linjc16/ctgov huggingface dataset:
Small Dense Low-density Lipoprotein in Patients With Prediabetes and Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
It is known that small dense LDL particles are associated with an increased cardiovascular risk. LDL particles can be separated by gradient gel electrophoresis (GGE) according to their size. The risk to suffer from coronary heart disease is 3-7 fold elevated in subjects with small dense LDL particles compared to subjects with large LDL particles. This study aims at evaluating the predictive value of small dense LDL particles in patients with prediabetes and type 2 diabetes mellitus concerning future changes in intima media thickness, flow-mediated dilation and other risk factors of atherosclerosis (e.g. insulin resistance). 60 patients with prediabetes or type 2 diabetes will be recruited for the study. Assessment will include medical history (risk factors), physical examination (blood pressure, BMI, waist-to-hip ratio), collection of serum, oral glucose tolerance test, measurement of intima media thickness and endothelial dysfunction by ultrasound. All measurements will be repeated after 2 years. Data will be analysed to assess whether the amount of small dense LDL particles can predict further structural and functional changes of the cardiovascular system or changes in the severity of the disease (insulin resistance).

Conditions
-----------------
Prediabetes / Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - male gender impaired fasting glucose OR type 2 diabetes (ADA criteria) BMI > 25 kg/m2 given informed consent Exclusion criteria: - HbA1c > 9.0% insulin therapy fasting glucose > 11mmol/l total cholesterol > 6.5 mmol/l OR triglycerides > 2.5 mmol/l malignant or severe renal, hepatic, pulmonary, neurological or psychiatric disease alcohol or drug abuse HIV infection.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- | --- |
Identification of Novel Markers of Human Lung Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate new therapies for advanced lung disease.

Detailed Description
-----------------
This research study is being conducted to learn about the progression and cause of lung disease. By agreeing to be a part of this study, you will allow the lung tissue which would normally have been discarded after your procedure, to be used for research purposes to allow us to understand more about your condition which may potentially lead to novel treatments and therapeutics. For this study, the investigators will isolate specific cells from the lung tissue and measure cellular, molecular and genetic mechanisms responsible for regulating lung disease. No other type of research will be performed on these samples nor will the samples be given to other investigators for unrelated research.

Official Title
-----------------
Identification of Novel Markers of Human Lung Disease

Conditions
-----------------
Lung Diseases, Interstitial

Intervention / Treatment
-----------------
* Other: novel biomarkers of lung disease


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any one on lung transplant list Exclusion Criteria: HIV positive

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

| Intervention/Treatment |
| --- |
|Other: novel biomarkers of lung disease|we will be identifying molecular, genetic, and cellular markers of lung disease|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The development of novel therapeutics for interstial lung disease | Our research on these human lung cells will provide critical data which will aid in the diagnosis and treatment of a variety of different lung diseases, which have no cure. | 10 years |
The Expression of PTEN Protein and mRNA in Malignant Cells of Chronic Myelomonocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the level of a specific protein (PTEN) in the cancer cells of chronic myelomonocytic leukemia (CMML) patients. This protein might be involved in the transformation from normal blood cells to leukemia cells. The PTEN protein has not been investigated in CMML specifically but it has been discovered in closely related cancers. If this study demonstrates an abnormality in this protein, future testing will be designed to evaluate the genetic abnormality that resulted in lack of the normal presence of this protein. The goal is that the results of this study will help to develop new drugs and strategies to treat the future patients with CMML by understanding the abnormality of the disease at the cellular and molecular levels. The results of this study can also be utilized by future studies to develop individualized treatment to patients who have abnormal levels of this protein.

Official Title
-----------------
The Expression of PTEN Protein and mRNA in Malignant Cells of Chronic Myelomonocytic Leukemia

Conditions
-----------------
Chronic Myelomonocytic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be at least 18 years or older. Subject must sign informed consent. For study population only, the subject must have a CMML diagnosis based on the WHO 2009 criteria. For control population only, the subject must be deemed healthy with no hematologic disorders.

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 |
| --- | --- |
| Subjects diagnosed with CMML<br>Subjects ages 18 and older with a CMML diagnosis based on the WHO 2009 criteria, and who have signed an informed consent are eligible to participate in the study population of this clinical trial. A total of 12 patients will be consented. | |
| Control Group<br>The control group will consist of subjects ages 18 years or older who are healthy (i.e. no hematologic disorders) and have signed an informed consent. A total of 10 healthy control subjects will be consented. | |

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
-----------------
To evaluate the phosphate and tension homolog deleted on chromosome ten (PTEN) protein level in leukemia cells from patients with CMML., To identify the PTEN genetic defect in patients with deficient PTEN protein levels., To evaluate the role of PTEN deregulation in CMML pathogenesis.
Feasibility Study to Assess the Scan, Fit and Print Process for the Aveera Patient Matched CPAP Mask

Study Overview
=================
Brief Summary
-----------------
Feasibility study to assess the scan, fit and print process for the Aveera Patient Matched CPAP Mask

Detailed Description
-----------------
Assess the process of scan, fit and print Subjective/objective assessment of fit of the Aveera during the 2 week use for leaks and comfort Ethnographic insights into the user experience of the scan, fit, print process.

