cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability up to 6 Years of Intravenous (i.v.) Secukinumab in Pediatric Participants With Juvenile Psoriatic Arthritis (JPsA).

The purpose of this study is to determine the PK, safety and tolerability of multiple doses of intravenous (i.v.) secukinumab in pediatric participants with JPsA

This is a multicenter, open-label study with an optional treatment extension period to evaluate pharmacokinetics, safety and tolerability (up to 6 years) of i.v. secukinumab in pediatric patients with JPsA.

Eligibility Criteria:
Key Inclusion Criteria:

* Participants parent's or legal representative(s) written informed consent and child's assent, if appropriate, must be obtained before any study related activity or assessment is performed. Of note, if the participant reaches age of consent (as per local law) during the study, they will also need to sign the corresponding study ICF (Informed Consent Form).
* Males and females ≥2 years old to \<18 years old at the time of screening.
* Confirmed diagnosis of JPsA according to the modified International League of Associations for Rheumatology (ILAR) classification criteria that must have occurred at least 6 months prior to screening.
* Active JPsA disease defined as ≥3 active joints (swollen or if not swollen must be both tender and limited range of motion) at baseline (BSL).
* Inadequate response (≥1 month) or intolerance to ≥1 Non-Steroidal Anti-Inflammatory Drug (NSAID) at screening.
* Inadequate response (≥2 months) or intolerance to ≥ 1 Disease Modifying Anti-Rheumatic Drug (DMARD) at screening.
* Concomitant use of the following second-line agents such as disease-modifying and/or immunosuppressive drugs to treat the JPsA will be allowed:

  * Stable dose of methotrexate (MTX) (maximum of 20 mg/ m2 BSA/ week) for at least 4 weeks prior to the BSL visit, with folic/folinic acid supplementation (according to standard medical practice of the center).
  * Stable dose of an oral corticosteroid (CS) at a prednisone equivalent dose of \<0.2 mg/kg/day or up to 10 mg/day maximum, whichever is less, for at least 7 days prior to BSL.
  * Stable dose of no more than one NSAID for at least 1 week prior to BSL.

Key Exclusion Criteria:

* Participants with body weight less than 10 kg at screening.
* Use of other investigational drugs within 4 weeks or 5 half-lives of BSL, or until the expected pharmacodynamic effect has returned to BSL, whichever is longer.
* History of hypersensitivity to study drug or its excipients or to drugs of similar chemical classes.
* Participants with active inflammatory bowel disease or active uveitis at screening or BSL.
* Fulfilling diagnostic criteria for any International League of Associations for Rheumatology (ILAR ) juvenile idiopathic arthritis (JIA) category other than JPsA at BSL.
* Participants treated with prohibited medication
* Participants taking any non-biologic DMARD at screening except for MTX.
* Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.

Other inclusion/exclusion criteria may apply
Electrical Stimulation in Patients With Prolonged Mechanical Ventilation

Muscle atrophy and diaphragm dysfunction are common complication in patients with prolong mechanical ventilator (PMV) and is associated with increased rate of weaning failure and days of hospitalization. Electrical stimulation (ES) has been shown to be beneficial in patients with severe chronic heart failure and chronic obstructive pulmonary disease. The purpose of this study is to examine the effects of ES on skeletal muscle function, pulmonary mechanics and hospitalization outcomes in patients with PMV.

BACKGROUND AND PURPOSE: Muscle atrophy and diaphragm dysfunction are common complication in patients with prolong mechanical ventilator (PMV) and is associated with increased rate of weaning failure and days of hospitalization. Electrical stimulation (ES) has been shown to be beneficial in patients with severe chronic heart failure and chronic obstructive pulmonary disease. The purpose of this study is to examine the effects of ES on skeletal muscle function, pulmonary mechanics and hospitalization outcomes in patients with PMV.

METHODS: Patients who have been on mechanical ventilator for more than 21 days will be recruited from respiratory care center (RCC). All subjects will be randomly assigned into three groups: ES in abdominal muscles (ES-Abd, n=30),ES in brachial biceps (ES-bicep, n=30) and sham group(Sham). Subjects in both groups will receive ES in muscles for 30 min/session, 2 sessions/day for 10 days with the same setting except area of ES. The muscle function will be assessed by skin-fold thickness and muscle strength. The pulmonary function will be assessed by: lung compliance, airway resistance, tidal volume, minute volume and maximal inspiratory pressure. The hospitalization outcome will be followed up until patients are discharged from RCC. The outcomes variables include: weaning rate and duration, mortality, days of ventilator, and length of RCC stay.

