linjc16/ctgov huggingface dataset:
Compliance With American Diabetes Association Treatment Guidelines for Adult Ketoacidosis

Study Overview
=================
Brief Summary
-----------------
At this time, Saint Mary's Medical Center is currently in the process of implementing a standardized diabetic ketoacidosis (DKA) protocol. The first main goal of this project will be to evaluate patient outcomes to determine the effects of treating patients without a standardized protocol and to establish a baseline on how patients are being treating with DKA. The final goal of the project will be to compare outcomes of those patients not placed on the protocol to those that were treated using SMMC newly implemented DKA protocol. The overall goal of this project is to determine the benefit of an institutional DKA protocol.

Official Title
-----------------
Compliance With American Diabetes Association Treatment Guidelines for Adult Ketoacidosis

Conditions
-----------------
Diabetic Ketoacidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to St. Mary's Medical Center with DKA >/= 18 years of age Exclusion Criteria: < 18 years of age

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 |
| --- | --- |
| 2<br>Patients treated for DKA under DKA protocol implemented by hospital | |
| 1<br>To establish a baseline on how patients are being treating with DKA in general and without a standardized DKA protocol | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay |  | Time in hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU length of stay |  | hospital stay | 
| ICU length of stay Hypoglycemic events (BG<60) |  | hospital stay | 
| Time to correction of glucose level and anion gap |  | hospital stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acidosis, Diabetic, Diabetic Acidosis, Diabetic Ketosis, Ketoacidosis, Diabetic, Ketosis, Diabetic
Survival With Patients Treated With Salivary Gland Cancer

Study Overview
=================
Brief Summary
-----------------
Salivary gland malignancies is very heterogenous group of tumors regarding tumor histology and localization. The aim of this study is to assess main clinical and pathological parameters related to patients survival

Detailed Description
-----------------
The retrospective study enrolled medical charts of the patients treated due to salivaly gland cancers in the Clinic for maxillofacial surgery at Clinical center of Vojvodina in the period of 1. January 1996. to 31. December 2021. Patients demographics, type of the tumor, localization, TNM status and patohystological parameters were evaluated for patients survival and disease free periods

Official Title
-----------------
Prognostic Factors for Survival of Patients With Salivary Gland Malignancies

Conditions
-----------------
Salivary Gland Cancer, Salivary Gland Neoplasms

Intervention / Treatment
-----------------
* Procedure: Surgical intervention with or without postoperative adjuvant therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with salivary gland malignancies treted in the Clinic for maxillofacial surgery Exclusion Criteria: Incomplete medical data Patients with metastatic tumord of salivary gland Patients with recurrent malignancies of salivary glands sent from other clinics
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 free of the disease<br>Patients treated due to SGC without local recurrence or metastases | Procedure: Surgical intervention with or without postoperative adjuvant therapy<br>* Surgical intervention with or without postoperative adjuvant therapy<br>|
| Patients with the disease<br>Patient with relapse of SGC, metastases or died due to SGC | Procedure: Surgical intervention with or without postoperative adjuvant therapy<br>* Surgical intervention with or without postoperative adjuvant therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients survival | Survival of patients treated due to SGC during observation period of minimum 2 years | Through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Salivary gland cancer, Survival, Prognostic factors
Peripheral Four-wavelength Near-infrared Spectroscopy Measurement: a Comparison Between EQUANOX and O3 in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Near-infrared spectroscopy (NIRS) is a continuous and non-invasive technology that measures regional tissue oxygen saturation (rSO2). Whatever the anatomical site of measurement, a normal value of rSO2 would suggest a good adequacy between oxygen supply and consumption at the regional level. Beside the trend ability of previous 2 or 3-wavelength devices, a new 4-wavelength generation of NIRS monitors which could reliably assess real-time absolute values of rSO2 is now available. The investigators aimed to compare peripheral absolute rSO2 values given by the 4-wavelength EQUANOX device 7600 (Nonin Medical, Plymouth, Mn) and the new O3 device (Masimo, Irvine, CA) during conventional cardiac surgery.

Official Title
-----------------
Peripheral Four-wavelength Near-infrared Spectroscopy Measurement: a Comparison Between EQUANOX and O3 in Cardiac Surgery

Conditions
-----------------
Conventional Cardiac Surgery With Bypass

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Scheduled for conventional elective cardiac surgery with cardiopulmonary bypass Hospitalized in the Teaching University Hospital Louis Pradel (Lyon, France) Patient agreement Exclusion Criteria: Age<18 years Black skin Emergencies Patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Peripheral absolute rSO2 values | Peripheral absolute rSO2 values given by the 4-wavelength EQUANOX device 7600 (Nonin Medical, Plymouth, Mn) and the new O3 device (Masimo, Irvine, CA) during conventional cardiac surgery. | at conventional cardiac surgery (Day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial pressure | General monitoring | at conventional cardiac surgery (Day 1) | 
| heart rate | General monitoring | at conventional cardiac surgery (Day 1) | 
| pulse oxygen saturation | General monitoring | at conventional cardiac surgery (Day 1) | 
| bispectral index | General monitoring | at conventional cardiac surgery (Day 1) | 
| Inotrope drugs doses |  | at conventional cardiac surgery (Day 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NIRS, Regional oxygen saturation, cardiac surgery with bypass
Diagnostic Breath Analysis for Detection of Ventilator Acquired Pneumonia (VAP)

Study Overview
=================
Brief Summary
-----------------
Breath samples from patients with Ventilator Acquired Pneumonia (VAP) will be analyzed to identify Volatile Organic Compounds (VOC) that have been specifically associated with VAP in previous animal models. Primary outcome measures will include the assessment of the zNose Diagnostic Breath Analysis System in the early detection of VOC's associated with VAP.

