linjc16/ctgov huggingface dataset:
Cerebral Small Vessel Disease Registry Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the clinical spectrum and natural progression of Cerebral Small Vessel Disease (CSVD) and in a prospective multicenter study, to assess the clinical, genetic and epigenetic features of patients with CSVD, , to find independent imaging markers, and to optimize clinical management.

Official Title
-----------------
Cerebral Small Vessel Disease Registry Study

Conditions
-----------------
Cerebral Small Vessel Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sign informed consent. Age>18 At least one of the following CSVD MRI characteristics: ①recent small subcortical infarct;②lacune of presumed vascular origin;③white matter hypertensity of presumed vascular origin;④perivascular space;⑤cerebral microbleeds;⑥brain atrophy Exclusion Criteria: Unable to cooperate with inspectors Non-vascular white matter lesions Other cognitive diseases (such as alzheimer's disease, Parkinson's disease or thyroid disease) Serious systemic illness, such as heart, liver, kidney disease or major mental illness Contraindications for imaging examination

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall outcomes in patients with cerebral small vessel disease. | record the occurrence of stroke and use modified Rankin Scale (mRS) to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. | From date of enrollment until the date of death from any cause, assessed up to 30 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the development of the burden of microbleeds in MRI | using MARS scale to evaluate the development of the burden of microbleeds | From date of enrollment until the date of death from any cause, assessed up to 30 years | 
| the development of the burden of white matter hypertension in MRI | using Fazakes scale to evaluate the development of the burden of white matter hypertension | From date of enrollment until the date of death from any cause, assessed up to 30 years | 
| the development of lacunes in MRI | record the number and location of lacunes | From date of enrollment until the date of death from any cause, assessed up to 30 years | 
| the development of enlarged perivascular space in MRI | record the number and location of enlarged perivascular space | From date of enrollment until the date of death from any cause, assessed up to 30 years |
Risk Factor Analysis for Developing Metabolic Syndrome in Korean Adults

Study Overview
=================
Brief Summary
-----------------
In Asia, the prevalence of metabolic syndrome have been dramatically increased. Therefore, the investigators intend to the collect the blood sample, laboratory, anthropometric, and body composition parameters prospectively to examine the risk factors of metabolic syndrome. Furthermore, the investigators will collect the data of carotid IMT and branchial ankle pulse wave velocity to clarify the metabolic risk factors of atherosclerosis.

Conditions
-----------------
Metabolic Syndrome, Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Apparently healthy people who underwent medical routine check up in Korea Health Promotion Center. age > 20 years Exclusion Criteria: History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization) Stage 2 hypertension Severe renal or hepatic disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| Apparently Health People<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of various cardiovascular risk factors (inflammatory markers, hepatokines, adipokines, body composition parameters) for developing metabolic syndrome in prospective design |  | 36months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship of various cardiovascular risk factors (inflammatory markers, hepatokines, adipokines, body composition parameters) with metabolic syndrome and atherosclerosis measured by baPWV and carotid IMT in cross sectional design |  | 36months |
Afatinib Plus Nimotuzumb for NSCLC

Study Overview
=================
Brief Summary
-----------------
To find the optimal dose of afatinib and nimotuzumab in patients who acquired resistance to gefitinib or erlotinib.

Official Title
-----------------
A Phase Ib Study of Afatinib Plus Nimotuzumab in Non-small Cell Lung Cancer Patients Who Progressed With Reversible EGFR TKI

Conditions
-----------------
NSCLC

Intervention / Treatment
-----------------
* Drug: afatinib (30 or 40mg) + nimotuzumab (100 or 200mg)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed diagnosis of stage IIIB or IV NSCLC Presence of EGFR sensitizing mutations (L858R mutation in exon 21 or exon 19 deletion) or response by RECIST on prior gefitinib or erlotinib or stable disease on prior gefitinib or erlotinib for at least 6 months Disease progression on treatemtn with gefitinib or erlotinib within 30 days Biopsy on disease progression Age ≥20 years ECOG performance status of 0, 1, or 2 Measurable disease by the criteria of RECIST 1.1 Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance ≥ 45 mL/min Exclusion Criteria: Known interstitial lung disease Prior treatment with EGFR targeting antibodies or BIBW 2992 Prior three or more lines of chemotherapy for advanced NSCLC Significant bowel disease impairing drug absorption Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases. Patients with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and corticosteroid use has been discontinued for at least 2 weeks prior to the first dose of study drug. Screening of asymptomatic patients without history of CNS metastases is not required.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: afatinib + nimotuzumab<br> | Drug: afatinib (30 or 40mg) + nimotuzumab (100 or 200mg)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal tolerated dose | To establish maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) for BIBW 2992 and nimotuzumab in patients with acquired resistance to erlotinib or gefitinib | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acquired resistance, gefitinib, erlotinib
Epidemiology and Immunology of Hemophilia A Inhibitors

Study Overview
=================
Brief Summary
-----------------
To determine the risk factors associated with inhibitor formation in hemophilia A and to study the mechanism of tolerance in the murine hemophilia A model.

