linjc16/ctgov huggingface dataset:
Biomarker-s of Abusive Head Trauma by Proteomics

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to highlight biomarker-s of Abusive Head Trauma by proteomics analyses on the serum of child victims of abuse.

Official Title
-----------------
Identification of Novel Biomarker-s of Abusive Head Trauma on Serum by Proteomics

Conditions
-----------------
Abuse, Child, Protein Disorder, Blood

Intervention / Treatment
-----------------
* Other: Blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age : 0-2 y.o Medical consultation for malaise, seizure (without fever), loss of consciousness, traumatic bain injury, or cranioplasty Blood test during medical care Accepted informed consent Exclusion Criteria: Refused informed consent For control groups : medical history of child abuse For AHT group : rare metabolic disease (Menkes, etc..)

Ages Eligible for Study
-----------------
Maximum Age: 2 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 |
| --- | --- |
| Abusive Head Trauma (AHT)<br> | Other: Blood test<br>* Proteomic analyses on serum<br>|
| Accidental traumatic brain injury<br> | Other: Blood test<br>* Proteomic analyses on serum<br>|
| Cranioplasty<br> | Other: Blood test<br>* Proteomic analyses on serum<br>|
| Infant malaise without AHT<br> | Other: Blood test<br>* Proteomic analyses on serum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Highlight novel biomarker-s of AHT | Proteomic analyses will be made on serum of infant victim of AHT. Results will be compare with control groups (traumatic brain injury, cranioplasty, malaise). | Hospital admission to discharge (up to 3 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abusive head trauma, proteomic, biomarker
The Role of Methycobalamin in Early Dementia Patients With Vitamin B12 Deficiency and Hyperhomocysteinaemia.

Study Overview
=================
Brief Summary
-----------------
Patients who fit the inclusion criteria are admitted into the study. They are given 3 IV injection of MBL in the first week and one tablet three times a day for 16 weeks.

Conditions
-----------------
Dementia With Vitamin B12 Deficiency

Intervention / Treatment
-----------------
* Drug: Mecobalamin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Patients with Dementia Serum B12 < 200 pmol/l Serum Homocysteine level > 11.0 micro mol/L Exclusion: Significant communication problems deafness, dysarthria, dysphasia etc. unstable DM or hypertension alcohol abuse co-existing diseases which may affect cognition e.g. cognitive cardiac failure, respiratory failure folate < 10 g/dl haemoglobin concentration < 10g/d abnormal thyroid function test or VDRL

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mecobalamin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mattis dementia rating scale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Category fluency test |  |  | 
| Delirium rating scale |  |  | 
| CNPI |  |  | 
| MMSE |  |  | 
| Plasma homocysteine |  |  | 
| Plasma isoprostane |  |  |
Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental Pain

Study Overview
=================
Brief Summary
-----------------
Evaluation of the efficacy and safety of a single dose of an ibuprofen effervescent tablet in the treatment of pain following third molar extraction in comparison to single doses of placebo, standard ibuprofen tablets, and effervescent aspirin plus vitamin C tablets.

Official Title
-----------------
Ibuprofen 400 mg Effervescent Tablet Dental Pain Study II

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: effervescent ibuprofen tablets
* Drug: effervescent Aspirin plus Vitamin C tablets
* Drug: ibuprofen tablets
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Moderate or severe post-operative pain following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction In general good health with no contraindications to the study medication or rescue medication (tramadol or acetaminophen + hydrocodone) Use of only short-acting local anesthetics with or without vasocontrictor and/or nitrous oxide Exclusion: Presence of a serious medical condition (e.g., poorly controlled hypertension, diabetes, or hyper-/hypo-thyroidism; significantly impaired renal, cardiac, or hepatic function) Acute localized dental alveolar infection at the time of surgery that could confound the post-surgical evaluation Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically-approved method of contraception

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: effervescent ibuprofen tablets<br> <br> |
| Active Comparator: 2<br> | Drug: effervescent Aspirin plus Vitamin C tablets<br> <br> |
| Active Comparator: 3<br> | Drug: ibuprofen tablets<br> <br> |
| Placebo Comparator: 4<br> | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sum of pain relief and pain intensity difference scores |  | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to meaningful pain relief |  | 8 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental pain, analgesic, NSAID, ibuprofen, aspirin
Virtual Reality for Tibial Eminence Fractures

Study Overview
=================
Brief Summary
-----------------
Tibial eminence fracture, a bony avulsion of the anterior cruciate ligament (ACL) from its insertion on the intercondylar eminence,1 was first described by Poncet in 1875. 2 Also known as tibial spine fractures, these injuries occur most commonly in skeletally immature patients between the ages of 8 and 14 years

Official Title
-----------------
Virtual Reality Training Combined With a Physical Therapy Program in the Rehabilitation of Patients After Tibial Eminence Fractures

Conditions
-----------------
Tibial Fractures

Intervention / Treatment
-----------------
* Other: physical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age of children from five to nine children have fracture in tibial eminence Exclusion Criteria: children have fracture in tibial eminence grade III

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 9 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control Group<br>children received selected physical therapy exercises | Other: physical therapy<br>* physical therapy-specific exercises<br>|
| Experimental: Study Group<br>children received selected physical therapy exercises plus virtual reality training | Other: physical therapy<br>* physical therapy-specific exercises<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale | assessment severity of pain | pain assessment at day 0 | 
| Visual analogue scale | assessment severity of pain | pain assessment at day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A universal goniometer | assessment te range of knee extension | assessment te range of knee extension at date 0 | 
| A universal goniometer | assessment te range of knee extension | assessment te range of knee extension at date 180 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tibial eminence fracture, Virtual reality
Isolated Pelvic and Limb Perfusion in the Treatment of Locally Advanced Sarcoma of Pelvis and Limbs' Girdle

Study Overview
=================
Brief Summary
-----------------
This study looks at isolated pelvic perfusion and limbs' girdle with 1 mg tumor necrosis factor alpha (TNFa) in the treatment of locally advanced sarcoma of the pelvis and limbs' girdle.

Official Title
-----------------
Isolated Pelvic and Limb Perfusion With 1mg TNFa in the Treatment of Locally Advanced Sarcoma of Pelvis and Limbs' Girdle

Conditions
-----------------
Sarcoma of Pelvis

Intervention / Treatment
-----------------
* Drug: Tasonermine (TNFa)
* Drug: Melphalan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Soft tissue or bone sarcomas locally advanced of the pelvis or limbs' girdle Exclusion Criteria: Resectable tumor without mutilation

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tasonermine (TNFa)|nan|
|Drug: Melphalan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate on MRI |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological response |  |  | 
| Objective responses |  |  | 
| Rate of conservative treatments |  |  | 
| Overall survival and disease free survival |  |  | 
| Local and systemic toxicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Limbs' girdle
PWV for Cardiovascular Complication After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Arterial stiffness has been suggested as an independent risk factor for the development of coronary artery disease and stroke. Pulse wave velocity (PWV) is an noninvasive established index to quantify arterial stiffness. Therefore, we try to investigate the correlation between PWV values and cardiovascular complications like stroke, acute renal failure, or perioperative myocardial infarction after cardiac surgery.

Official Title
-----------------
Evaluation of Pulse Wave Velocity as a Predictive Factor for Postoperative Cardiovascular Complication After Cardiac Surgery: a Prospective Study

Conditions
-----------------
C.Surgical Procedure; Cardiac

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac surgery patients who sign the informed consent Exclusion Criteria: Chronic renal failure (Cr>1.5mg/dL), Dialysis patients Previous stroke Left ventricular dysfunction (EF <50%) ASO with claudication < 40 years

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| Postoperative cardiovascular complication and parameters | Stroke, Delirium, Newly developed atrial fibrillation, ARF, Peak CK-MB and troponin I levels measured at 12 and 24 hours after surgery, Peak estimated GFR and corresponding creatinine | within the first 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| E/e' and e' measured by transthoracic echocardiography with color-coded tissue dopper imaging in patients undergoing non-valvular cardiac surgery | peak early transmitral filling velocity during early diastole (E), mean early velocity at the septal mitral annulus (e') | baseline and within the first 14 days after surgery |
Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety and tolerability of ODM-201 in patients with castrate resistant prostate cancer.

Official Title
-----------------
Safety and Tolerability of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Extension Study to Study 3104001

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: ODM-201


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Successful completion of study protocol 3104001 Response or stable disease in study 3104001 at week 12 Exclusion Criteria: New serious concurrent medical condition Not able to swallow the study drug

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

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

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: ODM-201<br> | Drug: ODM-201<br>* ODM-201 administered orally daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | Adverse events from start of ODM-201 treatment (in ARADES 3104001 study) until end of study visit (in ARADES-EXT 3104002 study). Median duration on study treatment was 11,0 months. | From first dose of study treatment up to 4 weeks after last dose of study treatment |
Correlation of Laparoscopic Experience and Functional Brain Activation: A PET Scan Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the research is to determine how practicing laparoscopic motor tasks affects the functional anatomy of the brain, and to investigate whether there is a correlation between surgical experience and functional brain activition. Additionaly, the investigators plan to use eye-tracking technology to see if the use of this technology can distinguish surgeons of various skill levels. The investigators hope that this study leads to new and effective methods of training surgical residents. All of the data will be collected at The Feinstein Institute for Medical Research, and may be used in future studies, which may or may not be related to urological diseases.

Official Title
-----------------
GAC 0201 Correlation of Laparoscopic Experience and Functional Brain Activation: A Pet Scan Study

Conditions
-----------------
Brain Function

Intervention / Treatment
-----------------
* Other: observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Urology resident or fellow at Long-Island Jewish Hospital Urology attending surgeon with previous laparoscopic experience Medical Student Research Fellow with no previous laparoscopic experience Right hand dominant subjects No known neorologic defect reported by the subject - Exclusion Criteria: Left-hand dominant subjects Self-reported neurologic defect reported by the subject -

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: observational<br>This is an observational study. no intervention occurs in subjects. their performance in a laparoscopic trainer is observed and correlated with brain activity | Other: observational<br>* PET Scan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laparoscopic experience |  | 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Comparison of experienced and novice laparoscopic surgeons
Long-term Urodynamics in Individuals With Neurogenic Lower Urinary Tract Dysfunction

Study Overview
=================
Brief Summary
-----------------
The long-term changes of bladder function in individuals with lower urinary tract dysfunction will be investigated. Patients presenting for regular urodynamic examination of bladder function will be included. Bladder diary details and urodynamic data will be collected in order to investigate bladder function.

Official Title
-----------------
Retrospective Analysis of Long-term Urodynamics in Individuals With Neurogenic Lower Urinary Tract Dysfunction

Conditions
-----------------
Neurogenic Lower Urinary Tract Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neurogenic lower urinary tract dysfunction urodynamic data Exclusion Criteria: duration of neurogenic lower urinary tract dysfunction < 10 years < 5 urodynamic follow-ups

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 |
| --- | --- | --- |
| maximal detrusor storage pressure |  | 12 month after previous investigation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bladder capacity |  | 12 month after previous investigation | 
| bladder compliance | The relationship between a change in bladder volume and the change in detrusor pressure (ΔDV/ΔDP). | 12 month after previous investigation | 
| maximal detrusor voiding pressure |  | 12 month after previous investigation | 
| reflexive bladder volume |  | 12 month after previous investigation |
Partial PTEN Deletion in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Detection of chromosome 10q23 deletion including PTEN locus in breast cancer patients. Correlation between PTEN deletion and clinicopathological characteristics in breast cancer patients.

Detailed Description
-----------------
Breast cancer is the most common carcinoma detected in women, accounting for about one fifth of new cancer cases in females. In Egypt breast cancer is the most common malignancy in women, accounting for 38,8% of cancers in this population, with the estimated number of breast cancer cases nearly 22700 in 2020 and forecasted to be approximately 46000 in 2050. Surgical removal of the cancer represents the standard of care followed by radiation and adjuvant therapy in patients considered to be at particular risk for systemic disease. Estimation of prognosis is of vital importance for tailoring adjuvant therapy in individual breast cancer patients. Conventional pathological parameters such as histological grade, tumor size and presence of lymph node metastasis are not accurate enough to select subsets of patients who are at sufficiently low risk of progression to be spared extensive adjuvant therapy without compromising the prognosis. Much hope is placed on cytogenetic features analysis which might help to improve prediction of patient prognosis. Fluorescence in situ hybridization (FISH) is a molecular cytogenetic technique that enables the detection of genetic abnormalities such as gene amplification, deletions, and chromosomal rearrangements. Deletions of chromosome 10q23 including the PTEN (phosphatase and tensin homolog) locus are known to occur in breast cancer patients. The PTEN gene is a phosphatase which metabolises PIP3, the lipid product of PI 3-kinase, directly opposing the activation of the oncogenic PI3K/AKT/mTOR signalling network. Inactivation of PTEN leads to constitutively activated levels of AKT, thus promoting cell growth, proliferation, survival and migration through multiple downstream effectors. PTEN is one of the most frequently deleted genes in various human cancer types. In breast cancer, the frequency of PTEN deletions or reduced expression varies from 4 % to 63 %.

Official Title
-----------------
Partial PTEN Deletion and Its Relation to Clinicopathological Characteristics in Breast Cancer Patients

Conditions
-----------------
PTEN Gene Deletion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all stages of breast cancer in females. Exclusion Criteria: breast cancer in males.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of chromosome 10q23 deletion including PTEN locus in breast cancer patients. | Correlation between PTEN deletion and clinicopathological characteristics in breast cancer patients. | baseline |