linjc16/ctgov huggingface dataset:
SaRS-Cov-2 Antibodies Following Exposure to Coronavirus Disease 2019 (COVID-19) and/or Vaccination in Nursing Homes

Study Overview
=================
Brief Summary
-----------------
Presence of SaRS-Cov-2 antibodies following exposure to Coronavirus Disease 2019 (COVID-19) and/or vaccination is a major indicator of immunization. Few data exit about serology response in nursing homes (NHs), i.e. in the most vulnerable population for developing severe forms of the disease. Residents and health professionals in 9 nursing homes (NHs) with SaRS-Cov-2 antibodies detection after exposure (either COVID-19 or vaccine) All biological tests were performed in the frame of the standard care of residents and health professionals and all participants did not express opposition for using anonymously their data for the purpose of this academic analysis. In addition all Directors and Physicians of these NHs accepted to participate in this study

Official Title
-----------------
SaRS-Cov-2 Antibodies Following Exposure to COVID-19 and/or Vaccination in Nursing Homes

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

Intervention / Treatment
-----------------
* Diagnostic Test: SARS-CoV-2 antibodies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For Residents: Living in one of the 9 Nursing Homes that participate in this study Having a SARS-COV-2 post vaccination serology. Having no objection for using the results of the serology for the purpose of this analysis For Health Professionals: Working in one of the 9 Nursing Homes that participate in this study, Having a SARS-COV-2 post vaccination serology. Having no objection for using the results of the serology for the purpose of this analysis Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 110 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 |
| --- | --- |
| Residents in Nursing homes<br> | Diagnostic Test: SARS-CoV-2 antibodies<br>* Analysis of the results of the serological response to COVID-19 and/or Vaccine<br>|
| Health professionals in Nursing homes<br> | Diagnostic Test: SARS-CoV-2 antibodies<br>* Analysis of the results of the serological response to COVID-19 and/or Vaccine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of SARS-COV-2 antibodies | Study of the SARS-COV-2 antibodies according to the history of COVID-19 and vaccinal status in Nursing Home residents and in health professionals | Through study completion average 6 months Retrospective analysis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV-2, Antibodies, Vaccination, Nursing Homes
Clinical and Radiographic Outcomes After AMIC Treatment for Talus Osteochondral Lesion Trattamento Artroscopico Delle Lesioni Osteocondrali Dell'Astragalo Con Tecnica AMIC

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to evaluate clinical and radiographic outcomes in patients undergone all-arthroscopic autologous matrix induced chondrogenesis for symptomatic osteochondral talar lesions

Official Title
-----------------
Valutazione Dell'Epidemiologia e Dei Risultati Radiografici e Clinici Nel Trattamento Artroscopico Delle Lesioni Osteocondrali Dell'Astragalo Con Tecnica AMIC

Conditions
-----------------
Talar Osteochondral Defect of Ankle, Pain, Arthroscopy

Intervention / Treatment
-----------------
* Other: AT-AMIC (arthroscopic talus autologous matrix induced chondrogenesis)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 years males and females patients underwent arthroscopic cartilage reconstruction surgery with AMIC technique for osteochondral lesions of the talus Exclusion Criteria: age <18 years at the time of surgery patients with previous surgery on the affected ankle

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Other: Chondro-gide - Geistlich<br>Arthroscopic use of chondro-gide to treat symptomatic osteochondral talar lesion | Other: AT-AMIC (arthroscopic talus autologous matrix induced chondrogenesis)<br>* to fill arthroscopically osteochondral talar lesion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiologic reduction of the lesion | A reduction of at least 30% of the lesion is to be expected | 5 years |
Provider Perspectives on Beta-lactam Therapeutic Drug Monitoring Programs in the Critically Ill

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to characterize various healthcare practitioners' perspectives on implementation of beta-lactam therapeutic drug monitoring in critical care practice.

Official Title
-----------------
Provider Perspectives on Beta-lactam Therapeutic Drug Monitoring Programs in the Critically Ill: a Multicenter Mixed-methods Study

Conditions
-----------------
Sepsis, Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Providers involved with beta-lactam TDM for critically ill patients Exclusion Criteria: None

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 |
| --- | --- | --- |
| Frequency of drug level testing recommended | Indication of how many critically ill patients treated with beta-lactams should receive TDM. | Baseline | 
| Nature of drug level testing recommended | Indication of which types of critically ill patients treated with beta-lactams should receive TDM | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determinants of beta-lactam TDM implementation | List of factors associated with successful beta-lactam TDM implementation | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics, therapeutic drug monitoring, mixed methods, implementation science, beta-lactam antibiotic
Clinical Evaluation of the APTIMA® HPV Assay Using the PANTHER™ System

Study Overview
=================
Brief Summary
-----------------
The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.

