linjc16/ctgov huggingface dataset:
Efficacy and Safety of Biphasic Insulin Aspart 30 for the Treatment of Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this observational study is to collect efficacy and safety data of biphasic insulin aspart (NovoMix® 30) in type 2 diabetes under normal clinical practice conditions.

Official Title
-----------------
A Clinical Experience Programme to Collect Data on the Safety and Efficacy of NovoMix® 30 in the Treatment of Patients With Type 2 Diabetes in Jordan

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects from hospitals or clinics, diagnosed with type 2 diabetes mellitus
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BIAsp 30 users<br> | Drug: biphasic insulin aspart 30<br>* Administered via an insulin injection device. Dosages varied according to individual patients' medical requirement as determined by their attending clinician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (glycosylated haemoglobin) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FBG (Fasting Blood Glucose) |  |  | 
| Quality of life assessed through the WHO-DTSQ (World Health Organization-Diabetes Treatment Satisfaction Questionnaire) |  |  | 
| Incidence of adverse events |  |  | 
| Incidence of hypoglycaemic episodes |  |  |
PPARgamma Activation by Losartan in Hypertensive Patients: The Importance of Losartan-Metabolites

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether losartan metabolites are effective in inducing PPARγ target genes in monocytes in losartan-treated patients.

Detailed Description
-----------------
The losartan metabolite EXP3179 potently induces the activity of the peroxisome proliferator-activated receptor γ (PPAR-γ) as a partial agonist in vitro. PPAR-γ is a nuclear hormone receptor and functions as a regulator of lipid- and glucose metabolism. PPAR-γ ligands improve insulin sensitivity and glucose tolerance, and reduce cardiovascular morbidity and mortality in diabetic patients. Angiotensin II receptor 1-blocking and PPAR-γ-activating properties of losartan metabolites in patients would markedly improve the pharmacological profile of losartan by combining anti-hypertensive and highly beneficial metabolic actions. We developed the following hypothesis: Hypertensive patients chronically treated with losartan exhibit sufficient plasma levels of EXP3179 to activate PPARγ. PPARγ target genes are induced in monocytes from losartan-treated patients.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: losartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 19-80 Sex: male or female Prior diagnosis of treated hypertension Treatment with losartan 100mg/daily during at least the past 2 months (n=20/ case); or: no prior angiotensin receptor 1-blocker treatment during the last 2 months (n=10/ control). Exclusion Criteria: Non-steroidal anti-inflammatory drugs (exception: Acetyl salicylic acid) for the past 21 days (due to structural homologies to glitazones, and activating effects on PPARγ) Therapy with glitazones for the past 21 days.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 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 |
| --- | --- |
| A<br>Patients chronically treated with drug losartan | Drug: losartan<br>* Daily treated with losartan 100mg for at least the past 2 months (retrospective, no new drug treatment/ intervention)<br>|
| B<br>Patients not chronically treated with losartan | |

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
-----------------
hypertension, angiotensin receptor blockers, peroxisome proliferator activated receptor gamma
Nasal Swab studyComparison of Effectiveness of Povidone-iodine Versus Saline Versus 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP Swabs for Decolonizing Intranasal MSSA/MRSA

Study Overview
=================
Brief Summary
-----------------
To determine if routinely available 10% povidone-iodine swabs are more effective than saline and 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP for decolonizing MRSA.

Official Title
-----------------
Comparison of Effectiveness of Povidone-iodine Versus Saline Versus 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP Swabs for Decolonizing Intranasal MSSA/MRSA

Conditions
-----------------
MRSA/ MSSA Colonization of the Nares

Intervention / Treatment
-----------------
* Drug: Saline
* Drug: Povidone-Iodine
* Drug: 5% Povidone-Iodine USP swabs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All potential total hip and total knee arthroplasty candidates All femoroacetabular osteoplasty patients All pelvic acetabular osteotomy patients All core decompression patients Exclusion Criteria: Any trauma patients Any tumor patients Any patient with periprosthetic joint infection Any patient with surgical site infection Any patient with known MRSA infection Any patients allergic to povidone-iodine Patients with thyroid disease

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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: povidone-iodine<br> | Drug: Povidone-Iodine<br> <br> |
| Active Comparator: 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP swabs<br> | Drug: 5% Povidone-Iodine USP swabs<br> <br> |
| Placebo Comparator: Saline<br> | Drug: Saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MSSA/MRSA colonization in the nares | Subjects will undergo a swab of their nares to undergo PCR analysis to determine if they are effectively decolonized four hours after initial treatment | 4 hours | 
| MSSA/MRSA colonization as tested by PCR | Subjects will undergo a swab of their nares to undergo PCR analysis to determine if they are effectively decolonized four hours after initial treatment | 24 hours |
Effect of Propofol on Remifentanil-induced Postoperative Hyperalgesia in Patients Undergoing Thyroid Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that propofol infusion during surgery can affect the remifentanil hyperalgesia compared to sevoflurane inhalation.The outcome will be measured by a verbal numerical rating score (VNRS) and mechanical punctuating pain by electronic von frey filament.

