linjc16/ctgov huggingface dataset:
Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the PK properties in fed and fasted men and women.

Official Title
-----------------
An Open Label, Single Dose, Cross-over Study to Assess the Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: Lorcaserin 10mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females aged between 18 and 65 years (inclusive) Able to give signed informed consent BMI 27-45 kg/m2, inclusive Eligible male and female subjects must agree not to participate in a conception process. Considered to be in stable health in the opinion of the Investigator. Exclusion Criteria: Prior participation in any study of lorcaserin. Clinically significant new illness in the 1 month before screening Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol History of any of the following cardiovascular conditions: Myocardial infarction (diagnosed by cardiac enzyme[s] and/or diagnostic ECG), CVA, TIA or RIND within 6 months of screening; Cardiac arrhythmia requiring medical or surgical treatment within 6 months of screening Unstable angina History of pulmonary artery hypertension Positive result of HIV, hepatitis B or hepatitis C screens Malignancy within 2 years of the screening visit (except basal cell or squamous cell carcinoma with clean surgical margins) Initiation of a new prescription medication within 1 month prior to screening. Recent history (within 2 years prior to the screening visit) of alcohol or drug/solvent abuse or a positive screen for drugs of abuse at screening. Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening Use of SSRIs,SNRIs, and other medications must meet the washout period.

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

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lorcaserin 10mg<br> | Drug: Lorcaserin 10mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetic properties of a single oral dose of lorcaserin in the fed versus fasted state |  |  |
Examining Parkinson's Disease-Related Retirement: Results of Turkey

Study Overview
=================
Brief Summary
-----------------
Although Parkinson Disease's (PD) is usually associated with an older patient population, 5% of patients are diagnosed at age 50 and 30% before 65 years of age. This shows that many patients with PD have diagnosed during the active study and have long periods of normal retirement. After the diagnosis of Parkinson's patients, the duration of leaving of employment vary between 0 and 25 years. It was found that patients' full-time working capacity decreased by up to 80% and they quitted earlier than the general population. The disability associated with PD is thought to be a factor in this situation. Nevertheless, the reasons for early retirement are not fully known and more information is needed on the specific problems of PD in order for patients to continue their career. The aim of our study is to examine the impact of Parkinson's disease on retirement and to contribute to Turkey's data. Patients with PD admitted to the Parkinson's disease outpatient clinic, which is the biggest clinic of Turkey about neurology, are included in the study. It is planned to meet with 75 patients on 31/12/2018 and to reach the end of the data collection phase.

Official Title
-----------------
Examining Parkinson's Disease-Related Retirement: Results of Turkey

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be between 30-85 aged Parkinson Disease diagnosis according to the United Kingdom Brain Bank criteria To be treated with antiparkinson Exclusion Criteria: Dementia Severe cognitive impairment Not willing to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Qualitative interview | The researcher conducted interviews to find out about things that could not be directly observed. Interviews have been done face to face and used to collect personal experiences about Parkinson Disease and work life. | The researcher interviewed for about half an hour at once time with each participant. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson Disease, Early Retirement,
Is Involucrin Has a Role in Verruca Vulgaris? A Clinical and Immunohistochemical Study

Study Overview
=================
Brief Summary
-----------------
Vitamin D3 plays important role in keratinocyte differentiation and had been used recently in verruca vulgaris. Aim of the work: To assess the expression of involucrin in verrucae vulgaris before and after injection of vitamin D3. Subjects and Methods: This study included 60 patients with verrucae vulgaris subjected to intralesional injection of vitamin D3 at three weeks interval for a maximum of five sessions. Immunohistochemical assessment of involucrin was done before and after injection and compared to skin biopsies from 30 healthy individuals

Official Title
-----------------
Is Involucrin Has a Role in Verruca Vulgaris? A Clinical and Immunohistochemical Study

Conditions
-----------------
Verruca Vulgaris, Involucrin

Intervention / Treatment
-----------------
* Drug: Cholecalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with multiple verruca vulgaris Patients with with verrucae vulgaris with size more than 3 cm Exclusion Criteria: Patients with a past history of allergic response to vitamin D. Pregnant or lactating females. Hepatic patients. Renal patients. Patients with bleeding tendency.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cholecalciferol injection<br> | Drug: Cholecalciferol<br>* Cholecalciferol injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of verrucae | Decrease of verrucae size Decrease of verrucae number | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Involucrin expression | Change of expression pattern of involucrin by immunohistochemical study Change of expression grade of involucrin by immunohistochemical study | 3 months |
Changes in iOS in IPF