Detailed Description
-----------------
On clinical suspicion of VAP, breath samples will be collected from the expiratory limb of the patient's ventilator tubing circuit. A sterile Tedlar collection bag will be used to connect to the sample port and collect the breath sample. The expiratory limb sample port will be utilized to ensure maintenance of the integrity of the ventilator circuitry. The breath samples will be analyzed via the ZNose breath analysis system. Immediately following collection of breath samples, bronchoalveolar lavage fluid (BALF) will be collected and subjected to bacteriology testing for confirmation of VAP-positive and VAP-negative patients.

Official Title
-----------------
Pilot Study to Evaluate Diagnostic Breath Analysis for Early Detection of Ventilator Acquired Pneumonia (VAP)

Conditions
-----------------
Bacterial Infections

Intervention / Treatment
-----------------
* Device: Collection of exhaled breath sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥ 48 hours of ventilation with suspected VAP infection. Suspicion of VAP infection based on clinical evaluation criteria: Three or more positive out of the following: Tympanic temperature > 38 °C or < 35.5 °C Blood leukocytosis (10,000/µl) More than ten leukocytes in Gram stain of tracheal aspirate (in high-flow field) Positive culture of tracheal aspirate New, persistent, or progressive infiltrate on chest radiograph Exclusion Criteria: Patients with pre-existing structural lung disease (COPD, asthma, lung cancer, etc.), thrombocytopenia (< 40,000/µL) and other coagulation abnormalities.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnostic Breath Analysis: VAP<br>Collection of exhaled breath samples | Device: Collection of exhaled breath sample<br>* Collect exhaled breath sample from patients with suspected VAP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Breath Analysis | Diagnostic analysis of Volatile Organic Compounds in exhaled breath samples These are compared to known compounds associated with sepsis in exhaled breath in septic rats, such as the oliphenones. | 6 months |
PRP Prevents Recurrence of Intrauterine Adhesions

Study Overview
=================
Brief Summary
-----------------
Effect of platelet-rich plasma (PRP) on uterine scar fibrosis, endometrial receptivity and pregnancy outcome in patients with severe intrauterine adhesions

Detailed Description
-----------------
Inclusion criteria: patients with intrauterine adhesions (AFS score >9 points); age 21 to 40 years old, with fertility requirements. Study design:prospective, randomized controlled cohort study, patients with intrauterine adhesions were randomized into two groups, the control group and the intervention group (intraoperative and postoperative 1 week postoperative PRP). The surgical procedures and postoperative medication regimens were the same. Compare the biochemical pregnancy rate, clinical pregnancy rate, abortion rate and live birth rate after hysteroscopic resection in PRP group and control group, and explore the effect of PRP on pregnancy outcome after intrauterine adhesion.

Official Title
-----------------
Platelet-rich Plasma(PRP) Prevents Recurrence of Intrauterine Adhesions

Conditions
-----------------
Intrauterine Adhesion

Intervention / Treatment
-----------------
* Procedure: Platelet-rich plasma
* Procedure: gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Patients with intrauterine adhesions (AFS score >9 points); age 21 to 40 years old, with fertility requirements - Exclusion Criteria:Endometrial tuberculosis, endometrial polyps, uterine submucosal fibroids, endometrial hyperplasia, endometrial malignant lesions, premature ovarian failure, chromosomal abnormalities -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 37 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP<br>Platelet-rich plasma | Procedure: Platelet-rich plasma<br>* Platelet-rich plasma intrauterine injection<br>|
| Sham Comparator: Gel<br>Self-crosslinking sodium hyaluronate gel | Procedure: gel<br>* Self-crosslinking sodium hyaluronate gel intrauterine injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AFS score | AFS score | 1 year |
Phase 1 Drug Interaction Study of the Effect of Apixaban on the PK of Digoxin in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effects of Apixaban on the Pharmacokinetics (PK) of multiple-dose Digoxin in healthy subjects.