Official Title
-----------------
Feasibility Study to Assess the Scan, Fit and Print Process for the Aveera Patient Matched CPAP Mask

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Aveera


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age Both genders Currently prescribed fixed pressure CPAP or APAP for the treatment of OSA Currently CPAP pillows and nasal mask users Patients who are adherent as defined by conventional standards (i.e. 4 hours per night/70% of the nights) Exclusion Criteria: Unwilling to wear the AVEERA Concern about privacy of data Pregnant Full face mask user Any medical condition deemed by the investigator to pose an issue with the subject's participation. Upper limit of CPAP pressure of ≥ to 15 cm H20 or APAP a upper limit pressure setting of ≥17cm H2O Requires the use of supplemental oxygen

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Aveera<br>This is a prospective, open label study to assess the scan, print and fit process to see if the Aveera will be able to be used with conventional CPAP therapy devices | Device: Aveera<br>* Subjects will use the 3D crafted CPAP mask. All subjects will receive a mask to use<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) Measure time frame from scanning to mask fit and subjective patient feedback of mask fit | Assess the clinical utility of using a 3D scanning process, printing and fit assessment | 2 weeks |
Genetic Study of Lupus Patients and Their Families

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to perform genetic testing in and to collect information from families affected by lupus in order to identify the genetic factors associated with systemic lupus erythematosus (SLE).

Detailed Description
-----------------
Little is known about the genetic factors that predispose people to developing SLE. Genes in patients with SLE may provide clues about SLE's pathogenesis. This study will compare genes from SLE patients, their unaffected family members, and control participants. Travel to the study site is not required. In this study, blood samples will be collected from people diagnosed with SLE, their unaffected family members, and condition-matched controls. Participants will be asked questions about their health and will provide a small blood sample. Participants will also be asked to provide written permission for release of medical information, so that their disease status can be verified through medical record review or through consultation with their doctors. Study personnel may contact participants in the future for follow-up questions and additional blood draws, if the participant agrees.

Official Title
-----------------
Gene Mapping in Women With SLE

Conditions
-----------------
Systemic Lupus Erythematosus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of SLE OR a family member of participant diagnosed with SLE Exclusion Criteria: Pregnancy or breastfeeding
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 |
| --- | --- |
| 1<br>SLE patients | |
| 2<br>Unaffected family members of SLE patients | |
| 3<br>Control participants | |

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
-----------------
Lupus, SLE
The Correlations Between Clinical Effect and Emotional State

Study Overview
=================
Brief Summary
-----------------
To analyze the correlations between preoperative emotional state and postoperative clinical effect among patients undergoing lumbar surgery

Detailed Description
-----------------
Preoperative emotional state and postoperative clinical effect of patients undergoing lumbar surgery will be evaluated and compared. Then the relations of anxiety and depression on quality of life will be analyzed.

Official Title
-----------------
Analysis of Correlations Between Preoperative Emotional State and Postoperative Clinical Effect in Patients Undergoing Lumbar Surgery

Conditions
-----------------
Emotional Disorder

Intervention / Treatment
-----------------
* Other: emotional state


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with relevant symptoms of lumbar degenerative diseases; patients with bad emotional state,such as anxiety or depression. Exclusion Criteria: spinal tumor; spinal trauma; congenital spinal disease; patients diagnosed psychosis; patients with incomplete clinical informations.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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 |
| --- | --- |
| lumbar surgery patients<br>patients undergoing lumbar surgery with or without anxiety or depression emotional state | Other: emotional state<br>* anxiety or depression state evaluated by emotional scale<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of patient's quality of life | difference of scores of clinical effect scales | Baseline and two weeks postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of patients's emotional state | difference of scores of emotional state scales | Baseline and two weeks postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lumbar surgery, emotional state
Acute Haemodynamic Impact of an IV Glucose-injection

Study Overview
=================
Brief Summary
-----------------
Patients with peritoneal dialysis will be administered an IV glucose-injection to evaluate the haemodynamic impact of this injection. The patients will be matched with healthy volunteers.

Official Title
-----------------
Acute Haemodynamic Impact of an IV Glucose-injection

Conditions
-----------------
Peritoneal Dialysis

Intervention / Treatment
-----------------
* Drug: Administration of an IV glucose-injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years old Stable clinical condition Either peritoneal dialysis (at least one month) either matched healthy subject Exclusion Criteria: Heart Failure Diabetes requiring insulin treatment

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Administration of an IV glucose-injection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemodynamic parameters |  |  | 
| Glycemia |  |  |
Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of ranolazine, an FDA-approved medication for the treatment of angina, on heart function by using echocardiography.

