cyrilzakka/clinical-trials huggingface dataset:
A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY1142524 in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease

The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in type II diabetic patients with a clinical diagnosis of diabetic kidney disease. BAY1142524 or placebo will be given on top of evidence-based standard of care for diabetic kidney disease. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in urinary albumin creatinine ratio. Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 64 valid patients have to complete treatment with verum and 32 valid patients have to complete treatment with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 Diabetes Mellitus and a clinical diagnosis of diabetic kidney disease (DKD) (as judged by the investigator) who have finished their up-titration with an angiotensin receptor blocker (ARB) or an ACEI (angiotensin-converting enzyme inhibitor) to their maximum tolerated dose at least 3 months prior to the screening visit, whereby the maximum tolerated dose has to be at least as high as the minimal recommended dose of an ARB or ACEI according to local and/or international guidelines. Patients have to be treated with an ARB or ACEI, but not with both simultaneously, without any adjustments to this therapy for at least 4 weeks prior to the screening visit.
* UACR \>50 mg/g and \<3000 mg/g in 2 out of 3 consecutive morning void samples at the screening and the baseline visit
* estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m\*2 and \<90 mL/min/1.73 m\*2 (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\]) at the screening visit and the baseline visit

Exclusion Criteria:

* Non-DKD if it is the main diagnosis contributory to chronic kidney disease (CKD), as judged by the investigator
* Known bilateral clinical relevant renal artery stenosis (\>75%)
* New York Heart Association (NYHA) Class IV
* Acute kidney injury or dialysis within the last 3 months before the screening visit
* Renal replacement therapy during study conduct
* Renal allograft in place or a scheduled kidney transplant during study conduct
* Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for heart failure in the last 3 months prior to screening visit
* Clinically relevant hepatic dysfunction
* Uncontrolled hypertension as evidenced by systolic blood pressure \>160 mmHg, diastolic blood pressure \>100 mmHg (mean of triplicate values at the screening or baseline visit)
Effect of an Immunotoxin on Activated Human Macrophages in Those With Allergic Rhinitis or Mild Intermittent Asthma

The primary objective of this study is to isolate macrophages by using bronchoalveolar lavage (BAL) for different in vitro experiments.

Therefore, following a baseline BAL, allergen, endotoxin, and saline will be instilled into three different lung segments during the first bronchoscopy. After 24 hours during a second bronchoscopy, BAL fluid will be collected in these challenged segments to harvest invaded cells for in vitro experimentation. In addition, segmental bronchial biopsies will be taken to assess the degree of local inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of atopy (allergic rhinitis or mild intermittent asthma)
* Age 18-55 years
* Nonsmoker (\> 5 years)
* Forced expiratory volume in 1 second (FEV1) \> 70% of the predicted value
* A positive skin prick test for grass mix or D. pteronyssinus at or within 12 months prior to the screening visit
* Informed consent
* Females with negative pregnancy test

Exclusion Criteria:

* Infections of the respiratory tract within the last month
* Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
* Pathological findings in blood tests (differential blood count, blood clotting, electrolytes, liver enzymes, retention parameters)
* Subject is undergoing allergen desensitization therapy
* Permanent medication
* Systemic or inhaled corticosteroid use within the last month
* Anti-inflammatory medication within the last month
* Pregnancy
* Neurological or psychiatric disease or history of drug or alcohol abuse which would interfere with the subject's proper completion of the protocol assignment
* There is a risk of non-compliance with study procedures
* Participation in a clinical trial 30 days prior to enrolment
A 3-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease (SCD) Patients

A long term observational study in sickle cell disease will enhance the understanding of the disease patterns, current transfusion practices, treatments and outcomes in sickle cell disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with HbSS, HbS/beta-thalassemia and HbSC
* Age \> 2 years old.
* Written informed consent by the patient or legal guardians, and pediatric assent where indicated.

Exclusion Criteria:

* Patients with Sickle Cell trait (HbAS) are not eligible for the study
* Patient or legal guardians unable or unwilling to give consent, or pediatric assent where indicated.
Knowledge, Attitude and Practice of Physicians Toward The Prescription of Proton Pump Inhibitors in Egypt

The aim of this study is to identify the knowledge , attitude and practice toward PPI use among doctors in Egypt

Proton pump inhibitors (PPIs) were developed in the '80s and their use has continuously grown. They represent the first choice in the treatment of acid-related diseases and are currently themost prescribed drugs in the world \[1\].

In addition, PPIs have become the 8th therapeutic class on the prescription list in 2013. This impacted on health care costs especially in the last decade: in 2010, USA paid $13.9 billion for PPIs \[3\].

Several studies described a range of adverse events related to longterm PPI use \[5,6\], some of them are related to increased gastric pH which could alter intestinal bacterial flora and drugs or electrolyteabsorption. Another issue is represented by potential pharmacological interactions between PPIs and other drugs, due to interference with liver metabolic systems, and competition for renal excretion \[7-16\].

