cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic and Pharmacoscintigraphic Comparison of TobrAir® 6.0 With TOBI® and TOBI® Podhaler™

This study compares pharmacokinetic profiles of tobramycin delivered by TobrAir® 6.0 device with TOBI® nebulizer system and the TOBI® Podhaler™ device. In addition, lung deposition of tobramycin delivered by TobrAir® 6.0 device and by TOBI® nebulizer system will be determined.

This is an open-label, randomized, single dose, cross-over study in healthy subjects. Each subject receives tobramycin with 3 different inhalation devices:

* 75 mg tobramycin delivered to the airways via TobrAir® 6.0.
* 300 mg tobramycin (TOBI®) delivered to the airways via the PARI LC® PLUS/PARI TurboBoy® SX.
* 112 mg tobramycin (4x28mg dry powder capsules) delivered to the airways via the TOBI® Podhaler™.

Each dose is separated by a minimum washout of at least 68 h.

Blood samples for PK analysis of tobramycin will be collected at regular time intervals until 24 h post-dose. For TobrAir 6.0 and TOBI/PARI only, all dosed subjects will undergo scintigraphic assessments.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males or non-pregnant, non-lactating healthy females
* Aged 18 to 65 years
* Body mass index of 18.0 to 29.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
* Must provide written informed consent
* Must agree to use an adequate method of contraception

Exclusion Criteria:

* Participation in a clinical research study within the previous 3 months
* Subjects who have previously been enrolled in this study
* Females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test at admission and be using an appropriate method of contraception)
* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
* History of chronic respiratory disorders (including asthma) as judged by the investigator
Electrical Muscle Stimulation on Muscle Mass, Strength, and Body Composition

In recent years, electrical muscle stimulation (EMS) devices have been developed as a complementary training technique that is novel, attractive, and time-saving for physical fitness and rehabilitation. While it is known that EMS training can improve muscle mass and strength, most studies have focused on the elderly or specific patient populations. The aim of this study was to investigate the effects of frequency-specific EMS combined with resistance exercise training for 8 weeks on muscle mass, strength, power, body composition, and parameters related to exercise fatigue. Additionally, we aimed to evaluate the feasibility and safety of EMS as an exercise aid to improve body composition. We recruited 14 male and 14 female subjects who were randomly assigned to two groups with gender parity (7 male and 7 female/group): (1) no EMS group and (2) daily EMS group. Blood biochemical routine analysis was performed every 4 weeks from pre-intervention to post-intervention, and body composition, muscle strength, and explosive power were evaluated 8 weeks before and after the intervention. We also performed an exercise challenge analysis of fatigue biochemical indicators after 8 weeks of intervention.


Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* smoking or drinking habits
* cardiovascular disease
* neuromuscular disease
* metabolic disease
* asthma
* pregnancy
* body mass index (BMI) over 27
Clinical Trial of YuWell YE660D Blood Pressure Monitor in General Population According to the ISO 81060-2:2018

The purpose of this study is to evaluate the accuracy of the YuWell YE660D oscillometric upper-arm blood pressure monitor for clinic and home in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018).


Eligibility Criteria:
Inclusion Criteria:

* 12 Years and older;
* Subjects voluntarily participate in the clinical trial and sign the informed consent.

Exclusion Criteria:

* Disturbance of consciousness;
* Patients requiring hemodialysis;
* Taking anticoagulant drugs due to cardiovascular and cerebrovascular diseases;
* Pregnant and lactating women;
* Patients with cardiac arrhythmias;
* Other conditions that the investigator considers ineligible for clinical trial.
Ketamine Co-induction for Patients With Major Depressive Disorder

Ketamine hydrochloride, an anesthetic medication, has been demonstrated to acutely and rapidly improve depressive symptoms but not yet been adequately studied for this effect when used as part of a general anesthetic for surgery. This proposed single-centre, double-blinded, randomized clinical trial of adult patients with depression presenting for gynecologic surgery would compare severity of depressive symptoms between patients receiving and not receiving ketamine as part of their general anesthetic.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depressive disorder
* Presentation for gynecologic surgery requiring a general anesthetic

Exclusion Criteria:

* Marked co-morbid cardiovascular disease
* Marked co-morbid respiratory disease
* History of intracranial hypertension
* History of seizures
* ASA Physical Status Classification IV or greater
* History of psychosis
* Current pregnancy
* Contraindication to ketamine administration
Clinical Experience With Numeta in Preterm Infants

