linjc16/ctgov huggingface dataset:
Dose Reducing Door-to-balloon Time in ST-elevation Myocardial Infarction Cause Less Cost?

Study Overview
=================
Brief Summary
-----------------
The investigators tried to determined whether the less D2B time led to costs savings benefited insurance payer and better outcomes to patients.

Detailed Description
-----------------
The relationship between the quality of care and costs has been discussed widely. Higher costs of care did not bring better outcomes, vice versa. However, as the rising spending of health care, the health care providers, insurance payers, governments, and consumers begin to pursue the higher quality of cares with lowest costs. In surgical experiences, improving the process of care succeeded to improve the quality of care and reduce the costs. In patients with acute ST-Segment elevation myocardial infarction (STEMI), A Door-to-Balloon (D2B) time of less than 90 minutes has been established as the gold standard for primary percutaneous coronary intervention (PCI) and was associated with lower in-hospital mortality.9 Only less literatures discussed the costs and the quality of care in acute STEMI, and whether improving processes of care associated with lower costs was still controversial. The Premier Hospital Quality Incentive Demonstration (PHQID) in United State improved the processes of care but had not a significant effect on cost. Another single hospital experience in Indiana, USA, showed that the reducing D2B time in STEMI decreased the insurance payments as well as the total hospital costs. However, this study design was before-and-after intervention analysis, did not actually measure the impact of D2B time. Besides, the payment system in this study was prospective payment, not fee-for-service payment in Taiwan. In this study, we tried to determined whether the less D2B time led to costs savings benefited insurance payer and better outcomes to patients.

Official Title
-----------------
Better Quality With Less Cost? A Single Hospital Experience on Reducing Door-to-balloon Time in ST-elevation Myocardial Infarction

Conditions
-----------------
Acute STEMI, Primary Percutaneous Coronary Arterial Intervention

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: self visit acute STEMI by ECG definition Exclusion Criteria: non-diagnosis on first ECG transferred diagnostic angiogram only

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 |
| --- | --- |
| acute STEMI, Primpary PCI<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Collection of Anonymized Samples

Study Overview
=================
Brief Summary
-----------------
This is a generic sample collection study for collecting blood, stool, rectal swabs, nasal washes, nasopharyngeal aspirates, nasopharyngeal swabs, throat swabs, nasal swabs, and urine from human sources. Subjects will be recruited from BioFire Diagnostics employees and from the general community. Subjects may be asked about recent or ongoing illness at the time of specimen collection and these symptoms will be recorded and attached to the sample. No other identifying information will be collected and the samples will be kept anonymous.The samples may be used internally or by external sites, such as the clinical study sites, for evaluating and determining performance characteristics of in vitro diagnostic devices.

Official Title
-----------------
Collection of Anonymized Samples for Use in Product Development and Clinical Trials

Conditions
-----------------
Gastrointestinal Disease, Healthy, Respiratory Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consenting adult Exclusion Criteria: Weigh less that 110 lb for blood collection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCR Amplification Curves | PCR amplification curves will be used to confirm the presence or absence of target analytes. | 10 years |
Lorlatinib Continuation Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to provide continued treatment access and safety follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer sponsored lorlatinib parent studies that will be closed. Additional follow-up safety data collection will permit further characterization of the safety profile of lorlatinib in participants continuing to receive study intervention

Official Title
-----------------
LORLATINIB (PF-06463922) CONTINUATION PROTOCOL: AN OPEN-LABEL, SINGLE-ARM CONTINUATION STUDY FOR PARTICIPANTS WITH ALK-POSITIVE OR ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) CONTINUING FROM PFIZER SPONSORED LORLATINIB CLINICAL STUDIES

Conditions
-----------------
Non-Small-Cell Lung Cancer, NSCLC

Intervention / Treatment
-----------------
* Drug: Lorlatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1 - Any participant who is receiving study treatment and deriving clinical benefit (as determined by the Principal Investigator) in a Pfizer-sponsored Lorlatinib Parent Study. 2- Participants must agree to follow the reproductive criteria. 3- Adequate Bone Marrow, Liver, Renal, Pancreatic Function Exclusion Criteria: 1 - Female participants who are pregnant or breastfeeding. 2- Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lorlatinib<br>Lorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, continuously | Drug: Lorlatinib<br>* ALK-positive NSCL treatment<br>* Other names: PF-06463922;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events leading to permanent discontinuation of study intervention | Safety collection in this study will permit further characterization of the safety profile of lorlatinib | Baseline up to approximately 5 years | 
| Number of serious adverse events reported for all participants | Safety collection in this study will permit further characterization of the safety profile of lorlatinib | Baseline up to approximately 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALK, anaplastic lymphoma kinase
Evaluation of the Efficacy of Combination Treatment With Anakinra and Pegsunercept in Improving Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of anakinra (IL-1 ra) and pegsunercept (PEG sTNF-RI) when they are used together in improving the signs and symptoms of rheumatoid arthritis. The study will also evaluate the safety of the combination treatment and its effect on slowing down bone and joint destruction due to rheumatoid arthritis. The results will be compared to the effect when only 1 single medication (anakinra or pegsunercept) is used.