The huge increase in PPI use cannot be justified only by increased prevalence of acid-related diseases or extension of therapeutic indications. Some studies have shown that PPIs are often over-administered in hospital setting, inappropriately prescribed at discharge and maintained by general practitioners (GPs) \[1,17,18\] A recent research showed that 86% of patients who were prescribed PPIs did not have appropriate indications in the general medical ward of a tertiary Jordanian hospital \[2\]. Another study showed that PPI were taken by 25.4% of the patients hospitalized in an internal medicine department of a tertiary Greek hospital, but as many as 81.2% of them had no indications \[11\].

However, the knowledge and practice of physicians in Egypt toward the use of PPI is not well studied.

Eligibility Criteria:
Inclusion Criteria:

1. Physicians dealing with PPI therapy in their specialty including general practitioners, gastroenterologists and non gastroenterologist (hepatologists, otolaryngolists, surgeons, anesthesiologists, pediatriticians and internal medicine physicians.)
2. Who gave consent to participate at the beginning of the questionnaire.

Exclusion Criteria:

* who refuse to gave consent to participate
Emotional Labor, Physical Labor and Mental Labor of Hospice Care Nurses: A Mixed-method Study

Hospice care is a nurse-led multidisciplinary team care that provides physical, mental, and social care to end-of-life patients. According to the WHO, the role of hospice nurses is addressing suffering involves taking care of issues beyond physical symptoms, to support patients and their caregivers. Different from other disease care, hospice nurses face end-of-life patients and their families. As the primary nursing contact of a dying family, hospice nurses have a more intense and complex emotional experience. In China, with the improvement of human rights protection awareness, the nurse-patient relationship is particularly important, and the social requirements for nursing workers are also getting higher and higher. In addition, hospice nurses not only provide physical and psychological care to patients, but also provide comprehensive care to families of end-of-life patients. It is not just the mental work of learning expertise and dealing with emergency situations, and the physical labor of caring for large numbers of patients; but also requires emotional labor that has rarely been recognized before. When facing end-of-life patients and their families, it is particularly important to express appropriate emotions and pay emotional labor.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were nurses working as registered nurses for 6 months or more.

Exclusion Criteria:

* Nurses who were not directly involved in patient care (e.g., central sterile supply department nurses), and intern nurses were excluded.
Chia Seeds Consumption in Hypertriglyceridemia

Lifestyle changes including diet therapy and weight loss can improve hypertriglyceridemia (HTG) . Furthermore, increasing omega-3 fatty acids intake has therapeutic effects on HTG. Alpha-linolenic acid is the precursor of long-chain omega-3 fatty acid and it is abundant in sources such as chia seeds and flax seeds. Considering the high fiber and omega-3 content of chia seeds and the existing mechanisms for improving lipid profile through fiber and omega-3, animal studies have shown the positive role of chia seed consumption on lipid profile, glycemic and lipid factors, and inflammation. However, in human studies, conflicting results have been obtained and some studies have shown beneficial effects on blood lipid, glycemic, and inflammatory factors, but in some studies, no effect has been observed. The objective of this study is to determine the effects of chia seed consumption on lipids, glycemic and inflammatory factors in people with HTG.

This study is an unblinded randomized controlled clinical trial. The study will be conducted on people with mild to moderate hypertriglyceridemia whose fasting blood triglyceride levels were between 150-499 mg/dL in the previous two tests. Participants who meet the following criteria will not be included in the study: Being treated with fibrate medications, end-stage kidney disease, acquired immunodeficiency syndrome patients, cancer patients undergoing chemotherapy or radiotherapy, patients with liver cirrhosis, being treated glucocorticoids, continuous use of omega-3 supplements or in the past month, and pregnancy or lactation.

Patients will be randomly assigned to one of three study groups. The duration of the study will be 8 week. The groups are: the control group, which is given a placebo pearls containing sunflower oil. the omega-3 oil group will be given omega-3 pearls, and the chia seed group that will consume chia seeds. In addition, the participants of all three groups are subjected to a low-calorie diet. At the beginning and end of the study, the measurements include body weight, blood pressure, blood concentration of lipids, lipoproteins and inflammatory factors.

