linjc16/ctgov huggingface dataset:
Study of K201 Injection on Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, and safety.

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study of the Effects of K201 Injection, 2 mg/mL on the Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: K201 Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic atrial fibrillation Atrial fibrillation documented by ECG Adherence to local clinical standards or the ACC/AHA/ESC practice guidelines for atrial fibrillation regarding thrombo-embolic event prevention and treatment. Exclusion Criteria: Systolic blood pressure <100 mmHg Heart rate <50 bpm Temperature >38°C QT or QTcB >440 ms QRS >140 ms Paced atrial or ventricular rhythm on ECG Serum potassium <3.5 meq/L History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization History of amiodarone in last 6 months. Clinical evidence of acute coronary syndrome Acute pulmonary edema or embolism Hyperthyroidism Acute pericarditis History of failed electrical cardioversion at any time History of torsades des pointes History of familial long QT interval syndrome History of ventricular tachycardia requiring drug or device therapy History of NYHA Heart Failure Class 3 or 4.

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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: K201 Injection<br>* single intravenous infusion of Dose 1 - 10 or placebo (saline) or single oral capsule Dose A or placebo capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restoration of sinus rhythm |  | 24hrs |
Assessment of a B-Mode Ultrasound Technique for the Measurement of Carotid Artery Intima-Media Thickness

Study Overview
=================
Brief Summary
-----------------
This minimal risk protocol is designed to assess the reproducibility of B-mode ultrasound measurements of carotid intima media thickness (IMT) when the scans are performed in CC Radiology and read using a computerized edge reader. Up to 20 volunteers will have two ultrasounds performed within a 6-month period. IMT thickness is used as a surrogate marker for atherosclerosis and may be of value in clinical trials.

Detailed Description
-----------------
This minimal risk protocol is designed to assess the reproducibility of B-mode ultrasound measurements of carotid intima-media thickness (IMT) when the scans are performed in CC Radiology and read using a computerized edge reader. Up to 50 volunteers will have two ultrasounds performed within a 6-month period. IMT thickness is used as a surrogate marker for atherosclerosis and may be of value in clinical trials.

Official Title
-----------------
Assessment of a B-Mode Ultrasound Technique for the Measurement of Carotid Artery Intima-Media Thickness

Conditions
-----------------
Atherosclerosis, Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Adult (age 18 or older). Desire to participate in the study; willing and able to provide informed consent. No history of stroke or carotid disease.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Risk Factor, Atherosclerosis, Cardiovascular Disease, Computerized Edge Reader, Myocardial Infarction
Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.

Official Title
-----------------
An Open-Label, Two-Treatment, Two-Period, Randomized Cross-Over Study To Assess The Bioequivalence Between Commercial Doxycycline Carragenate And Monohydrate Tablet Formulations In Normal Healthy Male Subjects

Conditions
-----------------
Bacterial Infection

Intervention / Treatment
-----------------
* Drug: doxycycline monohydrate tablet
* Drug: doxycycline carragenate tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects between the ages of 18 and 55 years. Body Mass Index (BMI) of 18 to 30 kg/m2. Exclusion Criteria: Evidence or history of clinically significant abnormality. Any condition possibly affecting drug absorption. A positive urine drug screen.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: doxycycline monohydrate tablet<br> | Drug: doxycycline monohydrate tablet<br>* Tablet, 100 mg, Single dose<br>|
| Active Comparator: doxycycline carragenate tablet<br> | Drug: doxycycline carragenate tablet<br>* Tablet, 100 mg, Single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) of Doxycycline |  | 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose. | 
| Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Doxycycline | AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity. | 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bioequivalence
Risk of Acute Liver Failure Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the incidence of hospitalization with acute liver failure among patients with type 2 diabetes who are new users of Saxagliptin and those who are new users of other oral antidiabetic drugs.

Detailed Description
-----------------
Prospectively designed retrospective database study. This study will be conducted using administrative claims data and electronic medical records that are collected as part of routine clinical practice

Official Title
-----------------
Comparison of Risk of Hospitalization With Acute Liver Failure Between Patients With Type 2 Diabetes Initiating Saxagliptin and Those Initiating Other Oral Antidiabetic Treatments

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Newly prescribed Saxagliptin or an Oral Antidiabetic Drug (OAD) in a class other than Dipeptidyl peptidase IV (DPP4) inhibitors Enrolled in the respective database for at least 180 days prior to the first prescription of new OAD Have at least one diagnostic code for a type 2 diabetes-related condition Exclusion Criteria: Patients identified with a diagnostic code for acute liver failure within the 180-day baseline period Patients with DPP4 inhibitor exposure during the baseline period

