linjc16/ctgov huggingface dataset:
Measuring and Improving Medication Adherence in Kidney Transplant Patients

Study Overview
=================
Brief Summary
-----------------
Nonadherence to medication is a major obstacle to successful treatment of renal transplant patients. This study has two primary aims. The first is to test whether a culturally sensitive cognitive-behavioral adherence promotion program could significantly improve medication adherence to tacrolimus prescription. Participants will be randomly assigned to either group CBT or to standard care. The second aim is to pilot a novel strategy of adherence measurement - unannounced telephone pill counts, which has been shown to be a valid and reliable means to measure medication adherence in other patient populations. Participants will be recruited from waiting area of the kidney transplant clinic at SUNY Downstate Medical Center in Brooklyn, NY. Three unannounced telephone pill counts will be conducted prior to start of the intervention in order to establish baseline adherence and three pill counts will be conducted post-intervention. Tacrolimus trough concentration levels will also be collected as an additional biological measure of adherence.

Official Title
-----------------
The Use of Random Telephone Calls to Measure Immunosuppressive Therapy Adherence in Patients With Renal Transplants

Conditions
-----------------
Kidney Transplant Recipients

Intervention / Treatment
-----------------
* Behavioral: Cognitive-behavioral adherence promotion program
* Behavioral: Standard Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - current prescription of tacrolimus less than 98% adherence to medication prescription as determined by three baseline pill counts Exclusion Criteria: - lack of telephone to complete pill counts lack of English proficiency to participate in adherence promotion sessions

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: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group CBT<br> | Behavioral: Cognitive-behavioral adherence promotion program<br>* A culturally sensitive group cognitive behavioral therapy combined with adherence promotion.<br>|
| Active Comparator: Standard Care<br> | Behavioral: Standard Care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence as measured by unannounced telephone pill count |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of agreement between pill count data and laboratory tacrolimus levels |  | 3 months |
Molecular Breath Print of COPD Patients With Exacerbations Despite Triple Inhalational Therapy

Study Overview
=================
Brief Summary
-----------------
Determination of specific molecular breath patterns by secondary electrospray ionisation mass spectrometry (SESIHRMS) during and 8 weeks after a COPD exacerbation. Furthermore, breath patterns will be assessed for correlation and association to clinical outcomes and treatment.

Official Title
-----------------
Molecular Breath Print of COPD Patients With Exacerbations Despite Triple Inhalational Therapy (TripleEX)

Conditions
-----------------
COPD Exacerbation

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent age >= 18 years staged according to GOLD recommendations GOLD stage 2-4, risk groups A-D hospitalization due to COPD exacerbation subjects adherent to triple inhalational therapy (beta-2-sympathomimetics, anticholinergics, steroids) suitable for follow-up assessment <48 hours after initiation of antibiotic therapy or systemic steroid therapy Exclusion Criteria: physical or intellectual impairment precluding informed consent or protocol adherence known pregnancy congenital defects with direct impact on central metabolism e.g. amino acid metabolism defect uncontrolled diabetes (e.g. HbA1c >11% or Glc >20mmol/l). acute or chronic pulmonary disease other than COPD renal failure or renal replacement therapy (GFR < 15 mL/min)

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 |
| --- | --- |
| Exacerbators<br>Patients with COPD exacerbation | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled breath metabolites | Change in exhaled breath metabolites during vs after COPD exacerbation | twice during 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms | Correlation of breath metabolites with symtpoms (mMRC and CAT) | twice during 8 weeks | 
| Inflammation | Correlation of breath metabolites with CRP, eosinophils, exhaled NO | twice during 8 weeks | 
| Causative agents | Correlation of breath metabolites with sputum microbiology and viral swabs | twice during 8 weeks | 
| Treatment | Correlation of breath metabolites with inhalational durgs, steroids, antibiotics | twice during 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exhaled breath analysis, Mass spectrometry
Seroconversion in COVID-19 Recovered Population

Study Overview
=================
Brief Summary
-----------------
This study investigate the kinetics of IgG responses to both N and S proteins in the subjects who suffered from COVID 19 and then had recovered.

Detailed Description
-----------------
Coronaviruses (CoVs) are enveloped, single positive-strand RNA viruses belonging to the large subfamily Coronavirinae, which can infect mammals and several other animals.The continued spread of coronavirus disease 2019 (COVID-19) has prompted widespread concern around the world, and the World Health Organization (WHO), on 11 March 2020, declared COVID-19 a pandemic. Studies on severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) showed that virus-specific antibodies were detectable in 80-100% of patients at 2 weeks after symptom onset. Currently, the antibody responses against SARS-CoV-2 remain poorly understood and the clinical utility of serological testing is unclear Little is known about the kinetics, tissue distribution, cross-reactivity and neutralization antibody response in COVID-19 patients . The seropositivity rate of both IgM and IgG responses after onset and recovery of disease, and in the context of both N protein and S protein has not been clarified. The kinetics of antibody responses in critical cases or ICU patients has not been reported, and no studies have suggested whether antibody response is associated with disease prognosis

Official Title
-----------------
Seroconversion in COVID-19 Recovered Population: an Observational Study

