cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, PK and PD of SAD or MAD of APX-115 in Healthy Male Volunteers

This study aims to evaluate the safety, tolerabilty, pharmacokinetics and pharmacodynamics of single ascending doses and multiple ascending doses of APX-115 in healthy males. This study also aims to evaluate the effect of food consumption on the pharmacokinetics of APX-115 and potential interaction between caffeine and APX-115 in healthy males.


Eligibility Criteria:
Inclusion:

* Healthy male subject, aged between 18 and 45 years inclusive
* Certified as healthy by a comprehensive clinical assessment
* Normal dietary habits
* Normal ECG recording on a 12-lead ECG
* Signing a written informed consent prior to selection

Exclusion:

* Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, infectious or ocular disease
* Frequent headaches and / or migraine, recurrent nausea and / or vomiting
* Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position
* Blood donation (including in the frame of a clinical trial) within 2 months before administration
* General anaesthesia within 3 months before administration
* Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician
* Inability to abstain from intensive muscular effort
* No possibility of contact in case of emergency
* Any drug intake (except paracetamol or contraception) during the last month prior to the first administration
* History or presence of drug or alcohol abuse (alcohol consumption \> 30 grams / day)
* Excessive consumption of beverages with xanthine bases (\> 4 cups or glasses / day)
* Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests
* Positive results of screening for drugs of abuse
* Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development
* Administrative or legal supervision
Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.

A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine.

This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to steady-state nicotine pharmacokinetics, during 12 hours after start of the first administration. Multiple doses of each treatment are given once hourly during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 40 healthy smokers between 18-50 years, who have been smoking at least 20 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.

Eligibility Criteria:
Inclusion Criteria:

* Healthy smokers, smoking at least 20 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.
* Prior regular use of nicotine mouth spray
Hirudin Plus Aspirin in the Secondary Prevention of Cardioembolic Stroke Due to Nonvalvular Atrial Fibrillation

To investigate the efficacy and safety of hirudin plus aspirin therapy compared with warfarin in the secondary prevention of cardioembolic stroke due to nonvalvular atrial fibrillation.

For the patients with cardioembolic stroke due to atrial fibrillation,guidelines recommended warfarin as the secondary prevention therapy. But warfarin has its disadvantages such as risk of bleeding and the requirement of frequent INR monitoring. The underuse of warfarin is a prominent problem in China. In our study, patients with cardioembolic stroke were treated with hirudin plus aspirin or warfarin. The aim of our study was to compare efficacy and safety of hirudin plus aspirin and warfarin in secondary prevention of cardioembolic stroke due to nonvalvular atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

1. age of 18 or older with NVAF-related cardioembolic stroke
2. diagnosis of cardioembolic stroke conformed to the TOAST (Trial of Org 10172 in Acute Stroke Treatment) classification system in terms of the typical clinical presentation, neuroimaging profile, and vascular and cardiac evaluation
3. patients who were after 14 days of stroke onset and with stable clinical status.

Exclusion Criteria:

1. patients with rheumatic heart disease or history of heart valve surgery;
2. patients with acute coronary syndrome or percutaneous coronary intervention within 30 days previous to enrollment;
3. patients with active infective endocarditis;
4. patients with purpura disease or blood coagulation disorder;
5. patients who had active bleeding or the tendency to bleed;
6. patients with history of intracranial hemorrhage (ICH) or other serious bleeding events;
7. patients diagnosed with peptic ulcer disease within 30 days previous to enrollment;
8. patients who had esophageal varices;
9. patients who had trauma or major surgery within 30 days previous to enrollment or patients who planned to have major surgery;
10. patients with persistent blood pressure of 180/100mmHg or greater with or without anti-hypertension treatment;
11. patients who need chronic anticoagulant treatment due to disorders other than AF;
12. patients with severe liver and kidney dysfunction;
13. patients who were allergic to warfarin, aspirin or hirudin;
14. female patients who are pregnant or lactating.
Balanced Volume Replacement Therapy With Ringer's Acetate Solution in Burn Injury

This observational study compares the influence of Ringer's Lactate solution and Ringer's Acetate solution on organ function scores following severe burn injury.

In the early period following severe burn injury volume replacement with high amounts of crystalloids is necessary. In this study we compare the organ function scores of a historical patient group, treated with Ringer's Lactate solution, with an actual patient population, treated with Ringer's Acetate solution.

Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years and \<80years
* Burned surface area \>20% and \<70%
* Burn injury \< 24 hours
* Agreement to the study procedures

Exclusion Criteria:

* Burned surface area \> 70%
* Expected survival time \< 24 hours
* Acute or chronic heart failure NYHA III or IV
* Adult respiratory distress syndrome
* Renal failure
* Hepatic failure
Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Non-Fasting Conditions

The objective of this study is to compare the relative bioavailability of Losartan potassium/Hydrochlorothiazide 100/25 mg tablets (manufactured by Teva Pharmaceutical Industries, Ltd. and distributed by Teva Pharmaceuticals USA) with that of Hyzaar® 100/25 mg tablets (Merck) in healthy, adult, non-smoking subjects under non-fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking, male and female subjects at least 18 years of age.
* BMI (body mass index) of 30 or less.
* Females in this study must be physically unable to become pregnant (postmenopausal for at least 6 months or surgically sterile).
* Successful completion of a physical examination within 28 days of initiation of the study.
* Negative serum pregnancy test (females).

Exclusion Criteria:

* Subjects with a significant recent history of chronic alcohol consumption (past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic, or cardiovascular disease, tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis, or glaucoma will not be eligible for this study.
* Subjects whose clinical laboratory test values are outside the reference range and are deemed clinically significant by the Principle Investigator.
* Subjects who have a history of allergic responses to the classes of drugs being tested will be excluded from the study.
* Subjects who use tobacco in any form will not be eligible to participate in the study. 3 months abstinence is required.
* Subjects found to have urine concentrations of any of the tested drugs of abuse will not be allowed to participate.
* Subjects should not have donated blood and/or plasma for at least 30 days prior to the first dosing of the study.
* Subjects who have taken any investigational drug within 30 days prior to the first dosing of the study will not be allowed to participate.
* Female subjects who are pregnant or who are able (women with child bearing potential) to become pregnant during the study will not be allowed to participate.
* All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
* Subjects who do not tolerate venipuncture will not be allowed to participate.
BNP Guided Care in Addition to Multidisciplinary Care

HF is associated with repeated hospitalisations and poor prognosis.The aim of this study is to investigate whether BNP-guided care (BGC) in addition to multidisciplinary management(MM) improves outcome compared to HNC alone or usual care (UC) for decompensated HF patients after discharge.

Patients hospitalised with cardiac decompensation in 9 Viennese hospitals are randomised to BGC, MM alone, or UC. MM includes 2 consultations of a heart failure (HF) specialist 10 days and 2 months after discharge for recommending medical optimisation and care by a specialised HF nurse including 4 home visits and telephone contact. In addition, BGC includes intensified increase of medical treatment during repeated follow-up visits in a HF clinic in patients with an Nt-BNP level above 2200pg/ml at discharge.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical signs and symptoms of cardiac decompensation during the present hospitalisation
2. NYHA class III or IV at time of admission
3. Cardiothoracic ratio \> 0.5, and/or left ventricular ejection fraction \<40% documented by echocardiography

Exclusion Criteria:

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Tuning in to Kids in School - Competence Building and Collaboration in the Team Around Primary School Students

The current project is a randomized controlled trial of the Australian evidence-based parenting program Tuning in to Kids® which has been adapted for using with Norwegian elementary school teachers (Tuning in to Kids in Schools; TIKiS).

TIKiS aims to improve emotion socialization practices of primary school teachers so that children's emotional competence is promoted.

This project will determine effectiveness and implementation quality of TIKiS through questionnaire and observation measures given before and after the intervention, comparing intervention and wait-list control schools.

This project is a collaboration between the University of Oslo, the education agency and health agency in Oslo municipality, Norway.

A total of 20 schools will be recruited for the project, and randomly allocated to the intervention or wait-list control condition (10 in each). Teachers in the intervention schools will receive the TIKiS intervention delivered by trained facilitators. Facilitators of the teacher groups will be from staff from education and health agencies and will have at least a masters' degree in psychology, pedagogy or similar.

The TIKiS program facilitators attend a two day training in TIKiS. In addition, they will attend a 90-minute workshop and receive three days of 90-minute program supervision before they act as program facilitators for the teachers.