Official Title
-----------------
Effect of Apixaban on the Pharmacokinetics of Digoxin in Healthy Subjects

Conditions
-----------------
N/A - Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Apixaban
* Drug: Digoxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECGs), and clinical laboratory determinations Exclusion Criteria: • Any significant acute or chronic medical illness, history of important arrhythmias, history or evidence of abnormal bleeding or coagulation disorders, significant head injury within the last 2 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A: Digoxin<br>Digoxin tablet by mouth on specified days | Drug: Digoxin<br> <br> |
| Experimental: Treatment B: Apixaban and Digoxin<br>Apixaban and Digoxin tablets by mouth on specified days | Drug: Apixaban<br> <br> Drug: Digoxin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apixaban and Digoxin plasma concentration | Blood samples for Digoxin were collected on Days 8, 9, 10, 11, 18, 19, 20 & 21 Urine samples for Digoxin were collected for 24 hours post dose on Days 10 & 20. Blood samples for Apixaban concentration were collected on Days 18-20 | Days 8-21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability based on medical review of adverse event reports and the results of vital sign measurements, physical examinations, electrocardiograms, digoxin concentrations,and clinical laboratory tests |  | Days 1-22 |
Safety and Pharmacodynamics of SEL-068 Vaccine in Smokers and Non-Smokers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and pharmacodynamics of SEL-068. Increasing subcutaneous doses of SEL-068 will be administered to healthy non-smoker and smoker volunteers. The resulting safety profile and anti-nicotine antibody levels will be evaluated.

Official Title
-----------------
A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Pharmacodynamics of Increasing Subcutaneous Doses of SEL-068 in Healthy Non-Smoker and Smoker Adults

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Biological: SEL-068
* Biological: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Primary Inclusion Criteria: Healthy Smokers Healthy non-smokers Written informed consent Primary Exclusion Criteria: Prior exposure to nicotine vaccines Female subjects of childbearing potential Current use of immunosuppressive agents History of or current autoimmune disorder of immunosuppressive condition (e.g. HIV infection) Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device or biologic investigational research study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SEL-068<br> | Biological: SEL-068<br>* Sub-cutaneous injection, multiple dose<br>|
| Placebo Comparator: Saline<br> | Biological: Saline<br>* Sub-cutaneous injection, multiple dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of multiple subcutaneous injections of SEL-068 as assessed by frequency of vaccine related adverse events, graded by severity |  | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity of SEL-068 by measuring anti-nicotine antibody titers by Enzyme-Linked Immunosorbent Assay (ELISA). |  | 36 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nicotine vaccine, smoking vaccine, smoking cessation, SEL-068
Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study was to compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the percentage of patients who achieve the Assessment in Ankylosing Spondylitis (ASAS) response criteria (ASAS 20%) at week 12.

Official Title
-----------------
Multicenter, Double-Blind, Parallel, Placebo-Controlled, Randomised Phase 3 Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis: 12-Week Final Data

Conditions
-----------------
Ankylosing Spondylitis

Intervention / Treatment
-----------------
* Drug: Enbrel (etanercept)


Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion criteria Diagnosis of AS (defined by Modified New York Criteria for Ankylosing Spondylitis). Active AS (defined by the average of scores on the visual analog scale [VAS] of ≥ 30 for duration and intensity of morning stiffness and by 2 of the following: VAS for patient global assessment ≥ 30; average of VAS for nocturnal and total pain ≥ 30; BASFI ≥ 30 (all scores on a scale of 0 to 100). 18 to 70 years of age. Main exclusion criteria Complete ankylosis (fusion) of spine. Previous receipt of etanercept, antibody to tumour necrosis factor alpha (TNFα), or other TNFα inhibitors. Use of disease-modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, or methotrexate within 4 weeks of baseline.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enbrel (etanercept)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the |  |  | 
| percentage of patients who achieved the assessment in Ankylosing Spondylitis (ASAS 20%) response criteria at week 12. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess: 1) the safety of etanercept in this patient population; 2) the efficacy of etanercept |  |  | 
| compared with that of placebo using the ASAS response criteria at 50% and 70% levels at week 12. |  |  |
Evaluation of Sarcopenia-Related Malnutrition in Older Adults

Study Overview
=================
Brief Summary
-----------------
Sarcopenia and malnutrition are two geriatric syndromes that are frequently seen in the elderly and have multifactorial etiology and severe clinical effects. However, the results vary widely due to the many methods and criteria used in the diagnosis and prevalence rates of both syndromes. In this study, it is aimed to investigate the relationship between the GLIM (Global Leadership Initiative on Malnutrition) criteria and various sarcopenia levels, which are newly defined worldwide and have the widest spectrum so far in describing malnutrition.

Official Title
-----------------
Evaluation of Sarcopenia-Related Malnutrition in Older Adults According to GLIM (Global

Conditions
-----------------
Sarcopenia, Malnutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To get a score of 21 and above in the Mini-Mental State Examination To be able to walk independently or with the help of a device (cane, etc.) Exclusion Criteria: Individuals with a serious orthopedic (advanced hip or knee arthrosis, etc.) or neurologic conditions that may affect ambulation

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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 |
| --- | --- | --- |
| Malnutrition diagnosis according to GLIM criteria | Malnutrition diagnosis according to GLIM criteria | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sarcopenia diagnosis according to the European Working Group on Sarcopenia in Older People (EWGSOP) | Sarcopenia diagnosis | 30 minutes |