cyrilzakka/clinical-trials huggingface dataset:
Effect of Renin Angiotensin Aldosterone System Genetic Polymorphism on the Pharmacological Effect of Mineralocorticoid Receptor Antagonists in Patients With Myocardial Infarction

Early treatment of Myocardial Infarction patients with mineralocorticoid receptor antagonist with help reduces the incidence of cardiac remodeling and development into heart failure. Also studying aldosterone synthase (CYP11B2) and mineralocorticoid receptor (NR3C2) gene polymorphisms in Egyptian Myocardial Infarction patients will help tailor medication therapy and optimize therapeutic effects with the least adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* ST- segment elevation patients.
* Patients who are candidate for add-on treatment with Mineralocorticoid receptor antagonists (MRAs) to improve cardiac remodeling.
* Age of 18 years to 80 years.
* Written informed consent of the subject to participate in the study.

Exclusion Criteria:

* Contraindications to Mineralocorticoid receptor antagonists (MRA) including: serum potassium \>5.5 mEq/L at initiation; CrCl ≤30 mL/minute; concomitant use of strong CYP3A4 inhibitors; concomitant use with potassium supplements or potassium-sparing diuretics.
* Mild-to-severe valvular stenosis or severe (grade III/IV) valvular regurgitation
* Pregnant or nursing women.
* Non cardiac disorders associated with increased growth factor (e.g., HIV, Alzheimer, Crohn's disease, Cancer, glomerulonephritis, glomerulosclerosis, diabetic nephropathy, muscle atrophy, fibrotic conditions and burns).
* Patients with chronic heart failure with reduced ejection fraction (LVEF \<40%).
Electric Impedance Tomography

Evaluation of electrical impedance tomography to non-invasively monitor stroke volume when compared to reference measurements performed via right heart thermodilution


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac surgery which requires placement of pulmonary catheter
* Patients with right heart catheterization for diagnostic or therapeutic reasons

Exclusion Criteria:

* Patient unable to understand the study
* Patient unable to provide written consent or refusing his/her participation
* Patient suffering from a severe valvular insufficiency
* Patient allergic to ECG electrodes
A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia

This study will evaluate bioequivalence of two formulations of Ferric Carboxymaltose as measured by serum total iron, in adult patients with iron deficiency anemia.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients at least 18 - 65 years of age;
* Patients with a body mass index (BMI) between 18.5 - 35 and with a body weight of ≥50 kg - ≤130 kg;

Exclusion Criteria:

* Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product
* Patients with chronic kidney disease who are on dialysis of any kind.
* If female, is pregnant or nursing.
* Patients with blood loss leading to hemodynamic instability
* Patients with recent parenteral iron within 3 months prior to screening.

Other inclusion/exclusion criteria may apply.
Histological Study to Assess Safety and Efficacy of the TempSure Firm for Non-Invasive Lipolysis

This is a prospective, open-labeled, non-randomized, multi-center clinical study to collect safety and efficacy data on the TempSure Firm. The intended use of the TempSure device is to use the Firm handpieces for non-invasive lipolysis.

Up to 12 subjects will be enrolled at up to 3 study centers. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive 1 treatment on the abdomen with the TempSure firm. Subjects will undergo abdominoplasty surgery at one of 4 predetermined timepoint after an abdomen treatment: day 0 (within 24 hours after treatment), 10 days (+/- 3 days), 20 days (+/- 3 days), or 30 days (+/- 7 days). This will be determined by the availability of the subject and/or an as needed basis and this will be decided by the Investigator and the Sponsor.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 - 55 years old.
* Willing to receive treatments with the TempSure® device and willing to have biopsies taken from a control site and the treatment area (biopsies are collected after the abdominal tissue flap is removed during abdominoplasty surgery)
* Understand and accept obligation not to receive any other procedures on the treatment and control areas throughout the length of the study.
* Understand and accept the obligation and able to be present for all study visits
* Willing to comply with all requirements of the study and able to provide informed consent.

Exclusion Criteria:

Pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning to become pregnant prior to the end of the study.

* Currently enrolled in an investigational drug or device trial, or has received an investigational drug or investigational device treatment(s) in the area to be treated (or designated control area) 6 months prior to entering this study (or at the discretion of the Investigator) .
* Cuts, wounds, or infected skin on the area to be treated or designated control area
* On local, oral, or systemic anesthetic agents.
* Condition(s) or circumstance(s) that, in the investigators opinion, may put the subject at significant risk, may confound study results or may interfere significantly with subject participation.
Patch With Onion Extract and Allantoin for C-section Scar

The wound healing is a process occurring in response to dermal injury. The resulting scar may have various characteristics ranging from fine-line and asymptomatic to hypertrophic scars and keloids. Prevention or early treatment of pathological scars is the most appropriate approach. Among available remedies, gels and patches containing onion extract and allantoin have been demonstrated to be safe and effective in patients with scars of various origins and severity.

