linjc16/ctgov huggingface dataset:
Chronic Obstructive Pulmonary Disease (COPD) and Domestic Endotoxin (CODE)

Study Overview
=================
Brief Summary
-----------------
This project aims to characterize the independent effect of domestic endotoxin exposure on health status, as well as pulmonary and systemic inflammation, in former smokers with COPD. Positive findings from this study would be clinically relevant, as they would provide evidence to support aggressive reduction of ongoing endotoxin exposure in patients with COPD. The investigators also hope to make a methodological advance in the field of endotoxin exposure assessment by elucidating whether settled dust and/or airborne endotoxin measurements are the more relevant exposure of interest in epidemiological studies of respiratory disease. To fulfill the specific aims, the investigators will conduct a longitudinal study, including 75 former smokers with COPD. All subjects will have indoor air monitoring, in-home settled dust collections, home inspections as well as assessments of health status, quality of life (QOL), lung function and pulmonary and systemic inflammation.

Official Title
-----------------
COpd and Domestic Endotoxin (CODE)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient reported physician diagnosis of COPD/Chronic Bronchitis/Emphysema Cigarette Smoking > 10 pack-years Age > 40 years Has not smoked > 1 year Post BD FEV1/FVC ≤ 70% Post BD FEV1 (% predicted) 30-80% Ability and willingness to provide consent Exclusion Criteria: Non- English speaking Planning to move or live away from the home during the study period Co-morbid illnesses such as: Current physician diagnosis of Asthma Other pulmonary diseases Systemic disease requiring treatment with immunosuppressive agents Known alpha-1 antitrypsin deficiency Occupational exposure with high endotoxin exposure Within the last 6 months Use of oral corticosteroids

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| statistical analysis |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Obstructive Pulmonary Disease (COPD)
the Relationship Between Cleft Lip and / or Palate (Different Types) and ABO Blood Groups.

Study Overview
=================
Brief Summary
-----------------
Direct benefit of the research to assess the relationship between cleft lip and / or palate (different types) and ABO blood groups.

Detailed Description
-----------------
376 Egyptian cleft lip and/or palate patients ( age ranged from 2 days to 15 years ) With no syndrome. Blood group from records will be collected an d then assess the relationship between cleft lip and / or palate (different types) and ABO blood groups.

Official Title
-----------------
Distribution Of ABO Blood Groups In Relation To Cleft Lip And/or Palate .

Conditions
-----------------
Cleft Lip and Palate

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Egyptian Patients with cleft or/and palate The children's age ranged between 2 days and 15 years. Exclusion Criteria: syndromic patients

Ages Eligible for Study
-----------------
Minimum Age: 2 Days
Maximum Age: 15 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 |
| --- | --- | --- |
| Distribution of ABO blood group in relation to different types of cleft lip and/or palate . | ABO blood group | 6 months |
Entecavir to TAF Switch

Study Overview
=================
Brief Summary
-----------------
A research study to observe the safety, efficacy and tolerability of switching from Entecavir (ETV) to Tenofovir Alafenamide TAF in patients with chronic hepatitis B

Official Title
-----------------
Long-term Study to Observe Safety and Efficacy of TAF in Patients With Chronic Hepatitis B

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Drug: Tenofovir Alafenamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects, adult male and female ≥18 years of age with chronic hepatitis B with or without compensated cirrhosis Maintained on Entecavir for a minimum of 48 weeks Viral suppression (HBV DNA <20 IU/mL) for a minimum of 12 weeks prior to entry are eligible for this study. Estimated creatinine clearance ≥ 50 ml/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the baseline evaluation. Exclusion Criteria: Subjects with known poor or non-compliance Subjects with co-infection with HCV or HIV subjects with decompensated cirrhosis and HCC will be excluded to participate in the study. Pregnant women and those who wish to become pregnant during the course of the study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>SingleArm: TAF 25 mg | Drug: Tenofovir Alafenamide<br>* subjects switching from Entecavir to single arm TAF 25mg<br>* Other names: TAF;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results of viral Hepatitis B DNA to be <20 IU/mL | The proportion of subjects with plasma HBV DNA levels below 20 IU/mL at week 48. | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete viral suppression at study completion | The proportion of subjects with complete viral suppression, i.e., plasma HBV DNA level below 20 IU/mL at Week 96. | 96 Weeks | 
| Positive eGFR changes at study completion compared to Baseline visit | Change in eGFR from baseline to Week 96 | 96 weeks | 
| Improved Bone Mass Density at study completion | % change from baseline in BMD at the hip and lumbar spine at Week 96. | 96 weeks |
Study of Temozolomide in the Treatment of Brain Metastasis From Non-small-cell Lung Cancer (Study P02143)

Study Overview
=================
Brief Summary
-----------------
Brain metastases from solid tumors are diagnosed in more than 300,000 patients annually. Nonsmall cell lung cancer accounts for the majority of CNS mets. Treatment with whole brain radiation and steroids will improve neurologic symptoms in about 50% of patients although survival is short. This study will test the safety and efficacy of temozolomide in combination with radiation therapy in the treatment of patients with brain mets form nonsmall cell lung cancer.

Official Title
-----------------
A Phase II Study of Temozolomide (SCH 52365) in Subjects With Brain Metastasis From Non-Small-Cell Lung Cancer

Conditions
-----------------
Metastases, Neoplasm, Carcinoma, Non-Small-Cell Lung, Brain Neoplasms

Intervention / Treatment
-----------------
* Drug: temozolomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic confirmation of non-small-cell lung cancer Stable systemic disease Maximum of one prior chemotherapy regimen for metastatic systemic disease Radiotherapy for local control or palliative bony lesions is allowed Karnofsky of greater than or equal to 70% Adequate hematologic, renal and liver function Exclusion Criteria: Patients eligible for surgery of the brain Any previous chemotherapy for the brain metastasis Chemotherapy within 4 weeks or previous temozolomide Prior radiotherapy to the brain Radiation therapy to greater than 50% of the bone marrow Insufficient recovery from previous therapies Active nonmalignant systemic disease Inability to take oral medication Pregnant or nursing women Non use of adequate contraceptive techniques, negative urine pregnancy test is required Known AIDS related illness

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: temozolomide|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
-----------------
Brain mets, non-small cell lung cancer
Efficacy of Androgen Substitution for Hypogonadism in Men With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to get data of prevalence of testosterone deficiency in patient with T2DM in Russian Federation

Detailed Description
-----------------
Clinical and Epidemiological Characteristics and Efficacy of Androgen Substitution for Hypogonadism in Men With Type 2 Diabetes Mellitus Under Routine Clinical Practice (DESTINY)

Official Title
-----------------
Clinical and Epidemiological Characteristics and Efficacy of Androgen Substitution for Hypogonadism in Men With Type 2 Diabetes Mellitus Under Routine Clinical Practice

Conditions
-----------------
T2DM (Type 2 Diabetes Mellitus), Hypogonadism

Intervention / Treatment
-----------------
* Diagnostic Test: Laboratory tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male 45-60 years old Diagnosis of T2DM according to approved standards Signed Informed Consent Form Exclusion Criteria: Prepubertal hypogonadism of any genesis; Sexual and developmental disorders; Absence of at least one of the testicles; Cryptorchidism, including in the anamnesis; Injuries and / or surgical interventions on the genitals with loss of at least one of the testicles; Established diagnosis of panhypopituitarism in accordance with current recommendations / standards; Androgen therapy, administered at the time of the study or in the anamnesis; Admission of anabolic steroids; Alcoholism or drug addiction; Insolvency.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Laboratory tests|Testosterone HSBG Hb1Ac LH|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of hypogonadism in patients with T2DM | The prevalence of hypogonadism in patients with T2DM | 2017-2018 |
Testing the Validity of the Modified Confusion Assessment Method for the Emergency Department (mCAM-ED)

Study Overview
=================
Brief Summary
-----------------
The proposed Study validates the accuracy of the modified Confusion Assessment Method for the Emergency Department

Detailed Description
-----------------
Delirium is a complex neuropsychiatric syndrome with sudden change in cognition such as disturbance in orientation or memory particularly in elderly patients in the context of acute illness. Multiple complications such as falls or increased duration of hospitalisation may result in delirium. Long-term consequences may result in increased mortality rates and higher admissions rates to nursing homes. In 2012, delirium prevalence in the Emergency Department (ED) of the University Hospital Basel was 9.5% in patients with 65 years and over. Although a systematic delirium management was introduced in 2012, without systematic screening delirium detection rates varies between 20 and 40% only. The risk of non-detection over the complete hospitalisation is high when early delirium detection did not occur in the ED. In a preliminary evaluation we could show the usefulness of the mCAM-ED

Official Title
-----------------
Testing the Validity of the Modified Confusion Assessment Method for the Emergency Department (mCAM-ED) for the Recognition of Delirium in Elderly Patient Admitted to the Emergency Department

Conditions
-----------------
Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 65 years Exclusion Criteria: patients under resuscitation or fatal illness not speaking German being aphasic being deaf

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 115 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 |
| --- | --- | --- |
| Delirium measured by geriatricians using Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria | acute confusional states in patients | once during the stay at the emergency department which lasts an average of 24 hours | 
| Delirium measured by geriatricians using DSM-5 criteria | acute confusional states in patients | once during the stay at the emergency department which lasts an average of 24 hours | 
| Delirium measured by advanced practice nurses using the mCAM-ED | acute confusional states in patients | once during the stay at the emergency department which lasts an average of 24 hours | 
| degree of concordance between nurses' delirium measurement versus geriatricians' delirium measurement assessed in a four field matrix |  | once during the stay at the emergency department which lasts an average of 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
delirium detection
Clinical Significance of Smear or Culture Positive for Candida Spp. From Sputum Three Times a Week

