linjc16/ctgov huggingface dataset:
Effect of Pharyngeal Inhibition by rTMS on Swallowing Function

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to test the hypothesis that rTMS on the dominant swallowing hemisphere is able to modify swallowing coordination.

Detailed Description
-----------------
The aim of the study is to demonstrate that rTMS (on the dominant hemisphere, on the nondominant hemisphere and placebo rTMS) are able to modify swallowing coordination on healthy subjects. Swallowing function will be studied before and after rTMS with videomanometry.

Official Title
-----------------
Effect of Pharyngeal Cortical Area Inhibition Induced by rTMS on Swallowing Function in Healthy Subject: Video Fluoroscopic Study.

Conditions
-----------------
Oropharyngeal Dysphagia

Intervention / Treatment
-----------------
* Procedure: magnetic stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-50 years old healthy subjects Exclusion Criteria: epilepsia brain injury stroke pregnancy

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: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rTMS<br>rTMS on pharyngeal cortical area in healthy subjects | Procedure: magnetic stimulation<br>* rTMS on pharyngeal cortical area in healthy subjects or sham rTMS on pharyngeal cortical area in healthy subjects<br>|
| Placebo Comparator: Placebo<br>Sham rTMS on pharyngeal cortical area in healthy subjects | Procedure: magnetic stimulation<br>* rTMS on pharyngeal cortical area in healthy subjects or sham rTMS on pharyngeal cortical area in healthy subjects<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharyngeal pressure | Swallowing function will be studied before and after rTMS with videomanometry | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| swallowing time | Swallowing function will be studied before and after rTMS with videomanometry | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuromodulation, swallowing, magnetic stimulation, healthy subjects
FiO2 and Outcomes After Cardiac Surgery With Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
Conventionally, a relatively high level of fraction of inspired oxygen (FiO2) has been used for secure a margin of safety in patients undergoing cardiac surgery using cardiopulmonary bypass (CPB). Since the potential adverse effects of hyperoxemia (via reactive oxygen species, vasocontriction, perfusion heterogeneity, myocardiac injury, etc.), various studies on this topic has been performed. However, the results are conflicting and inconsistent, and the consensus about whether the use of additional oxygen supply in cardiac surgery using CPB has not been reached among practitioners yet.

Official Title
-----------------
Effect of Intraoperative Oxygen Tension on Patient Outcomes After Cardiac Surgery With Cardiopulmonary Bypass: a Pilot Study

Conditions
-----------------
Patients Undergoing Cardiac Surgery Using Cardiopulmonary Bypass

Intervention / Treatment
-----------------
* Other: Fraction of inspired oxygen level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients scheduled for cardiac surgery using cardiopulmonary bypass Exclusion Criteria: Planned implementation of deep hypothermic circulatory arrest Preoperative respiratory support with the fraction of inspired oxygen of 0.5 and more.

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FiO2 0.5<br> | Other: Fraction of inspired oxygen level<br>* A fraction of inspired oxygen level during cardiac surgery using cardiopulmonary bypass will be set differently: 0.5 versus 1.0.<br>|
| Active Comparator: FiO2 1.0<br> | Other: Fraction of inspired oxygen level<br>* A fraction of inspired oxygen level during cardiac surgery using cardiopulmonary bypass will be set differently: 0.5 versus 1.0.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital LOS | length of hospital stay after cardiac surgery using cardiopulmonary bypass | From the beginning of surgery until the hospital discharge after surgery through study completion, an expected average of two weeks |
Efficacy and Safety Study of SBG vs Placebo in Head and Neck Cancer Patients Undergoing Radiation Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of SBG vs placebo on oral mucositis in head and neck cancer patients undergoing radiation therapy.

Detailed Description
-----------------
The objective of the study is to evaluate the efficacy and safety of soluble beta-1,3/1,6-glucan (SBG) on oral mucositis compared to placebo in head and neck cancer patients undergoing radiation therapy with or without chemotherapy.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Study to Assess the Efficacy and Safety of SBG on Oral Mucositis in Head and Neck Cancer Patients Undergoing Radiation Therapy With or Without Chemotherapy