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 |
| --- | --- |
| Patients exposed to Saxagliptin<br> | |
| Patients exposed to oral antidiabetic drugs (not Saxagliptin)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants hospitalized with a diagnosis of acute liver failure |  | 18-months | 
| Number of participants hospitalized with a diagnosis of acute liver failure |  | 36-months | 
| Number of participants hospitalized with a diagnosis of acute liver failure |  | 54-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deaths due to acute liver failure |  | 18, 36 and 54 months | 
| Hospitalizations with acute liver failure and/or death due to acute liver failure |  | 18, 36 and 54 months | 
| Hospitalizations with acute liver injury |  | 18, 36 and 54 months |
The Effect of Rapid Fluid Challenge Under Pulmonary Artery Catheter Monitoring on Physiological Indexes of Patients With Septic Shock

Study Overview
=================
Brief Summary
-----------------
Fluid challenge is often carried out in septic shock patients. Its responsiveness usually requires invasive monitoring. The pulmonary artery catheter(PAC) is the most effective means of monitoring.To use non-invasive methods is very tempting. Investigators hypothesize that venous-to-arterial carbon dioxide difference,venous-to-arterial carbon oxygen difference, central venous-arterial carbon dioxide to arterial-venous oxygen content ratio and Central Venous SO2 variations provides feasible estimation on fluid responsiveness in septic shock patients.

Official Title
-----------------
The Effect of Rapid Fluid Challenge Under Pulmonary Artery Catheter Monitoring on Physiological Indexes of Patients With Septic Shock

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Other: fluid chanllenge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than 18 years old; less than 75 years old ICU patients Septic shock Monitored with pulmonary artery catheter (Swan-Ganz catheter) The decision of fluid challenge made by the treating physician Exclusion Criteria: Evidence of fluid overload Pregnancy Recently participated in other studies Severe heart failure

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
Intervention Model: Single Group Assignment
Interventional Model Description: A bag of 500ml of normal saline is infused within 15 minutes using a bag pressurized to 300 mmHg. All other treatments, including maintenance fluids, dose of vasoactive agents and ventilator settings, remain unchanged during the study period.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Septic shock<br>Patients (at least 18 years of age, no more than 75 years old) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of pulmonary artery catheter. Refractory hypotension was defined as need of vasopressors to maintain systolic blood pressure (SBP) no less than 90 mmHg despite adequate fluid resuscitation. | Other: fluid chanllenge<br>* A bag of 500ml of normal saline is infused within 15 minutes using a bag pressurized to 300 mmHg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac index change | Fluid responsiveness: increase in CI of at least 10% after fluid challenge ;Fluid nonresponsiveness:no increase or increase in CI less than 10%. | Immediately after fluid challenge |
MAVRIC VR ICD Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to collect information on the health status of patients receiving Marquis/Maximo VR Implantable Cardiac Defibrillators (ICDs), how the devices are being programmed and how this correlates to clinical patient outcome.

Official Title
-----------------
Marquis/Maximo VR ICD Programming Practices Registry (MAVRIC VR ICD Registry)

Conditions
-----------------
Ventricular Tachycardia, Ventricular Fibrillation

Intervention / Treatment
-----------------
* Device: Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age or older Patients implanted with a new or replacement Marquis VR or Maximo VR ICD Exclusion Criteria: Patients enrolled in a device study that affects treatment and/or programming

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: Registry|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
-----------------
defibrillators, LLECG, ventricular tachycardia, ventricular fibrillation
Autologous Bone Marrow Transplantation in Acute Non-Lymphoblastic Leukemia During First or Subsequent Remission

Study Overview
=================
Brief Summary
-----------------
Evaluate the role of high dose chemotherapy with autologous hematopoietic cell transplantation for AML.

Detailed Description
-----------------
To use high dose chemotherapy with autologous stem cell rescue to try to increase the chance of long term control and cure of the disease.

Official Title
-----------------
Autologous Bone Marrow Transplantation for Acute Non-Lymphoblastic Leukemia During First or Subsequent Remission

Conditions
-----------------
Leukemia, Myelocytic, Acute, Leukemia, Blood and Marrow Transplant (BMT)

Intervention / Treatment
-----------------
* Procedure: high dose chemotherapy then autologous hematopoietic cell transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- must be in remission adequate organ function Exclusion Criteria:- prior MDS active infection liver disease

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 69 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 |
| --- |
|Procedure: high dose chemotherapy then autologous hematopoietic cell transplant|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival (DFS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transplant related mortality (TRM) |  |  | 
| Toxicity |  |  | 
| Adequacy of cell collections |  |  | 
| Engraftment kinetics |  |  |
Role of Negative Pressure Wound Therapy in Latissimus Dorsi Flap Donor Site Seroma Prevention

Study Overview
=================
Brief Summary
-----------------
The use of NPWT as a post-operative dressing significantly reduces the incidence of seroma formation after harvesting LD flap.

