linjc16/ctgov huggingface dataset:
Clinical Study to Evaluate CryoBalloon™ Ablation System in Patients Undergoing Esophagectomy

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and treatment effect of the CryoBalloon™ Full Ablation System for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy

Detailed Description
-----------------
The primary outcomes for the study are the safety and treatment effect of the CryoBalloon™ Ablation System. An esophagectomy will be performed as scheduled following the ablation procedure; histopathological analysis of surgically-resected specimens will be performed to determine the treatment effect.

Official Title
-----------------
Clinical Study to Evaluate the CryoBalloon™ Full Ablation System for the Ablation of Human Esophageal Epithelium in Patients Undergoing Esophagectomy

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Device: CryoBalloon Ablation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Up to two (2) areas of 3 cm each non-ulcerated, columnar lined esophagus or squamous linted tissue suitable for ablation Older than 18 years of age at the time of consent Requires a clinically-necessary esophagectomy for esophageal cancer Patient has provided written informed consent using the Informed Consent Form approved by the Institution's reviewing Medical Ethics Committee (MEC) Exclusion Criteria: Patient refuses or is unable to provide written informed consent Patient has esophageal narrowing limiting access to the intended site of ablation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>To evaluate safety and treatment effect of the CryoBalloon Ablation System for the Ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy | Device: CryoBalloon Ablation System<br>* Tissue Ablation using CryoBalloon Ablation System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of CryoBalloon Ablation System | Incidence of device related serious adverse events | through study completion, an average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Performance | Ease of deployment of the CryoBalloon, procedure time, endoscope compatibility, device malfunction. | through study completion, an average of 2 weeks |
Treatment of Bevacizumab and Triamcinolone in Treatment or Macular Edema Secondary to CRVO

Study Overview
=================
Brief Summary
-----------------
Treatment of macular edema secondary to central retinal vein occlusion is more effective with combined therapy of bevacizumab and triamcinolone than bevacizumab alone.

Detailed Description
-----------------
Comparison of two groups with different treatment with registrations of outcome in BCVA and complications

Official Title
-----------------
Combined Treatment of Intravitreous Bevacizumab and Triamcinolone for the Treatment or Macular Edema Secondary to Central Retinal Vein Occlusion

Conditions
-----------------
Macular Edema, Central Retinal Vein Occlusion

Intervention / Treatment
-----------------
* Drug: bevacizumab and triamcinolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Macular edema secondary to central retinal vein occlusion BCVA worse than 20/40 Central macular >250 mc with OCT Exclusion Criteria: Diabetic retinopathy or other retinopathy Media opacity that does not allow following steroid responder diagnosed glaucoma or IOP > 21 mmHg
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

| Intervention/Treatment |
| --- |
|Drug: bevacizumab and triamcinolone|three applications monthly administrated of bevacizumab 2.5mg for group 1 and bevacizumab 2.5 mg + triamcinolone 4mg first dose followed by two of bevacizumab alone for the group 2|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Best corrected visual acuity and macular edema measured with OCT |  | Follow up to 3 , 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Report treatment complications |  | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Macular edema, central retinal vein occlusion, bevacizumab, triamcinolone
Tumor Feeding Vessels Deprivation Combined With Tyrosine Kinase Inhibitor in Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
To investigate the value of tumor feeding vessels deprivation combined with tyrosine kinase inhibitor in liver transplantation. Patients are enrolled into two groups according to the downstaging therapy they undergo before transplantion.

Official Title
-----------------
The Value of Tumor Feeding Vessels Deprivation Combined With Tyrosine Kinase Inhibitor in Liver Transplantation

Conditions
-----------------
Liver Transplant

Intervention / Treatment
-----------------
* Combination Product: PVHA or TACE


Participation Criteria
=================
Eligibility Criteria
-----------------
Voluntarily sign informed consent Patients whose preoperative pathological diagnosis of hepatocellular carcinoma exceeded the transplantation criteria Aged between 18 and 65 No other treatment was performed

