linjc16/ctgov huggingface dataset:
Association of Non-alcoholic Fatty Liver Disease and Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the association of non-alcoholic fatty liver disease and coronary artery disease. All patients presenting for coronary angiogram will receive the following examination: Transient Elastography and Controlled Attenuation Parameter using the FibroScan blood examination including biochemical markers The results of non-invasive liver steatosis and fibrosis measurement are compared with the results of coronary angiogram concerning the presence or absence of coronary artery disease.

Official Title
-----------------
Association of Non-alcoholic Fatty Liver Disease and Coronary Artery Disease

Conditions
-----------------
Nonalcoholic Steatohepatitis (NASH)

Intervention / Treatment
-----------------
* Device: Transient Elastography (FibroScan), Echosens, Paris, France
* Device: Controlled Attenuation Parameter (CAP), Echosens, Paris, France


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, 18 years and older Written consent Coronary angiogram planned Exclusion Criteria: Patients with mental diseases Pregnancy or lactation Ascites

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Transient Elastography (FibroScan), Echosens, Paris, France|nan|
|Device: Controlled Attenuation Parameter (CAP), Echosens, Paris, France|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver fibrosis scores I-IV (METAVIR) | METAVIR fibrosis scores: I = mild fibrosis II = significant fibrosis III = advanced fibrosis IV = cirrhosis |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steatosis fibrosis scores I-III | Steatosis scores: 0 = <5% I = 5-33% II = 33-66% III = >66% |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NASH; coronary artery disease
Evaluating the Impact of a Technologically-Enhanced Personal Coaching Program on Hemoglobin A1c in Type 2 Diabetics

Study Overview
=================
Brief Summary
-----------------
Participants diagnosed with Type 2 diabetes receive personal coaching from a Certified Diabetic Educator (CDE) over a six-month period. The coaching program is enhanced using an mobile application and care management platform.

Detailed Description
-----------------
Participants diagnosed with Type 2 diabetes receive personal coaching from a Certified Diabetic Educator (CDE) over a six-month period. The coaching program is enhanced by integrating a participant-facing mobile application with the coaching platform. Blood glucose test results automatically populate the coaching platform, providing the CDE with information that may better support their coaching efforts. The participants complete Diabetes Self Management Education (DSME) learning modules for the first 7-12 weeks. Following completion of the modules, the coach continues to provide support to the participant until 24 weeks after the participant's enrollment.

Official Title
-----------------
Evaluation of the Effects of a Technologically-Enhanced Personal Coaching Program on Hemoglobin A1c in Type 2 Diabetics

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Live diabetes coaching program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lives in the United States Speaks and understands English Has a Type 2 diabetes mellitus diagnosis Has a LifeScan Verio Flex blood glucose meter, which is connected to OneTouch Reveal ® app Has a verified A1c ≥ 8% Willing to participate in coaching program Exclusion Criteria: Uses a continuous glucose monitoring device Currently pregnant Unable to make lifestyle behavioral changes due to a cognitive or physical disability Has end stage renal disease (ESRD) diagnosis Is not able to read or understand English

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single-arm 24-week pre-post study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Live diabetes coaching program<br>Live diabetes coaching program | Behavioral: Live diabetes coaching program<br>* Live diabetes coaching program<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin A1c | Blood serum test to measure glucose control | A1c measured at baseline, at 12 weeks since study enrollment, and at 24 weeks since enrollment, which marks the participant's completion of the study |
Effects of 10 mg Monacolins on Vascular Health: a Clinical Trial

Study Overview
=================
Brief Summary
-----------------
This will be a double-blind randomized clinical trial carried out on subjects with suboptimal control of LDL-cholesterolemia, following a Mediterranean diet, and treated with a red yeast rice extract (containing 10 mg monacolin K per daily dose) or placebo, in order to evaluate the middle-term effects on vascular health evaluated by non invasive methods (Vicorder(R) apparatus)

Official Title
-----------------
Double-blind, Randomized Clinical Trial on the Middle-term Effect of the Red Yeast Rice Intake on Endothelial Function and Arterial Stiffness in Subjects With Suboptimal LDL-cholesterol Level in the Context of the Mediterranean Diet

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Dietary Supplement: Red yeast rice
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: LDL-cholesterol between 130 and 190 mg/dL Exclusion Criteria: Secundary prevention for cardiovascular disease Type 2 diabetes Assumption of lipid-lowering drug or dietary supplements Previous intolerans to read yeast rice including dietary supplements

