linjc16/ctgov huggingface dataset:
Characterization of Explanted Hernia Meshes From Human Subjects: A Multi-Center, Prospective Study

Study Overview
=================
Brief Summary
-----------------
This study will collect a large amount of hernia mesh explants and study the changes that occur in the materials in vivo to use the information to help design new mesh made from novel materials. We will have evidence that our current options are not only inadequate but can lead to complications. One of our main goals is to convince our colleagues to change their surgical practice by publishing and educating them with this data.

Detailed Description
-----------------
This study will collect a large amount of hernia mesh explants and study the changes that occur in the materials in vivo to use the information to help design new mesh made from novel materials. We will have evidence that our current options are not only inadequate but can lead to complications. One of our main goals is to convince our colleagues to change their surgical practice by publishing and educating them with this data. The objectives of this study are to establish the largest collection of explanted mesh materials in the country; demonstrate by common testing utilized by materials engineers, that in vivo exposure of mesh to the oxidants produced by phagocytosis may lead to chain scission, production of free radicals, and overall degradation of the material both physically and chemically; test mesh materials for a decrease in compliance, which would account for a tendency of mesh to stiffen while in the body reducing abdominal mobility and leading to chronic pain; characterize the histologic reaction of tissues to mesh; and utilize de-identified patient demographics to identify possible clinical characteristics which affect mesh degradation.

Official Title
-----------------
Characterization of Explanted Hernia Meshes From Human Subjects: A Multi-Center, Prospective Study

Conditions
-----------------
Hernia, Pathological Conditions, Signs and Symptoms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (persons 18 and older) Previous placement of hernia mesh material Current need for excision of previous mesh placement or current need for intra-abdominal surgical procedure Exclusion Criteria: No retained mesh prosthetic Non surgical candidate

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hernia mesh, Implanted mesh material, Explanted mesh material
Assessment of Long-term Impact Post COVID-19 for Patients and Health Care Professionals of the European Hospital

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to Assess of Long-term impact post COVID for patients and health care professionals.The patients and medical staff will be followed for 2 years in order to provide clinical and paraclinical data not yet published in the literature.

Official Title
-----------------
Assessment of Long-term Impact Post COVID-19 for Patients and Health Care Professionals of the European Hospital

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: Diagnostic Test: serology test for COVID-19


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥ 18 years, Symptomatic COVID-19 infection confirmed (by RT-PCR or ELISA serology) or probable (CT criteria), Having given free and informed written consent, Being affiliated with or benefiting from a social security scheme. Patients / caregivers may be included in several ancillary studies at the same time. Exclusion Criteria: -Subject to a measure for the protection of justice

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 |
| --- | --- |
| Symptomatic COVID-19 infection confirmed or probable<br>Patients and medical staff having symptomatic COVID-19 infection confirmed (by RT-PCR or ELISA serology) or probable (CT criteria) | Diagnostic Test: Diagnostic Test: serology test for COVID-19<br>* a serology test will be performed at M3<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of post-traumatic stress symptoms (Post traumatic Stress Disorder (PTSD) scale) at M3 for patients and caregivers | measure used to assess symptoms of post-traumatic stress disorder. Individuals should rate their experience with each of the 17 symptoms of PTSD on a scale of 1 to 5 (1 = not at all, 2 = a little, 3 = moderately, 4 = a little, and 5 = extremely) versus to a specific traumatic event | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of post-traumatic stress symptoms (PTSD scale) at M12 and M24 for patients and caregivers |  | 12 and 24 months | 
| Change from M3 in the score of the mental (MCS), physical (PCS) components and the scores of the individual domains of the questionnaire SF36 to M12 and M24 for the entire study population |  | 12 and 24 months | 
| % of patients presenting a positive result by ELISA serology (= without distinction of IgG, IgM and IgA) |  | 3 months | 
| Comparison of M0 chest CT results at each follow-up for the entire study population |  | 24 months |
International EXPAND Heart Pivotal Trial

Study Overview
=================
Brief Summary
-----------------
To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts that may not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation

Official Title
-----------------
International Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation (EXPAND Heart Trial)

Conditions
-----------------
Heart Transplant

Intervention / Treatment
-----------------
* Device: Preservation of Hearts for Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Registered male or female primary Heart transplant candidate Age ≥18 years old Exclusion Criteria: Prior solid organ or bone marrow transplant Chronic use of hemodialysis or diagnosis of chronic renal insufficiency Multi-organ transplant

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCS Preservation<br>OCS Preservation and Assessment | Device: Preservation of Hearts for Transplantation<br>* Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A composite endpoint of patient survival at Day-30 post transplant and absence of severe primary heart graft dysfunction in the first 24 hours post-transplantation |  | 30 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart transplant, heart preservation, beating heart transplant
Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

Study Overview
=================
Brief Summary
-----------------
The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop diuretics in patients with worsening heart failure (HF) and fluid overload.