Eligibility Criteria:
Inclusion Criteria:

* - Individuals who had fasting triglyceride concentration 150-499 mg/dL in their two previous tests

Exclusion Criteria:

* Being treated with fibrate medications
* Being treated glucocorticoids
* Being treated with anticoagulants (except aspirin)
* Continuous use of omega-3 supplements or in the past month
* End-stage kidney disease
* Acquired immunodeficiency syndrome patients
* Cancer patients undergoing chemotherapy or radiotherapy
* Patients with liver cirrhosis
* Pregnancy or lactation.
Coronary Artery and Systemic Autoimmune Disease: Diagnostics and Treatment

This study evaluates in vivo intracoronary imaging using intravascular ultrasound and optical coherence tomography and safety and efficacy of new generation fully bioresorbable vascular scaffolds in four well defined systemic autoimmune (rheumatoid arthritis, mixed connective tissue disease, systemic sclerosis, systemic lupus erythematosus) and concomitant coronary disease patients.

The aim of this study is to assess in vivo intracoronary anatomy using intravascular ultrasound and optical coherence tomography and assess the efficacy and safety of new generation fully bioresorbable vascular scaffolds in a systemic autoimmune and coronary heart disease patient population.

The following four well defined systemic autoimmune entities are linked to increased cardiovascular risk: rheumatoid arthritis, mixed connective tissue disease, systemic sclerosis and systemic lupus erythematosus. One of the main causes of death in systemic autoimmune subjects is cardiovascular disease. In-vivo intracoronary anatomy and pathology regarding systemic autoimmune diseases is unknown. Furthermore, all forms of revascularization in such patients yield sub-optimal results, with poor outcomes using even the most modern drug eluting metallic stents. This may be linked to a long term exaggerated chronic inflammation response to the metallic components. Thus, fully bioresorbable vascular scaffolds may prove more efficacious in systemic autoimmune subjects.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18+ years
* Signed and dated informed consent form
* Manifest autoimmune disease, consisting either of: rheumatoid arthritis or systemic lupus erythematosus or systemic sclerosis or mixed connective tissue disease under the care of a clinical immunologist
* Clinical indication for a coronary angiography as determined by a cardiologist

Exclusion Criteria:

* Age of 75+ years
* Glomerular filtration rate of under 30 ml/min
* Severely decreased left ventricular function (ejection fraction \<35%)
* Pregnancy or nursing
* Unclear immunological diagnosis
A Study of SSS17 in Healthy Subjects

This is a first-in-human, Phase 1, single-center, randomized, single-blind, placebo-controlled, single dose-escalation study to evaluate the safety, tolerability, PK, PD of SSS17 following oral administration in healthy subjects. Approximately 65 subjects (53 receiving active drug and 12 receiving placebo) will participate in this study.

The study will enroll healthy volunteers from a single academic medical center in China. All participants will be informed about the study and potential risks and required to provide written informed consent prior to undergoing study-related procedures.

The improved Fibonacci dose escalation design will be implemented. The protocol specifies 10 mg, oral, one time for the first cohort without placebo control. Successive cohorts will be given doses up to 540 mg with placebo parallel control. Only no observation meets the criteria under stop rules, dose will escalate to the next higher level.

The study will be divided into 2 stages: 1st period (fast) and 2nd period(fed).

First period (fast): Subjects will be allocated 1:4 to receive placebo or SSS17, which will be administered by oral route. At each dose, tolerability, safety, PK and PD characteristics will be investigated.

Second period (fed): in order to investigate the effects of food on PK and PD of SSS17. Subjects in one cohort will be administered again after meal on Day15. The accurate dose will be adjusted according to the findings in 1st period (fast)

Eligibility Criteria:
Inclusion Criteria:

* Body weight≥50 for male or ≥45 for female, and BMI between 19.0-26.0 kg/m2
* Good general health as determined by the investigator based on medical history, physical examination, vital signs, 12-lead ECG, clinical laboratory tests and B-type ultrasound test.
* Participants of reproductive potential must agree to utilize reliable methods of contraception from screening to 6 months after the last administration of the study intervention. No plan for sperm (or egg) donation or pregnancy.
* Understand and sign the informed consent.
* Ability to understand and follow study-related instruction

Exclusion Criteria:

* A known allergy to any component of the SSS17 formulation, or allergy history of two kinds of drugs or food
* Medical history or conditions of digestive system.
* Female volunteers who are pregnant, menstrual, lactating or menopause with hormone therapy.
* Eyes diseases, including diabetic retinopathy, age-related macular degeneration.
* Vascular anomalies.
* Drug, alcohol or nicotine addiction.
* Blood donation or bleeding (more than 200 ml). Experience of treatment with EPO or blood transfusion.
* Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed by the investigator to be of clinical relevance
* Abnormal results in test of TIBC, serum iron or ferritin
* Acute diseases before administration.
* Other situations that the researcher believes may affect validity judgment or are not suitable for participation
Translational Research Examining Acupuncture Treatment in Traumatic Brain Injury

The purpose of this study is to examine the effects of acupuncture on cerebral blood flow (CBF) and blood biomarkers during the acute 10-day window following traumatic brain injury, to determine if those changes correlate with changes in biomarkers of brain health, neuropsychological testing, and symptomatic presentation.