One of the most used natural products is a patch containing allium cepa and allantoin licensed for treatment of the scars including keloids. However, up to date, no controlled studies have evaluated the effects of such a device in women who have undergone Cesarean delivery. Therefore, the aim of this study was to investigate the effects of this patch on Cesarean section (C-section) scars.

This is an observational non-interventional study. Women who underwent C-section were consecutively recruited at University Hospital of Salerno. Taking into account the number of C-section the study population was divided into two groups: Group A included subjects without a prior history of C-section, group B subjects who had already undergone previous C-section. At baseline after stitches removal, scars assessment was made using digital photographs and the validate Patient and Observer Scar Assessment Scale (POSAS). After 4 weeks, during the outpatient visit, women from both group A and B were asked whether had applied some natural products on the scars or not. In this occasion, the C-section of the women who had applied a patch containing allium cepa and allantoin as well as those of women who had not used any products (who represented the control group) were re-evaluated as at baseline. The Observers were blinded. One of them performed the scars assessment at baseline, the other one after 4 weeks. During the outpatient visit an informed consent for participation was obtained by all the subjects costituing the study population. The participation to the study was voluntary

Eligibility Criteria:
Inclusion Criteria:

* subjects undergone Cesarean delivery;
* age \>18;
* voluntary participation to the study;
* informed consent release.

Exclusion Criteria:

* age \<18
* hypersensitivity to any constituent of the patch;
* pre-term birth, obesity,
* gestational diabetes,
* hypertension,
* infections,
* dermatologic diseases
* use of both systemic and topic corticosteroids;
* no informed consent release.
QI Study of a Practice Facilitator's Impact in Working With Clinics on Improving Dental, Lead & Obesity Measures for Children

Funded by the Ohio Department of Job and Family Services - Medicaid Technical Assistance and Policy Program (MEDTAPP), the "Child Health Excellence Center - a University-Practice-Public Partnership" (CHEC-UPPP) focuses on improving the health of Ohio's children in 3 target areas: 1) prevention of dental decay; 2) detection and management of overweight and obesity; and 3) lead screening. These topics represent critical public health issues for Ohio's children.

The study is based on strong evidence that interventions are needed to improve practice in the target areas and that achieving these goals represents fundamental improvements in child health care that would reduce morbidity and costs. The approach for the study involves a trained Practice Facilitator (PF) working with multiple pediatric and family medicine practices to create change tailored to individual practice preferences and methods of operation.

Our overall hypothesis is that a university-community consortium, utilizing evidence-based methods (involving education plus a facilitated, practice-tailored approach) will increase the rates of targeted services in primary care practices.

The research design involves a sample of 30 primary care practices (a combination of pediatric and family medicine) from across Northeast Ohio who have at least a 20% Medicaid patient population. We are using a cross-over study design. After the run-in period during which baseline data is collected via chart review and all practices receive basic education in the 3 focal areas of lead, dental and obesity screening, the practices will be randomly assigned to one of two groups.

The Phase 1 group will receive the practice-tailored intervention with the Practice Facilitator (PF) starting immediately after randomization and continuing for 6 months. The Phase 2 group will start their practice-tailored intervention with the PF 4 months post-randomization and continue through post-randomization month 10.

This design gives us a natural 'control' group (Phase 2 group) for the first four months post-randomization. The Phase 2 group will have had the same Run-in Phase education as the Phase 1 group, but will not be starting the practice-tailored intervention with the study facilitator for 4 months, at which time they will cross-over to their Intervention Phase.

Both Phase 1 and Phase 2 groups will have a 2 month Follow-up Phase after the completion of their 6 month Intervention Phase. During the Follow-up Phase they will strive to continue reaching the outcome measures on their own without the support of the PF. This will give us an opportunity to assess short-term sustainability of the rates of delivery of services achieved during the Intervention Phase.

Eligibility Criteria:
Inclusion Criteria:

* Practice site has 20% or more Medicaid patient population
* Practice is located in Northeast Ohio

Exclusion Criteria:

* Practice has less than 20% Medicaid patient population
* Practice is out of the targeted area
Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression

The primary purpose of your participation in this study is to help answer the following research question: Whether 12-week administration of EMSAM (selegiline transdermal system) is safe and effective for the treatment of adolescents (aged 12 through 17 years) with Major Depressive Disorder (MDD).

