linjc16/ctgov huggingface dataset:
Prevalence Survey in France of Unintentional Perioperative Hypothermia and Its Impact on Two Outcomes

Study Overview
=================
Brief Summary
-----------------
The primary objectives of the study are to perform a survey on the clinical management of unintentional hypothermia during surgery in France. to assess the impact of perioperative hypothermia on anemia and myocardial injury.

Detailed Description
-----------------
100 investigation centers in metropolitan France will participate in the study, targeting 2000 included patients (20 surgical interventions in each center). The duration of inclusion in each center should last at most 2 weeks. The selected surgical interventions will be those performed with a high frequency, practiced in all types of hospitals (public, private, university hospital or not), and requiring anesthesia of at leat 30 minutes (general, epidural or intrathecal anesthesia).

Official Title
-----------------
Prevalence Survey in France of Unintentional Perioperative Hypothermia and Its Impact on Two Outcomes: Blood Loss, Myocardial Injury After Non Cardiac Surgery

Conditions
-----------------
Hypothermia, Perioperative

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Non-ambulatory surgery. Duration of anesthesia > 30 minutes. Type of surgery: urology, gynecological, gastrointestinal, vascular and orthopedics surgery. Type of anesthesia: general, intrathecal or epidural anesthesia. patient ≥ 45 years. No opposition of patient to participate in the study. Exclusion criteria: Emergency surgery. Cardiac surgery, proctology surgery or thoracic surgery. Digestive endoscopy or surgical radiology. Septic surgery. Patient with at least one organ failure.

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- | --- |
| Core temperature | The temperature will be measured with the same type of thermometer in all investigator sites: SpotOn™ (3M France). | up to 24 hours | 
| blood loss | Blood loss will be assessed by haemoglobin variation between preoperative and the first post-operative day. | up to 24 hours | 
| myocardial injury | Troponin T will be measured after the surgical intervention (at least 6 hours after the end of the surgery) and on the second postoperative day (when the patient remains hospitalized). | up to 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypothermia, prevalence, perioperative, anemia, myocardial injury, troponin T, noncardiac surgery
Efficacy of Combination Therapy for Prevention of Effects of Malaria During Pregnancy

Study Overview
=================
Brief Summary
-----------------
This study is an investigation to compare the efficacy of two different intermittent sulfadoxine/pyrimethamine (SP) treatment regimens and intermittent sulfadoxine/pyrimethamine (SP) + artesunate (SP/AS) treatment of HIV negative and positive mothers in clearing placental parasitemia at delivery. If intermittent protective SP/AS treatment is equally efficacious and safe as intermittent protective SP, such a regimen could be adapted for programmatic use as a potentially more durable alternative to SP monotherapy in areas of increasing SP resistance.

Official Title
-----------------
Efficacy of Intermittent Sulfadoxine-Pyrimethamine and Sulfadoxine-Pyrimethamine + Artesunate Treatment in the Prevention of Malaria in Pregnancy in an Area With Chloroquine-Resistant Plasmodium Falciparum

Conditions
-----------------
Malaria

Intervention / Treatment
-----------------
* Drug: sulfadoxine/pyrimethamine
* Drug: sulfadoxine/pyrimethamine plus artesunate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 15 years of age or older First or second pregnancy between 16 and 36 weeks gestation Exclusion Criteria: Pregnancy prior to 16 weeks or after 36 weeks gestation Third or later pregnancy; Report previous allergic reactions to SP, AS, or unknown antimalarials; If the distance to their home is too great or too inaccessible for follow-up; Child's father refuses the woman's participation

