linjc16/ctgov huggingface dataset:
The Safety and Feasibility of MONOFIX on Fascial Closure of Mid-line Wound After Minimally Invasive Colorectal Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
This clinical trial aims to evaluate the safety and feasibility of mid-line fascial suturing using MONOFIX sutures in patients undergoing minimally invasive surgery for colorectal cancer.

Official Title
-----------------
Exploratory Clinical Trial for Evaluating the Safety and Efficacy of MONOFIX® on Fascial Closure of Mid-line Wound for Patients With Colon Cancer Underwent Minimally Invasive Surgery: Single-center, Non-blinded, and Single-arm Design

Conditions
-----------------
Colon Cancer, Rectal Cancer, Colon Adenocarcinoma, Rectal Adenocarcinoma

Intervention / Treatment
-----------------
* Device: Monofix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Colorectal adenocarcinoma Elective (or planned) curative surgery Laparoscopic surgery Midline incision less than 10 cm Exclusion Criteria: Previous laparotomy with midline incision more than 10cm. Systemic chemotherapy for any cause within the last 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monofix<br>In patients who underwent laparoscopic colorectal cancer surgery, the fascial closure of the midline incision was performed using a running suture type with Monofix, one of the barbed sutures. | Device: Monofix<br>* a new absorbable barbed suture device<br>|
| No Intervention: Control group<br>In patients who underwent laparoscopic colorectal cancer surgery, the fascial closure of the midline incision was performed using an interrupted suture type with PDS-II, one of the monofilament sutures. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisional hernia | Incisional hernia diagnosed by CT scan. | 18 months from surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound infection | In cases where microorganisms were identified in the wound culture results. | 1 month from surgery | 
| Wound bleeding | In cases where bleeding was visually observed from the wound or a hematoma was observed on the CT scan. | 1 month from surgery | 
| Wound dehiscence | In cases where the fascial closure was incomplete, causing part of the abdominal organs to protrude outside the abdomen, requiring surgical treatment. | 1 month from surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barbed suture, minimally invasive surgery
Molecular Analysis of the Sloane Project

Study Overview
=================
Brief Summary
-----------------
The Sloane Project is a UK wide prospective audit of screen detected non-invasive and atypical breast hyperplasias named after John Sloane an eminent pathologist interested in the field. Non invasive breast neoplasia accounts for 25% of all 'breast cancers' detected through breast screening and includes ductal carcinoma in situ (DCIS) and lobular carcinoma in situ (LCIS). Atypical hyperplasias are high risk but benign lesions found in 10% of benign biopsies performed through the NHS breast screening programme. The importance of these lesions rests on the increased risk of subsequently developing invasive breast cancer, with DCIS at highest risk (20 times greater than the general population) followed by LCIS (10 times greater) and atypical breast hyperplasia (4 times greater). The Sloane Project data are held by Public Health England (PHE) and provide full and detailed information about the patients' journey from diagnosis to treatment and outcome. The project aims to increase the understanding of how best to manage these early lesions which can lead to breast cancer. All NHS breast screening units in the UK are invited to submit data for the Sloane Project. Historically an exceptional  90% of centres in England, Scotland, Wales and Northern Ireland have participated on a voluntary basis. The objective of this research protocol is the collection of anonymised formalin fixed paraffin embedded (FFPE) tissue blocks from women whose data is held within the Sloane Project database in order to allow detailed analysis of the biological, molecular and genomic changes in these cases of in situ carcinoma and atypical hyperplasia and how these relate to the corresponding annotated clinical, pathological and radiological data already collected by and held in PHE. We seek to identify particular signature(s) that define which patients are likely to develop invasive disease, distinguishing the worrisome from indolent, non-worrisome lesions.

Official Title
-----------------
Molecular Analysis of Screen Detected Non-invasive Breast Cancer and Atypical Breast Hyperplasias Identified by the Sloane Project

Conditions
-----------------
DCIS, LCIS, Atypical Ductal Hyperplasia, Atypical Lobular Hyperplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DCIS (Ductal Carcinoma in situ) LCIS (Lobular Carcinoma in situ) Atypical hyperplasias
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 |
| --- | --- | --- |
| Progression of breast disease |  | From diagnosis to end of 2016 |
Efficacy of T-Dxd in the Treatment of HER2-positive BCBM After Prior Pyrotinib

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain metastases after treatment with pyrotinib

Official Title
-----------------
Efficacy and Safety of T-Dxd in the Treatment of HER2-positive Breast Cancer With Brain Metastases After Prior Pyrotinib Treatment