• Assess the safety and efficacy of EMSAM (selegiline transdermal system) versus placebo in adolescents (aged 12 through 17 years) who meet criteria for Major Depressive Disorder (MDD) without psychotic features, single or recurrent

Eligibility Criteria:
Inclusion Criteria:

* Male / Female outpatients 12 to 17 years of age diagnosed with Major Depressive Disorder (MDD). (Must have a Children's Depression Rating Scale-Revised \[CDRS-R\] with a total score of at least 45 at screening.)
* Female patients must test negative on a pregnancy at visit 1.
* Weight and height must be greater than the 10th percentile according to age and height,
* Assent and consent must be given.

Exclusion Criteria:

* Have a serious or unstable medical illness, psychological condition, clinically significant laboratory or ECG result, hypersensitivity to selegiline, or any other condition that in the opinion of the investigator would compromise participation in the study or be likely to lead to hospitalization during the course of the study.
* Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, pervasive development disorder or borderline personality disorder, as determined by the investigator.
* Have a risk of suicide
* Female patients who are either pregnant, nursing or have recently given birth.
* Use of any protocol prohibited medications or substances.
To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions

To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under non-fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery

Proportion of surgeries in which the primary endpoint (overall assessment) is classified as success.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with congenital VWD (von Willebrand Disease)
* Require therapy with a VWF (von Willebrand Factor) product to treat any major surgical procedure

Exclusion Criteria:

* Known coagulation disorder other than VWD
* Known history of, or suspected VWF or FVIII inhibitors
* Subjects with hepatic liver disease
* Known or suspected hypersensitivity or previous evidence of severe side effects to wilate or other VWF/FVIII concentrates
* Pregnant women in the first 20 weeks of gestation
Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen® in Insulin Naive Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on blood glucose control in insulin naive type 2 diabetes failing on secondary oral hypoglycaemic agent (OHA).


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Insulin naive diabetes
* Current treatment with OHA, secondary failure
* Body mass index (BMI) below 40 kg/m2
* HbA1c over 8.5%
* Willing and able to start with insulin therapy and to perform self-blood glucose monitoring

Exclusion Criteria:

* History of drug or alcohol abuse
* Receipt of the investigational drug within the last month prior to this trial
* Known or suspected allergy to trial products or related products
* Severe uncontrolled hypertension
* Any disease or condition, which the Investigator feels, would interfere with the trial
Helicobacter Pylori and Acute Alcohol Induced Pancreatitis

This study is performed to measure wether Helicobacter Pylori has an effect on the incidence and course of acute alcohol induced pancreatitis

A recent pilot study unexpectedly discovered, that Helicobacter pylori infection was rare in patients having their first acute alcohol induced pancreatitis (AAIP) when compared to subjects with similar alcohol use but no history of pancreatitis. This subject has not been studied in humans until now. Therefore we seek to study, with a larger material, wether AAIP is associated with lower prevalence of Helicobacter pylori, by measuring the antibodies against Helicobacter pylori from the sera of AAIP patients and from a control group of alcoholics with no history of AAIP.

Eligibility Criteria:
Inclusion Criteria:

* Acute alcohol pancreatitis (first)

Exclusion Criteria:

* Death during hospitalization
Intravenous Cannulation Using Vein Display Instrument and Without Using Vein Display Instrument in Pediatric Patients

This study aims to compare intravenous cannulation success rate between using vein display instrument and without using vein display instrument in pediatric patients.

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Parents' subjects were given informed consent before enrolling the study. After doing asepsis and antisepsis procedure and putting on the tourniquet the first group would get intravenous cannulation without vein displaying instrument. While for the second group, after doing asepsis procedure and tourniquet was put on, a vein display instrument was used to choose the vein. Intravenous cannulation was done after antiseptic procedure. After blood dripped out of the cannula, cannula was connected to the infusion set. Evaluation was done to assess vein route establishment, canulation attempt number and swelling. Data recorded were analyzed using Statistical Package for the Social Sciences (SPSS) using Chi-square test or Fisher Exact test. Significant value is p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 0-5 years old
* Subjects with difficult vein access (e.g. edema, obesity, chemotherapy history),
* Subjects whose parents had signed the informed consent
* Subjects with available vein access locations at the back of either hands.

Exclusion Criteria:

* Subjects who had infection signs at the designated vein access location
* Subjects in need of emergency procedures.

