cyrilzakka/clinical-trials huggingface dataset:
Metformin Pharmacokinetics in Patients With Chronic and Acute Heart Failure

The study evaluates the pharmacokinetics of metformin in heart failure patients in acute and chronic state in relation to metformin transporter genotypes. Participants have heart failure and type 2 diabetes treated with metformin.

Hypothesis:

Primary: The renal clearance of metformin is decreased in acute state of congestive heart failure compared with chronic state.

Secondary: Metformin trough values in HF patients are influenced by polymorphisms in transporter genes relevant to the pharmacokinetics of metformin.

Background: Heart failure (HF) is a common disease and diabetes/insulin resistance are present in approximately 50 % of HF patients. Metformin is the most commonly prescribed oral anti-diabetic drug, and a huge inter-individual variability in trough steady-state metformin concentration in type 2 diabetics have been demonstrated. Genetic polymorphisms in metformin transporter genes are likely to have a direct impact on metformin pharmacokinetics and variability in drug responses, but the influence of polymorphisms in these transporter genes on circulating metformin levels is presently unknown in HF patients.

Objectives:

A) To compare the pharmacokinetics of metformin in 12 diabetic patients with HF in acute and chronic state.

B) To investigate the influence of polymorphisms in genes encoding the metformin transporter proteins on metformin trough levels in 150 diabetic HF patients.

Design: An open, single-center study enrolling 12 patients with acute heart failure (study A) and 150 patients with stable chronic heart failure (study B). The participants have diabetes already treated with metformin prior to inclusion. Through repeated blood draws, the concentration of metformin will be determined along with genotyping for metformin transporter genes.

Primary outcome:

Study A: Changes in renal clearance of metformin between patients with acute and chronic heart failure.

Study B: Mean trough steady-state concentrations of metformin with emphasis on the intra-interindividual variability in HF patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with heart failure
* LVEF \< 45% within 12 months prior to inclusion
* NYHA-class I, II, III or IV
* Ability to understand the written patient information and to give informed consent
* Diabetes Type 2 (and in metformin treatment for \> 1 month)
* Stable dosage of metformin treatment for at least 1 week prior to examination

Exclusion Criteria:

* Age \< 18 years
* Current abuse of alcohol or drugs
Exploring Self-regulatory Processes in Anesthesiologists During Massive Transfusion

The purpose of the project is to investigate the function of self-regulatory processes in anesthesiologists and how application of these processes influence performance in a crisis situation.The investigators intend to explore specifically the first phase of self-regulation, i.e. the forethought phase which describes processes related to strategic planning, goal setting, goal orientation, and outcome expectation. The investigators hypothesize that prompting forethought before engaging in a simulated massive transfusion crisis situation will result in better task performance in anesthesiologists.

The investigators will conduct 3 studies building on each other.

* Pilot Study: the purpose of this study is to develop measurement tools for forethought, performance and a tool for prompting forethought. This study will include 2 attending anesthesiologists and 2 anesthesia residents (PGY2, 5).
* Study I: the purpose of this study is to validate the measurement tools for forethought, performance and the tool for prompting forethought. This will include 6 attending anesthesiologists, 6 PGY5 and 6 PGY2 anesthesia residents.
* Study II: the purpose of this study is to investigate if prompting forethought in anesthesia residents will result in better performance in a simulated massive transfusion than no prompting.

Eligibility Criteria:
Inclusion Criteria:

* Pilot study: attending anesthesiologists at St. Michael's Hospital , PGY5, PGY2 anesthesia residents at University of Toronto
* Study I: attending anesthesiologists at St. Michael's Hospital, PGY5, PGY2 anesthesia residents at University of Toronto
* Study II: PGY2, PGY3, PGY4 anesthesia residents at University of Toronto

Exclusion Criteria:

* Refusal to take part in the study
Reproductive Hormones And Pre-Clinical Cardiovascular Disease (CVD) In Women

Heart disease is not just the number one killer of women, it is also a leading cause of disability. While it is generally believed that heart disease in women is a disease of old age, the stark reality is that heart disease is responsible for more deaths than breast cancer AT ALL AGES. Also, when young women develop heart disease, they are more likely to die or become disabled than their male peers. Identifying women at risk for heart disease is an important step toward reducing the impact of this disease.

Although women can develop heart disease at any age, most women show signs and symptoms of disease about 10 years after men. For years, it has been thought that the reason for this lag is that women's hearts are protected by estrogen, and that when women go through menopause and lose their natural estrogen, they also lose their protection from heart disease. It has been assumed that if estrogen is replaced then protection will continue. These assumptions have not been proven. In fact, three large, randomized trials have shown no benefit from hormone replacement therapy in women known to have heart disease, and in fact have shown that hormone replacement may be harmful.