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

Intervention / Treatment
-----------------
* Drug: anakinra
* Drug: pegsunercept


Participation Criteria
=================
Eligibility Criteria
-----------------
diagnosed with rheumatoid arthritis for at least 6 months must be taking methotrexate * must not take DMARDS other than methotrexate during the study must not have had previous treatment with and protein-based TNF-alpha inhibitor (eg. etanercept, infliximab, PEG sTNF-RI, or D2E7) must not have had previous treatment with anakinra subjects must meet tender and swollen joint requirements at screening, have morning stiffness, and/or have elevated acute phase reactants

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: anakinra|nan|
|Drug: pegsunercept|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Phase IV Study of Elunate® (Fruquintinib) in Chinese Patients

Study Overview
=================
Brief Summary
-----------------
A phase IV study to characterize safety of Elunate® (Fruquintinib) in Chinese patients

Detailed Description
-----------------
This study is a prospective, open-label, multi-center, study design to obtain the safety information of participant after medication. The follow-up time points for each participant include first time signing the informed consent form,1 month after signing the informed consent form, 6 months after signing the informed consent form or 30 days after the last dose (whichever occurs first).

Official Title
-----------------
A Post-Marketing Clinical Study to Evaluate the Safety of Elunate® (Fruquintinib Capsules) in Chinese Patients.

Conditions
-----------------
Patient Safety

Intervention / Treatment
-----------------
* Drug: Elunate®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently using Elunate®(Fruquintinib) or will use Elunate®(Fruquintinib) within a week; Provision of informed consent by the patient. Exclusion Criteria: • Unsuitable for the study according to investigator's judgement.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Currently using Elunate® or will use Elunate®(Fruquintinib) within a week; Provision of informed consent by the patient. | Drug: Elunate®<br>* The recommended dose is 5 mg once daily (1 capsule, each capsule contains 5 mg of fruquintinib); three weeks of continuous drug administration followed by one week of drug free period (4 weeks as one treatment cycle).<br>* Other names: Fruquintinib;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AEs | % of patients with AEs according to CTCAE 4.03 | from the first administration of fruquintinib up to 6 months | 
| Incidence of ADRs | % of patients with ADRs according to CTCAE 4.03 | from the first administration of fruquintinib up to 6 months | 
| Incidence of SAEs | % of patients with SAEs according to CTC AE 4.03 | from the first administration of fruquintinib up to 6 months | 
| Incidence of AESI | % of patients with AESI according to CTC AE 4.03 | from the first administration of fruquintinib up to 6 months |
Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective, blinded, randomized clinical trial is to investigate whether a ventilator-piloted PRM at the end of laparoscopic bariatric surgery could reduce overall postoperative pain and nausea.

Official Title
-----------------
Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Bariatric Surgery

Conditions
-----------------
Pain, Postoperative, Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Procedure: Pulmonary recruitment maneuver
* Procedure: Laparoscopic bariatric surgery
* Device: Ventilator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective laparoscopic bariatric surgery (LBS) American Society of Anaesthesiologists (ASA) physical status classification I-II (with the exception of body mass index over 35 kg/m2) written consent Exclusion Criteria: conversion to open surgery complication, Clavien-Dindo grade ≥ II

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulmonary recruitment maneuver<br>Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery. | Procedure: Pulmonary recruitment maneuver<br>* The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.<br>Procedure: Laparoscopic bariatric surgery<br> <br> Device: Ventilator<br> <br> |
| Active Comparator: Control group<br>Ordinary ventilation at the end of laparoscopic bariatric surgery. | Procedure: Laparoscopic bariatric surgery<br> <br> Device: Ventilator<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | A questionnaire with a numeric rating scale (NRS) is used to evaluate pain intensity at 4, 12, 24, 36 and 48 hours postoperatively to assess pain intensity. The scale includes even numbers from 0 to 10, where 0 signifies no pain, and 10 signifies the worst imaginable pain. | 4, 12, 24, 36 and 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Nausea | A questionnaire was used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively. The questionnaire involved a numeric rating scale (NRS) from 0 to 10, where 0 signified no nausea, and10 the worst imaginable nausea. | 4, 12, 24, 36 and 48 hours after surgery |
Routine Follow up After Total Hip Arthroplasty Prior Periacetabular Osteotomy

Study Overview
=================
Brief Summary
-----------------
Follow up study of patients, who despite periacetabular osteotomy, need a total hip arthroplasty, to see outcome.

