linjc16/ctgov huggingface dataset:
Mediterranean Diet, Trimethylamine N-oxide (TMAO) and Anti-oxidants in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
Trimethylamine N-oxide (TMAO) is a small organic compound naturally present in fish and seefood or generated by the bacterial breakdown of dietary phosphatidylcholine and carnitine-containing foods within the human gut microbiome. Elevated serum TMAO was previously reported to be associated with an elevated risk for cardiovascular events. Aim of this study was to investigate the association between plasma levels of TMAO with the Mediterranean diet in a cohort of healthy adults.

Official Title
-----------------
Mediterranean Diet, Trimethylamine N-oxide (TMAO) and Anti-oxidants in Healthy Adults

Conditions
-----------------
Mediterranean Diet, Trimethylamine N-oxide, Cardiovascular Risk Factor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects of both gender Exclusion Criteria: age>65 years > BMI 30 kg/m2 vegetarians smokers gastrointestinal diseases or complaints chronic illnesses or other metabolic diseases (including trimethylaminuria) abnormal blood chemistry values indicative of organ dysfunctions nutritional supplements, antibiotics or probiotics within 2 months of recruitment

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Mediterranean Diet by Predimed Questionnaire | Validated 14-item tool of adherence to the Mediterranean diet, with three categories of adherence (≤5, low adherence, 6-9, average adherence and ≥10 points, high adherence) | September 2016 to December 2016 | 
| Trimethylamine N-oxide plasma levels | ultra high-performance liquid chromatography | September 2016 to December 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular risk | metabolic syndrome parameters; Homa Index; Framingham score; ASCVD Risk Estimator | September 2016 to December 2016 |
Computed Radiography (CR) Data Collection for Mammography Computer Aided Detection (CAD)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to collect an image library of diagnostic digital mammograms using the Carestream CR mammography system from patients who have histological-conformed breast cancer to demonstrate the clinical feasibility of this system for detection of breast cancer.

Official Title
-----------------
Computed Radiography (CR) Data Collection for Mammography Computer Aided Detection (CAD)

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: DIRECTVIEW CR Mammography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Requirements Women age 40 to 85 Recommended for biopsy and BI-RADS assessment of category 4 (suspicious abnormality) or 5 (highly suggestive of malignancy) Able to have MLO and CC views taken Good general health Able and willing to provide a written Informed Consent Exclusion Requirements Under age 40 Pregnant or suspicious of being pregnant Breast implants Breasts too large to be adequately positioned on a 24 x 30 cassette Personal history of breast cancer treated with a lumpectomy Unable or unwilling to provide a written Informed Consent form

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DirectView CR Mammography<br>Each subject will have routine clinical care imaging obtained and 4 standard mammogram views (RMLO, RCC, LMLO, LCC) using CR mammography. If routine mammograms were obtained on a day previous to enrollment in the study, those images (4 views; 2 views for mastectomy patients) will not be repeated for this study; only the CR images will be obtained. | Device: DIRECTVIEW CR Mammography<br>* 4 views screening mammogram<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect mammogram from patients with breast cancer using the Carestream Mammo CR device. |  | at completion of the study |
Salvage Surgery for Patients With Metastatic GIST With Rego

Study Overview
=================
Brief Summary
-----------------
Some researches have shown surgery may acquire progression-free (PFS) benefit for selected patients with metastatic gastrointestinal stromal tumor (GIST) who received first-line imatinib and second-line sunitinib. However, impact of salvage surgery on pre-treated GIST patients receiving third-line regorafenib facing progression is not yet reported. Investigators retrospectively reviewed patients with regorafenib treatment with salvage surgery.

Detailed Description
-----------------
Between 2014 and 2019, 41 metastatic GIST patients received regorafenib therapy. 35 out of 41 metastatic GIST patients who were on regorafenib therapy facing progression and 15 experienced local progression underwent salvage surgery. Thirty-five of 41 (85.4 %) pre-treated GIST patients receiving regorafenib who experienced disease progression after a median follow-up of 12.4 months of regorafenib use. 15 out of 35 (42.9%) metastatic GIST patients receiving regorafenib facing progression underwent salvage surgery.

Official Title
-----------------
Analysis of Benefit From Salvage Surgery for Highly Selected Patients With Metastatic Gastrointestinal Stromal Tumors Receiving Regorafenib Facing Local Progression

Conditions
-----------------
Gastrointestinal Stromal Tumors, Metastasis, Disease Progression

Intervention / Treatment
-----------------
* Procedure: Salvage surgery with massive debulking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients who is taking regorafenib after treatment failure by 1st line and 2nd line tyrosine kinase, namely Imatinib and Sunitinib. Patients with aforementioned condition and is facing local progression of disease or stationary disease. Exclusion criteria Systemic progression of disease ASA classification > 3

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Salvage surgery with massive debulking|For patients with regorafenib treatment and facing local progression, we remove the tumor with progression and achieve cytoreduction.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | the time period from start regorafenib to death | 01/2014 12/2019 | 
| Disease free survival | the time period after salvage surgery to disease reprogression | 01/2014 12/2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
regorafenib, Gastrointestinal Stromal Tumors, Metastasis, local progression, surgery
A Study Comparing Amounts of Tafamidis (PF-06291826) in the Blood Without Food in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
3 different formulations and doses of tafamidis will be compared. Subjects will be fasted for each test and every subject will test all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for 8 days. After 14 days, subjects will take a different formulation of tafamidis and tafamidis blood concentrations will be measured periodically for 8 days. After another 14 days, the last formulation will be tested in the same way.

