linjc16/ctgov huggingface dataset:
Continuous Glucose Monitoring (CGM) in Long Term Care (LTC) Facilities

Study Overview
=================
Brief Summary
-----------------
To prospectively determine the burden of hypoglycemia (minutes spent below 70 mg/dl per day, measured by continuous glucose monitor (CGM)) among residents of long term care facilities (LTC) with a diagnosis of type 1 or type 2 diabetes including key clinical subgroups (living in skilled nursing facility (SNF) or nursing home (NH), on different hypoglycemic medications). This aim will be achieved by recruiting 300 residents with diabetes in 4 LTC facilities. All participants will undergo masked CGM for 10 days.

Official Title
-----------------
Continuous Glucose Monitoring (CGM) to Assess Hypoglycemia in Older Adults With Diabetes in Long Term Care (LTC) Facilities

Conditions
-----------------
Diabetes, Hypoglycemia, Aging

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults >64 years with diagnosis of type 1 or type 2 diabetes Using glucose-lowering medication or insulin Exclusion Criteria: Currently taking or planning to take hydroxyurea Patient or Health care proxy refuses to sign consent form

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Long Term Care Residents Using Glucose Lowering Medication<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical hypoglycemia | minutes per day sensor glucose <70 mg/dL | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A1C |  | Baseline | 
| Time-in-range | percent/day over 10 days of glucose value between 90-180 mg/dl or 90-250 mg/dl depending current ADA recommendations) | Baseline | 
| Clinically significant hypoglycemia | minutes per day sensor glucose <54 mg/dl | Baseline | 
| Severe hypoglycemia | needing 3rd party assistance | Baseline | 
| Falls, hospitalization |  | Baseline | 
| Symptoms of hypoglycemia reported to the staff by the resident in between or at the time of fingerstick glucose monitoring (information derived from nursing notes) |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
older adults, hypoglycemia, continuous glucose monitoring, long-term care facilities
Anti-Xa Level With Thromboprophylactic Dosage Nadroparin in Critically Ill COVID-19 and Non-COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
Primary objective The objective of this study is to compare anti-Xa levels obtained with a standard high dose thrombosis prophylaxis in COVID-19 intensive care-patients compared with anti-Xa levels obtained with a normal dose thrombosis prophylaxis in non-COVID-19 intensive care patients. Secondary objectives To determine the incidence of anti Xa levels out of range of the established target anti Xa level in both groups. To determine the influence of relevant co-variates on the anti-Xa level in the COVID-19 and non-COVID-19 group.

Official Title
-----------------
Evaluation of Anti-Xa Levels With Nadroparin as Thrombosis Prophylaxis in COVID-19 and Non-COVID-19 Patients Admitted at the ICU

Conditions
-----------------
Critical Illness, Therapeutic Drug Monitoring, Venous Thromboembolism

Intervention / Treatment
-----------------
* Procedure: blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All COVID-19 patients > 18 years admitted at the ICU using nadroparin in a high thrombosis prophylactic dosage of 1 dd 5700 IU or 2 dd 5700 IU sc All medical non-COVID-19 patients admitted at the ICU using nadroparin in a standard prophylactic dosage of 1 dd 2850 IU sc. Minimum estimated length of stay on the ICU of 4 days Exclusion Criteria: o (History of) Heparin Induced Thrombocytopenia and Thrombosis

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 |
| --- | --- |
| COVID-19 ICU patients<br>Patients were administered as standard care once daily nadroparin 5700 IU sc (below 100 kg) or twice daily nadroparin 5700 IU sc (above 100 kg). | Procedure: blood sampling<br>* Blood sampling for the determination of anti-Xa peak levels 4 hours after administration of nadroparin sc.<br>|
| non-COVID-19 ICU patients<br>Patients were administered as standard care once daily nadroparin 2850 IU sc. | Procedure: blood sampling<br>* Blood sampling for the determination of anti-Xa peak levels 4 hours after administration of nadroparin sc.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of anti-Xa peak level | U/ml | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of anti-Xa levels within target range | Amount of levels within target range (in %) | 2 years | 
| Influence of covariates (nadroparin dosage, gender, age, weight, BMI, COVID-19, APACHE IV, vasopressor use, eGFR, fluid balance, CRP) on anti-Xa level | relevant correlation | 2 years |
Mirogabalin for Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the analgesic effect of mirogabalin in patients undergoing unilateral hip arthroplasty.