Eligibility Criteria:
Inclusion Criteria:

* age\>20 years old
* mechanical ventilation for more than 6 h/ day for more than 21 days -- medical stability (arterial blood gas value hydrogen power(pH): 7.35-7.45, atrial oxygen pressure(PaO2): 60 mmHg at 40% fraction of inspired oxygen inspired oxygen fraction (FiO2), absence of signs and symptoms of infection, and hemodynamic stability);

Exclusion Criteria:

* signs of acute infection (BT\>38.5℃，WBC\>12000 or \<3000 per unit
* neuromuscular disease at acute stage
* diagnosis of cancer at end-stage
* pregnancy
* BMI\>35kg/m2
A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES)

The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and effective compared to placebo for the treatment of the signs and symptoms of dry eye syndrome.

Single-center, double-masked, randomized, placebo-controlled study comprising 4 visits over the course of approximately 5 weeks. The study included a 1-week placebo (SkQ1 vehicle) run-in period between Visit 1 and Visit 2, and approximately 28 days of twice daily (BID) dosing (Visit 2 - Visit 4). Qualified subjects were randomized 1:1:1 to receive either 1.55 µg/mL SkQ1 ophthalmic solution, 0.155 µg/mL SkQ1 ophthalmic solution, or placebo (vehicle of SkQ1 ophthalmic solution).

The following primary endpoints were tested:

* Corneal Fluorescein staining in the inferior region Pre-CAE at Visit 4 (Day 29), as measured by the Ora Calibra Scale in the worst eye at baseline;
* Worst dry eye symptom (ocular discomfort, dryness, or grittiness - as determined from subject diary data recorded during the 1-week run-in period between Visit 1 and Visit 2) evaluated over the seven days preceding Visit 4 (not including day of visit) during the treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Be male or female of any race, at least 18 years of age
* Have provided written informed consent
* Have a reported history of dry eye syndrome
* Have a history of use or desire to use eye drops for dry eye

Exclusion Criteria:

* Have any clinically significant eye findings that require therapeutic treatment or may interfere with study parameters
* Have previously had LASIK surgery within the last 12 months
* Have used Restasis® within 30 days of Visit 1
* Be a woman who is pregnant, nursing or planning a pregnancy
* Be unwilling to submit a urine pregnancy test if of childbearing potential
* Have a known allergy and/or sensitivity to the test article or its components, including the preservative benzalkonium chloride
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1
* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics

This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous epinephrine, in healthy male and female adult volunteers. The current study is designed for a more thorough evaluation of the E004 Pharmacokinetics. Safety of E004 will also be evaluated, under augmented dose conditions.

E004 is formulated with epinephrine free base as the active ingredient, and hydrofluoroalkane (HFA-134a) as the propellant.

In order to differentiate the inhaled epinephrine from the fluctuating background of endogenous epinephrine 1, a stable-isotope deuterium (2H) labeled epinephrine (epinephrine-d3) preparation will be used to formulate E004 inhalers, denoted as E004-d3. PK of E004 at 125 mcg of epinephrine-d3 per inhalation, will be compared to that of the currently marketed, non-labeled, Epinephrine-CFC MDI as the Reference Control (220 mcg per inhalation).

This study is a randomized, evaluator-blind, single dose, two-arm, crossover, PK study, to be conducted in \~18 healthy, male and female, adult volunteers. PK will be studied using E004-d3 at 125 mcg per inhalation (Arm T). A currently marketed, non-labeled, Epinephrine CFC-MDI will be used as a Reference Control (Arm C).

