linjc16/ctgov huggingface dataset:
Screening of the Frailty Degree in the Emergency Department Short Stay Unit

Study Overview
=================
Brief Summary
-----------------
Screen all those> 65 years of age admitted to the Short Stay Unit for frailty, and detect those who are potentially fragile.

Detailed Description
-----------------
Demographic change has led to a change in the profile and age of hospitalized patients, an increase in age and in patients with multiple chronic diseases and more complex health needs is observed. Frailty is known to impact patient health outcomes with medical and surgical procedures. Thus, frailty is correlated with a greater presence of delirium, longer stays, a greater requirement for complementary examinations, a greater presence of mortality and other post-surgical complications, more dependence, more risks derived from hospitalization, and a greater need for convalescence after discharge.

Official Title
-----------------
Systematic Detection and Screening of the Frailty Degree in Patients Admitted to the Emergency Department Short Stay Unit

Conditions
-----------------
Frail Elderly Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 65 years of age admitted to the Short Stay Unit Exclusion Criteria: Patients under 65 years of age admitted to the Short Stay Unit

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To know the degree of frailty with the frail VIG index in patients admitted to the short-stay unit | The Frail Vig index (VIG is the spanish/catalan abbreviation for Comprehensive Geriatric Assessment) is a new, more concise Frailty index for rapid geriatric assessment, which contains 22 simple questions that assess 25 different deficits. The Frail VIG index score assesses the degree of frailty as a continuous variable. The value of the Frail VIG index is between 0 (absence of frailty) and 0.7 (severe frailty) | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elderly, frailty, short stay unit
Patients Who Underwent Surgical Procedures State of Readiness for Discharge

Study Overview
=================
Brief Summary
-----------------
In this study, it was aimed to evaluate the readiness status of patients who are planned to be discharged after the surgical procedure.

Detailed Description
-----------------
Objective: In this study, it was aimed to evaluate the readiness status of patients who are planned to be discharged after the surgical procedure. Method: Explanatory sequential mixed design will be used in accordance with the purpose of the study. The purpose of the exploratory sequential design is to clarify the relationships obtained with the quantitative data by applying the qualitative step. This pattern is applied in two stages. The first phase begins with the collection of quantitative data that will essentially answer the research question. In the second stage, qualitative data are collected and the collected data is interpreted to help explain the quantitative results.

Official Title
-----------------
Patients Who Underwent Surgical Procedures State of Readiness for Discharge: Mixed Methods Research

Conditions
-----------------
Surgery, Patients, Discharge Readiness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being 18 years or older, Willingness and willingness to participate in the study, Having undergone a surgical procedure, Healing / discharge as it is, Not having difficulties in understanding Patients who do not feel ready for discharge according to quantitative data and also agree to participate in the qualitative study Exclusion Criteria: Be under the age of 18, Being discharged without surgical procedure, Transfer to another department

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 |
| --- | --- | --- |
| Readiness status of patients whose discharge is planned | Readiness for Hospital Discharge Scale/Short Form | within 24 hours before discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reasons why patients are not ready for discharge | semi-structured interview form | within 24 hours before discharge |
Immunity and Nasal Fungal Colonization

Study Overview
=================
Brief Summary
-----------------
Fungal colonization causes opportunistic infection that may manifest when the host's immune status deteriorates. The purpose of this study was to determine the prevalence of fungal colonization in immunocompromised subjects compared to healthy controls.

Official Title
-----------------
Host Immunity and Nasal Fungal Colonization

Conditions
-----------------
Colonization, Asymptomatic

Intervention / Treatment
-----------------
* Other: nasal irrigation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Immunocompromised subjects included those who had known risk factors for fungal infection, including malignant diseases, diabetes, autoimmune disorders, renal or hepatic insufficiency, organ transplantation, or use of immunosuppressants Healthy volunteers had neither sinonasal symptoms nor nasal endoscopic inflammation. Exclusion Criteria: Patients were excluded if they were under 20 years old, were receiving antifungal medication, or were pregnant.
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> | |
| immunocompromised subjects<br> | Other: nasal irrigation<br>* regular saline nasal rinse<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nasal lavage pooled fungal microbiota |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nasal lavage aspergillus qPCR |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonization, microbiota, fungi, immunocompromised
Phase I Trial of DAR-901

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1, randomized, controlled, double-blind, multiple-dose, dose-ranging study of DAR 901, (an inactivated whole cell mycobacterial vaccine) to be conducted in HIV negative and HIV positive adults previously vaccinated with BCG. The goals of the trial are to determine the safety, tolerability, and immunogenicity of multiple doses of the vaccine at different dose levels, ranging from 0.1 to 1 mg.