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: T-DXd


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) Women ≥18 years of age :(2) pathological diagnosis of HER2-positive breast cancer, defined as positive immunohistochemistry detection (+++) or FISH(Fluorescent In Situ Hybridization); (3) Imaging evidence of brain metastases; (4) Progression of brain metastases after prior treatment with pyrotinib, defined as progression of new or pre-existing brain metastases during treatment with pyrotinib; (5)ECOG score ≤3 points; (6) The efficacy of T-DXd should be evaluated at least once after treatment; (7) Bone marrow and organ functions are basically normal; (8) Complete medical records Exclusion Criteria: Has uncontrolled or significant cardiovascular disease Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: T-DXd|Efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain metastases after treatment with pyrotinib|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central neryous system Progression Free Survival，CNS-PFS | The interval from the start of treatment to the onset of disease progression or death from any cause in the intracranial lesions | 3years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR)for intracranial and extracranial lesions | Percentage of patients with CompleteResponse (CR) and partial response (PartialResponse (PR) | 3years | 
| Overall Clinical Benefit Rate (CBR) for intracranial and extracranial lesions | Percentage of patients with complete response, partial response, and StableDisease (SD)≥6 months | 3years | 
| Overall survival (Oversall Survival, OS) and security | The interval between the start of treatment and death from any cause | 5years |
Correlation of Angle Kappa , Corneal High Order Aberrations and Total Eye Aberrations in Various Refractive Errors

Study Overview
=================
Brief Summary
-----------------
Identification of the correlation between angle kappa , corneal high order aberrations and total eye aberrations in myopic hyperopic and astigmatic patients

Detailed Description
-----------------
The patient will be thoroughly examined clinically on slit lamp detailed history will be obtained visual acuity will be measured and patient refraction will be taken then imaging on Sirius topographer will be used to obtain angle Kappa and high order aberrations of the cornea and I-design pentacam imaging will be used to get the total aberrations of the eye

Official Title
-----------------
Correlation of Angle Kappa , Corneal High Order Aberrations and Total Eye Aberrations in Various Refractive Errors

Conditions
-----------------
Aberration, Corneal Wavefront

Intervention / Treatment
-----------------
* Device: Pentacam Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with errors of refraction above the age of 18 No history of trauma. No other ocular disease . Exclusion Criteria: patient under age of 18 patients with systemic disease. patient with corneal diseases Patient who did any sort of occular surgery patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| myope<br>Patients with myopia | Device: Pentacam Imaging<br>* Imaging of the corneal surface<br>|
| Hypermetrope<br>Patients with hypermetropia | Device: Pentacam Imaging<br>* Imaging of the corneal surface<br>|
| Astigmatic<br>Patients with Astigmatism | Device: Pentacam Imaging<br>* Imaging of the corneal surface<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between angle Kappa and high order aberrations of the cornea and total aberrations of the eye in various refractive errors | does the refraction affect the angle kappa or the corneal high order aberrations or the total aberrations of the eye | baseline |
Intermediate-Size Expanded Access Protocol (EAP) for LP352

Study Overview
=================
Brief Summary
-----------------
This is an intermediate-size expanded access program (EAP) study. The purpose of this EAP is to provide continued access to LP352, an investigational drug product being investigated in patients with Developmental and Epileptic Encephalopathies (DEEs). The EAP study will allow continued treatment with LP352 for eligible patients diagnosed with treatment resistant DEEs who successfully completed an LP352 Clinical Trial (Enrollment by Invitation).

Official Title
-----------------
Expanded Access Treatment With LP352 for Patients With Developmental and Epileptic Encephalopathies (DEEs) Who Successfully Completed an LP352 Clinical Trial (Intermediate-Size EAP)

Conditions
-----------------
Dravet Syndrome, Lennox Gastaut Syndrome, Developmental and Epileptic Encephalopathies

Intervention / Treatment
-----------------
* Drug: LP352


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient and/or patient's legally authorized representative is willing and able to provide a written informed consent or assent form before participation in this EAP. An assent should be obtained from the patient, if possible. Assent must be obtained for adolescent EAP patients (<18 years of age) as required by local regulations. Patient with DEE who has successfully completed an LP352 Clinical Trial. Patient currently has clinical benefit from LP352 treatment, as assessed by their Treating Physician. Patient currently tolerates LP352 treatment and has no safety issue which would prevent continued treatment. Exclusion Criteria: Patient was discontinued from an LP352 Clinical Trial for any reason. Any serious and/or unstable new medical condition, psychiatric disorder, or other conditions at the time of transition to this EAP that could interfere with patient's safety, obtaining informed consent, assent, or compliance to this EAP protocol, in the opinion of the Treating Physician.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LP352|LP352 will be administered as a liquid either orally or through a G-tube or PEG tube.|

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
-----------------
epilepsy, Dravet Syndrome, Lennox Gastaut Syndrome, treatment resistant epilepsy, CDKL5 deficiency disorder, developmental and epileptic encephalopathy, tuberous sclerosis complex
Role of Abbreviated MRI in Follow-up of Hepatocellular Carcinoma .

Study Overview
=================
Brief Summary
-----------------
Role of ADC value and DWI in abbreviated MRI compared to post-contrast CT in follow-up of HCC after TACE.

