linjc16/ctgov huggingface dataset:
Laparoscopic Versus Open Incisional Hernia Repair

Study Overview
=================
Brief Summary
-----------------
Primary closure of incisional hernia without the use of a mesh shows recurrence rates of up to 54%. If a mesh is used, the defect can be closed tension-free. Using this method, recurrence rates have been reduced to 8-21%. Laparoscopic correction of incisional hernia is a relatively new technique in which the mesh is positioned intraperitoneally. Research has shown that this procedure is technical feasible and may have benefits for the patients. The ongoing debate about the merits of endoscopic versus open incisional hernia repair prompts the need for a level 1 randomized controlled trial.

Official Title
-----------------
Laparoscopic Versus Open Incisional Hernia Repair : A Randomized Clinical Trial

Conditions
-----------------
Postoperative Pain, Complications, Recurrence

Intervention / Treatment
-----------------
* Procedure: incisional hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hernia diameter between 3 and 15 cm location at the ventral abdominal wall at least 5cm from costae and inguinal area indication for elective repair age of 18 years or older written informed consent. Exclusion Criteria: contraindication for pneumoperitoneum an absolute contraindication for general anesthesia history of open abdomen treatment patients participating in other trials

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: open<br>open incisional hernia repair | Procedure: incisional hernia repair<br>* Tension-free open or laparoscopic incisional hernia repair<br>|
| Active Comparator: laparoscopic<br>laparoscopic incisional hernia repair | Procedure: incisional hernia repair<br>* Tension-free open or laparoscopic incisional hernia repair<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative analgesics use |  | 1 week | 
| complications |  | 4 weeks | 
| operation time |  | 1 day | 
| length of hospital stay |  | 4 weeks | 
| recurrence |  | 5 years | 
| mortality |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
operation time, length of hospital stay
Efficacy of Microcurrent Therapy for Treatment of Knee Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of microcurrent therapy at the knee pain.

Official Title
-----------------
Efficacy of Microcurrent Therapy for Treatment of Knee Pain

Conditions
-----------------
Acute Knee Pain

Intervention / Treatment
-----------------
* Device: Microcurrent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pain perceived as a minimum of 3/10 on a 0-10 pain scale No phobia of electrical stimulation No pain or anti-inflammatory medication will be taken during study Injury that began prior to 6-weeks ago before the onset of pain Grade II soft tissue injury Exclusion Criteria: Pregnancy Diabetes Mellitus Neuropathy Smoker Uncontrolled HTN Past surgery in the region to be treated by microcurrent Arthritis (RA) in the area to be treated by microcurrent Cardiovascular disease Allergic to tape/electrodes Ligament injury Patella Femoral Pain Syndrome (Anterior knee pain) Dementia Grade III soft tissue injury

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: microcurrent<br> | Device: Microcurrent<br>* Micrucurrent will be apply<br>|
| Sham Comparator: control<br> | Device: Microcurrent<br>* Micrucurrent will be apply<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain scale (NRS) for pain (0-10) |  | 4weeks |
Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
CP-675,206 (tremelimumab) is a fully humanized monoclonal antibody that binds to activated T lymphocytes and by enhancing their activation may produce a stimulation of the immune response against tumoral or viral antigens. In this clinical trial, the ability of tremelimumab to produce tumor responses among hepatitis C virus-infected patients with hepatocellular carcinoma not amenable to other therapies will be explored. Besides, the effect on the replication of the virus will be analysed.

Official Title
-----------------
Phase II Trial of Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma, Hepatitis C Virus Chronic Infection

Intervention / Treatment
-----------------
* Biological: CP 675,206


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unequivocal diagnosis of HCC unresectable disease not amenable to locoregional treatment. a 4-week washout period after sorafenib or any other systemic agent a 2-month washout period after internal or external radiation HCV chronic infection Child-Pugh stage A or B Measurable disease according to RECIST criteria ECOG < 2 expected survival > 3 months Adequate liver, renal and blood functions ability to sign informed consent Exclusion Criteria: previous treatment with an anti-CTL-4 agent serious infections or disease compromising general health status autoimmune disease that requires therapy treatment with immunosuppressors treatment with investigational agents other neoplasms except skin and bladder superficial tumors pregnancy or lactation SNC metastasis HIV infection relevant heart disease (NYHA class III or IV)

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: CP 675,206|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response by Response Evaluation Criteria In Solid Tumors (RECIST) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Hepatitis C Virus (HCV) viral load |  |  |
Assessment of Blood Pressure Control and Target Organ Damage in Patients With Chronic Kidney Disease and Hypertension -II

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find the change of blood pressure (BP) control pattern (true controlled, white-coat, masked, and sustained uncontrolled/ dipper, non-dipper, reverse-dipper, and extreme-dipper) in patients with chronic kidney disease (CKD) over 3 years. And Other objective is the relationship between the BP control pattern and the target organ damages such as renal function, proteinuria, left ventricular hypertrophy (LVH), and so on. In addition, we will find clinical factors related to the BP control pattern.

