnancy rate than general population, and a reduced ovarian reserve, due to the diseases and often to ovarian surgery. The aim of this study is to evaluate if a pre-treatment with danazol, an anti-estrogenic agent, may improve the otcome of IVF cycles in these women

Official Title
-----------------
Treatment With Danazol Before Controlled Ovarian Hyperstimulation in Women With Endometriosis Undergoing IVF

Conditions
-----------------
Endometriosis, Ovarian Cysts, Infertility

Intervention / Treatment
-----------------
* Drug: Danazol
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Clinical diagnosis of endometriosis previous laparoscopic surgery for ovarian endometriotic cysts infertility Exclusion Criteria: - age more than 40 years systemic disease antimulleran hormone (AMH)<1 and FSH>20

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br>patients treated with placebo for at least 4 months before IVF attempt | Drug: placebo<br>* administered daily like the active comparator<br>|
| Active Comparator: danazol<br>patients treated with danazol (100mg/day)for at least 4 months before IVF attempt | Drug: Danazol<br>* 100 mg day for 4 monthh in women with diagnosed endometriosis before IVF<br>* Other names: Danatrol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate | number of ongoing pregnancy for the number of IVF cycles | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate | number of embryos implanted for the total number of embryos transferred | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometriosis, ivf, ovarian reserve, danazol
Prediction of Lymphatic Metastasis in Esophageal Cancer by CT Radiomics

Study Overview
=================
Brief Summary
-----------------
This study proposes to establish a CT radiomics-based prediction model for identifying metastasis lymph nodes in esophageal cancer.

Detailed Description
-----------------
This study proposes to establish an image feature extraction and selection method for identifying lymph node metastasis of esophageal cancer.The study will consider the relationship between the main lesion and the suspected lymph node, extract association characteristics in order to improve the sensitivity and specificity of the CT radiomics-based prediction model for identifying metastasis lymph nodes. The study includes the construction of CT radiomics-based prediction model and the validation of the prediction model.

Official Title
-----------------
Prediction of Lymphatic Metastasis in Esophageal Cancer by CT Radiomics

Conditions
-----------------
Esophagus Cancer

Intervention / Treatment
-----------------
* Procedure: preoperative enhanced chest CT examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathologically proven esophageal cancer scheduled to preoperative enhanced chest CT and undergo surgery sign the patient informed consent Exclusion Criteria: failed to receive preoperative enhanced chest CT or undergo surgery inavailable pathological results for local lymph node status inquality of CT images for feature extraction patient quit
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| preoperative enhanced chest CT<br>The cohort contains patients with preoperative therapies and patients without preoperative therapies. Each patient receives regular preoperative enhanced chest CT; for patients with preoperative therapies, they usually undergo twice enhanced chest CT examination at before and after preoperative therapies, the CT images after preoperative therapies will be used for analysis | Procedure: preoperative enhanced chest CT examination<br>* Each patient will receive preoperative enhanced chest CT examination, and their CT images will be used for analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological local lymph node status | pathological lymph node status is defined as lymph node metastasis exist or not | Pathologic evaluation will be performed for each patient within 1 week after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
esophagus cancer; radiomics; computed tomograpy