linjc16/ctgov huggingface dataset:
Evaluation of Flexofytol® PLUS in Hand Joint Chronic Dyscomfort.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of curcuminoids and Boswellia serrata extracts combination (Flexofytol PLUS) in support to standard treatments during a 12-weeks period on hand pain on people with chronic hand joint discomfort.

Official Title
-----------------
Curcuminoids and Boswellia Serrata Extracts Combination Decreases Hand Joint Discomfort : Results From a Belgian Real-Life Experience

Conditions
-----------------
Hand Joint Discomfort

Intervention / Treatment
-----------------
* Dietary Supplement: Flexofytol PLUS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older dan 45 years old, With hand joint chronic discomfort, Regularly uses of paracetamol or NSAIDs to manage pain, Painful symptoms must have been present for more than 6 months, The patient assesses their pain on a visual pain scale and must be greater than 4 out of 10 over the last 48 hours. Exclusion Criteria: Related to previous and associated treatments: Corticosteroids injection in the 3 previous months, whatever the joint concerned, Use of Slow-acting drugs for OA and/or dietary supplements taken within less than 6 months prior to the study (ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy or homeopathy for hand joint discomfort..), Anticoagulant (coumarinic) treatment and heparin, General corticotherapy in the 3 previous months, Contraindication to paracetamol, curcumin, boswellia and NSAID's. Related to associated pathologies: Patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...), The patient has rheumatoid arthritis or gout, The patient has a bile obstruction. Related to patient: Pregnant or breastfeeding women.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Flexofytol PLUS|2 tablets in the morning and in the evening for minimum 6 weeks.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain using a Numerical Rating Scale (NRS) | Change from baseline of the mean pain over the last 48 hours evaluated by the patient on a 0 to 10 scale ( 0= no pain and 10=maximal pain) | 84 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hand joint pain, curcumin, boswellia serrata, support to standard treatment
Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children

Study Overview
=================
Brief Summary
-----------------
To determine the most cost effective way to treat children with perforated appendicitis we will randomize all children presenting with perforated appendicitis to initial operation, with in 24 hours of admission, or to initial antibiotics, with or without percutaneous drainage, and subsequent interval appendectomy after 8 weeks. Our outcomes will include cost, complications, length of stay, and quality of life measures.

Official Title
-----------------
Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children

Conditions
-----------------
Perforated Appendicitis

Intervention / Treatment
-----------------
* Procedure: Initial appendectomy
* Procedure: Interval appendectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:children Age 2-17 with a diagnosis of perforated appendicitis Exclusion Criteria: Age <2 and >18 Pregnancy Immunocompromise

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Initial appendectomy<br>children with complicated appendicitis will undergo initial appendectomy | Procedure: Initial appendectomy<br> <br> |
| Other: Interval appendectomy<br>children with complicated appendicitis will undergo initial antibiotic treatment followed by an interval appendectomy | Procedure: Interval appendectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost effectiveness |  | 3 months post entry into the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
appendicitis, perforated, children
The Development and Experimental Application of a New Thoracostomy Trocar

Study Overview
=================
Brief Summary
-----------------
Traditional closed thoracostomy exhibit certain shortcomings. Blind dissection is a lengthy process that is difficult for unskilled physicians, whereas the use of a traditional trocar is relatively likely to damage internal organs. In this study, investigators developed a new trocar and examined its usefulness.

Detailed Description
-----------------
The new trocar consists of a mold and a stylet; the mold has a hole in its side to ensure that the chest tube proceeds in only one direction. The mold also has a mark to indicate insertion depth. Sixteen participants without experience with thoracostomies observed one closed thoracostomy procedure using the new trocar and then performed three thoracostomies on a cadaver. For each of these thoracostomies, investigators measured the time required for chest tube insertion, the position of the tip of the chest tube within the thoracic cavity, the difficulty associated with the procedure, and the volunteer's confidence after the procedure.