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Red yeast rice<br>Red yeast rice extract 200 mg, containing 10 mg monacolin K per daily dose, 1 capsule per day, per 6 months | Dietary Supplement: Red yeast rice<br>* 1 capsule to be taken before to sleep, each day, for 6 months<br>|
| Placebo Comparator: Placebo<br>Placebo 200 mg (neutral fibre), 1 capsule per day, per 6 months | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow mediated dilation (FMD) change from the baseline to the end of treatment period |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12 hour fasting LDL-cholesterolemia change from the baseline to the end of treatment period |  | 6 months |
aCute HemORrhoidal Disease evALuation International Study

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess in real-life setting the effectiveness of conservative treatments on signs, symptoms and quality of life in patients consulting for hemorrhoids in acute phase of the disease

Official Title
-----------------
A Prospective, Observational (Non-interventional), International Study to Assess Conservative Treatments Effectiveness in Acute Phase of Hemorrhoidal Disease

Conditions
-----------------
Hemorrhoids

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years old; Patient consulting for symptomatic acute phase of hemorrhoidal disease Confirmed diagnosis of hemorrhoidal disease Exclusion Criteria: Patient consulting for emergency not related to hemorrhoidal disease; Patient currently taking any treatment for hemorrhoidal disease; Any anorectal procedure or surgery planned during the study ; Anorectal procedure or surgery performed or incomplete convalescence following anorectal procedure/surgery; Known present perianal sepsis, inflammatory bowel disease, colorectal malignancy, pre-existing sphincter injury, diseases of the anal canal; Pregnant or breastfeeding woman.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global improvement | Measured by Patient Global Impression of Change (PGIC) scale, and time to improvement. | Week 4 | 
| Signs and symptoms severity: pain, discomfort, bleeding, prolapse, swelling, itching, and soiling | Measured by VAS (Visual analogue scale) and questioning with 4 points rate | Week 4 | 
| Quality of Life | Measured by HEMO-FISS QoL | Week 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
observationnal, QoL
Evaluation of Blood Gas Syringes

Study Overview
=================
Brief Summary
-----------------
To assess the interchangeability and agreement between measurements from three blood gas syringes for the collection of blood for the analysis of multiple analytes as measured by differing manufacturers' multi-parameter analyzers.

Detailed Description
-----------------
This is a prospective, randomized, post-market study using fresh blood for analysis that is obtained from healthy subject volunteers. Trained phlebotomists will collect blood samples from subjects after confirmation of eligibility criteria. Blood samples will be drawn to fill all study syringe types in a randomized order. Each syringe type will be drawn per subject to analyze each of the available blood parameters in duplicate using three different multi-parameter analyzers. The analytes tested will vary per analyzer capabilities. All blood draws and analyte testing will be performed at an independent laboratory. The study is to confirm that all of the syringes tested provide consistent readings when analyzed using the most common multi-parameter analyzers used in hospital laboratories.

Official Title
-----------------
Post-Market Study Evaluating Analyzer Readings of Multiple Arterial Blood Gas Syringes

Conditions
-----------------
Blood Gas Analyte Values

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Willing and able to independently sign an English Informed Consent Have adequate veins for sampling blood from both right and left upper extremities Exclusion Criteria: Currently taking anti-coagulation medication Have a known bloodborne disease or bleeding tendency Have a known fear or adverse reaction to needles or blood Women who are pregnant or nursing

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 |
| --- | --- |
| Healthy Volunteers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in analyte values obtained from three different blood gas syringes for each analyzer tested | For each of the analytes that are tested, the analyte values from each of the three (3) syringe types tested will be compared for each of the three (3) multi-parameter analyzers. Average values for each analyte per patient, syringe and analyzer will be used for the comparison of syringes for each analyzer. | Blood analysis within 30 minutes of draw |
A Post-marketing Surveillance to Assess Safety and Efficacy of Twotopsplus.

Study Overview
=================
Brief Summary
-----------------
Post-marketing surveillance of Twotopsplus.

Detailed Description
-----------------
This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of MFDS for market authorization.

Official Title
-----------------
A Post-marketing Surveillance to Assess Safety and Efficacy of Twotopsplus.

