cyrilzakka/clinical-trials huggingface dataset:
A Study in Evaluating Bioequivalence of Test and Reference Vadadustat 450 MG and 150 MG Tablets and to Determine Food Effect on the 450 MG Tablet

This is a healthy volunteers study to assess the bioequivalence of vadadustat 450 mg tablets (Test A) compared to three 150mg tablets (Reference B). The study will also assess the effect of food on the bioavailability of vadadustat 450 mg tablet.

This is a randomized, open-label, single-dose, three-period crossover study in healthy adults to assess the bioequivalence of 3 X 150 mg vadadustat tablets (Test) compared to a single 450 mg vadadustat tablet (reference). Blood samples for vadadustat PK will be collected at pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12, 18, 24, 32, 40, and 48 hours post-dose. The study will also assess the effect of food on vadadustat bioavailability by evaluating the pharmacokinetics of the 450 mg tablet in fed and fasted subjects.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between ≥18 years and ≤55 years of age
* Healthy subjects per Investigator judgment as documented by the medical history, physical examination, vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and general observations.
* Have a body weight ≥50 kg and body mass index (BMI) ≥18.5 kg/m2 to 29.5 kg/m2 inclusive
* Understands the procedures, provides ICF and willing to comply with study requirements
* Willing and able to comply with the requirements of the study protocol.

Exclusion Criteria:

* Current or past history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease.
* History of cancer (except non- melanoma skin cancer) or history of chemotherapy use.
* Any surgical or medical condition or history that may potentially alter the absorption, metabolism, or excretion of study treatment, such as, but not limited to gastric bypass surgery or gastric or duodenal ulcers.
* History of severe allergic or anaphylactic reactions. Chronic daily medication use.
* History of drug abuse Excessive alcohol consumption.
* Smoking and the use of nicotine-containing products
* Consumption of grapefruit or grapefruit juice, pomelo, star fruit, Seville or Moro (blood) orange, or their associated products
* Participation in another clinical trial or exposure to any investigational agent.
* Donation of blood or significant blood loss or plasma donation.
* Any condition that would interfere with the ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the patient at undue risk.
Patient-derived Organoids of Lung Cancer to Test Drug Response

This is a single center, single arm, open and exploratory clinical study, with 50 cases planned for a period of 3 years. The purpose of this study is to evaluate the consistency and accuracy of a Patient-Derived Organoid (PDO) Model of lung cancer to predict the clinical efficacy of anti-cancer drugs, in order to predict the best chemotherapy regimen for each given patient.

The aim of the project is to use a combination of patient-derived organoid models:

* To amplify tumour tissue to obtain enough material for genomic and histological analysis
* to characterize the lung cancer sub-type
* To predict treatment (non)response.

The following points will be addressed:

1. First, the investigators plan to establish and characterize formation of organoids from biopsies of patients with lung cancer: in spheroids, in the 3D cellular model OncoCilAirTM (OncoTheis), and on the chick chorioallantoic membrane (CAM). Patient-derived organoids from tumoural tissue (PDO) will be characterized and compared to the original tumour.
2. Second, the investigators will test the chemoresponse (chemosensitivity and chemoresistance) of organoids to anti-cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven lung cancer
* Age ≥ 18
* Written informed and signed consent
* Accessible to biopsy and/or surgery sample of metastasis and/or primitive tumour

Exclusion Criteria:

* Less than 18 years of age
* Not able to give informed consent (language, intellectual capacities, etc.)
* Not accessible to biopsy and/or surgery sample
* Not enough lung tissue for a histological analysis or the remaining lung tissue is not enough to perform a routine pathological analysis.
Efficacy Study of Antimicrobial Catheters to Avoid Urinary Infections in Spinal Cord Injured Patients

The purpose of this trial is to make a comparison between the use of antiseptic silver alloy-coated silicone urinary catheters and the use of conventional silicone urinary catheters in spinal cord injured patients to prevent urinary infections.

