linjc16/ctgov huggingface dataset:
Laparoscopic Hernia Defect Obliteration With ProFlor-E

Study Overview
=================
Brief Summary
-----------------
This feasibility study highlights the features of the 3D dynamic responsive prosthesis ProFlor-E® for fixation free obliteration of inguinal hernia defect

Detailed Description
-----------------
The 3D dynamic-responsive prosthesis for inguinal hernia repair ProFlor-E® recently introduced to the market has been laparoscopically employed for the repair of one recurrent inguinal hernia previously managed with anterior open approach. The scope of this feasibility study is to demonstrate that the positive effects of the 3D implant already proven in open inguinal hernia repair are also effective or even superior for the laparoscopic of recurrent/bilateral inguinal hernias compared to conventional treatment concept.

Official Title
-----------------
Laparoscopic Fixation Free Obliteration of Inguinal Hernia Defect With the 3D Dynamic Responsive Implant ProFlor-E - Feasibility Study

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Device: ProFlor laparoscopic technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with recurrent inguinal hernia already repaired with open approach or suffering by bilateral inguinal hernias Exclusion Criteria: ASA >4 patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inguinal hernia repair laparoscopic<br>recurrent inguinal hernia after open repair or bilateral hernia patients | Device: ProFlor laparoscopic technique<br>* Inguinal hernia repair laparoscopic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of inguinal hernia defect obliteration with ProFlor | Effectiveness of the laparoscopic procedure for inguinal hernia repair with ProFlor | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | assessment of postoperative pain through Visual Analogue Scale | from early stage until 18 months postop | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inguinal hernia, Laparoscopic inguinal hernia repair, Inguinal hernia defect obliteration, Fixation free hernia repair, Regenerative scaffolds
Palonosetron Versus Ramosetron for the Prevention of Postoperative Nausea and Vomiting

Study Overview
=================
Brief Summary
-----------------
Ramosetron and palonosetron are more recently developed 5-hydroxytryptamine type 3 receptor antagonists and this randomized double blind study was designed to compare efficacy of ramosetron and palonosetron to prevent postoperative nausea and vomiting. Investigator hypothesized that palonosetron would have stronger and longer lasting antiemetic effect compared with ramosetron and evaluated the patients for the first 48 hours after surgery.

Official Title
-----------------
A Randomized Double Blind Study to Evaluate Efficacy of Ramosetron and Palonosetron for Prevention of Postoperative Nausea and Vomiting After Gynaecological Laparoscopic Surgery

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: palonosetron
* Drug: Ramosetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA Physical Status 1 or 2 Elective gynaecological laparoscopic surgery of ≥ 1h duration Exclusion Criteria: Anti-emetics, steroids, or psychoactive medications within 24 h of study initiation Vomiting or retching in the 24 h preceding surgery Cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry Ongoing vomiting from gastrointestinal disease

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Palonosetron<br> | Drug: palonosetron<br>* 0.075mg immediately before induction of anesthesia<br>|
| Sham Comparator: Ramosetron<br> | Drug: Ramosetron<br>* 0.3mg immediately before induction of anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative nausea and vomiting for 48 hours after surgery |  | for 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of nausea for 48 hours after surgery |  | for 48 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antiemetics, ramosetron, palonosetron, PONV(postoperative nausea and vomiting)
Observational Study for Non-motor Symptoms and Treatment in Parkinson's Disease Patients

Study Overview
=================
Brief Summary
-----------------
This study is implemented to identify factors having an impact on improvement or exacerbation of non-motor symptoms, to provide information contributing to development of medical care in this field and improvement of patients' QOL, and to clarify the association between the use of istradefylline and non-motor symptoms or QOL.

Official Title
-----------------
Japan-First-in Large Scale Observational Study for Non-motor Symptoms and Treatment in Parkinson's Disease Patients.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have wearing off under treatment with levodopa-containing drugs administered at least three times daily Patients who have at least one non-motor symptom as a complication Patients at least 20 years of age at the time of consent Patients who have given written consent Patients who are receiving outpatient care Exclusion Criteria: Patients with dementia or a score of 23 or less on the Mini-Mental State Examination (MMSE) Patients, in the opinion of the investigator or subinvestigator, having conditions impairing the proper assessment of the MDS-UPDRS or PDQ-8 (e.g., patients who are receiving treatment for malignant tumor)

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 |
| --- | --- |
| Parkinson Disease<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changing of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | MDS-UPDRS score will be collected from all registrant at each visit and on the last day of survey. | 52 weeks | 
| Changing of Parkinson's Disease Questionaire-8 (PDQ-8) score. | PDQ-8 score will be collected from all registrant at each visit and on the last day of survey. | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson Disease
Parenting Intervention and Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
This study aimed to test the effect of a parenting intervention on metabolic syndrome in African American youth. The investigators hypothesized that a parenting intervention would produce reductions in metabolic syndrome, particularly for those families that started out high in difficulties with parenting.