Drop out Criteria:

* Subjects resigned from the study
* Subjects rejected any next attempt of intravenous cannulation
* Subjects who received anesthetic drugs before intravenous cannulation.
An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease

The purpose of this study is to assess the safety and effectiveness of BMS-986165 compared to placebo in participants with moderately to severely active Crohn's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening, including ileal, colonic, or ileo-colonic disease distribution
* Must have had an inadequate response, loss of response, or intolerance to 1 or more of the standard treatments
* Must have active moderate to severe CD
* Men and women must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Severe or fulminant colitis that is likely to require surgery or hospitalization
* Presence of a diagnosis of alternative forms of colitis (infectious, inflammatory including ulcerative colitis, malignant, toxic, indeterminate, etc.) other than Crohn's Disease
* Previous exposure to BMS-986165 in any study
* Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic, psychiatric, or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant

Other protocol-defined inclusion/exclusion criteria apply
Efficacy and Safety of Conbercept in Macular Edema Secondary to Retinal Vein Occlusion

This is a Phase II, single arm, open label clinical trial. 60 RVO patients (including 30 BRVO and 30 CRVO, respectively) are enrolled in the study. The study included a fixed treatment period (3 months) and a PRN period (6 months). In the fixed treatment period patients will receive 3 consecutive monthly intravitreal of 0.5 mg Conbercept. In the PRN period, patients are monthly visited and retreatment will be needed according to the retreatment criteria pre-specified.


Eligibility Criteria:
Inclusion Criteria:

1. Ability and willingness to provide signed Informed Consent Form.
2. Age ≥ 18, both male and female。
3. Ocular Inclusion Criterion (Study Eye):

   * Diagnosis of Foveal center-involved macular edema due to RVO (both CRVO and BRVO) within 6 months.
   * Best corrected visual acuity (BCVA) letter score in the study eye of ≤ 73（Snellen equivalents 20/40）.
   * Central retinal thickness by OCT in the study eye ≥ 320 μm.

Exclusion Criteria:

1. Brisk afferent pupillary defect.
2. History of any anti-VEGF treatment in the study and/or system within 6 months before enrollment, and/or in the fellow eye within 3 month.
3. History of intraocular and/or peri-ocular corticosteroid use in the study eye within 3 months, and/or history of use steroids systemic (p.o., i.m., i.v.) within 1 month.
4. Any active infection involving the ocular including blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis in either eye.
5. Any inflammatory cells detected in the anterior chamber and/or vitreous in the study eye.
6. Presence of non-RVO disease, in the opinion of the investigator, might cause macular edema, such as AMD (wet or dry), diabetes retinopathy, uveitis etc.
7. Neovascular change in the study eye and/or neovascularization of the iris or neovascular glaucoma in study eye at baseline.
8. Patients with substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by equal or more than 3 lines or medicine or surgery treatment are needed in the study eye within 4 months.
9. Patients diagnosed with systemic immune diseases and any uncontrolled clinical disease.
10. Pregnant or nursing women.
11. Patients need to exclude in the opinion of investigator.
Follow-up of Patients Bound for PCI After Implementation of a Helicopter Emergency Medical System

This study compares patients bound for Percutaneous Coronary Intervention (PCI) who were transported by either ground ambulance or emergency medical helicopter. The investigators describe long-term follow-up in relation to mortality and labour affiliation.

Since 2003, percutaneous coronary intervention (PCI) for ST-Segment elevation myocardial infarction (STEMI) has been the preferred therapy in Denmark over fibrinolysis (thrombolysis) if performed within 120 minutes. Nevertheless, centralisation of designated PCI-centres may lead to systems delays as transport distance may be longer instead of just choosing thrombolysis at the nearest hospital.

As every minute counts when trying to minimize the ischemic injury and size of infarction following an acute coronary event, timely transportation by helicopter may facilitate overall prognosis.

As a part of a national initiative to improve prehospital care of patients with time critical illness such as myocardial infarction (MI), the first Danish Helicopter Emergency Medical System (HEMS) was implemented in the eastern part of Denmark May 1st 2010.

An initial study on 450 patients investigating short-term effects, found that HEMS significantly reduced time from the first electrocardiogram (ECG) diagnosis on-scene to arrival at the cardiac catheterisation laboratory (CCL) despite longer transport distances. Investigators also found a lower, but insignificant 30-day mortality in HEMS patients, adjusted OR=0.40 (95% CI=0.12-1.39, p=0.14).

The aim of the present study is to investigate long-term effects of HEMS in relation to mortality and labour market affiliation.

Eligibility Criteria:
Inclusion Criteria:

* The investigators include all STEMI patients having acute coronary angiography performed at the PCI centre at Copenhagen University Hospital, Rigshospitalet in a 40-month period from January 1st 2010 until April 30th 2013; and who were diagnosed with STEMI within the geographical area covered by both HEMS and GEMS. Patients with multiple contacts; only first contact is eligible.

Exclusion Criteria:

* The investigators exclude patients with cardiac arrest before hospital admission. For labour market analyses the investigators exclude patients not working full time three weeks prior to admission.