Official Title
-----------------
Effect of Propofol on Remifentanil-induced Postoperative Hyperalgesia in Patients Undergoing Thyroid Surgery

Conditions
-----------------
Hyperalgesia

Intervention / Treatment
-----------------
* Drug: propofol, sevoflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing thyroidectomy Age 20-65 American Society of Anesthesiologists physical status classification I or II Exclusion Criteria: History of chronic pain, Regular use of analgesic, antiepileptic or antidepressive drugs History of drug & alcohol abuse Psychiatric disorder Use of opioids within 24hrs Renal disease with decreased glomerular filtrate ratio Neuromuscular disease, Severe cardiac disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: sevoflurane<br>Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min. patients who are in this group will be infused propofol intraoperatively. | Drug: propofol, sevoflurane<br>* Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min (group1 and 2) group 1 (Active Comparator, sevoflurane)will be infused propofol intraoperatively. group 2(Experimental, propofol) will be inhaled sevoflurane intraoperatively.<br>|
| Experimental: propofol<br>Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min. patients included this group will be inhaled sevoflurane intraoperatively. | Drug: propofol, sevoflurane<br>* Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min (group1 and 2) group 1 (Active Comparator, sevoflurane)will be infused propofol intraoperatively. group 2(Experimental, propofol) will be inhaled sevoflurane intraoperatively.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tactile pain thresholds adjacent to the surgical wound assessed by von Frey hair before the induction and at postoperative 24 & 48 hrs |  | postoperative 48 hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
remifentanil, hyperalgesia
Mbarara Acute Heart Failure Registry

Study Overview
=================
Brief Summary
-----------------
This is a prospective cohort to describe clinical characteristics, predictors of poor outcomes both during hospitalization and at home, functional status, and quality of life among patients aged 13 years or more, consecutively admitted with acute decompensated heart failure at Mbarara Regional Referral Hospital.

Detailed Description
-----------------
This is a prospective observational cohort study to collect comprehensive data of heartfailure patients during and after hospitalization for acute heart failure at Mbarara Regional Referral Hospital (MRRH), Uganda. The investigators will collect sociodemographic, clinical, quality of life, functional status, and clinical cardiovascular disease measures during hospitalization and follow up for up to 1 year from the date of enrollment.

Official Title
-----------------
Mbarara Acute Heart Failure Registry: Opportunities to Improve Care of Patients Hospitalized With Acute Decompensated Heart Failure in Mbarara Regional Referral Hospital, Uganda

Conditions
-----------------
Heartfailure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted with a confirmed clinical diagnosis of acute heartfailure aged 13 years or above at Mbarara Regional Referral Hospital, Uganda Exclusion Criteria: Body swelling from kidney disease, liver disease or malnutrition. Acute kidney disease with no previous history/documentation of heart disease. History suggestive of chronic kidney disease with no previous history/documentation of heart disease. History suggestive of chronic liver disease with no previous history/documentation of heart disease.

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- | --- |
| All-cause mortality |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospitalization | Length of hospital stay | 1 year | 
| Quality of life using the SF-36 questionnaire | Quality of life will be measured using SF-36 questionnaire. | 1 year | 
| Functional status using the Kansas city cardiomyopathy questionnaire | Kansas city cardiomyopathy questionnaire will be used to measure functional status during hospitalization and quarterly after hospitalization with acute heartfailure. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heartfailure, 1-year mortality, heartfailure quality of life, sub-Saharan Africa
Reduction of Catheterization Radiation Exposure Pad

Study Overview
=================
Brief Summary
-----------------
The RECAP-trial is a randomized controlled, double blinded, superiority trial studying the efficacy of the RADPAD®, a protective drape, that potentially reduces the scattered radiation received by the operator during diagnostic angiograms and percutaneous coronary interventions.

Detailed Description
-----------------
A total of 750 consecutive diagnostic angiograms and percutaneous coronary interventions were randomly assigned to the radiation-attenuating (RADPAD®), a dummy drape or a control group in a 1:1:1 ratio. The drapes will be used in addition to conventional shielding material. Primary radiation exposure is measured blindly by a dose aware meter (Philips) positioned at a set location on the operator. Radiation exposure is measured by the X-ray systems (DAP in Gy·cm2). The primary outcome is the effective dose received by the first operator (mSv/Gy·cm2).