Detailed Description
-----------------
In this study, the investigators conducted a parenting intervention (Strong African American Families, or SAAF). Families (mothers with their 11 year old child) were randomized to either the parenting intervention or to a control group. Those in the intervention group received 7 group sessions with the parent and child aimed at promoting better family relationships. Those in the control group received 3 mailings about child development and stress management. At age 25, youth were assessed on metabolic syndrome. The investigators hypothesized that the parenting intervention would produce reductions in metabolic syndrome relative to the control group, particularly for those families that started out high in difficulties with parenting.

Official Title
-----------------
Parenting Intervention and Metabolic Syndrome

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Behavioral: Parenting Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 5th graders - Exclusion Criteria: None -

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 12 Years

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
Interventional Model Description: The intervention involved 7 parenting sessions with mothers and their children that taught nurturant parenting techniques, effective communication skills, and about the importance of developing and following household rules.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Parenting intervention, 7 weekly sessions, each session 2 hours in length. | Behavioral: Parenting Intervention<br> <br> |
| No Intervention: Control<br>3 mailings about child development and stress management. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic syndrome diagnosis (based on International Diabetes Federation criteria using a clinical assessment of obesity, blood pressure, cholesterol, glucose) | Metabolic syndrome diagnosis | 14 years post-intervention | 
| Metabolic syndrome components | Number of components of metabolic syndrome that were clinically elevated | 14 years post-intervention |
Decision Making in Neonatology : a Qualitative Study

Study Overview
=================
Brief Summary
-----------------
This study aimed to describe and understand the decision making process in neonatology in situations of limiting of withdraw life sustaining treatments, by conducting interviews with physicians from one neonatology unit.

Official Title
-----------------
Decision Making in Neonatology : a Qualitative Study

Conditions
-----------------
Premature Birth

Intervention / Treatment
-----------------
* Other: semi-structured interviews


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physicians in charge of new born babies for whom a decision making regarding limiting or withdrawing treatments is emerging. physicians' informed consent to participate to an interview parents' informed consent to collect data concerning their new born. Exclusion Criteria: - Not fluent French speaker

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 |
| --- | --- |
| Physicians<br> | Other: semi-structured interviews<br>* individual semi-structured interviews<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| semi-structured interviews | qualitative data analysis - theorical saturation | 3 months |
Assessment of EyeArt Performance With Retinal Cameras

Study Overview
=================
Brief Summary
-----------------
The study evaluates the performance of the EyeArt system for detecting diabetic retinopathy from images captured using retinal cameras and operators.

Official Title
-----------------
Assessment of EyeArt Performance With Retinal Cameras

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Procedure: Retinal imaging
* Drug: Mydriatic Agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of diabetes mellitus; Understanding of study and provision of written informed consent; and 22 years of age or older. Exclusion Criteria: Persistent visual impairment in one or both eyes; History of retinal vascular (vein or artery) occlusion; History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications; Subject is contraindicated for fundus photography (for example, has light sensitivity); Subject has contraindications for mydriatic medications or is unwilling or unable to dilate; Subject is currently enrolled in an interventional study of an investigational device or drug; or Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable dilated fundus photographs.

Ages Eligible for Study
-----------------
Minimum Age: 22 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 |
| --- | --- |
| AB<br> | Procedure: Retinal imaging<br>* Subjects will undergo retinal imaging before and/or after administration of mydriatic agent<br>Drug: Mydriatic Agent<br>* Subjects will be administered mydriatic medication to dilate their pupils.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall agreement between the results from multiple EyeArt operations | Overall agreement is defined as the fraction of cases where the multiple EyeArt operation results agree with each other. | 1 visit (1 day) |
Short Term Observational Study in DEB Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to better understand disease extent and to identify appropriate methodologies to evaluate (dystrophic epidermolysis bullosa) DEB in a quantitative and qualitative manner.