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient diagnosed with hypertension. The patient who is first prescribed and administered Twotopsplus Tab. Exclusion Criteria: The patients who are overreacting to this drug or its components. The patients with severe renal impairment.
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 |
| --- | --- | --- |
| Incidence of adverse event after this drug administration in general medical practice. | Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events. | 12weeks | 
| Incidence of serious adverse event after this drug administration in general medical practice | Any serious adverse events occurred after this drug dosing will be recorded. Description of serious adverse event(s) including type of serious adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the serious adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be serious adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be serious adverse events. | 12weeks |
Computer-assisted Screening for Intimate Partner Violence in Family Practice

Study Overview
=================
Brief Summary
-----------------
This study tested the effectiveness of computer-assisted screening for identifying patients at risk of intimate partner violence (IPV) in a Canadian family practice. It was hypothesized that the use of computer-assisted screening among female patients would lead to higher rates of IPV discussion-opportunity and IPV detection during medical consultations, compared to patients receiving standard medical care.

Official Title
-----------------
Computer-assisted Screening for Intimate Partner Violence in Family Practice - a Randomized Controlled Trial

Conditions
-----------------
Screening for Partner Violence

Intervention / Treatment
-----------------
* Device: Interactive computer based health-risk survey before doctor's visit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: woman at least 18 years of age visiting one of the participant physicians in a current or recent intimate relationship during the last 12 months having the ability to speak and read English and give consent Exclusion Criteria: visiting a provider other than the regular family physician new patient previously approached for the study very sick had a dual appointment (herself and accompanied dependent)

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Interactive computer based health-risk survey before doctor's visit|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discussion-opportunity about risk of partner abuse during physician-patient medical encounter (audiotaped data) |  |  | 
| Detection of partner abuse during physician-patient medical encounter (audio taped data) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient acceptance of the computer-assisted screening(paper-pencil exit survey) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RCT, randomized controlled trial, partner violence, IPV, screening, family practice, computer
Tumoral Circulating Cells and Colorectal Cancer Progression

Study Overview
=================
Brief Summary
-----------------
Prospective research of circulating tumor cells as markers of progression risk in colorectal cancer.

Detailed Description
-----------------
This study aims at allowing a better understanding of which circulating tumor cells (CTC) have the higher risk of metastasis of in the overall population of CTC. Prospective monocenter open-label study. In the frame of the management of the disease, blood samples will be collected at different times of treatment, regarding disease status (localized of stage II/III, metastatic non resectable, metastatic potentially resectable). Tissue samples will be collected for patients scheduled for surgery.

Official Title
-----------------
Characterization of Tumoral Circulating Cells According to Stage of Progression of Colorectal Cancers

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Procedure: Blood and tumor samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient of more than 18 years old Histological diagnosis of colic adenocarcinoma metastatic or not Before any treatment with systemic chemotherapy Patient affiliated to, or beneficiating of the national security Patient having signed informed consent Exclusion Criteria: Patient with previous chemothrapy treatment Patient with more than one evolutive tumoral pathology Patient under long-term immunosuppressor treatment Patient with severe infection Pregnant or breasting woman Person in an emergency situation, adult subject to a legal protection measure (a guardian, guardianship or safeguard of justice), or unable of expressing his / her consent.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colorectal Cancer<br>Localized stage II/III (group 1), metastatic non resectable (group 2), metastatic potentially resectable (group 3). Additional blood samples specific for the research will be collected. Tissue samples will be taken on surgical specimens from surgery. | Procedure: Blood and tumor samples<br>* Blood and tumor samples<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of CTC features | Changes in the number of CTC with high risk to form metastasis, defined as an aggregation of phenotypic, molecular and functional characteristics. | Group 1: at surgery, 4 (+/- 1) weeks post-surgery, at progression. Group 2: before chemotherapy, after 4 months treatment (responders), at progression. Group 3: before neoadjuvant surgery, at surgery, 4 (+/- 1) weeks post-surgery, at progression. |
Photosensitivity of the Skin Under Azathioprin in Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Photosensitivity of the skin to UVA and UVB will be determined

Detailed Description
-----------------
Photosensitivity of the skin to UVA and UVB in renal transplant recipients with and without azathioprine will be determined. Azathioprine will be discontinued and photosensitivity determined after a wash-out period of three months Trial with medicinal product

Official Title
-----------------
Photosensitivity of the Skin Under Azathioprin in Renal Transplant Recipients

Conditions
-----------------
Skin Cancer

Intervention / Treatment
-----------------
* Drug: Discontinuation of Azathioprin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Renal transplant recipients under azathioprin Exclusion criteria: Treatment with Prograf (Tacrolimus)

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>one arm only. Crossover study | Drug: Discontinuation of Azathioprin<br>* Discontinuation of Azathioprin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photosensitivity of the skin to UVA and UVB |  | 2 years |