Official Title
-----------------
A Phase 1, Open-Label, Three-Period Randomized, Single Dose Study To Estimate The Relative Bioavailability Of Pf-06291826 (Tafamidis) Free Acid Capsule Formulation Versus Commercial Capsule In Healthy Subjects Under Fasted Conditions

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

Intervention / Treatment
-----------------
* Drug: tafamidis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males or females of non-child bearing potential. Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs). Exclusion Criteria: Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic). Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study. Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4x20 mg tafamidis meglumine soft gel capsule<br> | Drug: tafamidis<br> <br> |
| Experimental: 48.8 mgA tafamidis free acid capsule<br> | Drug: tafamidis<br> <br> |
| Experimental: 61 mgA tafamidis free acid capsule<br> | Drug: tafamidis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time Curve (AUC) |  | 168 hours | 
| Maximum Observed Plasma Concentration (Cmax) |  | 168 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |  | 168 hours | 
| Mean residence time (MRT) |  | 168 hours | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 168 hours | 
| Plasma Decay Half-Life (t1/2) |  | 168 hours |
Study Evalutating the Pharmacokinetics (PK) and Safety of a Single Dose of Desvenlafaxine Sustained Release (DVS SR)

Study Overview
=================
Brief Summary
-----------------
To assess the initial pharmacokinetic profile of single doses of 25mg and 50 mg of DVS SR to healthy subjects.

Official Title
-----------------
A Randomized, Open-Label, Single-Dose Parallel Group Study of the Pharmacokinetic Profile, Safety, and Tolerability of 25- and 50-mg Desvenlafaxine Sustained Release (DVS SR) in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: Desvenlafaxine Sustained Release (DVS SR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Men or non-pregnant, non-lactating women Body mass index 18 - 30 kg/m2 Body weight greater than or equal to 60kg

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Desvenlafaxine Sustained Release (DVS SR)|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major Depressive Disorder, MDD
Non-contact ECG Sensor System for COVID19

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is two-fold. First we would like to confirm that non-contact ECG provides equivalency to current contact methods of obtaining ECG data. Second we would like to investigate whether non-contact ECG can detect ECG changes prior to the onset symptoms from COVID19.

Official Title
-----------------
Evaluating Non-contact ECG Sensor System for Early Detection of COVID19

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Device: Non-contact ECG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any employee of Lake Forrest Memorial Hospital presenting to work Age greater than 18 years-old Exclusion Criteria: Age less than 18 years-old Non-employee

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 |
| --- | --- |
| Participant ECG<br>The study has one arm, I.e., we will collect daily ECGs in 100 participants and track their ECG over three months. We will then compare ECGs pre and post COVID-19 diagnosis in any participant diagnosed with COVID-19 to assess for any early ECG changes that may aid with diagnosing. | Device: Non-contact ECG<br>* A non-contact ECG will be used to detect a patient cardiac electrical activity.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECG changes associated with COVID-19 | Assess different ECG changes in participants diagnosed with COVID-10 | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, ECG, Arrhythmia
Flemish Inguinal and Femoral Hernia Prospective Registry

Study Overview
=================
Brief Summary
-----------------
Prospective registry. The purpose of this clinical trial will be to measure surgical outcome parameters (e.g. recurrence, chronic pain and other quality indicators) after inguinal hernia repair using Patient Reported Outcome Measures (PROMs) in the short- and long-term.

Detailed Description
-----------------
The primary objective is to investigate moderate to severe chronic pain 1 year after inguinal or femoral hernia repair, defined as numeric rating scale (NRS) ≥ 4, during daily activities. The secondary objectives are: Surgical Site Occurrence (SSO) after 30 days Scope and incidence of pre- and postoperative pain (NRS 0 to 10) The difference between pre- and postoperative NRS scores (relative NRS score) Presence of pain and impact of pain on daily life activities Satisfaction and quality of life Sexual function Anxiety and depression Catastrophizing Recurrence Development of a predictive model for chronic pain.

