linjc16/ctgov huggingface dataset:
Dynamic Scaffold Versus Lichtenstein Open Hernioplasty.

Study Overview
=================
Brief Summary
-----------------
Evaluating the outcomes of patients undergoing open anterior inguinal hernioplasty comparing two different techniques: Lichtenstein/plug and mesh and ProFlor. The outcomes of these two groups of patients, respectively the Lichtenstein inguinal hernia repair with static flat mesh and the defect obliteration with 3D dynamic scaffold Proflor, are compared in respect to defined variables along stages: intraoperative, early and long term postoperative.

Official Title
-----------------
The DySLOH Study: Dynamic Scaffold Versus Lichtenstein Open Hernioplasty. A Comparative Outcome Assessment Between the Two Techniques.

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

Intervention / Treatment
-----------------
* Procedure: inguinal hernia repair with mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients were individuals aged between 18 and 85 years old, competent to give consent, affected by clinically relevant primary inguinal hernia scheduled to undergo elective inguinal hernia repair and eligible for outpatient surgical procedure with local anesthesia. Exclusion Criteria: Recurrent inguinal hernia Incarcerated inguinal hernia Hernia not in the inguinal area Signs of obvious local or systemic infection ASA score > 4 Presenting with unstable angina or NYHA class of IV Pregnant Active drug user Immunosuppression, chemotherapy Chronic renal insufficiency Abdominal ascites Infection in area of the surgical field BMI >35

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ProFlor<br>patients underwent to inguinal hernia repair with use of ProFlor dynamic scaffold | Procedure: inguinal hernia repair with mesh<br>* inguinal hernia repair with mesh<br>|
| Active Comparator: Lichtenstein<br>patients underwent to Lichtenstein inguinal hernia repair | Procedure: inguinal hernia repair with mesh<br>* inguinal hernia repair with mesh<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early postoperative complications | bleeding, hematoma and infections | 30 days after surgery | 
| patients clinical outcome | VAS score | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of quality of life during the postoperative period | Carolina Comfort Scale - CCS | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inguinal hernia repair, ProFlor technique, lichtenstein hernia repair
Evaluation of TIP Urethroplasty With Spongioplasty-Dartosoraphy Reinforcement in Pediatric Hypospadias

Study Overview
=================
Brief Summary
-----------------
The study aimed to evaluation of Tubularized incised palate urethroplasty with spongioplasty-dartosoraphy reinforcement (group A) through comparing of functional and cosmetic results of this technique with the conventional TIP urethroplasty (group B).

Official Title
-----------------
Evaluation of TIP Urethroplasty With Spongioplasty-Dartosoraphy Reinforcement in Pediatric Hypospadias

Conditions
-----------------
Hypospadias, Complication,Postoperative

Intervention / Treatment
-----------------
* Procedure: Tubularized Incised Plate (TIP) urethroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lees than 14 years Distal hypospadias urethral plate size more than 6mm glans size more than 14 mm Exclusion Criteria: recurrent cases Proximal; hypospadias

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 14 Years

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

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 |
| --- | --- |
| Active Comparator: Group with Spongioplasty<br>patients underwent TIPU with spongioplasty-Dartosoraphy reinforcement | Procedure: Tubularized Incised Plate (TIP) urethroplasty<br>* tubularization of urethral plate with or without spongioplasty<br>|
| Active Comparator: Group without Spongioplasty<br>patients underwent TIPU with dorsal dartos flap interposition without spongioplasty | Procedure: Tubularized Incised Plate (TIP) urethroplasty<br>* tubularization of urethral plate with or without spongioplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urethrocutaneous fistula | Rate of fistula | 12 months | 
| meatal stenosis | Rate of metal stenosis | 12 months | 
| glans dehiscence | Rate of glans dehiscence | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TIPU, Distal and midpenile hypospadias, Spongioplasty-dartosoraphy, pediatric HOSE
SMCV Assessment on Brain Swelling in Patients With SAH From Ruptured Artery Aneurysm

Study Overview
=================
Brief Summary
-----------------
Superficial cerebral veins findings in assessment of brain swelling in patients with aneurysmal subarachnoid hemorrhage who underwent intravenenous DSA examinations

Detailed Description
-----------------
Superficial cerebral veins findings in assessment of brain swelling in patients with aneurysmal subarachnoid hemorrhage who underwent intravenenous DSA examinations.To explore the relationship between the structure of middle and superficial cerebral veins in cerebral angiography and cerebral edema after ischemia-reperfusion of anterior circulation with large core infarction.

