linjc16/ctgov huggingface dataset:
Efficacy and Safety of Intravitreal Vascular Endothelial Growth Factor Trap-eye in Patients With Polyploidal Choroidal Vasculopathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of aflibercept for treatment of polypoidal choroidal vasculopathy without active polyp.

Conditions
-----------------
Polypoidal Choroidal Vasculopathy Without Active Polyp

Intervention / Treatment
-----------------
* Drug: aflibercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: polypoidal choroidal vasculopathy without active polyp decreased visual acuity by subretinal fluid and hemorrhage involving foveal center Exclusion Criteria: polypoidal choroidal vasculopathy with active polyp previous photodynamic therapy more than three times anti-VEGF injection within one month photodynamic therapy or intraocular steroid treatment within three months

Ages Eligible for Study
-----------------
Minimum Age: 19 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: polypoidal choroidal vasculopathy without polyp<br> | Drug: aflibercept<br>* Three monthly intravitreal aflibercept (2mg) injections Five bimonthly intravitreal aflibercept (2mg) injections Rescue treatment: Verteporfin photodynamic therapy Loss of five ETDRS letters or one Snellen line of vision from baseline Presence of subretinal fluid or intraretinal fluid despite three consecutive (monthly or bimonthly) aflibercept injection Presence of active polyp on indocyanine green angiography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of best-corrected visual acuity (ETDRS letters) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of subretinal hemorrhage | Total number of months when subretinal hemorrhage are detected on fundus photographs. | during 1 year | 
| presence of fluid in macula evidenced by optical coherence tomography | Total number of months when fluid in macula are detected on optical coherence tomography | during 1 year | 
| change of indocyanine green angiography | Change of indocyanine green angiography will include followings New appearance of polypoidal structure Any change in size of the greatest linear dimension of lesion Any change in size and activity of branching vascular network | during 1 year | 
| Number of eyes which need rescue treatment (photodynamic therapy) | In this study, photodynamic therapy will be performed as a rescue therapy according to the necessary criteria. | during 1 year | 
| safety outcomes | frequency and severity of ocular adverse event | one year |
Role of T Helper 17 and Regulatory T Cells in Delayed Graft Function

Study Overview
=================
Brief Summary
-----------------
Delayed graft function (DGF) increases risk of acute rejection after kidney transplantation (KTx). Interleukin-6, which is produced in DGF, is critical in directing naive T helper cells differentiation towards T helper 17 (Th17) and away from regulatory T (Treg) cells. The investigators hypothesize there is an increase in Th17 and a decrease in Treg expression in KTx recipients with DGF compared to those without, leading to immunologic consequences. The investigators will test their hypothesis by measuring in both groups expression of Th17, Treg, and related cytokines in blood, urine, kidney biopsy, and kidney preservation fluid, and correlating these results with immunologic events.

Detailed Description
-----------------
All adult recipients of a primary kidney transplant will be eligible. Subjects will have blood samples drawn from which we will isolate lymphocytes and analyze the Treg population based on surface markers as well as a functional assay. The measures of Treg function will be compared to outcomes including DGF, graft survival and graft function, as well as the development of immunological complications such as donor-specific antibody production, acute rejection, IFTA and opportunistic infection.

Official Title
-----------------
Can T Helper 17 and Regulatory T Cells Explain the Pathophysiology of Delayed Graft Function in Renal Transplant Recipients?

Conditions
-----------------
Delayed Graft Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney transplant recipients Exclusion Criteria: None

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Delayed graft function<br>These are patients in whom dialysis is required following transplantation. | |
| Immediate function<br>These are patients in whom no dialysis is required and creatinine declines by >20% in the first 24 hours following transplantation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft function | Kidney graft function as measured by GFR | 1 year |
Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement

Study Overview
=================
Brief Summary
-----------------
This study sought to evaluate the impact of Virtual Reality (VR) tools in procedural planning of transcatheter aortic valve replacement (TAVR).

Detailed Description
-----------------
A prospective study involving 11 patients referred for TAVR was conducted. A multidetector computed tomography (MDCT) was used to acquire and segment the anatomy of the access route and landing zone. From the information obtained with the MDCT in DICOM format, the investigators built a virtual platform (VisuaMed, Teacher Team. Valencia. Spain) that contains all the clinical information of the patients and a virtualized model of their anatomy. Wearing VR devices, the professional was able to walk inside  the anatomy in an interactive and immersive way. Decisions after the evaluation of routine clinical images were compared with those after experience with VR models and intraprocedural findings.

