linjc16/ctgov huggingface dataset:
Endobronchial Ultrasound Transbronchial Needle Aspiration Of Enlarged Mediastinal In Interstitial Lung Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the findings of mediastinal/hilar LN sampling by EBUS-TBNA in patients with non-sarcoidosis interstitial lung disease ( ILD) who demonstrate LN enlargement on chest imaging. Patients with non-sarcoidosis ILD referred for bronchoscopy will undergo LN sampling by EBUS-TBNA. Cytology results will be recorded along with clinico-radiologic features, BAL findings, histology and final ILD diagnosis.

Official Title
-----------------
Study Of Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Cytology Of Enlarged Mediastinal & Hilar Lymph Nodes Detected In Interstitial Lung Disease

Conditions
-----------------
Interstitial Lung Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-sarcoidosis ILD (low probably of sarcoidosis based on radiology), referred for bronchoscopy (BAL, TBLB or TBCB) in the Interventional Pulmonology Unit at Sheba Medical Center Patients with LN enlargement ≥1 cm in short diameter at stations 2, 4, 7, 10 or 11 (LN stations accessible to EBUS-TBNA) Exclusion Criteria: known ILD ILD with no indication to bronchoscopy contraindication to bronchoscopy .

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessing the findings of mediastinal/hilar LN sampling by EBUS-TBNA in patients with non-sarcoidosis ILD who demonstrate LN enlargement on chest imaging. |  | during the procedure/surgery |
Safety and Efficacy of NovaTears® + Omega-3 (0.2%) Eye Drops on Signs and Symptoms of Dry Eye

Study Overview
=================
Brief Summary
-----------------
This PMCF study is carried out following successful CE marking of NovaTears® + Omega-3 and is intended to generate systematic clinical data on the safety and performance of the device when used in accordance with the intended purpose.

Official Title
-----------------
A Multi-Center, Single Arm, Post-Market Clinical Follow-up Study to Evaluate the Safety and Efficacy of NovaTears® + Omega-3 (0.2%) Eye Drops on Signs and Symptoms of Dry Eye

Conditions
-----------------
Evaporative Dry Eye Disease

Intervention / Treatment
-----------------
* Device: NovaTears® + Omega-3 (Perfluorohexyloctane with 0.2% w/w Omega-3 fatty acid ethyl esters)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed ICF (Informed Consent Form) and data protection form Patient-reported history of DED in both eyes Have an Ocular Surface Disease Index (OSD) score ≥ 25 at Visit 1 Have Meibomian Gland Dysfunction (MGD) at Visit 1. Ability and willingness to follow instructions, including participation in all study assessments and visits Exclusion Criteria: Women who are pregnant, nursing or planning a pregnancy Ocular surface pathology, clinically significant slit-lamp findings, abnormal lid anatomy, active ocular allergies Wear of contact lenses Known allergy or sensitivity to the medical device or its components Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 60 days before Visit 1. Clinical site employees or immediate family members of the same

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 |
| --- | --- |
| NovaTears® + Omega-3<br> | Device: NovaTears® + Omega-3 (Perfluorohexyloctane with 0.2% w/w Omega-3 fatty acid ethyl esters)<br>* Eye drops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to confirm the performance, relieving symptoms and improving signs of DED, and to evaluate safety and tolerability of topical NovaTears® + Omega-3 (0.2%) eye drops, when used in accordance with its approved labeling | This PMCF study is intended to provide systematic clinical data supporting the safety and performance of the medical device NovaTears® + Omega-3 (0.2%). | 2 months |
Serum Markers as a Bioassay for Unipolar Depression

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to validate a biomarker assay for unipolar depression based on serum proteins involved in inflammation, metabolism, and stress response. The study will compare patients with a current major depressive episode to individuals with no history of depression. The hypothesis is that the assay can serve as a diagnostic tool that would be more objective than standard diagnostic questionnaires.

