linjc16/ctgov huggingface dataset:
Effects of Noninvasive Brain Stimulation on Brain Activity and Appetite

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to identify brain mechanisms by which Noninvasive brain stimulation (NIBS) could decrease hyperphagia. The investigators will synchronously deliver NIBS and measure brain activity in a randomized, crossover, sham-controlled, fully blind study. This work will reveal brain mechanisms to reduce hyperphagia and may contribute to new therapeutic avenues to treat this eating disorder.

Conditions
-----------------
Hyperphagia

Intervention / Treatment
-----------------
* Device: Noninvasive brain stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hyperphagic Exclusion Criteria: Psychiatric disorders Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Noninvasive brain stimulation: active<br>In active condition, subject will receive stimulation during all the duration of the experimental session. | Device: Noninvasive brain stimulation<br> <br> |
| Placebo Comparator: Noninvasive brain stimulation: sham<br>In sham condition, subject will receive stimulation only at the beginning and at the end of the experimental session. | Device: Noninvasive brain stimulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food craving assessed by the Food Cravings Questionnaire - State |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain activity assessed by electroencephalography |  | 1 hour | 
| Brain activity assessed by blood-oxygen-level dependent contrast imaging |  | 1 hour |
Survival Outcomes of Uterine Malignancies in Chinese Population

Study Overview
=================
Brief Summary
-----------------
This study aims to determine survival outcomes (overall survival and progression-free survival) of primary uterine malignancies in China and relevant risk factors in a prospective cohort study.

Official Title
-----------------
Survival Outcomes of Uterine Malignancies in Chinese Population

Conditions
-----------------
Endometrial Neoplasms, Survival

Intervention / Treatment
-----------------
* Other: Follow-up for death and recurrence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary uterine malignancies. Exclusion Criteria: Metastatic malignancies to uterine corpus
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Follow-up for death and recurrence|All patients are followed up to determine definite date of diagnosis, recurrence and death.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Survival duration from diagnosis to death | 5 years | 
| Progression-free survival | Survival duration from last treatment after remission to recurrence | 5 years |
Neurological Complications at Stroke Patients With Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
It is to be investigated if a correlation exist between the development of the HbA1c value and the complication rate is following a stroke.

Detailed Description
-----------------
The immediate objective of the study is to find out if a correlation between blood sugar control in diabetics and the incidence of complications after a stroke exists. The study has a high practical importance because any consequences in the treatment of diabetes mellitus can be implemented without affecting costs.

Official Title
-----------------
Neurological Complications at Stroke Patients With Diabetes Mellitus During the First Six Months After a Cerebral Ischemia

Conditions
-----------------
Stroke, Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stroke patients on the Stroke Unit with hyperglycemia with cerebral ischemia within the last 24 hours Exclusion Criteria: Patients with intracerebral hemorrhage Pregnant patients Patients with sensory aphasia

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 |
| --- | --- |
| HbA1c ≤ 7<br>Stroke patients with mild diabetes mellitus HbA1c ≤ 7 | |
| HbA1c ≥ 7,5<br>Stroke patients with severe diabetes mellitus HbA1c ≥ 7,5 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome six months after the cerebral ischemia | Functional outcome for the National Institutes of Health Stroke scale, the Barthel Index and Modified Ranking Scala six months after the cerebral ischemia. | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional cerebral ischemia | Additional cerebral ischemia six months after the first cerebral ischemia | six months | 
| Mortality | Mortality in the first 6 months after the primary cerebral ischemia | sixt months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus, Stroke
Improvement of Lung and Thoracic Compliance in ARDS Patients in Prone Position by Using Inflatable Air Bag

Study Overview
=================
Brief Summary
-----------------
ARDS is frequent in ICU and may lead to many complications and to death. Prone position is widely used in ADRS patients and demonstrated to decrease mortality. Regarding the chest wall compliance data are missing but the theorical response is that this compliance is decreased in a prone position mainly due to anterior chest and abdomen compression in this position which are more compliant that dorsal part of the body. As well prone position could be associated with complications as pressure ulcers. Because prone position is associated with complications, air bag were developped to decrease pressure on the chest and abdomen and to decrease pressure ulcers. Then, trying to improve chest compliance in prone position and reducing the risk of pressures ulcers could be a challenge with this system in comparison with standard care.

Official Title
-----------------
Improvement of Lung and Thoracic Compliance in ARDS Patients in Prone Position by Using Inflatable Air Bag

Conditions
-----------------
ARDS, Prone Position, Mechanical Ventilation, Airbag

Intervention / Treatment
-----------------
* Other: prone position with airbags
* Other: prone position without airbags


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with ARDS under mechanical ventilation with P/F ratio<150 Age >18 y/o Admitted in the medical ICU of Amiens under mechanical ventilation sedated, With signed informed consent (patient or relative if patient is not conscious) Exclusion Criteria: patients not eligible for a prone position Patients with tracheostomy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prone position with airbags<br> | Other: prone position with airbags<br>* prone position with airbags<br>|
| Active Comparator: prone position standard of care<br> | Other: prone position without airbags<br>* prone position without airbags<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variation of Lung compliance between both groups |  | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARDS, prone position, mechanical ventilation, airbag
GLASS Classification and CLTI

Study Overview
=================
Brief Summary
-----------------
Critical limb threatening ischemia CLTI 'is not a separate local disease but also it is a part of generalized vascular disorder. A clinical syndrome that can be presented by many symptoms and signs as rest pain, gangrene and chronic ulceration more than 2 weeks (1).