Official Title
-----------------
Mirogabalin and Pain After Total Hip Arthroplasty: a Double-blind, Randomized, Placebo-controlled Trial

Conditions
-----------------
Hip Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Arm I (mirogabalin group)
* Drug: Arm II (placebo group)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty American Society of Anesthesiologists class 1-3 Exclusion Criteria: Major prior ipsilateral open hip surgery Allergies to drugs used in research Difficult to manage diabetes mellitus (including insulin dependence) Chronic use of gabapentin or pregabalin (regular use for more than 3 months) Patients taking cimetidine, probenecid, or lorazepam Patients with moderate or severe hepatic impairment (AST/ALT 2.5 times or more of the upper limit of normal) Estimated glomerular filtration rate < 60 mL/min/1.73m2 Dependence on opioids In the case of subjects who cannot read the consent form (e.g. illiterate, foreigners, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 19 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: mirogabalin group<br>perioperative mirogabalin | Drug: Arm I (mirogabalin group)<br>* Take two capsules of Mirogabalin 5 mg within 30 minutes before going to the operating room. Patients take 5 mg of mirogabalin twice daily at 12-hour intervals until POD 7 days.<br>|
| Sham Comparator: placebo group<br>placebo | Drug: Arm II (placebo group)<br>* It is performed in the same way as Arm l.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numeric rating scale at flexion | A score of 0 indicates no pain and a score of 10 indicates maximum pain. | postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numeric rating scale at flexion | A score of 0 indicates no pain and a score of 10 indicates maximum pain. | up to 3 month after surgery |
DevElopMent of Clinical PATHwaYs to the Diagnosis of Heart Failure With Preserved Ejection Fraction

Study Overview
=================
Brief Summary
-----------------
Prevalence of heart failure with preserved ejection fraction (HFpEF) continues to increase in the developed world, likely because of the increasing life expectancy and an increasing number of elderly patients. Transthoracic echocardiography is essential for the diagnosis of HFpEF according to the current guidelines. The HFA-PEFF and H2FPEF diagnostic algorithms rely on clinical characteristics and echocardiography findings that indicate the presence of diastolic dysfunction. These diagnostic algorithms are not applicable in remote areas where expert echocardiography cannot be performed due to the absence of modern ultrasound systems and lack of qualified specialists. Therefore, it is important to develop an algorithm to evaluate pre-test probability of HFpEF without echocardiographic markers, so it can be easily used in the primary outpatient care setting by any specialist. The aim of this study is to find the associations between clinical and epidemiological characteristics and changes of intracardiac hemodynamics in patients with dyspnea and decreased exercise tolerance.

Official Title
-----------------
DevElopMent of Clinical PATHwaYs to the Diagnosis of Heart Failure With Preserved Ejection Fraction (EMPATHY-HF)

Conditions
-----------------
Heart Failure With Preserved Ejection Fraction (HFpEF)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients complaining of shortness of breath, with two or more chronic non-communicable diseases (patients with comorbidities) Exclusion Criteria: Morbid obesity; Any chronic diseases in the stage of exacerbation and / or decompensation; Systemic diseases, cancer; Cardiac arrhythmias: persistent atrial fibrillation or paroxysmal atrial fibrillation with frequent paroxysms; History of myocardial infarction, stroke, heart failure with reduced ejection fraction; Storage diseases, hypertrophic cardiomyopathy, concentric hypertrophy; Congenital and acquired heart defect;

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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 with HFpEF<br> | |
| patients without HFpEF<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An increased of post-exercise E/e' ratio |  | during diastolic stress test (baseline) | 
| An increased of post-exercise pulmonary artery systolic pressure (PASP) |  | during diastolic stress test (baseline) |
Application of Al18F-octreotide PET/CT in Neuroendocrine Tumor

Study Overview
=================
Brief Summary
-----------------
This is an open-label whole-body PET/CT study for investigating the value of Al18F-octreotide PET/CT in patients with Neuroendocrine Tumor

Detailed Description
-----------------
Octreotide is an artificial replacement for the natural growth hormone inhibitor in humans. It is a small peptide hormone consisting of 14 amino acids and is widely distributed in neuroendocrine cells, with the highest density in the brain, peripheral neurons, endocrine pancreas and gastrointestinal tract. Under pathological conditions, some tumour cells show overexpression of growth inhibitory receptors, such as endocrine tumours of the pancreas, pituitary adenomas, pheochromocytomas, paragangliomas, carcinoid tumours, medullary thyroid carcinomas, small cell lung carcinomas and other neuroendocrine tumours. Therefore, the sensitivity and specificity of octreotide imaging is high. This study will provide a visual, reproducible and non-invasive imaging method for the diagnosis of neuroendocrine tumours through Al18F-octreotide PCT/CT imaging, providing an intuitive and clear imaging basis for clinical diagnosis, differential diagnosis and treatment, contributing to the development of medicine and science in the field of positron imaging.

Official Title
-----------------
Application of Al18F-octreotide PET/CT in Neuroendocrine Tumor

Conditions
-----------------
Neuroendocrine Tumor

Intervention / Treatment
-----------------
* Drug: Al18F-octreotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with suspected or clearly diagnosed Neuroendocrine Tumor signed written consent. Willing and able to cooperate with all projects in this study. Exclusion Criteria: pregnancy; breastfeeding; any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Al18F-octreotide PET/CT<br>Al18F-octreotide PET/CT will be performed on patients with suspected or clearly diagnosed Neuroendocrine Tumor. The patients were injected with Al18F-octreotide and underwent PET/CT scan 20 40min after the injection. | Drug: Al18F-octreotide<br>* Al18F-octreotide I was injected into the patients before the PET/CT scans<br>* Other names: Al18F-NOTA-TATE;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic value | Sensitivity and Specificity of Al18F-octreotide PET/CT for Neuroendocrine Tumor | through study completion, an average of 1 year] |
Vit D Receptor Gene Polymorphism