The aim of this prospective noninterventional study is to evaluate the clinical application of Numeta® in preterm infants and critically ill neonates in comparison to individualized prescribed parenteral nutrition. With the prescription software Cato-PAN® (by Cato software solutions) exact valid prescriptions for ordering parenteral nutrition solutions for premature infants are compared. Each PN solution is prescribed individually as well as with Numeta. Prescriptions were mirrored with respect to weight, venous approach, total volume and amount of enteral feeding, 24h medication and flipped vice versa. The key nutrient for calculating Numeta prescriptions was protein. The results of PN prescriptions were compared with each other/ESPGHAN recommendations. The investigators hypothesize that nutrimental content of Numeta prescriptions is equal to individually prescribed .parenteral nutrition solutions


Eligibility Criteria:
Inclusion Criteria:

* preterm infants \<37 weeks gestational age
* parenteral nutrition therapy

Exclusion Criteria:

* hypersensitivity to egg, soy or peanut proteins or to any of the active substances
* congenital abnormality of the amino acid metabolism
* pathogenically elevated plasma concentrations of sodium, potassium, magnesium, calcium and/or phosphorous
* severe hyperglycemia
* severe hyperlipidemia
* severe disorders of lipid metabolism characterized by hypertriglyceridemia
Identification of Genetic Factors Determining Disease Course in the New Type of Coronavirus Infection, COVID-19

The study aims to identify environmental factors and genetic (gene mutation and gene expression) changes, which influencing the course of the disease the new type of coronavirus infection COVID-19 in patients nationwide in a multicenter study.

At first in the study will be performed 200 patients, selected for a homogeneous groups on the basis of the patient's anamnestic data, genetic testing.

Following the interim analysis, based on the results, another 800 people are planned to involve.


Eligibility Criteria:
Inclusion Criteria:

* confirmed covid 19 infection

Exclusion Criteria:

* informed refusal
VI-1121 for the Treatment Alzheimer's Disease

The purpose of this study is to determine whether VI-1121 is safe, well tolerated, and effective as a daily treatment for Alzheimer's disease that is worsening despite current treatment.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of Alzheimer's disease
* CT or MRI within 2 years prior to study
* stable dose of current Alzheimer's treatment for at least 3 months

Exclusion Criteria:

* advanced, severe, progressive or unstable disease
* history of cerebrovascular disease or myocardial infarction within 6 months
Non-interventional Study of the Effect of Smoking Status of the Patient on the Success of Etanercept Therapy in Psoriasis

Pilot observational study to describe the relationship between the smoking status of a psoriatic individual and the success of etanercept therapy in psoriasis treatment

non-interventional study There is no sampling

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of chronic plaque type psoriasis for at least 6 months as determined by the subjects medical history, and confirmation of the diagnosis through physical examination by the investigator Patients who are scheduled by their dermatologist to initiate treatment with Etanercept

Exclusion Criteria:

Previous or current treatment with antipsoriatic biologic drugs, such as etanercept, infliximab, adalimumab, ustekinumab, alefacept, efalizumab Chronic or acute infections requiring intravenous or oral anti-infectives within 14 days prior to the Baseline visit
Tear Lipid Layer Thickness With Emollient Eye Drops

Crossover comparison of lipid layer thickness with two artificial tear formulations

This study will objectively evaluate two US Monograph lubricant eyedrop formulations (Allergan, plc). Refresh Optive ADVANCED will be compared to an investigational formula with additional compendial ingredients (Refresh Optive MEGA 3) in subjects with dry eye symptoms and lipid layer thickness \< 75 nm at baseline in a randomized, cross-over (masked subject) design. We seek to objectively evaluate the increase in lipid layer thickness from baseline at 15 minutes and 1 hour after each eye drop has been instilled. The Stroboscopic Video Color Microscope of King-Smith is used for non-invasive lipid layer thickness measurement.

Eligibility Criteria:
Inclusion Criteria:

* Age - at least 30 years

  * Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI)
  * Ability to give informed consent
  * Willing to spend time for the study; approximately one hour for a screening visit and additional 4 hours for the study assessments. Study assessment will be conducted over 2 visit days, approximately 1 1/2 hours per day.
  * Either gender
  * Any racial or ethnic origin
  * Stroboscopic Video Color Microscope tear lipid thickness ≤ 75 nm

Exclusion Criteria:

* Use of any ocular prescription medication (such as but not limited to, glaucoma medications, anti-inflammatory eye drops and Restasis) used within 14 days of the screening visit or started prior to the measurement visit(s).

  * Currently having punctal plugs inserted in lacrimal puncta
  * Current eye disease, infection or inflammation that affects the surface of the eye such as, but not limited to moderate or greater blepharitis and ocular allergy. Clinically significant (active treatment) of blepharitis, Sjogren's disease or other systemic disease that could influence Meibomian Gland Dysfunction, corneal, conjunctival, or eyelid abnormalities that could influence lipid layer thickness, conjunctivitis of any cause, ocular infection or systemic medication such as diuretics or drugs that could influence tear secretion, or sensitivity to any of the ingredient in the eye drop being tested,
  * Past eye surgery, such as, but not limited to, refractive surgery. Subjects who have had cataract removal surgery more than one year ago, but less than 10 years ago may be considered as potential subjects.
  * Female subjects may not be pregnant or lactating. (Subject will be asked to self report these conditions.)
  * Infectious diseases (for example, hepatitis, tuberculosis) or an immuno-suppressive disease (for example, HIV). (Subjects will be asked to self-report these conditions.)
  * Inability to complete the screening and examination
  * Inability to provide analyzable data. For example, subjects who cannot keep their eye open during the entire measurement interval (due to early blinking) or provide a readable eye image (due to eyelid laxity) or cannot sit still for 1 minute.
Observation of Patients With Transfusional Hemosiderosis Treatment With Deferasirox

This study will observe patients with transfusional hemosiderosis treated with deferasirox in actual practice setting.


Eligibility Criteria:
Inclusion Criteria:

-Patients treated with deferasirox for transfusional hemosiderosis according to the local prescribing information.

(the patients are either beginning treatment with deferasirox at the time of enrollment in the sentinel site monitoring or are currently under treatment with deferasirox and have started the treatment under prescription up to twelve months prior to enrollment in the sentinal site monitoring.

Exclusion Criteria:

* Patients with non-transfusional hemosiderosis
* Patients treated with deferasirox in an interventional clinical trial

Other protocol-defined inclusion/exclusion criteria may apply.
The Efficacy and Safety of Platelet-rich Fibrin and Platelet Rich Plasma in Female Pattern Hair Loss Patients

The goal of this clinical trial is to compare between platelet-rich fibrin and platelet-rich plasma in female pattern hair loss . The main question\[s\] it aims to answer are:

* efficacy between platelet-rich fibrin and platelet-rich plasma
* safety between platelet-rich fibrin and platelet-rich plasma Participants will be divided into 2 side of treatment with composed of

  1. Platelet rich plasma
  2. Platelet rich fibrin

Subject was treated both platelet-rich fibrin and platelet-rich plasma for 3 times which 1 month interval then will be followed up at 4 months and 6 months after last treatment

Eligibility Criteria:
Inclusion Criteria:

* Age 20-55 years
* Female
* Subject who was diagnosed with Female pattern hair loss in Ludwig Classification 2 (part width 2-4 centimeters) by Dermatologist

Exclusion Criteria:

* Pregnancy or Lactation subjects
* Subject with history of platelet dysfunction, low platelet, anemia, cirrhosis, cancer, or immunocompromised host
* Subject who are active smoking and alcoholism
* Subject who has dermatitis, scar or infection at intervention area
* Subject who has history of allergy to anesthesia drug
* Subject who taking NSAIDs, Hormonal drug, anticoagulants drug
* Subject who has psychiatric condition diagnosed by psychiatrist
* Subject who are not allowed to take a photo
Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia

To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.

The intent of this study was to assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure patients receiving or not receiving erythropoietin. After an extensive enrollment period, patients were randomized to receive oral iron (ferrous sulfate, 325mg three times daily (TID) for 56 days) or IV iron sucrose (total 1000mg, 500mg X 2 OR 200mg X 5 within two weeks). Erythropoietin schedule was to remain unchanged during the 56 day study.

Eligibility Criteria:
Inclusion Criteria:

* Hemoglobin \< or = 11.5 gm/dL
* Stable dose or not receiving EPO
* Renal Anemia

Exclusion Criteria:

* IV iron with last 6 months
* Chronic infection, malignancy,major surgery within last month
* Blood Transfusion with last two months
* Significant blood loss within last 3 months
* Concomitant sever diseases of the liver
A Study of LCZ696 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers

This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of LCZ696 200 mg in subjects with mild and moderate hepatic impairment compared to matched healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* All subjects:

  * Male and female subjects aged 18-75 years.
  * Body weight at least 55 kg with a body mass index between 18-35 kg/m2.
* Hepatic impairment subjects:

  * Mild or moderate hepatic impairment.

Exclusion Criteria:

* All subjects:

  * Clinical manifestations of postural symptomatic hypotension at screening or baseline.
  * History of hypersensitivity to LCZ696 or to drugs of similar classes.
* Hepatic impairment subjects:

  * Hepatic impairment due to non-liver disease.
  * Treatment with any vasodilator, autonomic alpha blocker or beta2 agonist within 2 weeks of dosing.
  * Encephalopathyy Stage III or IV.
  * Primary biliary liver cirrhosis or biliary obstruction.
  * History of gastro-intestinal bleeding within 3 months prior to screening.
* Healthy subjects:

  * Any surgical or medical condition which might significantly alter the distribution, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
  * Use of prescription drugs, herbal supplements, and/or over-the-counter medication, dietary supplements (vitamins included) within 2 weeks prior to initial dosing.

Other protocol-defined inclusion/exclusion criteria may apply.
RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding

A large proportion of women with menstruating potential with newly diagnosed VTE or atrial fibrillation, treated with apixaban will have less menstrual blood loss than patients randomized to rivaroxaban.

Heavy menstrual bleeding (HMB) complicates the treatment of approximately 9-25% of patients treated with orally administered anti-Xa anticoagulants for venous thromboembolism (VTE, including either pulmonary embolism or deep vein thrombosis). In particular, recent evidence has suggested an increase in length and severity of menstrual bleeding for women treated with rivaroxaban, and this effect may be less severe apixaban treatment.(1;2) Increase in uterine bleeding with rivaroxaban has necessitated hysterectomy in rare cases.(3) Other complications of HMB include reduced drug adherence, decreased perception of wellness (quality of life) and anemia.(4;5) The anti-Xa agents may increase HMB more than vitamin K antagonists.(1) However, in the principal investigators' experience treating over 100 women of menstruating age with rivaroxaban for VTE with varying degree of HMB, no woman has expressed desire to switch to a VKA even when offered this option (unpublished data). We have successfully reduced perception of HMB by switching from rivaroxaban to apixaban in six patients. Comparison of published and supplemental data from AMPLIFY and AMPLIFY Extend to EINSTEIN and EINSTEIN extend trials also support a lower rate of uterine bleeding with apixaban compared with rivaroxaban, although exact comparisons are difficult to make.(6;9) Myers et al recently reported a 9.4% rate of HMB with apixaban, compared with a 25% rate of HMB with rivaroxaban.(2) Accordingly, we hypothesize that women with menstruating potential with newly diagnosed VTE or atrial fibrillation/flutter, treated with apixaban will have less menstrual blood loss than patients randomized to rivaroxaban.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant women, age 18-50

  * For study purposes, evidence of negative pregnancy is accounted for by the treating physician's initiation of treatment with oral anticoagulants
* Objectively diagnosed VTE or atrial fibrillation/flutter
* Patient reported active menstruation - does not apply to women who were recently pregnant
* Clinical plan and patient agreement to treat with oral anticoagulation for 3 months or longer
* Patients must have a working telephone

Exclusion Criteria:

* Package insert exclusions for Eliquis (Apixban) or Xarelto (Rivaroxaban): \[active pathological bleeding or severe hypersensitivity reaction to XARELTO or ELIQUIS (e.g., anaphylactic reactions)\]
* Plan to become pregnant in the next three months.
* Concomitant prescribed use of aspirin or thienopyridenes or other platelet inhibiting drugs
* Plan for surgical hysterectomy or endometrial ablation
* Known uterine cancer
* Von Willebrand's disease, or hemophilia
* Known coagulopathy from liver disease
* Conditions likely to preclude adherence to study procedures: Active intravenous drug use, known alcoholism, homelessness, or uncontrolled psychiatric illness.
Validation of an Allergic Rhinitis Control Test in Teenagers

Allergic rhinitis is a common condition that affects adults as well as children and adolescents, often with impaired quality of life. Patients often report a poor level of satisfaction with the effectiveness of their treatment and are always looking for more drug combinations to improve their symptom. Several tools exist for assessing control of allergic rhinitis, but none has been validated in adolescents or in children. A study conducted in 2008, resulted in the validation of a self-administered control test of allergic rhinitsis (ARCT) in patients from 12 years of age. However, this study included only 67 adolescents aged 12 to 17 years old and lacked power.

In this new study,the investigators propose, following exactly the same procedure as the pilot study of 2008, to confirme the validation of unmodified Adult questionnaire in adolescents 12 to 17 years inclusive.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 12 to 17 years old, consulting a practitioner for an allergic rhinitis
* parents formulated their study participation agreement by signing the consent form.

Exclusion Criteria:

* Patients that are already treated for the actual episode of allergic rhinitis and are satisfied of the treatement.