Official Title
-----------------
Flemish Inguinal and Femoral Hernia Prospective Registry

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Device: Surgical inguinal or femoral hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Consecutively all patients with a groin hernia (inguinal and/or femoral hernia) operated starting 01.01.2018. Male and female 18 years or older Operated of supervised by a participating surgeon (participating in this study is not necessarily by a whole surgical department of a hospital, but by specific surgeons) Elective and emergency surgery Primary and recurrent hernia Metachronous and synchronous hernia Signed informed consent form Exclusion criteria Younger than 18 years Not operated or supervised by participating surgeon Pregnant at inclusion in the registry No signed informed consent form

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Inguinal or femoral hernia repair<br>All consecutive inguinal or femoral hernia repair (primary or mesh) | Device: Surgical inguinal or femoral hernia repair<br>* Surgical inguinal or femoral hernia repair (primary or mesh)<br>* Other names: Hernia repair;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic pain after inguinal hernia repair | To investigate moderate to severe chronic pain 1 year after inguinal or femoral hernia repair, defined as numeric rating scale (NRS) ≥ 4, during daily activities. | 5 years |
Effect of Cocoa Supplementation in Training Athletes Microbiota and Metabolome

Study Overview
=================
Brief Summary
-----------------
It has recently been suggested that cocoa may improve exercise performance and recovery. This study aim to evaluate the plasma and fecal metabolome after 10 weeks of cocoa supplementation during the training period in recreational athletes to detect possible metabolites involved in the observed benefits of cocoa in athletes

Official Title
-----------------
Effect of Cocoa Supplementation in Training Athletes Microbiota and Metabolome: Effects on Acute and Adaptive Exercise

Conditions
-----------------
Healthy Athletes

Intervention / Treatment
-----------------
* Dietary Supplement: cocoa
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-45 years of age high physical condition (VO2 ≥ 55 ml/kg/min) BMI 18-25 kg/m2 Exclusion Criteria: antibiotics intake during 3 months prior to the study, smoking nutritional complements ergogenic complements prebiotics probiotics vegetarian or vegan diet chronic medication gastrointestinal surgery Any diagnosed disease

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cocoa group<br>5 g/day of flavonoid-rich defatted cocoa for 10 weeks | Dietary Supplement: cocoa<br>* Sachets of 5 grams of cocoa daily supplementation<br>|
| Placebo Comparator: Placebo group<br>5 g/day of maltodextrin for 10 weeks | Dietary Supplement: Placebo<br>* Sachets of 5 grams of maltodextrin daily supplementation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal microbiota | Abundance of bacterial taxa determined by 16SRNAr gene sequencing | Changes from baseline to 10 weeks of intervention | 
| Fecal metabolome profile | Abundance of fecal metabolites, metabolic networks, and metabolic pathways determined by High Pressure Liquid Chromatography-Mass Spectrometry | Changes from baseline to 10 weeks of intervention | 
| Plasma metabolome profile | Abundance of blood metabolites, metabolic networks, and metabolic pathways activity determined by High Pressure Liquid Chromatography-Mass Spectrometry | Changes from baseline to 10 weeks of intervention |
Alcohol Consumption and Gallbladder Cancer

Study Overview
=================
Brief Summary
-----------------
This case-control study matched by age and sex was performed to evaluate the region specific risk factors for gallbladder cancer in Jeju island, Korea.

Detailed Description
-----------------
In order to estimate region-specific risk factors for gallbladder cancer (GBC) in Jeju island, Korea the investigators performed a case-control study. Among 124 GBC patients and 7088 health controls, the investigators randomly selected 78 cases and 78 age-sex matched controls (1:1 matching) and compared their demographic features, combined diseases, and personal histories about known risk factors until now.

Official Title
-----------------
Alcohol Consumption and Gallbladder Cancer: Case-control Study in Jeju Island, Korea.

Conditions
-----------------
Gallbladder Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Case group : newly diagnosed gallbladder cancer patients in Digestive Disease Center, Department of Internal Medicine in Cheju Halla General Hospitalduring 2008-2013 Control group : 1:1 age-sex matched controls underwent health care screening program in Department of Health Promotion Center in Cheju Halla General Hospital for 2008-2012. Exclusion Criteria: Case group Ambiguous diagnosis primary tumor involving common bile duct follow up loss without pathologic confirmation Incomplete clinical records Couldn't be assessed the results of operation or radiologic imaging. Control group Cases unavailable for gallbladder imaging (abdominal ultrasonography ,computed tomography, or magnetic resonance imaging) Cases underwent previous cholecystectomy before enrollment.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gallbladder cancer case group<br>Gallbladder cancer case group was defined as newly diagnosed gallbladder cancer diagnosed as GBC at the Department of Internal Medicine in Cheju Halla General Hospital, Jeju, Korea from 2009 to 2013. | |
| Age and sex matched control group<br>Age and sex matched control group was determined as age-sex matched subjects selected from the participants of Health Promotion Center in the same institute from 2009 to 2012. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with alcohol consumption |  | Up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gallbladder cancer, Case-control study, Risk factor, Alcohol consumption, Polypoid lesions of gallbladder, Biliary stone