Study Overview
=================
Brief Summary
-----------------
The present cross-sectional observational study was conducted after the university ethical committee approved the research (NU/CEC/2020/0339). This study included 376 adults in the age group of 18-40Yrs. The patient information sheet briefed the study details and usage of salivary samples. Informed consent was obtained from participants. Healthy individuals free of associated systemic conditions, individuals not under any nutritional supplementation were included in the study, and lactating mothers, smokers, and menopausal women were excluded

Detailed Description
-----------------
The present cross-sectional observational study was conducted after the university ethical committee approved the research (NU/CEC/2020/0339). This study included 376 adults in the age group of 18-40Yrs. The patient information sheet briefed the study details and usage of salivary samples. Informed consent was obtained from participants. Healthy individuals free of associated systemic conditions, individuals not under any nutritional supplementation were included in the study, and lactating mothers, smokers, and menopausal women were excluded. Further, the subjects were divided into active and caries-free based on caries experience. Two indexing methods were utilized to record the decay status, i.e., Decay, Missing, filled (DMFT) and Pulpal, Ulcerative, Fistula (PUFA) scores. Caries active group was further divided into a High-risk group (DMFT=< 10), Moderate risk (DMFT= 4-9), and Low risk (DMFT=1-3). Questionnaire: Baseline information was gathered, including specifics on age, sex, height, weight, dietary preferences (non-veg/veg), and dental hygiene practices.

Official Title
-----------------
Vit D Receptor Gene Polymorphism and Its Possible Association With Prevalence of Dental Caries

Conditions
-----------------
Vitamin D Status

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy individuals free of associated systemic conditions Individuals not under any nutritional supplementation Exclusion Criteria: lactating mothers smokers menopausal women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| High risk<br> | Other: questionnaire<br>* questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DMFT scores | Scores are 1 for dental caries present and 0 for dental caries absent | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D Gene Polymorphism, Dental Caries, Cathelicidins
Multi-center Study on Reducing Postoperative Pulmonary Complications in Elderly Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to carry out demonstrative comprehensive intervention for elderly patients in several hospitals to observe whether it can reduce the incidence and mortality of perioperative pulmonary complications in elderly patients and improve their perioperative prognosis.

Detailed Description
-----------------
This study investigated the incidence of postoperative pulmonary complications in various hospitals, and carried out demonstrative comprehensive intervention for elderly patients in several hospitals according to the comprehensive intervention system program of perioperative pulmonary complications, to observe whether the perioperative prognosis can be improved and the quality of life can be improved, thus verifying and optimizing the current evaluation system and intervention system, and providing evidence support for further extensive application.

Official Title
-----------------
Multi-center Study on Reducing Postoperative Pulmonary Complications in Elderly Patients Based on Comprehensive Intervention System

Conditions
-----------------
Postoperative Pulmonary Complications

Intervention / Treatment
-----------------
* Other: Application of integrated intervention system programs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 65 years or older receiving invasive ventilation during general anesthesia for surgery Exclusion Criteria: preoperative mechanical ventilation procedures related to a previous surgical complication a second operation after surgery organ transplantation discharged within 24 hours after surgery

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Application of integrated intervention system programs | Other: Application of integrated intervention system programs<br>* Application of integrated intervention system programs<br>|
| No Intervention: Control group<br>No intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pulmonary complications |  | within one week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pulmonary complications |  | 30 days after surgery |
Extraocular Muscle Stretching as a Weakening Procedure

Study Overview
=================
Brief Summary
-----------------
Interventional case series. Non-operated patients with an indication of medial rectus muscle weakening surgery (deviation up to 20 PD) who could cooperate with topical or sub-Tenon's anesthesia. Clinical workup includes routine complete ophthalmological evaluation. One double needle 6/0 Mersilene suture is used on each side of the muscle at 4 mm distance of the insertion and pulled / stretched to insert in the sclera 3-5 mm posterior to the muscle locking passes. Seven patients with esotropia of 12-20 PD were included.

Official Title
-----------------
Stretching of an Extraocular Rectus Muscle as a Weakening Procedure

Conditions
-----------------
Strabismus, Comitant

Intervention / Treatment
-----------------
* Procedure: Extraocular muscle stretching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring weakening of medial rectus muscle(s) for 12-20 PD of esotropia who could cooperate with topical / sub-Tenon's anesthesia, and had no previous eye muscle surgery Exclusion Criteria: Patients with previous strabismus surgery

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
Intervention Model: Single Group Assignment
Interventional Model Description: Extraocular muscle procedure
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extraocular muscle stretching arm<br> | Procedure: Extraocular muscle stretching<br>* Extraocular muscle stretching to test its efficacy as a weakening procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance deviation at 2 months after surgery | Distance deviation at 2 months after surgery (alternate prim and cover) | 2 months |