linjc16/ctgov huggingface dataset:
Effect of Smoking, Abstention and Nicotine Replacement Therapy on Wound Healing

Study Overview
=================
Brief Summary
-----------------
The aim was to determine the wound healing capacity in healthy never smokers and smokers who continue to smoke, or quit smoking using transdermal nicotine patch versus placebo patch.

Detailed Description
-----------------
Two wound healing models were applied: the excisional skin biopsy model to study wound histology and the suction blister model to study epidermal regeneration and skin transudate. In addition blood sampling was made to validate compliance to the study arms and to study systemic markers of collagen metabolism and oxidative stress. In addition, wound infections and wound ruptures were recorded post hoc as complications to the excisional skin biopsy model were not expected to occur.

Official Title
-----------------
Effect of Smoking, Abstention and Nicotine Replacement Therapy on Wound Healing

Conditions
-----------------
Wound Healing

Intervention / Treatment
-----------------
* Drug: Transdermal nicotine patch
* Drug: Placebo patch
* Behavioral: Smoking cessation
* Behavioral: Continuous smoking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: daily smokers smoking between 15-25 cigarettes per day and never smokers Exclusion Criteria: chronic medical disease atopic dermatitis or other skin disease pregnancy menopause allergy to dressings or patches current or recent medication with corticosteroids or NSAID

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: continuous smoking<br>subjects smoke 20 cigarettes per day | Behavioral: Continuous smoking<br>* subjects smoke 20 cigarettes per day<br>|
| Active Comparator: smoking cessation and NRT<br>subjects quit smoking and use transdermal nicotine patch | Drug: Transdermal nicotine patch<br>* 15mg/16h + 10mg/16h to be used 24h<br>* Other names: Nicorette patch;Behavioral: Smoking cessation<br> <br> |
| Placebo Comparator: smoking cessation and placebo patch<br>subjects quit smoking and use placebo patch | Drug: Placebo patch<br> <br> Behavioral: Smoking cessation<br> <br> |
| No Intervention: never smokers<br>subjects being never smokers and who refrain from smoking | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound healing |  | 1, 4, 8, and 12 weeks |
Cardiac Septal Hypertrophy in the Fetus of Diabetic Mother and Its Effect on Postnatal Cardiac Function

Study Overview
=================
Brief Summary
-----------------
Good glycemic control is superior to poor glycemic control in reducing risk of interventricular septum thickness among fetuses of diabetic mothers

Detailed Description
-----------------
Good glycemic control is superior to poor glycemic control in reducing risk of interventricular septum thickness among fetuses of diabetic mothers specially during third trimester of pregnancy

Official Title
-----------------
Cardiac Septal Hypertrophy in the Fetus of Diabetic Mother and Its Effect on Postnatal Cardiac Function

Conditions
-----------------
Cardiology in Fetus of Diabetic Mother

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnancy gestational age 36 weeks Exclusion Criteria: congenital anomalies obstetric complications medical disorders other than diabetes

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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 |
| --- | --- | --- |
| To study interventricular septum thickness in fetus of diabetic mother and correlate it with good glycemic control. | To study interventricular septum thickness in fetus of diabetic mother and correlate it with good glycemic control during third trimester of pregnancy. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac function in infant of diabetic mother | To correlate postnatal cardiac function to interventricular septum thickness to reach cut of value of septum thickness for prenatal prediction of symptomatic cardiomyopathy in infant of diabetic mother. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiology, fetus of diabetic mother
Alternative Splicing and Leukemia Initiating Cells

Study Overview
=================
Brief Summary
-----------------
Aberrant RNA splicing and mutations in spliceosome complex in acute myeloid leukaemia (AML) are frequent. It have been shown that some splicing variants had a prognostic value in AML. AML are characterized by their propensity to relapse because of the persistence of leukaemia initiating cells (LICs). The aim of this study is to determine the splice variants on AML initiator cells and define a splicing pattern.

Official Title
-----------------
Alternative Splicing and Leukemia Initiating Cells

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Other: Assessment of splicing variants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years-old Patients treated at the south lyon hospital center Patients with a diagnosis of acute myeloid leukemia confirmed in cytology and whose involvement of the 11q23 locus was confirmed by in situ hybridization Patients for whom a sample is available in the cytogenetic laboratory of the south lyon hospital center Exclusion Criteria: None

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 |
| --- | --- |
| Splicing variants<br>Sample of acute myeloid leukaemia primary cells | Other: Assessment of splicing variants<br>* This is a biological study with primary samples without any intervention on patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polymerase chain reaction | Transcriptome analysis to determine the splicing variants on acute myeloid leukaemia initiator cells. The analysis will focus on the gene encoding ABCA3 transporter and genes known to be mutated in patients with acute myeloid leukemia (FLT3, NPM1, c-Kit, N et K-RAS). The duration of selection of samples is estimated to be one month. | 1 month | 
| Ribonucleic acid sequencing | Transcriptome analysis to determine the splicing variants on acute myeloid leukaemia initiator cells. The analysis will focus on the gene encoding ABCA3 transporter and genes known to be mutated in patients with acute myeloid leukemia (FLT3, NPM1, c-Kit, N et K-RAS). The duration of selection of samples is estimated to be one month. | 1 month |
Mapping Mood in the Subthalamic Nucleus in Parkinson's Disease (PD)

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to determine the vulnerability of mood-related neurocircuitry in Parkinson Disease (PD) using deep brain stimulation of the subthalamic nucleus (STN DBS).