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| PVHA<br>Patients undergo tumor feeding vessels deprivation combined with tyrosine kinase inhibitor before liver transplantation | Combination Product: PVHA or TACE<br>* PVHA or TACE<br>|
| TACE<br>Patients undergo TACE therapy combined with tyrosine kinase inhibitor before liver transplantation | Combination Product: PVHA or TACE<br>* PVHA or TACE<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the value of tumor feeding vessels deprivation combined with tyrosine kinase inhibitor in liver transplantation | the value of tumor feeding vessels deprivation combined with tyrosine kinase inhibitor in liver transplantation | 2016-2025 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AFP reduction of patients | AFP reduction after tumor trophovascular deprivation combined with tyrosine kinase inhibitors. | 2016-2025 | 
| survival time of patients | the effect of tumor trophovascular deprivation combined with tyrosine kinase inhibitor treatment on the overall survival time of patients after transplantation | 2016-2025 | 
| the prognosis of patients | the prognosis of patients undergoing tumor trophovascular deprivation in combination with tyrosine kinase inhibitors | 2016-2025 |
Effect of Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist (NAVA) in Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
=================
Brief Summary
-----------------
The investigators' aim is to study the effect of pressure support ventilation at two levels of PEEP and Pressure Support versus neurally adjusted ventilatory assist (NAVA) in COPD patients.

Detailed Description
-----------------
In this study, two levels of pressure support and PEEP during pressure support ventilation are compared with neurally adjusted ventilatory assist (NAVA) in COPD patients by measuring respiratory mechanics, intrinsic PEEP, work of breathing and patient's level of comfort.

Official Title
-----------------
Effect of Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist (NAVA) in COPD Patients

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Procedure: PSV and NAVA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable COPD patients during non invasive mechanical ventilation Exclusion Criteria: Haemodynamic instability Coma

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>COPD patients | Procedure: PSV and NAVA<br>* evaluated the effect of PSV and NAVA on breathing pattern, respiratory effort, gas exchange and level of breathing comfort in COPD patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory mechanics, gas exchange, work of breathing |  | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort of breathing |  | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gas exchange, pressure support ventilation, respiratory mechanics, COPD, NAVA
Developmental Sequelae of Severe Chronic Lung Disorders

Study Overview
=================
Brief Summary
-----------------
To determine the impact of bronchopulmonary dysplasia (BPD) on childhood development, family functioning, and parental stress.

Detailed Description
-----------------
BACKGROUND: Bronchopulmonary dysplasia in infancy has been shown to be related to less optimal physical and psychological functioning later in life. Although infants with the disorder increased from 1978 to 1988, little was known about potential developmental problems early in life which might lead to the documented negative sequelae shown in previous research. DESIGN NARRATIVE: In this longitudinal study, infants were followed from birth and given standardized assessments of developmental and physical functioning. Demographic, birth, and medical data were collected at baseline through chart review. Standardized questionnaires measuring parental stress and family support were administered to the parents. Infants were followed at eight months, and one, two, and three years at which time parental measures were repeated and standardized assessments made of the children's physical growth, medical status, cognitive, language and behavioral development. Feeding behaviors were assessed through standardized observation and interview at each visit. Data were evaluated descriptively as well as through a series of multivariate analyses of variance with repeated measures. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Bronchopulmonary Dysplasia, Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

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

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

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 |
| --- | --- | --- |
Oral Calcium in Pregnant Women With Hypertension

Study Overview
=================
Brief Summary
-----------------
To determine of providing calcium supplementation to women with pre-existing hypertension reduces the level of blood pressure, requirement for antihypertensive drugs, and incidence of pre-eclampsia.

Detailed Description
-----------------
BACKGROUND: Maternal and fetal complications are more likely to occur in pregnant women with preexisting hypertension. Alterations in calcium metabolism, the renin angiotensin system, and intracellular free calcium concentration have been identified in this high risk population. The beneficial effects of calcium supplementation on blood pressure and the incidence of superimposed pre-eclampsia may be due to correction of the hormonal and cellular basis for vasoconstriction. The trial sought to prove that oral calcium lowered parathyroid hormone, reduced intracellular free calcium, and decreased vascular endothelin production, resulting in vasodilation and compensatory stimulation of the renin-angiotensin system. DESIGN NARRATIVE: Randomized. Double blind. In this observational study, subjects were assigned to two grams of supplemental elemental calcium or to placebo at 13 to 15 weeks gestation. The trial determined the effect of oral calcium supplementation on: the level of blood pressure; the need for antihypertensive drugs; forearm and peripheral vascular resistance; the incidence of maternal complications, including pre-eclampsia and eclampsia; and plasma levels of vitamin D3, ionized calcium, parathyroid, renin activity, angiotensin II, endothelin, nitrate/nitrite, prostacyclins, and intracellular calcium concentrations in lymphocytes and platelets. These variables were measured prior to randomization and every two months throughout pregnancy and the postpartum. Support ended in July 1999. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension, Pre-Eclampsia, Pregnancy Toxemias, Vascular Diseases