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

Intervention / Treatment
-----------------
* Diagnostic Test: IgG SARS CoV2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects recovered from COVID 19 confirmed on PCR or clinically Exclusion Criteria: subjects who have not been confirmed suffering from COVID 19 by PCR or clinically
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: IgG SARS CoV2|IgG SARS CoV 2 will be checked in serum of COVID 19 recovered population|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgG SARS CoV2 | Presence or absence of SARV CoV2 IgG antibodies | 5 months |
Integrated Clinical-radiological Analysis of Hypoxia Markers in Pediatric Osteosarcomas

Study Overview
=================
Brief Summary
-----------------
The aim of this pilot study is therefore to retrospectively measure the volume and percentage of necrosis on diagnostic MRI in T1 sequence and in parallel to study the expression of immunohistochemical markers of hypoxia (HIF-1α, CAIX , HIF-2α, pS6, phosphomTor, CD163 and CD68) on diagnostic biopsies of high-grade osteosarcomas from 2007 to 2018 in the Strasbourg center, focusing on the pediatric population. The investigators will systematically carry out a correlation analysis between these different parameters and with the clinical data of these same patients (response to chemotherapy, presence of metastases or not and overall and recurrence-free survival). This will eventually make it possible to highlight new prognostic markers at diagnosis.

Official Title
-----------------
Integrated Clinical-radiological Analysis of Hypoxia Markers in Pediatric Osteosarcomas - Single-center Pilot Study of 32 Patients

Conditions
-----------------
Osteosarcoma in Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject ≤ 20 years at diagnosis Subject having been treated for osteosarcoma in the OS2006 protocol or treated according to Supported at Strasbourg University Hospitals between 05/01/2007 and 10/31/2018 Availability of its diagnostic tumor material stored in paraffin having an MRI diagnostic evaluation comprising the injected T1 sequences necessary for the analysis of the volume / necrotic proportion. Exclusion Criteria: Opposition of the patient (or his legal representatives if he is a minor) to participate in the study Diagnosis other than osteosarcoma Biological tissue from a patient who does not meet all the inclusion criteria Patient under legal protection Patient under guardianship or guardianship

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 20 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 |
| --- | --- | --- |
| Retropsective study of pediatric osteosarcomas |  | Files analysed retrospectively from January 01, 2007 to December 31, 2018 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteosarcoma, Necrosis, Immunohistochemical markers of hypoxia, Hypoxia, Chemotherapy, Metastasis
Covid-19 Pandemic and Use of Video Laryngoscopy

Study Overview
=================
Brief Summary
-----------------
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes a highly contagious infection with the highest viral load in the upper respiratory secretions. Despite using personal protective equipment, SARS-CoV-2 contamination to the healthcare personnel is possible during the airway management of infected patients. Direct laryngoscopy remains as the most common method for endotracheal intubation. Our study aimed to compare the use of video laryngoscopy with direct laryngoscopy for tracheal intubation in adult patients receiving general anesthesia for elective surgery during the COVID-19 pandemic.

Official Title
-----------------
Airway Management During the Covid-19 Pandemic: A Comparison of Direct Laryngoscopy Versus Video Laryngoscopy

Conditions
-----------------
COVID-19 Pneumonia

Intervention / Treatment
-----------------
* Device: Videolaryngoscope
* Device: Macintosh Laryngoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II Elective surgery Exclusion Criteria: Intraoral or neck surgery gastroesophageal reflux delayed gastric emptying pregnancy scoliosis

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Videolaryngoscopy<br>The patients were intubated with the C-MAC PM-Karl Storz Video laryngoscope. | Device: Videolaryngoscope<br>* C-MAC PM-Karl Storz<br>|
| Active Comparator: Laryngoscopy<br>The patients were intubated with the Macintosh laryngoscope. | Device: Macintosh Laryngoscope<br>* Laryngoscope<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation time | Time from Beginning of Intubation to Full Ventilation of the Lungs | First 5 minutes of the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation Comfort | Scale(0=bad, 1=moderate, 2=good 3=very good) | First 5 minutes of the operation | 
| Cormack-Lehane Scoring | Scale(1= Full view of glottis, 2=Partial view of glottis 3=Only epiglottis seen, none of glottis seen 4=Neither glottis nor epiglottis seen) | First 5 minutes of the operation |
Comparison of Quality of Recovery Between Remimazolam and Propofol Anesthesia in Patients Undergoing Arthroscopic Meniscectomy

Study Overview
=================
Brief Summary
-----------------
This study aims to compare quality of recovery after surgery and anesthesia between patients undergoing arthroscopic meniscectomy under general anesthesia with either propofol or remimazolam based total intravenous anesthesia. This study is a randomized trial with a 50% probability of being assigned to either group. Randomization will be done by an anesthesiologist not involved in anesthesia or postoperative outcome assessment. Patients and the investigator in charge of postoperative outcomes assessment will be blinded to group allocation.

