linjc16/ctgov huggingface dataset:
Nurses' Level of Knowledge on Skin Tears: A Cross-Sectional Study

Study Overview
=================
Brief Summary
-----------------
Skin tears (ST) are one of the skin integrity problems encountered in healthcare settings with rates equal to or greater than pressure injuries. However, the importance of this problem has been emphasized in the literature in recent years. This study was conducted to determine the knowledge level of nurses about ST.

Detailed Description
-----------------
The population of the study consisted of all nurses working in acute care hospitals in Turkey. The sample size of the study was calculated as 384 nurses. The data of the study were collected in the form of online and paper-based surveys (an introductory information form and the Skin Tear Knowledge Assessment Instrumen)

Official Title
-----------------
Determination of Nurses' Level of Knowledge on Skin Tears in Acute Care Hospitals: A Cross-Sectional Study

Conditions
-----------------
Nurse's Role, Wound, Knowledge, Attitudes, Practice

Intervention / Treatment
-----------------
* Other: Knowledge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: were employed as a nurse for at least 1 year cared for patients aged 65 and over agreed to participate in the study Exclusion Criteria: • nurses who filled in the data collection tools incompletely
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 |
| --- | --- |
| Nurse<br>Nurses who (1) were employed as a nurse for at least 1 year, (2) cared for patients aged 65 and over and (3) agreed to participate in the study were included in the study. | Other: Knowledge<br>* Measuring the level of knowledge about skin tears<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Tear Knowledge Assessment Instrument | Skin Tear Knowledge Assessment Instrument was developed by Van Tiggelen et al. (2021) | one month |
Usability of the PreView PHP for Home Use in Intermediate AMD Patients

Study Overview
=================
Brief Summary
-----------------
To demonstrate the ability of intermediate AMD subjects to follow the instructions for use and properly operate on their own the Preview PHP in home use environment, after going through training session.

Detailed Description
-----------------
The study purpose is to demonstrate that the target population can use the system after going through a supervised training session. The PreView PHP will be operated in the same manner in the simulated setting as it will be in future home use.

Official Title
-----------------
Usability of the PreView PHP for Home Use in Intermediate Age Related Macular Degeneration Patients

Conditions
-----------------
Age Related Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Capable and willing to sign a consent form and participate in the study Subjects diagnosed as intermediate AMD in at least one eye Age ≥65 years VA with habitual correction better than 20/60 in the study eye Ability to speak, read and understand instructions in English or Hebrew Qualified to use the device by health care professional Exclusion Criteria: Evidence of macular disease other than AMD or glaucoma in the study eye Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP. Any non-macular related ocular surgery or macular surgery performed within 3 months prior to study entry in the target eye Participation in another study with the exclusion of AREDS study Patients diagnosed with geographic atrophy (GA)

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 |
| --- | --- |
| 1<br>Subjects diagnosed with Dry AMD | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects who successfully completed the test by themselves, in a home simulated environment |  | 2 clinic visits | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMD
Non-Interventional Study of Cough Variant Asthma Treatment With Pulmicort®Respules® in Children Outpatients

Study Overview
=================
Brief Summary
-----------------
This open label, non-interventional study is to show the efficacy of Pulmicort®Respules® in cough variant asthma in patient aged 5-year old or younger in outpatient department

Official Title
-----------------
A Non-Interventional Study of Cough Variant Asthma Treatment With Pulmicort®Respules® in Patient Aged 5-Year Old or Younger in Outpatient Department

Conditions
-----------------
Cough Variant Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent Patient who has been prescribed Pulmicort® Respules® according to physician's judgement, irrespective of the inclusion in the study. The usage of Pulmicort® Respules® follows local authorised package insert. Exclusion Criteria: Allergy to any ingredient of Pulmicort® Respules® With history of Leukotriene Modifier (LM) usage prior to 2 weeks of recruitment or following plan. Have used systemic/inhaled steroid prior to 2 weeks of recruitment

Ages Eligible for Study
-----------------
Maximum Age: 5 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 |
| --- | --- | --- |
| Patient Symptom Score |  | 7 weeks (plus or minus 3 days ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Compliance Report |  | 7 weeks (plus or minus 3 days ) | 
| Investigator Assessment Report |  | 7 weeks (plus or minus 3 days ) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cough variant asthma, Pulmicort® Respules®, Chinese patient Eligibility
Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Under Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study designed to characterize the pharmacokinetics and comparative bioavailability of Roxane Laboratories' codeine sulfate tablets after oral administration of 60 mg doses as 1 x 60 mg, 2 x 30 mg and 4 x 15 mg under fasted conditions.

