linjc16/ctgov huggingface dataset:
Confocal Laserscanning Microscopy for Detection of Barretts Esophagus

Study Overview
=================
Brief Summary
-----------------
Four quadrant biopsies in regular ranges is the goldstandard in monitoring this disease. The ideal situation for the endoscopist is to visualize cellular structures, which implies having microscopic imaging available. A potential candidate to fill this gap could be confocal fluorescence microscopy (Cellvizio®-GI and Mauna Kea Technologies). To compare the gold standard with the confocal fluorescence microscopy for detection of metaplastic - or intraepithelial neoplastic changes of barrett-suspicious esophageal mucosa this study has been initiated.

Official Title
-----------------
Confocal Laserscanning Microscopy for Detection of Barretts Esophagus. A Blinded Multi-Center Study.

Conditions
-----------------
Barrett Esophagus

Intervention / Treatment
-----------------
* Procedure: confocal laser microscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 and 80 years regular esophagogastroduodenoscopy for patients with known barrett esophagus (at least stadium C0M1) patients presenting for endoscopic mucosectomy with intraepithelial neoplastic changes <1cm patients presenting with suspected intraepithelial neoplastic changes patients receiving acid suppressive therapy in standard dose for at least 4 weeks Exclusion Criteria: no informed consent thrombocytopenia, quick <50%, PTT >50 sec patients with coronary heart disease or existent valve plasties women with potential pregnancy patients with chronic renal failure patients with allergies patients with chronic obstructive pulmonary disease

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: confocal laser microscopy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy of confocal laser scanning microscopy for detection of metaplasia or neoplasia in Barrett´s esophagus |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inter- and intra observer variability for confocal laser scanning microscopy |  |  |
Bladder Cancer Longitudinal Biorepository for Development of Novel Therapeutics/Biomarkers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create a registry, which is a bank of information about patients who have had similar medical conditions and treatments. The registry will be used by researchers to learn more about long term outcome of patients with bladder cancer, how bladder cancer tissues are related to tumor development, recurrence and survival.

Official Title
-----------------
Bladder Cancer Longitudinal Biorepository for Development of Novel Therapeutics/Biomarkers

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Other: Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who present to clinic with presumed bladder cancer or have a diagnosis of bladder cancer are eligible to participate Patients can participate in any additional research studies during the patients' participation within this protocol. Exclusion Criteria: Patients who do not have presumed bladder cancer will not be eligible

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 |
| --- | --- |
| BC Patients<br>Patients with bladder cancer. This registry involves no intervention. Blood, urine, and tissue samples will be collected to be used for research. | Other: Registry<br>* Patient registry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood, urine and tissue characteristics of bladder cancer patients | Samples will be collected over a 24 month period for patients to build a biorepository for future research on how they are related to tumor development, recurrence and survival. | 24 months |
What is the Gold Standard of Airway Management in the Anticipated Difficult Airway

Study Overview
=================
Brief Summary
-----------------
A prospective Observationalstudie to analyze the current significance of the awake flexible endoscopy in German hospitals.

Detailed Description
-----------------
The aim of the study is to analyze the current significance of the awake flexible endoscopy in German hospitals, to identify strategies to securing the airway in patients with a anticipated difficult airway. The participants complete a pre-prepared questionnaire.

Official Title
-----------------
Survey on the Current Significance of the Flexible Endoscopy as the Gold Standard for Airway Management in Patients With Anticipated Difficult Airway

Conditions
-----------------
Airway Morbidity

Intervention / Treatment
-----------------
* Device: Airway Management in patients with a anticipated difficult airway


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: experience in anesthesia or intensive care Exclusion Criteria: no
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Airway Management in patients with a anticipated difficult airway|survey of anesthesists and intensive care physician of the perfomans with the flexible endoscope in patients with a anticipated difficult airway|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| What is the current practice for Airway Management in patients with a anticipated difficult airway? | Evaluation of the current practice to secure the airway in patients with a anticipated difficult airway | through study completion, an average of 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| What is the most preferred technique for awake flexible endoscopy? | Evaluation of application (nasal/oral), local anesthestics | through study completion, an average of 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
flexible endoscopy, awake intubation
Compassionate Use of Defibrotide for Patients With Veno-occlusive Disease of the Liver

Study Overview
=================
Brief Summary
-----------------
Veno-occlusive disease (VOD) of the liver is a significant complication for some patients undergoing hematopoietic stem cell transplantation. This disease is thought to be a toxicity secondary to chemotherapy or radiation-induced damage to the epithelial cells of the blood vessels in the liver. VOD is categorized as mild, moderate or severe. Historically, there has been no method to treat the disease. Recently, however, there have been investigations into the use of a new agent called defibrotide. The primary purpose of this protocol is to provide defibrotide to patients with severe VOD. Because this drug has not been approved by the FDA, use of this medication under the auspices of this IND treatment plan is for compassionate use only.