Detailed Description
-----------------
NPWT was left in place on donor site with constant pressure between -125 and -80 mmHg to reduce seroma formation

Official Title
-----------------
Role of Negative Pressure Wound Therapy in Latissimus Dorsi Flap Donor Site Seroma Prevention

Conditions
-----------------
NPWT, Latissimus Dorsi Flap, Breast Reconstruction

Intervention / Treatment
-----------------
* Device: The negative pressure wound therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 20-60 years Underwent breast reconstruction with LD Flap Exclusion Criteria: Locally advanced cancer

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPWT group<br>Negative pressure wound therapy was used to prevent donor site seroma formation | Device: The negative pressure wound therapy<br> <br> * Other names: NPWT;|
| No Intervention: Control group<br>Conventional method was used to the donor site | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of seroma |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aspirated Volume |  | 3 months | 
| Frequency of Aspiration |  | 3 months |
A Study of LY3314814 in Participants With Liver Impairment

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether LY3314814 can be safely prescribed in participants with liver impairment without a dose adjustment. Participants will be on study for 11 days with follow-up about 7 days afterward.

Official Title
-----------------
Pharmacokinetics of LY3314814 in Subjects With Hepatic Impairment

Conditions
-----------------
Hepatic Impairment

Intervention / Treatment
-----------------
* Drug: LY3314814


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Have a Body Mass Index (BMI) of 18 to 40 kilogram per meter square (kg/m²), inclusive, at the time of screening Exclusion Criteria: Have a history of or current significant ophthalmic disease, particularly any eye problem involving the retina Have moderate or severe vitiligo or any other clinically significant disorder of skin or hair pigmentation Have acute unstable neuropsychiatric disease Have active or uncontrolled neurologic disease, or clinically significant head injury

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3314814 Control<br>LY3314814 administered orally to participants with normal hepatic function | Drug: LY3314814<br>* Administered orally<br>|
| Experimental: LY3314814 Mild<br>LY3314814 administered orally to participants with mild hepatic impairment | Drug: LY3314814<br>* Administered orally<br>|
| Experimental: LY3314814 Moderate<br>LY3314814 administered orally to participants with moderate hepatic impairment | Drug: LY3314814<br>* Administered orally<br>|
| Experimental: LY3314814 Severe<br>LY3314814 administered orally to participants with severe hepatic impairment | Drug: LY3314814<br>* Administered orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of LY3314814 | PK: AUC(0-∞) of LY3314814 | Baseline through 240 hours after the administration of study drug | 
| PK: Maximum Observed Drug Concentration (Cmax) of LY3314814 | PK: Cmax of LY3314814 | Baseline through 240 hours after the administration of study drug |
The Utility of Breath Biopsy as a Screening Tool for HCC

Study Overview
=================
Brief Summary
-----------------
The aim of this pilot study is to examine whether there is a discriminating ability of the breath sample analysis to capture biomarkers specific to the HCC in the breath of affected individuals. If positive, our research could open up a new horizon for cost-effective and feasible screening tools.

Detailed Description
-----------------
20 Participants will be included in the study. Ten Cirrhotic patients with HCC and 10 Cirrhotic patients without HCC. The first group is patients with HCC secondary to cirrhosis. The second group will be patients with cirrhosis who are currently on the standard surveillance program with no HCC. Confirmation of the absence of HCC would have been ensured via a recent advanced imaging modality (dynamic CT scan or MRI) in the ongoing surveillance programme. Participants will breathe into either a mouthpiece or collection tube then Breath samples will be analyzed via an analyzer to detect the volatile organic compounds (VOC) and quantitatively compare them

Official Title
-----------------
The Utility of Breath Biopsy as a Screening Tool for HCC: A Pilot Study

Conditions
-----------------
HCC, Cirrhosis, Liver

Intervention / Treatment
-----------------
* Diagnostic Test: Breath Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhotic patients with HC. Cirrhotic patients without HCC Exclusion Criteria: Patients with more than one primary cancer (HCC in addition to other cancer) Patients who are not aware of the diagnosis Patients in whom the diagnosis of HCC is not clear and only suspected Patients with severe chronic obstructive pulmonary disease (COPD) or severe asthma.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCC<br>Participants are diagnosed with HCC on top of cirrhosis | Diagnostic Test: Breath Biopsy<br>* Analysis of breath samples to identify volatile molecules specific to HCC<br>|
| Cirrhosis with no HCC<br>Participants are diagnosed with cirrhosis but have no HCC | Diagnostic Test: Breath Biopsy<br>* Analysis of breath samples to identify volatile molecules specific to HCC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volatile organic compounds specific to HCC | Quantitative analysis of the volume and pattern of volatile compounds in the breath of the individuals with HCC compared to that in the breath of individuals without HCC but with the same underlying disease | 6 months |