linjc16/ctgov huggingface dataset:
Efficacy and Safety of Jaktinib in Patients With COVID-19 Pneumonia.

Study Overview
=================
Brief Summary
-----------------
This was a randomized, double-blind, placebo-controlled parallel study.

Official Title
-----------------
Efficacy and Safety of Jaktinib in Patients With COVID-19 Pneumonia.

Conditions
-----------------
COVID-19 Pneumonia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age, male or female; History of COVID-19 infection within 1 week; Subjects with HRCT consistent with viral pneumonia (Judged by investigator) and meeting any of the following criteria: With fever, respiratory symptoms; Shortness of breath present,RR ≥30 breaths/min. Clear consciousness, Capable and voluntary informed consent. Exclusion Criteria: Unable to take tablets orally Or suspected hypersensitivity to Jaktinib, drugs of the same class, or their excipients, Patients with severe gastrointestinal dysfunction affecting drug absorption; Any person meeting criteria for critical pneumonia; Patients considered unsuitable for this trial by the investigator.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jaktinib<br>Jaktinib 100mg BID | Drug: Jaktinib<br>* 100mg of Jaktinib (given as two 50mg tablets) administered orally Twice daily(BID) with best available treatment.<br>|
| Placebo Comparator: Placebo<br>placebo | Drug: Placebo<br>* Placebo (given as two placebo tablets) administered orally BID with best available treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Recovery | Recovery assessed by the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS). Time to reach NIAID-OS 1, 2, or 3 for the first time. NIAID-OS: 1 Not hospitalized, no limitations on activities. 2 Not hospitalized, limitation on activities and/or requiring home oxygen. 3 Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care. | Day 1 to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who require invasive mechanical ventilation due to disease progression at Day 3, 7, 1 4 or EOT |  | Day 3, 7, 14 or EOT | 
| Mortality | Proportion of patients with all-cause mortality at Day 28 | Day 1 to Day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumonia, COVID-19 Infection
Clinical Outcome of Pericardial Closure Using Gentrix Following Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
A descriptive comparative project will be conducted to determine if there is a difference in outcomes for adult patients requiring pericardial reconstruction using CorMatrix compared to Gentrix

Detailed Description
-----------------
A descriptive, comparative project will be conducted utilizing a retrospective chart review on patients at Methodist Mansfield Medical Center(MMMC) undergoing cardiac surgery requiring pericardial repair between the dates of January 1, 2017 through December 31, 2022. The project will compare outcomes of a pre- and post-intervention following use of Gentrix ECM and the CorMatrix Extracellular Matrix(ECM) pericardial patch using information gathered from the patient's electronic health record (EHR). The main outcome measures of post-operative Length of Stay(LOS), all-cause unplanned readmission within 30 days, and significant pleural effusion requiring thoracentesis within 30-days and 60 days as well as long-term (12 months) patient outcomes.

Official Title
-----------------
Clinical Outcome of Pericardial Closure Using Gentrix Following Cardiac Surgery

Conditions
-----------------
Clinical Outcome of Pericardial Closure Using Gentrix

Intervention / Treatment
-----------------
* Procedure: Pericardial Closure Using Gentrix Following Cardiac Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have undergone a Coronary Artery Bypass Grafting(CABG) or valve repair/replacement surgery requiring pericardial reconstruction. CABG or valve repair/replacement surgery must have been either elective or urgent status Exclusion Criteria: -CABG or valve repair/replacement surgery classified as emergent status Surgery classified as redo-sternotomy

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 |
| --- |
|Procedure: Pericardial Closure Using Gentrix Following Cardiac Surgery|To determine feasibility and effectiveness of Gentrix for cardiac use, and if this product is patient population specific.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative hospital LOS | 30-day all-cause unplanned readmissions after discharge Significant pleural effusion requiring thoracentesis within 30 days of surgery Significant pleural effusion requiring thoracentesis within 60 days of surgery | 30 days |
Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma

Study Overview
=================
Brief Summary
-----------------
Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma

Official Title
-----------------
Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma

Conditions
-----------------
Nasopharyngeal Carcinoma

Intervention / Treatment
-----------------
* Drug: Endostar and Envafolimab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥65 years with newly pathologically confirmed NPC Karnofsky performance status ≥60 Clinical stage III-IVA (Union for International Cancer Control and American Joint Committee on Cancer staging system for NPC, 8th edition) Adequate organ function Exclusion Criteria: Cancer history Prior radiotherapy, cytotoxic chemotherapy, immunotherapy or target therapy Life-expectance within 6 months

