linjc16/ctgov huggingface dataset:
Characterization of Sitting Postures in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the intra and inter-subjects variability of the pressure measurement cartography in healthy and well and able volunteers, sitting on a rigid base during two hours.

Detailed Description
-----------------
The purpose of this study is to understand the formation of pressure sore, to improve the care of paraplegic patients. This pilot study is going to help to establish a model in healthy volunteers in the prevention of pressure sores.

Official Title
-----------------
Characterization of Sitting Postures in Healthy Subjects

Conditions
-----------------
Pressure Ulcer

Intervention / Treatment
-----------------
* Device: Orthotest CE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more or equal than 18 years old age between 20 and 30 years old affiliation to social security or similarly regime Exclusion Criteria: Person with pacemaker Person with a history of lumbar pain, chest or/and cervical pain. Person with an history of lumbar, chest or/and cervical muscular disorders, Person with history of circulatory problems, Person with history of skin pathologies at the seat area, Protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health Person having a total annual compensation for the participation in biomedical research higher than €4460.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pressure Measurement<br> | Device: Orthotest CE<br>* Orthotest CE is a rigid base mapping system composed by 1024 pressure transducers uniformly distributed in a 35x35 cm surface. Orthotest CE is a product manufactured by Vista-Medical. The patient sit on the rigid base during 2 hours to record the pressure and all the data needed for the pilot study. Pressure measurement<br>* Other names: Mapping system;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of intra and inter-subjects variability of the pressure measurements for the whole population included. | Sit pressure measurements of all subjects of the study | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between interface pressure measurements and postural data. | Sit pressure measurements Video recording | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pressure Ulcer, prevention
Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending doses of GAP 134 administered as 6-day continuous IV infusions to healthy subjects.

Official Title
-----------------
An Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously as 6-Day Continuous Infusions to Healthy Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: GAP-134
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Men or women of non childbearing potential (WONCBP) aged 18 to 50 years inclusive at screening. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥50 kg. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital sign measurements, and 12-lead electrocardiogram (ECG). Serum creatinine level must be less than 1.30 mg/dL. (Normal range: 0.44 to 1.24 mg/dL.) Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay. Exclusion Presence or history of any disorder that may prevent the successful completion of the study. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. Any surgical or medical condition that may interfere with the distribution, metabolism, or excretion of the test article. Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1. Any history of clinically important cardiac arrhythmias. Familial history of long QT syndrome or unexpected cardiac death. History of drug abuse within 1 year before study day 1. History of alcoholism within 1 year before study day 1.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GAP-134<br> | Drug: GAP-134<br> <br> |
| Placebo Comparator: placebo<br> | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as determined by reported adverse events, laboratory test results, and ECGs |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters |  | 9 days |
Spanish Validation Of Quality of Life Questionnaire (QOLIE-10) For Epilepsy

Study Overview
=================
Brief Summary
-----------------
Validation of qolie-10, an epilepsy specific quality of life questionnaire in patients treated with lamotrigine or valproic acid. Comparison of quality of life of epileptic patients treated with lamotrigine or valproic acid. Determination and assessment of the comparative safety of lamotrigine or valproic acid. Assessment and comparison of body image perception in women treated with lamotrigine or valproic acid.

Official Title
-----------------
Validation Of Qolie-10 For Epilepsy, Comparison Of Quality Of Life In Patients Treated With Lamotrigine Or Valproic Acid

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: lamotrigine
* Drug: valproic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosis of epilepsy and normal neurological examination. Patients receiving lamotrigine or valproic acid at stable doses in monotherapy initiated 2 -4 months before. Exclusion criteria: Pregnant or lactating women. Previous treatment with lamotrigine or valproic acid. Secondary epilepsy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lamotrigine|nan|
|Drug: valproic acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Validity, feasibility and reliability of qolie-10 (test-retest, internal consistency) 2. Qolie-10 scores between groups 3. Body image scores between groups |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events: nature and number between groups |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lamotrigine, quality of life, qolie-10, epilepsy, Validation of questionnaire
COVID-19 Infection Control Using H2O2 Mouth Wash and Nasal Spray

Study Overview
=================
Brief Summary
-----------------
Hydrogen peroxide is produced physiologically by oral bacteria and plays a significant role in the balance of oral microecology since it is an important antimicrobial agent. In the epithelial cells, the enzyme superoxide dismutase catalyzes a reaction leading from hydrogen peroxide to the ion superoxide. The induced oxidative stress stimulates a local innate response via activation of the toll-like receptors and the NF-κB. Those kinds of reactions are also activated by viral infections. Virus-induced oxidative stress plays an important role in the regulation of the host immune system and the specific oxidant-sensitive pathway is one of the effective strategies against viral infections. Therefore, nose/mouth/throat washing with hydrogen peroxide may enhance those local innate responses to viral infections. The investigators hypothesised that a treatment with a mouth wash and a nasal spray containing a diluted solution of hydrogen peroxide may accelerate the negativisation rate of a positive PCR swab test for SARS-CoV-2 (COVID-19).

