linjc16/ctgov huggingface dataset:
Use of Motor Rehabilitation Courses in Children With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
In 2022, the prevalence of Cerebral Palsy (CP) is 2.5 cases per 1000 live births. In France, 125,000 persons are affected by CP. Many treatments and therapies exist to reduce CP-related disorders, but CP remains uncurable. Motor Rehabilitation Courses (MRC) are one of those therapies used with children with CP. Their uses has not been studied in France yet. The aim of this survey is to find out about the use of motor rehabilitation courses for children with CP and, where appropriate, the content of these courses. This questionnaire will be used to determine the use and different types of MRS in which children participate.

Detailed Description
-----------------
In total, the questionnaire contains 131 items divided into 13 groups. The estimated filling time is 20 minutes. The questionnaire is divided as follows: INFORMATION DOCUMENT FOR THE RESEARCH PARTICIPANT About the person with cerebral palsy About the respondent About the usual motor rehabilitation About participation in motor rehabilitation courses 7) 8) Information about MRS 9) Relationship of care or treatment received to participation in MRS 10) Information about the child 11) Information about the child's environment 12) Additional comments from the respondent regarding the MRS 13) Respondent's opinion on the questionnaire

Official Title
-----------------
Use of Motor Rehabilitation Courses in Children With Cerebral Palsy in 2022

Conditions
-----------------
Cerebral Palsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child with a diagnosis of cerebral palsy Aged between 6 and 18 years Exclusion Criteria: Child diagnosed with CP after age 6 Between 1 and 6 years of age

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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 |
| --- | --- | --- |
| Prevalence of the use of motor rehabilitation courses in children with cerebral palsy | Prevalence of the use of motor rehabilitation courses | Each participant will answer for 20 minutes an expert-validated questionnaire on the internet once recruited in the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral palsy, Children, Motor rehabilitation course, Survey and Questionnaire
Acute Kidney Injury Among Pediatric Cancer Patients At South Egypt Cancer Institute

Study Overview
=================
Brief Summary
-----------------
Cancer is the second most frequent cause of premature death in children. The incidence of pediatric cancer varies by region and country, but it is generally considered rare with an estimated 300,000 new cases diagnosed worldwide. Acute kidney injury in pediatric cancer patients refers to the sudden and often temporary loss of renal function, which can lead to a variety of complications if not treated correctly.

Detailed Description
-----------------
Primary: To determine the cumulative incidence of AKI using KDIGO criteria in pediatric patients with malignancy in South Egypt Cancer Institute (SECI) Secondary: Incidence of Hospital-acquired and community-acquired AKI Asses the risk factors of the incidence of AKI To determine in-hospital outcome (time to in-hospital death, length of hospital stay, and time to kidney recovery) of AKI. This is a prospective study that will be carried out in the Paediatric Oncology and Haematological Malignancies Department including patients diagnosed with malignant tumours and hospitalized from 1st April 2023 for one year duration.

Official Title
-----------------
Acute Kidney Injury Among Pediatric Cancer Patients At South Egypt Cancer Institute

Conditions
-----------------
To Determine the Cumulative Incidence of AKI Using KDIGO Criteria in Pediatric Patients With Malignancy in South Egypt Cancer Institute (SECI)

Intervention / Treatment
-----------------
* Diagnostic Test: kidney function test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Children of both sexes (aged from 1 month to 18 years at diagnosis) Patients with either hematological malignancies or solid tumors admitted to the Paediatric Oncology and Haematological Malignancies Department Exclusion Criteria: Children who had an unconfirmed cancer diagnosis. Children more than 18 years at diagnosis. Children with preexisting chronic kidney disease (CKD) that defined as the presence of structural or functional kidney damage that persist over minimum of three month The patient underwent hematopoietic stem cell transplantation. Patients with 1 s.Cr level. Patient underwent renal transplant.

Ages Eligible for Study
-----------------
Minimum Age: 30 Days
Maximum Age: 18 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: kidney function test|blood sample for kidney function test|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the cumulative incidence of AKI using KDIGO criteria in pediatric patients with malignancy in South Egypt Cancer Institute (SECI) |  | from November 2023 till November 2024 |
New Daily Persistent Headache Survey

Study Overview
=================
Brief Summary
-----------------
Purpose: to explore headache characteristics and treatment effects of patient with new daily persistent headache (NDPH) through an online survey. Research design: Online survey of patients with new daily persistent headache. Risks: Risks include a breach of confidentiality as well as fatigue from taking the survey online. Importance of knowledge that may recently be expected to result: The study aims to discover new information in a very understudied disease. This information could, in future studies, help change the diagnostic criteria or lead to new treatment options.

Official Title
-----------------
New Daily Persistent Headache Patient Experience Survey

Conditions
-----------------
New Daily Persistent Headache (NDPH), New Daily Persistent Headache

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with NDPH that have been diagnosed by a health care professional (no documentation is needed, participant must simply state that he or she has been diagnosed) Exclusion Criteria: Unable to speak English (the survey is only in English) Unable to use a computer to take the online survey

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- |
| New daily persistent headache (NDPH) group<br>Participants with NDPH will be administered an online survey. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survey data |  | At study completion, expected to be in 6-12 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Constant headache, Refractory headache disorder
Rectus Sheath Block in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of a type of peripheral nerve block, Rectus Sheath Block. Does the rectus sheath block decrease opioid consumption postoperatively after cardiac surgery? Does the rectus sheath block decrease VAS pain scores postoperatively after cardiac surgery? Study participants will be assigned to receive either rectus sheath block or no block.

Official Title
-----------------
Rectus Sheath Block in Cardiac Surgery

Conditions
-----------------
Cardiac Disease, Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: Rectus sheath block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: Adults 18-85 years old Scheduled to undergo cardiac procedures involving chest tubes Male or female Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: ASA class V Urgent or emergent surgery Contraindications to administration of local anesthesia (e.g. local anesthetic allergy) History of substance abuse or chronic opioid use Patient refusal or inability to consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rectus Sheath Block<br> | Procedure: Rectus sheath block<br>* Participants will receive an ultrasound guided rectus sheath block with local anesthetic<br>|
| No Intervention: No block<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | Amount of opioid consumption required postoperatively | 72 hours postoperatively | 
| VAS pain scores | VAS pain scores (1-10, 1 being no pain and 10 being worst pain) recorded postoperatively | 72 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in ICU | Amount of time spent in ICU postoperatively | 72 hours | 
| Length of hospital stay | Length of time spent in hospital postoperatively | 72 hours | 
| Time to extubation | Length of time requiring postoperative mechanical ventilation | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac surgery, regional anesthesia
Perioperative Examination of Inflammatory Markers in Relation to Sentinel Lymph Node Biopsy in Patients With Melanoma; a Pilot Study

Study Overview
=================
Brief Summary
-----------------
We want to test if an association between sentinel lymph node biopsy (SLBN) and a systemic inflammatory response can be made.

Detailed Description
-----------------
Sentinel lymph node biopsy (SLBN) is essential in staging melanoma and properly selecting patients for adjuvant immunotherapy. However, surgically induced inflammation can potentially aid in progression of remaining malignant cells and affect prognosis. The inflammatory marker neutrophil-to-lymphocyte ratio (NLR) is also a negative prognostic and predictive marker in serval malignancies, among melanoma. However, it is not yet established if SLNB induces a systemic inflammatory response.

Official Title
-----------------
Perioperative Examination of Inflammatory Markers in Relation to Sentinel Lymph Node Biopsy in Patients With Melanoma; a Pilot Study

Conditions
-----------------
Melanoma, Surgery

Intervention / Treatment
-----------------
* Procedure: Blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (>18 years of age) Diagnosed with invasive cutaneous melanoma Eligible for SLNB (Melanoma stage ≥ T1b) Obtained signed informed consent Exclusion Criteria: Pregnancy

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 |
| --- | --- |
| Patients with melanoma<br>Patients with melanoma undergoing sentinel lymph node biopsy with perioperative blood samples. | Procedure: Blood samples<br>* Blood samples<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutrophil-to-lymphocyte ratio | Ratio between neutrophil granulocytes and lymphocytes | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pro-inflammatory cytokines | IL-1b, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNF-α, and IFN-γ | 1 Day | 
| Acute phase reactants | CRP, LDH | 1 Day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melanoma, Surgery, Neutrophil-to-lymphocyte ratio, Surgical inflammation
Interest of a Nursing Consultation in the Empowerment of the Patient With Rheumatoid Arthritis in the Management of His Subcutaneous Biotherapy

Study Overview
=================
Brief Summary
-----------------
Biotherapy present specifics risks that patients must know and learn to manage. A national survey has been carried in this study to evaluate patients safety skills. (wording:  cross study of safety skills of 677 patients treat by biopharmaceuticals for an inflammatory rheumatism). This survey has allowed showcasing patients difficulties in managing their treatment, including for those under subcutaneous biotherapy. More than 60% patients interviewed doesn't know symptoms to bring them to consult and mainly postpone to their injection. The aim of this study is to prove that nursing consultation can allow the patient to become independent in treatment management and thus avoid occurrence of adverse event.

Official Title
-----------------
Interest of a Nursing Consultation in the Empowerment of the Patient With Rheumatoid Arthritis in the Management of His Subcutaneous Biotherapy

Conditions
-----------------
Biotherapies, Rheumatology, Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Device: nursing consultation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient suffering from rheumatoid arthritis followed by Rheumatology consultation of Amiens-Picardie University Hospital Patient treated by Subcutaneous Biotherapy for at least 6 months at the time of inclusion Major patient Patient having signed an informed consent Exclusion Criteria: Minor patient Patient with cognitive impairment diagnosed by a physician Patient under tutorship or curatorship Patient deaf or hard of hearing Patient not fluent in the French language (at the decision of the investigator)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nursing consultation<br> | Device: nursing consultation<br>* nursing consultation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of BIOSECURE score between baseline and after nurse consultation | Biosecure questionnaire is assessing patient theoretical and practical understanding of biotherapy. Highest score is 100. | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nurse consultation, biotherapies, Rheumatology, Rheumatoid Arthritis
Bioequivalence Study in Healthy Subjects by Using of Chlorpromazine HCl 100mg Tablets

Study Overview
=================
Brief Summary
-----------------
This clinical study is an open label, randomized, fasting condition, single-dose, two-period crossover study to compare the bioequivalence of Chlorpromazine HCl 100mg Tablets after oral administration in healthy subjects.

Official Title
-----------------
An Open Label, Randomized, Fasting, Single-dose, Two-period Crossover Study to Compare the Bioequivalence of Chlorpromazine HCl 100mg Tablets After Oral Administration in Healthy Subjects.

Conditions
-----------------
Healthy Subject

Intervention / Treatment
-----------------
* Drug: Chlorpromazine HCl 100mg Tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Healthy subjects, over the age of 19 years old Weight: At least 50.0 kg and Body mass index (BMI) between 18.0-30.0 kg/m2. All subjects should be judged normal and healthy during a pre-study medical evaluation Subjects who has no birth or chronic disease and must be in good health as determined by physical exmination and medical tests including biochemistry, urinalysis, serology and hematology etc in serum/urine. Subject is willing to participate and to Sign written informed consent form Female subjects of childbearing age who use contraception other than hormonal contraception. Subjects who has no history of psychical disorder within the last five years Main Exclusion Criteria: Subjects who have a medical history specified in protocol Subjects who are expected to have the prohibited medication and activity etc. during the study period Subjects who can not comply with requirements as per protocol Pregnant women or breast-feeding women or men and women who has possibility of pregnancy Subjects who are not suitable for the clinical trial

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Drug: Chlorpromazine HCl 100mg Tablets<br>* single-dose administered after a 10-hour overnight fast.<br>|
| Experimental: Group B<br> | Drug: Chlorpromazine HCl 100mg Tablets<br>* single-dose administered after a 10-hour overnight fast.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast |  | Up to 72 hours | 
| Cmax |  | Up to 72 hours |
Outcome of Kasai Portoenterostomy in Biliary Atresia in Upper Egypt

Study Overview
=================
Brief Summary
-----------------
Kasai portoenterostomy is the key standard operation for biliary atresia. The aim of the study is to evaluate the short-term outcome of Kasai portoenterostomy for biliary atresia infants in Upper Egypt.

Detailed Description
-----------------
It is a cross-sectional retrospective multicenter study from Upper Egypt. The data will collected from the medical records of three university hospitals in Upper Egypt from January 2019 to December 2019. Inclusion and exclusion criteria Inclusion criteria included all neonates diagnosed with biliary atresia in the previous period and managed by Kasai portoenterostomy. Exclusion criteria were neonates without a confirmed diagnosis of biliary atresia.

Official Title
-----------------
Outcome of Kasai Portoenterostomy in Biliary Atresia in Upper Egypt

Conditions
-----------------
Biliary Atresia

Intervention / Treatment
-----------------
* Procedure: Kasai portoenterostomy operation.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all neonates diagnosed with biliary atresia in the previous period and managed by Kasai portoenterostomy. Exclusion Criteria: Exclusion criteria were neonates without a confirmed diagnosis of biliary atresia.

Ages Eligible for Study
-----------------
Minimum Age: 4 Weeks
Maximum Age: 19 Weeks

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| all neonates diagnosed with biliary atresia and managed by Kasai portoenterostomy.<br>all neonates diagnosed with biliary atresia in the previous period 2019 and managed by Kasai portoenterostomy. | Procedure: Kasai portoenterostomy operation.<br>* Kasai portoenterostomy operation for biliary atresia patients.<br>* Other names: Kasai operation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of jaundice clearance | the clearance of jaundice measured by total serum bilirubin < 1.2 mg \ dL and direct bilirubin < 0.3 mg dL within one year postoperatively | from 3 months up to one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholestasis, Neonate jaundice, Cholangitis, Short-term outcome, Survival with the native liver
Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in combination with FDG-PET/CT imaging in women with vulva cancer tumour size >4 cm, multifocal tumors and local recurrences.

Official Title
-----------------
Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer ( SENTIVUC II)

Conditions
-----------------
Vulva Cancer, Sentinel Lymph Node

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with vulva cancer, tumor > 4 cm, multifocal tumor, or local recurrences in vulva Exclusion Criteria: Previous external irradiation of the vulva or groins Former sentinel node or inguinal lymphadenectomy in the relevant groin Known allergy to ICG or iodine Patient is in active treatment for other cancer and/or disseminated disease

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

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

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 |
| --- | --- | --- |
| Sensitivity | Sensitivity of sentinel lymph node mapping | Three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative predictive value | Negative predictive value of sentinel lymph node mapping | Three years |