Study Overview
=================
Brief Summary
-----------------
Idiopathic pulmonary fibrosis (IPF) is a condition where scar tissue (called fibrosis) builds up in the lungs. It usually gets worse over time. Fibrosis causes the lungs to become stiff, and reduces the amount of oxygen that the lungs can take up. People with IPF complain of worsening breathlessness, which limits their day to day activities. Lung function tests are breathing tests that measure how well your lungs are working, and are used by doctors to decide whether to start or stop medicines in people with IPF. However, people with IPF tell us that lung function tests require a lot of effort, can make them cough and feel very short of breath. About 1 in 5 people with IPF are unable to perform lung function results accurately. This might unfairly lead to some people with IPF not receiving the right medications or for their medications to be stopped too soon. Impulse oscillometry (iOS) uses sound waves to measure the stiffness of the lung, and has been used successfully in children who are unable to perform normal lung function tests. The overall aim of the research is to see whether changes in iOS measures can give useful information about the lungs in patients with IPF; for example, by judging the overall impact of the disease on the lungs, or predicting future deterioration. We will look at how iOS changes over time in patients with IPF, and to see whether these measurements can tell us about whether IPF is getting worse or predict important health events, such as hospital admission. We will compare change in iOS with changes in other tests used to monitor IPF and with patient reported ratings of change in their condition. This will help decide the amount of iOS change that is noticed and considered meaningful by people with IPF.

Official Title
-----------------
Changes in Impulse Oscillometry Measurements and Outcomes in Idiopathic Pulmonary Fibrosis

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of idiopathic pulmonary fibrosis made by specialist multidisciplinary team according to international standards Able to provide written informed consent Exclusion Criteria: Contraindication to performing conventional lung function tests, e.g untreated TB, haemoptysis, pneumothorax, unstable cardiovascular status, recent eye, thoracic or abdominal surgery, thoracic, abdominal or cerebral aneurysm, acute illness (including diarrhoea and vomiting). Unable to create seal on mouthpiece

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oscillometry measurements of reactance |  | 12 months |
European Study of POBA Versus Cotavance(R) Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia (EURO CANAL)

Study Overview
=================
Brief Summary
-----------------
To evaluate the procedural safety and to identify and characterize therapeutic and functional endpoint assessments in subjects with documented critical limb ischemia who received treatment with the Cotavance Paclitaxel-Coated Balloon vs. those who received POBA only.

Official Title
-----------------
European Study of POBA Versus Cotavance Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia

Conditions
-----------------
PAD

Intervention / Treatment
-----------------
* Device: Cotavance Paclitaxel Coated Balloon
* Device: Standard balloon angioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Subjects with CLI Exclusion Criteria: Participation in another research trial Medical conditions the study doctor will assess

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cotavance<br> | Device: Cotavance Paclitaxel Coated Balloon<br>* DEB<br>|
| Active Comparator: Standard balloon angioplasty<br>POBA | Device: Standard balloon angioplasty<br>* POBA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate procedural safety |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify and characterize therapeutic and functional endpoint assessments |  | 5 years |
Preoperative Anxiety's Incidence and Related Factors in Surgical Patients

Study Overview
=================
Brief Summary
-----------------
Preoperative anxiety is often described as an uncomfortable, tense unpleasant mood before surgery, an emotional response to a potential challenge or threat to reality. Data show that adult patients with preoperative anxiety rate of 30-40%. The main reason for the occurrence of patients for surgery, anesthesia and other factors of fear. Preoperative anxiety itself is not a mental illness, but studies have confirmed that the occurrence of preoperative anxiety and postoperative complications were positively correlated, and the existence of preoperative anxiety in patients with conventional postoperative analgesic effect is poor. At present, there are still few studies on the relationship between preoperative anxiety and postoperative complications and analgesia. At the same time, there is a lack of large sample size to study the incidence of preoperative anxiety and its related predictors.

Detailed Description
-----------------
Surgical patients often have varying degrees of preoperative anxiety.The aim of this study was to determine the incidence of preoperative anxiety and related predictors, and to evaluate the effect of anxiety on anesthesia and postoperative pain and prognosis. The study also showed that prostaglandin, catecholamines, cortex Effects of alcohol and inflammatory cell level on postoperative pain in patients with preoperative anxiety.

Official Title
-----------------
Preoperative Anxiety's Incidence and Related Factors in Surgical Patients

Conditions
-----------------
Elective Surgery, Intravenous Anesthesia, Preoperative Anxiety

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-70 years old Sign that informed consent is willing to participate in the study Education: primary school and above 1 days after elective general anesthesia surgery ASA score grade I-III Exclusion Criteria: Emergency surgery Severe mental illness patients (such as anxiety, depression, schizophrenia, etc.) Taking anti-anxiety or antidepressants (benzodiazepines, tricyclic antidepressants, selective serotonin inhibitors, monoamine oxidase inhibitors, etc.)

