linjc16/ctgov huggingface dataset:
Dornase Alfa Administered to Patients With COVID-19 (DACOVID)

Study Overview
=================
Brief Summary
-----------------
Mechanically ventilated patients with coronavirus disease 2019 (COVID-19) have a mortality of 24-53%, in part due to distal mucopurulent secretions interfering with ventilation. Dornase alfa is recombinant human DNase 1 and digests DNA in mucoid sputum. Nebulized dornase alfa is FDA-approved for cystic fibrosis treatment. DNA from neutrophil extracellular traps (NETs) contributes to the viscosity of mucopurulent secretions. NETs are found in the serum of patients with severe COVID-19, and targeting NETs reduces mortality in animal models of acute respiratory distress syndrome (ARDS). Thus, dornase alfa may be beneficial to patients with severe COVID-19-acting as a mucolytic and targeting NETs.

Detailed Description
-----------------
Demographic, clinical data, and outcomes were collected from the electronic medical records of five mechanically ventilated patients with COVID-19-including three requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO)-treated with nebulized in-line endotracheal dornase alfa co-administered with albuterol (used to increase delivery to the alveoli), between March 31 and April 24, 2020. Data on tolerability and responses, including longitudinal values capturing respiratory function and inflammatory status, were analyzed.

Official Title
-----------------
Nebulized In-line Endotracheal Dornase Alfa and Albuterol Administered to Mechanically Ventilated COVID-19 Patients: A Case Series

Conditions
-----------------
COVID-19, Mechanical Ventilation

Intervention / Treatment
-----------------
* Drug: Dornase Alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mechanically ventilated patients with COVID-19 Exclusion Criteria: healthy, non-ventilated

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dornase Alfa|nebulized in-line endotracheal dornase alfa co-administered with albuterol|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants discharged from the intensive care unit (ICU) | discharge from ICU will be determined from the enterprise health record reporting database | 2 months | 
| Number of participants who survived COVID-19 | survival will be determined from the enterprise health record reporting database | 2-4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in FiO2 | fraction of inspired oxygen requirements will be measured | 2 months |
Clinical Study of Effectiveness of Radiotherapy Before Surgery in High-risk Relapse Hepatocellular Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the effectiveness of radiotherapy before surgery in high-risk relapse hepatocellular cancer patients.

Official Title
-----------------
Effectiveness of Radiotherapy Before Surgery in Patients With High-risk Relapse Hepatocellular Carcinoma

Conditions
-----------------
Carcinoma, Hepatocellular

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of HCC In high risk of recurrence of HCC but still can endure palliative resection KPS scores are >90 With Child-Pugh Class A liver funcion, serum bilirubin< 1.5*normal maxism; ALT and AST< 1.5*normal maxism; normal creatinine and urea nitrogen; WBC>4×109/L, Hb>110g/L, PLT>90X109/L. Have signed informed consent Exclusion Criteria: HCC cannot be operated With Child-Pugh Class B/C Have other organ cancer, excluding curative non-melanotic skin cancer and carcinoma in situ of cervix Have other severe disease With active hepatitis Have accepted local radiation therapy in other hospitals KPS scores≤70 Tumor edges cannot be defined Have severe cirrhosis complication Intensity modulated radiation therapy cannot reach required dose Cannot cooperate Lactant or pregnant Cannnot be informed

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: radiation<br> | Radiation: radiotherapy<br>* radiotherapy before surgery<br>|
| No Intervention: no radiation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiotherapy, General Surgery
Restart Anticoagulation in Patients With Spontaneous Intracerebral Hemorrhage and Mechanical Heart Valves

Study Overview
=================
Brief Summary
-----------------
The investigators retrospectively reviewed the electronic medical records of the patients with spontaneous cerebral hemorrhage and mechanical valves from 2015 to 2020 in the second affiliated hospital of Zhejiang university medical college. Medical documents and patient data were reviewed, including patient age, gender, type of mechanical heart valve, replacement time, replacement site, underlying disease, anticoagulant drugs at admission, type of cerebral hemorrhage, treatment mode, time without anticoagulant, length of stay, mortality, etc

Official Title
-----------------
Restart Anticoagulation in Patients With Spontaneous Intracerebral Hemorrhage and Mechanical Heart Valves

Conditions
-----------------
Cerebral Hemorrhage

Intervention / Treatment
-----------------
* Drug: Low molecular weight heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with spontaneous cerebral hemorrhage and mechanical valves Exclusion Criteria: age<18y pregnant patients death in 24 hours without anticoagulant

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 |
| --- | --- |
| cerebral hemorrhage<br> | Drug: Low molecular weight heparin<br>* Anticoagulation therapy<br>|
| thromboembolism<br> | Drug: Low molecular weight heparin<br>* Anticoagulation therapy<br>|
| no thromboembolism and cerebral hemorrhage<br> | Drug: Low molecular weight heparin<br>* Anticoagulation therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival and death patients after follow-up investigation for 60 months | the patients with spontaneous cerebral hemorrhage and mechanical valves in the second affiliated hospital of Zhejiang university medical college. | 2015-2020 |
Comparative Study of Non-contact Tonometers for Intraocular Pressure and Corneal Cell Thickness Measurements

Study Overview
=================
Brief Summary
-----------------
The primary objective of this clinical study is to collect clinical data to support FDA 510(k) submissions for the Topcon CT-800, CT-1, CT-1P and TRK-2P non-contact tonometers. The secondary objective is to evaluate any adverse events found during the clinical study.

Official Title
-----------------
Comparative Study of the Topcon Tonometers - CT-800, CT-1, CT-1P and TRK-2P to Demonstrate Conformance to ANSI Z80.10-2009 Ophthalmic Instruments -Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and to the Applicable Supplemental Information Sheet and Comparison of Pachymetry Values for CT-1P and TRK-2P With the Konan CellChek Plus (Predicate)

Conditions
-----------------
Intraocular Pressure, Corneal Pachymetry

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age of either sex and any race or ethnicity; Willing and able to provide written informed consent prior to any study procedures being performed; Willing and able to follow all instructions and attend all study visits; Best Spectacle Corrected Visual Acuity (BSCVA) of 0.3 logMAR (20/40 Snellen equivalent) or better in both eyes as measured using an ETDRS chart. Exclusion Criteria: Only one functional eye; Poor or eccentric fixation; Corneal scarring or have had corneal surgery, including corneal laser surgery; Microphthalmos; Buphthalmos; Contact lens wearer, meaning having worn soft contact lenses within the past 3 months and/or rigid permeable gas lenses within the past 6 months; Dry eyes, meaning having been diagnoses by a physician with dry eyes and currently using a prescribed medication; Lid squeezer - blepharospasm; Nystagmus; Keratoconus; Any other corneal or conjunctival pathology or infection; Condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Male and female adults 18+ years of age<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement of intraocular pressure measurements from predicate vs. investigational device |  | Single timepoint - 1 day | 
| Agreement of central corneal thickness measurements from predicate vs. investigational device |  | Single time point - 1 day |
The Effects of Anaesthetic Agents on Postoperative Delirium

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prove the correlation between the post-operative delirium (POD) and anesthetic agents. The investigators hypothesized that intravenous anaesthetics would show the lower incidence of POD, compared with inhalation anaesthetics in off-pump CABG.

Detailed Description
-----------------
The medical records of the patients undergoing off-pump coronary artery bypass grafting (CABG) in Konkuk University Medical Centre from Jan 2010 to Aug 2014 were retrospectively reviewed.

Official Title
-----------------
The Effects of Anaesthetic Agents on Postoperative Delirium in the Patients Undergoing Off-pump Coronary Artery Bypass Grafting Surgery

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing off-pump coronary artery bypass grafting Exclusion Criteria: Other concurrent surgery Conversion from off-pump coronary artery bypass grafting to on-pump coronary artery bypass grafting
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Propofol group<br>Patient anesthetized using propofol | |
| Sevoflurane group<br>Patients anesthetized using sevoflurane | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative delirium |  | up to postoperative 7 days |
Study Evaluating CCI-779 in Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to compare the therapeutic response and safety of 3 oral dose levels of CCI-779, with placebo in subjects with active rheumatoid arthritis (RA) who have been receiving stable doses of methotrexate (MTX) for at least 8 weeks.

Official Title
-----------------
A Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Safety of 3 Different Oral Dose Levels (1, 2, And 4 Mg) of CCI-779 in Subjects With Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: CCI-779
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet American College of Rheumatology (ACR) criteria for RA Have active RA consisting of ≥ 6 swollen and ≥ 6 painful joints ACR functional class I-III Exclusion Criteria At screening the subject's prior medications are reviewed. (Prior history of disease-modifying antirheumatic drug (DMARD) use is recorded, including the start and stop dates of the most recently taken DMARDs) Significant concurrent medical diseases Abnormal chest radiograph, including findings consistent with interstitial pneumonitis, granulomatous disease, or pleural effusion and/or infiltration

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>CCI-779 1 mg dose to be taken orally daily up to 12 weeks. | Drug: CCI-779<br> <br> |
| Experimental: B<br>CCI-779 2 mg dose to be taken orally daily up to 12 weeks. | Drug: CCI-779<br> <br> |
| Experimental: C<br>CCI-779 4 mg dose to be taken orally daily up to 12 weeks. | Drug: CCI-779<br> <br> |
| Placebo Comparator: D<br>Placebo dose to be taken orally daily up to 12 weeks. | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Improved Muscle Function in Duchenne Muscular Dystrophy Through L-Arginine and Metformin

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to show that the intake of L-arginine and metformin improves muscle function and delays disease progression in patients with Duchenne's muscular dystrophy.

Detailed Description
-----------------
This is an investigator-initiated, open-label, single-center, proof-of-concept-study. The study medication consists of L-arginine and metformin. The duration of the study is 16 weeks and comprehends one screening and four study visits.

Conditions
-----------------
Duchenne Muscular Dystrophy

Intervention / Treatment
-----------------
* Drug: Metformin
* Drug: L-Arginine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Molecular diagnosis of DMD Patients 7 - 10 years of age at time of screening Ambulant Exclusion Criteria: Previous (3 months or less) or concomitant participation in another therapeutic trial Use of L-arginine, L-citrulline or metformin within the last 3 months Known individual hypersensitivity to L-citrulline or metformin Other chronic disease or clinical relevant limitation of renal, liver, heart function according to discretion of the investigator

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 10 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-arginine and metformin<br>7.5 g L-arginine p.o. and 500 mg metformin p.o. per day (3x 2.5 g, respectively 3x 250 mg) for 16 weeks | Drug: Metformin<br> <br> Drug: L-Arginine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change of muscle metabolism | mitochondrial protein expression analysis in muscular biopsies | baseline to week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In vivo change of muscle metabolism | indirect calorimetry, Dual-Energy X-Ray Absorptiometry, quantitative thigh muscle MRI, clinical score of muscle performance | baseline to week 16 |
Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Galeterone

Study Overview
=================
Brief Summary
-----------------
This is an open label, single dose, 1 period study of [14C] galeterone.

Detailed Description
-----------------
This is an open label, 1 period study under fed conditions. Six (6), healthy, adult, non tobacco using, male subjects will be enrolled. Screening of subjects will occur within 28 days prior to dosing. On Day 1, a single dose of radio-labeled galeterone will be administered orally. Blood, urine, and fecal samples will be collected until release criteria are met to measure total radioactivity, for analysis of galeterone concentrations, and for potential metabolic profiling.

Official Title
-----------------
An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Galeterone in Healthy Male Subjects After Oral Administration

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: galeterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, adult, male, 19 to 55 years of age, inclusive, at screening. Continuous non smoker who has not used nicotine containing products for at least 3 months prior to dosing. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol. Exclusion Criteria: History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI. History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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 |
| --- | --- |
| Experimental: Single dose of [14C]-galeterone<br>[14C]-galeterone will be supplied as 325 mg capsules (powder in capsule [PIC]). The treatment to be administered will be 2600 mg ( 500 µCi) (8 x 325 mg capsules). | Drug: galeterone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radioactivity concentration equivalents in plasma |  | 168 hours | 
| Single dose galeterone concentrations in plasma |  | 168 hours | 
| Route(s) of elimination of a single [14C]galeterone dose |  | 8 days | 
| Mass balance of a single [14C]galeterone dose |  | 8 days | 
| Ratio of whole blood to plasma 14C radioactivity |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers
Physical Activity Return After Popliteal Artery Entrapement Syndrome Surgery

Study Overview
=================
Brief Summary
-----------------
evaluation of physical activity return after popliteal artery entrapement syndrome surgery with the tegner activity scale

Official Title
-----------------
Physical Activity Return After Popliteal Artery Entrapement Syndrome Surgery With Tegner Activity Scale

Conditions
-----------------
Popliteal Artery Entrapment

Intervention / Treatment
-----------------
* Behavioral: tegner acticity scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: popliteal artery entrapement syndrome surgery between 2010 and 2020 at the university center of Angers Exclusion Criteria: denied to participate

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: surgery patient<br>phone call after surgery to answer the tegner activity scale | Behavioral: tegner acticity scale<br>* phone call to complete the tegner activity scale after surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison | comparison between tegner activity scale results before and after surgery. Tegner activity scale is from 0 to 10, minimum 0 and maximum 10. Higher score means a better outcome | change from baseline of the tegner activity scale 1 year after surgery |