To better understand the role of hormones and heart disease, the investigators propose to look at markers of heart disease in healthy women and compare this to their natural hormone levels. One of the markers known to be related to heart disease is carotid artery intima-medial thickness (c-IMT) which can be measured by creating an ultrasound picture of an artery in the neck. The investgators will use c-IMT scans and serum blood samples from women in the NIH-sponsored Los Angeles Atherosclerosis Study (LAAS), a large epidemiologic study that followed participants for 8 years. The proposed study will use risk factor information, serum samples and c-IMT scans collected from the female participants (about 269 women) over the 8 years of follow-up. The total sample size is 269 subjects, each of whom donated 3 blood specimens for the LAAS study. This research will examine those specimens (800 in total). It will also measure other markers of heart disease, including inflammation (hsCRP) and diabetes (insulin and glucose). All information has been obtained and there will be no need to collect additional information from participants nor additional blood specimens.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Females
* 40-60 years of age
Health-related Quality of Life and Psychosocial Aspects of Diabetes Technology (Insulin Pumps)

This study will be prospective comparative trial comparing between insulin pumps vs Multiple daily injections (MDI) in treatment of type 1 diabetes mellitus (T1DM) in terms of health- related quality of life (HRQL) and efficacy of glycemic control (HbA1c level )

Hypothesis:

Type 1 diabetes is characterized by autoimmune destruction of insulin-secreting pancreatic b cells leading to disturbed glucose regulation and overt hyperglycemia which leads to variable consequences and complication. Consequently, individuals with type 1 diabetes have a lifelong dependency on insulin replacement therapy.

Aim of the Work:

To compare the psychosocial impact of insulin pumps versus multiple daily injections in treatment of type 1 diabetes mellitus (Via questionnaire) in terms of health-related quality of life and efficacy of glycemic control (HbA1c level).


Eligibility Criteria:
Inclusion Criteria:

* 1.Type 1 diabetes mellitus.
* 2.Patients who are on insulin pumps must be for at least 3 months on them

Exclusion Criteria:

* 1. Other types of DM e.g., T2DM, MODY.
* 2. Patients with other comorbidities; cardiac, renal, neurological, hepatic ....etc.
Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases

The aim of this study is to investigate whether intravenous ciprofloxacin is as effective as cefepime for the initial treatment of febrile neutropenia developed in patients with hematologic diseases.

Infectious complications during neutropenic periods are major causes of morbidity and mortality especially for patients with hematological diseases, and prompt initiation of antibiotic therapy is warranted for those who develop febrile neutropenia. As for initial therapeutic agents, beta-lactam antibiotics, i.e., third- or fourth-generation cephalosporins and carbapenems have been used frequently because of their strong and broad-spectrum of action. However, under these conditions, development of resistance mediated by a beta-lactamase is concerned, and there is a need for alternative non-beta-lactam antibiotics for this indication. Ciprofloxacin is a potent agent covering against wide range of strains including Pseudomonas aeruginosa, and expected as a potential candidate. We have therefore planned a prospective randomized controlled trial designed to compare intravenous ciprofloxacin with cefepime for febrile neutropenic patients.

Eligibility Criteria:
Inclusion Criteria:

* Hematologic disease
* Ages between 15 and 79 years
* Axillary temperature of 38.0 C or greater on one occasion or of 37.5 to 37.9 C lasting for more than 1 hour
* Absolute neutrophil count of less than 500/microL
* T-Bil level less than 2.0 times the upper limit of normal
* Cre level less than 1.5 times the upper limit of normal
* Written informed consent

Exclusion Criteria:

* Past history of allergic reaction to the study drug
* Positive for HIV antibody
* Pregnant or lactating women
* Family history of auditory disturbance
* Having received systemic antibacterial therapy within 14 days
* Receiving systemic antifungal or antiviral therapy except fluconazole or acyclovir for cases undergoing transplantation
* No recovery of neutrophil count of 1,000/microL or higher from the previous febrile episode
* On treatment with ketoprofen
* On treatment with sodium valproate
* Septic shock
Exploratory Study Evaluating the Effects of Dermo-cosmetic RV5026B Applied for 2 Months in Adults With Erythrocouperosis

This exploratory study aims to evaluate the effects of the test product RV5026B - ET1732 on erythema, as well as on the sensations of discomfort and relief perceived in subjects with erythrocouperose and associated pityriasis folliculorum.

We wish to evaluate:

* firstly the test product alone in order to quantify the effects on the signs \& symptoms on the entire face,
* then the contribution of the test product in addition to a reference topical treatment.

The test product RV5026B - ET1732 was developed to:

* Reduce redness, even if it has already set in, and help limit its reappearance
* Soothe the sensations of heating and discomfort associated


Eligibility Criteria:
Main inclusion criteria:

* Man or woman aged 18 to 75 years old
* Subject presenting erythrocouperosis associated with pityriasis folliculorum of the face with erythema of mild to severe intensity according to the IGA clinical rating on both cheeks
* High density of Demodex on both cheeks: SSSB1 \> 5 D/cm² or SSSB2 \> 10 D/cm²

Main non-inclusion criteria:

- Subject presenting, on the day of inclusion, a dermatological condition of the face other than that studied

1. ORAL/GENERAL TREATMENTS that were planned to be taken during the study OR that were taken:

   A. In the last 3 months:

   - Any change in hormone replacement therapy.

   - Any oral treatment Vit A or derivatives

   B. In the last 4 weeks:

   - Any change in oral drug treatment that could modify the skin characteristics of the subjects and interfere with the performance of the study product

   - Tetracyclines

   - Immunosuppressant

   - Antiparasitic

   - Corticosteroid or NSAID taken for more than 5 consecutive days

   C. In the last 2 weeks:

   - Antibiotic with known cutaneous impact
2. LOCAL TREATMENTS that were planned to be taken during the study OR that were taken:

   A. In the last 3 months:

   - Vascular laser of the face

   B. In the last 4 weeks:

   - Any topical medicinal product on the face that could modify the skin characteristics of the subjects and interfere with the performance of the study product.

   C. In the last 10 days:

   - Changes to any topical cosmetic product (toiletries, care products and makeup) on the face

   D. In the last 7 days:
   * Topical antiseptic on the face
   * Any topical cosmetic product applied to the face that could modify the skin characteristics of the subjects and interfere with the performance of the product under study

   E. Since the last wash performed the night before:

   - Application of topical treatment, rinsed or non-rinsed dermocosmetic product on the face
A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis

The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious anterior uveitis


Eligibility Criteria:
Inclusion Criteria:

* Documented history of non-infectious anterior, anterior and intermediate- or panuveitis
* Currently uncontrolled uveitis for a minimum of 2 weeks despite use of oral and/or topical corticosteroid,or subjects who are intolerant of local corticosteroid therapy due to the development of an ocular hypertensive response or subjects for whom oral corticosteroid is contraindicated.
* Grade of 2+ or higher for anterior chamber cells at time of enrollment
* Considered by the investigator to require corticosteroid-sparing therapy.
* Subjects not planning to undergo elective ocular surgery during the study

Exclusion Criteria:

* Uveitis of infectious etiology
* Presence of an ocular toxoplasmosis scar
* An immune suppression regimen that includes an alkylating agent within the previous 90 days
Effect of Adiposity on Hepatic and Peripheral Insulin Resistance in Type 1 Diabetes

The purpose of this study is to assess the effects of adiposity on resistance to insulin's ability to suppress hepatic glucose production and to stimulate peripheral glucose metabolism in adolescents with type 1 diabetes. In addition, this study will also examine the role of fatty liver disease on the insulin resistance of obesity in adolescents with type 1 diabetes.

A major focus of this program of research will be directed at advancing the understanding of the metabolic consequences of obesity and puberty in adolescents with T1D. Thus, an innovative aspect of this research is that it will be the first to use these sophisticated metabolic techniques to examine the effects of obesity and hepatic steatosis on insulin sensitivity in pubertal adolescents with T1D; namely, the 2-step hyperinsulinemic euglycemic clamp with tracer enhancement, which will allow for definition of hepatic and peripheral insulin resistance, glycerol turnover, and glucose and fat oxidation. Further, a second novel aspect is that this will be the first study to utilize gold standard MRI methods to quantify and compare intrahepatic fat content in lean and obese adolescents with T1D. This will allow a global and more detailed understanding of the potential alterations of insulin's effects on key insulin sensitive tissues in youth that are impacted by both T1D and obesity. Furthermore, evaluation of biomarkers for insulin resistance and fatty liver disease in this population will be performed for the first time.

Eligibility Criteria:
Inclusion Criteria:

* All Participants:

  1. Clinical diagnosis of T1D
  2. HbA1c ≤9%
  3. Diabetes duration of at least 12 months

Adolescents with T1D:

1. Age 12-16 years
2. BMI \<75th for lean pediatric subjects, \> 85th percentile for overweight/obese pediatric subjects;
3. Tanner stage 2-5
4. Parent able to provide written consent and participant able to provide assent
5. Not meeting MRI safety criteria
6. Claustrophobia that will prevent participation in the MRI

Lean, young adults with T1D:

1. Age 18-24 years
2. BMI 18.5-24.9 kg/m2
3. Able to provide written consent.

Exclusion Criteria:

1. Use of adjunctive diabetes medications
2. Weight loss medications within the past six months
3. Current psychiatric disorders, including eating disorders (DSM-V criteria)
4. Known liver disease other than nonalcoholic hepatic steatosis
5. Females who are pregnant or lactating
6. Anemia or another medical condition that precludes participation in the study
Pre-Discharge Bundle for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease to Reduce Readmissions

Hospital readmissions for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) pose burdens to the healthcare system and patients. The aim of this study was to determine whether a screening and educational tool, administered prior to discharge, would result in a decrease in the rate of hospital readmissions.