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety level | as measured by STAI (state-trait anxiety questionnaire) | All patients are evaluated one day before surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain score | as measured by visual smileys scale | at 3 hours, 6 hours, 24 hours, 48 hours after surgery |
ELVR in PH Patients With Severe Emphysema

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of endoscopic valve implantation in patients with COPD and PH on hemodynamics, symptoms, exercise tolerance and quality of life in 10 patients in a prospective study. An improvement of objective parameters may also have a prognostic significance

Detailed Description
-----------------
So far there is no treatment of COPD in addition to the established treatment of concomitant PH. Administration of PH-specific medication outside of clinical trials is not recommended in new guidelines for PH of the ERS/ESC. The influence of endobronchial valve implantation on the PH has not been studied in detail. The purpose of this study is to investigate the effect of endoscopic valve implantation in patients with COPD and PH on hemodynamics, symptoms, exercise tolerance and quality of life in 10 patients in a prospective study. An improvement of objective parameters may also have a prognostic significance

Official Title
-----------------
Effect of Endoscopic Lung Volume Reduction (ELVR) on Pulmonary Hypertension (PH) in Patients With Severe Emphysema and Pulmonary Hypertension

Conditions
-----------------
COPD, Pulmonary Emphysema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed patient consent form men and women >30 years Clinically indicated endoscopic lung volume reduction Pulmonary hypertension according to Group 3.1 of the Dana Point classification Severe pulmonary emphysema FEV1 <45% RV> 150% TLC> 100% Maximum of medical therapy according to GOLD heterogeneous emphysema Detected in the HR-CT Confirmation of the heterogeneity of emphysema by computer-assisted quantification (YACTA ®) stable COPD No exacerbation in the last 8 weeks Cortisone dose <20 mg prednisolone equivalent Non-or ex-smoker Nicotine abstinence> 4 months Actual CoHb <2.5% Diagnosis of pulmonary hypertension (PH), invasively diagnosed by right heart catheterization: Mean pulmonary arterial pressure (mPAP)> 25 mmHg Pulmonary capillary wedge pressure (PCWP) <15 mmHg Pulmonary vascular resistance (PVR)> 320 dyne * sec * cm-5 Exclusion Criteria: PH of Group 1, 2, 4, 5 of the Dana Point Classification Previous operations s/p Lung resection (lobectomy / pneumonectomy) s/p endoscopic lung volume resection significant bronchiectasis Sputum volume> 4 tablespoons / day Severe cardiac comorbidities: s/p myocardial infarction in the last 6 weeks Congestive heart failure Cardiomyopathy with highly impaired LVF Clopidogrel in long-term medication Respiratory insufficiency: PaCO2 mmHg at rest> 55 current pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- | --- |
Genetic Studies in Liver Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Hepatocellular carcinoma (HCC) is one the most common malignancies in the world, especially in sub-Saharan Africa and Southeast Asia. Since 1984, it has been the leading cause of cancer death in Taiwan. About 6000-8000 people died of this cancer every year in Taiwan. DNA microarray (DNA chip) is a very powerful tool to clarify the genetic changes in cancers. Expression profiling techniques have been used to simultaneously monitor the expression of thousands of genes from human tumor samples. It has been successfully used to predict clinical outcome and survival as well as classify different types of cancer. In this study, we will use the DNA chip to study the genetics in liver cancer patients.

Detailed Description
-----------------
The clinical samples will be collected in the NTUH, while the DNA microarray works will be done in Biomedical Engineering Center (BMEC) of ITRI. Patients A total of 40 cases of HCC patients (20 HBV-related HCC and 20 HCV-related HCC) who received surgical resection in National Taiwan University Hospital will be enrolled from our tissue banks. The diagnosis of HCC was confirmed by pathological examination. The surgical specimens were frozen immediately after surgery and stored in -140°C. The clinicopathological data will be retrospectively obtained from chart reviews. Another total of 40 new HCC patients who receive surgical resection in National Taiwan University Hospital will be collected. The healthy subjects and patients chronically infected with HBV or HCV without HCC will be used as controls. The whole bloods will be collected before, one and six months after operation. The diagnosis of HCC will be confirmed by pathology. In addition to the whole bloods, the surgical specimens will be frozen immediately after surgery and stored in -140°C.

Official Title
-----------------
Identification of Differentially Expressed Genes in Hepatocellular Carcinoma With DNA Microarrays

Conditions
-----------------
Hepatocellular Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hepatocellular carcinoma Exclusion Criteria: multiple cancers

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |