linjc16/ctgov huggingface dataset:
Glucocorticoid Receptor Antagonism in Subclinical Cushings

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effects of reducing the activity of endogenous glucocorticoid in patients with low-grade cortisol excess

Official Title
-----------------
A Pilot Study of the Effect of a Glucocorticoid Receptor Antagonist in Patients With Subclinical Cushings

Conditions
-----------------
Subclinical Cushing's

Intervention / Treatment
-----------------
* Drug: Mifepristone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be eligible for inclusion if: they are males and over 18, lack clinical features classically associated with Cushing's syndrome; have evidence of excess circulating cortisol Exclusion Criteria: Evidence of local or systemic malignancy; overt Cushing's syndrome; severe uncontrolled diabetes mellitus or hypertension; pregnancy; clinically significantly impaired cardiovascular function (e.g. stage IV cardiac failure); severe liver disease (liver enzymes ≥ 3 x the institutional upper limit of normal range); significantly impaired renal function (eGFR <30/min); uncontrolled severe active infection; treatment with approved or experimental steroidogenesis inhibitors, adrenolytic agents, within four weeks of admission; In women, known endometrial cancer, history of endometrial hyperplasia or vaginal bleeding of unknown cause; requirement for inhaled or systemic glucocorticoids for existing disease; impaired mental capacity or markedly abnormal psychiatric evaluation that precludes 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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mifepristone|Use of mifepristone 200mg bd for 8 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose homeostasis |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subclinical Cushing's
Spiration IBV® Valve System and Spiration Airway Sizing Kit

Study Overview
=================
Brief Summary
-----------------
This procedure allows patients to use the Humanitarian Use Device, IBV® Valve System.

Detailed Description
-----------------
IBV® Valve System The Spiration® IBV Valve System is a device to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy, or lung volume reduction surgery (LVRS). An air leak present on postoperative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. IBV Valve System use is limited to 6 weeks per prolonged air leak.

Official Title
-----------------
The Humanatarian Use of the Spiration IBV® Valve System and Spiration Airway Sizing Kit for Use in Patients at The Ohio State University Medical Center.

Conditions
-----------------
Management of BPF (Bronchopleural Fistulae)

Intervention / Treatment
-----------------
* Device: treatment with valves (The Spiration® IBV Valve System)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unresolved BPF Not candidate for surgical repair

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: treatment<br>Loading IBV® Valve System | Device: treatment with valves (The Spiration® IBV Valve System)<br>* treat BPF<br>* Other names: IBV Valve System;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resolution of BPF (Bronchopleural Fistulae) | expected resolution of BPF (Bronchopleural Fistulae) in three weeks | 6 weeks | 
| resolutin of BPF | anticipated the with the use of valves the BPF would improve and the valves can be removed in 6 weeks | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BPF(Bronchopleural fistulae)
A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to compare the pharmacokinetics of ASP1941 in type 2 diabetes mellitus patients with normal renal function and those with mild or moderate renal impairment.

Official Title
-----------------
An Open-Label Study to Assess the Effect of Different Grades of Renal Impairment in Japanese Patients With Type 2 Diabetes Mellitus on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP1941 Relative to Type 2 Diabetes Mellitus Patients With Normal Renal Function

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: ASP1941


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic patients for at least 12 weeks Fasting plasma glucose level of < 240 mg/dL Body Mass Index ( BMI )20.0 - 35.0kg/m2 GFR value based on the Japanese GFR estimation equation at screening, of ≥ 30 ml/min/1.73m2 Exclusion Criteria: Type 1 diabetes mellitus patients Receiving insulin within 12 weeks before screening Diabetic ketoacidosis Dysuria and/or urinary tract infection, genital infection Significant renal, hepatic or cardiovascular diseases Severe gastrointestinal diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal renal function group<br>oral | Drug: ASP1941<br>* oral<br>|
| Experimental: Mild renal impairment group<br>oral | Drug: ASP1941<br>* oral<br>|
| Experimental: Moderate renal impairment group<br>oral | Drug: ASP1941<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of ASP1941 |  | For 72 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary levels of ASP1941 |  | For 72 hours after dosing | 
| Urinary glucose excretion |  | For 72 hours after dosing | 
| Safety assessed by adverse events, vital signs, laboratory tests and 12-lead ECGs |  | For 72 hours after dosing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary glucose excretion, Diabetes mellitus, ASP1941
Distribution and Prognostic Impact of Oncogenic Drivers in Metastatic Lung Adenocarcinoma : a Retrospective Monocentric Study in Nancy University Hospital Center

Study Overview
=================
Brief Summary
-----------------
The recent discovery of oncogenic drivers has revolutionized the management of advanced lung cancer by development of tyrosine kinase inhibitors targeted therapies. Prevalence of daily tobacco use is evaluated at 31,3 % in Grand-Est region, the only French region with a statistically significative difference for smoking habits. This region shows a higher incidence (+ 13 %) and mortality for lung cancer in comparison to the average for other French regions. The objectives of our studie were to estimate the distribution of oncogenic drivers and analyse their prognostic impacts in the Nancy University Hospital Center metastatic lung adenocarcinoma's population.

Official Title
-----------------
Distribution and Prognostic Impact of Oncogenic Drivers in Metastatic Lung Adenocarcinoma : a Retrospective Monocentric Study in Nancy University Hospital Center

Conditions
-----------------
Adenocarcinoma of Lung Stage IV, Adenocarcinoma of Lung, Response to Tyrosine Kinase Inhibitor in, Somatic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lung adenocarcinoma Patients diagnosed at a metastatic stage Patient who benefited an oncogenic driver research on their histologic samples Medical follow-up entirely done in Nancy Central Hospital Exclusion Criteria: Patients with double histology Synchronous cancer Patients with surgical care

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 |
| --- | --- | --- |
| Overall survival | Time (in months) from anatomopathological diagnosis to death | over a period of 5 years (Day 0 = anatomopathological diagnosis) | 
| Progression Free survival | Time (in months) from anatomopathological diagnosis to progression of the disease assessed by RECIST criteria | over a period of 5 years (Day 0 = anatomopathological diagnosis) | 
| Distribution in percentage of main oncogenic drivers in histological samples from metastatic lung adenocarcinoma | Distribution in percentage of main oncogenic drivers (KRAS, EGFR, ALK, ROS-1, BRAS and HER2), assessed by Sanger sequencing or FISH method in histological samples from metastatic lung adenocarcinomas | At base line (Day 0 = anatomopathological diagnosis) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution in percentage of metastasis sites according oncogenic drivers | Distribution in percentage of metastatic sites assessed by CT-scan for metastatic lung adenocarcinomas according oncogenic drivers (KRAS, EGFR, ALK, ROS-1, BRAS and HER2) | At baseline (Day 0 = anatomopathological diagnosis) |
Study to Evaluate the Efficacy and Safety of Daglutril Compared to Placebo on Top of Losartan in Type 2 Diabetics With Overt Nephropathy and Well Controlled Hypertension

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the end of treatment effect of Daglutril compared to placebo on top of losartan.

Official Title
-----------------
A Randomized, Double-Blind, Placebo Controlled, Two-Treatment and Two-Period Cross-Over, Mono-Center Study to Evaluate the Efficacy and Safety of Daglutril 300 mg Once Daily Compared to Placebo on Top of Losartan in Type 2 Diabetics With Overt Nephropathy and Well Controlled Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Daglutril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: treated with optimized dose of losartan (constant dose for at least four weeks before randomization and throughout the whole study period) for at least four weeks urinary albumin excretion ≥ 20 and < 1000 µg/min sitting systolic/diastolic blood pressure (SBP/DBP) < 140/90 mmHg at the end of placebo run-in phase Exclusion Criteria: known secondary hypertension decompensated congestive heart failure

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Daglutril|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
-----------------
blood pressure, diabetic nephropathy, proteinuria
Dynamic Heart Failure Prediction With Real-time Functional Status Data in the Ambulatory Setting

Study Overview
=================
Brief Summary
-----------------
Heart failure is the number one cause of hospital readmission in those over 65 years of age and the current standard-of-care of weight self-monitoring is inadequate to predict exacerbation. This project aims to improve the monitoring of heart failure disease progression through the use of real-time, up-to-date data obtained both from a smart phone-based tool and from the electronic health record. The goal is to develop a low-risk, clinically validated method to estimate dynamic heart failure risk to enable the provision of earlier, more effective outpatient interventions that decrease hospitalization.

