linjc16/ctgov huggingface dataset:
Assessment of the Impact of Gadolinium Injection on the Measurement of the QSM Signal

Study Overview
=================
Brief Summary
-----------------
Patients meeting the inclusion and non-inclusion criteria will be offered to participate in the study. If they agree, they will perform an MRI without injection to obtain the QSM then perform the MRI with injection that was prescribed to them as part of the care, then they will perform a second time the MRI without injection to obtain the QSM. They will also answer a short questionnaire documenting their previous exposure to gadolinium.

Detailed Description
-----------------
Patients meeting the inclusion and non-inclusion criteria will be offered to participate in the study. If they agree, they will perform an MRI without injection to obtain the QSM then perform the MRI with injection that was prescribed to them as part of the care, then they will perform a second time the MRI without injection to obtain the QSM. They will also answer a short questionnaire documenting their previous exposure to gadolinium.

Official Title
-----------------
Assessment of the Impact of Gadolinium Injection on the Measurement of the QSM Signal

Conditions
-----------------
White Matter Disease

Intervention / Treatment
-----------------
* Device: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients over 18 years old with an inflammatory CNS pathology to benefit as part of care from an MRI with injection of gadolinium consent to participate in the study beneficiary of a social protection scheme Exclusion Criteria: pregnant or breastfeeding woman patient benefiting from a legal protection measure Patient having performed more than 3 MRI exams with gadolinium injection during his life Secondary exclusion criteria : motion artifact not allowing image interpretation patient who has not completed one of the following sequences: T1 anatomical, FLAIR, or QSM pre-gadolinium injection. Secondarily excluded patients will be replaced up to a maximum of 25 patients.

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 |
| --- |
|Device: MRI|SWI QSM 1.0iso 8 echos sequence performed before and after the injected MRI prescribed as part of the treatment. * Sense 2 * 2: 9min33s|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean of the delta observed between the QSM of the white matter before and after injection of gadolinium | mean of the delta observed between the QSM of the white matter before and after injection of gadolinium | 1 DAY |
A 12-Month Study to Evaluate the Efficacy and Safety of Once-Daily Instillation of Combination Glaucoma Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the intraocular pressure(IOP)-lowering efficacy of a combination IOP-lowering therapy in patients with open-angle glaucoma or ocular hypertension.

Official Title
-----------------
A 12-Month Study to Evaluate the Efficacy and Safety of Once-Daily Instillation of Combination Glaucoma Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Glaucoma, Open-angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solution
* Drug: Latanoprost 0.005%/Timolol 0.005% ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - As specified in protocol Exclusion Criteria: - As specified in protocol

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Travoprost/Timolol<br>1 drop in the affected eye(s) once daily in the morning for 12 months | Drug: Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solution<br>* Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension<br>|
| Active Comparator: Latanoprost/Timolol<br>1 drop in the affected eye(s) once daily in the morning for 12 months | Drug: Latanoprost 0.005%/Timolol 0.005% ophthalmic solution<br>* Commercially marketed ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Intraocular Pressure (IOP) |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, POAG, OAG, OHT
Efficacy and Cost Effectiveness of Malaria Diagnosis Procedures and the Rational Use of ACT in Zanzibar

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess performance and cost-effectiveness of rapid diagnostic test(RDT) aided malaria diagnosis versus symptom-based/clinical diagnosis in patients of all ages with reported fever last 48 hours alone in primary health care settings in Zanzibar.

Official Title
-----------------
Efficacy and Cost Effectiveness of Malaria Diagnosis Procedures and the Rational Use of ACT in Zanzibar

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

Intervention / Treatment
-----------------
* Device: Rapid Diagnostic Test for P. falciparum malaria


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient attending the study sites and reporting history of fever within past 48 hours or other symptoms compatible with malaria and giving their informed consent, will be eligible for the study. Exclusion Criteria: Patient's refusal to consent will disqualify participation in the study.
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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Rapid Diagnostic Test for P. falciparum malaria|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Zolpidem Postmarketing Study in Adolescent Patients With Insomnia

Study Overview
=================
Brief Summary
-----------------
To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized double blind-controlled trial

Official Title
-----------------
Zolpidem Postmarketing Clinical Study: A Double Blind, Placebo Controlled Group Comparative Trial in the Adolescent Patients With Insomnia

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Drug: Zolpidem (Myslee®)
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed as having nonorganic insomnia of nonorganic sleep disorder in ICD10 patients whose age at the time of obtaining consent is 12 years or over and 18 years or below Exclusion Criteria: patients with schizophrenia or manic-depressive illness patients with insomnia caused by physical diseases patients having a history of hypersensitivity to zolpidem patients with attention-deficit hyperactivity disorder