The primary aim of this study is to examine the effects of acupuncture on brain function and cognition during the acute 10-day window following mild traumatic brain injury.

Traumatic brain injuries (TBI) affect an estimated 1.7 to 2.3 million Americans every year. As the clinical importance of managing those with TBI grows, it is essential that therapies to help in the recovery and management of post-concussion symptoms are identified. Currently, the number one recommended treatment strategy is physical and cognitive rest, followed by gradual return to daily activities and exercise.

Cerebral blood flow declines following TBI, and can remain in a depressed state for ongoing lengths of time. The cellular vulnerability and symptomatic presentation following TBI is likely due to the metabolic imbalance between decreased cerebral blood flow and increased demand for glucose and adenosine triphosphate production. Animal and human studies have shown that acupuncture at locations both locally on the head and neck, as well as distally on the arms, hands, legs, and feet, can increase cerebral blood flow through the left (L) and right (R) middle cerebral artery (MCA), internal carotid artery (ICA), and basilar artery (BA).

Acupuncture has a long history of use in the treatment of acute and chronic pain, headaches, migraines, nausea, anxiety, and sleep disorders, however, studies specific to the utilization of acupuncture in managing symptoms following TBI are lacking.

The investigators hypothesize that that acupuncture treatments may improve cerebral blood flow resulting in overall improvements in brain function and cognition following TBI. Acupuncture may provide a safe treatment to improve outcomes following a TBI, and increase the rate of recovery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-50
* Documented TBI (for TBI-ACUP and TBI-SHAM arms)
* Visual acuity and hearing adequate for outcomes testing
* Fluency in English
* Ability to provide informed consent
* Acupuncture naïve

Exclusion Criteria:

* Significant polytrauma that may interfere with follow-up and outcome assessment
* Patients with major debilitating baseline mental health disorders that would interfere with the validity of outcome assessment due to TBI
* Patients on psychiatric hold
* Patients with major debilitating baseline neurological diseases impairing baseline awareness, cognition, or validity of outcome assessment due to TBI
* Significant history of pre-existing conditions that would interfere with the likelihood of follow-up and validity of outcome assessment due to TBI
* Pregnancy in female subjects
* Prisoners or patients in custody
* Current participation in an observational or intervention trial for TBI
* Non-English speakers
Sarcopenia Screening in Elderly Individuals

In this study, it is aimed to evaluate parameters such as sarcopenia screening, muscle mass measurement, loss of strength that may develop due to sarcopenia, loss of balance and related fall, decrease in functionality, fragility and decreased physical activity in individuals aged 65 years and older in Kırıkkale city center.

Although aging occurs in all periods in the human body, physical, mental and physical aging becomes visible as you get older. This situation is caused by physiological aging, environmental factors, existing chronic diseases and related symptoms. Today, increasing life expectancy and aging population must be taken into account. Since the age-related symptoms of elderly individuals are compatible with the consequences of aging, they can be ignored as a natural process, and therefore its progression cannot be prevented. With our project, it is aimed that screening for sarcopenia will be an exemplary study throughout Turkey and this type of screening will be widespread. In addition, it is aimed to divide elderly individuals into groups as presarcopenia, sarcopenia and severe sarcopenia, and to provide necessary guidance, protective and prevention approaches, strengthening and exercise training.

Demographic data of elderly individuals (age, gender, height, weight, BMI (Body mass index will be obtained by dividing body weight (kg), height (m) squared) occupation, etc.), chronic diseases (hypertension, diabetes, chronic obstructive pulmonary disease) (COPD), rheumatic diseases), drugs used, smoking, alcohol habits, and assistive device use, and the 'Clinical Vulnerability Scale' to evaluate the cognitive status of individuals through the 'Mini Nutritional Assessment form (MNA)'. 'Standardized Mini-Mental Test' to assess balance and walking, 'Tinetti balance and walking test' to evaluate balance and walking, 'Falling Risk Self-Assessment Scale' to assess falls, 'Functional Independence and Challenge Scale' to measure functional independence in activities of daily living. 'Short Physical Performance Test' (KFPT), Sarcopenia screening test (SA) to assess physical fitness RC-F), it is planned to use the Physical Activity Scale for the Elderly (PASE) to evaluate the level of physical activity, to use hand dynamometer, to evaluate muscle strength, and to measure the muscle mass of individuals with an inbody bioimpedance device.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 65 and over
* Their willingness to participate in the study
* A score of 24 or higher on the Mini Mental State Test (MMDT)

Exclusion Criteria:

* Individuals under the age of 65
* Individuals who cannot communicate well
* Elderly individuals who cannot walk independently, have any orthopedic or neurological problems
* Individuals who do not want to participate in the study
* Individuals not eligible for bioimpedance analysis (pregnant individuals with pacemakers).