linjc16/ctgov huggingface dataset:
Effects of Sleep Extension on Glucose Metabolism in Chronically Sleep Deprived Individuals

Study Overview
=================
Brief Summary
-----------------
This is a randomized cross over study of the effect of 2-week sleep extension in chronically sleep deprived non-diabetic individuals on glucose metabolism.

Conditions
-----------------
Sleep Extension, Glucose Metabolism

Intervention / Treatment
-----------------
* Behavioral: Sleep extension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: self-reported sleep duration =<6 hours/night during the week with a desire to sleep at least 7 hours/night Exclusion Criteria: shift workers, diabetes history, drugs affecting sleep or glucose metabolism, insomnia symptoms, high risk for sleep apnea, smoking or excess alcohol use

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Continue with habitual sleep duration | |
| Experimental: Intervention<br>Sleep extension | Behavioral: Sleep extension<br>* Sleep extension by 1 hour for 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose metabolism | Glucose and insulin values from 75 gram OGTT | 2 weeks |
Adrenal Tumors - Pathogenesis and Therapy

Study Overview
=================
Brief Summary
-----------------
The pathogenesis of adrenal tumors is still not fully elucidated and the treatment options for malignant tumors are poor. The current study investigates different aspects of the pathogenesis of adrenal tumors and evaluates different therapeutic options in patients with adrenocortical carcinoma.

Official Title
-----------------
Investigation of the Tumorigenesis of Adrenal Tumors and Evaluation of New Therapeutic Options - Untersuchungen Zur Tumorgenese Von Nebennierentumoren Und Evaluation Neuer Therapieoptionen

Conditions
-----------------
Adrenal Tumors, Adrenocortical Carcinoma, Cushing Syndrome, Conn Syndrome, Pheochromocytoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adrenal tumor detected by imaging Exclusion Criteria:

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- |
| Tumor<br>Tumor material and corresponding biosamples from patients with adrenal tumors | |
| control group<br>Biomaterial from patients without adrenal tumor | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Predicting Long-term Outcomes After Cardiac Arrest by Using Serum NGAL

Study Overview
=================
Brief Summary
-----------------
This study was performed to determine the prognosis of patients after cardiac arrest using serum markers called NGAL. The initial NGAL values of patients with post-cardiac arrest syndrome are checked by blood tests, and the long-term neurological prognosis and survival rate are collected after 6 months.

Detailed Description
-----------------
Serum NGAL is currently being used as a test to determine the likelihood of developing renal failure. However, in a previous study, serum NGAL correlated with neurological prognosis in post cardiac arrest syndrome patients. This prospective study attempts to see the role of serum NGAL as a prognostic factor by including a sufficient number of patients.

Official Title
-----------------
Predicting Long-term Outcomes After Cardiac Arrest by Using Serum NGAL: A Prospective, Observational Study

Conditions
-----------------
Out-of-Hospital Cardiac Arrest

Intervention / Treatment
-----------------
* Diagnostic Test: serum NGAL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients who underwent targeted temperature management after out-of-hospital cardiac arrest. Exclusion Criteria: Patients who did not survived 3 days after cardiac arrest. Pre-existing end-stage renal disease or dependence on renal replacement therapy

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 |
| --- | --- |
| good neurologic outcome<br>Patients with good neurological prognosis after 6 months (CPC 1, 2). serum NGAL is collected. | Diagnostic Test: serum NGAL<br>* serum NGAL was measured at 0, 24, 48, and 72 hours after recovery of spontaneous circulation.<br>|
| poor neurologic outcome<br>Patients with poor neurological prognosis after 6 months (CPC 3, 4, 5). serum NGAL is collected. | Diagnostic Test: serum NGAL<br>* serum NGAL was measured at 0, 24, 48, and 72 hours after recovery of spontaneous circulation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term neurologic outcome | Patients' CPC score after 6 months (good outcome : CPC score 1, 2 / poor outcome : CPC score 3, 4, 5) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with Overall Survival at 6 months | 6-month survival rate of patients' | 6 months |
Prevalence of Long-term Respiratory Complications of Severe SARS-CoV-2 Pneumonia - COVID-19

Study Overview
=================
Brief Summary
-----------------
Studies performed after coronavirus epidemics (severe acute respiratory syndrome coronavirus, SARS-CoV and Middle East respiratory syndrome coronavirus, MERS-CoV) have shown a long-term impact on respiratory morbidity, musculoskeletal and psycho-social repercussions. Patients with SARS-CoV pneumonia had fibrotic pulmonary sequelae at 45 days (lower DLCO in 27.3% of cases and radiological lesions in 21.5% of cases). In the MERS-CoV pneumonia study, patients had radiological sequelae in 33% of cases and the 12-month evaluation showed persistence of radiological abnormalities in 23.7% of the cases despite an improvement in respiratory function. Clinical presentation and therapeutic management of severe SARS-CoV-2 infection are in part similar to those induced by SARS-CoV and MERS-CoV. Long-term respiratory complications are therefore expected.