Official Title
-----------------
Reduction of the Operator's Radiation Exposure During CAG and PCI With RADPAD, a Randomized Controlled Double-blinded Trial

Conditions
-----------------
Radiation; Exposure Occupational, Coronary Interventions

Intervention / Treatment
-----------------
* Device: (sham) radiation absorbing drape (RADPAD®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All CAGs and PCI's Exclusion Criteria: Other interventional procedures

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiation absorbing drape<br>Conventional protection measurements. Additionally, a lead-free protective, disposable drape containing bismuth and antimony (RADPAD®) is placed onto the sterile drape on the patient between the operator and the image intensifier. | Device: (sham) radiation absorbing drape (RADPAD®)<br> <br> |
| Active Comparator: Dummy group<br>Conventional protection measurements. Additionally, a dummy, silicone, disposable drape (appearing identical to the experimental arm) is placed onto the sterile drape on the patient between the operator and the image intensifier. | Device: (sham) radiation absorbing drape (RADPAD®)<br> <br> |
| No Intervention: Control goup<br>Only conventional protection measurements. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary operator radiation exposure (mSv) |  | immediately post-procedure |
Sleep Positional Trainer for Positional Sleep Apnea After Mandibular Advancement Device (MAD) Therapy

Study Overview
=================
Brief Summary
-----------------
The investigators will perform a clinical trial comparing mandibular advancement device (MAD) therapy with sleep positional trainer (SPT) and the combination of MAD and SPT in patients with positional sleep apnea using MAD. Patients are invited for 2 consecutive polysomnographies (PSGs) in randomized order: one PSG with SPT, one PSG with SPT and MAD. PSGs are performed at the Antwerp University Hospital.

Official Title
-----------------
Evaluation of Sleep Position Trainer for Positional Sleep Apnea Patients After Therapy With Mandibular Advancement Device (MAD)

Conditions
-----------------
Positional Sleep Apnea, Mandibular Advancement Device

Intervention / Treatment
-----------------
* Device: Sleep Position Trainer (SPT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with supine dependent Obstructive Sleep Apnea (OSA) after Mandibular Advancement Device (MAD) Therapy: Apnea Hypopnea Index (AHI) supine ≥ 2x AHI non supine 5 < AHI < 50/h sleep on polysomnography (PSG) with MAD in situ ≥ 20% supine position during PSG with the MAD in situ AHI non-supine < 10/h en AHI supine ≥ 10/h on PSG with MAD in situ Unchanged Body Mass Index (BMI)(BMI ± 1 kg/m²) at moment of inclusion compared to BMI at baseline PSG Exclusion Criteria: age < 18 years

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 |
| --- | --- |
| Other: SPT in patients with MAD<br> | Device: Sleep Position Trainer (SPT)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparing Fitbit® Quality of Measured Sleep to Sleep Measured by Polysomnography in the Sleep Lab

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate a commercial tool on the market (Fitbit®) that also quantifies sleep. No one has studied how pediatric patients perform with it and how accurate it is in measuring their quality of sleep. This study will use the obstructive sleep apnea (OSA) questionnaire completed by parents and Fitbit® together and evaluate how they perform against the polysomnography (PSG).

Official Title
-----------------
Comparing Fitbit® Quality of Measured Sleep to Sleep Measured by Polysomnography in the Sleep Lab

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Fitbit
* Other: OSA questionnaire
* Diagnostic Test: Polysomnography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who consent/assent to wearing Fitbit® band over wrist overnight during sleep study and parents who consent to answering questionnaire. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum 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: Fitbit<br>Patients will wear a Fitbit bracelet during their sleep study. | Device: Fitbit<br>* Wearable activity & sleep tracker.<br>Other: OSA questionnaire<br>* Parents will complete a questionnaire assessing the potential symptoms their child is experiencing that are related to obstructive sleep apnea (OSA).<br>Diagnostic Test: Polysomnography<br>* All participants will be undergoing a sleep study as part of their clinical care.<br>* Other names: Sleep study;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total sleep time | Compare the sleep times recorded on the Fitbit vs the sleep study. | At the end of the sleep study - average 6 hrs. |
Pilot Trial of Preoperative Chlorhexidine Gluconate (CHG) Skin Preparation

Study Overview
=================
Brief Summary
-----------------
Pilot study to evaluate and compare activity of investigational preoperative preparation (2% CHG) with comparator (2% CHG).

Detailed Description
-----------------
Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Various application times were evaluated. Efficacy was assess using the Tentative Final Monograph (TFM) criteria.

Official Title
-----------------
Pilot Trial Assessment of the Antimicrobial Efficacy of Medline 2% CHG Cloth Preoperative Skin Preparation

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Drug: CHG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy No dermatological conditions Exclusion Criteria: Sensitivity to CHG Sensitivity to natural latex rubber or adhesive skin products

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2% CHG 1 min<br>single administration, 1 min application time | Drug: CHG<br>* Varied application times<br>* Other names: Chlorhexidine Gluconate;|
| Experimental: 2% CHG 2 min<br>single administration, 2 min application time | Drug: CHG<br>* Varied application times<br>* Other names: Chlorhexidine Gluconate;|
| Experimental: 2% CHG 3 min<br>single administration, 3 min application time | Drug: CHG<br>* Varied application times<br>* Other names: Chlorhexidine Gluconate;|
| Active Comparator: Comparator 2% CHG<br>Single administration, Marketed CHG | Drug: CHG<br>* Varied application times<br>* Other names: Chlorhexidine Gluconate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Log Reduction of Bacterial Flora on Abdomen and Groin Sites | Evaluate the Log Reduction of Normal Flora at various sites and timepoints | 10 min, 6 hr and 8 hr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgical Skin Preparation