Detailed Description
-----------------
The APTIMA HPV Assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. The APTIMA HPV Assay does not discriminate between the 14 high-risk types. Cervical specimens collected in ThinPrep Pap Test vials containing PreservCyt® Solution with commercially available collection devices (broom-type device or cytobrush/spatula combination) may be tested with the APTIMA HPV Assay either pre- or post-Pap processing. The assay is used with the TIGRIS System and the PANTHER System. The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.

Official Title
-----------------
Clinical Evaluation of the APTIMA® HPV Assay Using the PANTHER™ System

Conditions
-----------------
Human Papilloma Virus Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the sample had an aliquot with a valid positive or negative APTIMA HPV Assay TIGRIS System result (from testing under protocol 2007HPVASCUS30) an aliquot is available and suitable for testing, and the sample was randomly selected for inclusion. Exclusion Criteria: sample integrity was compromised (eg, stored under unacceptable conditions)

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

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 |
| --- | --- |
| AHPV positive and negative subjects<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV Assay result Agreement between TIGRIS and PANTHER Systems | Percent Positive Agreement: The number of samples with a positive HPV Assay result on TIGRIS and PANTHER divided by the number of samples with a positive HPV Assay result on TIGRIS, multiplied by 100 Percent Negative Agreement: The number of samples with a negative HPV Assay result on TIGRIS and PANTHER divided by the number of samples with a negative HPV Assay result on TIGRIS, multiplied by 100 | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HPV
A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.

Official Title
-----------------
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia

Conditions
-----------------
Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness, Severe Hypoglycemia

Intervention / Treatment
-----------------
* Biological: VX-880


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Clinical history of T1D with > 5 years of duration At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment Stable diabetic treatment Consistent use of continuous glucose monitor (CGM) for at least 3 months before Screening and willingness to use CGM for the duration of the study Key Exclusion Criteria: Prior islet cell transplant, organ transplant, or cell therapy Other protocol defined Inclusion/Exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: VX-880<br> | Biological: VX-880<br>* Infused into the hepatic portal vein.<br>* Other names: Formerly known as STx-02;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | From VX-880 infusion to end of study (up to 5 years) | 
| Proportion of Participants Free of Severe Hypoglycemic Events With Either a Glycosylated Hemoglobin (HbA1c) <7.0% or a ≥ 1% Reduction in HbA1c From Baseline |  | At 1 year after VX-880 infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants who are Insulin Independent |  | At 1 year after VX-880 infusion | 
| Changes in Stimulated C-peptide |  | At 1 year after VX-880 infusion |
31P Magnetic Resonance Spectroscopy Fructose Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of an oral fructose challenge on liver adenosine triphosphate (ATP) reserves using 31P magnetic resonance spectroscopy (MRS) as a potential measure measure of liver health.

Detailed Description
-----------------
This study uses 31P spectra acquired from the liver in healthy subjects following a fructose drink to monitor ATP levels. This is also related to baseline BMI, liver glycogen and liver lipid levels

Official Title
-----------------
Investigating the Effects of an Oral Fructose Challenge on Hepatic ATP Reserves in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Dietary Supplement: Fructose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Age 18 - 30 BMI 20 - 27 kg/m^2 Healthy Exclusion Criteria: Smokers Liver disease or Metabolic Disorders Metal implants (not suitable for MRI)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fructose<br>Oral Fructose Challenge (75 g fructose in 500 ml water) followed by 75 minutes 31P MRS | Dietary Supplement: Fructose<br>* Oral Fructose Challenge (75 g fructose in 500 ml water) following overnight fast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic ATP reserves following an oral fructose challenge | Monitor hepatic ATP levels following an oral fructose challenge using 31P magnetic resonance spectroscopy | 2 hours post prandial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate hepatic ATP depletion / recovery with BMI, liver lipids and liver glycogen | Measure baseline liver lipid and glycogen using magnetic resonance spectroscopy and correlate BMI, lipid and glycogen levels with rate of ATP depletion and recovery following an oral fructose challenge | 2 hours post prandial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NAFLD, Oral Fructose Challenge, 31P MRS, Liver, Subjects
Genetic Markers of Circulating Tumor DNA for Monitoring Breast Cancer Patients in Costa Rica

Study Overview
=================
Brief Summary
-----------------
The use of circulating tumor DNA (ctDNA) as a noninvasive test for breast cancer monitoring throughout the course of the disease

Detailed Description
-----------------
The concentrations of the cell free DNA (cfDNA) and somatic mutations in circulating tumor DNA (ctDNA) in serial samples correlate with the number of days of the progression-free period and with the overall survival.