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sulfadoxine/pyrimethamine|nan|
|Drug: sulfadoxine/pyrimethamine plus artesunate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| placental parasitemia |  |  | 
| reported or noted adverse reactions |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parasitemia at delivery (maternal peripheral, placental and cord) |  |  | 
| maternal illness |  |  | 
| birth weight |  |  | 
| gestational age |  |  | 
| fetal and infant health |  |  | 
| impact of maternal HIV infection on efficacy of malaria prevention during pregnancy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malaria, birthweight, placental malaria, intermittent protective treatment, sulfadoxine/ pyrimethamine, artesuate, combination therapy, Pregnancy
Non-linear Multimodal Microendoscopy for Lung Cancer Pathology

Study Overview
=================
Brief Summary
-----------------
For this study the investigators are looking to do the following: To characterize human lung lesions by nonlinear microscopy using ex vivo tissues. To establish the first spectral/structural database for nonlinear optical microimaging of normal and abnormal lung tissue.

Detailed Description
-----------------
For this study the investigators are looking to do the following: To characterize human lung lesions by nonlinear microscopy using ex vivo tissues. In particular, to investigate collagen content and ultrastructure with SHG (second harmonic generation) microscopy, to characterize cell and nuclear morphology and lipid vesicle content with THG (third harmonic generation) and CARS (coherent anti-Stokes Raman scattering) microscopy and to conduct spectroscopic and lifetime characterization of MPF (multiphoton fluorescence) signals in cancerous, benign, and normal tissues. To establish the first spectral/structural database for nonlinear optical microimaging of normal and abnormal lung tissue, from which to generate diagnostic algorithms, both to optimize the operating parameters of planned nonlinear endoscopic imaging and to serve as the basis for nonlinear optical histopathology.

Official Title
-----------------
Non-linear Multimodal Microendoscopy for Lung Cancer Pathology

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older. Patients with confirmed or suspected lung cancer who require lobectomy as part of standard-of-care. Exclusion Criteria: Patients deemed on clinical grounds not to be medically fit for a lobectomy Patients where there is a high clinical suspicion of lymphoma (to avoid mixing the data sets). Patients unable to give informed 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 |
| --- | --- |
| Malignant<br>Tissue sample | |
| Benign<br>Tissue sample | |
| Normal<br>Tissue Sample | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nonlinear optical microscopy for cancerous tissue detection in human lung lesions |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The first spectral/structural database for nonlinear optical micro-imaging of normal and abnormal lung tissue |  | Two Years |
Short-course Hypofractionated Radiotherapy for Localized Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This study is aimed at providing further clinical evidence to support or refute the current understanding of biological sensitivity of prostate cancer to fractionated radiotherapy. Determining the morbidity and cancer control provided by a 4-week course of treatment will greatly influence future radiotherapy services for patients with localized prostate cancer.

Detailed Description
-----------------
This study is aimed at providing further clinical evidence to support or refute the current understanding of biological sensitivity of prostate cancer to fractionated radiotherapy. Determining the morbidity and cancer control provided by a 4-week course of treatment will greatly influence future radiotherapy services for patients with localized prostate cancer.

Official Title
-----------------
A Phase I/II Study of Escalated-dose Short-course Hypofractionated Radiotherapy (55 Gy/16 Fractions/4 Weeks) for Localized Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage T1 and T2 prostate cancer Prostate specific antigen (PSA)>=20 and Gleason score<=6 PSA<=15 and Gleason score 7 Signed informed consent Exclusion Criteria: No hip prosthesis, pins or screws No previous pelvic radiotherapy No inflammatory bowel disease

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: radiotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rectal morbidity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
image-guidance, prostate cancer, radiotherapy, hypofraction, radiosensitivity
Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
Since the 1990s, the concept of anesthesia without morphine (OFA) has been developed. The principle is based on the fact that in a sleeping patient a sympathetic reaction marked by hemodynamic changes does not reflect a painful phenomenon, that a painful phenomenon in a sleeping patient is not memorized, that hormonal stress, sympathetic reaction and inflammatory reaction can be controlled by therapeutic classes other than a morphine agent. This therapeutic management would avoid the side effects associated with the use of morphine. In cardiac surgery, no studies have evaluated the effect of an OFA on morphine consumption and on a post-operative composite endpoint. Lidocaine was only studied in the context of cardioprotection and neuroprotection. Studies found a cardioprotective effect with a decrease in episodes of rhythmic disorders, and neuroprotective with a non-constant improvement in postoperative cognitive functions, but all these studies were performed during opioid anaesthesia (opioid agent use)/ The purpose of our study is to demonstrate that general anesthesia without opioid (OFA) is associated with a decrease in post-operative morphine consumption and an improvement in the patient's post-operative well-being (complications, confusion, vigilance, length of stay).