Official Title
-----------------
A Prospective Short-term Study to Evaluate Methodologies for the Assessment of Disease Extent, Impact, and Wound Evolution in Patients With Dystrophic Epidermolysis Bullosa (DEB)

Conditions
-----------------
Dystrophic Epidermolysis Bullosa

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent is provided. Patients 18 years of age and older, and parent(s)/legal guardian(s) of patients younger than 18 years of age, must provide written informed consent prior to participating in the study; additionally, informed assent will be obtained from patients younger than 18 years of age as specified by local requirements. Patient must have a documented diagnosis of DEB based on genetic analysis showing a mutation in COL7A1 or, in the opinion of the investigator, a confirmed diagnosis of DEB based on histologic criteria (antigen mapping or electron microscopy). Patient must have at least 5 wounds that are suitable for imaging, in the opinion of the investigator, at the time of enrollment. Patient is willing and able to undergo the protocol-specified procedures. Exclusion Criteria: Patient has used or is currently using experimental treatment for DEB including, but not limited to, bone marrow transplantation, systemic immune suppression, or experimental procedures that involve live cells, with potential for systemic spread such as gene transfer, stem cell infusions, or other cell type injections such that, in the opinion of the investigator, inclusion poses an unacceptable risk to the patient or interpretation of these study data. Patient has squamous cell carcinoma with evidence of locally invasive disease or distant metastases. Patient is pregnant.
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 |
| --- | --- | --- |
| Wound Surface Area (WSA) of patient- and investigator-selected wounds |  | Over 4 weeks | 
| Wound Surface Area (WSA) as a percentage of Body Surface Area (BSA) in patients with DEB |  | Over 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number, severity and relationship to study procedures of adverse events (AEs) and serious AEs (SAEs) |  | Over 4 weeks |
Endothelial Vasomotor Function in the Framingham Study

Study Overview
=================
Brief Summary
-----------------
To determine whether the presence of endothelial dysfunction is an independent risk factor for cardiovascular disease events.

Detailed Description
-----------------
BACKGROUND: Current research suggests that loss of the vasodilator, anti-thrombotic, and anti-inflammatory properties of the vascular endothelium plays a dynamic role in the pathogenesis of cardiovascular disease. Impaired endothelial function, including impaired nitric oxide-dependent vasodilation is associated with cardiovascular disease risk factors. Further, there is growing evidence that endothelial function can be improved by risk modification. However, the available studies have not definitively resolved the issue of the cross-sectional correlates of endothelial dysfunction because they have been limited to small samples of highly selected patients. For example, it remains unclear whether hypercholesterolemia, hypertension, or elevated glucose levels are independent determinants of endothelial dysfunction. Most importantly, no study has shown a relation between endothelial dysfunction and increased cardiovascular risk. Such a demonstration would increase our understanding of the pathogenesis of cardiovascular disease and aid clinicians in identifying high risk individuals who would benefit most from intervention. DESIGN NARRATIVE: Using non-invasive brachial artery ultrasound, endothelial function was examined in about 3,800 men and women of the Framingham Heart Study. The cross-sectional correlates of endothelial function with known coronary risk factors were examined and cross-sectional analyses were performed on the relation of endothelial function to prevalent cardiovascular disease. Observations were made of the adjusted relation of endothelial function to incident and recurrent cardiovascular events. The central hypothesis was that the presence of endothelial dysfunction was an independent risk factor for cardiovascular disease events. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Vitiligo and the Koebner Phenomenon (Model of Vitiligo Induction and Therapy: a Clinical and Immunological Analysis)

Study Overview
=================
Brief Summary
-----------------
We will investigate the process of vitiligo induction and the influence of different commonly used cream treatments on this process. Studies comparing different treatments for vitiligo in the induction stage of the disease are still missing. The study hypothesis = cream treatment can stop actively spreading vitiligo lesions during the early induction stage of the disease.

Official Title
-----------------
Vitiligo and the Koebner Phenomenon (Model of Vitiligo Induction and Therapy: a Clinical and Immunological Analysis)

Conditions
-----------------
Vitiligo

Intervention / Treatment
-----------------
* Drug: topical tacrolimus treatment
* Drug: topical pimecrolimus treatment
* Drug: local mometasone furoate treatment
* Drug: cold cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female, Age 18-70 years, Extensive vitiligo (> 50% body surface area), Patients asking for depigmenting therapy, Not pregnant. Exclusion Criteria: Children, Non extensive vitiligo (< 50% boy surface area), Patients not asking for depigmenting therapies, Pregnant.

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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: topical tacrolimus<br> | Drug: topical tacrolimus treatment<br>* 4 applications (day 1,day 3, day 6 and day10)<br>|
| Active Comparator: topical pimecrolimus<br> | Drug: topical pimecrolimus treatment<br>* 4 applications (day 1, day 3, day 6 and day 10)<br>|
| Active Comparator: local steroids<br> | Drug: local mometasone furoate treatment<br>* 4 applications (day 1, day 3, day 6 and day 10)<br>|
| Placebo Comparator: cold cream<br> | Drug: cold cream<br>* 4 applications (day 1, day 3, day 6 and day 10)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of skin pigmentation in the treated area | digital image analysis system for surface measurement | after 1 day, 10 days, 30 days and 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitiligo