linjc16/ctgov huggingface dataset:
Vitamin D and Inflammatory Markers of Cardiovascular Disease in African Americans With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Recent clinical trials in non diabetics showed that vitamin D supplementation markedly reduced serum levels of C-reactive protein (CRP), interleukin-6, and tissue matrix metallo-proteinases. Our study objective is to evaluate if administration of vitamin D in African Americans with hypovitaminosis D and DM Type 2 decreases serum levels of inflammatory/thrombotic markers such as CRP: Highly Sensitive C Reactive Protein.

Detailed Description
-----------------
Other questions in our study: In diabetic African American patients, Prevalence of vitamin D deficiency? Correlation/relationship between vitamin D levels, Calcium level, parathyroid hormone (PTH) and Inflammatory markers Setting: All visits will take place at the Fantus Diabetes Clinic.

Official Title
-----------------
Does Administration of Vitamin D in African Americans With Hypovitaminosis D and Type 2 DM Improve Inflammatory Markers of Cardiovascular Disease?

Conditions
-----------------
Vitamin D Deficiency, Diabetes

Intervention / Treatment
-----------------
* Drug: Ergocalciferol
* Drug: Placebo pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African Americans DM type 2 Exclusion Criteria: symptomatic vitamin D deficiency hypocalcemia hypercalcemia malabsorption liver disease patients with creatinine > 1.5. (CKD >/= 3) pregnancy
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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ergocalciferol<br>The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week) | Drug: Ergocalciferol<br>* Active Comparator: Ergocalciferol The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week)<br>* Other names: Vitamin D;|
| Placebo Comparator: Placebo pill<br>The investigators will give intervention group 12 weeks of placebo pill (in pill every week) | Drug: Placebo pill<br>* The investigators will give control group 12 weeks of 1 placebo pill every week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of inflammatory markers |  | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of Vitamin D, PTH and Calcium |  | Baseline and 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inflammatory markers
Implantable Systems Performance Registry

Study Overview
=================
Brief Summary
-----------------
The Implantable Systems Performance Registry (ISPR) was developed to evaluate the long-term reliability and performance of market-released Medtronic Neuromodulation infusion and stimulation products. Completion Notice: The ISPR was created by Medtronic to monitor the performance of commercially available products. This registry was initially designed to track performance of Medtronic's implantable infusion and spinal cord stimulation systems beginning in August 2003 and June 2004, respectively. Medtronic DBS Systems were added to the ISPR in June 2009, and Sacral Neuromodulation Systems in April 2010. Medtronic retired the ISPR in April 2016 and merged the data collected from this registry into the Product Surveillance Registry (PSR). Please refer to that record, Clinical Trials identifier: NCT01524276, for further information.

Official Title
-----------------
Implantable Systems Performance Registry

Conditions
-----------------
Spinal Cord Stimulation, Deep Brain Stimulation, Drug Infusion (Implantable Pumps), Sacral Neuromodulation

Intervention / Treatment
-----------------
* Device: Various


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for an implant or replacement with a market-released Medtronic implantable drug pump, spinal cord stimulator, deep brain stimulator, or sacral nerve stimulator Exclusion Criteria: Patient who is or will be inaccessible for follow-up at an ISPR study site Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study
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 with a device implant<br>Patients implanted and consented at a study center with a market-released Medtronic implantable drug pump, spinal cord stimulator, deep brain stimulator, or sacral nerve stimulator. | Device: Various<br>* Patients implanted and consented at a study center with a market-released Medtronic implantable drug pump, spinal cord stimulator, deep brain stimulator, or sacral nerve stimulator.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Product Performance | To quantify and compare the rates of device-related events for market-released Medtronic Neuromodulation infusion and stimulation devices | Annually | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Registry, Pain, Chronic Pain, Back Pain, Intractable Spasticity, Parkinson's Disease, Essential Tremor, Dystonia, Implantable Pumps, Incontinence
Change in Cognitive Function in Obese Patients After Bariatric Surgery - an Observational Study

Study Overview
=================
Brief Summary
-----------------
Bariatric surgery provides a strong and long-term effect in reducing weight in obese subjects. Studies showed that obesity and its comorbidities are associated with a lower cognitive performance. The aim of the researchers study is to examine the cognitive performance of the patients before and after bariatric surgery.

Official Title
-----------------
Change in Cognitive Function in Obese Patients After Bariatric Surgery - an Observational Study

Conditions
-----------------
Obesity, Bariatric Surgery

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 40 Age: 18-60 Exclusion Criteria: BMI < 40 Age < 18 and > 60 Presence of Cancer Presence of Chronic Inflammatory Diseases Presence of Addiction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Bariatric Surgery<br> | Other: Observation<br>* Observational study to examine changes in cognition following bariatric surgery after one year.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| performance in a neuropsychological test battery before and after surgery |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| performance in neuropsychological test battery 12 month after surgery compared to performance after 6 month and baseline performance |  | 12 month | 
| performance in further cognitive tests |  | 6 - 12 month | 
| surrogat parameters, blood parameters |  | 6-12 month |
Response Evolution Chart

Study Overview
=================
Brief Summary
-----------------
This study evaluates patient response to a motivation evolution chart for a medical-nutrition intervention as a continuation of a previous study: adherence to an overweight and obesity treatment available at: https://www.ncbi.nlm.nih.gov/pubmed/25101227

Official Title
-----------------
Adherence to an Overweight and Obesity Treatment: the Evolution Chart

Conditions
-----------------
Obesity, Overweight, Motivation, Adherence, Patient

Intervention / Treatment
-----------------
* Other: Lifestyle-medicine intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Voluntary assistance Clinical diagnosis of overweight Clinical diagnosis of obesity Patient desire to improve their aesthetic image and health status Exclusion Criteria: This study does not consider patients who tried a diet to lose weight in the previous month or earlier

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Lifestyle-medicine intervention<br>Photographic follow-up every 4 weeks | Other: Lifestyle-medicine intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution registration by photograph | To register Body Image of patients regarding results to a medical nutrition treatment | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
motivation, Treatment adherence, Waist circumference, obesity, overweight
Sculptra for Décolletage Crepiness and Wrinkling

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of Sculptra as a volume agent to improve décolletage crepiness and wrinkling.

Conditions
-----------------
Décolletage

Intervention / Treatment
-----------------
* Other: Sculpta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female volunteer Aged from 40-70 years on the day of screening No known medical conditions that may interfere with study participation Moderate to severe crepiness and wrinkling of the décolletage Willingness to not use any products on their décolleté for the duration of the study Read, understand, and sign informed consent forms Willingness to sign photography release form Willing and able to comply with all follow-up requirements Willingness to undergo a series of three Sculptra injections, 2-3 months apart, in their décolletage Exclusion Criteria: Any significant skin disease at treatment area Any medical condition which could interfere with the treatment Inability or unwillingness to follow the treatment schedule Inability or unwillingness to sign the informed consent History of poor wound healing History of keloid formation History of HIV, hepatitis, immuno-compromised Pregnant or lactating Previous use of deep chemical peels on the treatment area Previous injections of Sculptra in the décolletage Known hypersensitivity to Sculptra or any of its ingredients Previous laser or light based treatments to the treatment area 6 months prior to the screening visit

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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: Sculptra<br>Sculptra, an injectable implant containing microparticles of ply-L-lactic acid, carboxymethylcellulose, non-pyrogenic mannitol and sterile water, will be injected into the decolletage. | Other: Sculpta<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in décolletage crepiness and wrinkling in treatment area as measured by 5 point décolletage wrinkle scale |  | Screening, Treatment 1, Treatment 2, Treatment 3, 1 Month Follow up, 3 Month Follow up and 6 Month Follow up |
End-Tidal Carbon Dioxide as a Measure of Carboxyhemoglobin in Carbon Monoxide Poisoning

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a relationship exists between EtCO2 and carboxyhemoglobin levels in carbon monoxide exposure. Our hypothesis is that a liner relationship exists between EtCO2 and carboxyhemoglobin in carbon monoxide poisoning.

Official Title
-----------------
End-Tidal Carbon Dioxide as a Measure of Carboxyhemoglobin in Carbon Monoxide

Conditions
-----------------
Carbon Monoxide Exposure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Carbon monoxide exposure Exclusion Criteria: Less than 18 years old Suicide attempt Unable to provide informed consent Pregnant

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 |
| --- | --- |
| Carbon Monoxide Exposure<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EtCO2 | The EtCO2 level is measured by capnography and compared to the carboxyhemoglobin level. | Immediately upon study enrollment, an average time of 30 minutes post arrival to the hospital. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carbon Monoxide, Carboxyhemoglobin, End-tidal carbon dioxide, Capnography
Causes of Mortality in Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The causes of mortality in kidney transplant patients and the risk factors for mortality have been widely published. However, there is a high variability according to geographical areas and time. Recent studies suggest that the classical hierarchy of causes of mortality, i.e. the predominance of cardiovascular causes of death, could be overturned by the increase in infectious and cancer-related deaths. Investigators will try to highlight this paradigm shift and the related risk factors by studying two large French transplantation databases.