Official Title
-----------------
The Development and Experimental Application of a New Thoracostomy Trocar

Conditions
-----------------
Pneumothorax

Intervention / Treatment
-----------------
* Device: Trocar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Senior medical students without prior experience with closed thoracostomies Exclusion Criteria: Wrist disease, Pregnancy, Do not want to participate

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 30 Years

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

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

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

Design Details

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Closed thoracostomy<br>Closed thoracostomy using the new trocar by novice | Device: Trocar<br>* Closed thoracostomy using the new trocar<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to closed thoracostomy |  | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The accuracy of the position of the tip of the chest tube | Yes or No | 5 minutes |
REGistry of Long-term AnTithrombotic TherApy-1

Study Overview
=================
Brief Summary
-----------------
To assess the rates of ischemic and hemorrhagic complications of long-term antithrombotic therapy in patients with chronic coronary syndromes

Detailed Description
-----------------
The register is a Russian prospective single-center observational study of patients who have indications for long-term antithrombotic therapy in connection with chronic coronary syndromes

Official Title
-----------------
Registry Dedicated to Assess the Risk of Ischemic and Hemorrhagic Complications of Long-term Antithrombotic Therapy in Patients With Chronic Coronary Syndromes

Conditions
-----------------
Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), Peripheral Artery Disease

Intervention / Treatment
-----------------
* Drug: Antiplatelet Drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: coronary artery disease , confirmed by history of myocardial infarction, or revascularization, or definitive evidence of CAD on imaging Exclusion Criteria: Subjects who are unwilling or unable to provide informed consent. ACS within 12 months before inclusion Severe CHF (NYHA IV) Stroke within 6 months before inclusion Severe liver or muscle disease Severe kidney disease / renal failure with creatinine > 3 mg/dl Conceivable impossibility to come in touch with the patient or his family at 1-year after the intervention -

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

| Intervention/Treatment |
| --- |
|Drug: Antiplatelet Drug|single or dual antiplatelets, triple antithrombotic theraphy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite of major adverse cardiovascular events (MACE) | stroke, myocardial infarction, stent thrombosis [definite or probable], or urgent revascularization, cardiac death | inclusion up to 5 years | 
| composite of any bleeding events | major, clinically relevant nonmajor, minor (BARC, ISTH) | inclusion up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of peripheral atherosclerosis | Assessment will be performed with the use of duplex scanning | inclusion | 
| Mutations in following genes | CYP2C19*, ABCB1 | inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Artery Disease, Peripheral Artery Disease
mHealth Messages to Sustain Recent Weight Loss - Phase 2

Study Overview
=================
Brief Summary
-----------------
To assess the feasibility to translate an automated weight loss message intervention to a weight loss clinic population. Aim 1: To assess feasibility of translating the intervention in a clinic for patients who recently completed a structured weight loss program. Aim 2: To assess the ability to capture a trajectory of self-reported weight over 6 months through an automated intervention.

Detailed Description
-----------------
The investigators will recruit 100 participants who are clients at the Duke Diet and Fitness Center. At baseline the investigators will collect demographic information such as, their age, weight, education. When participants complete their respective program at the DFC they will receive a daily weight loss sustaining text message at 8:00 A.M. for 60 days. Participants will also receive weekly messages for 6 months asking them to self-report their weight. Thereafter, they will receive an automated message monthly for 18 months asking them to self-report their weight.

Official Title
-----------------
Mobile Health Messages to Sustain Recent Weight Loss - Phase 2

Conditions
-----------------
Weight Loss

Intervention / Treatment
-----------------
* Behavioral: mHealth Texting for Weight Loss


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A client of Duke diet and Fitness Center (DFC) Are able to speak and read English Should complete a diet and fitness program at the DFC. Client should own a mobile smart phone to personally receive text messages. Client should have access to a web-based survey to self-report their weight. Exclusion Criteria: No exclusions

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Weight Loss<br>We will send the study participate a daily text message for 2 months to their phone at 8 A.M. and a weekly text message for 6 months asking them to report their weight through a 2-question online survey. After that, a monthly text message for 18 months asking them to report their weight. | Behavioral: mHealth Texting for Weight Loss<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's weight loss | The study is being done to asses the ability to translate an automated weight loss message intervention to a weight loss clinic population. | 2 years | 
| Percentage of subjects who self-report weight to the clinic |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mobile Technology, Diet and Fitness
Biological Collection and Registry of Patients Who Will Have a TAVR (Transcatheter Aortic Valve Replacement) Intervention

Study Overview
=================
Brief Summary
-----------------
A sample of plasma and whole blood will be obtained at 4 time points (pre-procedural, early post-procedural, at hospital discharge and during an eventual visite at 3 or 6 months post-procedural). Test for platelet reactivity (LTA, light transmittance aggregometry and Elisa PRI, Platelet reactivity index), multimeric VWF (von Willebrand factor) and blood level of NET: neutrophil extracellular traps(flow cytometry and ELISA) analyses will be performed at the time of blood sampling. Aliquots of plasma will be stored and frozen for further analyses

Detailed Description
-----------------
There are two major objectives: To correlate changes in VWF, platelet reactivity and blood level of NET after TAVR with clinical outcomes To correlate changes in VWF, platelet reactivity and blood level of NET with antithrombotic regimens after TAVR (direct anticoagulants apixaban versus standard of care, ie Vitamin K antagonist or antiplatelet therapy).