Detailed Description
-----------------
Secondary objectives of this protocol include the following: To describe the toxicities of defibrotide in patients with VOD. To describe the response rate of VOD in patients receiving defibrotide.

Official Title
-----------------
Compassionate Use of Defibrotide for Patients With Veno-Occlusive Disease

Conditions
-----------------
Hepatic Veno-occlusive Disease

Intervention / Treatment
-----------------
* Drug: Defibrotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with clinical or pathologic diagnosis of veno-occlusive disease. The following criteria will be used: Hyperbilirubinemia (greater than or equal to 2mg/dl) and two of the following: (hepatomegaly, ascites, or weight gain [greater than or equal to 5% of baseline]); OR, Patient who do not fulfill criteria in #1 but who have pathologic or radiographic evidence of VOD.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Defibrotide|Defibrotide to be administered approximately every 6 hours at an initial dose of 6.25 mg/kg/dose. Subsequent doses will be escalated with a plateau of 15 mg/kg/dose (or 60 mg/kg/day total). For patients with persistent VOD, the dose may be escalated by 10 mg/kg/day as needed to a maximum of 110 mg/kg/day total.|

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
-----------------
Hepatic Veno-occlusive Disease
A Study of MSI-1256F (Squalamine Lactate) To Treat Wet Age-Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
Age-Related Macular Degeneration (AMD) is a degenerative eye disease of the retina that causes a progressive loss of central vision. AMD is the leading cause of legal blindness among adults age 50 or older in the Western world. AMD presents in two different types - dry and the more severe wet form. Wet AMD is caused by the growth of abnormal blood vessels in the macula. Squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels. This study will test the safety and efficacy of Squalamine in the treatment of AMD.

Official Title
-----------------
A Phase 2, Randomized, Open Label, Safety, and Pharmacodynamic Study of Squalamine Lactate for Injection for the Treatment of Minimally Classic or Active Occult Choroidal Neovascularization Associated With Age-Related Macular Degeneration

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Drug: MSI-1256F (Squalamine Lactate)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult subjects ≥ 50 years of age. minimally classic or active occult choroidal neovascularization associated with age-related macular degeneration in one or both eyes. baseline best corrected visual acuity score between 35 to 65 letters according to the Early Treatment of Diabetic Retinopathy Study protocol. central retinal thickness by optical coherence tomography of > 250 microns. lesions > 9 disc areas. > 25% fibrosis in the lesion. Exclusion Criteria: Previous history of triamcinolone, bevacizumab, ranibizumab, or pegaptanib sodium injection therapy in the study eye. retinal or optic nerve disease. uncontrolled diabetes. ongoing malignancy.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MSI-1256F (Squalamine Lactate)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety profile of squalamine lactate at doses ranging from 40 mg to 160 mg of squalamine lactate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate short-term effects on best corrected visual acuity and changes in subretinal CNV as measured by optical coherence tomography |  |  | 
| To evaluate short-term effects on best corrected visual acuity and changes in subretinal CNV as measured by fluorescein angiography |  |  |
Austria Study - Analysis of Difference Between Active and Passive Fixation Leads

Study Overview
=================
Brief Summary
-----------------
In this study the difference between screw in leads actively fixed in the septum and tined leads passively fixed in the apex concerning electrical parameters and implantation time will be evaluated. In addition the influence of the stimulation location by type of lead on QRS width, ejection fraction and NYHA class will be evaluated using and electrocardiogram and echocardiogram.

Official Title
-----------------
Analyse Der Unterschiede Zwischen Aktiv-fixierenden Und Passiv-fixierenden Stimulations-Elektroden Hinsichtlich Implantationsdauer Und Elektrischer Parameter

Conditions
-----------------
Bradycardia, Heart Block, Sick Sinus Syndrome

Intervention / Treatment
-----------------
* Device: Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age < 18 years, indication for pacemaker implantation according to current guidelines, written consent of the patient Exclusion Criteria: Live expectancy < 6 months, pregnancy or women without contraception in birth bearing age, inability or refusal to sign consent form, simultaneous participation in another clinical trial, contraindication for any procedure required during pacemaker implantation, patients who need other pacemaker systems including pacing leads than those required by the protocol, heart failure (LVEF <35%, QRS-Width>150ms), functional (rate dependent) bundle branch bloc

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 |
| --- | --- |
| Experimental: Active fixation lead<br>Active fixation lead was implanted | Device: Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip<br> <br> |
| Active Comparator: Passive fixation lead<br>Passive fixation lead was implanted | Device: Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QRS width |  |  | 
| Ejection fraction |  |  | 
| NYHA class |  |  |
Regional Anesthesia

Study Overview
=================
Brief Summary
-----------------
Both techniques are efficacious for sacral anesthesia during vaginal surgeries. Dural puncture epidural technique allows partial confirmation of epidural catheter placement.