Official Title
-----------------
A Single Dose, 3-Period, 3-Treatment, 6-Sequence Crossover Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Tablet Formulations Under Fasting Conditions

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Codeine Sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to codeine sulfate or any comparable or similar product.

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Codeine Sulfate|15 mg, 30 mg and 60 mg Tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 21 Days |
Phase IIa Study to Investigate the Efficacy and Safety of SPP635 in Diabetic and Hypertensive Patients With Albuminuria

Study Overview
=================
Brief Summary
-----------------
This is a phase II a, double-blind, randomized, parallel-design, four-week study to investigate the efficacy, safety and tolerability of two different doses of SPP635 in type II diabetic patients with mild to moderate hypertension and albuminuria. The total study duration for patients completing the entire study will be approximately 7 weeks including a 2 weeks Screening Phase, 1 week Wash-out Phase, 4 week Treatment Phase and 1 week Follow-up Phase. All treatments other than certain antihypertensive drugs (which are to be washed-out) with an effect on BP and all antidiabetic treatments must be kept at stable dose during the whole study. A maximum of 50 patients in total is planned to be enrolled.

Official Title
-----------------
A Phase IIa, Double-Blind, Randomized, Parallel-Design, Four-Week Study to Investigate the Efficacy and Safety of Two Different Doses of the Renin-Inhibitor SPP635 Once Daily in Type II Diabetic Patients With Mild to Moderate Hypertension and Albuminuria

Conditions
-----------------
Hypertension, Type II Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: SPP635


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men or women, 18 to 75 years hypertension diabetes mellitus type II albuminuria Exclusion Criteria: donation of blood in the past month significant illness history of malignancy Heart failure, stroke, myocardial infarction, transient ischaemic attack, or hypertensive encephalopathy within the past 6 months Current or past history of clinically significant electrocardiogram (ECG) abnormalities such as permanent 2nd degree atrioventricular (AV) block or higher, unstable angina, percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG) or cerebrovascular accident in the last three months

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>high dose | Drug: SPP635<br>* oral once daily<br>|
| Experimental: 2<br>lower dose | Drug: SPP635<br>* oral once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ABPM |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sitting PB |  | 28 days |
Efficacy of a Brown Seaweed Powder for Glycemic Control

Study Overview
=================
Brief Summary
-----------------
The objectives of this trial are to confirm efficacy in human of a brown seaweed powder and explore dose-response relationship by comparing two different doses. The primary endpoint is incremental area under the curve (iAUC, mmol*min/L) for blood glucose.

Official Title
-----------------
Efficacy of a Brown Seaweed Powder for Glycemic Control

Conditions
-----------------
Blood Glucose

Intervention / Treatment
-----------------
* Dietary Supplement: 500 mg InSea2®
* Dietary Supplement: 250 mg InSea2®
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females aged between 18-45 y Normoglycemic (fasting blood glucose <5.6 mmol/L) Body mass index (BMI) 18.5-29.9 kg/m2 Able to consume bread products Exclusion Criteria Fasting blood glucose > 5.6 mmol/L Systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease Presence of a gastrointestinal disorder within the past year Presence of major gastrointestinal surgeries Thyroid problems Smokers Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgement Women that are currently pregnant or lactating, or not using an appropriate contraception method Excessive alcohol intake (more than 2 drinks per day or more than 9 drinks per week) Allergic to shellfish (crab) or molluscs Weight gain or loss of at least 10lbs in previous three months

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 500 mg InSea2®<br> | Dietary Supplement: 500 mg InSea2®<br> <br> |
| Active Comparator: 250 mg InSea2®<br> | Dietary Supplement: 250 mg InSea2®<br> <br> |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental area under the curve (iAUC, mmol*min/L) of blood glucose | Incremental area under the curve (iAUC, mmol*min/L) | 0, 15, 30, 45, 60, 75, 90, 120, 150, 180 and 210 min |
Prevalence of Wild-Type Transthyretin Cardiac Amyloidosis Among Patients Undergoing Carpal Tunnel Release Surgery - A Prospective Study

Study Overview
=================
Brief Summary
-----------------
Patients above the age of 60 will be recruited at their carpal tunnel release surgery. Biopsies will be taken from the wrist and examined for the presence of amyloid protein. A amyloid-positive biopsy will refer the patients for cardiac examination. If the result of the cardiac examination is suspected cardiac amyloidosis, the patient will be referred for a diagnostic TC99-DPD scintigraphy. If the scintigraphy is positive, the patient will be referred for right heart catherization (RHC) and an exercise test. Myocardial biopsies will be taken at the RHC and examined with electron microscopy and high resolution respirometry.