Official Title
-----------------
Validation of Serum Markers as a Bioassay for Unipolar Depression

Conditions
-----------------
Major Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (Depressed): Aged 18 to 60. Meets DSM-IV criteria for Unipolar Major Depression, either single or recurrent. 21 item Hamilton Depression rating scale score greater than 18. Capable of providing informed consent. Has an established residence and phone number. Exclusion Criteria: Meets DSM-IV criteria for Bipolar Disorder, Schizophrenia, Schizoaffective disorder or other major Axis I Psychiatric disorders (except for depression and phobia per above). Addison's Disease, Cushing's Disease, or other known dysfunction of the HPA-cortisol axis. Rheumatoid arthritis, lupus, or other condition associated with increased inflammation. Regular use of non-steroidal anti-inflammatory medications, steroids, or other medications know to interact with the inflammatory process of the HPA axis. A medical condition or regular use of a mediation, which I the opinion of the investigator is likely to influence the inflammatory or HPA responses. Pregnancy. Meets DSM-IV criteria for substance abuse or dependence in the last month. Regular cigarette smoking. History of fainting or other significant adverse event during blood drawing in the past.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Major Depressive Disorder<br>Adults with major depressive disorder who are experiencing a current depressive episode. | |
| Healthy controls<br>Individuals without any Axis I psychiatric diagnosis who are matched to depressed subjects by age and sex. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein biomarker MDDScore. |  | 0 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on Hamilton Depression Rating Scale (HDRS). |  | 0 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomarker, depression, blood test
Comparative Study of the Magnetic-controlled Capsule Endoscopy Versus Standard Gastroscopy

Study Overview
=================
Brief Summary
-----------------
Passive video capsule endoscopy is the criterion standard for small-bowel diseases but cannot be used for the large gastric cavity.This blinded prospective study investigates the accuracy of the magnetic-controlled capsule endoscopy compared to gastroscopy in patients with gastric symptoms and indication for upper GI Endoscopy.

Official Title
-----------------
A Double-center Self-controlled Comparative Study of the Magnetic-controlled Capsule Endoscopy Versus Standard Gastroscopy for Gastric Diseases

Conditions
-----------------
Gastric Symptoms, Indicated for Upper GI Endoscopy

Intervention / Treatment
-----------------
* Device: MCE
* Device: Standard gastroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with gastric symptoms and indicated for Upper GI endoscopy Age of 18 years to 70 years Exclusion Criteria: Patients with impaired bowel movement from ileus or organic digestive diseases Patients with known large and obstructing tumors of the upper GI tract Patients after upper GI surgery or abdominal surgery altering GI anatomy Patients under full anticoagulation Patient in poor general condition Patients using equipment that may be affected by radio transmission Patients using equipment that may be affected by magnetic field Pregnancy or suspected pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: magnetic-controlled capsule endoscocpy (MCE)<br>patients were assigned to swallow MCE first, followed by the gastroscopy | Device: MCE<br>* MCE first, followed by standard gastroscopy<br>Device: Standard gastroscopy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of magnetic-controlled capsule endoscopy(MCE) Versus Standard Gastroscopy in the diagnosis of diffuse and local lesions |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examination times of capsule and standard gastroscopy |  | 1 hour | 
| Patient acceptance of capsule gastroscopy and standard gastroscopy |  | 3 days | 
| Adverse events of both procedures |  | 2 weeks |
Thymic Tolerance in Pediatric Heart Transplantation

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that injecting donor bone marrow cells into the recipient thymus gland at the time of heart transplantation in children will prove to be feasible and safe. They further hypothesize that recipients receiving donor bone marrow will experience less acute rejection events with reduced long-term requirements for immunosuppressive medications when compared to controls who do not receive marrow but who are managed under an identical immunosuppressive protocol.

Official Title
-----------------
Thymic Tolerance in Pediatric Heart Transplantation

Conditions
-----------------
Heart Transplantation

Intervention / Treatment
-----------------
* Procedure: donor bone marrow cell injection into thymus gland


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Less than 21 years of age at listing Listed for primary orthotopic heart transplant at Children's Hospital of Pittsburgh, between 04/01/04 and 03/31/08 Exclusion Criteria: History of prior transplant Listed for multi-organ transplant Sensitized against human HLA tissue types Documentation of total thymomectomy during a prior surgery

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 20 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: donor bone marrow cell injection into thymus gland|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if intra-thymic inoculation of donor bone marrow cells at time of heart transplantation in children will reduce frequency of acute rejection as well as long-term requirements of immunosuppressive medications when compared to control patients |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare results of serial in vitro immunological monitoring among patients receiving intra-thymic bone marrow and controls |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone marrow, transplantation tolerance, thymus, pediatric heart transplantation
Single and Multiple Dose Safety, Tolerability, and Pharmacokinetics Study of PF-04805712 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To assess the safety and tolerability of escalating single and multiple doses of the compound in healthy volunteers

Official Title
-----------------
A Phase 1 Randomized, Double Blind (3rd Party Open), Placebo Controlled Combined Single And Multiple Dose Safety, Tolerability And Pharmacokinetics Study Of Orally Administered PF-04805712 In Healthy Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: PF-04805712