Study Overview
=================
Brief Summary
-----------------
The definition of pulmonary candidiasis is still unclear.In China, isolation of candida spp. form sputum twice or three times a week has been regarded as the microbiological evidence of pulmonary candidiasis. The investigators hypothesize that patients who present respiratory symptoms and lung infiltrates together with smear of culture positive for candida spp. from sputum three times a week can not be diagnosed as pulmonary candidiasis.

Official Title
-----------------
Diagnosis of Pulmonary Candidiasis

Conditions
-----------------
Pulmonary Candidiasis

Intervention / Treatment
-----------------
* Drug: fluconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 85ys>age>14ys APACHE II<25 Lung infiltrates together with at least one of the following symptoms:cough, sputum, dyspnea with or without fever smear or culture positive for candida spp. from sputum Exclusion Criteria: Pregnancy Hypersensitivity to fluconazole Isolated candida was non-sensitive to fluconazole Severe liver or renal diseases who can not tolerate fluconazole treatment With at least one of the following high risk factors:organ transplantation, neutropenia>10ds, long term glucocorticoids therapy(equal to prednisone 30mg/d longer than 2 weeks), immunosuppressive therapy within 30ds, AIDS With one of the microbiological evidence:isolation of candida spp. from blood or other kinds of sterile site(not including urine), filamentous fungi isolated from sputum or BALF, cryptococcus isolated from sputum or CSF, galactomannan antigen positive twice for blood Probable or possible pulmonary aspergillosis Definite oral or esophageal candidiasis

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fluconazole|Intravenous or oral 400 md/d|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| invasive candidiasis |  | in hospital |
Evaluation of the Optimal Technique for Determination of Renal Function of Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the optimal technique for determination of the renal function of critically ill patients.

Official Title
-----------------
Evaluation of the Optimal Technique for Determination of the Renal Function of Critically Ill Patients

Conditions
-----------------
Renal Function, Critical Illness

Intervention / Treatment
-----------------
* Procedure: Measurement of inulin clearance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years old Intensive care patient Given informed consent Arterial infusion A bladder catheter Exclusion Criteria: Diurese < 400 mL/d

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Measurement of inulin clearance|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the determination of the renal function by other means than the golden standard, inulin clearance |  |  |
Bypass vs. Ecmo in Lung Transplantation (BELT)

Study Overview
=================
Brief Summary
-----------------
This study seeks to compare outcomes of 2 different methods of cardiopulmonary support during lung transplant surgeries.

Detailed Description
-----------------
This study will compare use of extracorporeal membrane oxygenation (ECMO) and heart-lung bypass (CPB) during lung transplant procedures and their short and long term outcomes.

Official Title
-----------------
Randomized Clinical Trial of Intraoperative Extracorporeal Membrane Oxygenation (ECMO) Versus Cardiopulmonary Bypass (CPB) in Lung Transplantation

Conditions
-----------------
Lung Transplant; Complications

Intervention / Treatment
-----------------
* Device: Extracorporeal Membrane Oxygenation
* Device: Cardiopulmonary Bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. The study population will be all patients requiring cardiopulmonary support while undergoing lung transplantation at our institution. Exclusion Criteria: Patients undergoing concomitant cardiac operations with indication for obligate use of cardiopulmonary bypass Patient with specific anatomy that require full cardiac decompression such as severe pulmonary hypertension or large heart that are shifted severely into the left chest Patients with high likelihood of significant pleural bleeding that will require returning the blood back into the cardiotomy reservoir Patients bridged to transplant with ECMO Cystic fibrosis/bronchiectasis/resistant infection patients where surgeon will need to remove both lungs prior to implantation Patients who the surgeon feels would be better served with CPB rather than ECMO- These patients will be entered into a registry and followed.

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 |
| --- | --- |
| Cardiopulmonary Bypass<br>There will be 40 patients placed on cardiopulmonary bypass during lung transplantation. | Device: Cardiopulmonary Bypass<br>* CPB is used during lung transplant procedure<br>|
| Extracorporeal Membrane Oxygenation<br>There will be 40 patients placed on ECMO during lung transplantation. | Device: Extracorporeal Membrane Oxygenation<br>* ECMO is used during lung transplant procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for Blood Transfusion | Number of pRBC transfusion that resulted due to postoperative bleeding | 72 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiopulmonary Bypass, Extracorporeal Membrane Oxygenation, Primary Graft Dysfunction, Hemorrhage, Mechanical Ventilator