Detailed Description
-----------------
BACKGROUND: The major hypothesis of this study is that suppression of immunoregulatory cytokines will prevent factor VIII inhibitor formation in the hemophilia A murine model: if successful, a treatment protocol could be developed for individuals identified to be at highest risk for inhibitor formation. Through this approach to the epidemiology and immunology of inhibitor formation, the health care of individuals with hemophilia may be improved. The study is in response to a Request for Applications released in 1998 on the Immunogenetics of Inhibitor Formation in Hemophilia. . DESIGN NARRATIVE: A case-control study is conducted comparing prevalent hemophilia patients with inhibitors identified in the HMS Study with three age-matched controls without inhibitors to determine clinical and laboratory characteristics associated with inhibitor development. A histocompatibility study is conducted identifying patterns of HLA Class II antigens by molecular typing in hemophilic subjects identified in HMS, with and without inhibitors, which may be linked to inhibitor formation. An animal tolerance study is conducted in the hemophilia A murine model, evaluating blockade of T cell costimulatory pathways by CTLA4-Ig and anti-CD40L mAb, to prevent inhibitor formation. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Blood Disease, Hemophilia A

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 |
| --- | --- | --- |
Retrospective Analysis of Skin/Soft Tissue Primary NK/T Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
To study clinical features, prognostic factors and treatment outcome and to develop a possible prognostic index in skin/soft tissue primary NK/T cell lymphoma patients.

Official Title
-----------------
Retrospective Analysis of Skin/Soft Tissue Primary NK/T Cell Lymphoma

Conditions
-----------------
Extranodal NK/T Cell Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed extranodal NK/T cell lymphoma primary site is skin or soft tissue Exclusion Criteria: involvement of upper aerodigestive tract
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 |
| --- | --- | --- |
Prevalence of ESBL-producing Enterobacteriaceae as Carbapenem-resistant Enterobacteriaceae in Nursing Homes.

Study Overview
=================
Brief Summary
-----------------
This study evaluates individual and collective factors of ESBL and CRE carriage in nursing homes.

Detailed Description
-----------------
Epimiological data concerning ESBL an CRE, may differ between nursing home and hospital or community but poor data are available. Multi-drug resistant bacteria carriage is associated with individual and collective factors wich have to be defined in nursing homes.

Official Title
-----------------
Determination of the Prevalence of ESBL-producing Enterobacteriaceae as Carbapenem-resistant Enterobacteriaceae in Nursing Homes in Franche-Comté (France).

Conditions
-----------------
Drug Resistance, Bacterial

Intervention / Treatment
-----------------
* Diagnostic Test: rectal swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: voluntary residents present in the institution on the study day Exclusion Criteria: dement-wandering resident unlikely to cooperate

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>realization of a rectal swab or stool sample for all the résidents included in the study. | Diagnostic Test: rectal swab<br>* stool samples by rectal swab<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ESBL and CRE carriage | number of residents colonized with a extented-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL) or carbapenem-resistant Enterobacteriaceae (CRE) | the day of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient and establishment factors associated with ESBL and CRE carriage with a questionnaire | evaluation of risk factors associated with ESBL and CRE carriage and disseminationwith a questionnaire. | the day of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRE, multidrug resistance, nursing home, ESBL
Efficacy and Safety of Ruxolitinib in Patients With Myelofibrosis

Study Overview
=================
Brief Summary
-----------------
Ruxolitinib is a Janus kinase (JAK) 1/2 inhibitor currently used in the treatment of Myelofibrosis (MF). Ruxolitinib confirmed improvements in splenomegaly, MF-related symptoms and survival benefit in COMFORT and JUMP studies. At present, the real-world data on the efficacy and safety of ruxolitinib in the treatment of MF in China is still insufficient. The aim of this study was to evaluate the efficacy and safety of ruxolitinib in patients with MF and to provide guidance for the usage of ruxolitinib in MF in China.This was a retrospective, multicenter study of MF patients who received ruxolitinib treatment in Shandong province from August 2012 to December 2021. Data were analyzed using SPSS. Overall survival (OS) and Event-free survival (EFS) were estimated using the Kaplan- Meier method.

