cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial to Evaluate Pharmacokinetic Interaction of ATB-1011 and ATB-1012 in Healthy Adult Volunteers

To evaluate the interaction between two investigational products by comparing and analyzing pharmacokinetic interactions and safety in steady state after multiple oral administration of ATB-1011 or ATB-1012 alone or in combination in healthy adult volunteers.

* Arm A: To evaluate the effect of ATB-1012 on the safety and pharmacokinetic properties of ATB-1011 in steady state.
* Arm B: To evaluate the effect of ATB-1011 on the safety and pharmacokinetic properties of ATB-1012 in steady state.

Eligibility Criteria:
Inclusion Criteria:

1. Those who are over 19 years old at the screening visit
2. Those with a body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 with a weight of 50 kg or more (45 kg or more for women) at the screening visit
3. Those who do not have clinically significant congenital or chronic diseases and have no pathological symptoms or findings upon medical examination at the screening visit
4. Those who determined as suitable study subjects by the principal investigator (or a delegated sub-investigator) in result of planned and conducted laboratory tests such as hematology, blood chemistry, serum, and urine tests according to the characteristics of the investigational product.

Exclusion Criteria:

- 1) Those who have a clinically significant disease or have a history of such disease in the digestive system, cardiovascular system, endocrine system, respiratory system, blood/tumor, infectious diseases, kidney and genitourinary system, mental and nervous system, musculoskeletal system, immune system, otorhinolaryngology, skin system and ophthalmic system.

2) Those who have a history of gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the absorption of drugs or have gastrointestinal diseases 3) Those who have taken drugs that induce and inhibit metabolism enzymes such as barbital drugs within 1 month of the first administration date, or have taken drugs that may interfere with this clinical trial within 10 days of the first administration date. (However, participation is possible depending on the characteristics of pharmacokinetics and pharmacodynamics such as interactions with investigational products or half-life of concomitant drugs) 4) Those who participated in other clinical trials or bioequivalence studies and administered the investigational products within 6 months of the first administration date.
Pharmacokinetics of CFTR Modulators in Pregnant Individuals and in Postpartum Breastfeeding Mothers

This study aims to evaluate the pharmacokinetic changes during pregnancy, postpartum, and in breast milk in cystic fibrosis patients receiving a cystic fibrosis transmembrane conductance regulator (CTFR) modulator, including Elexacaftor, Tezacaftor, Ivacaftor, or Lumacaftor.

The advent of cystic fibrosis transmembrane conductance regulator (CFTR) therapy has significantly increased the life expectancy for individuals with cystic fibrosis (CF).

As a result, adults with CF are more likely to have families than they have in the past.

Although the overall pregnancy rate among women with CF age 18-44 is declining (mirroring trends in the general population), the overall number of pregnancies is increasing due to the increasing number of adults with CF. However, little is known about CFTR modulator use in pregnant or breastfeeding mothers, as outlined in a recent review of CF-therapies in pregnant and breastfeeding women. Presently, there is one report of an uncomplicated pregnancy during ivacaftor use, and one case of a successful pregnancy in a woman who was maintained on lumacaftor/ivacaftor with reported maternal and fetal drug levels. In this study, we aim to study the pharmacokinetics of CFTR modulators in pregnancy as well as while breastfeeding.

This information will hopefully improve counseling while offering them for CF patients given the tremendous improvements seen in non-pregnant adults.

Eligibility Criteria:
Inclusion Criteria:

* Female 18 years of age and older
* Female who has a diagnosis of cystic fibrosis
* Female who is taking cystic fibrosis transmembrane conductance regulator (CFTR) modulator medication during pregnancy and postpartum

Exclusion Criteria:

* Female \< 18 years of age
* Female with cystic fibrosis who is not taking cystic fibrosis transmembrane conductance regulator (CFTR) modulator medication during pregnancy and postpartum
* Participant has contraindication to breastfeeding or not planning to breastfeed
[SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES]

The primary objective of the study is to compare the effect of 90-day treatment with ticagrelor (180 mg \[two 90 mg tablets\] loading dose on Day 1 followed by 90 mg twice daily maintenance dose for the remainder of the study) vs acetylsalicylic acid (ASA)-aspirin (300 mg \[three 100 mg tablets\] loading dose on Day 1 followed by 100 mg once daily maintenance dose for the remainder of the study) for the prevention of major vascular events (composite of stroke, myocardial infarction \[MI\], and death) in patients with acute ischaemic stroke or transient ischaemic attack (TIA).


