linjc16/ctgov huggingface dataset:
Gastric Tolerability and Pharmacokinetics of DMMET-01

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the gastric tolerability and the pharmacokinetics of a new drug for the treatment of type 2 diabetes, DMMET-01, in healthy volunteers.

Official Title
-----------------
Gastric Tolerability and Pharmacokinetics of DMMET-01. Daily Intake for 30 Days, in Normal Alimentation Conditions, in Healthy Volunteers.

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

Intervention / Treatment
-----------------
* Drug: DMMET-01


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mexican healthy subjects with normal clinical laboratory test results and imaging (hematology, blood chemistry, urine test, VDRL, Hepatitis B, HIV, chest radiography and electrocardiogram) Exclusion Criteria: Familiar or personal history of diabetes History of drug or alcohol abuse within the 2 years prior to the study A smoking habit greater tha 10 cigarettes per day Intercurrent disease Intercurrent treatment with any drug

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: DMMET-01<br> | Drug: DMMET-01<br>* 1050.6 mg daily for 30 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DMMET-01 Plasmatic concentration |  | 48 hrs (7.5; 15; 30; 45; 60; 75; 90; 120; 150; 180; 205; 240; 360; 480; 600; 720; 1440 and 2880 min) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lanza score |  | 30 days (0 and 30) | 
| plasmatic glucose |  | 24 hours (6,12,18 and 24) | 
| glycated hemoglobin |  | 24 hours (0 and 24) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Diabetes, gastric tolerability
The Effect of Contrast Agents on the Anticoagulant Properties of Oral Factor Xa Inhibitors

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effect of iohexol as a contrast agent on the anticoagulant activity of oral factor Xa inhibitors.

Detailed Description
-----------------
The study included 65 people who underwent contrast computerized tomography (CT). The study patients were divided into 4 groups. Patients in group 1 were using rivaroxaban (20 patients), patients in group 2 were using apixaban (20 patients), patients in group 3 were using edoxaban (20 patients), and group 4 was the control group (5 volunteers). Iohexol (60 ml) was used as a contrast agent. Two tubes were used to collect 2 ml of blood from the patients at 4 hours after the drug dose (rivaroxaban, apixaban, or edoxaban) and 1 hour after the contrast CT (CT was performed 3 hours after the drug was taken). In the control group, at any time and 1 hour after contrast CT, 2 tubes of 2 ml of blood were collected. The anticoagulant properties of rivaroxaban, apixaban, and edoxaban were evaluated using anti-factor Xa levels.

Official Title
-----------------
Bursa Postgraduate Hospital

Conditions
-----------------
Contrast Agents and Oral Factor Xa Inhibitor

Intervention / Treatment
-----------------
* Drug: computerized tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the use of oral factor Xa inhibitors (patients with nonvalvular AF and CHA2DS2-VASc Score ≥2), age of 21-80 years, no contraindications for anticoagulation use, GFR greater than 30, volunteering to participate in the study, and patients who needed to use contrast agent (iohexol) for CT examination. - Exclusion Criteria: coagulopathy, severe hepatic insufficiency, chronic systemic or inflammatory diseases, patients lighter than 60 kg, malignancy, creatinine value above 1.5 mg/dl, and not providing consent to participate in the study -

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 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 |
| --- | --- |
| rivaroxaban group<br>20 rivaroxaban using patients | Drug: computerized tomography<br>* Anti Factor Xa level<br>|
| apixaban group<br>20 apixaban using patients | Drug: computerized tomography<br>* Anti Factor Xa level<br>|
| edoxaban group<br>20 edoxaban using patients | Drug: computerized tomography<br>* Anti Factor Xa level<br>|
| control group<br>5 control group patients | Drug: computerized tomography<br>* Anti Factor Xa level<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti Factor Xa level |  | 14 days |
COMMUNITY STUDY- A Study to Collect Information for the Cordio System

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, observational, non-interventional, prospective, Single-arm, open study for database establishment for R&D purposes. R&D data will be analyzed retrospectively in order to validate algorithm efficacy. The study will be conducted in the following settings: outpatinets clinics

Official Title
-----------------
A Multi-Center Observational Study to Collect Information Related to the Clinical Significance and Performance of the Cordio System

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

Intervention / Treatment
-----------------
* Device: Cordio System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years. Symptomatic Heart Failure Patient. The patient is willing to participate as evidenced by signing the written informed consent. Male or non-pregnant female patient. Exclusion Criteria: Subject who, in the Investigator's opinion, unable to comply with the daily use of the App due to mental disorders (e.g., depression, dementia). Patient who has had a major cardiovascular event (e.g., myocardial infraction, stroke) within 3 months prior to screening visit. Patient with severe alcohol or drug use. Psychological instability, inappropriate attitude or motivation. Patient with life threatening debilitating disease other than cardiac. Subject currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.