Official Title
-----------------
Mapping Mood in the Subthalamic Nucleus in PD

Conditions
-----------------
Anxiety, Parkinson's Disease, Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for STN-DBS subjects: Age 40 or older DBS STN Surgery in past 2 to 36 months Ability to tolerate turning off Stimulators Ability to read and comprehend questions English speaking Exclusion Criteria for STN-DBS subjects: Other severe complications post surgery: stroke, seizure, major loss of consciousness, other brain trauma/surgery, or head injuries(i.e. near drowning), encephalitis, or hydrocephalus, blindness, deafness Clinically determined Dementia ( Most recent MMSE score of >24) Inclusion Criteria for Control subject: Age 40 or older Ability to read and comprehend questions English speaking Exclusion Criteria for Control subject: Other severe complications post surgery: stroke, seizure, major loss of consciousness, other brain trauma/surgery, or head injuries(i.e. near drowning), encephalitis, or hydrocephalus, blindness, deafness Clinically determined Dementia ( Most recent MMSE score of >24) Plans to have DBS STN surgery in the next 24 months

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| STN DBS Group<br>PD patients with deep brain stimulators in the subthalamic nucleus. Subjects within this group will be placed into either a 1 contact group, or 2 contact group, depending on contact location requirements for this study. | |
| Control Group<br>PD patients without deep brain stimulator surgery, with similar symptoms to the study group. | |

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
-----------------
Anxiety, Subthalamic Nucleus, Deep Brain Stimulation, Depression, Parkinson's Disease
Personalizing Immune Checkpoint Inhibitor Therapy

Study Overview
=================
Brief Summary
-----------------
This prospective, observational study will evaluate whether vitro testing of tumor tissue and white blood cells from patients with lung cancer who are being treated with immune checkpoint inhibitors and other standard of care approaches, predicts clinical response to these agents.

Detailed Description
-----------------
Overall Goal: The long-term goal of this study is to predict whether checkpoint inhibitors will be effective in individual patients with solid tumors. Objectives: In this pilot study to be conducted in ten subjects with lung cancer who are to receive checkpoint inhibitors, we will use cellular and molecular techniques to characterize tumor immunogenicity anti-tumor T-cell response effect of checkpoint inhibitors on antigen presentation and T-cell response, and the tumor microenvironment Planned enrollment: • Ten subjects with lung cancer Methods for Informed Consent: Investigators will approach subjects for informed consent

Official Title
-----------------
Personalizing Immune Checkpoint Inhibitor Therapy for Solid Tumors

Conditions
-----------------
Lung Cancer Stage IV

Intervention / Treatment
-----------------
* Other: Blood and tumor tissue analysis, Clinical response.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with lung cancer about to undergo diagnostic/excisional biopsy with the intent to receive therapy with immune checkpoint inhibitors Availability of fresh tumor tissue removed at excisional biopsy or diagnostic biopsy Informed consent Exclusion Criteria: • Lack of informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Blood and tumor tissue analysis, Clinical response.|DNA sequencing and functional testing of peripheral blood mononuclear cells. DNA and RNA sequencing and immune cell analysis of tumor. Clinical response at 12 months.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-tumor immune response | Tumor antigen presentation and anti-tumor T-cell response | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response | Clinical response is defined as 50% or greater decrease of the sum of the products of two-dimensional measurements of lesions on imaging within the first year. | 12 months for each subject | 
| Tumor microenvironment | Tumor mutation burden from tumor genome landscape using DNA sequencing, tumor transcriptome with RNA sequencing, tumor infiltrating immune cells with flow cytometry | 24 months total study duration |
Exploration of Cerebral Pathophysiology During and After CABG Using CPB

Study Overview
=================
Brief Summary
-----------------
Purpose: The purpose of this study is to examine cerebral oxidative and inflammatory stress and cerebral hemodynamics during and after coronary artery bypass grafting and correlate with postoperative cognitive function.

Detailed Description
-----------------
Postoperative cognitive decline is a well-known and well-described complication following coronary artery bypass grafting. Severity ranges from postoperative delirium to stroke, but the majority of patients with postoperative cognitive decline following coronary artery bypass grafting have decline in recent and remote memory in particular. The reason for the cognitive decline is still not fully understood though many reasons have been proposed. Inflammation and oxidative stress may contribute to the postoperative cognitive dysfunction which may also be in combination with a reduced cerebral autoregulation.

