linjc16/ctgov huggingface dataset:
CryoSpray Ablation(tm)Thoracic Patient Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create a patient registry to collect and analyze information on subjects treated with the CryoSpray Ablation™ System post-510K approval.

Detailed Description
-----------------
The proposed registry is a prospective, multi-center study of patients that are currently undergoing CryoSpray Ablation™. A maximum of 50 investigational sites will participate in this study. The study population consists of patients who are being treated with the CryoSpray Ablation™ System for thoracic diseases. Enrolled subjects must have a signed consent form for data collection.

Official Title
-----------------
CryoSpray Ablation(tm)Thoracic Patient Registry

Conditions
-----------------
Lung Cancer, Emphysema, Chronic Bronchitis, COPD, Asthma, Sarcoidosis, Mesothelioma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are being treated with the CryoSpray Ablation™ System for lung and for thoracic diseases. Exclusion Criteria: Subjects with thoracic or airway obstructions and diseases who were not treated with the CryoSpray Ablation™ System. Subjects under the age of 18 years. Subjects unable to provide consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Primary objectives of the study are to enable analysis of patient outcomes 2 years following final treatment and estimate the effectiveness of the device in eradicating, decreasing and downgrading of the diseases. |  | 2 years post-treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malignant Airway Disease, Benign Airway Disease, Lung Cancer, Emphysema, Chronic Bronchitis, COPD, Asthma, Sarcoidosis, Mesothelioma, CryoSpray Ablation, Cryotherapy, Cryospray, Cryo
Correspondence of ScO2 and Cardiac Output in Hemodialysis

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate the correspondence between changes in central venous oxygen saturation (ScO2) and in cardiac output during hemodialysis. In 12 hemodialysis patients with an A-V fistula, a thoracic bioimpedance cardiograph will be validated for cardiac output measurements during ongoing hemodialysis. Provided this validation is satisfactory, impedance cardiography cardiac output and ScO2 will be measured at intervals during hemodialysis in 25 hemodialysis patients with a central vascular access. Absolute values and trends will be compared.

Official Title
-----------------
ScO2 and Cardiac Output - Correspondence Study in Hemodialysis Patients

Conditions
-----------------
Hemodialysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ambulatory hemodialysis patients in the Copenhagen University Hospital department of Nephrology. Exclusion Criteria: Age below 18 years. Failure to give informed consent.

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 |
| --- | --- |
| Hemodialysis patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Prevalence of Secondary Hyperparathyroidism Among Patients With Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the prevalence of secondary hyperparathyroidism among patients with diabetic nephropathy.

Official Title
-----------------
Prevalence of Secondary Hyperparathyroidism Among Patients With Diabetic Nephropathy

Conditions
-----------------
Secondary Hyperparathyroidism, Diabetic Nephropathies

Intervention / Treatment
-----------------
* Diagnostic Test: intact parathyroid hormone level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: [1] Age was above 18 years, [2] Patient had diabetic nephropathy which was diagnosed based on the presence of urinary albumin/creatinine ratio (uACR) ≥ 30 mg/gm ± 24 hours' urinary protein measurement ≥ 300 mg/day Exclusion Criteria: [1] patients were already receiving cinacalcet and/or [2] patients had undergone neck surgery for parathyroidectomy.

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 |
| --- |
|Diagnostic Test: intact parathyroid hormone level|obtain intact parathyroid hormone level from patients records.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intact parathyroid level | intact parathyroid level | within 1 hour from attending in the clinic |
A Pilot Study for PK/PD Parameter of Colchicine in Chronic Kidney Disease Patient.

Study Overview
=================
Brief Summary
-----------------
A pilot study for PK/PD parameter of colchicine in Chronic kidney disease patient.

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: colchicine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: from 18yrs to 80yrs , man and women the patient who are taking colchicine On screening, the patient shows that MDRD GFR >= 10 ml/min and <= 50 ml/min the patient sign on the concent form Exclusion Criteria: the patient have experience to take medication that have an effect on renal function At least, the average level of two separate blood pressure ( 2min interval ) shows that SBP <= 100 mmHg or >=160 mmHg and DBP <=60 mmHg >=100 mmHg, or Heart rate < 40 beats/min or > 90 beats/min pregnancy or anticipate pregnancy with 6 month hypersensitivity to colchicine acute hepatitis or the level of AST or ALT is over 2times of normal range or the level of bilirubin is over 2.0 mg/dL serum albumin < 3.5 mg/dL or > 5mg/dL urinary retension, prostatic hyperplasia the patient show gout attack on taking colchicine the patient who have gastro-intestinal disease ( ex, crohn's disease, acute or chronic pancreatitis, ulcer )or who have the surgical history of gastrointestine. the patient who should take Atazanavir, Amprenavir, Apreptant, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, verapamil, cyclosporine, ranolazine the patient who had taken part in the other study within 3months the patient who had gotten blood transfusion pregnant, breast feeding