Official Title
-----------------
Causes of Mortality in Kidney Transplant Recipients, a Paradigm Shift

Conditions
-----------------
Renal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult subject (≥18 years old) during transplantation Transplantation performed between 01/01/2008 and 31/12/2014 Kidney transplant subject, double transplants kidney + pancreas, or kidney + islets of Langherans Subject previously transplanted other organs Subject not objecting, after being informed, to the reuse of their data for the purposes of this research Exclusion criteria: Subject who expressed their opposition to participating in the study Subject having received a double transplant during the same operation: kidney + heart, kidney + liver, kidney + lungs

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Distribution of the causes of death of kidney transplant recipients presented in the form of percentage |  | Six months of starting dialysis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal disease, kidney transplant
Genetic Risk Factors for Severe Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a specific genetic factor influences the severity of asthma symptoms.

Detailed Description
-----------------
Asthma is one of the most common chronic diseases in the United States. It is well known that asthma susceptibility is inherited; however, it is unknown if asthma severity is heritable. Studies suggest that levels of interleukin-16 (IL-16) may influence asthma severity. This study will examine the role of differences in the control region of the IL-16 gene in a racially diverse group of asthmatics and nonasthmatics and will determine if the IL-16 gene control region is related to asthma severity. Participants in this study will undergo lung function and blood tests; they will also complete a questionnaire about their respiratory health. Asthmatic participants will complete a severity-of-asthma questionnaire.

Official Title
-----------------
Genetic Risk Factors for Severe Asthma

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for Asthmatic Participants: Diagnosis of asthma Inclusion Criteria for Non-asthmatic Participants: No diagnosis of asthma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 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 |
| --- | --- |
| Asthmatics<br>People who have asthma | |
| Controls<br>People who do not have asthma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examination of the relationship between the IL-16 promoter genotype and the presence of the asthma phenotype |  | Throughout study | 
| Examination of the relationship between the IL-16 promoter genotype and asthma severity |  | Throughout study | 
| Examination of the serum IL-16 concentration and the serum IL-16:IL-9, IL-16:IL-13, and IL-16: TNF-alpha ratios as possible intermediate phenotypes lining the IL-16 promoter genotype to asthma severity |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Storage of DNA from all 600 participants for future study into the determinants of asthma severity |  | Throughout study |
Incidence and Prognostic Value of Delirium in Patients With Acute Coronary Syndromes

Study Overview
=================
Brief Summary
-----------------
The Purpose of this study is to evaluate the incidence of delirium in patients with acute coronary syndromes admitted to a Intensive Care Unit Patients.

Detailed Description
-----------------
The present study is a prospective, two-centre registry aimed at assessing the incidence, prevalence and prognostic significance of delirium in elderly patients with acute coronary syndromes

Official Title
-----------------
Long-term Prognostic Value of Delirium in Elderly Patients With Acute Coronary Syndrome Admitted to Two Cardiac Intensive Care Units: a Prospective Study

Conditions
-----------------
Delirium

Intervention / Treatment
-----------------
* Diagnostic Test: Confusion Assessment Method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission in Cardiac Intensive Care Unit Age ≥ 65 years Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Delirium patients<br>Patients positive to Confusion Assessment Method (CAM) assessment ad admission and during hospital stay | Diagnostic Test: Confusion Assessment Method<br>* Administration of Confusion Assessment Method at patent over 65 years at admission and every day until discharge<br>|
| control group<br>Patients negative to Confusion Assessment Method (CAM) assessment ad admission and during hospital stay | Diagnostic Test: Confusion Assessment Method<br>* Administration of Confusion Assessment Method at patent over 65 years at admission and every day until discharge<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnosis of delirium by confusion assessment method | incidence of delirium in elderly patients with coronary acute syndromes | within 24 hours of admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events incidence | any adverse event occurred to patients during hospital stay not due to the illness | 6 months |
Epidemiological Study on Asymptomatic Infections and Mild Illness With Covid-19 in Shanghai

Study Overview
=================
Brief Summary
-----------------
this study is to clarify the epidemiological characteristics of Omicron variant infected persons in Shanghai, such as distribution characteristics, host and clinical characteristics, disease outcome and risk factors. especially asymptomatic infections.

Official Title
-----------------
Epidemiological Study on Asymptomatic Infections and Mild Illness With Covid-19 in Shanghai

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

Intervention / Treatment
-----------------
* Biological: Vaccination completion status


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SARS-Cov-2 RNA positive. asymptomatic or mild clinical manifestation. informed consent signed. Exclusion Criteria: informed consent rejected.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 infections<br>SARS-Cov-2 RNA positive without symptom or with mild clinical manifestations | Biological: Vaccination completion status<br>* the relation between vaccination completion status and the target population<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral clearance time | time from viral RNA positive to negative | 2 months |