Conditions
-----------------
Head and Neck Cancer, Oral Mucositis

Intervention / Treatment
-----------------
* Drug: SBG
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with a normal oral mucosa who is scheduled to receive radiation therapy for their head and neck cancer will be enrolled into the study. Patients with previous head and neck cancer and/or radiation therapy in the head and neck area and history/clinical evidence of active significant acute or chronic conditions that may compromise the ability to evaluate or interpret the effects of the study treatment on mucositis will be excluded.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br> | Drug: SBG<br>* Soluble beta-1,3/1,6-glucan is a solution for oral use<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Solution for oral use<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the proportion of patients in the two arms who develop severe oral mucositis |  | During radiation therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Radiation therapy, Radiotherapy, Oral Mucositis, SBG
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Parkinson's Disease

Detailed Description
-----------------
This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Parkinson's Disease. Patients will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Official Title
-----------------
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Biological: AlloRx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Parkinson's Disease Understanding and willingness to sign a written informed consent document Exclusion Criteria: Active infection Active cancer Chronic multisystem organ failure Pregnancy Clinically significant Abnormalities on pre-treatment laboratory evaluation Medical condition that would (based on the opinion of the investigator) compromise patient's safety. Continued drug abuse Pre-menopausal women not using contraception Previous organ transplant Hypersensitivity to sulfur Anticoagulation medicine use
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group (AlloRx)<br>Single intravenous infusion of 100 million cells | Biological: AlloRx<br>* cultured allogeneic adult umbilical cord derived mesenchymal stem cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (adverse events) | Clinical monitoring of possible adverse events or complications | Four year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's Disease, stem cell treatment
Evaluation of the Improvement of Independence by the Resumption of a Significant Activity Such as a Cooking Workshop in Adult Patients With Stroke Benefiting From Traditional Rehabilitation

Study Overview
=================
Brief Summary
-----------------
A non-randomized, monocentric, pilot study comparing the level of independence for each individual with significant resumption of activity in adult patients with stroke

Official Title
-----------------
Evaluation of the Improvement of Independence by the Resumption of a Significant Activity Such as a Cooking Workshop in Adult Patients With Stroke Benefiting From Traditional Rehabilitation

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: Activity of everyday life


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient older than 18 years old Primary stroke or recurrence on stroke having no previous sequelae Stroke older than 3 weeks Ability to understand treatment and sufficient motivation Problem Activity Indicated in CMOP (Canadian Measure of Occupational Performance) Barthel Index > 60 Patient who received oral and written information about the protocol and who did not show opposition to participate in the study Exclusion Criteria: Dermatological pathology with wounds on the unhealed upper limbs Patient in contact and droplet isolation A psychiatric history requiring hospitalization in specialized settings for more than 2 months Any condition that may limit participation or interfere with analysis of results

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with stroke<br> | Other: Activity of everyday life<br>* Kitchen workshop<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline level of independence in a population of adult patients with stroke having participated in cooking workshop at week 3 | Evaluation of independence by Functional Independence Measure score | Day 0, Week 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the patient's quality of life | Evaluation of the patient's quality of life by the Medical Outcome Study (MOS)Short Form (SF-36 ) questionnaire | Day 0, Week 3 | 
| Evaluation of the patient's self-esteem | Evaluation of the patient's self-esteem by Rosenberg Self Estimate Scale | Day 0, Week 3 |
Detection of COVID-19 in Saliva Collection

Study Overview
=================
Brief Summary
-----------------
Since December 2019, the world has faced a pandemic of COVID-19, an infectious disease caused by SARS-CoV-2, a virus that emerged in China. The reference diagnosis is based on the search for the SARS-COV-2 genome in the nasopharyngeal sample. Carrying out this sample requires the competence of a healthcare professional and presents some inconveniences for the tested patient. Because saliva collection is simple, non-invasive, painless and inexpensive, and can be performed by poorly trained personnel, it could be an alternative to the reference nasopharyngeal sample. SARS-CoV2 detection in human saliva could be a potential diagnosis of COVID infection.

Official Title
-----------------
Evaluation of the Performance of a Saliva Sample Versus a Nasopharyngeal Sample in the Diagnosis of COVID-19 by RT-PCR

Conditions
-----------------
Sars-CoV2, RT-PCR, Saliva Collection, Nasopharyngeal Sample

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient hospitalized at the Amiens CHU in a COVID-19 unit patient seen as outpatient in the area of infectious pathologies for COVID-19 infection Exclusion Criteria: Patients under 18 patients under guardianship or curators

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Detection of SARS-CoV-2 RNA in the saliva sample | Detection of SARS-CoV-2 RNA in the saliva sample | day 1 | 
| Concordance between the Saliva sample and the nasonasopharyngeal sample SARS-CoV-2 RT-PCR results | Concordance between the Saliva sample and the nasonasopharyngeal sample SARS-CoV-2 RT-PCR results | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sars-CoV2, RT-PCR, Saliva collection, nasopharyngeal sample
Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) - Assay

Study Overview
=================
Brief Summary
-----------------
Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.