Official Title
-----------------
Comparison of Quality of Recovery Between Remimazolam and Propofol Anesthesia in Patients Undergoing Arthroscopic Meniscectomy

Conditions
-----------------
Adult Patients 19 or Older Scheduled for Elective Arthroscopic Meniscectomy

Intervention / Treatment
-----------------
* Drug: Propofol TIVA
* Drug: Remimazolam TIVA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients 19 or older, ASA class I III, scheduled for arthroscopic meniscectomy under general anesthesia and eligible for LMA use. Exclusion Criteria: Patient refusal, patients unable to read consent form, active URI or uncontrolled asthma, pneumonia, history of allergies to propofol or benzodiazepines, decreased liver or kidney function, heart failure of ejection fraction<55%, pregnant or breastfeeding patients, history of substance abuse/addiction

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br>Patients receiving general anesthesia with propofol-based total intravenous anesthesia | Drug: Propofol TIVA<br>* Patients will receive propofol-based TIVA with propofol and remifentanil TCI (target controlled infusion)<br>|
| Experimental: Remimazolam<br>Patients receiving general anesthesia with remimazolam-based total intravenous anesthesia | Drug: Remimazolam TIVA<br>* Patients will receive remimazolam-based TIVA with remimazolam infusion and remifentanil TCI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery (QoR)-40 questionnaire | Quality of recovery assessed with the QoR-40 questionnaire, which is a widely-used, self-rated, self-completed questionnaire for postoperative patients. | Postoperative 24 hours |
Longitudinal Followup of Patients Under Substitution Therapy From the Moment They Enter a Specialized Care Center for Addicts to the Period They Are Monitored by a General Practitioner Outside the Specialized Care Center

Study Overview
=================
Brief Summary
-----------------
This study is part of the french priorities of the 2007-2011 addiction plan. Priority #2 of the plan underlines the need to improve practices and access to opioid substitution treatment. Priority 3 stresses the importance of articulation and coordination between specialized structures and community medicine to optimize the quality of care and to ensure continuity in the followup of these patients. This study focuses on the followup of patients under substitution therapy from the moment they enter a specialized care center for addicts to the period they are monitored by a general practitioner outside the specialized care center. The assessment described in this study should allow to harmonize and keep a continuity in patient monitoring.

Official Title
-----------------
Longitudinal Followup of Patients Under Substitution Therapy From the Moment They Enter a Specialized Care Center for Addicts to the Period They Are Monitored by a General Practitioner Outside the Specialized Care Center

Conditions
-----------------
Addiction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients entering a specialized medical care center for addicts Exclusion Criteria: Patients refusing to sign the consent for participation
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 |
| --- | --- | --- |
| Evolution of the severity score to heroin addiction (TMSP score) |  | From the time patients start to be followed in the specialized care center to the time they leave the specialized care center (up to 5 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the score of quality of life scale |  | From the time patients start to be followed in the specialized care center to the time they leave the specialized care center (up to 5 years) | 
| Evolution of the severity score to heroin addiction (TMSP score) |  | From the time patients leave the specialized care center to the time they are followed by a general practitioner (up to 5 years) | 
| Evolution of the score of quality of life scale |  | From the time patients leave the specialized care center to the time they are followed by a general practitioner (up to 5 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Substitution Therapy, Specialized Care Center for Addicts
Impact of Zinc and Vitamin D3 Supplementation on the Survival of Aged Patients Infected With COVID-19

Study Overview
=================
Brief Summary
-----------------
Mortality from Covid-19 increases with age, reaching 14.8% from the age of 80. The severity of the infection is linked to the acute respiratory distress syndrome (ARDS) which requires intensive care. ARDS is the consequence of the reactional inflammatory storm that damages the lungs. Aged subjects are particularly prone to zinc and vitamin D deficiency. These two micronutrients are able to modulate the immune response by reducing the inflammatory storm. The hypothesis is that supplementation with zinc and vitamin D would reduce the inflammatory reaction which worsens ARDS and leads to the death of subjects infected with Covid-19.

Official Title
-----------------
Impact of Zinc and Vitamin D3 Supplementation on the Survival of Institutionalized Aged Patients Infected With COVID-19

Conditions
-----------------
SARS-CoV 2

Intervention / Treatment
-----------------
* Dietary Supplement: Zinc gluconate
* Dietary Supplement: 25-OH cholecalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Institutionalized Exclusion Criteria: Life expectancy < 1 month independently of Covid-19 infection (overall subjects) Known hypercalcemia History of renal lithiasis

Ages Eligible for Study
-----------------
Minimum Age: 60 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: Group supplementation<br> | Dietary Supplement: Zinc gluconate<br>* Zinc gluconate capsule 15 mg x 2 per day during 2 months<br>Dietary Supplement: 25-OH cholecalciferol<br>* 25-OH cholecalciferol drinkable solution 10 drops (2000 IU) per day during 2 months<br>|
| No Intervention: Group usual treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate in asymptomatic subjects at inclusion |  | Two months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate in symptomatic subjects at inclusion |  | Two months after inclusion | 
| Survival rate in overall subjects | symptomatic subjects and asymptomatic subjects | Two months after inclusion | 
| Cumulative incidence of Covid-19 infection in asymptomatic subjects at inclusion |  | Within two months after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Survival, Covid-19, Aged subjects, Zinc, 25-OH cholecalciferol