Official Title
-----------------
Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement (TAVR)

Conditions
-----------------
Aortic Stenosis, Severe

Intervention / Treatment
-----------------
* Diagnostic Test: TAVR planning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe aortic stenosis considered for TAVR procedure at a single Institution Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TAVR standard<br>TAVR planning evaluated without VR and TAVR planning after VR analysis | Diagnostic Test: TAVR planning<br>* TAVR planning without VR vs after VR<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TAVR procedure planning (prosthesis size, implant technique requirements, potential risks) | Does the TAVR procedure planning change after VR? | Baseline |
Alternate-Day Buprenorphine Administration. Phase IV - 5

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if three times a subject's daily maintenance dose will hold for 72 hours without changes in agonist and antagonist effects.

Official Title
-----------------
Alternate-Day Buprenorphine Administration. Phase IV

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 49 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Opioid withdrawal |  |  | 
| Opioid agonist effects |  |  | 
| Dose identification |  |  | 
| Pupil diameter |  |  |
Comparison of Antibody Levels in Children and Adolescents After Initiation of Insulin Therapy by Either Insulin Aspart or Soluble Human Insulin

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. This is a single-centre, retrospective trial aiming at comparing the antibody levels in children and adolescents.

Official Title
-----------------
Safety/Efficacy Trial Using Stored Serum Samples to Investigate the Immunogenicity of Insulin Aspart and Soluble Human Insulin in Children and Adolescents From Onset of Type 1 Diabetes

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

Intervention / Treatment
-----------------
* Drug: soluble human insulin
* Drug: isophane human insulin
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent obtained before any trial-related activities Any subjects at onset of Type 1 Diabetes Treatment with either Insulin Aspart and Soluble Human Insulin or Soluble Human Insulin and Isophane Human Insulin / Mixtard® for at least 9 months from the time of diagnosis of diabetes Exclusion Criteria: Treatment with immunosuppressive agents For the Insulin Aspart + Isophane Human Insulin: Treatment with insulin analogues other than Insulin Aspart or treatment with fast acting human insulin for a period of 7 days or more during the treatment period For the Soluble Human Insulin and Isophane Human Insulin group: Treatment with insulin analogues Other diseases influencing immune response Unable or unwilling to provide consent

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: soluble human insulin|nan|
|Drug: isophane human insulin|nan|
|Drug: insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin aspart specific, human insulin specific and cross reacting antibodies |  | measured up to at most 2.5 years after diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  |  | 
| Insulin requirements |  |  | 
| Incidence of hypoglycaemic episodes |  |  |
Implantation of Bone Marrow Cells to Treat Avascular Necrosis of Femoral Head (ANFH)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of autologous enriched bone marrow cell implantation combined with core decompression to single core decompression for the treatment of avascular necrosis of femoral head.

Official Title
-----------------
Control Study of Implantation of Enriched Bone Marrow Cells for the Treatment of Avascular Necrosis of Femoral Head

Conditions
-----------------
Avascular Necrosis of Femur Head

Intervention / Treatment
-----------------
* Procedure: core decompression
* Procedure: Enriched BMCs implantation combined with core decompression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: femoral head necrosis patients stage I/II/III (Ficat) age from 18 to 55 years stop steroid treatment for minimal 6 months Exclusion Criteria: age younger than 18 or older than 55 any hemopathy tumor femoral head/neck fracture

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: control group:core decompression<br>single core decompression | Procedure: core decompression<br>* minimal surgical invention to drill a core to the femoral head to release pressure<br>|
| Active Comparator: Treatment group: BMCs+core decompression<br>Enriched bone marrow cells combined with core decompression | Procedure: Enriched BMCs implantation combined with core decompression<br>* Patients are subjected to bone marrow aspiration from the anterior iliac crest. Mononuclear cells are enriched from patients' bone marrow by centrifuge, which are grafted with autologous cortical bone and implanted to the necrotic zone of the femoral head.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of Visual Analogue Scale | Change from baseline in 24 months | before invention and 24 months after invention | 
| change of lequensne algofunctional index | change from baseline in 24 months | before invention and 24 months after invention | 
| change of WOMAC index | change from baseline in 24 months | before invention and 24 months after invention |
Effects of N-acetyl Cysteine During Percutaneous Coronary Intervention

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effects of N-acetyl cysteine on periprocedural myocardial infarction and major cardiac and cerebral events in patients undergoing percutaneous coronary intervention and who have moderate to high risk for contrast induced nephropathy.

