linjc16/ctgov huggingface dataset:
Evaluation of Plasma Alcohol Concentration in Patients Receiving Paclitaxel or Docetaxel

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate plasma alcohol concentration in patients receiving Paclitaxel or Docetaxel infusion.

Detailed Description
-----------------
In this study, there is no experimental treatment, or experimental care.

Official Title
-----------------
Prospective Evaluation of Plasma Alcohol Concentration in Patients Receiving Paclitaxel or Docetaxel Infusion

Conditions
-----------------
Tumors

Intervention / Treatment
-----------------
* Other: blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chemotherapy with docetaxel or paclitaxel on an every 3-week schedule. Patient with bitherapy are eligible only if the taxane is the first infusion. All type of tumor. Age>18 years old. Signed written informed consent. Exclusion Criteria: Patient under 18. Patient with bitherapy, if docetaxel or paclitaxel is not administered first. Patient deprived of liberty.

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: blood sampling|Other: Blood sampling 10mL of peripherical blood will be collected specially for the study. It's an additional blood sampling compare to the normal follow up of the patient.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of plasma alcohol | Measure of the plasma alcohol level before and after a taxane-based therapy (docetaxel or paclitaxel) | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients receiving docetaxel or paclitaxel. All tumors.
Noninvasive Assessment of Metabolic Associated Fatty Liver Disease (MAFLD) in Chinese Population

Study Overview
=================
Brief Summary
-----------------
Attenuation imaging (ATI) technology independently developed by Canon medical is a non-invasive examination technology for quantitative detection and analysis of liver steatosis. The technique is simple, rapid and quantitative diagnosis, and is suitable for screening and popularization of early liver steatosis in MAFLD. As noninvasive and effective detection measures of liver inflammation and liver fibrosis, SWD and SWE are more and more widely used in the quantitative diagnosis of liver inflammation and fibrosis. Therefore, ATI combined with SWD / SWE detection can quantitatively diagnose different pathological stages (steatosis, necrotizing inflammation and liver fibrosis) in the development of MAFLD, so as to provide an important basis for treatment.

Official Title
-----------------
Assessment of Metabolic Associated Fatty Liver Disease (MAFLD) in Chinese Population Using ATI / SWE / SWD: a Prospective Multicenter Study

Conditions
-----------------
Metabolic-dysfunction-associated Fatty Liver Disease (MAFLD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being a Chinese citizen aged 18 to 85 years; meeting the diagnostic criteria for MAFLD; willing and able to provide informed consent; having a platelet count of at least 50 × 109/L and prothrombin activity of ≥50%. Exclusion Criteria: The pregnant. Patients who have received or are undergoing systemic chemotherapy. Patients with hepatitis C, alcoholic liver disease (more than 5 years of drinking history, equivalent to alcohol volume ≥ 40g / D in male and ≥ 20g / D in female), drug-induced liver disease or autoimmune hepatitis. Those who re fuse to sign informed consent; There was a significant risk of bleeding (platelet < 50x109 / L, prothrombin activity < 50%).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Correlation between ATI / SWD / SWE parameters and the degree of steatosis, inflammation and fibrosis in MAFLD patients |  | from October 2020 to june 2022 |
ESOXC-ER Efficacy and Safety of an Extended Release (ER) Formulation of Oxcarbazepine (Apydan Extent) in Epileptic Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the observational study is to investigate the safety of oxcarbazepine extended release (ER) during long-term therapy in epileptic patients. In addition, quality of life parameters should be documented if assessed.

Official Title
-----------------
Efficacy and Safety of an ER-formulation of Oxcarbazepine (Apydan Extent) in Epileptic Patients Under Consideration of Quality of Life Parameters

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with focal epileptic seizures with or without secondary generalised tonic-clonic seizures mono- or combination therapy male and female from the age of 6 Exclusion Criteria: hypersensitivity to oxcarbazepine MR or one of its excipients

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- | --- |
| tolerability and safety |  | 12 months per patient | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
open, non-interventional
Clinical Outcome Of Hormonal Receptor Positive, Her-2 Negative Breast Cancer In Taiwan

Study Overview
=================
Brief Summary
-----------------
Breast cancer is the most common cancer in Taiwanese women. Most of them were diagnosed in relatively early stages. Only 700 metastatic breast cancer were registered in Official Cancer Registration 2012, while more than11,305 were registered as early breast cancer. With broadly application of aromatase inhibitors, hormonal-receptor-positive breast cancer patients can survive longer and longer. However, there is no prevalence of metastatic breast cancer can be available yet. NHIA database coverage is more than 90% population in Taiwan, thus it can be an appropriate surrogate of prevalence. In this retrospective database analysis, we will explore the real world experience on aromatase inhibitor use for breast cancer in Taiwan.