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Gemcitabine Combined With Endostar and Envafolimab<br>Neoadjuvant therapy consisting of gemcitabine (1000mg/m2 d1,8) , endostar (150mg 3-day continuous infusion) and envafolimab (240mg d1) was given every 3 weeks for 3 cycles. Endostar, administered every 3 weeks (150mg 3-day continuous infusion), was given concurrently with intensity-modulated radiotherapy. | Drug: Endostar and Envafolimab<br>* Neoadjuvant therapy consisting of gemcitabine (1000mg/m2 d1,8) , endostar (150mg 3-day continuous infusion) and envafolimab (240mg d1) was given every 3 weeks for 3 cycles. Endostar, administered every 3 weeks (150mg 3-day continuous infusion), was given concurrently with intensity-modulated radiotherapy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with grade 3 or higher adverse events (AEs). | The primary endpoint was the safety profile. AEs were scored according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | Up to 24 weeks |
IV SafeLock Device Functionality in Emergency Department

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to evaluate the functionality of the IV SafeLock in the clinical emergency department setting.

Official Title
-----------------
Functionality of the IV SafeLock Device in Emergency Department Setting

Conditions
-----------------
Intravenous Access

Intervention / Treatment
-----------------
* Device: IV SafeLock


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Emergency Department nurses who are consenting and willing to perform tasks. Their patient population will include stable patients 18 or over, who present through triage, are medically stable, are able to verbally consent and require intravenous access. Exclusion Criteria: Emergency Department nurses who are unwilling to consent to use IV SafeLock on their patient population. The patient population will exclude pregnant patients, children, prisoners, patients with dementia, or any member of protected class as specified by IRB. The patients must be medically stable and not include patients presenting with acute stroke, acute myocardial infarction, severe sepsis or shock.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emergency Department Nurses<br>Registered nurses will use the IV SafeLock Device on patients during care in the emergency department. | Device: IV SafeLock<br>* Designed to prevent patient access to intravenous lines in the hospital setting. The device locks with an institution specific key and protects the hub as well as all tubing access points.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functionality of the IV SafeLock | Measured on a likert scale for nurse evaluation of IV SafeLock | Baseline |
Psyco Quality of Life and Procreation BRCA1/2

Study Overview
=================
Brief Summary
-----------------
Women with breast and/or ovarian cancer or with a family history carried these pathologies can makeo genetic counseling in order to investigate whether they are carriers of the BRCA1/2 genetic mutation. This mutation exposes them to develop breast cancer from 50 to 80% and from 27 to 65% of developing ovarian cancer. BRCA1/2 mutations are inherited as an autosomal dominant manner and therefore there is a 50% probability of transmitting the mutation to the progeny. For this reason, women who have BRCA 1/2 mutation may be less likely to want children than those who test negative. The decision to have children could worry both for the probability to transfer the genetic mutation or because the parenthood could be compromised by the illness and/or by premature death. In previous studies, the psychological condition of patients with BRCA 1/2 mutations, with or without children, was only partially investigated. For this reason the main goal of the study is to deeply investigate the specific psychological condition, with particular attention to the guilt feelings on the possibility to transfer the genetic mutation to the progeny. In this wai it could be useful to development a therapeutic strategies aimed at the best adaptation of the patients to the new health condition.

Official Title
-----------------
Women With BRCA1/2 Mutation: Guilt Feelings and Impact on Procreation Decision

Conditions
-----------------
Breast Cancer, Genetic Predisposition

Intervention / Treatment
-----------------
* Behavioral: Genetic predisposition to breast cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with BRCA1/2 mutation affected or not by breast neoplasm Women with BRCA1/2 mutation affected or not by breast neoplasm and with at least a son/daughter Women with at list middle school diploma Women available to do interviews Exclusion Criteria: Women with other oncological pathology Women with cognitive deficient and/or inability to comply to the requirements of the study

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Genetic predisposition to breast cancer|Guilt feelings about procreating|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of feeling guilting | ISGR-15s Il PFQ-2 PHQ-9 | 24 monts |
Effect of Novel Antidiabetic Drug Combined With Angiotensin Receptor/Neprilysin Inhibitor on Urinary Protein

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the combination of SGLT2i and ARNI in type 2 diabetic patients with combined albuminuria could reduce urinary protein more significantly than single agent.

Detailed Description
-----------------
This project is a single-center retrospective cohort study to obtain the biochemical index levels of urinary albumin creatinine ratio, urinary protein creatinine ratio, blood renal function, blood lipids, and blood glucose at the immediate, 3rd, 6th, and 12th month of cohort inclusion in each group of patients.