Hospital readmissions for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) pose burdens to the healthcare system and patients. A current gap in knowledge is whether a pre-discharge screening and educational tool, administered to patients with COPD, reduces readmissions and emergency department (ED) visits.

A single center, randomized trial of patients admitted with AECOPD. Patients will be randomized to control (standard care) or "bundle" group in which patients receive smoking cessation counseling, screening for gastroesophageal reflux disease and depression or anxiety, standardized inhaler teaching, and a 48-hour post-discharge phone call.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of COPD with the presence of an AECOPD
* Age \> 40
* Current or ex-smoker with history of at least 20 pack-years

Exclusion Criteria:

* Past history of asthma, interstitial lung disease, bronchiectasis, presence of airway hardware (e.g. tracheal stents or tracheotomy), lung cancer, any other cancer with a life expectancy of less than 1 year
* Presence of a language barrier
* Residence in a nursing home
* Intensive care unit stay during the current admission
* Delirium or dementia.
Effect of Antenatal Education on Fear of ChildBirth

The aim of this study was to investigate the effects of antenatal education on birth fear, depression, anxiety, stress, maternal self-efficacy, and mode of delivery in primiparous pregnant women

There is still a lack of evidence regarding the effects of antenatal education on birth fear, maternal self-efficacy, anxiety, stress, depression, and mode of delivery. Therefore, this study aimed to investigate the effects of antenatal education on birth fear, anxiety, stress, depression, maternal self-efficacy, and mode of delivery

Eligibility Criteria:
Inclusion Criteria:

* Literate
* Childbirth at fullterm (born at 38-42 weeks)
* Nulliparous women
* Women between the ages of 18-35
* Singleton pregnancy in 20 and 36 weeks of gestation
* Having a healthy newborn
* No participation in another prenatal program
* Absence of any psychiatric illness or comorbidities
* No use medications for a diagnosed mental disorder
* Baby with normal birth weight and APGAR score of 8 and above
* Women who have not developed postpartum complications
* Women without complicated/high-risk pregnancies, who do not experience a perinatal death or stillbirth
* Speaks and understands Turkish
* Women with a total fear of childbirth score W-DEQ-A ≥60 will be included.
* Women who give birth through vaginal route

Exclusion Criteria:

• Women who do not meet the sample selection criteria
How to Get a Better Dry Weight in End-stage Renal Disease (ESRD) Population for Improving Blood Pressure Control

End-stage renal disease (ESRD) is a common clinical condition. In this population, the prevalence of systemic hypertension is high and its adequate control can determinate the outcome.

The first step for a good control of blood pressure in renal patients is adjusting his/her dry weight. Actually, dry weight is assessed based on clinical examination and blood pressure.

The electrical bioimpedance is a simple and portable device. The investigators design a randomized clinical trial for evaluating two ways of getting the best dry weight for hemodialysis patients.

A basal 24h ABPM will be taken before the randomization. Then, 2 weeks later the dry weight be revised, the investigators will get a second 24h ABPM.

End-stage renal disease (ESRD) is a common clinical condition over the world. In this population, the prevalence of systemic hypertension is high and its adequate control can determinate the outcome.

The first step for a good control of blood pressure is giving a dry weight for the patient. We can understand dry weight or target weight as that one which the patient feels comfortable and there aren't clinical signals of volemic overload as edema, dyspnea, orthopnea, jugular turgency, hepatomegalia. Classically, the dry weight is assessed based on clinical examination, blood pressure and experience of hemodialysis staff.

The electrical bioimpedance is a very simple method that possibilities access the corporal compartments, including the body water, using a small and not expensive portable device.

Trying to study new forms for getting the ideal dry weight, we design a randomized clinical trial for evaluating two ways of getting a dry weight for hemodialysis patients.

One group will be dry weight fixed by bioimpedance data and in another group the dry weight will by a clinical protocol.

We will take a 24h ABPM basal from all patients before the randomization. Then, 2 weeks later the dry weight be revised, a second ABPM will be taken. The results will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ESRD, clinically stable, under hemodialysis therapy at two clinics in the North of Rio Grande do Sul.

Exclusion Criteria:

* Clinical unstability, like: infection in course ou recent acute cardiovascular disease (less then 3 months).