Official Title
-----------------
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Multiple-Dose, Dose-Ranging Study of the Safety and Immunogenicity of DAR-901, a Killed, Non-Tuberculous Mycobacterial Vaccine, in HIV-negative and HIV-positive Adults Who Have Previously Received BCG

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Biological: DAR-901
* Biological: BCG
* Biological: Sterile saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects: age 18-65, prior BCG vaccine (scar) 56 HIV negative subjects: negative ELISA for HIV (48 subjects with negative IGRA, 8 subjects with positive IGRA) 21 HIV positive subjects: positive ELISA for HIV, on ART (13 subjects with negative IGRA, 8 subjects with positive IGRA) Exclusion Criteria: pregnancy, positive serology for hepatitis B or C, active tuberculosis immunosuppression, severe medical illness -

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAR-901<br>Intradermal administration at 0, 2 and 4 months Three dose groups in dose escalation: 0.1 mg, 0.3 mg and 1.0 mg, all constituted in 0.1 mL | Biological: DAR-901<br> <br> |
| Active Comparator: BCG<br>Intradermal injection of 0.1 mL saline at 0 mos, 2 mos, intradermal injection of 0.1 mL BCG at 4 mos | Biological: BCG<br> <br> |
| Placebo Comparator: Sterile saline<br>Intradermal injection of 0.1 mL sterile saline at 0, 2 and 4 mos | Biological: Sterile saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Subjects will be followed for both systemic side effects and injection site reactions | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity | Cellular and humoral responses to the vaccine antigen will be tested at baseline and after each of 3 doses of vaccine | 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BCG, Tuberculosis, HIV, TB Vaccines
Effects of Atorvastatin on Adiponectin Levels and Insulin Sensitivity In Hypercholesterolemic Patients

Study Overview
=================
Brief Summary
-----------------
High dose atorvastatin may worsen insulin sensitivity.

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: statin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypercholesterolemia Exclusion Criteria: chronic renal disease

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: atorvastatin 10 mg, 80 mg<br> | Drug: statin<br> <br> |

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
-----------------
insulin sensitivity
Digitized Grip Strength

Study Overview
=================
Brief Summary
-----------------
Rheumatoid arthritis (RA) is the most common chronic inflammatory arthritis in adults. Monitoring of disease activity is based on Disease Activity Score 28 (DAS 28). There are also validated questionnaires for self-assessment of the disease by the patient. Grip strength measured using a digitized sensor used by the patient could be an additional tool to the remote monitoring of patients with RA. Main Objective : To evaluate the correlation between the measurement of grip strength in the dominant hand measured by a digital sensor and activity of RA assessed by DAS 28 Secondary objective : Evaluate the correlation between grip strength of the dominant hand and : scores of fatigue and pain (VAS and FACIT) the self-assessment scores known in RA : functional index Health Assessment Questionnaire (HAQ) and scores of activity RAPID3 and RADAI5. It is a cross-sectional study involving 150 patients followed in our department for RA. Grip strength of the dominant hand will be measured by a digitalized sensor during a single visit integrating into the routine monitoring of patients.

Official Title
-----------------
Evaluation of Grip Strength With Digitized Sensor in Adults With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Device: Digitized sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rheumatoid arthritis whatever its activity Above 18 years old patients Exclusion Criteria: Other condition that may affect the level of fatigue and / or grip strength Insufficient level of understanding to perform the measurement and self-report questionnaires

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RA patients<br> | Device: Digitized sensor<br>* Measure of grip strength of the dominant hand<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| grip strength | Evaluate the correlation between the measurement of grip strength in the dominant hand measured by a digital sensor and activity of RA assessed by DAS 28 | visit 1 |
Secondary Intervention and Surveillance After EVAR

Study Overview
=================
Brief Summary
-----------------
This is a retrospective cohort study of consecutive patients submitted to elective EVAR, between February/2009 and May/2019 in a single institution. Symptomatic or ruptured AAA, mycotic aneurysms, isolated iliac aneurysms and complex abdominal aortic repairs were excluded. The primary outcomes were freedom from secondary intervention and compliance with follow-up, defined as surveillance imaging performed within a periodicity no longer than 18 months.

Official Title
-----------------
Secondary Intervention and Surveillance After Abdominal Aortic Aneurysm Endovascular Repair: Retrospective Cohort Study