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy at screening;
* No clinically significant respiratory, cardiovascular and other systemic or organic illnesses;
* Body weight ≥ 50 kg for men and ≥ 45 kg for women,
* Sitting blood pressure ≤ 135/90 mm Hg;
* Demonstrating negative HIV, HBsAg and HCV-Ab screen tests;
* Women of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
* Properly consented
* Other criteria apply

Exclusion Criteria:

* A smoking history of ≥10 pack-years, or having smoked within 6 months;
* Upper respiratory tract infections within 2 wk, or lower respiratory tract infection within 4 wk, prior to Screening;
* Any current or recent respiratory conditions that might significantly affect pharmacodynamic response to the study drugs;
* Known intolerance or hypersensitivity to the study MDI ingredients;
* Having been on other investigational studies, or donated blood, in the last 30 days;
* Other Criteria Apply
Gastro-intestinal and Hormonal Responses to Systemic Inflammatory Disease

The aim of this study is to describe hormonal responses and changes of the gastrointestinal (GI) tract during healthy and catabolic inflammatory conditions.

Participants will receive isocaloric, isonitrogenous beverages of either whey or 3-OHB+whey in a randomized crossover design during either healthy (overnight fast) or catabolic conditions (inflammation/endotoxemia + 36 h fast and bed rest).

Background: Endotoxemia (LPS) is known to cause fever, inflammation and nausea, but the underlying mechanisms are unknown. In a human disease model comprising LPS-induced inflammation, 36 hour fast and bed rest the investigators want to investigate mechanisms accounting for the nausea and decreased food intake often observed in hospitalized patients.

Aim: This study aims to investigate total transit time and motility of the GI-tract together with the regulation of gut- and appetite hormones following catabolic conditions compared with healthy controlled conditions

Hypothesis:

Catabolic stress (endotoxemia/inflammation + 36 h fast and bed rest) induces GI-tract and hormonal changes compared with healthy conditions (overnight fast)

Interventions:

In a randomized crossover design, eight healthy, lean, young men will undergo either:

i) Healthy conditions (overnight fast) + whey protein

ii) Catabolic conditions (Inflammation (LPS) + 36-hour fast and bed rest\*) + whey protein

iii) Catabolic conditions (Inflammation (LPS) + 36-hour fast and bed rest\*) + 3-ketone/whey protein

Beverages will be isonitrogenous with 45 g whey protein + 20 g maltodextrin +/- 50 g of 3-OHB. Bolus/sip administration will be applied (1/3 bolus, 2/3 sip).Beverages will be isocaloric (fat will be added to interventions without 3-OHB)

\*LPS will be administered (1 ng/kg) the day prior to the study together with fast and bed rest. On the study day LPS (0.5 ng/kg) will be injected.

Eligibility Criteria:
Inclusion Criteria:

* Between 20-40 years of age
* Body mass index between 20-30 kg/m\^2
* Healthy
* Oral and written consent forms obtained prior to study day

Exclusion Criteria:

* Recent immobilization of an extremity that is not fully rehabilitated
* Lactose, lidocain or rubber allergies
* Current disease
* Use of anabolic steroids
* Smoking Former major abdominal surgery (Or current problems with the GI tract) \>10 hours of exercise/weak Present ketogenic diets or high-protein diets Blood doner that does not want to discontinue blood donations until study completion Pending MR scan
Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and antiviral activity of multiple, ascending doses of ABT-267 (also known as ombitasvir) administered as two-day monotherapy followed by ABT-267 in combination therapy with other direct-acting antiviral agents (DAAs) ABT-450 with ritonavir (ABT-450/r) and ABT-333 (also known as dasabuvir) plus ribavirin (RBV) in patients with chronic Hepatitis C virus (HCV) infection without cirrhosis.

An open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-267 as monotherapy for 2 days, followed by ABT-267, ABT-450 with ritonavir (ABT-450/r) and ABT-333 plus ribavirin (RBV) combination therapy for 12 weeks in treatment-naïve, non-cirrhotic patients with chronic hepatitis C virus (HCV) infection. The study included post-treatment follow-up for 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between the age of 18 and 70 years, inclusive, at time of enrollment.
* Subject has never received antiviral treatment for hepatitis C virus (HCV) infection.
* Body mass index (BMI) is ≥ 18 to \< 38 kg/m\^2. BMI is calculated as weight measured in kilograms (kg) divided by the square of height measured in meters (m).
* Chronic HCV genotype 1-infection for at least 6 months prior to study enrollment.
* Subject has plasma HCV RNA level \> 10,000 IU/mL at screening