Eligibility Criteria:
Inclusion Criteria:

* Men or women equal or elder 40 years of age
* Either acute ischaemic stroke or high-risk TIA as defined here and randomisation occurring within 24 hours after onset of symptoms

Key Exclusion Criteria:

* Planned use of antithrombotic therapy in addition to study medication including antiplatelets (eg, open label ASA, GPIIb/IIIa inhibitors, clopidogrel, ticlopidine, prasugrel, dipyridamole, ozagrel, cilostazol) and anticoagulants (eg, warfarin, oral thrombin and factor Xa inhibitors, bivalirudin, hirudin, argatroban, unfractionated and low molecular weight heparins). - Any history of atrial fibrillation, ventricular aneurysm or suspicion of cardioembolic pathology for TIA or stroke. - Planned carotid, cerebrovascular, or coronary revascularisation that requires halting study medication within 7 days of randomisation. - Receipt of any intravenous or intra-arterial thrombolysis or mechanical thrombectomy within 24 hours prior to randomisation - History of previous symptomatic non-traumatic intracerebral bleed at any time (asymptomatic microbleeds do not qualify), gastrointestinal (GI) bleed within the past 6 months, or major surgery within 30 days.
Computer-assisted Diabetes Self-management Interventions

This project evaluates the effectiveness of different aspects of a program to assist type 2 diabetes patients with dietary changes. It evaluates the effectiveness of Personalized Self-Management Training and Community Resources support, using a randomized design. This study will also evaluate what percent of patients are willing to participate in such a program, and what percent of primary care physicians are willing to recommend it to their patients.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Diagnosed for at least one year
* Patient of a primary care provider

Exclusion Criteria:

* No telephone
* Not speaking English
ETASCAI Pilot Project

This pilot study aims to investigate the chronic effects of ETAS® on cognitive, affective and inflammatory outcomes in healthy adults aged 60-80 years with mild to moderate subjective cognitive complaints.

This pilot study will employ a double-blind, randomised, placebo-controlled parallel design to investigate the chronic effects of 12-week-long ETAS® consumption on affective, inflammatory, metabolic, and anthropometric outcomes in healthy older adults with mild to moderate subjective cognitive complaints. Thirty participants will be randomised to Intervention 1, Intervention 2, or Placebo groups where they will be consuming capsules containing 300mg ETAS®, 1500mg ETAS®, or placebo, respectively, for 12-weeks. Outcome measures will be acquired before and after a 12-week chronic supplementation. These will include cognitive measures of overall cognitive functioning, executive function, and cognitive failures; affective measures of depression and anxiety symptomatology; quality of life, and sleep; gastrointestinal symptomatology; inflammatory measures of IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNF-α, CRP; systolic and diastolic blood pressure, as well as height, weight, hip and waist circumference. In addition, tau from plasma will be recorded at all timepoints.

Eligibility Criteria:
Inclusion Criteria:

* Aging between 60-80 years old
* Having normal vision and hearing
* Having a body mass index between 18.5 and 30
* Having mild to moderate subjective cognitive complaints

Exclusion Criteria:

* Smoking
* Having food allergies or intolerances
* Following restrictive and/or unbalanced diets
* Changing dietary intake majorly in past month
* Being diagnosed with any psychiatric or neurologic conditions (e.g. schizophrenia, depression, dementia) including eating disorders
* Being diagnosed with any cardiometabolic diseases (including type II diabetes and cardiovascular disease), or suffering from hypertension or thrombosis related disorders or suffer from thyroid disease
* Being anaemic
* Currently taking anticoagulants, antiplatelet medication, antidepressants, proton-pump inhibitors
* Currently consuming prebiotic or probiotic supplements
* Continuous antibiotic use for \> 3 days within 1 month prior to enrolment
* Continuous use of weight-loss drug for \> 1 month before screening
* Having inflammatory bowel disease; coeliac disease; total colectomy or bariatric surgery; irritable bowel disease; end stage renal disease; active cancer, or treatment for any cancer, in last 3 years
Relation of Diet to Heart Disease Risk Factors in Children