Conditions
-----------------
Abdominal Aortic Aneurysm Without Rupture

Intervention / Treatment
-----------------
* Procedure: EVAR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This is a retrospective cohort study of consecutive patients submitted to elective EVAR, between February/2009 and May/2019 in a single institution. Exclusion Criteria: Symptomatic or ruptured AAA, mycotic aneurysms, isolated iliac aneurysms and complex abdominal aortic repairs were excluded.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients that had secondary interventions after EVAR<br> | Procedure: EVAR<br>* Endovascular repair of abdominal aortic aneurysms<br>|
| Patients without secondary interventions after EVAR<br> | Procedure: EVAR<br>* Endovascular repair of abdominal aortic aneurysms<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participant with secondary intervention (SI) after EVAR | SI included: access-related SI included suture of access bleeds, distal thrombo-embolectomy, patch angioplasty, or thromboendarterectomy of the common femoral artery; limb graft occlusion was defined as a thrombotic obstruction of blood flow in one or both endograft limbs, being a potential threat to the limb; lower limb ischemia was considered when there was a decrease in arterial perfusion of the limb, that was not related with limb graft occlusion; endoleak; stent migration was reported if no simultaneous type 1 endoleak was observed. | 5 years follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participant with compliance with follow-up after EVAR | Non-compliance with surveillance was defined by an 18 months period in which no surveillance imaging was performed. | 5 years follow up |
Autologous Fat Grafting With PRP (Platelet Rich Plasma) to Anophthalmic Sockets

Study Overview
=================
Brief Summary
-----------------
After people lose an eye, for whatever reason, they often experience fat atrophy of the tissues in the orbit. This leads to a sunken appearance that is often not correctable by a cosmetic shell prosthesis. Current techniques to correct this deformity are inadequate/ invasive. Injection of various gels (Restylane, Radiesse) are temporary had have their own disadvantages. This study seeks to demonstrate an improvement in the retention of injected autologous fat by mixing in autologous PRP (platelet rich plasma).

Official Title
-----------------
Autologous Fat Grafting to Anophthalmic Sockets With PRP (Platelet Rich Plasma) Using a Closed Cannula Technique

Conditions
-----------------
Orbital Atrophy

Intervention / Treatment
-----------------
* Procedure: autologous fat grafting with PRP to anophthalmic orbits


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anophthalmos, orbital atrophy - Exclusion Criteria:poor anesthesia risk, people outside a 100 mile radius of New York City -

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 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: fat grafting with PRP to anophthalmic orbits<br>There is only one arm to this study. People with orbital atrophy and loss of an eye are to be injected with autologous fat mixed with autologous PRP (platelet rich plasma) and observed for at least one year for evidence of retention of the injected fat | Procedure: autologous fat grafting with PRP to anophthalmic orbits<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved retention of autologous fat injected into anophthalmic sockets | Non contrast MRIs of the orbits are obtained before, immediately after, and one year after injection of autologous fat mixed with autologous PRP (platelet rich plasma) | 1-5 yrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anophthalmic orbits, autologous fat, platelet rich plasma, orbital atrophy, anophthalmos, cannula
Analysis of Prevalence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy

Study Overview
=================
Brief Summary
-----------------
Achalasia is an uncommon disorder that results from the degeneration of ganglion cells of the myenteric plexus in the lower esophageal wall. Peroral endoscopic myotomy (POEM) is a minimally invasive procedure capable of overcoming limitations of achalasia treatments. This study aimed to: 1) identify the prevalence of reflux esophagitis and asymptomatic GERD in patients who underwent POEM, and 2) evaluate patient and intraprocedural variables associated with post-POEM GERD.

Official Title
-----------------
Analysis of Incidence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy

Conditions
-----------------
Achalasia, GERD

Intervention / Treatment
-----------------
* Other: Patients who underwent POEM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females who are 18 years of age and older and are willing to sign an Informed Consent Form (ICF) Achalasia patients who underwent POEM Exclusion Criteria: Lack of written consent for participation in the study Conditions which are contraindication to Esophagogastroscopy and High-resolution Esophageal Manometry

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 |
| --- |
|Other: Patients who underwent POEM|chalasia patients were recruited from a single center. The pre- and postoperative assessments included Eckardt scores, GerdQ questionnaire, high-resolution esophageal manometry, esophagogastroscopy and pH monitoring.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of gastroesophageal reflux after peroral endoscopic myotomy (POEM) |  | 36 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peroral endoscopic myotomy, High-resolution esophageal manometry
Prospective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
Laparoendoscopic single site cholecystectomy is associated with better cosmetic results and recovery compare to laparoscopic cholecystectomy.

Official Title
-----------------
Prospective Evaluation of Laparoendoscopic Single Site Versus Laparoscopic Cholecystectomy

Conditions
-----------------
Gallbladder Disease

Intervention / Treatment
-----------------
* Procedure: LESS cholecystectomy
* Procedure: Laparoscopic cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gallbladder disease Age: 18-99 Exclusion Criteria: intolerance to laparoscopy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LESS cholecystectomy<br>LESS cholecystectomy | Procedure: LESS cholecystectomy<br>* LESS cholecystectomy<br>|
| Active Comparator: Laparoscopic cholecystectomy<br>Laparoscopic cholecystectomy | Procedure: Laparoscopic cholecystectomy<br>* laparoscopic cholecystectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body image scale |  | 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain VAS |  | 10 days | 
| Analgesic requirement |  |  | 
| time to return to work |  |  | 
| scar scale |  | 1 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cholecystectomy, gallbladder, laparoscopy, laparoendoscopic