Official Title
-----------------
Efficacy and Safety of Ruxolitinib in Patients With Myelofibrosis: A Retrospective Multicenter Study

Conditions
-----------------
Myelofibrosis

Intervention / Treatment
-----------------
* Drug: Ruxolitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients aged ≥18 years with a diagnosis of primary or secondary MF by World Health Organization and International Working Group for Myeloproliferative Neoplasms Research and Treat- ment (IWG-MRT) criteria; Received ruxolitinib treatment for ≥3 months. Exclusion Criteria: Malignant tumors with other progression or myelofibrosis secondary to other diseases; Exclude myelofibrosis patients after splenectomy; Patients with poor compliance with case follow-up or lost to follow-up.

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 |
| --- | --- |
| MF patients who received ruxolitinib treatment<br> | Drug: Ruxolitinib<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with a ≥35% reduction in palpable spleen volume from baseline. | Reduction in spleen volume is measured by magnetic resonance imaging/computerized tomography (MRI/CT). | From Week 0 through Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with ≥50% reduction in Total Symptom Score (TSS) from baseline. | TSS is assessed by the MPN-10. | From Week 0 through Week 24 |
Study of Intracellular Nucleotide Pools Determination as Biomarker of the Efficacy of the Induction Treatment in Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
Treatment of acute myeloid leukemia (AML) consists in two main phases: induction and consolidation. Standard chemotherapy combination for induction treatment associates cytarabine (AraC), a nucleoside analog, and an anthracycline (most often daunorubucin). About 60-70% of patients achieved complete remission after this standard chemotherapy. As cytarabine competes with endogenous nucleotides to exert its activity, the aim of this protocol is to study in vivo the effect of intracellular nucleotide pools on the efficacy of the induction treatment. Thus, intracellular nucleotides levels will be determined in peripheral blood mononuclear cells of patients with acute myeloid leukemia before treatment, and results will be compared with the efficacy of the treatment. This parameter will be assessed by the achievement of complete remission.

Official Title
-----------------
Study of Intracellular Nucleotide Pools Determination as Biomarker of the Efficacy of the Induction Treatment in Acute Myeloid Leukemia

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

Intervention / Treatment
-----------------
* Biological: Biological analyses


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients Inclusion Criteria: age over 18 years acute myeloid leukemia standard induction chemotherapy with cytarabine and daunorubicin patients who received the information and did not object to participate to the study Patients Exclusion Criteria: - patients with acute myeloid leukemia 3 healthy volunteers Inclusion Criteria : adults without known hematological disease, adults who received the information and did not object to participate in the study healthy volunteers Exclusion Criteria : - Volunteers with known hematological disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| acute myeloid leukemia patients<br>Patients over 18 years with acute myeloid leukemia | Biological: Biological analyses<br>* Biological analyses will be realized on samples collected before induction treatment and at the end of bone marrow aplasia i.e. about day 30 to determine the nucleotide pools in peripheral blood mononuclear cells.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission | Primary endpoint will be the achievement of complete remission after induction treatment and bone marrow aplasia. | 30 days |
ApoB48 Metabolism in Plasma and Interstitial Fluid

Study Overview
=================
Brief Summary
-----------------
Postprandial increases in the levels of atherogenic chylomicron remnant lipoprotein particles have long been considered a presumable risk factor for the development of atherosclerosis with time, also in normolipidemic subjects. apoB-48 (Chylomicron) in blood is a specific marker for intestinal derived lipoproteins. Specific aim: To determine if apoB-48 containing lipoproteins may appear in IC in the postprandial state after a standard meal and investigate the effect fasting and feeding have on levels of lipids, apolipoproteins and the cholesterol component of lipoproteins in IF and plasma. Methodology: Intercellular fluid will be collected using the cup technique. IF will be collected in intervals corresponding to different periods after food intake. The IF from these different occasions will then be analysed and compared using FPLC and Elisa.

Official Title
-----------------
ApoB48IC2 Metabolism in Plasma and Interstitial Fluid

Conditions
-----------------
Diabetes Mellitus, Type 2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years. For the T2D study group: Diagnosed with type 2 diabetes. Exclusion Criteria: For subjects with type 2 diabetes: Systemic inflammatory disease that requires active treatment Thyroid disease that requires active treatment Skin disease that requires active treatment and causes significant changes in the area of the skin that is to be investigated Treatment with oral glucocorticoids Levels of SR, TSH, T4 or Hemoglobin in the blood pronouncedly outside the reference range Pregnancy For healthy controls: Registered disease in the health declaration that requires continuous systemic treatment. Exception to the above: well controlled hypertension in which case the subject should not have treatment with more than one antihypertensive drug, the drug must not be an alpha-blocker or beta-blocker or thiazide diuretic Skin disease that requires active treatment and causes significant changes in the area of the skin that is to be investigated Blood pressure pronouncedly above 140/90 Blood test results pronouncedly outside the reference range Pregnancy

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 |
| --- | --- |
| Type 2 diabetes patients<br> | |
| Healthy controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ApoB48 levels in blood and interstitial fluid |  | 7 hours |