Metabolites of dietary phosphatidylcholine- choline and trimethylamine N-oxide (TMAO)- were recently identified as being associated with myocardial infarction in a case-control study. The latter TMAO is a gut-microflora-derived choline metabolite that has been shown to be a potent risk factor for cardiovascular disease (CVD). This pilot study seeks to use information derived from a dietary questionnaire in children to test the association of dietary choline intake to plasma levels of TMAO as well as the relationship between plasma choline levels and components of atherogenic dyslipidemia (increased triglycerides and small LDL, and reduced HDL cholesterol). An ancillary goal of this study is to build on existing programs of community outreach to local Oakland/Berkeley minority communities, and to develop an infrastructure for family-based and community participation in clinical research across the full age spectrum and among diverse populations. This pilot study will examine the association of dietary choline intake assessed by food frequency questionnaires to biomarkers of CVD risk in 40 children (\> 7 years of age) and their parents as there is no information regarding this relationship in children. The results of this pilot study will form the basis for a proposal to carry out a randomized intervention trial to directly test the effects of dietary choline intake on plasma TMAO and lipoprotein levels. Ultimately, better understanding of the relationship between dietary choline intake and CVD risk factors may facilitate the formulation of appropriate dietary choline recommendations in children and adults.

From interested participants (children and parents) we will obtain:

1. Informed consent
2. Anthropometric measurements - height, weight, waist and hip circumference, blood pressure, % body fat by bioimpedance (Tanita scale).
3. Health History Questionnaire
4. Food Frequency Questionnaire
5. Fasting blood sample- We will collect a total of 40 ml of blood (less than 3 ml/kg for the entire study). The blood samples will be used to measure triglyceride, LDL-cholesterol, HDL-cholesterol, glucose, insulin, apoA1, apoB, C-reactive protein, lipoprotein subfraction analysis by ion mobility, DNA for inclusion in our DNA biobank, choline, TMAO and other metabolites related to heart disease risk.

Standard Blood sampling: Using standard blood collection procedures, blood samples will be collected from participants after a 12-14 hour fast. The blood will be collected in tubes containing the following preservative solution: 3.0 gms EDTA (dipotassium), 1.7 mg P-Pack, 0.15 gms gentamycin sulfate, 0.15 gms chloramphenicol, 5.96 mls aprotinin (Sigma A-6279), and 0.30 gms sodium azide all of which are diluted to 20mls with doubly deionized water. Plasma is separated by immediate centrifugation at 4°C. Lipid and lipoprotein measurements are performed and aliquots of plasma are frozen for future analyses.

Eligibility Criteria:
Inclusion Criteria:

* Children \>7 years of age and their parents

Exclusion Criteria:

* Antibiotics
* Pregnant or breastfeeding women
Automated Early Warning Scoring on Surgical Normal Wards

Establishment of early warning systems in hospitals was strongly recommended in recent guidelines to detect deteriorating patients early and direct them to adequate care. Upon meeting of predefined trigger criteria Medical Emergency Teams (MET) should be directed to these patients. The present study analyses the effect of introduction of an automated early warning and trigger system on two peripheral wards hosting a highly complex surgical patient cohort.

The deployment of an electronic monitoring and notification system is accompanied by data acquisition over 12 months (intervention) using four routine databases: Hospital patient data management, anesthesia database, local data of the German Resuscitation Registry, and measurement logs of the automated patient monitoring and alert system (intervention period only). A preceding time period of 12 months served as control.