Official Title
-----------------
the Effect of Novel Antidiabetic Drug Combined With Angiotensin Receptor/Neprilysin Inhibitor Over Monotherapy on Urinary Protein in Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes, Antidiabetic Drugs

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years Clinical diagnosis of type 2 diabetes mellitus Immediate urine albumin creatinine ratio greater than 30mg/g Signed informed consent and available for follow-up Exclusion Criteria: severe renal insufficiency, i.e. eGFR ≤ 30ml/min/1.75m2 clinical diagnosis of various acute and chronic urinary tract infections combined with various serious infectious diseases combined with acute complications of diabetes mellitus end-stage malignancy pregnancy and lactation

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SGLT2i+ARNI<br>patients in this group received SGLT2i combined with ARNI medication。 | |
| SGLT2i only<br>patients in this group received SGLT2i medication only。 | |
| ARNI only<br>patients in this group received ARNI medication only。 | |
| control<br>patients in this group received neither SGLT2i nor ARNI。 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary protein changes | to determine whether the combination of SGLT2i and ARNI in type 2 diabetic patients with combined albuminuria could reduce urinary protein more significantly than single agent. | 2023.03-2024.03 |
Comparative Study Between Transcoronoid and Infrazygomatic Anterior Maneuvers

Study Overview
=================
Brief Summary
-----------------
new technique in targeting V2 under ultrasound guidance

Detailed Description
-----------------
the classical approach of V2 transcoronoin for practitioner is considered as difficult with significant failure rate with sustained V3 motor stimulation our approach infrazygomatic anterior out of plane is considered much easier in achieving pure V2 stimulation without V3 which make the thermal radio frequency 80 Celsius can be performed safely

Official Title
-----------------
Comparative Study Between Transcoronoid and Infrazygomatic Anterior Maneuvers to Localize the Maxillary Nerve Under Ultrasound Guidance

Conditions
-----------------
Trigeminal Neuralgia

Intervention / Treatment
-----------------
* Procedure: V2 thermal radio frequency


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:above 40 severe pain normal neurological examination - Exclusion Criteria:metastasis allergy to medication used radio frequency precautions previous failed radio frequency or microvascular decompression gamma knife coagulpathy sepsis or active infection at site of needle entry -

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transcoronoid<br>participants are TN patients complain TN without secondary causes of trigeminal neuralgia underwent V2 targeting through coronoid notch | Procedure: V2 thermal radio frequency<br>* V2 targeted thermal radio frequency safely without sustained V3 stimulation<br>|
| Experimental: infrazygomatic anterior out of plane<br>participants are TN patients complain TN without secondary causes of trigeminal neuralgia underwent V2 targeting through infrazygomatic anterior out of plane | Procedure: V2 thermal radio frequency<br>* V2 targeted thermal radio frequency safely without sustained V3 stimulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-efficacy and safety of infrazygomatic anterior out of plane 2- how can infrazygomatic maneuver can help in decrease the chance of targeting V3 in addition V2 during injection | new method used to target V2 to decrease the chance of failure and to lessen the number of trials required the tools of measurement was the stimulation in volt and number of trial by No. | 2 years |
A Study to Evaluate the Effect of Food on LOXO-783 in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to measure how much of LOXO-783 is in the bloodstream and how the body handles and eliminates LOXO-783 when administered in fasting and fed states in healthy participants. The study will also evaluate the safety and tolerability of LOXO-783. Participation could last up to 63 days including screening period.

Official Title
-----------------
A Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of LOXO-783 in Healthy Adult Subjects

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

Intervention / Treatment
-----------------
* Drug: LOXO-783


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive Exclusion Criteria: Females who are lactating or of childbearing potential Clinically significant history of any drug sensitivity, drug allergy, or food allergy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LOXO-783 (Fasted State)<br>LOXO-783 administered orally to participants who are in fasted state | Drug: LOXO-783<br>* Administered orally.<br>* Other names: LY3849524;|
| Experimental: LOXO-783 (Fed State - Low Fat Meal)<br>LOXO-783 administered orally to participants who are on low fat meal | Drug: LOXO-783<br>* Administered orally.<br>* Other names: LY3849524;|
| Experimental: LOXO-783 (Fed State - High Fat Meal)<br>LOXO-783 administered orally to participants who are on high fat meal | Drug: LOXO-783<br>* Administered orally.<br>* Other names: LY3849524;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783 | PK: Cmax of LOXO-783 | Predose on Day 1 up to 96 hours postdose | 
| PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC [0-∞]) of LOXO-783 | PK: AUC [0-∞] of LOXO-783 | Predose on Day 1 up to 96 hours postdose |