Official Title
-----------------
Observational Study of Blood Pressure Control Pattern and the Impact on the Target Organ Damages

Conditions
-----------------
Hypertension, Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: with informed consent 20 <= age < 75 years diagnosed as hypertension 6 months (or 3 visits) prior to enrollment, taking anti-hypertensive drugs over 3 months all-cause chronic kidney disease patients with 15 <= estimated GFR < 90 no change of anti-hypertensive drugs within 2 weeks and good compliance Exclusion Criteria: changed prescription according to ambulatory blood pressure monitoring (ABPM) regularly had acute kidney injury/hospitalization had a proteinuria of > 6 g/day (spot urine protein to creatinine ratio > 6.0 g/g Cr) had end stage renal disease (ESRD) with dialysis and/or were a kidney recipient had diseases, such as uncontrolled arrhythmia, uncontrolled bronchial asthma/chronic obstructive pulmonary disease, or primary endocrinologic diseases except diabetes mellitus were pregnant/lactating women were night shift workers.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 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 |
| --- | --- |
| chronic kidney disease, hypertension<br>20 <= age < 75 years 15 <= estimated glomerular filtration rate (GFR) < 90 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of blood pressure control pattern in patients with CKD |  | 1 year after enrolling the last participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) target organ damages in kidney and heart |  | 1 year after enrolling the last participant | 
| 2) the relationship between the change of BP control pattern and the target organ damages |  | 1 year after enrolling the last participant | 
| 3) assessment of related clinical factors with BP control pattern |  | 1 year after enrolling the last participant |
An Observational Study For Ambrisentan

Study Overview
=================
Brief Summary
-----------------
The purpose of the programme is to collect safety data on ambrisentan when used in clinical practice

Detailed Description
-----------------
The purpose of the programme is to collect safety data on ambrisentan when used in clinical practice

Official Title
-----------------
A Post-Marketing Observational Surveillance Programme for Ambrisentan (VOLT)

Conditions
-----------------
Hypertension, Pulmonary

Intervention / Treatment
-----------------
* Drug: ambrisentan


Participation Criteria
=================
Eligibility Criteria
-----------------
subjects who have been prescribed ambrisentan for a medically appropriate use (see approved product label)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ambrisentan prescribed subjects<br>ambrisentan prescribed subjects | Drug: ambrisentan<br>* ambrisentan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety monitoring |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety monitoring |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Arterial Hypertesion, observational safety
Comparison of the Efficacy of Fractional Er:YAG Laser for Acne Scar

Study Overview
=================
Brief Summary
-----------------
Compare the efficacy of frational Er:YAG laser and that of bipolar frequency with diode laser treatment.

Detailed Description
-----------------
In acne scar treatment, ablational laser would be superior to nonablative laser treatment. Frational Er:YAG laser treatment is a effective treatment plan for acne scar without severe adverse effects.

Official Title
-----------------
Comparitive Study of Efficacy and Safety Between Fractional Er:YAG Laser and Bipolar Radiofrequency Treatment for Acne Scar

Conditions
-----------------
Scar

Intervention / Treatment
-----------------
* Procedure: Er:YAG laser
* Procedure: Bipolar radiofrequency with diode laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate acne scar Exclusion Criteria: taking steroids, nonsteroidal antiinflammatory drug, and isotretinoin anyone who received acne scar procedures within 6 months underlying diabetes mellitus, keloid, or malignancy

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Er:YAG laser<br>acne scar treatment using Er:YAG laser | Procedure: Er:YAG laser<br>* acne scar treatment using Er:YAG laser<br>|
| Active Comparator: Bipolar radiofrequency with diode laser<br>Bipolar radiofrequency with diode laser | Procedure: Bipolar radiofrequency with diode laser<br>* acne scar treatment with bipolar radiofrequency combined with diode laser<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global asessment of acne scar | 5 point grading of acne scar | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECCA | quantative assessement of acne scar | 12 weeks | 
| adverse effect assessment | adverse effect assessment | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acne scar, Laser therapy, wound healing
A Continuous Glucose Monitor Based Insulin Bolus Calculator

Study Overview
=================
Brief Summary
-----------------
This study examines the safety of an app-based insulin bolus calculator that utilizes glucose values from a continuous glucose monitor

Detailed Description
-----------------
Individuals with type 1 diabetes and those with type 2 diabetes who are prescribed bolus insulin must decide on an insulin dose for any given meal. This dose is often based on what they are eating and their glucose value. Insulin bolus calculators may be helpful in recommending an insulin dose. This study examines the safety of an app-based insulin calculator manufactured by Welloc (Columbia, MD). This app uses the glucose value and trend arrow, in certain circumstances, to recommend a bolus insulin dose. This study is a single arm trial where continuous glucose monitoring metrics such as time in range will be measured before and after the study participants are given the app.