Official Title
-----------------
Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas

Conditions
-----------------
Opioid Free Anaesthesia, Opioid Anaesthesia

Intervention / Treatment
-----------------
* Procedure: Opioid free anaesthesia
* Procedure: Opioid anaesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 years cardiac surgery with cardiopulmonary bypass Exclusion Criteria: patient with chronic analgesia treatment patient on antidepressive therapy gabapentin use preoperative cognitive dysfunction patient treated with zyvoxid

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 |
| --- | --- |
| Opioid free anaesthesia<br>patient anesthtesized with lidocaine, ketamine and dexamethasone | Procedure: Opioid free anaesthesia<br>* patient anesthtesized with lidocaine, ketamine and dexamethasone<br>|
| Opioid anaesthesia<br>patients anesthetized with sufentanil ketamine and dexamethasone | Procedure: Opioid anaesthesia<br>* patients anesthetized with sufentanil ketamine and dexamethasone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption | Total morphine consumption over the first 48 post operative hours in milligrammes | Day 2 | 
| Complications | composite end point of post operative complications (cardiac, neurological, renal, respiratory) | Day 7 |
Detection of AD Biomarkers in Tear Fluid

Study Overview
=================
Brief Summary
-----------------
Detection of AD biomarkers in tear fluid

Official Title
-----------------
Detection of AD Biomarkers in Tear Fluid

Conditions
-----------------
Cognitive Impairment

Intervention / Treatment
-----------------
* Other: Tear sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: . Inclusion criteria were an MMSE score ≥ 20 and a CDR score from 0 to 1, thereby including patients across the whole clinical spectrum (i.e. from subjective cognitive disorder to (mild) dementia). Exclusion Criteria: Exclusion criteria at baseline were neurological diseases (such as Normal Pressure Hydrocephalus, Morbus Huntington, brain tumor, epilepsy, encephalitis, recent Transient Ischemic Attack (TIA) or cerebrovascular accident (CVA) (< 2 years), or TIA/CVA with concurrent (within three months) cognitive decline) and a history of psychiatric disorders (such as schizophrenia, bipolar disorder or psychotic problems, current major depressive disorder (within 12 months), or alcohol abuse).
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 |
| --- | --- |
| Dementia<br>Dementia | Other: Tear sampling<br>* Tear sampling using Schirmer's strips<br>|
| MCI<br>Mild cognitive impairment | Other: Tear sampling<br>* Tear sampling using Schirmer's strips<br>|
| SCD<br>Subjective cognitive decline | Other: Tear sampling<br>* Tear sampling using Schirmer's strips<br>|
| HC<br>Cognitively healthy control | Other: Tear sampling<br>* Tear sampling using Schirmer's strips<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of AD biomarkers in tear fluid |  | Baseline |
Validation of the Stardust Cardio-Respiratory Recorder

Study Overview
=================
Brief Summary
-----------------
Introduction: The full night polysomnography (PSG) in sleep lab is the gold standard to Obstructive Sleep Apnea (OSA) diagnosis. However, there is a need to evaluate simple and accurate home diagnostic equipment that can reliably detect or exclude OSA. The aim of our study was to evaluate if an ambulatory portable monitor (SD) is accurate to measure apnea-hypopnea index (AHI) in OSA patients referred to a Sleep Lab. Methods: Patients with clinical suspicion of OSA were selected. Three-order randomized evaluations had been performed within a period of two weeks: the 1) SD (Stardust®, Respironics, Inc, USA) was used at patients home (SD home), 2) SD was used simultaneously with PSG in the sleep lab (SD+PSG lab) and 3) PSG was performed without the use of SD (PSG lab). Four AHI were generated and analyzed: AHI from SD home, AHI from SD of SD+PSG lab, AHI from PSG of PSG+SD lab and AHI from PSG lab. The analyses of SDs and PSGs recordings were performed by two blinded technicians.