Official Title
-----------------
Assessment of Superficial Cerebral Venous Structures in Brain Swelling in Patients With Subarachnoid Hemorrhage From Anterior Communicating Artery Aneurysmal

Conditions
-----------------
Arterial Aneurysm

Intervention / Treatment
-----------------
* Radiation: Cerebral Venography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: age 18-70 years; Hunt-Hess grade IV-V on admission; single aneurysm in the anterior circulation; interventional embolization of aneurysm is the first choice, and preoperative ventricular puncture drainage and intracranial pressure probe placement. Exclusion criteria: Hunt-Hess grade I-III on admission; patients with blood bubble-like aneurysm or accompanying intracranial hematoma who are not suitable for interventional embolization; those who directly choose craniotomy and clipping; poor general condition or combined with pregnancy , malignant tumors, etc.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Whole-brain venography<br>Cerevbral venography | Radiation: Cerebral Venography<br>* Cerebral Venography Observation by DSA examinations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Death | One year | 
| Bleeding events | Intracerebral Hemorrhage | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain swelling | Brain swelling score | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain Swelling,Subarachnoid Hemorrhage,Artery Aneurysmal
RC48-ADC in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) in patients with breast cancer.

Official Title
-----------------
Disitamab Vedotin (RC48-ADC) in Patients With Breast Cancer: a Real World Study

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

Intervention / Treatment
-----------------
* Drug: Disitamab vedotin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed breast cancer; Prior or current use of Disitamab vedotin (RC48-ADC); Exclusion Criteria: Participating in clinical trials involving Disitamab vedotin (RC48-ADC) or not.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RC48-ADC<br>RC48-ADC for breast cancer | Drug: Disitamab vedotin<br>* recommended but not required regimen of 2.0mg/kg, iv, day1, every 2 weeks<br>* Other names: RC48-ADC;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival | The time from the date of starting Disitamab Vedotin to the date of disease progression as per RECIST version 1.1 or death from any cause, whichever occurs first. | From the date of starting Disitamab vedotin to the date of first documentation of progression or death (up to approximately 1 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Adverse events during Disitamab Vedotin regimen will be assessed according to the NCI CTCAE v5.0. | From the date of starting Disitamab vedotin to the end of the treatment (up to approximately 1 year) |
Demographics, Characteristics and Outcomes of Male Breast Cancer Patients at Methodist Health System

Study Overview
=================
Brief Summary
-----------------
To determine the number of MBC cases as well as the demographics, characteristics, and outcomes of MBC patients at Methodist Health System (MHS).

Detailed Description
-----------------
Male breast cancer (MBC) is a rare disease without sufficient clinical data supporting the management and treatment. The treatment of MBC arises from data extrapolated from female breast cancer (FBC). MBC has higher mortality than FBC. Previous studies have suggested differences between MBC and FBC; however, treatments remain the same for both. Larger studies in MBC are needed to provide more clinical data to help guide treatment.

Official Title
-----------------
Demographics, Characteristics and Outcomes of Male Breast Cancer Patients at Methodist Health System

Conditions
-----------------
Male Breast Cancer Patients

Intervention / Treatment
-----------------
* Procedure: managing Male Breast Cancer Patients at Methodist Health System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • ≥ 18 years of age Patients diagnosed with ductal carcinoma in situ or invasive lobular carcinoma of the breast Exclusion Criteria: 18 years of age Prisoners Pregnant or breastfeeding

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: managing Male Breast Cancer Patients at Methodist Health System|To determine the number of MBC cases as well as the demographics, characteristics, and outcomes of MBC patients at Methodist Health System (MHS).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis Rates of patients with MBC and FBC | complications of treatment | 13 years | 
| Recurrence rates of Patients with MBC and FBC | Recurrence rates of Patients with MBC and FBC | 13 years | 
| Duration of remission in Patients with MBC and FBC | Duration of remission in Patients with MBC and FBC | 13 years | 
| The Overall Survival of patients with MBC and FBC after receiving treatment | The Overall Survival of patients with MBC and FBC after receiving treatment | 13 years | 
| Determine the complications of Treatment in patients with MBC and FBC | Determine the complications of Treatment in patients with MBC and FBC | 13 years |
Clinical Effect Evaluation of Laparoscopic Surgery for Ovarian Benign Tumors by Different Approaches

Study Overview
=================
Brief Summary
-----------------
Main purpose: To compare the intraoperative and postoperative recovery of laparoscopic surgery for ovarian benign tumors through different approaches; Secondary objective: Will vNOTES increase the risk of cesarean section during pregnancy and affect the quality of sexual life after surgery.

Official Title
-----------------
Clinical Effect Evaluation of Laparoscopic Surgery for Ovarian Benign Tumors by Different Approaches

Conditions
-----------------
Laparoscope, Malignant Ovarian Tumor, Single-site Surgery

Intervention / Treatment
-----------------
* Procedure: operation ways


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preoperative consideration was for benign ovarian tumors requiring surgical treatment. Exclusion Criteria: (1) Ovarian malignant tumor or borderline tumor was considered before surgery or proved during surgery. (2) Severe endometriosis, previous severe pelvic inflammation, peritonitis, and other serious pelvic adhesions are considered. (3) Pregnancy status. (4) Postoperative follow-up is not convenient and lost visitors.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| multi-port laparoscopic surgery<br> | Procedure: operation ways<br>* nothing<br>|
| transumbilical laparoendoscopic single-site surgery<br> | Procedure: operation ways<br>* nothing<br>|
| vaginal natural orifice transluminal endoscopic surgery<br> | Procedure: operation ways<br>* nothing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peroperative bleeding | peroperative bleeding | during the operation time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative exhaust time | postoperative exhaust time | within 3 days after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transumbilical laparoendoscopic single-site surgery,Giant malignant ovarian tumor
Smoking Cessation in a Cohort HIV+ Rio de Janeiro, Brazil.

Study Overview
=================
Brief Summary
-----------------
The study was carried out within a large, urban prospective cohort of PLHIV at the Instituto Nacional de Infectologia Evandro Chagas (INI). Located in Rio de Janeiro, Brazil, INI is a national public referral center for PLWHA receiving primary care since 1998. From December 2019, adults who had attitudes toward quitting smoking and had no contraindications to study pharmacotherapy were enrolled by active site searching

Official Title
-----------------
Smoking Cessation is Associated With Short-term Improvement of Vascular Health in a Cohort of People Living With HIV in Rio de Janeiro, Brazil.

Conditions
-----------------
Smoking Cessation, Brachial Flow Mediated Dilatation, Nicotine Replacement Therapy

Intervention / Treatment
-----------------
* Drug: Nicotine replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: individuals were deemed as regular smokers, defined as the consumption of one or more pack (20 cigarettes) per week in the past 6 months, and expired carbon monoxide (CO) measurement > 10 ppm at the screening visit. Exclusion Criteria: previous use of transdermal nicotine patches or bupropion in the last 6 months; (ii) contraindication to nicotine patches; (iii). Pregnancy; (iv) breastfeeding

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Relapse | Drug: Nicotine replacement<br>* Nicotine patches<br>|
| Group 2<br>Smoking cessation | Drug: Nicotine replacement<br>* Nicotine patches<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FMD | Flow mediated brachial artery dilatation | 12 months |
A Preoperative Model to Predict the Lymphovascular Invasion in Pancreatic Ductal Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
Importance: Lymphovascular invasion (LVI) is a poor prognosis pathologic feature in pancreatic ductal adenocarcinoma (PDAC) patients. Neoadjuvant therapy may bring survival benefits to these patients. Objective: To construct a preoperative model which could predict LVI in PDAC patients and further validate it in other cohorts. Design, Setting, and Participants: Patients from 3 three tertiary hospitals were included in this study. Univariate and multivariate Logistic regression analyses were conducted to define independent prediction factors of LVI. A nomogram was constructed based on the result of multivariate analysis.The predictive value of the model was assessed using receiver operating characteristic (ROC) curves and the maximum Youden index of the ROC curve was defined as the cut-off point. The calibration plot was utilized to assess the concordance of the model. The decision curve analyses (DCA) were applied to estimate the clinical benefit of using this model to predict LVI.

Official Title
-----------------
Development and Validation of a Preoperative Model to Predict the Lymphovascular Invasion of Pancreatic Ductal Adenocarcinoma: a Multicenter Retrospective Study

Conditions
-----------------
Predictive Cancer Model, Pancreas Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were pathologically diagnosed as PDAC and received curative surgery. Exclusion Criteria: Patients with distant metastasis; Patients who received neoadjuvant therapy; Patients with a survival time of less than 1 month.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free survival | Time from operation to the detection of recurrence or last follow-up | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time between surgical resection to death or the last follow-up. | 10 years |
Acute Clinical Outcomes of Hemorrhagic Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Acute clinical outcomes 1. Mortality 2. Arrhythmia 3. Readmission 4. CVA 5. ADHF

Official Title
-----------------
Acute Clinical Outcomes of Hemorrhagic Myocardial Infarction

Conditions
-----------------
Acute Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-85 years of age Primary PCI Post-PCI cardiac biomarker labs

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Prevalence of acute mortality | 30-days and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute heart failure | Prevalence of acute heart failure | 30-days and 6 months | 
| Arrhythmia | Prevalence of acute arrhythmia | 30-days and 6 months |
HOme USability Evaluation

Study Overview
=================
Brief Summary
-----------------
To validate the usability and safety of the Liberty Analyser.

Official Title
-----------------
HOme USability Evaluation

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Device: Entia Liberty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing systemic anti-cancer therapy (SACT) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2 at enrolment Adequate English language skills (not requiring a translator) to participate in participant training and use the Entia Liberty analyser Patients capable of providing written informed consent Exclusion Criteria: History or current diagnosis of haematological malignancy Patients with eyesight or hearing limitations or other disabilities that preclude the use of the Entia Liberty analyser or participation in training Inadequate use and understanding of the English language, requiring a translator

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 |
| --- |
|Device: Entia Liberty|Home monitoring|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Entia Liberty Analyser is easy to use | Users can easily carry out a test using the Entia Liberty Analyser | Through study completion, 1 day | 
| The Entia Liberty Analyser is safe to use | Results obtained using the Entia Liberty Analyser are valid and reliable | Through study completion, 1 day |