Official Title
-----------------
The Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction

Conditions
-----------------
Ranolazine, Diastolic Heart Failure, Tissue Doppler Ultrasound, Echocardiography

Intervention / Treatment
-----------------
* Drug: ranolazine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate of severe diastolic dysfunction, E/Ea>12 Preserved systolic function NYHA Class I-II Exclusion Criteria: QTc >450 msec at enrollment Taking medications that prolong QT interval or are potent inhibitors of CYP3A Significant coronary artery disease Severe valvular disease Hepatic disease Severe kidney disease Women of childbearing age Prior serious ventricular arrhythmia

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Active drug for 2 weeks, then washout period for 2 weeks, then placebo for 2 weeks | Drug: ranolazine<br>* extended release 500 mg twice a day for two weeks<br>* Other names: Ranexa;|
| Other: 2<br>Placebo for 2 weeks, then washout for 2 weeks, then ranolazine for 2 weeks | Drug: ranolazine<br>* extended release 500 mg twice a day for two weeks<br>* Other names: Ranexa;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in E/Ea |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in mitral inflow parameters (E, A, IVRT, DT) |  | 2 weeks | 
| Changes in tissue doppler parameters (Ea, Aa) |  | 2 weeks | 
| Changes in pulmonary venous inflow (S, D, a reversal) |  | 2 weeks |
METASARC: Patterns of Care and Outcomes in METAstatic Soft Tissue SARComa

Study Overview
=================
Brief Summary
-----------------
Well-designed observational studies of individuals with rare tumors are needed to improve patient care, clinical investigations, and the education of healthcare professionals. The patterns of care, outcomes, and prognostic factors of a cohort of 2225 patients with metastatic soft tissue sarcomas who were diagnosed between 1990 and 2013 and documented in the prospectively maintained database of the French Sarcoma Group will be analyzed with a focus on : number/frequency of systemic treatments per patient, number/frequency of patients with locoregional treatment of the metastasis, number/frequency of patients with chemotherapy, number/frequency of patients with an off-label drug. Outcome (time-to-next treatment [TNT] and overall survival [OS]) will be reported according to histological subtype, as well as the association between TNT and OS. Prognostic factors of OS will be investigated.

Official Title
-----------------
Patterns of Care and Outcomes of Patients With METAstatic Soft Tissue SARComa in a Real-life Setting: the METASARC Observational Study

Conditions
-----------------
Sarcoma, Metastases, Chemotherapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: advanced soft tissue sarcoma age > 18 Exclusion Criteria: -

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 |
| --- | --- |
| patients with metastatic softtissue sarcomas diagnosed between 1990 and 2013<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation Between Time to Next Treatment (TNT) and Overall Survival (OS) Under First-line Treatment | TNT: time from the systemic treatment onset to the next treatment or death due to any cause, whichever came first. OS: time from the systemic treatment onset to death | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patterns of care, outcome, time to next treatment, overall survival
Treatment of Acute Stroke With Cromolyn(Single Dose)

Study Overview
=================
Brief Summary
-----------------
Mastocytes were proven to have a central rule in their development of the lipoid plaque of the vascular system. Mastocytes also has an important role in the stabilisation of the plaque in the building of the brain barrier. Different animal studies show that the inhibition of the mastocyte activity decreases significantly the risk of secondary bleeding post ischaemic stroke.It was also shown that post stroke inflammation process was also blocked by the inhibition of mastocytes.Other studies showed up to 100% decrease in the brain barrier disruption and post stroke oedema, after treatment with mastocyte inhibitors. Cromolyn is a synthetic drug which has an anti-allergic effect by inhibition of the mastocytes. This drug is a well known,safe drug and is the main sub-substance that was used in the previously mentioned studies.

Conditions
-----------------
Acute Stroke

Intervention / Treatment
-----------------
* Drug: CROMOLYN
* Drug: sugar pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infarction of the anterior Circulation system. Both genders Age > 20 years NIHSS > 5 - Exclusion Criteria: Non- ischaemic stroke Additional disease of the CNS Known allergy to cromolyn Diseae of mastocytosis Renal or Hepatic failure (acute or chronic) Inability to sign consent form (dementia or sensory aphasia) Lacunar infarctions INfarction present in cerebellum or brain stem -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

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

Design Details

Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: sugar pill<br>sugar pill dissolved in water to be given 4 times a day 30 minutes prior to meals | Drug: sugar pill<br>* sugar pill Dissolved in water taken 4 times daily 30 minutes prior to meals<br>|
| Active Comparator: Cromolyn<br>Cromolyn dose of 200mg(dissolved in water) will be given 4 times a day(30 minutes before a meal) | Drug: CROMOLYN<br>* Cromolyn 200mg (dissolved in water) given 4 times a day<br>* Other names: GASTROCOM;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |