linjc16/ctgov huggingface dataset:
Effect of Brivaracetam in Photosensitive Epileptic Subjects

Study Overview
=================
Brief Summary
-----------------
to assess the effect of brivaracetam on the photoparoxysmal EEG response in photosensitive epileptic subjects

Official Title
-----------------
A Placebo-controlled, Single-blind, Multi-center Study to Explore the Photoparoxysmal Response in Photosensitive Epileptic Subjects After One Single Oral Dose of Brivaracetam in Capsules.

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: Brivaracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: epileptic subjects with generalized PPR Exclusion Criteria: more than 2 concomitant antiepileptic drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Single


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify lowest single oral dose producing maximal decrease or suppression of intermittent photic stimulation (IPS)photoparoxysmal response (PPR) in photosensitive epileptic subjects pre-dose |  |  | 
| post placebo during 24h and post brivaracetam for up to 72 h |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess relationship between plasma concentrations and changes in photosensitivity frequency range, time of onset and duration of suppressing effect |  |  | 
| Safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
POC, photosensitive, epileptic, brivaracetam, PPR, AED
Clinical Decision Biological Biomarker and Prognosis Prediction of Hepatocellular Carcinoma by Deep Learning

Study Overview
=================
Brief Summary
-----------------
Developing a deep learning model based on contrast-enhanced ultrasound (CEUS) to predict the prognosis of hepatocellular carcinoma (HCC) and aid choose operation decisions

Detailed Description
-----------------
Collecting CEUS and clinical data of HCC from different institutions retrospectively. Developing a deep learning model based on CEUS to predict the prognosis of HCC. Developing a deep learning model based on CEUS to choose a better operation (ablation or surgery) of HCC patients. Then, validating the deep learning model in the prospective data.

Official Title
-----------------
A Deep Learning Model Based on Contrast-enhanced Ultrasound to Aid Clinical Decisions and Predict Biological Biomarker and Prognosis of Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma, Contrast-enhanced Ultrasound, Prognosis, Surgery, Ablation

Intervention / Treatment
-----------------
* Procedure: Surgery
* Procedure: Ablation (Microwave ablation or Radiofrequency ablation)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with HCC (Ia, Ib, IIa stage) China liver cancer staging who underwent resection or ablation without macro-vascular invasion Child-Pugh A/B grade HCC is proved by pathological examination or two enhanced imaging CEUS (Sonovue or Sonozoid) images are performed two weeks before the operation Invasive biomarker or prognosis of HCC available CEUS images are included in at least three stages (Arterial phase, Portal phase, and Late phase) Exclusion Criteria: postop follow-up loss or expired less than 3 months patients with co-malignancy poor images quality for analyzing

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 |
| --- |
|Procedure: Surgery|hepatectomy|
|Procedure: Ablation (Microwave ablation or Radiofrequency ablation)|image-guided ablation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free survival (RFS) | Recurrence-free survival is defined as the time elapsed between a predefined point in time (the date of diagnosis, randomization or the intervention) and any recurrence (local, regional, or distant) or death due to any cause (death is an event). | Immediately after the surgery or ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | Recurrence included local tumor progression, regional recurrence, or distant recurrence. | Immediately after the surgery or ablation |
Immunohistochemical Staining of p16 for the Screening of Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
Cyclin kinase inhibitor P16INK4A has overexpression in cervical cancer, and hence becoming an alternative method for cervical cancer screening. This study is to investigate the clinical value of P16INK4A and high-risk human papillomavirus (hrHPV) detection of cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). All eligible participants accept P16INK4A testing, with cytology and/or hrHPV assay. P16INK4A immunohistochemical staining is performed on the retained specimens of cytology. The primary endpoint is the diagnostic accuracy of P16INK4A compared with cytology and/or hrHPV status based on histology results. The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.

Official Title
-----------------
Immunohistochemical Staining of p16 for the Screening of Cervical Cancer

Conditions
-----------------
Cervical Cancer Screening, p16 Protein, Cytology, High-risk Human Papillomavirus, Diagnostic Accuracy, Histology, Cervical Intraepithelial Neoplasia

Intervention / Treatment
-----------------
* Diagnostic Test: p16 protein expression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or older Signed an approved informed consents With sufficient cytology sample for p16 testing With definite results of cytology and/or high-risk human papillomavirus and cervical histology Exclusion Criteria: Not meeting all of the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: All eligible participants as a cohort, accept P16INK4A testing, with cytology and/or hrHPV assay
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>All eligible participants as one group accept P16INK4A testing, with cytology and/or hrHPV assay. | Diagnostic Test: p16 protein expression<br>* P16INK4A immunohistochemical staining is to be performed in residual cytology samples.<br>* Other names: p16INK4A immunohistochemical staining;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of p16 protein expression | Diagnostic accuracy of p16 protein expression for detecting cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+) | Two years |
Impact of VeinViewer® Vision to Guide Peripheral Venipuncture in Geriatrics

Study Overview
=================
Brief Summary
-----------------
Peripheral venipuncture is a common procedure in geriatrics. This procedure due to altered cutaneous alteration and venous capital associated with age poses problems of comfort and quality of life of elderly patients hospitalized. There is little data from the literature that highlights the difficulties of venipuncture in the context of old age. New venous visualization technologies by infrared spectroscopy (NIR) such as VeinViewer® Vision (VVV) have been developed to guide the placement of a peripheral venous (VVP) or venipuncture (PV) route.

Official Title
-----------------
Impact of VeinViewer® Vision to Guide Peripheral Venipuncture in Geriatrics

Conditions
-----------------
Venipuncture, Geriatric

Intervention / Treatment
-----------------
* Biological: Venous puncture in elderly patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 75 years and over Patient hospitalized in a department of acute geriatrics, whose venipuncture was prescribed Exclusion Criteria: Patient not affiliated to a social security scheme Patient under legal protection

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Venous puncture using VVV at the beginning of the procedure<br> | Biological: Venous puncture in elderly patients<br>* Venous puncture in elderly patients<br>|
| Active Comparator: Venous puncture without VVV<br> | Biological: Venous puncture in elderly patients<br>* Venous puncture in elderly patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of the number of attempts to place the venous catheter for venipuncture |  | 3 days |
National Nurses Health Cohort Study (NNHS): a Web-based Ambispective Cohort Study in China

Study Overview
=================
Brief Summary
-----------------
The purpose of the current study was to build an ambispective cohort study of female nurses, based on existing physical examination and nurse work schedule data and a web-based questionnaire system, focusing on the effects of occupational, environmental, and lifestyle risk factors on the health of Chinese women.

Official Title
-----------------
National Nurses Health Cohort Study (NNHS): a Web-based Ambispective Cohort Study in China

Conditions
-----------------
Nurse Health

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female registered nurses, licensed practical nurses and/or midwives with informed consent are included in this study Exclusion Criteria: student nurses training nurses
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nurses working in PUTH<br>Participants will be recruited from Peking University Third Hospital through cluster sampling. Female registered nurses, licensed practical nurses and/or midwives with informed consent are included in this study. The exclusion criteria are student nurses and training nurses. | Other: Observational<br>* It is an observational study, and no intervention will be provided.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychophysical health related events | psychophysical health related events will be collected by web-based questionnaire and hospital information system. | From 2010 to 2022 | 
| mental health | National Aeronautics and Space Administration Task Load Index was used to evaluate the mental workload every year. | From 2020 to 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep quality | Pittsburgh sleep quality index was used to evaluate the sleep quality every year. | From 2020 to 2022 | 
| social support | Self developed perceived social support scale was used to evaluate the level of social support every year. | From 2020 to 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psychophysical health, career development, stress, metabolic indexes
Short Term Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Confirm the inhibitory effect of recombinant human insulin-like growth factor I (IGF-I) on insulin secretion in children with hyperinsulinism. II. Define the effects of short term IGF-I therapy on postprandial blood sugar levels in this patient population. III. Characterize the effects of short term IGF-I therapy on fasting behavior, and other insulin dependent parameters, in this patient population.

Detailed Description
-----------------
PROTOCOL OUTLINE: Octreotide and/or diazoxide are discontinued on day 1, and fasting blood glucose is monitored. Patients receive test meals of Sustacal on days 3 and 4 and are assessed for insulin response. Beginning on day 5, patients are given recombinant human insulin-like growth factor I subcutaneously every 12 hours for a total of 3 doses. The first dose (on day 5) is given 30 minutes before a Sustacal challenge, the second dose is followed by a bedtime snack, and the third dose (on day 6) is followed by a supervised fast.