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 |
| --- | --- |
| Cordio<br>Cordio R&D database to develop the Cordio System | Device: Cordio System<br>* App, cloud and web device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R&D Database & Efficiency | Building R&D recording database and retrospectively Cordio System needs to reach correlation between the system generated alerts to HF exacerbation | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability | Questionnaires with SUS scale and specific app questions in order to assess the app usability | 2 years |
Question Prompt List for Orthopaedic Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether providing patients with a question prompt list (QPL) prior to their orthopaedic surgery clinic appointment improves their perceived involvement in care (PICs) score compared to being given 3 questions from the AskShareKnow model

Official Title
-----------------
Does Giving a Question Prompt List to Patients With Orthopaedic Conditions Improve Their Perceived Involvement in Care? A Randomized Controlled Trial

Conditions
-----------------
Tendon Injuries, Fracture, Arthritis, Sprains, Strains, Tumor, Pain

Intervention / Treatment
-----------------
* Other: Question Prompt List
* Other: 3 questions list


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: common orthopaedic condition new patient Exclusion Criteria: -

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Question Prompt List<br> | Other: Question Prompt List<br>* Question prompt list for common orthopaedic conditions<br>|
| Active Comparator: 3 questions list<br> | Other: 3 questions list<br>* 3 questions from the AskShareKnow model<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived involvement in care scale | The Perceived involvement in care scale PICS measures a patient's perceived involvement in their visit. it is a 13 item validated scale, scored 0-13, with higher scores indicating greater perceived involvement | Immediately after the clinical encounter, same day as clinical encounter |
Non-vitamin K Oral Anticoagulants in Cardioversion

Study Overview
=================
Brief Summary
-----------------
Non-vitamin K oral anticoagulants (NOAC) have been shown to be safe and effective alternatives to warfarin for stroke prevention in patients with nonvalvular AF (NVAF). There are yet limited real life data on outcomes following elective cardioversion in AF patients treated with NOACs. The aim of this study is to investigate the complications and the use of NOACs in AF patients undergoing cardioversion.

Official Title
-----------------
Non-vitamin K Oral Anticoagulants in Cardioversion of Atrial Fibrillation. FinCV3

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AF patients undergoing cardioversion 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 |
| --- | --- | --- |
| Incidence and predictors of thromboembolic complications |  | 31 days after cardioversion of persistent AF | 
| Incidence and predictors of bleeding |  | 31 days after cardioversion of persistent AF | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of recurrence of AF |  | 31 days after cardioversion of persistent AF | 
| Hemodynamic complications of cardioversion |  | 31 days after cardioversion of persistent AF | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, Anticoagulation, Cardioversion
Acute Cholecystitis With Concomitant Choledocholithiasis: Unicentric Study of Prevalence and Predictive Factors

Study Overview
=================
Brief Summary
-----------------
The management of cholelithiasis with choledocolithiasis is extensively known, whereas for Acute Calculous Cholecystitis (ACC) with choledocolithiasis or common bile duct stones (CBDS), a common entity, there is a lack of protocols for optimising treatment. The main hypothesis of our study is: a correct stratification of the concomitant CBDS probability at ACC diagnosis would optimize its treatment as early targeted treatment could be performed. One-step management of ACC with CBDS by a specialised hepatobiliary team would represent a benefit to the patient in terms of morbi-mortality, admission time and number of admissions. The aim of our study is to identify high / intermediate probability criteria for CBDS associated when diagnosing CA. This is a retrospective study of patients who were operated on with an emergent cholecystectomy in our center from 01/2012 to 12/2019.

Detailed Description
-----------------
Data will be obtained from the hospital (Consorci Sanitari del Maresme) clinical database. The Ethics Committee approval has been obtained.

Official Title
-----------------
Acute Cholecystitis With Concomitant Choledocholithiasis: Unicentric Study of Prevalence and Predictive Factors for Its Diagnosis and Management

Conditions
-----------------
Acute Cholecystitis, Choledocholithiasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Exclusion Criteria: Non urgent cholecystectomy

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CBDS risk | Probability of CBDS presence at the moment of AC diagnose based on classification on risk modified from Maple et al. 2010: high, intermediate or low | From diagnostic to surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative cholangiography | Percentage of patients who underwent intraoperative cholangiography (IOC) in each group: % | During the surgery | 
| Postoperative morbidity | Adverse events (biliary fistula presence and ERCP (endoscopic retrograde cholangiopancreatography) requirements) identification during the postoperative period: Y/N | From surgery to 1 year | 
| Readmission | Requirement of readmission after discharge | From discharge to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Cholecystitis, Choledocholithiasis, Urgent cholecystectomy, Risk factors
Impact of Timing of PD Assessments on Measures of Platelet Reactivity in Patients Undergoing PCI Treated With Cangrelor

Study Overview
=================
Brief Summary
-----------------
This study is assessing the impact of timing of PD assessments on measures of platelet reactivity in patients undergoing PCI treated with cangrelor.