Eligibility Criteria:
Inclusion Criteria:

* Admission to one of the participating wards

Exclusion Criteria:

* none
Smoking Interventions in General Medical Practices

Primary care physicians can play an important role in reducing tobacco smoking in the population. The general practice is a suitable setting for implementing proactive smoking interventions, because a large proportion of the population can be regularly reached in a favorable psychological state. Further, a trustful interpersonal relationship between the practitioners and their patients is supposed to increase the susceptibility to preventive measures. However, currently general practitioners are not capitalizing this advantage although evidence based treatments are available, which are effective and cost-effective. Outreach programs combining educational and practice-based measures have been found to be effective in engaging practitioners in screening and in giving advice. Computer expert-system and brief counseling interventions, which are based on the Transtheo-retical Model of behavior change (TTM), are promising approaches for the entire population of practitioners and smoking patients. For large scale implementation, data are needed about the degree of integration in every day routine clinical practice that could be achieved by implementing such interventions. Objectives: Evaluating different strategies for the implementation of proactive smoking interventions in general practices. Methods: In a randomized controlled trial, 150 randomly selected general practices of a defined German region will be included. The procedure comprises the implementation of 1) an on-site computer expert-system intervention, 2) a counseling intervention provided by the practitioner, or 3) the computer expert-system plus the counseling intervention. During an implementation phase of one month, two on site training sessions and support by phone will be provided. Routine use of the interventions will be monitored for the following 6 months. Main outcome measures are the number and rate of identified and treated smokers. A follow-up assessment will be realized 12 months after practice attendance to determine the smoking status of the treated smokers.


Eligibility Criteria:
Inclusion Criteria:

* Practices with regular office hours
* Practices predominantly providing primary medical care for adults
* Patients with age 18 and older
* Patients with sufficient German language and cognitive capabilities to complete assessment
* Patients smoking within the preceding six month

Exclusion Criteria:

* Practices planing closure within the next 12 months
* Practices opening less than 12 months ago
Oxidative Stress in Polycystic Ovary Syndrome

The aim of the study was to determine changes in hematological and biochemical parameters and specific oxidative stress markers in patients with PCOS.


Eligibility Criteria:
Inclusion Criteria:

The PCOS group included patients with oligomenorrhea (menstrual period intervals of more than 35 days), clinical signs of hyperandrogenism (acne or hirsutism), biochemical signs of hyperandrogenism (with total testosterone of 100 ng/dL and above and patients with dehydroepiandrosterone sulfate of 400 g/dl and above), an LH/FSH ratio of over 3 on the second day of the menstrual period, a body mass index of 25 and above, and polycystic ovaries detected in suprapubic ultrasonography.

Exclusion Criteria:

Pregnant individuals, individuals with diabetes mellitus, metabolic syndrome, adrenal pathology, pelvic mass, and malignancy were not included in the study.
A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment

The objective of this study is to assess and compare the pharmacokinetic properties of YM178 in normal subjects and those with mild, moderate and severe renal impairment.


Eligibility Criteria:
Inclusion Criteria:

* good health other than renal impairment
* body mass index (BMI) between 18 and 40 kg/m2

Exclusion Criteria:

* subject with renal impairment has not been on stable dose of concomitant medication for at least 2 weeks
* subject has liver enzyme abnormalities
COVID-19 Convalescent Plasma Therapy

This study is an open-label trial in which hospitalized patients with risk factors of severe coronavirus disease 2019 \[COVID-19\] will be receive treatment with convalescent plasma (≤ 15 days from symptoms start).


Eligibility Criteria:
Inclusion Criteria:

* 18 Years and older
* Presence of risk factors of severe COVID 19 diagnosed by quantitative polymerase chain reaction by reverse transcription (RT-qPCR)
* Patients with no more than 15 days from the onset of symptoms
* Signed informed consent

Exclusion Criteria:

* Severely ill patients admitted directly to the ICU.
* Need for mechanical ventilation at the time of hospital admission, regardless of the time of clinical evolution.
* History of previous hypersensitivity to plasma transfusions.
* History of immunoglobulin A (IgA) deficiency
* Pregnancy
Cardiorenal Effecs of Losartan in Kidney Transplant Recipients

The influence of Losartan to cardiovascular and renal outcomes in patients after renal transplatation.

The benefits of cardio and nephroprotective properties of treatment with drugs blocking the renin angiotensin aldosterone system in the general population has already been shown. There are no data on the cardiac and renal effects of this type of treatment in patients after renal transplantation.