Official Title
-----------------
Comparative Study Between Dural Puncture Epidural Technique and Conventional Epidural Technique During Elective Gynecological Vaginal Surgeries

Conditions
-----------------
Anesthetic Regional Techniques for Vaginal Surgeries

Intervention / Treatment
-----------------
* Device: Whitacre spinal needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II --Age(25-55)years Height(150-170cm) Exclusion Criteria: patient refusal severe mitral or aortic stenosis

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conventional epidural<br>epidural needle: Tuhoy needle 1.3mm (18 G) with 20G multi-orifice epidural catheter | |
| Dural puncture epidural<br>epidural needle;Tuhoy needle 1.3mm (18G)with 20G multi-orifice epidural catheter and 25G Whitacre spinal needle | Device: Whitacre spinal needle<br>* 25G Whitacre spinal needle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of bilateral sacral sensory loss | sacral sensory loss is observed by needle brick | 4months |
Effect of 4 Liver Fibrosis Tests (PIIINP, CIV, LN, and HA) on the Prognosis of Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Liver biopsy is the reference method for the measurement of liver fibrosis. But it has many limitations, such as sampling error and individual variation in interpreting the results. Currently, serum liver fibrosis markers have been employed as non-invasive diagnosis of liver fibrosis and evaluation of the severity of liver fibrosis. They include laminin (LN), hyaluronic acid (HA), collagen type IV (CIV), and N-terminal propeptide of collagen III (PIIINP). However, few study was conducted to explore the role of these liver fibrosis markers in evaluating the prognosis of liver cirrhosis. Our hypothesis is that LN, HA, CIV, and PIIINP in combination or alone can predict the prognosis of liver cirrhosis.

Official Title
-----------------
Effect of 4 Liver Fibrosis Tests (PIIINP, CIV, LN, and HA) on the Prognosis of Liver Cirrhosis: A Single-center, Prospective, Observational Study

Conditions
-----------------
Liver Cirrhosis

Intervention / Treatment
-----------------
* Other: Venous blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients were admitted to our department. Patients were diagnosed with liver cirrhosis. Patients signed the informed consent and agreed to test serum liver fibrosis markers (PIIINP, CIV, LN, and HA). Exclusion Criteria: Non-cirrhotic patients. Malignancy. Severe cardiopulmonary diseases. Severe infectious diseases. Other diseases with a shortened lifespan. Pregnant and breastfeeding. Poor adherence.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Venous blood|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 6-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic decompensation events |  | 6-12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prognosis
Measurement of Soluble Factors and Particulate Matter in Induced Sputum and EBC in Inflammatory Diseases of the Lung

Study Overview
=================
Brief Summary
-----------------
In the present study inflammatory mediators will be isolated in induced sputum and exhaled breath condensate and will be correlated with particulate matter measured in these samples.Particulate matter will be assessed by partcle size distribution method and shape analysis. The aim of the study is to perform biological monitoring in environmental and occupational diseases in a non invassive fashion.

Conditions
-----------------
Asthma, Chronic Obstructive Pulmonary Disease, Interstitial Lung Diseases, Occupational Lung Diseases

Intervention / Treatment
-----------------
* Other: no generic names


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 7-80 Exclusion Criteria: FEV1 < 75% predicted pO2 < 75

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no generic names|nan|

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
-----------------
Primary disease or condition being studied: Asthma -COPD-Interstitial Lung Diseases-Occupational Lung Diseases
Role of microRNA in the Development of Cutaneous Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to analyze the differential expression of the miR transcriptome in the distinctive stages of the development of cutaneous squamous cell carcinoma (C-SCC). In this aim the investigators plan to recruit a cohort of 20 patients suffering of C-SCC and to collect from each of them, biopsies corresponding to i) non UV-exposed areas ii) UV-exposed areas, iii) actinic keratosis and iv) tumoral regions. Total RNAs will be prepared from each biopsy and the miRNA profiles will be characterized using a dedicated miR array.

Conditions
-----------------
Cancer of the Skin

Intervention / Treatment
-----------------
* Genetic: Arm A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient older than 40th, suffering of a C-SCC letter of consent signed by the patient to be registered to social security Exclusion Criteria: Pregnant women or breastfeeding. Small C-SCC (size < 6mm) Allergy to Xylocaine All vulnerable (minor, adult guardianship…)

Ages Eligible for Study
-----------------
Minimum Age: 40 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: ARM A<br>4 distinct biopsies will be taken in a non UV-exposed area (inner arm) in a UV-exposed area (external surface of the forearm) in a pretumoral region (actinic keratosis) inside the tumor | Genetic: Arm A<br>* 4 distinct biopsies will be taken in a non UV-exposed area (inner arm) in a UV-exposed area (external surface of the forearm) in a pretumoral region (actinic keratosis) inside the tumor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miRNAs | We will select the miRNAs differently expressed between biopsies obtained respectively from areas of normal, pretumoral and tumoral areas (candidate miRs = miRs potentially involved in tumor transformation of epidermal keratinocytes). This will be assessed by analyzing in each of the biopsies from each patient, the expression of different miRs that are known to date, using a dedicated microarray, then by checking the data obtained by quantitative PCR. | 1 year |