Intervention / Treatment
-----------------
* Behavioral: dietary supplements
* Drug: calcium


Participation Criteria
=================
Eligibility Criteria
-----------------
Pregnant women with chronic hypertension.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: dietary supplements|nan|
|Drug: calcium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Fistula-associated Anal Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
The fistula-associated anal adenocarcinoma is rare in patients suffering from anal fistulas. There is only little data available for this patient collective making characterization and management of this disease difficult. Late diagnosis and advanced tumor stage at diagnosis result in poor clinical outcome. It is the purpose of this study to evaluate patients clinically diagnosed with a FAAC and to further perform a histopathological characterization of the available tumor specimen.

Detailed Description
-----------------
All patients receiving surgery for an anal fistula in the years 1999 to 2019 at a tertiary university referral hospital were included in the analysis. A retrospective review of patients' charts was performed. Patients suffering from FAAC were eligible for histopathological analysis including immunohistochemistry and molecular profiling.

Official Title
-----------------
Fistula-associated Anal Adenocarcinoma - a Twenty Years' Single-center Experience.

Conditions
-----------------
Rectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anal fistula Exclusion Criteria: previous cancer of the anal canal
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 |
| --- | --- | --- |
| fistula-associated anal adenocarcinoma (FAAC) | include and analyze all patients suffering from FAAC | 1999-2019 |
Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This study is to explore the clinical efficacy of continuous Endostar infusion combined with radiotherapy in esophageal cancer patients.

Official Title
-----------------
Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Drug: Endostar
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological or cytological diagnosis of previously untreated stage I-III esophageal cancer Measurable disease according to RECIST criteria ECOG Performance Status 0-1 The length of esophageal carcinoma ≤ 10 cm Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 90g/L Renal function: Cr ≤ 2.0×UNL Hepatic function: BIL ≤ 2.0×UNL, ALT/AST ≤ 5.0×UNL Exclusion Criteria: Pregnant or lactating women Evidence of bleeding diathesis, serious infection Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension) Uncontrollable mental and nervous disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Treatment<br> | Drug: Endostar<br>* 75mg Endostar in 235mL normal saline, 24h continuous infusion, 6 weeks<br>Radiation: Radiotherapy<br>* 6～15MV X-ray, 2Gy/time，5times/week，6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) |  | 1 month after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | 2 years | 
| Time to Progression (TTP) |  | every three months until disease progression | 
| Clinical Benefit Rate (CBR) |  | 1 month after treatment | 
| Serum VEGF Levels |  | at baseline and 6 weeks | 
| Incidence of Adverse Events |  | up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophageal Cancer, Endostar, Radiotherapy
Combination Casodex® and Iressa™ in Locally Advanced Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the addition of ZD1839 Iressa™ to standard treatment with Casodex® (bicalutamide) for locally advanced prostate cancer can detect a difference in the rate of decrease of prostate specific antigen (PSA) levels.

Official Title
-----------------
A Randomized Placebo Controlled Study to Assess the Rate of PSA Decrease, Anatomical & Metabolic Changes in the Prostate Determined by MRI/3D-MRS & Histological Changes by Biopsy in Subjects With Locally Advanced Prostate Carcinoma Treated With Either Casodex® (Bicalutamide) Alone or the Combination of Casodex® & ZD1839 (Iressa™)

Conditions
-----------------
Locally Advanced Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Iressa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 80 years of age. Men with histologically confirmed locally advanced prostatic adenocarcinoma Exclusion Criteria: No prior treatment for prostate cancer, including surgery, radiotherapy, cryotherapy or thermotherapy. No abnormal laboratory values. No co-existing malignancies and any other significant clinical disorder or laboratory finding.

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the difference in the rate of PSA decrease between treatments over a 6 months period. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To detect changes in prostatic metabolites by using in vivo magnetic resonance spectroscopy (MRS) |  |  | 
| To detect changes in prostate gland using magnetic resonance imaging (MRI) |  |  | 
| To detect changes in serum tumor markers |  |  | 
| To assess histopathological changes |  |  |