Official Title
-----------------
Genetic Markers of Circulating Tumor DNA for Monitoring Breast Cancer in Patients of the Hospital San Juan de Dios From 2018 to 2020.

Conditions
-----------------
Metastatic Breast Cancer, Mutation, Point

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic breast cancer before the start of chemotherapeutic treatment Exclusion Criteria: Patients with incomplete clinical records

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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 |
| --- | --- | --- |
| Assessment of circulating free DNA (cfDNA) concentration (in ng/uL) obtained from peripheral blood (liquid biopsy). | Samples will be analyze with Real time PCR and fluorometric assay and compare with overall survival | 12 months | 
| Number of somatic mutation findings in circulating free DNA (cfDNA) obtained from peripheral blood (liquid biopsy) | Samples will be analyze with targeted NGS sequencing panel | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estrogen Receptor (ER), Progesterone Receptor (PR), Human Epidermal Growth Factor Receptor 2 (HER2) status | ER, PR, HER2 status | 24 months | 
| Overall survival of participant | Overall survival of participant | 24 months | 
| Cancer stage of participant | Cancer stage of participant | 24 months |
Intervention Study of Mind-Body Physical Activity in Frail Institutionalized Elderly

Study Overview
=================
Brief Summary
-----------------
Few previous studies have explored the effects of mind body approaches on health-related quality of life (HRQoL) in frail elderly. Cognition and action are an inseparable whole while functioning. A new intervention-based approach using familiarity based movements and a non-judgmental approach was labeled cognition-action. The investigators aimed to explore the effects of two different mind-body exercise types on (HRQoL) in frail institutionalized elderly. The investigators' main hypothesis is that adaptated physical activity in frail institutionalized elderly can improve HRQoL.

Official Title
-----------------
A Randomized Interventional Study of a Cognition-Action Physical Activity and Adapted Tai-Chi in Frail Institutionalized Elderly

Conditions
-----------------
Aging, Frailty

Intervention / Treatment
-----------------
* Behavioral: Mind-body exercises
* Behavioral: Adapted Tai-chi


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 65 and older Institutionalized Ability to get up alone or with technical or human help if necessary and ability to understand basic motor commands Have given a signed consent Exclusion Criteria: Terminally ill and bedridden patients Unable or unwilling to sign the consent Have participated in a study in the past 3 month

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CA<br>Cognition and action are an inseparable whole while functioning, a new intervention based approach using familiarity based movements and non judgmental approach was labeled cognition-action. | Behavioral: Mind-body exercises<br> <br> |
| Active Comparator: AT<br>Adapted Tai Chi is based on Tai Chi like movements | Behavioral: Adapted Tai-chi<br> <br> |
| No Intervention: C<br>Control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MOS SF-12 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go test |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tertiary prevention of disability
Aging Well, Sleeping Efficiently: Protecting Health In Later Life

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see whether protecting sleep quality in later life is important in continued healthy aging. The value of education in healthy sleep practices along with reducing time in bed each night by going to bed 30 minutes later, and of healthy dietary practices will be tested for their effects on sleep quality, health, and well being.

Detailed Description
-----------------
The goal of this project is to test the efficacy of restricting time in bed and education in healthy sleep practices for maintaining or even enhancing sleep consolidation and depth in subjects aged 75+ who are at risk for decay in sleep quality and daytime well being; to determine the associated benefits for health; and to examine the persistence of such effects for 12 months beyond the end of the 18-month intervention. This project focuses not on pathology but on prevention of sleep decay and preservation of sleep in individuals who have already evidenced successful aging.

Official Title
-----------------
AGEWISE Project 4: PROTECTING HEALTH IN LATER LIFE

Conditions
-----------------
Sleep, Health Promotion

Intervention / Treatment
-----------------
* Behavioral: Modest sleep deprivation with sleep hygiene education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 75 or older without sleep disorders without psychiatric disorders Folstein MMSE of 24 or greater Exclusion Criteria: Apnea-hypopnea index greater than 30 Mean sleep latency less than 6 Psychotropic medications present

Ages Eligible for Study
-----------------
Minimum Age: 75 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Modest sleep deprivation with sleep hygiene education|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polysomnographic measures of sleep consolidation, sleep depth and daytime sleepiness at baseline, 6mos.,12mos., 18mos.,30 mons. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical measures of sleep quality, general functioning, mental health at baseline,6 mos., 12 mons., 18mons.,30mons. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep, Sleep Hygiene, Modest sleep deprivation, Healthy Aging and sleep, Health Promotion