Official Title
-----------------
The Negativisation Rate of Positive PCR Swab Tests for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) After Treatment With Hydrogen Peroxide: a Double-blind Placebo-controlled Randomised Trial.

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Device: Hydrogen peroxide
* Device: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - recent positive SARS-CoV-2 PCER swab test Exclusion Criteria: - severe Covid19 disease

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Mouth wash and nasal spray containing a diluted solution of hydrogen peroxide | Device: Hydrogen peroxide<br>* Mouth wash and nasal spray 3 times a day for 3 days<br>|
| Placebo Comparator: Placebo<br>Mouth wash and nasal spray not containing a diluted solution of hydrogen peroxide | Device: Placebo<br>* Mouth wash and nasal spray 3 times a day for 3 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The negativisation rate of a positive SARS-CoV-2 (COVID-19) PCR nose swab test | A repeated SARS-CoV-2 PCR nose swab test after a previous positive SARS-CoV-2 PCR nose swab test | 4 days |
The Effect of MDZ on Movement During UIA Clipping

Study Overview
=================
Brief Summary
-----------------
This study is a randomized, controlled, double-blinded, and parallel design study. A total 64 patients will be randomized to receive midazolam or normal saline during unruptured intracranial aneurysm clipping surgery.

Official Title
-----------------
Effects of Midazolam on the Occurrence of Intraoperative Movement in Patients Undergoing Unruptured Intracranial Aneurysm Clipping Surgery: a Prospective Randomized Controlled Trial

Conditions
-----------------
Intraoperative Movement

Intervention / Treatment
-----------------
* Drug: Midazolam
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who undergo elective unruptured intracranial aneurysm clipping surgery American Society of Anesthesiologists grade 1,2,3 age > 18 year old Exclusion Criteria: Refuse to participate to the study Body Mass Index < 18.5 kg/m2 or > 35 kg/m2 Allergic history of benzodiazepine Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>Midazolam (0.03 mg/kg/30 min) will administered during UIA clipping through microscope. | Drug: Midazolam<br>* Midazolam (0.03 mg/kg/30 min) will administered during UIA clipping through microscope.<br>|
| Placebo Comparator: Control group<br>Normal saline (0.03 ml/kg/30 min) will administered during UIA clipping through microscope. | Drug: Normal saline<br>* Normal saline (0.03 mg/ml/30 min) will administered during UIA clipping through microscope.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative movement | Incidence | During microscopic surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor evoked potential amplitude | amplitude | immediately postoperative surgery | 
| Motor evoked potential Latency | Latency | immediately postoperative surgery | 
| Duration of mechanical ventilation time | duration | End of surgery to extubation time | 
| Duration of ICU stay | duration of ICU stay, day | From date of ICU admission until the date of first discharge from ICU, assessed up to 1 week | 
| Satisfaction score for intraoperative environment | using 11-point score (0=worst dissatisfied, 10=very sattisfied) | immediately postoperative surgery | 
| Postoperative delirium | Incidence | Postoperative 24 hour |
Effectiveness of Nefopam in Breast Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
Breast cancer surgery is known to cause severe acute postoperative pain, which can persist for a long time. The investigators administered nefopam preventively to patients undergoing total mastectomy or modified radical mastectomy with axillary lymph node dissection or sentinel lymph node biopsy, and evaluated its efficacy on acute and chronic postoperative pain.

Conditions
-----------------
Breast Neoplasm Malignant Primary

Intervention / Treatment
-----------------
* Drug: Nefopam
* Drug: Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total mastectomy Modified radical mastectomy Nipple-sparing mastectomy American Society of Anesthesiologists physical status I or II Postoperative use of intravenous patient-controlled analgesia Exclusion Criteria: Chronic analgesia medication Pregnancy Lactating women Previous operation history due to breast cancer Cooperation with other surgery Contraindication of nefopam

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Placebo use instead of nefopam | Drug: Normal Saline<br> <br> |
| Experimental: Nefopam<br>Intraoperative use of nefopam 40 mg | Drug: Nefopam<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of cumulative analgesia volume infused via intravenous patient-controlled analgesia device |  | At postoperative 4 hour, 24 hour, 48 hour, 72 hour, 10 day, and 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of numerical rating scale for postoperative pain |  | At postoperative 4 hour, 24 hour, 48 hour, 72 hour, 10 day, and 3 month |
Contrast Enhanced MRI of the CNS - Patients With Known Cerebral Neoplastic Lesions.

Study Overview
=================
Brief Summary
-----------------
Study to compare of two contrast agents in imaging brain lesions.