Conditions
-----------------
Transcatheter Aortic Valve Replacement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient undergoing TAVR intervention agreement given Exclusion Criteria: severe thrombopenia ( <40.10^9/L)

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 |
| --- | --- | --- |
| Major Adverse Cardiac Events | stroke/transient ischemic attack; acute coronary syndrome; hospitalization for cardiac insufficiency, cardiovascular or unexplained deaths will be collected at 12 month by phone contact with the patient or his/her relatives or his/her treating physician | 12 months | 
| Bleeding | Serious bleeding event (BLEED II or more) will be collected at 12 month by phone contact with the patient or his/her relatives or his/her treating physician | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean pressure transprosthetic gradient | value of the mean pressure transprosthetic gradient after TAVR procedure will be assessed by TTE (transthoracic echography) or TOE (transesophageal echography) | within ten days after valve replacement |
Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to examine how AZD6140 affects patients with severe kidney disease compared to volunteers with normal kidneys. Subjects in the study will receive one dose of AZD6140.

Official Title
-----------------
Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers

Conditions
-----------------
Renal Impairment

Intervention / Treatment
-----------------
* Drug: AZD6140


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have severe kidney disease Subjects who are matched to the kidney disease patients in terms of weight, age, and sex must have normal kidneys All women must be post-menopausal (no longer menstruating) or surgically sterile Exclusion Criteria: Patients requiring dialysis History of allergy to aspirin or clopidogrel Have increased bleeding risk (for instance uncontrolled high blood pressure or a recent major injury) Recent history of fainting or light-headedness

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD6140<br> | Drug: AZD6140<br>* single oral dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of AZD6140 in patients with severe kidney disease compared to volunteers with normal kidneys |  | Scheduled times during the 3 days after the study drug is taken | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of AZD6140 in patients with severe kidney disease compared to subjects with normal kidneys |  | Screening through completion of the study | 
| Measure the effect of AZD6140 on how well blood clots in patients with severe kidney disease compared to subjects with normal kidneys |  | Scheduled times during the 3 days after the study drug is taken | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal Impairment
Acute Appendicitis in Foreign Workers of Northern Israel

Study Overview
=================
Brief Summary
-----------------
To Compare the outcome to acute appendicitis in foreign workers to the native patients.

Detailed Description
-----------------
This is a retrospective case-control study. The investigators identified all patients aged 18-50 who were admitted to our institution between January 1st, 2013 and October 31st, 2018, with the diagnosis of acute appendicitis. The study group included all foreign workers and the control group was age, sex, and co-morbidities matched group from the local population. The investigators compared time to presentation, admission parameters and disease outcomes.

Official Title
-----------------
Acute Appendicitis in Foreign Workers of Northern Israel: a Retrospective Cohort Study

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Procedure: Laparoscopic appendectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18-50 who were admitted to our institution between January 1st, 2013 and October 31st, 2018, with the diagnosis of acute appendicitis Exclusion Criteria: Pregnant women Patient whose pathology report of the appendix was normal

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Foreign workers<br>Foreign workers aged 18-50 who were admitted to our institution between January 1st, 2013 and October 31st, 2018, with the diagnosis of acute appendicitis. | Procedure: Laparoscopic appendectomy<br>* Laparoscopic appendectomy performed for acute appendicitis<br>|
| Local patients<br>Local patients aged 18-50 who were admitted to our institution between January 1st, 2013 and October 31st, 2018, with the diagnosis of acute appendicitis. | Procedure: Laparoscopic appendectomy<br>* Laparoscopic appendectomy performed for acute appendicitis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of complicated disease | amount of cases defined as complicated acute appendicitis | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute appendicitis, Foreign workers, Complicated appendicitis