Official Title
-----------------
Validation of the Stardust Cardio-Respiratory Recorder

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient referred to Sleep Disorder Center because of: Excessive daytime sleepiness, Loud snoring, Witnessed apnea. Patient with ability to provide consent, ability and willingness to follow study procedures. Exclusion Criteria: Suspicion of insomnia, Restless leg syndrome, Periodic limb movements; or Other non-OSA sleep disorders. Patient experiencing acute illness, patients who are medically complex, and patients requiring supplemental oxygen or mechanical ventilation.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Prospective Evaluation of the Biomechanical Properties of the Thoracic Aorta Coupling Magnetic Resonance Imaging and In-vitro Elasticity Tests in Patients With Ascending Aortic Aneurysm

Study Overview
=================
Brief Summary
-----------------
The biomechanical properties of the aorta are currently poorly understood. A better understanding would optimize surgical indications and monitoring techniques for patients with thoracic aortic aneurysms.

Official Title
-----------------
Prospective Evaluation of the Biomechanical Properties of the Thoracic Aorta Coupling Magnetic Resonance Imaging and In-vitro Elasticity Tests in Patients With Ascending Aortic Aneurysm

Conditions
-----------------
Patient With Ascending Aortic Aneurysm With Surgical Indication for Replacement

Intervention / Treatment
-----------------
* Procedure: Cardiac MRI
* Other: in-vitro elasticity tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Person who has given oral consent Patient with ascending aortic aneurysm with surgical indication for replacement Age > 18 years old Scheduled surgery Exclusion Criteria: Person not affiliated to the national health insurance system Protected adult Pregnant or breastfeeding woman MRI Contraindication Emergency surgical procedure

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 |
| --- |
|Procedure: Cardiac MRI|Preoperative cardiac MRI|
|Other: in-vitro elasticity tests|in-vitro elasticity tests performed on a segment of ascending aorta collected during surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aortic compliance by cardiac MRI |  | Before surgery | 
| In-vitro testing of the elasticity of the aortic wall fragment collected during surgery. |  | through study completion, an average of 12 months |
Depression In Juvenile Diabetics

Study Overview
=================
Brief Summary
-----------------
Depression is one of the most common emotional problems among youths with insulin dependent diabetes mellitus (IDDM). It has been shown that depression in youths with IDDM lasts a while and may have a role in later complications of the medical condition. And yet, there are no psychological interventions appropriate for such youngsters. The purpose of this study is to modify a treatment called ''Contextual Psychotherapy'' (that has been developed for depressed youngsters) in order to address special needs of depressed youths with IDDM, and to ''pilot test'' the treatment. The youngsters to be recruited are those being cared for at the Diabetes Clinic of the Children's Hospital of Pittsburgh. The treatment includes a 3- month phase (16 sessions), followed by a 3-month ''booster'' phase (3 sessions), and two later follow-up evaluations.

Conditions
-----------------
Depression, Diabetes Mellitus, Insulin-Dependent

Intervention / Treatment
-----------------
* Behavioral: psychotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IDDM duration of less than 10 years No major medical disorder other than IDDM No psychotropic medications Meets psychiatric diagnostic criteria for depression Parent and child willing to participate Exclusion Criteria: Does not live withing commuting distance Mental retardation

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: psychotherapy|nan|

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
-----------------
depression