Official Title
-----------------
Prevalence of Wild-Type Transthyretin Cardiac Amyloidosis Among Patients Undergoing Carpal Tunnel Release Surgery - A Prospective Study

Conditions
-----------------
Transthyretin Amyloidosis, Transthyretin Cardiac Amyloidosis, Wild-Type Transthyretin-Related (ATTR)Amyloidosis

Intervention / Treatment
-----------------
* Diagnostic Test: Tenosynovial biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males above 65 years of age, females above 75 years of age. Scheduled idiopathic carpal tunnel release surgery. Informed written consent. Exclusion Criteria: Operation by other indication, e.g. Fracture Ganglion Known amyloidosis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Tenosynovial Biopsy<br> | Diagnostic Test: Tenosynovial biopsy<br>* Tenosynovial biopsy taken from the wrist at the carpal tunnel release surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of wild-type transthyretin cardiac amyloidosis | Diagnosis of wild-type cardiac amyloidosis will be determined by TC99-DPD scintigraphy, endomyocardial biopsy, or both. | Through study completion, 2 years. |
Is There a Relationship Between Previous Exposure to General Anesthesia and the Development of Alzheimer´s Disease?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare exposure to general anesthesia between cases with a diagnosis of Alzheimer´s disease and controls without diagnosis, through studies of medical records. The investigators wish to explore if there is a relationship between exposure to general anesthesia and the development of Alzheimer´s disease.

Official Title
-----------------
A Case-control Study of Exposure to General Anesthesia and a Diagnosis of Alzheimer´s Disease Later in Life.

Conditions
-----------------
Alzheimer´s Disease, General Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Alzheimer´s disease Previous exposure to anesthesia Exclusion Criteria: Inability to retrieve medical records
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 |
| --- | --- | --- |
| Exposure to general anesthesia |  | Up to 20 years in retrospect | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposure to inhaled anesthetics |  | Up to 20 years in retrospect |
Lymphocyte Markers As Predictors Of Responsiveness To Rituximab Among Patients With Idiopathic Nephrotic Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if lymphocyte markers predict response to rituximab among patients with idiopathic nephrotic syndrome

Official Title
-----------------
Lymphocyte Markers As Predictors Of Responsiveness To Rituximab Among Patients With Idiopathic Nephrotic Syndrome

Conditions
-----------------
Nephrotic Syndrome

Intervention / Treatment
-----------------
* Drug: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 1-18 years old at the time of diagnosis of nephrotic syndrome Steroid-dependent (SDNS) or steroid-resistant nephrotic syndrome (SDNS) Exclusion Criteria: eGFR <60 ml/min per 1.73m2 infantile onset of nephrotic syndrome nephrotic syndrome secondary to chronic infections such as hepatitis B, hepatitis C or human immunodeficiency virus, systemic lupus erythematosus, Henoch-Schönlein purpura, IgA nephropathy, membranoproliferative glomerulonephritis or membranous nephropathy current or previous therapy for tuberculosis presence of mutations in WT1, NPHS1, NPHS2 and TRPC6.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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: Rituximab<br> | Drug: Rituximab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response | Resolution of proteinuria (urine protein:creatinine <0.02 g/mmol or urine protein excretion <0.3 g/1.73m2/day) and ability to wean off prednisolone and calcineurin inhibitor at three months after the last dose of rituximab. | 3 months |
Vascular and Periodontal Disease - Microbial, Genetic and Histological Causalities

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze genetic polymorphisms in genes encoding pro-inflammatory cytokines, and study the genetic predisposition to chronic periodontitis (CP) in combination with atherosclerotic cardiovascular (ACD) and aneurysmal diseases. The investigators will also try to identify oral bacteria in atherosclerotic plaques and aneurysmal walls and thrombus. Histological analyses of atherosclerotic plaques and aneurysmal wall will be performed.

Official Title
-----------------
Periodontal-, Cardiovascular- and Aneurysmal Diseases.

Conditions
-----------------
Periodontitis, Vascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing vascular surgery at Oslo University Hospital, Aker, previously randomly collected patients with periodontitis, Exclusion Criteria: patients whom undergone antibiotic treatment the past month. patients whom undergone periodontal treatment the past 6 months. patients with no teeth
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
-----------------
Periodontitis, Vascular disease, Proinflammatory cytokines