Detailed Description
-----------------
Objective is to evaluate prevalence of long-term respiratory complications after severe SARS-CoV2 pneumonia.

Official Title
-----------------
Prevalence of Long-term Respiratory Complications of Severe SARS-CoV-2 Pneumonia

Conditions
-----------------
Severe SARS-CoV2 Pneumonia

Intervention / Treatment
-----------------
* Other: Blood sample and data record


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient Patient with with severe SARS-CoV2 pneumonia Patient consenting to participate to the study Patient enrolled in the national healthcare insurance program Exclusion Criteria: Patient under 18 years

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: adults with severe SARS-CoV2 pneumonia<br>adult with severe SARS-CoV2 pneumonia | Other: Blood sample and data record<br>* Blood sample and data record<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| medium-term respiratory complications | Interstitial lung disease diagnosed with a thoracic CT-scan | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long-term respiratory complications | Interstitial lung disease diagnosed with a thoracic CT-scan | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV2, long term, complication, pneumonia
A Registry of AL Amyloidosis (ReAL)

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to generate a large registry of patients with AL amyloidosis.

Detailed Description
-----------------
Thanks to this registry, it will be possible to collect data at diagnosis and during follow up, in order to be able to describe the natural history of AL amyloidosis in a real-world setting and to define and validate prognostic models, response and relapse criteria applicable at any point of the disease.

Official Title
-----------------
A Registry to Investigate Real-world Natural History, Impact of Therapies and Patterns of Progression of AL Amyloidosis (ReAL)

Conditions
-----------------
AL Amyloidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of systemic AL amyloidosis; treatment-naïve (pre-treatment data collected at participating center available for retrospective part); age ≥18 years; ability to understand and willingness to sign an informed consent (patients who already sign informed consent for clinical data to be used in retrospective analyses will be accepted); planned (or ongoing) follow-up at participating center. Exclusion Criteria: non-AL amyloidosis; previous treatment for AL amyloidosis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Creation of a registry of patients with AL amyloidosis |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amyloidosis, prognosis, registry
The Effect Of AVANDIA On The Late Asthmatic Response

Study Overview
=================
Brief Summary
-----------------
This study is to investigate the effects of AVANDIA on the asthmatic response.

Official Title
-----------------
A Randomised Double-blind Two-period Crossover Study to Investigate the Effect of Treatment With Repeat Doses of a PPAR Gamma Agonist on the Allergen-induced Late Asthmatic Response in Subjects With Mild Asthma Compared With Repeat Doses of Placebo

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Rosiglitazone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Mild asthmatic treated with short-acting beta agonists only, non-smoker. Exclusion criteria: Inability to abstain from medications other than short-acting beta agonists and paracetamol. Recent administration of steroids. Recent respiratory infection or exacerbation of asthma.

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: Crossover Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects receiving treatment 1<br>Eligible subjects will receive rosiglitazone immediate release tablet with a dose of 4 milligrams twice daily administered orally for 28 days followed by placebo oral tablet. | Drug: Rosiglitazone<br>* Rosiglitazone will be given as immediate release tablet of 4 milligrams administered orally for 28 days.<br>Drug: Placebo<br>* Subjects will also receive placebo oral tablet.<br>|
| Experimental: Subjects receiving treatment 2<br>Eligible subjects will receive placebo oral tablet followed by rosiglitazone immediate release tablet with a dose of 4 milligrams twice daily for 28 days. | Drug: Rosiglitazone<br>* Rosiglitazone will be given as immediate release tablet of 4 milligrams administered orally for 28 days.<br>Drug: Placebo<br>* Subjects will also receive placebo oral tablet.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of repeat oral doses of AVANDIA for 28 days on the late asthmatic response to inhaled allergen. Measured as lung function 4-10 hours after allergen challenge after 28 days dosing. |  | Up to 43 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The early asthmatic response to allergen, bronchial challenge, nitric oxide, markers of inflammation and safety/tolerability. |  | Up to 43 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma AVANDIA Inflammation
Evaluation of the Diagnostic of Hepatic Fibrosis With the in Severe Obese Patients Candidates to Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
Background: The XL probe of FibroScan was recently developed to realize liver stiffness measurements (LSM) in overweight patients. Severe obese patients have a high prevalence of liver injuries and could benefit of liver evaluation prior to bariatric surgery. Objectives: Assess the FibroScan applicability, reliability and diagnostic performances in severe obese patients' candidates for bariatric surgery.