Official Title
-----------------
Cerebral Oxidative and Inflammatory Stress and Cerebral Hemodynamics During and After Coronary Artery Bypass Grafting With Use of Cardiopulmonary Bypass

Conditions
-----------------
Ischemic Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ischemic heart disease admitted for coronary artery bypass grafting with the use of cardiopulmonary bypass Exclusion Criteria: Cerebrovascular disease

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ischemic heart disease<br>Patients admitted for coronary artery bypass grafting with the use of cardiopulmonary bypass | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral autoregulation | Flow measurement of middle cerebral artery and measurement of middel arterial pressure | 6 hours post operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative cognitive function |  | One day prior to operation and three days after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery bypass grafting, cardiopulmonary bypass, Cerebral oxidative stress, Cerebral inflammatory stress, Cerebral hemodynamics, Postoperative cognitive dysfunction
Prevention of Cerebral Infarction in Sickle Cell Anemia - Comprehensive Sickle Cell Center

Study Overview
=================
Brief Summary
-----------------
To conduct a prospective study aimed at the early detection and treatment of cerebral vascular disease prior to irreversible brain injury in young children with sickle cell anemia (SCA).

Detailed Description
-----------------
BACKGROUND: Cerebral infarction is a major contributor to childhood morbidity and mortality in sickle cell anemia (SCA) DESIGN NARRATIVE: The investigators tested the hypotheses that young children with SCA experienced a variable period of asymptomatic progressive central nervous system (CNS) vasculopathy prior to cerebral infarction; that pre-infarct CNS vasculopathy could be identified by non-invasive imaging techniques:MRI, magnetic resonance angiography (MRA), and transcranial Doppler (TCD); and that therapeutic intervention at this stage of the disease could significantly reduce the subsequent occurrence of cerebral infarction. MRI, MRA, TCD, and standardized neurologic and psychometric examinations were performed yearly in a cohort of homozygous Hb SS children enrolled at 2-4 years of age. Subjects without MRI evidence of cerebral infarction who had significant cerebral vasculopathy (cerebral arterial stenosis on MRA and/or elevated blood flow velocity on TCD) were randomized to receive either no therapy or chronic transfusion therapy, in order to determine the risk of subsequent cerebral infarction in untreated subjects with these abnormalities, and the extent to which transfusion therapy could significantly reduce the risk. Subjects with evidence of prior cerebral infarction on MRI, whether symptomatic or asymptomatic, were randomized to receive either chronic transfusion therapy alone ('standard therapy') or chronic transfusion therapy plus ticlopidine, in order to determine whether ticlopidine could significantly increase the efficacy of standard therapy in preventing recurrent cerebral infarction in SCA. Subjects with prior cerebral infarction were also offered the option of bone marrow transplantation if an HLA-identical non-SS sibling donor was available.

Conditions
-----------------
Anemia, Sickle Cell, Blood Disease, Cerebrovascular Disorders, Cerebrovascular Accident

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
A Multi-Center Protocol for Obtaining and Storing Human Samples for Immediate or Future Microbial, Immune, or Host Microbe Scientific Study

Study Overview
=================
Brief Summary
-----------------
The intent of this protocol is to salvage human-related material that is normally destined for destruction, so it can be used in infection-related scientific studies.

Detailed Description
-----------------
This clinical material can be studied in order to better understand the molecular, cellular, or ecological components of the infected or potentially infected tissue or device. These studies may be able to provide important insights into the keys of chronic infections, complex infections, medical biofilms, pathogen ecology, and healing.

Official Title
-----------------
A Multi-Center Protocol for Obtaining and Storing Human Samples for Immediate or Future Microbial, Immune, or Host Microbe Scientific Study

Conditions
-----------------
Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The Subject must be 18 years of age or older. The Subject must be mentally competent as determined by the Investigator. Exclusion Criteria: The Subject may not be currently incarcerated. The Subject may not be knowingly pregnant. The Subject may not be institutionalized. The Subject may not be an employee or student of the investigator or sponsor.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No treatment<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
-----------------
wound debridement, removed orthopedic implants, removed catheters or shunts, excised tonsils, amputated tissue, sputum, stool, or other excretions.
Diagnosis of Latent Tuberculosis(TB) Infection in Health Care Workers Using TST and Whole Blood Interferon-γ Assay

Study Overview
=================
Brief Summary
-----------------
The investigators think that the health care workers who contact frequently with active tuberculosis patients have more increased prevalence of LTBI compared with those who don't.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: health care workers Exclusion Criteria: active pulmonary tuberculosis previous Tuberculosis history below 20 years old history of hypersensitivity about PPD pregnant

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
latent tuberculosis prevalence of health care workers