Official Title
-----------------
The Treatment For Recurrent Female Breast Cancer After Initial Endocrine Therapy Among Taiwanese Population

Conditions
-----------------
ER/PR(+), Her2(-) Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hormonal receptor positive, human epidermal growth factor receptor 2 negative breast cancer Exclusion Criteria: -
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 |
| --- | --- | --- |
| clinical use of aromatase inhibitors in breast cancer | duration of treatment | base line, up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence | The prevalence of metastatic breast cancer with positive hormonal receptors with routine practice in Taiwan. | base line up to 60 months | 
| dose exposure | The dosage pattern of breast cancer with positive hormonal receptors with routine practice in Taiwan. | base line, up to 60 months | 
| overall survival | The overall survival of metastatic breast cancer with positive hormonal receptors with routine practice in Taiwan. | base line, up to 60 months | 
| treatment cost | The treatment cost of metastatic breast cancer with positive hormonal receptors with routine practice in Taiwan. | base line, up to 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hormonal receptor positive, human epidermal growth factor receptor 2 negative, breast cancer, aromatse inhibitor, overall survival, prevalence
A Study Of The Effect Of PF-04802540 On Sleep Measures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if PF-04802540 decreases REM sleep.

Official Title
-----------------
Subject- And Investigator-Blinded, Sponsor-Open, Randomized, Single-Dose, Placebo-Controlled, 3-Way Crossover Study To Study Effects Of PF-04802540 On Polysomnography Endpoints In Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: PF-04802540
* Drug: PF-04802540
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female (nonchildbearing potential) subjects between the ages of 18 and 55 years, inclusive Body Mass Index (BMI) between 18 to 32 kg/m2, inclusive, and a total body weight >45 kg (99 lbs) Non-users of nicotine Exclusion Criteria: Evidence or history of clinically significant medical illness A history of seizures, including childhood febrile seizures Any condition possibly affecting drug absorption

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: PF-04802540<br>* 5 mg capsule, single dose<br>|
| Experimental: B<br> | Drug: PF-04802540<br>* 15 mg capsule, single dose<br>|
| Placebo Comparator: C<br> | Drug: Placebo<br>* Placebo capsule, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| REM sleep percentage |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| REM sleep latency |  | 1 day | 
| Beta EEG power |  | 1 day | 
| Plasma concentrations of PF-04802540 and its metabolite, PF-04831035 |  | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PF-04802540, polysomnography, REM, cross over
Airway Inflammation In Patients With Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
This study was designed to look at effects of salmeterol/fluticasone propionate compared to placebo on airway inflammation in patients with chronic obstructive airways disease

Official Title
-----------------
A 13-week, Double-blind, Parallel Group, Multi-centre Study to Compare the Bronchial Anti-inflammatory Activity of the Combination of Salmeterol/Fluticasone Propionate 50/500mcg Twice Daily Compared With Placebo Twice Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Salmeterol/fluticasone propionate 50/500mcg Diskus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Established clinical history of chronic obstructive airways disease. Must be current or ex-smokers with a smoking history of at least 10 pack-years (e.g. 20 cigarettes/day for 10 years or 10 cigarettes/day for 20 years). Must have reduced lung function, defined as a Forced Expiratory Volume in 1 second (FEV1) of between 40-80% of predicted normal values. Exclusion Criteria: Diagnosis of any other serious disease and must have a chest X-ray to eliminate a diagnosis other than COPD.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Salmeterol/fluticasone propionate 50/500mcg Diskus|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the number of CD68+ and CD8+ inflammatory cells per area of biopsy tissue and the percentage and total number of neutrophils in induced sputum between salmeterol/fluticasone propionate and placebo |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the number of mast cells, CD45+,CD4+,IFN-gamma mRNA+,TNF-alpha mRNA+, per area of biopsy and the percentage and number of macrophages, eosinophils, lymphocytes in induced sputum between salmeterol/fluticasone propionate and placebo |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Airways, Pulmonary, Obstructive, Chronic, inflammation, salmeterol/fluticasone propionate
The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression

Study Overview
=================
Brief Summary
-----------------
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression

Detailed Description
-----------------
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression - a dose-ranging study

Official Title
-----------------
The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression

Conditions
-----------------
Treatment Resistant Depression

Intervention / Treatment
-----------------
* Drug: Psilocybin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of TRD Exclusion Criteria: Other comorbidities

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose<br>Low dose Psilocybin | Drug: Psilocybin<br>* Dose-finding<br>|
| Experimental: Medium dose<br>Medium dose Psilocybin | Drug: Psilocybin<br>* Dose-finding<br>|
| Experimental: High dose<br>High dose Psilocybin | Drug: Psilocybin<br>* Dose-finding<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3 | MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response >= 50% decrease and remission <= 10 total score. | Change from Baseline to Week 3 | 
| MADRS Change From Baseline to Week 3, Sensitivity Analysis | MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response >= 50% decrease and remission <= 10 total score. | Change from Baseline to Week 3 |
Contrast Nephropathy in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
To study the effect of radiocontrast material on kidney functions in diabetics with microalbuminuria

Detailed Description
-----------------
Study design: This study will be an observational prospective cohort study. Study population: Diabetics undergoing any intervention using radiocontrast material for any medical indication in Fayoum universiy hospital will be selected. There will be two arms of the study,each arm will contain 20 patients first arm diabetics on linagelptin, second arm diabetics on other DPP4 inhibitors. Data collection: Patients will be subjected to; full clinical examination,waist hip ratio assessment,BMI assessment fasting blood glucose,Serum uric acid, urine ACR, eGFR will be done before and after the investigation.