Official Title
-----------------
Evaluation of the Diagnostic of Hepatic Fibrosis With the XL Probe of the Fibroscan Versus Biopsies in Severe Obese Patients Candidates to Bariatric Surgery

Conditions
-----------------
Steatosis, Obesity, Fibrosis, Liver

Intervention / Treatment
-----------------
* Device: Evaluation of the Diagnostic of Hepatic Fibrosis With the XL Probe of the Fibroscan Versus Biopsies in Severe Obese Patients Candidates to Bariatric Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe obese patients candidate to bariatric surgery with no history of liver disease have a large prevalence of liver lesions.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Evaluation of the Diagnostic of Hepatic Fibrosis With the XL Probe of the Fibroscan Versus Biopsies in Severe Obese Patients Candidates to Bariatric Surgery|Evaluation of the Diagnostic of Hepatic Fibrosis With the XL Probe of the Fibroscan Versus Biopsies in Severe Obese Patients Candidates to Bariatric Surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elasticity measured with the Fibroscan XL | Liver elasticity will be measured non-invasively with Fibroscan. As this is a non-invasive measure, no adverse effects are expected. No treatment planned. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 53/5000 Evolution of elasticity after bariatric surgery | The evolution of elasticity will be measured non-invasively with fibroscan after bariatric surgery. NO adverse effects are expected in relation to this measure. | 3 years |
Changes in Cerebral Oxygenation Based on Intraoperative Ventilation Strategy

Study Overview
=================
Brief Summary
-----------------
The proposed research aims to investigate how different ventilation strategies may affect cerebral tissue oxygenation in the pediatric population. It will contribute to the literature exploring the NIRS monitoring device which is becoming increasingly utilized in a variety of anesthetic and critical care settings. It may help to guide clinical practice regarding optimal ventilation strategies, and how ventilation may be altered to correct suboptimal cerebral tissue oxygenation. This prospective study will include 50 patients undergoing posterior spinal fusion that requires placement of an arterial cannulation. There will be no change in the anesthetic or perioperative care of these patients. Tissue and cerebral oxygenation will be monitored using near infrared spectroscopy (NIRS).

Official Title
-----------------
Changes in Cerebral Oxygenation Based on Intraoperative Ventilation Strategy

Conditions
-----------------
Posterior Spinal Fusion

Intervention / Treatment
-----------------
* Device: NIRS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient undergoing spinal surgery Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Posterior spinal fusion<br>Patients undergoing spinal fusion surgery | Device: NIRS<br>* Cerebral oxygenation monitor which is standard of care for this surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cerebral Oxygenation Values Throughout the Procedure | Measured on the NIRS cerebral oxygenation monitor attached to the patient | prior to induction of anesthesia in the awake patient and following four ventilation strategies (average time frame of 15 mins. to 5 hours) |
Acne Treatment With Active Patches Which Contains Azelaic Acid, Citric Acid,Salicylic Acid and 2% Ascorbic Acid

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to demonstrate the effect of short treatment with active OPLON patches on Acne.

Detailed Description
-----------------
Patients with Acne Vulgaris were treated overnight with active patches. Effect is observed at the end of the treatment and 24 hours later.

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Device: OPLON active patch
* Device: Sham patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acne Vulgaris Over 18 years Signing informed consent Exclusion Criteria: Active treatment of acne Change in hormonal therapy Antibiotic treatment in a week prior to the experiment Sensitive skin Pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oplon Active Patch<br> | Device: OPLON active patch<br> <br> |
| Placebo Comparator: Placebo patch<br> | Device: Sham patch<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity Score of lesion | Lesions were ranked by investigator according to severity whereas: 0-clear, 1-mild, 2-moderate, 3-sever | •Severity Score of lesion [Time Frame: 24 hours following patch removal] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity Score of lesion | 0-clear, 1-mild, 2-moderate, 3-sever | •Severity Score of lesion [Time Frame: 12 hours with the patch] |
Observational Cohort Study of TachoSil (TC-018-IN)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect information, after exposure to TachoSil ®, of all thromboembolic events, immunological events and drug interactions leading to thromboembolic events or major bleeding. In addition, pharmacoeconomic data will be collected.

Official Title
-----------------
An Non-interventional, Prospective, Non-controlled Study of the Use of TachoSil in Supportive Treatment in Surgery for Improvement of Haemostasis Where Standard Techniques Are Insufficient.

Conditions
-----------------
Blood Loss, Surgical

Intervention / Treatment
-----------------
* Drug: Fibrinogen (human) + thrombin (human) (TachoSil)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects, treated with TachoSil ® by the participating physicians, will be registered with a set of basic data from their already existing data (i.e. no additional diagnostic procedures will be performed). Subjects who will provide their written informed consent to use existing data, allow direct access to data and data processing.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fibrinogen (human) + thrombin (human) (TachoSil)|treatment in surgery for improvement of haemostasis where standard techniques are insufficient|

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
-----------------
Collection of all thromboembolic events,, immunological events and drug interactions leading to thromboembolic events or major, bleeding after exposure to TachoSil®.