Detailed Description
-----------------
Cangrelor is characterized by reversible binding to the P2Y12 receptor and is promptly inactivated through dephosphorylation by ectonucleotidase leading to its very short plasma half-life. Consequently the timing at which PD assessments are performed after blood sample collection may impact measures of platelet reactivity in patients treated with cangrelor. We therefore hypothesize that measures of platelet inhibitory effects observed in cangrelor treated patients will reduce with time following blood sampling.

Official Title
-----------------
Impact of Timing of Pharmacodynamic Assessments on Measures of Platelet Reactivity in Patients Undergoing Percutaneous Coronary Intervention Treated With Cangrelor

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old CAD patients (stable CAD, NSTE-ACS, or STEMI) undergoing PCI and treated with cangrelor per standard of care. Treated with aspirin prior to the PCI procedure per standard of care Exclusion Criteria: Treatment with an oral P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) within past 10 days Treatment with oral anticoagulation (vitamin K antagonist, dabigatran, apixaban, rivaroxiban) within past 3 days Treatment with a glycoprotein IIb/IIIa inhibitor during PCI Fibrinolytics within 48 hours Known hemoglobin<10 gm/dL Known platelet count <80x106/mL Active bleeding or hemodynamic instability Known end stage renal disease on hemodialysis Known severe hepatic dysfunction

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cangrelor Group<br>This is the study cohort that the blood sample will be obtained from. There are no interventions | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in platelet reactivity | measure of change platelet reactivity at time points | wiithin 30 min, 1 hour, 2 hours, and 4 hours of blood sampling |
The National Danish Schizophrenia Project

Study Overview
=================
Brief Summary
-----------------
A prospective, longitudinal, multi-centre investigation (16 centres), including 562 patients, consecutively referred during two years, with a first-episode psychosis of ICD-10, F-2 type. Patients were treated with: 1) 'Supportive psychodynamic psychotherapy as a supplement to treatment as usual', 2) an 'Integrated, assertive, psychosocial and educational treatment programme', and 3) 'Treatment as usual'.

Detailed Description
-----------------
The study is a prospective, comparative, longitudinal study with an intervention period of a minimum of two years and a registration of data at baseline and 1, 2 and 5 years after inclusion. Three sub-cohorts with different treatment modalities were designed: Treatment1: 119 patients were, in addition to TaU, offered SPP, i.e. a scheduled manualised supportive individual psychotherapy (1 session of 45 min. per week, for a period of 1-3 years) and/or group psychotherapy (1 session of 60 min. per week for a period of 1-3 years). Anti-psychotic medication was given in doses based on individual needs; Treatment 2: 139 patients were offered IT, i.e. a scheduled, two-year long programme consisting of assertive community treatment, psycho-educational multi-family treatment (a.m. McFarlane, consisting of 4-6 families including the patients, meeting 1½ hour every second week for 1½ year), social skills training (concerning medication, self-management, coping with symptoms, conversational skills, problem and conflict solving skills), and antipsychotic medication (low dose strategy). This project, OPUS, has been described in detail elsewhere

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Behavioral: Psychosocial treatment/Psychodynamic treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consecutively referred patients, age 16-35 years, who suffered from a first-episode psychosis of the schizophrenic spectrum disorder (ICD-10, DF 20-29). - Exclusion Criteria: patients suffering from mental retardation or other organic brain damage, and patients who were not proficient enough in Danish due to their foreign origins.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Psychosocial treatment/Psychodynamic treatment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Dizziness Among First Time Users of Hearing Aids

Study Overview
=================
Brief Summary
-----------------
The score on the Dizziness Handicap Inventory (short version) before and after hearing aid fitting and usage will be compared

Official Title
-----------------
Dizziness Among First Time Users of Hearing Aids

Conditions
-----------------
Dizziness, Hearing Loss

Intervention / Treatment
-----------------
* Device: Hearing aids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hebrew speaking First time users of hearing aids Exclusion Criteria: Using a wheelchair Neurological disorders Spine of leg surgery in the previous 6 months

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 |
| --- | --- |
| First time users of hearing aids<br>Hearing aid fitting and usage | Device: Hearing aids<br>* Fitting of hearing aids (for the first time)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dizziness Handicap Inventory (short version) score. The scale measures the degree of dizziness associated handicap as experienced by the patient. Minimun score: 0 Maximum score: 13. A higher score means better outcome. | The change in the score a 2 months after fitting the hearing aids | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usage of hearing aids | The duration the participants used the hearing aids | 2 months |