Official Title
-----------------
Safety of a Real-time Continuous Glucose Monitor-based Insulin Bolus Calculator: The CGM-IBC Study

Conditions
-----------------
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Device: continuous glucose monitor based insulin bolus calculator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 1 diabetes type 2 diabetes using Dexcom G6 CGM system injecting bolus insulin Exclusion Criteria: pregnancy, insulin pump use

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: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single group open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGM insulin bolus calculator arm<br>All participants will receive the CGM insulin bolus calculator | Device: continuous glucose monitor based insulin bolus calculator<br>* Participants will use the bolus calculator with meals to calculate their insulin bolus doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time in range | time in range using the calculator app will be non-inferior to baseline time in range | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
continuous glucose monitor, insulin calculator
Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps (Yasargil-1)

Study Overview
=================
Brief Summary
-----------------
Although several studies have demonstrated the overall benefits of a laparoscopic approach for pelvic and para-aortic lymphadenectomy, complications remain a challenging scenario. Vascular injury occurs in 0.3% to 1.0% of laparoscopic procedures, with potentially lethal consequences. Vascular injuries are usually managed using coagulation, clamps or vascular sutures, but if these measures fail, laparotomy is inevitable. To date, few reports evaluated the use of minimally invasive surgery for lymph node debulking in gynecological cancer patients with metastatic bulky lymph nodes, with encouraging results, despite the small sample sizes. Nevertheless, new minimally invasive surgery techniques that may minimize intraoperative complications are necessary. Considering these elements, this multicenter retrospective analysis is aimed to evaluate intra- and post-operative surgical outcomes, after laparoscopic ultraradical lymph nodal debulking using Yasargil clamps in gynecological cancer patients with bulky lymph node metastases.

Official Title
-----------------
Evaluation of Surgical Outcomes After Laparoscopic Ultra-radical Lymph Node Debulking Using Yasargil Clamps for Gynecological Malignancies

Conditions
-----------------
Gynecologic Cancer

Intervention / Treatment
-----------------
* Procedure: Laparoscopic ultra-radical lymph node debulking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one bulky lymph node with size ≥ 25 mm Age > 18 years Body mass index (BMI) < 40 kg/m² Absence of abdominal adhesion syndrome and intraperitoneal dissemination at the time of laparoscopic evaluation Exclusion Criteria: Disease-free interval < 6 months and/or Performance status > 2 according to Eastern Cooperative Oncology Group (ECOG) criteria

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women affected by gynecological cancer<br>Women affected by gynecological cancer (cervical, endometrial, ovarian and vulvar cancer) | Procedure: Laparoscopic ultra-radical lymph node debulking<br>* Laparoscopic ultra-radical lymph node debulking using Yasargil clamps<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Any complication occurred | During the surgery and within 30 days after the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gynecological oncology, Gynecological cancers, Bulky lymph nodes, Laparoscopic ultra-radical lymph node debulking, Yasargil clamps, Complications, Surgical outcomes
Role Of Ketamine in Treatment-Resistant Major Depressive Disorder And Its Effect on Suicidality

Study Overview
=================
Brief Summary
-----------------
In this study we will assess the effect of Ketamine infusion on depressive symptoms and in particular its effect on Suicidal behavior, ideation and thoughts in patients with treatment- resistant MDD.

Detailed Description
-----------------
A Twice repetition of IV infusion of 0.5 mg/kg of ketamine produces an antidepressant response in individuals with treatment-resistant MDD The work aims to: To assess the onset of action and degree of improvement and the duration of antidepressant effect of ketamine in a sample of patients with treatment -resistant major depressive disorder. To find out whether the onset of Ketamine antidepressant effect is associated with an improvement of suicidality in those patients.

Official Title
-----------------
Role Of Ketamine in Treatment-Resistant Major Depressive Disorder And Its Effect on Suicidality

Conditions
-----------------
Treatment Resistant Depression

Intervention / Treatment
-----------------
* Drug: Ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients fulfilling diagnostic criteria of treatment-resistant MDD. Presence of suicidal risk. No comorbid medical or neurological conditions. Age above 18 years old. Both gender. Informed written consent from the patient or his legitimate. Exclusion Criteria: Presence of perceptual disturbance. History of sensitivity to ketamine. Refusal to participate in the study.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketamine group<br>half of participants will take ketamine | Drug: Ketamine<br>* Ketamine is a high-affinity, noncompetitive N-methyl-D- aspartate (NMDA) glutamate receptor antagonist it has been used in anesthesiology for more than 50 years the time course of antidepressant response to ketamine is characterized by an initial reduction in depressive symptoms within 2 h<br>|
| No Intervention: Placebo group<br>the other half of participants will not take any drugs | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Role of Ketamine as Antidepressant | the onset of action and degree of improvement and the duration of antidepressant effect of ketamine in a sample of patients with treatment -resistant major depressive disorder. | 1 year | 
| Effect of Ketamine on Suicidality | finding out whether the onset of Ketamine antidepressant effect is associated with an improvement of suicidality in those patients | 1 year |