Antiseptic Silver Alloy-Coated Silicone Urinary Catheters seems to be a promising intervention to reduce urinary tract infections; however, research evidence cannot be extrapolated to spinal cord injured patients.

The study is an open, randomized, multicentric, and parallel clinical trial with blinded assessment. The study includes spinal cord injured patients who require at least seven days of urethral catheterization as a method of bladder voiding. Participants are on-line centrally randomized and allocated to one of the two interventions (Antiseptic Urinary Catheters or Conventional Catheters). Catheters are used for a maximum period of 30 days or removed earlier at the clinician criteria.

The main outcome is the incidence of urinary tract infections by the time of catheter removal or at day 30 after catheterization, the event that occurs first. Intention-to-treat analysis will be performed, as well as a primary analysis of all patients.

The aim of this study is to assess whether silver alloy-coated silicone urinary catheters reduce urinary infections in spinal cord injured patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with traumatic or medical spinal cord injury
* Age of 18 years or above
* Patients who need an indwelling urinary catheter as a method of bladder drainage for at least 7 days.
* Patients who are willing to participate in the study and give their written informed consent (If a patient is unable to give written consent because of physical or mental disability, an affirmation of consent will be taken in his presence from his relative or legal guardian).

Exclusion Criteria:

* Patients who can benefit from other method of bladder drainage such as intermittent catheterization, suprapubic drainage, reflex voiding or use of an external collector.
* Patients with urinary tract infection at the moment of inclusion
* Current antibiotic use or use within 7 days prior to inclusion
* Outpatients with sporadic medical examinations (less than one per month)
* Known allergy to latex, silver salts or hydrogels.
* Patients with surgical interventions in the urinary tract that may interfere, at the investigator criteria, with the study results.
* Pregnant or breastfeeding woman.
Community Park-Based Programs for Health Promotion: Fit2Play Prospective Cohort Study

The Fit2Play prospective cohort study examines the effects of a park-based youth physical activity afterschool program on youth participant fitness and mental health outcomes. Duke will perform a secondary analysis of the data collected as part of the Fit2Play prospective cohort study run by Miami-Dade County Parks and Recreation.

The Fit2Play prospective cohort study examines the effects of a park-based youth physical activity afterschool program on youth participant fitness and mental health outcomes. The Fit2Play program was designed by a team of MDPROS professionals and UM faculty. It is a daily after-school park-based program (Monday-Friday, 2 PM-6 PM) that comprises (1) 60 minutes of physical activity that incorporates multiple sports (soccer, kickball, flag football) and activities from Sports, Play and Active Recreation for Kids (SPARK), a play- and evidenced-based, outcome-oriented, structured, active recreation program for children with a focus on developing and improving motor skills, movement knowledge, social and personal skills; and (2) 20-30 minutes of nutrition education lessons 1-2 times per week that incorporate EmpowerMe4Life, a health and wellness curriculum aligned to the National Health Education Standards for fifth grade and grounded in the American Heart Association's scientific recommendations in promoting heart-healthy lifestyles. Fit2Play programming is implemented by park coaches, who are hired with health and wellness training and/or education-specific background(s) with at least a high school degree. Participants are divided into younger (6-9 years) and older (10-14 years) age groups regardless of weight status, and coaches choose daily age-appropriate SPARK and other physical activities for each group. With an oversight from a registered dietician, similarly, the UM-MDPROS team has expanded the EmpowerMe4Life curriculum to include younger (6-9 years) and older (10-14 years) age group modules.

The research team includes a large community organization (Miami-Dade County Parks and Recreation Department). All consented Fit2Play participants (400-800 per year) complete a baseline (August/September) and post-test (May/June) assessment during each school year of participation that include demographic, mental health symptom questionnaires, satisfaction surveys, and on-site physical fitness and biometric measurements. Data collection is performed by a core MDPROS measurement team who are trained and certified by University of Miami School of Medicine faculty. In addition, MDPROS bachelor/master's level recreation directors oversee on-site measurement procedures and collection of all predata and postdata to ensure measurement fidelity. Data are then uploaded to a shared (parks and university) database via a data management team.

