linjc16/ctgov huggingface dataset:
VLDL-triglyceride Kinetics in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Type 2 diabetes is associated with diabetic dyslipidemia, which is a major risk factor for coronary heart disease. Triglycerides (TG) and cholesterol are transported in the system of lipoproteins, and the metabolism of these lipids in plasma is closely interrelated. Evidence suggests that increased concentration of very low-density lipoprotein triglyceride (VLDL-TG) is a central pathophysiological feature of the lipid and lipoprotein abnormalities in diabetic dyslipidemia. The objective of this study was to investigate VLDL-TG kinetics and aspects of peripheral VLDL-TG metabolism, i.e. to what extent VLDL-TG associated fatty acids (FA) are oxidized or deposited in regional adipose tissue, in subjects with type 2 diabetes and healthy controls in the postabsorptive state and during acute hyperinsulinemia using ex-vivo labeled VLDL-TG tracers.

Official Title
-----------------
VLDL-triglyceride Kinetics and -Metabolism in the Post Absorptive State and During Hyperinsulinemia in Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Other: Hyperinsulinemic euglycemic glucose clamp


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Exclusion Criteria: Known disease except type 2 diabetes (type 2 diabetic subjects) Smoking Alcohol abuse Prescription medication expect oral antidiabetics (type 2 diabetic subjects)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 2 diabetic men<br>Men with type 2 diabetes | Other: Hyperinsulinemic euglycemic glucose clamp<br>* Hyperinsulinemic euglycemic glucose clamp, duration 5 hours, plasma glucose 5 mmol/l, insulin dosage 1,0 mU•kg FFM/min, human insulin (Actrapid; Novo Nordisk A/S).<br>|
| Healthy men<br>Healthy men | Other: Hyperinsulinemic euglycemic glucose clamp<br>* Hyperinsulinemic euglycemic glucose clamp, duration 5 hours, plasma glucose 5 mmol/l, insulin dosage 1,0 mU•kg FFM/min, human insulin (Actrapid; Novo Nordisk A/S).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VLDL-TG production and clearance rates |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VLDL-TG oxidation |  |  | 
| VLDL-TG subcutaneous adipose tissue storage |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, Diabetic dyslipidemia, VLDL-TG kinetics, VLDL-TG metabolism
Optical Coherence Tomography Guided C&D

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to identify the presence of residual superficial and nodular basal cell carcinoma (BCC) status-post curettage and desiccation (C&D) by using optical coherence tomography (OCT).

Official Title
-----------------
Using OCT Imaging to Determine the Presence of Residual Tumor Cells After C&D for Superficial and Nodular BCC: A Prospective Study.

Conditions
-----------------
Basal Cell Carcinoma

Intervention / Treatment
-----------------
* Device: Optical Coherence Tomography (OCT)
* Procedure: Curettage & Desiccation (C&D) Procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of any: age, gender, Fitzpatrick skin type and ethnicity. Primary BCC of any type, except aggressive types that fit the criteria for Mohs surgery No prior treatment on the lesion within the last 3 months. Lesions anywhere except the head, neck and distal extremities. Willing and able to sign informed consent Exclusion Criteria: Aggressive BCC types. Recurrent tumors. Lesion treated within last 3 months. Lesions on head and neck (high risk areas) Lesions on distal extremities (thin epidermis not preferred for OCT). Pregnant women. Patients less than 18 years old. Prisoners. Any other condition or circumstance that, in the opinion of the Investigator, may compromise the subject's ability to comply with the study protocol

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: OCT Guided C&D Group<br>Participants in this group will receive OCT imaging immediately prior, immediately after and 2 months after post standard of care C&D. | Device: Optical Coherence Tomography (OCT)<br>* VivoSight Dx OCT system from Michelson Diagnostics Ltd. OCT will be used to visualize the tumor and lesion in the skin.<br>Procedure: Curettage & Desiccation (C&D) Procedure<br>* Standard of care C&D where the basal cell carcinoma lesion will be scraped to its base using a Fox dermal curette and an electrodesiccation machine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of residual basal cell carcinoma tumor cells | The incidence of residual superficial and nodular basal cell carcinoma tumor cells after standard of care C&D as assessed using the OCT. | 2 months (post C&D procedure) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Superficial basal cell carcinoma, Nodular basal cell carcinoma
Subjective Factors of Polymedication in the Elderly: a Qualitative Study of the Perceptions of Patients, Relatives and Referent Physicians.(DOSAGE)

Study Overview
=================
Brief Summary
-----------------
The DOSAGE Study is a qualitative transversal study aiming to describe and understand the subjective factors of polymedication in the elderly population (75 years old and more), defined as 10 simultaneous drugs. Semi-structured interviews will be conducted with patients, relatives and general practitioners in one French region. 20 situations will be included. After analysing the data of the individual interviews, focus groups will be conducted with health professionals.