Official Title
-----------------
Effects of N-acetyl Cysteine on Periprocedural Myocardial Infarction and Major Cardiac and Cerebral Events in Patients Undergoing Percutaneous Coronary Intervention

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: N-acetyl cysteine
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years old undergoing percutaneous coronary intervention and who have moderate to high risk for contrast induced nephropathy (Mehran Score ≥ 5) Exclusion Criteria: Primary percutaneous coronary intervention Low risk for contrast induced nephropathy (Mehran Score < 5) Use of nephrotoxic agents (NSAIDs, aminoglycosides,recent contrast injection...) Infection Pregnancy, Lactation Renal failure requiring dialysis Hepatic failure History allergy for NAC History of Asthma Chronic nitrate usage Malignancy Use of corticosteroids Leukocytosis,Thrombocytosis,Anemia Blood pressure of >180/100mmHg despite anti-hypertensive therapy

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: saline<br>30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure | Drug: Saline<br> <br> |
| Experimental: n-acetyl cysteine<br>30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure | Drug: N-acetyl cysteine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| periprocedural myocardial infarction |  | postprocedural 3-6 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NAC side effects (Asthma exacerbation, pruritus, dyspnea) |  | during hospitalization at 48 hours | 
| major cardiac and cerebral events |  | 1 year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
n-acetyl cysteine, percutaneous coronary intervention
Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrent simple febrile seizures.

Detailed Description
-----------------
To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrence of simple febrile seizures in children aged 6 months to 5 years.

Official Title
-----------------
Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures: Randomized Clinical Trial

Conditions
-----------------
Febrile Seizures

Intervention / Treatment
-----------------
* Drug: oral melatonin
* Drug: oral diazepam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 6 months to 5 yrs . Simple febrile seizures Exclusion Criteria: Complex febrile seizures Child with history of neonatal seizure. Afebrile seizures. History of anticonvulsive therapy. Children suffering from epilepsy. Children with abnormal EEG. Children with abnormal neurological examination. Positive family history of epilepsy.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 5 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Melatonin<br>melatonin 0.3mg/kg/8 hours, orally. Given only during the febrile illness. | Drug: oral melatonin<br>* Both melatonin and diazepam were given only during the febrile illness.<br>|
| Active Comparator: Diazepam<br>oral diazepam 1mg/kg/day divided into 3 doses. Given only during the febrile illness. | Drug: oral diazepam<br>* Both melatonin and diazepam were given only during the febrile illness.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence of febrile seizures during febrile illness |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effect of medications reported in children |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melatonin, Diazepam, recurrence, prophylaxis, Febrile convulsions
Angiogenic Switch in Patients With Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
A group of colorectal cancer (CRC) patients treated with chemotherapy and Bevacizumab (Bev) maintain the same sensitivity after progression to maintenance treatment because they remain dependent on VEGF angiogenic mediator, while other patients in whom there is an angiogenic switch (AS) become dependent on other angiogenic cytokines and become resistant to Bev chemotherapy combinations .

Official Title
-----------------
Angiogenic Switch as Predictor of Response to Chemotherapy in Patients With Metastatic Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Xelox or Xeliri Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of stage IV colorectal adenocarcinoma. Age ≥ 18 years . Measurable disease by RECIST criteria. Life expectancy ≥ 6 months. Candidate to receive treatment with first-line chemotherapy. Availability of tumor tissue. Exclusion Criteria: Patients who have received prior treatment with first-line chemotherapy for metastatic disease. Patients in whom there is contraindication to the administration of either drug used in the study: capecitabine, irinotecan, oxaliplatin or Bev. Patients receiving anticoagulant oral treatment. Patient with diagnosis of other malignancies within 5 years prior to diagnosis except basal cell carcinoma or cervical carcinoma · in situ. · The inclusion of patients with malignant disease diagnosed more than 5 years ago without recurrence in the previous 3 years will be analyzed individually Patients with bone disease as the only manifestation of the disease.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemotherapy treatment<br>Chemotherapy treatment with Xelox or Xeliri and bevacizumab | Drug: Xelox or Xeliri Bevacizumab<br>* Chemotherapy treatment<br>* Other names: Angiogenic study;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Days from cycle one day one to progression | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | Feasibility of doing a clinical prospective trial with a measure od plasma citoquines. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
angiogenic switch, plasma cytokines, Colon cancer