Detailed Description
-----------------
The Global Vascular guidelines 'GVG proposes a new Global Anatomic Staging System (GLASS), GLASS incorporates two novel and important concepts, the target arterial path (TAP) and estimated limb-based patency (LBP). Based on appropriate angiographic imaging, the TAP is defined by the treating surgeon or internationalist as the optimal arterial pathway to restore in-line (pulsatile) flow to the ankle and foot. LBP allows more direct comparison of anatomic outcomes across revascularization strategies in CLTI. The complexity of disease traversed by the TAP is integrated in the GLASS. Femoropopliteal (FP) and infrapopliteal (IP) arterial segments are individually graded on a scale of 0 to 4.(2)(3) Using a consensus based matrix, these segmental grades are combined into three overall GLASS (I-III) stages for the limb, reflecting the complexity of the disease with a proposed likelihood of immediate technical failure ' ITF  and 1 year LBP  after endovascular intervention of  TAP ' (1)

Official Title
-----------------
The Relationship Between the Global Limb Anatomic Staging System (GLASS) and Short Term Outcomes of Endovascular Management of Infrainguinal Lesions in Patients With Chronic Limb Threatening Ischemia (CLTI)

Conditions
-----------------
Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with infrainguinal CLTI Exclusion Criteria: Patients with concomitant Aorto-iliac lesions Acute ischemia patients Post Traumatic ischemia
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 |
| --- | --- | --- |
| Imitate technical failure | Failure of passage of wire or Recoil of vessels during angioplasty | 1 year | 
| Limb based patency at 1 year | Patent vessels after endovascular management | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amputation free survival at 1 year | Limb preserved after endovascular intervention | 1 year | 
| Mortality Rate at 1 year | Death after endovascular intervention | 1 year | 
| Amputation rate at 1 year | Amputation after endovascular intervention | 1 year |
Pharmacokinetic of Posaconazole in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
The posaconazole pharmacokinetic in critically ill patients will be studied in a prospective, non-interventional, monocentric observational trial.

Detailed Description
-----------------
The posaconazole pharmacokinetic in critically ill patients will be studied in a prospective, non-interventional, monocentric observational trial. Plasma specimens will be retrieved on consecutive days (max. 7 days) in order to measure posaconazole levels during the treatment episode.

Official Title
-----------------
Pharmacokinetic of Intravenous Posaconazole in Critically Ill Patients

Conditions
-----------------
Therapeutic Drug Monitoring, Critical Illness

Intervention / Treatment
-----------------
* Other: Posaconazole Therapeutic Drug Monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: treatment with intravenous posaconazole critically ill patient written declaration of consent Exclusion Criteria: - no declaration of consent

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 |
| --- | --- |
| Posaconazole Therapeutic Drug Monitoring<br>Therapeutic Drug Monitoring of posaconzole is performed by measuring posaconazole concentrations in serum | Other: Posaconazole Therapeutic Drug Monitoring<br>* Therapeutic Drug Monitoring is performed by measuring posaconazole concentrations in serum on seven consecutive days (anticipated).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posaconazole Drug Exposure | Measurement of posaconazole concentration in serum | seven days from therapystart | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| population-pharmacokinetic analysis 1 | Analysis of Peak Plasma Concentration (Cmax) for posaconazole in the given cohort. | 12 months after close out | 
| population-pharmacokinetic analysis 2 | Analysis of Area under the plasma concentration versus time curve (AUC) for posaconazole in the given cohort. | 12 months after close out | 
| Evaluation of probability of target attainment of posaconazole | Analysis of Monte-Carlo-Simulations in order to asses novel dosing regimens for posaconazole. | 12 months after close out |
Home Diagnosis and Treatment of Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
Obstructive Sleep Apnea (OSA) is a common and underrecognised condition. The diagnosis of OSA is typically made after an in-lab polysomnography (PSG) which requires an overnight stay in a sleep laboratory. Many sleep laboratories have long waiting lists for PSG. There are a number of portable devices which may be useful in home diagnosis of OSA, however there is limited data on outcomes of OSA diagnosed and treated at home. In this study we propose to compare diagnostic accuracy of a home monitoring device with a PSG and outcomes of OSA therapy when implemented at home vs in the sleep laboratory.