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males and females of non-childbearing potential. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-04805712<br> | Drug: PF-04805712<br>* ascending single and multiple doses starting at 30 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Adverse events, vital signs measurements, telemetry, 12 lead ECGs, blood and urine safety tests. |  | 12 weeks | 
| Pharmacokinetics: PK parameters will be determined after single dose, fasted and (at one dose) fed, and at steady state (fasted or fed depending on single dose data). |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics: Urinary LTE4 |  | 12 weeks |
Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects by Dermal Application of a LEO 29102

Study Overview
=================
Brief Summary
-----------------
The principal aim of this study is to obtain safety, tolerability and pharmacokinetic data when LEO 29102 is administered cutaneously as single and multiple doses to healthy subjects. The study is divided into one single dose part, one part to compare pharmacokinetics between gender and one multiple dose part.

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: LEO 29102
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will be Caucasian males and females between 18 and 55 years of age and with a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive. Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations Exclusion Criteria: Subjects who suffer from, or show signs of eczema or other skin lesions. Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity), or a marketed drug within the past 3 months prior to the first dosing occasion. Subjects with a significant history of drug allergy as determined by the Investigator. Subjects with known immunocompromised state due to treatment with immunosuppressive drugs or due to history of a disease leading to immunocompromised status.

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEO 29102<br> | Drug: LEO 29102<br> <br> |
| Placebo Comparator: LEO 29102 vehicle<br> | Drug: Placebo<br>* Placebo Comparator: LEO 29102 vehicle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events (AEs) and change from baseline in vital signs (blood pressure, pulse rate, respiratory rate and oral body temperature), ECG, telemetry,clinical laboratory and local tolerability assessments |  | 7 days after last dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LEO 29102 and metabolites in blood and urine |  | 72 hours after dosing |
Study of the Impact of Hypersplenism and Splenectomy on Hepatocarcinogenesis in Patients With Posthepatitic Cirrhosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the impact of splenectomy coupled with portal-azygous disconnection on hepatocarcinogenesis in patients with post-hepatitic cirrhosis after hepatitis B or C virus infection by retrospective case-control study,We hope to find a new idear and method to prevent or cure HCC.

Detailed Description
-----------------
A case-control study was carried out. The factors studied include age, gender, ascites, hepatic encephalopathy, ALT, AST, TBIL, ALP, GGT, Child-Pugh classification of liver function, and history of splenectomy with portal-azygous disconnection during the treatment of portal hypertension. According to the Child-Pugh classification, these cases were graded as A, B, and C. And according to the ranges of the normal reference values of the data, they were categorized into two groups including a normal group and an abnormal group.The data mainly comes from FMMU and Xi'an jiaotong university from the year of 2002 to 2012.

Official Title
-----------------
Multicentric Retrospective Case Control Study of the Impact of Hypersplenism and Splenectomy on Hepatocarcinogenesis in Patients With Posthepatitic Cirrhosis

Conditions
-----------------
Liver Cirrhosis, Carcinoma, Hepatocellular, Splenomegaly, Laparotomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: after surgery Exclusion Criteria: without surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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
-----------------
Posthepatitic cirrhosis;, Hepatocarcinogenesis;, Splenectomy;
Intra Hospital Mortality Risk Factors in Patients Admitted to Cardiac Intensive Care Units in 2017 in France

Study Overview
=================
Brief Summary
-----------------
Retrospective, observational cohort study. Objectives: To identify intra hospital mortality risk factors in patients admitted admitted to cardiac intensive care units (CICU). The clinical main endpoint will be the observed percentage of deaths that occured during the year 2017 in french CICU. To identify the length of stay key determiners of patients admitted in french CICU. The study will use data from one of the french nationwide healthcare systems database (SNDS) : the national hospital discharge database (PMSI) to be precise.

Official Title
-----------------
Intra Hospital Mortality Risk Factors in Patients Admitted to Cardiac Intensive Care Units in 2017 in France: A Nationwide Retrospective Observational Cohort Study Using Data From the French Hospital Discharge Database

Conditions
-----------------
Heart Disease, Acute Coronary Syndrome, Acute Cardiac Failure, Heart Rhythm Disorders, Valve Pathologies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Being admitted at least one time in a french CICU in 2017 Being covered by the mandatory french national health insurance plan in 2017 without discontinuity Exclusion criteria: Being older than 18 years of age

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate | Observed percentage of deaths that occured during the year 2017 in french CICU | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay at a CICU | Length of stay at a CICU | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac intensive care unit, Organization, Prognostic score