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MDRD eGFR 10 50 ml/min/1.73m2<br> | Drug: colchicine<br>* colchicine 1T tid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum colchicine level |  | 0,1,6 hours |
Biomarkers for Prognosis of Ambulatory Chronic Heart Failure Patients

Study Overview
=================
Brief Summary
-----------------
Biomarkers representing distinct biological domains including neurohormonal, inflammatory, metabolic-nutritional, oxidative-nitrosative and myocardial injury, might alone or in combination provide prognostic information on mortality in heart failure patients with preserved or impaired systolic function.

Detailed Description
-----------------
Upon enrollment in the study, Troponin I (cTn I), BNP, norepinephrine, plasma renin activity, aldosterone, high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6), soluble receptor of interleukin 2 (sIL-2R), leptin, prealbumin, free malondialdehyde, 15-F2t-isoprostane and protein-bound nitrotyrosine were measured in stable ambulatory, non diabetic, elderly heart failure patients. Patients were followed up until death or study termination (31st January 2009).

Official Title
-----------------
Circulating Biomarkers as Prognostic Indicators of Death in Ambulatory Heart Failure Patients

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: symptomatic congestive heart failure lasting at least six months reduced exercise tolerance impaired or preserved left ventricular ejection fraction cardiomegaly Exclusion Criteria: acute infection rheumatoid or other autoimmune diseases primary cachectic states (cancer, thyroid disease, severe liver disease) severe chronic lung disease neuromuscular disorders myocardial infarction within the previous 20 weeks diabetes mellitus chronic renal failure (serum creatinine level > 2.0 mg/dl, >177 micromol/L)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| heart failure<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Contact Force Sensing Use in Atrial Fibrillation Ablation

Study Overview
=================
Brief Summary
-----------------
There are multiple important factors which need to be monitored when conducting ablation for atrial fibrillation. The contact between the catheter tip and the inside of the heart wall is now measurable and may improve the effectiveness of catheter ablation for atrial fibrillation patients.

Detailed Description
-----------------
This study compares patients who have this procedure where this contact information is known (unblinded) versus those where the contact information is not known (blinded). The outcome is the rate of acute reconnection at 1 hour after achieving pulmonary vein isolation.

Official Title
-----------------
The Role of Contact Force Sensing in Electrical Pulmonary Vein Isolation When Conducting Atrial Fibrillation Ablation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: Ablation
* Procedure: Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic AF Exclusion Criteria: Recent CVA Contraindication to warfarin therapy

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Contact Force Known<br>Ablation with contact force data known | Procedure: Ablation<br>* Atrial Fibrillation Ablation with SmartTouch catheter<br>|
| Experimental: Contact Force Not Known<br>Contact Force data unavailable during ablation | Procedure: Ablation<br>* Atrial Fibrillation Ablation with SmartTouch catheter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Acute Pulmonary Vein Reconnection |  | 1 hour post procedure |
A Comparison of Optive in Patients Previously Using Systane for the Treatment of Dry Eye

Study Overview
=================
Brief Summary
-----------------
To evaluate the effectiveness of NGT (Optive) vs. Systane Tears for patients with moderate to severe dry eye disease.

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: Optive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: · Dry eye disease diagnosis Patients must currently be using Systane tears at least once a day and for at least 1 month. Normal lid position and closure Male or female of legal age of consent Informed consent has been obtained Likely to complete all required follow-up visits Exclusion Criteria: · Concurrent enrollment in an investigational drug or device study, or participation in such a study within 30 days of entry into this study. Subject has a condition, or is in a situation which, in the investigator's opinion, may put the subject at a significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study Evaluating Single Doses of BLI-489 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, and tolerability of single doses of BLI-489 administered intravenously in healthy subjects, and also how the drug is absorbed and eliminated.