Exclusion Criteria:

* History of severe, life-threatening or other significant sensitivity to any drug.
* Females who are or plan to become pregnant or breastfeeding or males whose partner is pregnant or planning to become pregnant.
* Recent history of drug or alcohol abuse that could preclude adherence to the protocol.
* Positive test result for hepatitis B surface antigen or anti-human immunodeficiency virus (HIV) antibodies.
* Any current or past clinical evidence of cirrhosis (e.g., ascites, esophageal varices), or a liver biopsy or FibroTest/aspartate aminotransferase to platelet ratio (APRI) or FibroScan® showing cirrhosis or extensive bridging fibrosis.
Evaluation of Inflammatory Markers and Periodontal Viruses on Periodontitis Patients With CAD

To assess and compare the demographic variables, periodontal parameters, cardiac parameters and the expression of periodontal viruses (CMV, HSV and EBV) and inflammatory biomarkers(PTX-3, TLR-2 \& TLR-4) in periodontally healthy and generalized periodontitis patients with and without coronary artery disease(CAD).

A total of 240 subjects will be recruited based on the power of the study. The selected subjects will be divided into four groups based on the inclusion and exclusion criteria.

1. GROUP I: 60 healthy subjects ( No generalised periodontitis and no CAD)
2. GROUP II: 60 generalised periodontitis subjects without CAD
3. GROUP III: 60 CAD subjects without generalised periodontitis
4. GROUP IV: 60 subjects with Generalised periodontitis and CAD

Sub-gingival plaque samples will be collected from the subjects of all the four groups. Coronary artery plaque samples will be collected from the patients who were indicated for coronary artery bypass graft surgery (CABG) among group III and group IV.

The demographic variables , periodontal parameters , cardiac parameters , expression of periodontal viruses and inflammatory biomarkers will be measured in all four groups ,

Eligibility Criteria:
Inclusion Criteria:

1. Patients willing to participate in the study.
2. Patients with 30 to 65 years of age group
3. Both genders
4. Patients should have minimum of 10 natural teeth.
5. In case of group III and IV patients with coronary heart disease to be included.

Exclusion Criteria

1. Patients who had undergone periodontal therapy within the previous 6 months.
2. Type I and II Diabetes mellitus
3. Sarcoidosis patients.
4. Carcinoma patients.
5. Rheumatic arthritis patients.
6. Tuberculosis patients.
7. Immunosuppressive conditions.
8. Patients with other inflammatory diseases.
Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon

Drug-coated balloon (DCB) is an alternative choice for denovo lesions in coronary artery disease patients with high bleeding risk. Intravascular ultrasound (IVUS) can provide more details of coronary anatomy and stent implantation, overcoming a number of limitations of coronary angiography. However, the benefit of IVUS-guided DCB treatment has not been investigated. This study is designed to compare IVUS-guided and Angiography-guided DCB treatment for coronary denovo lesions in patients with high bleeding risk.

This is a prospective, multicenter, randomized controlled trial that aims to enroll 260 patients with high bleeding risk.

All patients with coronary denovo lesions suitable for DCB treatment will undergo 1:1 randomization to either IVUS guidance or Angiography guidance using the Central Randomization System.

All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol. Data and images will be collected during the index procedure, and at the predefined 7-month coronary angiography follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

1. De novo lesions, suitable for DCB treatment.
2. Patients with high bleeding risk.

Exclusion Criteria:

1. Target lesion length \> 15mm.
2. Severe calcified lesions.
3. Left main disease.
4. Ostial lesions.
5. Three-vessel disease.
6. Acute myocardial infarction within 48 hours.
7. Target vessel received stent implantation.
8. Hemodynamic instability.
Evaluation of the Accuracy and Precision of the INRatio® Prothrombin Time (PT) Monitoring System With New INRatio Test Strip Designed for Low Sample Volume and Heparin Insensitivity

This is a multi-center study designed to evaluate the accuracy and precision of the INRatio® Prothrombin Time (PT) Monitoring System, utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, when used by trained medical professionals for the quantitative determination of PT and International Normalized Ratio (INR) in fingerstick and venous whole blood from subjects on oral anticoagulation therapy (OAT). These results will be compared to those PT/INR results obtained on plasma from the same subjects as analyzed at a central laboratory with the Sysmex CA-560 System.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years of age or older);
* Willing and able to provide written informed consent and comply with study procedures;
* Subjects on oral anticoagulation therapy. This inclusion criterion is waived for the 20 normal healthy volunteers who must NOT be on warfarin or any other anticoagulant drug.