Official Title
-----------------
Contrast-enhanced MRI Examination of Cerebral Neoplastic Enhancing Lesions: Comparison of Diagnostic Efficacy of Gd-DOTA 0.5M and Gadobutrol 1.0 M at 0.1 mmol/kg Body Weight: Intraindividual Comparison Clinical Study.

Conditions
-----------------
Neoplastic CNS Lesions

Intervention / Treatment
-----------------
* Drug: Gadovist® (Gadobutrol, BAY86-4875)
* Drug: Dotarem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Known neoplastic CNS lesions

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Gadovist® (Gadobutrol, BAY86-4875)<br>* 0,1 mmol/kg of body weight in the vein, single administration<br>|
| Active Comparator: Arm 2<br> | Drug: Dotarem<br>* 0,1 mmol/kg of body weight in the vein, single administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary analysis will be the comparison of the enhancements characteristics of Gadobutrol and Gd-TOTA on a lesion per lesion basis. |  | October 2007 to November 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neoplastic CNS lesions, Contrast enhanced MRI, Comparison
Anti-tumor Immune Response in Patients With Cancer Undergoing Radiation Therapy

Study Overview
=================
Brief Summary
-----------------
This research trial studies the effect of radiation therapy on tumor immunity. Standard radiation therapy destroys tumor cells. In response to tumor cell death caused by radiation therapy, the body has an ability to stimulate an anti-tumor response (immunity), but this response is often ineffective in shrinking tumor tissue. Collecting samples of blood from patients before, during, and after radiation therapy to study in the laboratory may help doctors learn more about the effects of radiation therapy on anti-tumor response.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To assess the effect of radiation therapy on tumor immunity. OUTLINE: Samples of blood are collected before, during, and within two weeks after radiation therapy and then stored for analysis of anti-tumor immunity.

Official Title
-----------------
The Effect of Radiation Therapy on Tumor Immunity

Conditions
-----------------
Malignant Neoplasm

Intervention / Treatment
-----------------
* Other: cytology specimen collection procedure
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated Institutional Review Board (IRB)-approved Informed Consent form for the study Received an explanation of the study, including satisfactory answers to all questions related to the proposed research Is undergoing physician directed radiation treatment Exclusion Criteria: The potential Subject is unwilling or hesitant to participate for any reason and/or fails to complete the appropriate Informed Consent form

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 |
| --- | --- |
| Ancillary-Correlative (blood banking)<br>Samples of blood are collected before, during, and within two weeks after radiation therapy and then stored for analysis of anti-tumor immunity. | Other: cytology specimen collection procedure<br>* Undergo blood sample collection<br>* Other names: cytologic sampling;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome measures include changes in tumor-specific immune responses and general immune signature in patients undergoing Radiation Treatment. Reportable endpoints are absolute values of and changes in innate & adaptive immune cells and serum markers. |  | The time line of interest covers a baseline, pre-treatment sample as well as mid-treatment and a post-treatment, follow-up sample at 3 months. |
Transient Receptor Potential Vanilloid One (TRPV1) Receptor Expression in Children With Retrosternal Pain

Study Overview
=================
Brief Summary
-----------------
We would like to evaluate the changes in nerve innervation and TRPV1 receptor expression along with microscopic changes associated with heart burn and abdominal pain

Detailed Description
-----------------
Approximately 5% of children between 10-17 years of age report symptoms of heart burn, epigastric pain or regurgitation. This study will evaluate the changes in nerve innervation and TRPV1 receptor expression in children having upper endoscopy for evaluation of heart burn and abdominal pain.

Official Title
-----------------
Capsaicin-sensitive Transient Receptor Potential Vanilloid One (TRPV1) and Tyrosine Kinase (TrkA) Receptor Expression in Children With Retrosternal Pain

Conditions
-----------------
Epigastric Pain, Retrosternal Pain, Esophagitis, Gastrointestinal Symptoms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Retrosternal and/or epigastric pain and esophagitis Retrosternal and/or epigastric pain but no macroscopic or microscopic esophagitis Gastrointestinal symptoms such as diarrhea, regurgitation, rumination, vomiting, feeding aversion, non-organic failure to thrive, celiac disease with no macroscopic or microscopic esophageal inflammation

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 17 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 |
| --- | --- |
| EXPERIMENTAL<br>Children undergoing an endoscopy for retrosternal chest pain, epigastric pain, regurgitation, heart burn or dyspepsia. | |
| CONTROL<br>Children undergoing an endoscopy for reasons not stated in the experimental group condition (i.e. celiac disease, rectal bleeding, polyps, weight loss, malabsorption). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the TRPV1 expression in the esophageal mucosa of children with esophagitis and to correlate the TRPV1 expression with severity of mucosal inflammation and microscopic changes. |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Capsaicin, TRPV1, Nerve growth factor, TrkA, Retrosternal pain, Epigastric pain, Esophagitis, Gastrointestinal symptoms