Official Title
-----------------
Prevalence of Contrast Nephropathy in Type 2 Diabetes Patients With Microalbuminuria

Conditions
-----------------
Kidney Function Affection Upon Exposure to Radiocontrast, Diabetes, Microalbuminuria

Intervention / Treatment
-----------------
* Drug: Linagliptin Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetics on DPP 4 inhibitor treatment Exclusion Criteria: Diabetics on insulin

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| diabetics on linagelptin<br>Diabetic patients were given linagelptin for blood glucose control | Drug: Linagliptin Oral Tablet<br>* Linagliptin for blood glucose control<br>|
| diabetics on other DPP4 inhibitors<br>Diabetic pateints were given other DPP4 inhibitors eg: vlidagliptin for blood glucose control | Drug: Linagliptin Oral Tablet<br>* Linagliptin for blood glucose control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| affection of estimated glomerular filtration rate | A significant decrease in estimated glomerular filtration rate (eGFR) | Two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in serum uric acid | A significant rise in serum uric acid | Two months |
Auricular Acupuncture for Analgesia During Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The aim is to investigate whether auricular acupuncture is superior to sham acupuncture in relief of acute pain and in reduction of analgesics in patients during total hip arthroplasty

Official Title
-----------------
Auricular Acupuncture (AA) vs. Sham Acupuncture for Complementary Analgesia During Elective Total Hip Arthroplasty: a Randomized Controlled Trial

Conditions
-----------------
Acute Pain, Total Hip Arthroplasty

Intervention / Treatment
-----------------
* Procedure: Auricular acupuncture (procedure)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with an American Society of Anesthesiologists physical status of I to III scheduled for elective hip arthroplasty because of degenerative osteoarthritis under general anesthesia. Surgery time does not exceed 100 minutes. Patients without previous opioid medication. Patients ranged 45-85 years old. Patients who have given informed consent. Exclusion Criteria: Pregnant or nursing females. Recidivist alcoholics. Local or systemic infection. Age < 45 and > 85 years. Surgery time more than 100 minutes. Intraoperative complications (bleeding, required blood transfusion more than 4 units of packed cells , cardiovascular instability, required catecholamines). Patients consumed opioid medication before surgery. Patients with prosthetic or damaged cardiac valves. Patients who are unable to understand the consent form. History of psychiatric disease.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 85 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

| Intervention/Treatment |
| --- |
|Procedure: Auricular acupuncture (procedure)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative analgesics requirement |  |  |
Degenerative Cervical Myelopathy Repository

Study Overview
=================
Brief Summary
-----------------
To create a research repository of patients with known degenerative cervical myelopathy (DCM) and a control cohort of subjects who have non-myelopathic spinal disease. This repository will be used to assess functional and/or biological measures that may allow for improved prediction of symptomatic progression and response to treatment in patients with DCM. In addition, this repository will be used to develop a risk assessment scale to accurately predict functional outcomes following operative management of DCM.

Official Title
-----------------
Development of a Predictive Outcome Model for Patients With Degenerative Cervical Myelopathy Using Objective Functional and Biological Measures.

Conditions
-----------------
Cervical Myelopathy

Intervention / Treatment
-----------------
* Other: Standard clinical care procedures and outcome measurements.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of degenerative cervical myelopathy Diagnosis of cervical degenerative disease without myelopathy Exclusion Criteria: None outside or diagnostic requirements and age limits.

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 |
| --- | --- |
| DCM group<br>Subjects diagnosed with degenerative cervical myelopathy. | Other: Standard clinical care procedures and outcome measurements.<br>* Standard of care surgical interventions, imaging impressions, laboratory results, and outcome measurements will be collected and analyzed.<br>|
| Control group<br>Subjects diagnosed with cervical spinal disease without myelopathic symptoms. | Other: Standard clinical care procedures and outcome measurements.<br>* Standard of care surgical interventions, imaging impressions, laboratory results, and outcome measurements will be collected and analyzed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data comparison between DCM and control groups | This study is to determine biomarkers associated with DCM and analyze objective clinical measures to determine more predictable and potentially effective treatments for patients diagnosed with cervical myelopathy. | 2 years |