In the intervention condition, school leaders will attend adapted three 90-minute group sessions to assist with implementation. All teachers in the intervention schools will attend introduction sessions outlining the program. Then teachers and other relevant school staff (special education teachers, resource teachers, social teachers and assistants) in grade 1-4 (the first 4 years of elementary school) will attend six x 90 minute group sessions led by a pair of program facilitators.

In intervention and control schools, facilitators of groups, teachers and relevant school staff will complete questionnaires at baseline and follow-up. Observations of classes of these teachers and staff will be conducted at baseline and follow-up.

Control schools will receive the intervention following completion of all follow-up measures.

Eligibility Criteria:
Inclusion Criteria:

* School staff that work with children in grades 1.-4.

Exclusion Criteria:

* (Exclusion from analysis) school staff in the intervention school that did not participate in the intervention.
Efficacy of Calcium Silicate Pulp-capping; a Randomized Controlled Clinical Trial

This study aims to investigate the tooth nerve response to a recently introduced therapeutic filling material (calcium silicate cement) called Biodentine and to assess the quality of the overlying filling compared to another material (glass ionomer cement) called Fuji IX used more commonly. Also to compare the effectiveness of cone beam computed tomography x-rays compared to conventional periapical x-rays in detecting lesions around these teeth.

Tooth decay is one of the most widespread diseases in the world. Very often, a patient comes to the dental clinic when experiencing pain which commonly means the decay is deep and is very close to or has penetrated the nerve of the tooth. When the decay is very close to the pulp or nerve of the tooth, a procedure called pulp capping is done in an attempt to save the tooth and to prevent root canal treatment. A material has been introduced to the market for this purpose, called Biodentine. This study aims to investigate the nerve response to this material and to assess the quality of the overlying filling compared to another material (glass ionomer cement) used more commonly. Also, X-rays are a routine procedure used to assess how close the decay is to the nerve and to see if there are abnormalities around the tooth. However conventional X-rays may not be accurate. A new technique called Cone Beam Computed Tomography (CBCT) has been developed which shows a 3-D image of the tooth and may be more accurate. We aim to compare the images gained from conventional X-rays and CBCT to help improve diagnosis and care planning for patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients either male or female over the age of 16 (who can consent for themselves) in good general health
2. A minimum of one carious lesion (occlusal, proximal, or MOD)
3. Positive pulp response to electric pulp test and thermal stimulation.

Exclusion Criteria:

1. Patients with clinical symptoms of irreversible pulpitis who need root canal treatment
2. The presence of fistulas or swelling
3. Anterior teeth with aesthetic concerns
4. External or internal root resorption
5. Multiple teeth with carious lesions in the same quadrant,
6. Mobile teeth or tenderness to percussion.
7. Pregnant women, in view of requirements for radiographs.
8. Patients younger than 16.
9. Patients unable to give consent
Comparison of Femoral and Obturatory Nerve Joint Branches Conventional Radiofrequency Thermocoagulation ,Intraarticular Steroid Injection and Pericapsular Nerve Group (PENG) Block in Chronic Hip Pain

In this study ,the investigators aimed to show the decrease in pain levels and the effect on quality of life of patients who underwent chronic hip painRFT , intraartıcular steroid injection and Peng block.

Hip pain is a common medical condition with increasing age.The effectiveness of conservative methods used in hip pain is limited.Since the lifespan of prostheses used in hip surgery is limited, new methods are needed in the treatment of pain.The anterior sensory innervation of the hip joint is provided by the articular branches of the femoral and obturatory nerve. Today, the most commonly used techniques for hip pain are corticosteroid administration into the hip joint, pericapsular nerve group (PENG) block application, and radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves. The aim of this study is to compare the effects of these three procedures in hip pain.

Eligibility Criteria:
Inclusion Criteria:

1. be over 18 years old
2. Written consent has been obtained
3. Those with chronic hip pain for more than 3 weeks

Exclusion Criteria:

1. Major psychiatric illness
2. The patient has lumbar compression pain or referred pain
3. Patients using anticoagulant agents
4. Patients with infection in the area to be treated
5. Those who are allergic to local anesthetics
6. Those who are allergic to betamethasone
7. Pregnancy
8. Patients who underwent hip surgery during the 3-month follow-up period during the study
Whole Food Plant-Based Diet for HIV-Associated Reduction in Cardiovascular Risk (PLANT-HART)

The goal of this clinical trial is to evaluate the impact of using a whole food plant-based diet in the reduction of cardiovascular risk related to HIV in people who live with HIV infection.