Official Title
-----------------
Ascending Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of BLI-489 Administered Intravenously to Healthy Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: BLI-489
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women of nonchildbearing potential, 18 to 50 years of age inclusive at screening. Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to 50 kg. Healthy as determined by the investigator on the basis of the screening evaluations. Nonsmoker of smoker of fewer than 10 cigarettes per day as determined by history. Exclusion Criteria: Presence of history of any disorder that may prevent the successful completion of the study. History of drug abuse within 1 year.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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: 1<br>BLI-489 | Drug: BLI-489<br> <br> |
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by the number of adverse events and serious adverse events. Tolerability will be assessed based upon the occurrence of dose limiting toxicities. |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics as evaluated by drug concentrations in the blood and urine. |  | 4 days |
Factors Affecting the Prognosis of Patients With Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
Endometrial cancer is the second common gynecologic malignancy in Taiwan. The prevalence has been overcome the epithelial ovarian cancer because of the change of life style to western style recently. Most patients with endometrial cancer are stage I & II, the most histology is still endometrioid adenocarcinoma (type I endometrial cancer). In statistics, advanced stage (FIGO stage III and IV) is approximately 16% of all cases. Most patients has good outcome of endometrial cancer because their surgical stage is belonged to early stage. However, the recurrence, distant metastases and mortality are high if the diseases is confirmed to be advanced stage. The adjuvant therapies after staging/debulking operation are systemic chemotherapy and whole pelvic radiation therapy/ brachytherapy. Whether the adjuvant therapy can cure the disease of not is still controversial. Because of the rarity of the advanced endometrial cancer, varies adjuvant therapeutic modalities, eg. chemotherapy only, pelvic radiation therapy only, combination of chemotherapy and radiation therapy or sequential sandwich therapy were ever used for such group patients in each medical center. But the case number is insufficient and limited to show the survival or progression free benefit during the statistics. Besides, the surgical procedures and adjuvant therapy for early endometrial cancer is still remained to be determined. The investigators are also interested to analyze the factors affecting their survival. The investigators will perform a retrospective study to review the data of patients with endometrial cancer in Department of Obstetrics & Gynecology in Far Eastern Memorial Hospital.

Conditions
-----------------
Endometrial Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Time interval: from 1991 to date. Comprehensive surgical staging or debulking procedure. All female patients with endometrial cancer who underwent surgery for endometrial cancer at Far Eastern Memorial Hospital. Exclusion Criteria: Not comprehensive staging/debulking procedure. Patients who died of postoperative complications within 30 days after surgery were excluded from the survival analysis.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 99 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 |
| --- | --- |
| cases with endometrial cancer<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors affecting overall survival and disease-free survival of endometrial cancer |  | 20 years |
XL999 Administered Intravenously to a Subject With Advanced Malignancies

Study Overview
=================
Brief Summary
-----------------
Cancer is a worldwide clinical and economic problem. Conventional approaches to treating cancer include surgery, radiotherapy, and cytotoxic chemotherapy as single modalities or as combined therapies. Recently, targeted therapies including antibodies and small molecule inhibitors have also demonstrated clinical benefit. It is now possible to study different genetic lesions involved in cancer types due to advances in genomic methodologies. The investigational drug in this study, XL999 inhibits multiple receptor tyrosine kinases, including VEGF receptor (VEGFR2/KDR), platelet derived growth factor receptors (PDGFRβ), fms-like tyrosine kinase receptor 3 (FLT3), fibroblast growth factor receptors (FGFR1, FGFR3), RET, and KIT, and thus, interferes with multiple cellular processes simultaneously and will likely have effects on the integrity of tumor neovasculature and angiogenesis. Together with the ability to induce a novel cell cycle arrest, the spectrum of activities that XL999 exhibits may reduce both tumor cell proliferation and angiogenesis in the clinic. The rationale and purpose of this maintenance study is to allow a subject receiving clinical benefit from XL999 to continue treatment.

Official Title
-----------------
Single Patient Treatment Study for the Use of XL999 Administered Intravenously to a Subject With Advanced Malignancies Previously Enrolled in Study XL999-900

Conditions
-----------------
Advanced Malignancy

Intervention / Treatment
-----------------
* Drug: XL999


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is eligible to continue to receive XL999 in the absence of progressive disease and unacceptable XL999-related toxicity. Exclusion Criteria: Progressive disease.

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 |
| --- |
|Drug: XL999|The treatment will consist of 4-week cycles in which the subject will receive XL999 administered as a 4-hour IV infusion every other week. The subject will continue to receive 4-week cycles of XL999 in the absence of progressive disease, unacceptable drug-related toxicity, and as long as the drug is available.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
XL999, Advanced Malignancy
Quality of Life and Visual Function in Uveitis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to measure the quality of visual function and quality of daily living in patients with anterior, posterior, and panuveitis.

Detailed Description
-----------------
The National Eye Institute Visual Functioning Questionnaire, version August 2000 (NEI VFQ-25) and the Medical Outcomes Study (MOS) 36 Item Short Form Health Survey Instrument (SF-36) (RAND 36-Item Health Survey 1.0 Questionnaire) will be administered by a trained interviewer. Socio-demographic and clinical data will be collected for additional QOL parameter.

Conditions
-----------------
Anterior Uveitis, Posterior Uveitis, Panuveitis, Uveitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide written informed consent Subjects of either gender Age greater than or equal to 18 years of age Diagnosed with Uveitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uveitis, Quality of life, Visual function