Official Title
-----------------
A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Aquadex System in Patients With Heart Failure and Fluid Overload

Conditions
-----------------
Heart Failure (for Example, Fluid Overload)

Intervention / Treatment
-----------------
* Device: Aquadex Smartflow® System
* Drug: IV Loop Diuretics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Man, or non-pregnant woman Admitted to the hospital with a diagnosis of acute decompensated heart failure On regularly prescribed oral loop diuretics, Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors or a Mineralcorticoid Receptor Antagonists (MRA) prior to admission Fluid overload manifested by at least three clinical indications (e.g., edema, an excess of at least 10 pounds of fluid, etc.) Provide written informed consent Exclusion Criteria: New diagnosis of heart failure Acute coronary syndromes Creatinine ≥ 3.0 mg/dl or planned renal replacement therapies at the time of enrollment Contraindications to systemic anticoagulation Severe concomitant disease expected to prolong hospitalization or cause death in less than 90 days Sepsis or ongoing systemic infection Active myocarditis Constrictive pericarditis or restrictive cardiomyopathy Severe aortic stenosis Any condition in the opinion of the investigator that would prevent the patient from follow-up/survival

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aquadex ultrafiltration therapy<br> | Device: Aquadex Smartflow® System<br>* ultrafiltration<br>|
| Active Comparator: IV loop diuretics<br> | Drug: IV Loop Diuretics<br>* diuretics<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first heart failure (HF) event | Heart Failure (HF) event defined as any HF rehospitalization or unplanned use of IV loop diuretics, vasoactive medications or Aquadex therapy in any outpatient setting. | within 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, Fluid overload
Improving the Pregnancy Rate With Endometrial Sampling Before Intrauterine Insemination

Study Overview
=================
Brief Summary
-----------------
Endometrial sampling improves the pregnancy rates in superovulation-IUI cycles

Detailed Description
-----------------
Endometrial sampling is performed using the standard technique in the outpatient department. Similarly, superovulation with gonadotrophins will be performed according to our standard practice.Endometrial sampling will be done in the follicular phase not later than day 10 of the cycle. Endometrial sampling will be performed using Pipelle sampling catheter. The Pipelle is inserted gently through the cervical canal into the uterine cavity and advanced slowly till just resistance felt by the operator. Then, the piston is withdrawn to create negative suction and gentle movement of Pipelle up and down in the uterine cavity is performed while it is against the uterine wall. The Pipelle catheter is withdrawn gently and any obtained specimen will be sent for histopathological examination.

Official Title
-----------------
Improving the Pregnancy Rate With Endometrial Sampling Before Intrauterine Insemination

Conditions
-----------------
Infertility, Clinical Pregnancy Rate

Intervention / Treatment
-----------------
* Procedure: Endometrial sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women undergoing superovulation with gonadotrophins and intrauterine insemination. All women with cervical factor, mild male factor and/or unexplained infertility. At least one patent Fallopian tube. Exclusion Criteria: Bilateral tubal disease Severe male factor infertility Intrauterine pathology (submucosal fibroid, endometrial polyp, adhesions) Women with positive cervical culture and/or acute vaginal infection
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Group 1 patients will receive standard superovulation-IUI treatment without endometrial sampling | |
| Active Comparator: 2<br>Group 2 patients will receive standard superovulation-IUI treatment with endometrial sampling performed in the preceding cycle. It will be done in the follicular phase not later than day 10 of the cycle | Procedure: Endometrial sampling<br>* Endometrial sampling performed in the preceding cycle. It will be done in the follicular phase not later than day 10 of the cycle<br>* Other names: Clinical pregnancy rate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of clinical pregnancy |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility, Clinical pregnancy rate
A DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of topical R1 and R2 for prophylaxis of acute radiation dermatitis in patients with breast cancer receiving radiotherapy.

Detailed Description
-----------------
All women will be given two types of Jell. One should be applied immediately after radiation and the second one, 3 times every day. All women will complete detailed questionnaire every two weeks and will be evaluated by the treating team at the same time.All women will be evaluated two weeks after end of radiation period.