Therefore, the observational, case-control study was designed in a population of kidney transplant recipients.

The study group consists of patients treated with antihypertensive drugs including Losartan at a minimum dose of 50mg.

The control group consists of patients treated with antihypertensive drugs, without the renin angiotensin aldosterone system blockade.

Blood pressure will be controlled in accordance with the current recommendations.

The primary aim of this study is to determine whether, in renal transplant recipients with hypertension, losartan, angiotensin II receptor antagonist improves cardiovascular and graft outcome i.e. reduces incidence of cardiovascular complications and slows progression of graft insufficiency. Secondary objective is to determine whether losartan 1. delays the occurrence of cardiovascular complications, 2. slows progression of graft insufficiency, 3. is the safe drug in renal transplant recipients, 4. decrease albuminuria and other surrogate markers of graft injury or cardiovascular involvement.

Eligibility Criteria:
Inclusion Criteria:

740 patients, either sex, either non-diabetic or diabetic who underwent the kidney transplantation and who:

1. Are at least three months post-transplantation
2. Have hypertension.
3. Have an estimated glomerular filtration rate greater than or equal to 30 ml/min/1.73 m2

Exclusion Criteria:

1. Pregnant or the possibility of becoming so and breast feeding.
2. Angioedema from an Angiotensin Converting Enzyme (ACE) inhibitor or Angiotensin Receptor Blocker (ARB) in the history.
3. Serum potassium greater than 5.5 mmol/l on two or more occasions in the preceding three months.
4. Graft artery stenosis (i.e. psv of more than 200 cm/s in doppler usg)
5. Left ventricular dysfunction that requires an ACE inhibitor or an ARB
6. New immunosuppressive agent was started or previous immunosuppressant stopped in the three months prior to study entry or plan to switch immunosuppressive agents within next three months.
7. Currently on four or more blood pressure pills and have an average blood pressure over three visits greater than 150/100.
8. Currently on an ACE-inhibitor or an ARB or treatment with an ACE inhibitor or ARB after kidney transplantation lasted more than 3 months.
9. Had an acute coronary syndrome, episode of malignant hypertension, stroke or transient ischaemic attack in the three months prior to study entry.
SOURCE XT REGISTRY

This registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that are undergoing treatment with the commercially available Edwards SAPIEN XT™ Valve, and delivery devices.

Consecutive patient data should be collected at discharge, 30 days and 12 months post-implant. Subsets of patients may undergo additional follow-up.

Eligibility Criteria:
Inclusion Criteria:

* The SAPIEN XT™ THV is indicated for use in patients with symptomatic aortic stenosis requiring TAVI who have a high risk for operative mortality, or are "non-operable"

Exclusion Criteria:

* Non-valvular or congenital aortic stenosis
* Pre-existing prosthetic heart valve in the Aortic position or a non-calcified aortic valve
* Severe (\>3+) mitral insufficiency or aortic regurgitation \> 3+
* Active bacterial endocarditis or other active infections
* Severe ventricular dysfunction with ejection fraction \< 20%
* Coronary artery disease-related unstable angina
* Inability to tolerate anticoagulation / antiplatelet therapy
Remission Induction and Sustenance in Graves' Disease 2

ATD therapy for Graves' disease is one of the commonly used options for therapy of the hyperthyroidism. The investigators study how to optimally keep patients in remission.

A detailed description of patients entering the initial observational phase of the study (RISG1) has been published:

Laurberg P, Nygaard B, Andersen S, Carlé A, Karmisholt J, Krejbjerg A, Pedersen IB, Andersen SL. Association between TSH-Receptor Autoimmunity, Hyperthyroidism, Goitre, and Orbitopathy in 208 Patients Included in the Remission Induction and Sustenance in Graves' Disease Study. J Thyroid Res. 2014;2014:165487. doi: 10.1155/2014/165487.

Eligibility Criteria:
Inclusion Criteria:

* Graves hyperthyroidism in remission after ATD

Exclusion Criteria:

* Age \< 18, severe concomitant disease