Official Title
-----------------
Subjective Factors of Polymedication in the Elderly: a Qualitative Study of the Perceptions of Patients, Relatives and Referent Physicians.(DOSAGE)

Conditions
-----------------
Frail Elderly Syndrome

Intervention / Treatment
-----------------
* Other: individual interviews


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For patients: Men and women aged 75 and over Beneficiary of a prescription of medicinal products fulfilling the conditions of major polymedication: to include 10 different drugs whatever the way of use (per os, subcutaneous, intravenous, intra muscular, cutaneous, instillation) Informed consent stating that the subject understood the purpose and methodology of the study and agrees to participate in the study. For the relatives: Men and women 18 years of age or older Informed consent Regularly participating in helping the patient's daily life For Physicians : Identified as the patient's physician or family physician. Informed consent Exclusion Criteria: Persons with proven and significant cognitive impairment preventing the completion of semi-strutured interviews Person who does not speak French easily Generally, any person unlikely to cooperate in the study Adults under guardianship Refusal of relatives and/or general practitioner to participate to the study

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Qualitative Research<br>Semi-structured interviews with patients, relatives and general practitioners. | Other: individual interviews<br>* Semi-structured individual interviews with patients, relatives and general practitioners.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 60 semi-structured interviews | Qualitative data analysis - Theorical saturation | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elderly people, polymedication,, ethics, qualitative research
Study to Evaluate Immune Responses in Neurologically Normal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study whether immune cells capable of killing tumors that express proteins associated with paraneoplastic neurologic syndrome (PNS) can be found in small cell lung cancer and ovarian cancer patients. The presence of these cells may play a role in tumor immunity in these patients. The protocol involves neurological examinations and collection of blood.

Detailed Description
-----------------
See brief description

Official Title
-----------------
Tumor Immunity in Neurologically Normal Patients

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females ages 25 -75 If leukapheresis: Hepatitis B surface antigen negative if tested* Hepatitis C antibody negative if tested* HIV antibody negative if tested* Venereal disease reaction level (VDRL) negative if tested* No known IV drug users Hemoglobin > 8.5 White blood cell count > 3,800 Platelets > 120,000 International normalized ratio (INR) < 2 (verified only if clinically indicated) If large blood draw (1/2 to 1 unit) in lieu of leukapheresis: Hepatitis B surface antigen negative if tested* Hepatitis C antibody negative if tested* HIV antibody negative if tested* VDRL negative if tested* No known IV drug users HgB > 10.0 WBC > 3,800 Platelets > 120,000 INR < 2 (verified only if clinically indicated) Exclusion Criteria: No known neurologic disease 2. No known central nervous system (CNS) metastasis on clinical exam 3. No chemotherapy within 1 month 4. No New York Heart Association class III/IV status 5. No pulmonary disease which limits daily activities 6. No anticoagulation therapy

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 |
| --- | --- |
| Cancer patients<br>SCLC and gynecological cancer patients and unrelated cancer patients with presence of PND-specific CTLs. | |
| Normal<br>Normal volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paraneoplastic neoplastic disease antibody titer, Cytotoxic T Lymphocyte activity, and clinical data in neurologically normal patients with small cell lung cancer and gynecologic tumors, with tumors unrelated to PNDs, and in normal control patients. |  | Duration of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
paraneoplastic; autoimmunity;
Studying Gene Expression in Tissue Samples From Young Patients With Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at gene expression in tissue samples from young patients with acute myeloid leukemia.

Detailed Description
-----------------
OBJECTIVES: Examine mRNA from pediatric patients with acute myeloid leukemia with 11q23 translocations by reverse transcriptase-PCR to quantify expression of EVI1 splice variants. OUTLINE: Cryopreserved mRNA from diagnostic samples is analyzed for gene expression by reverse transcriptase-PCR.

Official Title
-----------------
EVI-1 Expression in Pediatric AML With 11q23 Abnormalities

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Genetic: RNA analysis
* Genetic: gene expression analysis
* Genetic: reverse transcriptase-polymerase chain reaction
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of pediatric acute myeloid leukemia with 11q23 abnormalities PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: RNA analysis|nan|
|Genetic: gene expression analysis|nan|
|Genetic: reverse transcriptase-polymerase chain reaction|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of the expression of EVI1 splice variants |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
childhood acute myeloid leukemia/other myeloid malignancies
Exercise Training in Children With Congenital Heart Defect

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate the effects of exercise training on exercise capacity, physical activity (PA), health-related quality of life (HRQoL), and the psychosocial factors affecting PA in sedentary congenital heart defect (CHD) children and healthy sedentary children. The degree of improvement after exercise training were compared between CHD children and healthy sedentary children.