Detailed Description
-----------------
Hepatocellular carcinoma (HCC) is the 5th most common cancer in the world and the most common in Egypt . Trans-arterial chemoembolization (TACE) is the treatment recommended for unresectable HCC according to Barcelona clinic liver cancer staging and is widely used . HCC is nourished only by the hepatic artery, so TACE causes ischemia and coagulative necrosis. However; viable neoplastic tissue residual may be seen after TACE. Assessment of post-TACE tumor response is important in determining treatment success and in guiding future therapy . Many studies have assessed the diagnostic performance of multiphasic contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI) in diagnosis of HCC with noted higher sensitivity of MRI compared to CT. CT or MRI are recommended for assessment of response after treatment as well . Diffusion-weighted imaging (DWI) and apparent diffusion coefficient (ADC) are functional MRI techniques that detect signal changes in tissues due to water proton motion. The intact membranes of viable tumor cells restrict water diffusion, whereas necrotic tumor cells with disrupted cell membranes exhibit increased water diffusion and which differentiate the biological activity of HCC

Official Title
-----------------
Role of Abbreviated MRI in Follow-up of Hepatocellular Carcinoma Following Locoregional Treatment.

Conditions
-----------------
Hepatocellular Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent TACE for unresectable HCC with patent portal vein based on Doppler, no ascites, and satisfactory liver function. Age between 20-year old and 85-year old Exclusion Criteria: Estimated GFR less than 60 Previous history of severe allergic reaction to the iodinated contrast agent Patients with claustrophobia who can't undergo MR examination. Patients having cochlear implants or cardiac pacemaker

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between tumor enhancement in arterial phase expressed as Hounsfield unit number and ADC value. | correlation between tumor enhancement in arterial phase expressed as Hounsfield unit number and ADC value. | Baseline |
Correlation Between Serum Uric Acid and Pulmonary Hypertension in Obstructive Sleep Apnea Syndrome

Study Overview
=================
Brief Summary
-----------------
This study aimed to correlate serum uric acid levels and PAH in OSAHS patients.

Detailed Description
-----------------
Obstructive sleep apnea-hypopnea syndrome is the most common form of SRBDs. Recurrent hypoxia, that accompanies OSAHS increases the degradation of ATP, which in turn increase uric acid concentration that can be used as a biomarker of tissue hypoxia in OSAHS. There is still debate about whether OSAHS is an independent contributor to pulmonary arterial hypertension. AIM OF THE WORK This study aimed to correlate serum uric acid levels and PAH in OSAHS patients. Methods We enrolled 100 patients diagnosed with OSAHS using polysomnography. Patients were divided into three severity groups: mild OSA (5 ≤ AHI < 15), moderate OSA (15 ≤ AHI < 30), and severe (30 ≤ AHI < 60). Serum uric acid was measured the morning after polysomnography. All patients underwent standard echocardiograms, and Pulmonary artery systolic pressure calculation was done.

Official Title
-----------------
Correlation Between Serum Uric Acid and Pulmonary Arterial Hypertension Based on Echo Probability in Patients With Obstructive Sleep Apnea Syndrome

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Diagnostic Test: polysomnography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of OSAHS by overnight polysomnography (AHI ≥ 5/ hr) ≥18 years old. Exclusion Criteria: Other sleep disorders as narcolepsy or hypersomnia were excluded as well as Patients with neuropsychiatric disorders. Hemodynamically unstable patients Patients with other chronic respiratory or cardiac diseases Patients with other known causes of pulmonary hypertension Patients with any disease or on medication that could alter excretion or urinary metabolism of uric acid such as Excessive uric acid production

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with Obstructive sleep Apnea<br>Patients with Obstructive sleep Apnea | Diagnostic Test: polysomnography<br>* polysomnography and serum uric acid measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study aimed to correlate serum uric acid levels and Pulmonary Arterial Hypertension in Obstructive Sleep Apnea Hypopnea Syndrome patients. | This study aimed to correlate serum uric acid levels and Pulmonary Arterial Hypertension in Obstructive Sleep Apnea Hypopnea Syndrome patients. | one Year |
A Study to Investigate the Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency

Study Overview
=================
Brief Summary
-----------------
The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.

Detailed Description
-----------------
The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.

Official Title
-----------------
The Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency: An Open-label, Single-arm, Multicenter Phase 3 Study

Conditions
-----------------
GHD

Intervention / Treatment
-----------------
* Drug: PEG-somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Investigator-determined diagnosis of GHD prior to the historical initiation of daily rhGH trerapy Participant must be 6 months to 17 years old Tanner stage <5 at Visit 1 Open epiphyses Normal fundoscopy at Screening Written, signed, informed consent of the participant's parent(s)/LAR(s) and written assent of the participant Exclusion Criteria: History or presence of malignant disease Children with diabetes mellitus Major medical conditions and/or presence of contraindications to GH treatment Pregnancy Participation in any other study of an investigational agent within three months prior to Visit 1 Prior exposure to investigational drug or any other long-acting growth hormone Any other reason per investigator's discretion

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 17 Years

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

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: GenSci004<br> | Drug: PEG-somatropin<br>* PEG-somatropin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events of once-weekly GenSci004 in children with GHD | Incidents of adverse events | 108 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized Height Velocity (AHV) | Measured in centimeter per year (cm/year) | 104 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GHD, growth hormone deficiency