Official Title
-----------------
Dynamic Prediction of Heart Failure Using Real-time Functional Status and Electronic Health Record Data in the Ambulatory Setting

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

Intervention / Treatment
-----------------
* Diagnostic Test: 6 Minute Walk Test Smart phone Application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized for decompensated heart failure Age >=18 years Owns a smart phone Willing to measure self assess 6 minute walk test weekly Exclusion Criteria: None

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Observational Arm<br>Participants will be asked to measure self-assessed 6 minute walk test via the smart phone application twice a week for 2 months after discharge from a heart failure hospitalization, and weekly thereafter for 6 months. | Diagnostic Test: 6 Minute Walk Test Smart phone Application<br>* The intervention requests participants to user the smart phone application at prescribed frequencies during the follow-up period.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart failure hospitalization | hospital inpatient admission or emergency room visit | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart failure mortality | Death from heart failure | 12 months |
Hypofractionated Imrt (Vmat-Ra) For Elderly Patients With Newly Diagnosed High Grade Glioma

Study Overview
=================
Brief Summary
-----------------
To assess the effect of IMRT using VMAT rapidarc approach, followed by adjuvant temozolomide on survival and quality of life in elderly, poor performance status patients with newly diagnosed HGG.

Detailed Description
-----------------
Investigators designed this study with the aim to assess the effect of IMRT using VMAT rapidarc approach, followed by adjuvant temozolomide on survival and quality of life in elderly, poor performance status patients with newly diagnosed HGG. The potential advantage of this approach is deliver a more selective irradiation to tumor's target with reducing the dose to normal brain and to allow the delivery of a higher dose, optimizing the therapeutic window.

Official Title
-----------------
Hypofractionated Imrt (Vmat-Ra) With Temozolomide For Elderly Patients, Unsuitable For Surgery With Newly Diagnosed High Grade Glioma

Conditions
-----------------
Glioma

Intervention / Treatment
-----------------
* Radiation: Radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged ≥ 70 years Karnosky performance status (KPS) ≤60 Histologically confirmed HGG after tumor biopsy GBM Anaplastic Astrocytoma Anaplastic Oligoastrocytoma Anaplastic Oligodendroglioma without IDH1 mutation and no codeletion 1p19q Estimated survival ≥ 3 months. Normal liver, Kidney and bone marrow function Written informed consent Exclusion criteria: Prior radiation therapy Other primary cancer Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiation<br>To evaluate safety and feasibility of hypofractionated Intensity Modulated Radiotherapy | Radiation: Radiation<br>* hypofractionated IMRT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall Survival | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HGG
Application of Standardized Cleaning and Disinfection Mode of HFT Surface in Hospital Infection Prevention and Control

Study Overview
=================
Brief Summary
-----------------
The scientific, feasible and effective mode of standardized cleaning and disinfection of ICU high-frequency contact surfaces is discussed and verified.

Detailed Description
-----------------
This study is a multi-center unified interventional study, using the front and rear control method, it is proposed to improve the ICU traditional cleaning and disinfection method on the basis of the ICU high-frequency contact surface status survey, explore the best frequency and disinfection method of ICU high-frequency contact surface cleaning and disinfection, establish a multi-center unified ICU high-frequency contact surface standardized cleaning and disinfection mode, in order to achieve the ideal cleaning and disinfection effect, effective prevention and control of ICU hospital infection occurrence and transmission.

Official Title
-----------------
Application of Multi-center Unified High-frequency Contact Surface Standardized Cleaning and Disinfection Mode in Hospital Infection Prevention and Control in ICU

Conditions
-----------------
Hospital Infection

Intervention / Treatment
-----------------
* Behavioral: cleaning and disinfection mode for surfaces with high frequency contact
* Behavioral: Routine procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High-frequency contact with the surface of an object by ICU patients and their surroundings; informed consent. Exclusion Criteria: Admission < 24 hours; < 18 years old; hospital infection prior to admission to the ICU.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Multi-center unification, before-after study,
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: routine group<br>In accordance with the intensive care unit hospital infection prevention and control norms requirements | Behavioral: Routine procedure<br>* clean the high frequency contact surface like other surfaces<br>|
| Experimental: Experimental group<br>Implement a multi-center unified ICU high-frequency contact surface standardized cleaning and disinfection mode | Behavioral: cleaning and disinfection mode for surfaces with high frequency contact<br>* According to the results of the survey on the status of high frequency contact surface, the corresponding frequency and method of cleaning and disinfection are determined. Set up a multidisciplinary quality control team.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hospital infections | the difference of Incidence of hospital infections | 1 year |
FinESS Registry Study

Study Overview
=================
Brief Summary
-----------------
A prospective, post-approval registry study assessing subject rhinosinusitis symptomatic status over time following treatment with FinESS Sinus Treatment using self-administered quality of life survey data.

Official Title
-----------------
FinESS Registry Study

Conditions
-----------------
Rhinosinusitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults 18 years or older undergoing balloon dilation with FinESS Sinus Treatment and have provided voluntary consent to participate in Registry Exclusion Criteria: none

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FinESS Treatment<br>Subjects undergoing treatment with the FinESS Sinus Treatment System | |

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

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