linjc16/ctgov huggingface dataset:
Everolimus Related Pneumonitis in MBC

Study Overview
=================
Brief Summary
-----------------
To study the drug-related pneumonitis during mTOR inhibitor therapy in patients with metastatic breast cancer.

Official Title
-----------------
Drug-related Pneumonitis During mTOR Inhibitor Therapy in Patients With Metastatic Breast Cancer: A Radiographic Patternbased Approach

Conditions
-----------------
Everolimus, Pneumonitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal woman (or premenopausal women treated with LHRHa) diagnosed with HR+，HER2- metastatic breast cancer Treated with everolimus for at least one month in metastatic setting With baseline and at least one follow-up chest CT during everolimus therapy. Complete medical history Exclusion Criteria: Incomplete medical history Radiographic imaging unavailable

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 |
| --- | --- |
| pneumonitis group<br>Patients who developed drug-related pneumonitis after treated with everolims | |
| non-pneumonitis group<br>Patients who didn't develop drug-related pneumonitis after treated with everolims | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiographic pattern | Quantitive measure of lung CT | 2 months | 
| PFS | Progression free survival | 2 months |
Onset Time of Thiopental Versus Propofol in the Elderly

Study Overview
=================
Brief Summary
-----------------
This study is aimed at increasing the safety of the use of anaesthesia in an elderly population (> 60 years). Patients with decreased physiological reserve, including all elderly patients, have an increased risk of getting an erroneous induction bolus. This project will investigate how fast elderly patients (> 60 years) fall asleep during bolus induction of anaesthesia with two of the most used hypnotics, thiopental and propofol, evaluated with BIS-monitoring and clinical signs of anaesthetic depth. The hemodynamic response will also be evaluated.

Official Title
-----------------
Onset Time of Thiopental Versus Propofol in the Elderly

Conditions
-----------------
Induction of Anaesthesia, Age

Intervention / Treatment
-----------------
* Drug: Thiopental
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective surgical patients above 60 years of age, with an indication of general anaesthesia during surgery. Informed consent. The patient must be legally competent. The patient must be able to read and understand Danish. Exclusion Criteria: Known allergic reactions to thiopental, propofol, lidocaine or alfentanil Body Mass Index (BMI) <18 and > 35. NYHA-class > 2.

Ages Eligible for Study
-----------------
Minimum Age: 60 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thiopental<br>Thiopental for induction of anaesthesia. | Drug: Thiopental<br>* Thiopental given as a bolus dose of 2,5 mg/kg.<br>* Other names: Thiomebumalnatrium, thiomebumal;|
| Active Comparator: Propofol<br>Propofol for induction of anaesthesia. | Drug: Propofol<br>* Propofol given as a bolus dose of 1 mg/kg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset-time defined as the time from started induction bolus to: - Time to BIS-value <50. |  | 120 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamical effect (bloodpressure/pulse) every 60 seconds. |  | 120 seconds | 
| Onset-time defined as the time from started induction bolus to: - Time to loss of grip. |  | 120 seconds | 
| Onset-time defined as the time from started induction bolus to: - Time to eye closure. |  | 120 seconds | 
| Onset-time defined as the time from started induction bolus to: - Time to ciliary reflex cessation. |  | 120 seconds |
Expanded Access Remdesivir (RDV; GS-5734™)

Study Overview
=================
Brief Summary
-----------------
Disease caused by 2019 Novel Coronavirus also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

Detailed Description
-----------------
The treatment of communicable Novel Coronavirus (CODIV-19) of 2019 with Remdesivir (RDV; GS-5734™) also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

Official Title
-----------------
Intermediate-Size Patient Population Expanded Access Treatment Protocol for Coronavirus Disease 2019 (COVID-19) Remdesivir (RDV; GS-5734™)

Conditions
-----------------
Coronavirus Disease 2019

Intervention / Treatment
-----------------
* Drug: Remdesivir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DoD-affiliated personnel as defined in DoDI 6200.02, which includes emergency-essential civilian employees and/or contractor personnel accompanying the Armed Forces who are subject to the same health risk as military personnel Have a laboratory-confirmed COVID-19 diagnosis with moderate to severe disease presentation as determined by the principal investigator Patient or legally authorized representative (LAR) provides written informed consent, except as noted in 21 CFR 50.23 Understands and agrees to comply with planned study procedures Available for clinical follow-up for duration of the treatment and follow-up period Woman of childbearing potential must Have a negative pregnancy test within 24 hours before starting treatment Agree not to become pregnant during treatment and for 1 months after receiving remdesivir (Treatment will be a maximum of 10 doses given over a 10-day interval) Use at least 2 reliable forms of effective contraception, including 1 barrier method, during treatment and for 1 month after the treatment period Exclusion Criteria: ALT/AST ≥ 5 times the upper limit of normal Stage 4 severe kidney disease or requiring dialysis (i.e. eGFR <30) Anticipated transfer to another hospital that is not a study site within 72 hours Allergy to any components of the study medication [GS-5734, sulfobutylether β-cyclodextrin sodium (SBECD) and hydrochloric acid and/or sodium hydroxide] Concomitant antiviral therapy (lopinavir/ritonavir [Kaletra]) Pregnant or nursing
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Remdesivir|Remdesivir (RDV,GS-5734) is a monophosphoramidate prodrug of an adenosine analog with potent activity against an array of RNA virus families including Filoviridae, Paramyxoviridae, Pneumoviridae, and Orthocoronavirinae, through the targeting of the viral RNA dependent RNA polymerase (RdRp).|

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
-----------------
COVID-19, GS-5734, Remdesivir, SARS-CoV-2
Risk Factors of Meconium Obstruction and Respiratory Distress Syndrome in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Although the pathophysiology of meconium obstruction of prematurity (MOP) is not clear, it is known that the decrease of the intestinal peristalsis due to decreased intestinal perfusion during antenatal or perinatal period. Recently, the level of citrulline has been used as an index of function and injury of the small intestine State. This study aimed to evaluate citrulline level of cord blood as a marker for early detection and observe changes in intestinal blood flow in MOP patient. And We aimed to confirm the efficacy of the AT/ET ratio (ratio of the pulmonary artery time-to-peak velocity interval to the right ventricular ejection time) of the prenatal pulmonary artery as a noninvasive predictor of neonatal respiratory distress syndrome.

Official Title
-----------------
Prospective Cohort for Finding Risk Factors of Meconium Obstruction and Respiratory Distress Syndrome in Preterm Infants

Conditions
-----------------
Meconium Obstruction of Prematurity, Respiratory Distress Syndrome in Premature Infant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: premature infants born less than 34 weeks from mother with pregnancy induced hypertension, pre-eclampsia or eclampsia Exclusion Criteria: major congenital anomalies infants with hypotension while using inotropics

Ages Eligible for Study
-----------------
Maximum Age: 34 Weeks

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 |
| --- | --- | --- |
| Comparison of citrulline level between the meconium obstruction group and the normal feeding advance group | check the citrulline llevel from blood at birth | within 6 hours after birth | 
| Comparison of prenatal AT/ET ratio of fetal pulmonary artery between respiratory distress syndrome group and the normal respiration group | Check the AT/ET ratio of fetal pulmonary artery within 10 days before birth | within 10 days before delivery |
MiCLASP Post Market Clinical Follow-Up (PMCF) Study

Study Overview
=================
Brief Summary
-----------------
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair.

Detailed Description
-----------------
The objectives of this clinical study are to collect data on the safety of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair and on the effectiveness of the Edwards PASCAL System and Edwards PASCAL Precision System in improving MR, functional status and quality of life in a post market setting.

Official Title
-----------------
Transcatheter Repair of Mitral Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post Market Clinical Follow-Up (PMCF)

Conditions
-----------------
Mitral Regurgitation, Mitral Insufficiency

Intervention / Treatment
-----------------
* Device: Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mitral TEER patients eligible per the current approved indication after Heart Team discussion and agreement Patient is willing and able to attend all follow-up visits and to perform all tests Provision of written informed consent Exclusion Criteria: Patients are not eligible per the current Instructions for Use Non-elective or emergency TEER procedure for mitral regurgitation Patients in ICU prior to the index procedure

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

| Intervention/Treatment |
| --- |
|Device: Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System|Transcatheter Valve Repair with Edwards PASCAL and PASCAL Precision System|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with major adverse events (MAE rates) | The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days | 30 days | 
| Change in mitral regurgitation severity (scale of 0-4+) by echocardiography | Mitral regurgitation severity will be assessed by echocardiography at timepoint discharge on a scale from 0-4+ and compared to timepoint baseline Mitral regurgitation severity | Discharge: defined as discharge or 7 days post-procedure, whichever comes first |
Incidence of Trauma Induced Coagulopathy in Patients With Prehospital Administration of Fibrinogen

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to find out the incidence of trauma induced coagulopathy in patients with severe trauma who received fibrinogen prior admission to emergency department during prehospital care.

Detailed Description
-----------------
The study will commence following the Approval by The Ethics Research Committee. All patients admitted to emergency department from the 1st of July 2018 to the 30st of June 2020 will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. After admission to emergency department the blood samples will be taken and blood tests and viscoelastic tests will be performed. All data and results will be entered in the study form. Statistical analysis will be performed and incidence of trauma induced coagulopathy estimated. 28-day mortality will be also monitored.

Official Title
-----------------
Incidence of Trauma Induced Coagulopathy in Patients With Prehospital Administration of Fibrinogen

Conditions
-----------------
Trauma, Hemorrhage, Coagulopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: multiple trauma, injury severity score (ISS) ≥16 administration of fibrinogen in prehospital care age 18-80 years Exclusion Criteria: ISS 75 pregnancy therapeutic anticoagulation therapeutic antiaggregation

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trauma induced coagulopathy | Incidence of trauma induced coagulopathy | day of enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28day mortality |  | 28 days after enrolment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
trauma induced coagulopathy, multiple trauma, fibrinogen
HD10 for Early Stages

Study Overview
=================
Brief Summary
-----------------
This study is designed to find the optimum radiation dose and number of cycles for an ABVD chemotherapy combined with an involved field irradiation. It is to be tested whether the reduction from 4 to 2 cycles of ABVD and/or the reduction of the radiation dose from 30 to 20 Gy is feasible without a loss of efficacy.

Conditions
-----------------
Hodgkin´s Lymphoma

Intervention / Treatment
-----------------
* Drug: Adriamycin
* Drug: Bleomycin
* Drug: Vinblastine
* Drug: DTIC
* Radiation: 30 Gy IF-RT
* Radiation: 20 Gy IF-RT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hodgkin´s lymphoma (histologically proven) CS (PS) IA, IB, IIA,IIB without any of the following risk factors: bulky mediastinal mass (> 1/3 maximum transverse thorax diameter) extranodal involvement ESR > 50 (A), > 30 (B-symptoms) 3 or more lymph node areas involved written informaed consent Exclusion Criteria: Leukocytes <3000/microl Platelets <100000/microl Hodgkin´s Disease as composite lymphoma Activity index (WHO) < grade 2

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br> | Drug: Adriamycin<br> <br> Drug: Bleomycin<br> <br> Drug: Vinblastine<br> <br> Drug: DTIC<br> <br> Radiation: 30 Gy IF-RT<br> <br> |
| Experimental: Arm B<br> | Drug: Adriamycin<br> <br> Drug: Bleomycin<br> <br> Drug: Vinblastine<br> <br> Drug: DTIC<br> <br> Radiation: 20 Gy IF-RT<br> <br> |
| Experimental: Arm C<br> | Drug: Adriamycin<br> <br> Drug: Bleomycin<br> <br> Drug: Vinblastine<br> <br> Drug: DTIC<br> <br> Radiation: 30 Gy IF-RT<br> <br> |
| Experimental: Arm D<br> | Drug: Adriamycin<br> <br> Drug: Bleomycin<br> <br> Drug: Vinblastine<br> <br> Drug: DTIC<br> <br> Radiation: 20 Gy IF-RT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hodgkin´s lymphoma, early stages
Eptinezumab in Healthy Japanese Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate how eptinezumab enters, moves through and exits the body. Safety and tolerability will also be investigated.

Detailed Description
-----------------
The study will consist of 18 healthy Japanese subjects, divided into two single dose cohorts with 9 subjects in each cohort.

Official Title
-----------------
Interventional, Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Eptinezumab in Healthy Japanese Subjects

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

Intervention / Treatment
-----------------
* Drug: Eptinezumab
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Japanese subjects with a BMI of ≥ 18.5 and ≤ 25 kg/m2 Other in- and exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 100 mg eptinezumab<br> | Drug: Eptinezumab<br>* Eptinezumab - single intravenous infusion<br>|
| Experimental: Cohort 2 300 mg eptinezumab<br> | Drug: Eptinezumab<br>* Eptinezumab - single intravenous infusion<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo - single intravenous infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax eptinezumab | maximal observed plasma concentration | From dosing to week 12 | 
| AUC(0-t) eptinezumab | area under the plasma concentration-time curve from zero to time t | From dosing to week 12 | 
| AUC(0-inf) eptinezumab | area under the plasma concentration-time curve from zero to infinity | From dosing to week 12 | 
| Systemic Clearance of eptinezumab |  | From dosing to week 12 |
Treatment of Gingival Recession Using Mesenchymal Stem Cells

Study Overview
=================
Brief Summary
-----------------
Treatment of patients with gingival recession by injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel

Detailed Description
-----------------
Treatment of patients with gingival recession by injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel (1×106cells/0.2 ml). The volume of the mixture is divided into 4 equal injections in the gingival region of one tooth (one place injection volume is 0.05 ml of mixture).

Official Title
-----------------
Treatment of Gingival Recession Using Autologous Adipose-derived Mesenchymal Stem Cells

Conditions
-----------------
Gingival Recession

Intervention / Treatment
-----------------
* Biological: mesenchymal stem cells
* Other: standard treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -gingival recession Exclusion Criteria: pregnancy breast-feeding acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis mental disorders

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mesenchymal stem cells<br>standard treatment according to clinical protocols plus mesenchymal stem cells | Biological: mesenchymal stem cells<br>* autologous mesenchymal stem cells<br>Other: standard treatment<br>* standard treatment according to clinical protocols<br>|
| Active Comparator: control<br>standard treatment according to clinical protocols | Other: standard treatment<br>* standard treatment according to clinical protocols<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients cured | number of patients cured | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gingival Recession