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum 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: 1<br>Oral | Drug: Zolpidem (Myslee®)<br>* Oral<br>* Other names: FK199B;|
| Experimental: 2<br>Oral | Drug: Zolpidem (Myslee®)<br>* Oral<br>* Other names: FK199B;|
| Placebo Comparator: 3<br>Oral | Drug: placebo<br>* Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean daily sleep latency for double-blind period |  | 2 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean daily total hours of sleep |  | 2 Weeks | 
| Mean daily frequency of intermediate awaking |  | 2 Weeks | 
| Mean daily time of intermediate awaking |  | 2 Weeks | 
| Impression of patient for double-blind period |  | 2 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insomnia, Zolpidem, Adolescent
Feeding Infant Formula With Added Probiotics and Whey Protein Concentrate

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of feeding an infant formula containing L. paracasei ssp. paracasei strain F19 or Whey Protein Concentrate.

Official Title
-----------------
Feeding Infant Formula With Added Probiotics and Whey Protein Concentrate

Conditions
-----------------
Focus on Healthy Infants

Intervention / Treatment
-----------------
* Other: Probiotic
* Other: Whey protein concentrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria (formula-fed group): healthy infants of mothers who could not or voluntarily resigned completely from breast-feeding at infant age 14 plus/minus 3 days Inclusion criteria (breast-fed group): healthy infants exclusively breast-fed from birth and mothers intending to breastfeed >80% until at least 5th month of age (meaning through the 4th month of age). Inclusion criteria (all infants): delivered between 37 and 42 weeks of gestation birth weight >2500 g and <4000 g parent or the subject's legal representative speak and understand Chinese Exclusion criteria (formula-fed group): fully or partially breast-fed infants infants breast-fed >20% Exclusion criteria (breast-fed group): infants fed >20% infant formula Exclusion criteria (all infants): malformations, handicaps or congenital diseases that could affect normal feeding or growth treatment with antibiotics

Ages Eligible for Study
-----------------
Maximum Age: 2 Weeks

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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics F19<br>F19 in an infant formula | Other: Probiotic<br> <br> |
| Experimental: Whey protein concentrate<br>Whey protein concentrate in an infant formula | Other: Whey protein concentrate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infections episodes (gastrointestinal and upper and lower respiratory infections) |  | 4 yrs |
Cohort of Hospitalized Patients Suspected of Leptospirosis

Study Overview
=================
Brief Summary
-----------------
COLEPT is a prospective interventional study that intends to better inform about leptospirosis, a neglected zoonotic infectious disease. During prospective follow-up of hospitalized acute leptospirosis cases, the participants will be assessed during 1 year for epidemiological, clinical, bacteriological and immunological data. Main intervention consists in blood sampling and biological bank constitution.

Official Title
-----------------
Cohort of Hospitalized Patients Suspected of Leptospirosis

Conditions
-----------------
Leptospirosis

Intervention / Treatment
-----------------
* Other: Blood and urine sampling and blood banking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinico-biological manifestations compatible with acute leptospirosis OR proven leptospirosis with serological testing or PCR onset of symptoms within 21 days participant benefits of health insurance Exclusion Criteria: participant's refusal, or refusal from his relatives in case of major incapacity of the eligible participant precluding expression of his will (coma, stay in intensive care unit))

Ages Eligible for Study
-----------------
Minimum Age: 1 Day

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hospitalized patients diagnosed with leptospirosis<br>hospitalized patients diagnosed with leptospirosis: 12 months of follow up with biological samples and data collection | Other: Blood and urine sampling and blood banking<br>* In routine management, blood and urine will be sampled for each patients and specific analyses carried out. Only blood samples will be banked.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease severity | Rate of death or severe organ insuffisiency | 0 to 21 days after onset of symptoms | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
leptospirosis, hospitalization
Change of Body Composition After Kidney Transplantation in Korea

Study Overview
=================
Brief Summary
-----------------
The graft survival in kidney transplantation has been improving after the introduction of new immunosuppressive agents. Therefore, other complications after transplantation are concerned; one of those is obesity. Several factors are attributable to obesity in kidney transplant recipients. The body composition such as fat mass and lean mass is important concept in overweight patients. Some studies have been conducted on the change of body composition in kidney transplants. However, all of them are studied among Caucasians or using dual energy X-ray absorptiometry (DEXA). In this study, the investigators plan to study the body composition among Asian kidney transplant recipients using the bioelectrical impedance analysis (BIA).