Exclusion Criteria:

* Hematocrit less than 25 or greater than 55%;
* Lupus or antiphospholipid syndrome (APS)
* Vulnerable populations deemed inappropriate for study by the site's principal investigator.
* Already participated in this study.
Characterization of Biophysical and Mechanical Parameters on Skin of Breast Cancer Patients

Aim of this study is to characterize the chemical/physical and structural parameters of the skin in patients with breast cancer undergoing oncological adjuvant treatment in order to understand how to prevent and manage adverse skin events during hormone therapy, also through the formulation of new functional dermocosmetics.

Breast cancer is the most frequent neoplasm in women in industrialized countries. After surgery, an adjuvant systemic treatment is generally proposed (hormone therapy, chemotherapy, molecular targeted therapy).

Side effects of endocrine treatments, including skin toxicities, are frequent and often underestimated, leading to poor treatment adherence that can compromise therapeutic outcomes. Among adjuvant chemotherapy treatments, one of the most used drug is Paclitaxel: at skin level it can induce rash, dry skin and itching.

The combination of radiotherapy with these oncological treatments could aggravate cutaneous side effects.

Aim of this study is to characterize the chemical/physical and structural parameters of the skin in patints with breast cancer undergoing adjuvant treatment, performing specific skin tests with professional instruments and adequate personnel. The evaluation will be carried out in Estrogen Receptor (ER) positive breast cancer patients undergoing adjuvant therapy with Tamoxifen or Aromatase Inhibitor or Paclitaxel +/- adjuvant radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* age between 40 and 70 years
* subjects who are receiving treatment with tamoxifen, aromatase inhibitor or paclitaxel in adjuvant therapy +/- adjuvant radiotherapy
* subjects who are receiving hormonal therapy must have suspended any chemotherapy for at least 30 days

Exclusion Criteria:

* presence of known chronic skin pathologies before adjuvant treatment start (psoriasis, lupus, atopic dermatitis)
* inability to understand and will
* unavailability to carry out all the tests required by the protocol
Learning Yoga to eNhance Cancer Survivorship

This study aims to conduct a single-arm pilot test of online yoga classes for young adult cancer survivors (YACS). Study hypotheses are that LYNC will be feasible (enrollment of \> 50% of eligible) and acceptable (75% attendance at all sessions). In addition, analyses of preliminary efficacy outcomes will examine whether participants report potential improvements in psychosocial and physical wellbeing.

This study will recruit YACS (n=30) for an 8-week course (75-minute yoga classes delivered once per week) delivered online via videoconferencing software such as Zoom or Bluejeans. During yoga classes, all participants will be able to see one another, to simulate the group experience of being in an in-person class. Participants will complete patient-reported outcomes of physical and psychosocial wellbeing at baseline (prior to class 1) and post-intervention (after class 8), as well as post-intervention measures of feasibility/acceptability (e.g., ease of accessing online classes, satisfaction with yoga classes, helpfulness of online yoga, barriers/dislikes associated with online yoga). All surveys will be administered via REDCap. In addition, the investigators will compute rates of retention (% of consenting subjects who complete post-intervention assessment) and adherence (# of yoga classes attended).

Eligibility Criteria:
Inclusion Criteria:

* Age 25-39
* History of cancer diagnosed at age \>18
* \>2 months post-treatment for cancer
* Eastern Cooperative Oncology Group (ECOG) performance status (0-2)
* Access to internet-connected device with camera and capacity for full-screen display (e.g., laptop or desktop computer; tablet or smart phone with Air Play to full-size monitor)

Exclusion Criteria:

* Regular use of yoga (i.e., once or more per week) since cancer diagnosis/treatment
* Unable to complete forms and yoga classes in English
* Adults who are cognitively impaired, pregnant, imprisoned or otherwise detained