The main questions it aims to answer are:

* Does a whole food plant-based diet, nonrestrictive in calories and low in fat, reduce the cardiovascular risk associated with HIV infection in people with HIV infection?
* Does the whole food plant-based diet permit achievement goals in specific metabolic markers of cardiovascular risk (such as Cholesterol, C Reactive Protein)? Participants will follow a non-calorie restricted, low fat, whole food plant-based diet for 8 weeks Researchers will compare standard nutritional care to see if there is a difference in the main outcomes

The participants in the group within the intervention will follow a Whole Food Plant-Based Diet for 8 weeks, which consists of increasing the daily consumption of fruits and vegetables, including sources of vegetable protein such as legumes (beans, lentils, chickpeas, peas, etc. ), soybeans and their derivatives (tofu, textured soybeans, soymilk), and whole grains (oats, wheat, rice, quinoa, corn), nuts and seeds high in omega-3 fatty acids (chia, flaxseed, hemp ), minimize processed foods and foods high in saturated fat. There will be no caloric restriction, however, visual support will be provided, in the form of a traffic light, to distinguish the frequency with which each type of food can be consumed. A small recipe book will be provided with suggestions for breakfast, lunch, and dinner dishes. Patients will receive vitamin b12 supplements of 1000 micrograms twice a week.

There will be no caloric restriction, however, visual support will be provided, in the form of a traffic light, to distinguish the frequency with which each type of food can be consumed. A small recipe book will be provided with suggestions for breakfast, lunch, and dinner dishes. Patients will receive vitamin b12 supplements of 1000 micrograms twice a week.

The participants in the other group will attend a consultation with a nutritionist every month in which will receive recommendations about nutrition and lifestyle in order to reduce cardiovascular risk.

Eligibility Criteria:
Inclusion Criteria:

* Over 20 years but under 60 years
* Individuals with a BMI \>25
* Individuals with some classic cardiovascular risk factor (dyslipidemia, smoking, type 2 diabetes mellitus, systemic arterial hypertension, obesity)
* Individuals under ART with adequate CD4+ cell count and viral load undetectable

Exclusion Criteria:

* Patients currently diagnosed with AIDS
* Patients who have suffered an AMI and/or stroke
* Patients who use drugs
* Patients who have had poor adherence to ART
Geriatric Population COVID-19 Observational Study (GEROCOVIDobs)

The GeroCovid e-Registry is a European de-identified clinical data electronic registry of geriatric patients at risk or suffering from COVID-19 (suspected and confirmed cases) observed since 1st March 2020 in the participating investigational sites.

Older adults (≥ 65 years) and pre-geriatric population (≥60 years and \<65 years) are the ones most at risk from complications of COVID-19, including increased mortality, possibly in relationship with their comorbidity and frailty status.

The GeroCovid e-registry is intended to track Covid-19 pandemic impact on the general geriatric population and on age/care-setting related sub-populations.

The analysis of results is expected to facilitate the adoption of optimal standard of geriatric care during the pandemic.

Eligibility Criteria:
Inclusion Criteria:

1. Applying only to the " Acute Ward Patients " cohort:

   1. Hospitalised patients
   2. Suspected or known SARS-CoV-2 infection
2. Applying only to the "Nursing Homes (RSA)" cohort:

   1. Nursing Home Resident Older Adults
   2. Suspected or known SARS-CoV-2 infection
3. Applying only to the" Home and outpatients' care " cohort:

   a. Outpatients at risk of SARS-CoV-2 infection
4. Applying only to the" Dementia outpatients " cohort:

   1. Outpatients suffering from dementia according to NIA-AA criteria
   2. At risk of SARS-CoV-2 infection
   3. Ongoing treatment with anti-cholinesterase- dugs and/or anti-psychotics
5. Applying only to the" At home " cohort:

   a. Outpatients at risk of SARS-CoV-2 infection
6. Applying only to the " Outcomes " cohort:

   1. Age≥65 years
   2. Hospitalised patients diagnosed with SARS-CoV-2 infection

Exclusion Criteria:

1. Lack of a signed Informed Consent if the patient received and understood the information about the study.
2. Lack of a signed declaration by the responsible physician stating that no explicit opt-out advanced directives by the subject were known to be in place at the moment of inclusion if it had been impossible to inform the patient due to her/his state of consciousness and/or awareness of disease condition.