Official Title
-----------------
Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) Assay

Conditions
-----------------
Sunscreen Agents

Intervention / Treatment
-----------------
* Drug: BAY 987516
* Drug: SPF 15 Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female of an age of 18 to 70 years inclusive; Fitzpatrick Skin Type I, II and/or III for SPF testing; Good health as determined from the CRO Subject History Form (SHF); Signed and dated Informed Consent Form; Signed and dated Health Insurance Portability and Accountability Act (HIPAA) Form; An unambiguous minimal erythema dose (MED).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPF evaluation<br>Subjects with good health as determined from the CRO Subject History Form (SHF) and Fitzpatrick Skin Type I, II and/or III were included for SPF testing. | Drug: BAY 987516<br>* Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.<br>Drug: SPF 15 Control<br>* Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of water resistant SPF | For the sunscreen Test Material, two test sites were used; one for before immersion and one for after 2 hours of water immersion. One additional test site area was used for the control SPF determination, on each subject, as per the COLIPA Sun Protection Factor Test Method. | 16-24 hours post exposure |
Pharmacodynamics, Pharmacogenetics, Clinical Efficacy and Safety of Tradipitant for Functional Dyspepsia

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of tradipitant relative to placebo on gastric motor functions, satiation, and postprandial symptoms in patients with functional dyspepsia.

Official Title
-----------------
Pharmacodynamics, Pharmacogenetics, Clinical Efficacy and Safety of Tradipitant for Functional Dyspepsia

Conditions
-----------------
Functional Dyspepsia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to provide written consent Body Mass Index (BMI) of 18-35 kg/m2 Absence of other diseases which could interfere with interpretation of study results Exclusion Criteria: Current H. pylori infection Pregnancy or nursing Recent history of Alcohol Use Disorder or Substance Use Disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tradipitant<br>Oral Capsule | Drug: Tradipitant<br>* Tradipitant Capsule<br>|
| Placebo Comparator: Placebo<br>Oral Capsule | Drug: Placebo<br>* Placebo Capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accommodation gastric volumes measured by single photon emission computed tomography (SPECT) |  | 4 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tradipitant, NK-1 antagonist, neurokinin 1 receptor
Evaluation of Effects of Multiple Dose Regimens of CHF 5074 on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of multiple dose regimens of CHF 5074 administered once per day up to 2 years on potential biomarkers of neurodegeneration in subjects with mild cognitive impairment.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Multiple Dose Regimens of CHF 5074 for up to 2 Years on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: CHF 5074 1x
* Drug: CHF 5074 2x
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One or two Ɛ4 alleles of the apolipoprotein E (APOE) gene. Diagnosis of amnestic Mild Cognitive Impairment. Mini-Mental State Examination score higher than 24 at screening. Exclusion Criteria: Diagnosis of Alzheimer's disease. Any medical condition that could explain the subject's cognitive deficits. MRI scans having evidence of pre-specified brain abnormalities. History of stroke. Vitamin B12 or folate deficiency. Skin cancers and any cancer that is being actively treated. Diagnosis of schizophrenia or recurrent mood disorder. Abnormal kidney function. Concomitant use of any study prohibitive medication.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 64 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHF 5074 1x<br>oral tablet, multidose | Drug: CHF 5074 1x<br>* oral tablet, 1x, once a day for 24 months<br>|
| Experimental: CHF 5074 2x<br>oral tablet, multidose | Drug: CHF 5074 2x<br>* oral tablet, 2x, once a day for 24 months<br>|
| Placebo Comparator: Placebo<br>placebo, oral tablet, multidose | Drug: Placebo<br>* oral tablet,once a day for 24 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effects on change from baseline on brain atrophy |  | pre-dose, Months 6, 12, 18, 24 and Washout | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the presence of other biomarkers of neuronal degeneration |  | Day 1 | 
| To determine the presence of other biomarkers of neuronal degeneration |  | Month 24 |