Official Title
-----------------
Routine Follow up After THA in PAO Patient

Conditions
-----------------
Hip Dysplasia, Osteotomy of Pelvis, Total Hip Arthroplasty

Intervention / Treatment
-----------------
* Other: Routine followup


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PAO and THA Exclusion Criteria: time since THA less than 4 yrs
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PAO, osteoarhritis, THA<br> | Other: Routine followup<br>* questionnaires<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Does previous PAO compromise the function of a secondary THA | To describe the radiographic status (ex. cup positioning, calcifications, signs of loosing etc) of the THA, the physical function of the THA ( Harris Hip Score), and pt reported outcome measurements (SF36 and WOMAC). | Up to 10 years after THA surgery |
Single and Multiple Ascending Dose Study of NGM120 in Healthy Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose is to evaluate the safety, tolerability, and PK of NGM120 in healthy adult subjects

Official Title
-----------------
A Phase 1 Randomized, Double Blind, Placebo Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NGM120 in Healthy Adult Subjects

Conditions
-----------------
Cachexia

Intervention / Treatment
-----------------
* Biological: NGM120
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal ECG findings Exclusion Criteria: Significant history or clinical manifestation of any allergic, dermatological, hepatic, renal, hematological, pulmonary, metabolic, cardiovascular, gastrointestinal, neurological, or psychiatric disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: NGM120<br>Single Dose | Biological: NGM120<br>* Subcutaneous Injection<br>|
| Placebo Comparator: Part A: Placebo<br>Single Dose | Other: Placebo<br>* Subcutaneous Injection<br>|
| Experimental: Part B: NGM120<br>Multiple Dose | Biological: NGM120<br>* Subcutaneous Injection<br>|
| Placebo Comparator: Part B: Placebo<br>Multiple Dose | Other: Placebo<br>* Subcutaneous Injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A Arm-Single Dose: Treatment Emergent Adverse events | Percentage of total subjects with Treatment Emergent Adverse event | 28 days | 
| Part B Arm-Multiple Dose: Treatment Emergent Adverse events | Percentage of total subjects with Treatment Emergent Adverse event | 84 days |
Measurement of Echogenic Area in the Border of the Fetal Ventricles

Study Overview
=================
Brief Summary
-----------------
Sonographic coronal section in the lateral fetal ventricles shows echogenic area in the ventricles borders creating an halo around the ventricles. Histologically this area correlates to the Stratified transitional field. In this study we would like to measure this area for the purpose of creating a nomogram.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women 22-37 GA well dated pregnancy singleton pregnancy Exclusion Criteria: no first trimester dating multifetal pregnancy known CNS abnormalities in the fetus small for gestational age

Ages Eligible for Study
-----------------
Minimum Age: 22 Weeks
Maximum Age: 37 Weeks

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
-----------------
echogenic halo around lateral fetal ventricles
Intubating Conditions During Propofol-remifentanil Anesthesia With Topical Lidocaine

Study Overview
=================
Brief Summary
-----------------
When not using neuromuscular blocking agent, even at optimal dosage, target-controlled infusion (TCI) of propofol and remifentanil occasionally produce unsatisfactory intubating conditions. Therefore, the investigators evaluated that the effect of tracheal lidocaine on the intubating conditions for tracheal intubation during anesthesia induction of propofol and remifentanil TCI without neuromuscular blocking agent in day-case anesthesia.

Detailed Description
-----------------
Anesthesia was induced with propofol-remifentanil TCI with the effect-site concentration of 5μg/ml and 5ng/ml, respectively. After TCI, 3 ml of normal saline or 3 ml of 4% lidocaine was instilled to larynx and trachea, following intubation was performed.

Official Title
-----------------
Effect of Tracheal Lidocaine on Intubating Conditions During Propofol-remifentanil TCI Without Neuromuscular Blockade

Conditions
-----------------
Drug Usage

Intervention / Treatment
-----------------
* Drug: lidocaine
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I, II patients undergoing general anesthesia for reduction of nasal bone fracture Exclusion Criteria: bronchial asthma, COPD, hypertension, anticipated difficult airway

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: control<br>3 ml of normal saline was instilled to larynx and trachea | Drug: lidocaine<br>* 3 ml of 4% lidocaine was instilled to larynx and trachea<br>* Other names: 4%lidocaine;|
| Active Comparator: lidocaine<br>3 ml of 4% lidocaine was instilled to larynx and trachea before endotracheal intubation | Drug: normal saline<br>* 3 ml of normal saline was instilled to larynx and trachea before endotracheal intubation<br>* Other names: control;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall acceptable conditions for tracheal intubation | Four minutes after start of propofol-remifentanil TCI, 3 ml of normal saline or 3 ml of 4% lidocaine was instilled to larynx and trachea, and one minute later, intubation was performed in double-blinded fashion. | baseline from 5 min of TCI was maintained | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intubating conditions, propofol, remifentanil, topical lidocaine