Official Title
-----------------
Phase II, Double Blinded, Randomized Study of R1 and R2 (Waterjel) Verses Aloe Vera Jell for the Prevention and Treatment of Radiation Induced Dermatitis in Breast Cancer Patients

Conditions
-----------------
Breast Cancer, Radiation Dermatitis, Erythema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman with histologically confirmed breast cancer who underwent lumpectomy and requires adjuvant radiation therapy with 2 Gy/fx to a total dose of 50 Gy. Women who received neoadjuvant or adjuvant chemotherapy are eligible for the study. Three weeks is the minimal interval between chemotherapy and start of radiation therapy. Patient able to understand the study designed and cooperate with instructions of use. Patient able to sign informed consent Exclusion Criteria: Woman with lactose allergy (lactose intolerance are eligible) Woman with known connective tissue disorder Woman with uncontrolled diabetes Patients receiving radiation protocol with 2.64 Gy/fx or 1.8 Gy/fx Woman who is unable to sign an informed consent
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer patient receiving RT<br>Total dose:2Gy/Fx | |

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast conserving surgery, Radiation dermatitis
The Safety of Thoracentesis, Tunneled Pleural Catheter, and Chest Tubes in Patients Taking Novel Oral Anti-Coagulants

Study Overview
=================
Brief Summary
-----------------
To assess risks of bleeding in those individuals receiving Novel Oral Anti-Coagulant (NOAC) medications, admitted to the hospital and require thoracentesis, chest tube or tunneled pleural catheter placement.

Detailed Description
-----------------
The research component of this study simply observes and documents the outcomes of these procedures. Patients will undergo an analysis of their pre-procedural hematocrit and this will be compared to their post-procedural (next day) hematocrit.

Official Title
-----------------
The Safety of Thoracentesis, Tunneled Pleural Catheter (Pleurx), and Chest Tubes in Patients Taking Novel Oral Anti-Coagulants (NOAC).

Conditions
-----------------
Pleural Effusion, Thoracic Effusion

Intervention / Treatment
-----------------
* Drug: Novel Oral Anti-Coagulants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 y/o Unilateral or bilateral pleural effusion Ability to provide consent or consent given for the procedure and research study Exclusion Criteria: Adults who refuse to provide 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients taking NOAC's<br>Patients with unilateral or bilateral pleural effusions who undergo thoracentesis, chest tube, or pleurx placement and are taking Novel Oral Anti-Coagulants (NOAC). | Drug: Novel Oral Anti-Coagulants<br>* Novel Oral Anti-Coagulant (NOAC) medications (i.e. Eliquis, Plavix, Xarelto etc.)<br>* Other names: NOAC;|
| patients not taking NOAC's<br>Patients with unilateral or bilateral pleural effusions who undergo thoracentesis, chest tube, or pleurx placement who are not taking Novel Oral Anti-Coagulants (NOAC). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of bleeding | Reduced risk of bleeding in individuals receiving Novel Oral Anti-Coagulants as well as those that are in the control group will be assessed by having the patients undergo an analysis of their pre-procedural hematocrit which will be compared to their post procedural (next day) hematocrit | 2 years |
Study Evaluating Prevenar in the Prevention of Invasive Pneumococcal Disease (IPD) in the Paediatric Population in Spain.

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the postlicensure effectiveness of Prevnar in the prevention of IPD in the Spanish paediatric population (children younger than 5 years)

Official Title
-----------------
Effectiveness of Prevnar in the Prevention on IPD in the Paediatric Population in Spain

Conditions
-----------------
Invasive Pneumococcal Disease

Intervention / Treatment
-----------------
* Drug: Pneumococcal 7-valent conjugate vaccine Prevnar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children from 0 up to 5 years attending to the hospital's emergency department will be evaluated for IPD. Diagnosis of IPD will be based on positive pneumococcal isolation in any sterile location, such us blood or spinal fluid.

Ages Eligible for Study
-----------------
Maximum Age: 5 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 |
| --- | --- |
| 1<br>Children from 0-5 years of age evaluated for IPD | Drug: Pneumococcal 7-valent conjugate vaccine Prevnar<br> <br> * Other names: PREVNAR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Kinesiotaping on Elbow Joint Proprioception

Study Overview
=================
Brief Summary
-----------------
assessing the effects of kinesiotape application on elbow joint proprioception

Detailed Description
-----------------
assessing the effects of kinesiotape application on elbow joint proprioception by evaluating joint position sense

Official Title
-----------------
Effect of Kinesiotaping on Elbow Joint Proprioception

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

Intervention / Treatment
-----------------
* Procedure: kinesiotape
* Procedure: sham taping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-85 years Exclusion Criteria: any elbow disorders any neurological disorders

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: kinesiotape<br>kinesiotaping group | Procedure: kinesiotape<br>* an elastic adhesive tape<br>|
| Sham Comparator: control<br>sham group | Procedure: sham taping<br>* a sham taping without the tension<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proprioception by evaluating the joint position sense | proprioception by evaluating the joint position sense of the elbow at 70 and 100 degrees of flexion | 35 minutes |