Conditions
-----------------
Hyperinsulinism

Intervention / Treatment
-----------------
* Drug: recombinant human insulin-like growth factor I


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of hyperinsulinism (i.e. evidence of fasting hypoglycemia with inadequate suppression of insulin, normal pituitary and adrenal function, and increased insulin action) Suboptimal control of blood sugar (i.e. inability to fast at least 10 hours with a blood sugar of 60 mg/dL or greater) No suspected insulinoma Must be currently managed on a regimen of diazoxide, octreotide and/or frequent feedings to control hypoglycemia --Prior/Concurrent Therapy-- See Disease Characteristics --Patient Characteristics-- Hematopoietic: No anemia or other concerns of blood volume depletion Renal: No renal dysfunction Other: No known malignancy No other major medical conditions

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: recombinant human insulin-like growth factor I|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endocrine disorders, hyperinsulinism, rare disease
The Impact of Memantine on Electroconvulsive Therapy (ECT): Will it Improve Response and Protect Against Cognitive Problems?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether memantine will enhance the therapeutic of effect on depression and prevent memory and other cognitive problems caused by ECT.

Detailed Description
-----------------
Patients will be assigned randomly either to a treatment group or a placebo groups. All patients in both groups will be receiving standard ECT. The treatment group will receive memantine. All patients will be given a battery of cognitive tests and test of depression before ECT treatments start, after the 6th ECT treatment and after the completions of ECT. An analysis will be performed to see if memantine causes any impact on the response to ECT and prevents memory and cognitive impairment.

Official Title
-----------------
Memantine Augmentation of Electroconvulsive Therapy in Patients With Major Depression

Conditions
-----------------
Major Depressive Disorder

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets criteria for Major Depressive disorder Exclusion Criteria: Neurological disease Mental retardation Seizure disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Memantine arm<br>Patient receiving ECT and Memantine | Drug: memantine<br>* patient will receive 5mg daily for 7day then 10 mgm daily<br>* Other names: Namenda;|
| Placebo Comparator: placebo<br>25 patients receiving ECT will will receive placebo | Drug: memantine<br>* patient will receive 5mg daily for 7day then 10 mgm daily<br>* Other names: Namenda;Drug: Placebo<br>* will give placebo that looks like memantine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of whether Memantine protects memory and cognitive impairment caused by ECT. |  | 6 to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether memantine will improve response of Depression to Electroconvulsive therapy. |  | 6-8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
electroconvulsive therapy, memantine, cognitive function, memory
Implant-Associated P. Aeruginosa Bone And Joint Infections : Experience In A Regional Reference Center In France

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to describe the bone or joint infection due to Pseudomonas aeruginosa in patients having implant.

Official Title
-----------------
Implant-Associated P. Aeruginosa Bone And Joint Infections : Experience In A Regional Reference Center In France

Conditions
-----------------
Bone and Joint Infection

Intervention / Treatment
-----------------
* Other: Bone or joint infection due to Pseudomonas aeruginosa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients having BJI on implant caused by Pseudomonas aeruginosa Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Description of BJI due to Pseudomonas aeruginosa<br>patients having bone and joint infection on implant due to Pseudomonas aeruginosa | Other: Bone or joint infection due to Pseudomonas aeruginosa<br>* Description of bone or joint infection on implant due to Pseudomonas aeruginosa<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description and rate of bone or joint infection on implant caused due to Pseudomonas aeruginosa | Description of the type of infection due to P. aeruginosa : patients and type of implant, profile of the bacterium, medical and chirurgical treatment, rate | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events occurring under medical treatment against Pseudomonas aeruginosa | description of adverse events occurring under medical treatment against Pseudomonas aeruginosa in BJI | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption) | 
| Rate of Treatment Failure | Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption) |
Evaluation of Partial and Total Femoral Replacement

Study Overview
=================
Brief Summary
-----------------
Several surgical options for the reconstruction of massive bone defects have been described and include biologic methods with autografts and allografts, and the use of tumor endoprostheses (total femoral replacement, TFR). Several types of modular TFR are available, but nevertheless unpredictable outcomes and high complication rates have been described from most authors. The aim of the present study was to compare complication rates after TFR performed with modular total femur prosthesis MML (Fa. ESKA/Orthodynamics) in patients with and without malignant disease.

Official Title
-----------------
Evaluation of Partial and Total Femoral Replacement Treated in a Single Orthopedic Centre

Conditions
-----------------
Survival, Prostheses

Intervention / Treatment
-----------------
* Device: MML (Fa. ESKA/Orthodynamics)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total or partial femoral replacement Exclusion Criteria: Failure of device

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with TFR<br>Patients treated with TFR for oncologic or non-oncologic reason | Device: MML (Fa. ESKA/Orthodynamics)<br>* Classification of complications according to MSTS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of device | Any device-related complications are defined failure | 2 years |