Detailed Description
-----------------
We will randomise patients suspected to have OSA to either home evaluation and treatment (using a portable monitor and auto-CPAP) or in-lab evaluation with a PSG and manually-titrated CPAP. We will obtain sleep, sleepiness and quality of life questionnaires, vigilance testing and blood pressure at baseline and after 1, 2, 4 and 12 weeks of therapy. We will also assess and compare compliance with CPAP therapy in each arm of the study.

Official Title
-----------------
Can Obstructive Sleep Apnea be Diagnosed at Home? A Randomised Trial of Home vs.in-Lab Diagnosis and Treatment of OSA.

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

Intervention / Treatment
-----------------
* Device: Continuous Positive Airway Pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult ( age > 18) suspected OSA no coexisting heart or lung disease not in a safety-sensitive occupation 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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Continuous Positive Airway Pressure|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleepiness score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  |  | 
| Vigilance tests |  |  | 
| Sleep quality |  |  | 
| CPAP compliance |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep apnea, home monitoring, CPAP
Metabolic Adaptations to Diabetes in African Americans

Study Overview
=================
Brief Summary
-----------------
We do not know why diabetic patients cannot protect themselves against low blood sugar. Therefore, in this study, we will perform a comprehensive assessment of the body's response to low blood sugar by measuring changes in blood hormones, blood sugar production, and nerve signals.

Detailed Description
-----------------
Morning and afternoon hypoglycemic episodes of 70, 60, or 50 mg/dl produce increased blunting of subsequent counterregulation dependent upon the depth of preceding hypoglycemia. We wanted to test this hypothesis in healthy African American individuals to determine if there is a difference in their responses to varying depths of hypoglycemia.

Official Title
-----------------
Metabolic Adaptations to Diabetes

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Procedure: glucose clamp
* Procedure: glucose clamp
* Procedure: glucose clamp
* Procedure: glucose clamp


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males and females aged 18-40 yrs with no family history of diabetes mellitus. All prospective volunteers will have routine blood tests to screen for biochemical, hormonal and hematological abnormalities. Female volunteers will also undergo an HCG urine pregnancy test. Exclusion Criteria: Prior or current history of poor health Abnormal results following blood and physical examination Pregnancy

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

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Single 2 hour hyperinsulinemic euglycemic clamp study at  90 mg/dl. | Procedure: glucose clamp<br>* 2 hour hyperinsulinemic euglycemic clamp (90 mg/dl)<br>|
| Experimental: 2<br>Single 2 hour hyperinsulinemic hypoglycemic clamp study at  70 mg/dl. | Procedure: glucose clamp<br>* 2 hour hyperinsulinemic hypoglycemic clamp (70 mg/dl)<br>|
| Experimental: 3<br>Single 2 hour hyperinsulinemic hypoglycemic clamp at  60 mg/dl. | Procedure: glucose clamp<br>* 2 hour hyperinsulinemic hypoglycemic clamp (60 mg/dl)<br>|
| Experimental: 4<br>Single, 2 hour hyperinsulinemic hypoglycemic clamp at  50 mg/dl. | Procedure: glucose clamp<br>* 2 hour hyperinsulinemic hypoglycemic clamp (50 mg/dl)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| catecholamines |  | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypoglycemia, African Americans
Fast Spectral Imaging Device for Tumor Margin Mapping

Study Overview
=================
Brief Summary
-----------------
The objective of the proposed research is to develop a clinical-trial-ready device and to evaluate its practical utility as a routinely used intra-operative tool. Our multidisciplinary group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. The proposed technology will be a multi-channel optical assay device for intra-operative imaging of margins in specimens excised from patients undergoing breast conserving surgery (partial mastectomy) or mastectomy.

Official Title
-----------------
Fast Spectral Imaging Device for Tumor Margin Mapping

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing a partial mastectomy or mastectomy for the treatment of an invasive or non-invasive breast malignancy Age > 18 Clinically detectable disease either by physical examination or radiographic studies Patients of all ethnic and gender groups will be included. Protocol accrual will be reviewed annually to include a determination of minority and gender representation. If accrual demonstrates under representation of any group with comparison to disease incidence in that group, appropriate measures will be undertaken to increase participation of patients of that minority or gender group. Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Patients considered in vulnerable populations

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Degradation<br>30 mastectomy, partial mastectomy, and mammoplasty samples will be analyzed to define the effective post-excision time window in which the device must be used before the results can no longer be evaluated. The mammoplasty specimens are necessary to assess normal tissue outcomes. | |
| Reproducibility<br>25 Partial Mastectomy cases will be analyzed to distinguish between different implementation methods of the technology. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To perform a critical evaluation of the device in a practical clinical setting | (1) In order to define the effective post-excision time window in which the device must be used, which ultimately has bearings on the final product indications for use. (2)To analyze the different methods of implementation of the technology. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, breast carcinoma in situ, ductal breast carcinoma in situ, invasive carcinoma, invasive ductal carcinoma, invasive lobular carcinoma