Detailed Description
-----------------
Exercise groups took 12-week exercise training, twice in hospital and once at home, using a video game so-called Dance Dance Revolution (DDR), while the control group kept their daily routines.

Official Title
-----------------
The Effect of Exercise Training on Exercise Capacity, Physical Activity, and Health-related Quality of Life in Children After Repair of Congenital Heart Defect

Conditions
-----------------
Congenital Heart Disease

Intervention / Treatment
-----------------
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with congenital heart defect s/p repair > 6 months Sedentary lifestyle Exclusion Criteria: Unstable hemodynamics Impaired mental and cognition Systemic disease

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Exercise<br>Dance Dance Revolution (DDR) | Other: Exercise<br>* Using a video game so-called Dance Dance Revolution (DDR)<br>* Other names: Dance Dance Revolution (DDR);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximal treadmill exercise test |  | 12 wks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise capacity, Physical activity, Quality of life
Do Home Monitors Improve Blood Pressure Control?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if home blood pressure monitors can help decrease blood pressure in patients with diabetes at a low income clinic.

Conditions
-----------------
Hypertension, Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Home blood pressure monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years old, diabetes as defined by HgA1C over 6.5%, uncontrolled blood pressure (SBP > 130 and or DBP > 80) Exclusion Criteria: pregnancy, transplanted organ, MI/CHF/CVA within 3 months, dialysis, arrhythmia, metastatic cancer, dementia, visual or hearing difficulties

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>This group will not get a home blood pressure monitor. | |
| Experimental: Home monitors<br>This group will be given a home blood pressure monitor to use. | Behavioral: Home blood pressure monitor<br>* The patients using home monitors checked their blood pressure on Monday, Wed, and Friday. They took 2 measurements 5 minutes apart after sitting 5 minutes in the left arm.<br>* Other names: Home monitor: Omron BP760 upper arm monitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in blood pressure over time | We are measuring the change in blood pressure between 2 groups: the intervention group which will be using home blood pressure monitors and the control group which will get care as usual for their blood pressure. | baseline and 3 months |
Extension of a Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen

Study Overview
=================
Brief Summary
-----------------
This study is an extension to younger patients of the currently ongoing national, multicenter, open-label, randomized phase III HAPLOMUDELDERLY which evaluates elderly patients with hematological malignancies, justifying an allo-HSCT from an alternative donor when a MRD has not been identified. It will extend the investigation of these two modalities of allo-HSCT to younger patients which are eligible to RIC.

Official Title
-----------------
Extension of a Phase III Randomized Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen-HaploMUD-RIC-01

Conditions
-----------------
Acute Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma

Intervention / Treatment
-----------------
* Procedure: Hematopoietic stem cells transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hematological malignancy Age<55 years HCT-CI score ≥ 3 or non-eligible for myeloablative regimen Patients without a matched related donor Patients eligible for an allogeneic HSCT from an alternative donor Able to comply with the protocol Written informed consent Patient affiliated to the national Social Security regimen or beneficiary of this regimen Exclusion Criteria: Clinical or biological contraindication to allogeneic HSCT Pregnant or breast-feeding women. Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up. Severe concomitant disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: haploidentical related donors<br> | Procedure: Hematopoietic stem cells transplantation<br>* Allogeneic Hematopoietic stem cells transplantation<br>|
| Active Comparator: Matched unrelated donor<br> | Procedure: Hematopoietic stem cells transplantation<br>* Allogeneic Hematopoietic stem cells transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival | the time from randomization to the time of a first occurrence of an event with death, relapse or occurrence of severe cGVHD as event and considered as censored at the time of last follow-up visit | 5 years |
Pacific Northwest Udall Center (PANUC) Clinical Core

Study Overview
=================
Brief Summary
-----------------
This study evaluates cognitive impairment in subjects with Parkinson disease (PD) and similar neurological disorder through obtaining longitudinal clinical and neuropsychological data. The long term goal is to have a well-characterized subject population to contribute to our understanding of the natural history, diagnosis and ultimate treatment of cognitive impairment in patients with PD and similar disorders.

Official Title
-----------------
Pacific Northwest Udall Center (PANUC) Clinical Core

Conditions
-----------------
Parkinson Disease, Cognitive Impairment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Parkinson disease Over 18 years of age Exclusion Criteria: - Under 18 years of age

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