Conditions
-----------------
Kidney Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 20 years and over Exclusion Criteria: history of previous transplantation co-transplantation with other organs neuropsychological problem with diet (such as anorexia nervosa, bulimia)

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Kidney Transplantation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of body composition | fat mass, lean mass | 2 weeks, 1/3/6/9/12 months after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight, waist circumference |  | 2 weeks, 1/3/6/9/12 months after transplantation | 
| cholesterol, CRP |  | 2 weeks, 1/3/6/9/12 months after transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
body composition, obesity, kidney transplantation
Genomic Assessment of Patients With Severe Radiation Reactions

Study Overview
=================
Brief Summary
-----------------
Determine an underlying etiology behind unexpectedly severe reactions to radiation by blood draw.

Official Title
-----------------
Genomic Assessment of Patients With Severe Radiation Reactions

Conditions
-----------------
Radiation; Reaction

Intervention / Treatment
-----------------
* Other: Blood draw
* Other: Photograph
* Diagnostic Test: Autoimmune testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Weigh at least 110 pounds Healthy Exclusion Criteria: - Pregnant

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

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 |
| --- | --- |
| Patients with severe reactions to radiation<br>Two 12.5 mL blood draws and photograph of severe reaction, and autoimmune testing in patients without prior testing. | Other: Blood draw<br>* Two 12.5 mL blood draws<br>Other: Photograph<br>* Photograph of severe reaction, will be anonymized<br>Diagnostic Test: Autoimmune testing<br>* Autoimmune testing in patients without prior testing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole exome sequencing | Investigate genes potentially responsible for severe radiation reactions by getting blood draws. | baseline |
Large-scale Expansion and Characterization of Mesenchymal Stem Cells for Clinical Application

Study Overview
=================
Brief Summary
-----------------
According to many recent research, mesenchymal stem cells (MSC) isolated from synovial membrane and infrapatellar fat pad have higher ex vivo proliferation capacity, multipotency and ability to undergo chondrogenesis. Based on this concept, the investigators plan to get two removed tissues (synovial membrane and infrapatellar fat pad) from patients who have an operation of total knee replacement. The investigators are going to isolate and expand MSC from these two tissues respectively, and then compare the chondrogenesis ability for clinical application. In the other hand, the investigators plan to build techniques and procedures which comply with Good Tissue Practices (GTP)

Official Title
-----------------
Large-scale ex Vivo Expansion and Characterization of Synovial Membrane Mesenchymal Stem Cells (SM-MSC) and Infrapatellar Fat Pad Mesenchymal Stem Cells (IF-MSC) for Clinical Application

Conditions
-----------------
Knee Injuries

Intervention / Treatment
-----------------
* Other: 103024-F


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who have an total knee replacement surgery Exclusion Criteria: Patient who don't sign the agreement
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 103024-F<br>For patients who have an operation of total knee replacement, two removed tissues (synovial membrane and infrapatellar fat pad) will be collected for mesenchymal stem cell isolation. | Other: 103024-F<br>* mesenchymal stem cell isolation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell viability ratio of synovial membrane MSC and infrapatellar fat pad MSC from the first to the tenth cell passage |  | 6 months | 
| Doubling time of synovial membrane MSC and infrapatellar fat pad MSC from the first to the tenth cell passage |  | 6 months | 
| Percentage expression of cluster differentiation 90,105, 34, 45 surface markers of synovial membrane MSC and infrapatellar fat pad MSC from the first to the tenth cell passage |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcian blue staining of synovial membrane MSC and infrapatellar fat pad MSC |  | 6 months | 
| Tyep II collagen and aggrecan gene expression of synovial membrane MSC and infrapatellar fat pad MSC |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mesenchymal stem cells
Prospective Registry on Vascular Access in Interventions in Lazio Region

Study Overview
=================
Brief Summary
-----------------
Previous randomised studies showed that radial artery catheterisation for percutaneous cardiovascular procedures has a superior safety profile than femoral access, however the confirmation of these benefits in the real world by a large, specific, observational study is still lacking. We endeavoured to assess the access site-related outcomes of any percutaneous cardiovascular procedure by designing a prospective registry monitoring a consecutive sample of patients in a short period of time at nine Roman hospitals reflecting the contemporary state of health care.

Official Title
-----------------
Prospective Registry on Vascular Access in Interventions in Lazio Region

Conditions
-----------------
Postoperative Hemorrhages

Intervention / Treatment
-----------------
* Procedure: Any percutaneous cardiovascular procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing any percutaneous cardiovascular procedure Exclusion Criteria: Patients already enrolled in other clinical trials
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Radial approach | Procedure: Any percutaneous cardiovascular procedure<br> <br> |
| Active Comparator: 2<br>Femoral approach | Procedure: Any percutaneous cardiovascular procedure<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of: (a) major and minor bleedings, (b) access site vascular complications, (c) stroke |  | in-hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of (a) death, (b) myocardial infarction or reinfarction |  | in-hospital | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radial, Femoral, artery, Invasive cardiology safety