Eligibility Criteria:
Inclusion Criteria:

* All participants enrolled in the Miami-Dade Fit2Play study will be included in this secondary analysis

Exclusion Criteria:

* Anyone not enrolled in the Miami-Dade Fit2Play study will be excluded from this secondary analysis
Improvement Adherence to Clinical Practice Guidelines Using the Clinical Decision Support System in Patients With Hypertension and Atrial Fibrillation

The Clinical Decision Support Systems (CDSS) based on real clinical data and its own algorithms can help to make the right choice according to guidelines. The goal of the INTELLECT II study is to investigate treatment adherence to guidelines/science-based medicine and its impact on patient outcomes into two groups of doctors, clinical centers with standard care of treatment (control), and clinical centers using CDSS (active).

Hypertension and atrial fibrillation are 2 important public health priorities. There is a gap between evidence-based best management and actual clinical practice. To decrease this gap, clinical practice guidelines (CPGs), based on available evidence are employed. Clinical decision support system ("MedicBK") is a computer-based program that analyzes published evidence and provides prompts and reminders to assist health care providers in implementing clinical guidelines and science-based medicine at the point of care. The INTELLECT II trial is designed as a multicenter, cluster-randomized, single-blind, controlled study with blinded outcome assessment. Approximately 10 centers from Russia will be enrolled. Centers managing patients with symptomatic atrial fibrillation and/or hypertension will be randomized to either patient management with aid of CDSS ("MedicBK") or standard care.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Patients diagnosed with nonvalvular atrial fibrillation and hypertension and indications for therapy according to European guidelines.

Exclusion Criteria:

* Inability to adhere to study procedures
* Severe heart-valve disorder
* Stroke within 14 days or severe stroke within 6 months before screening
* Active bleedings
* Thyroid dysfunction
* Pregnancy
* Secondary hypertension
Closed-Loop O2 Use During Invasive Mechanical Ventilation Of Pediatric Patients

During mechanical ventilation (MV) hypoxemic or hyperoxemic events should be carefully monitored and a quick response should be provided by the caregiver at the bedside. Pediatric mechanical ventilation consensus conference (PEMVECC) guidelines suggest to measure SpO2 in all ventilated children and furthermore to measure partial arterial oxygen pressure (PaO2) in moderate-to-severe disease. There were no predefined upper and lower limits for oxygenation in pediatric guidelines, however, Pediatric acute lung injury consensus conference PALICC guidelines proposed SpO2 between 92 - 97% when positive end-expiratory pressure (PEEP) is smaller than 10 cm H2O and SpO2 of 88 - 92% when PEEP is bigger or equal to 10 cm H2O. For healthy lung, PEMVECC proposed the SpO2\>95% when breathing a FiO2 of 21%. As a rule of thumb, the minimum fraction of inspired O2 (FiO2) to reach these targets should be used. A recent Meta-analyze showed that automated FiO2 adjustment provides a significant improvement of time in target saturations, reduces periods of hyperoxia, and severe hypoxia in preterm infants on positive pressure respiratory support. This study aims to compare the closed-loop FiO2 controller with conventional control of FiO2 during mechanical ventilation of pediatric patients


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients older than 1 month and younger than18 years of age; hospitalized at the PICU with the intention of treatment with IMV at least for the upcoming 5 hours
* Requiring FiO2 ≥ 25% to keep SpO2 in the target ranges defined by the clinician
* Written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation

Exclusion Criteria:

* Patient with indication for immediate noninvasive ventilation (NIMV), High flow oxygen therapy (HFOT)
* Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine \> 1 mg/h
* Low quality on the SpO2 measurement using finger and ear sensor (quality index below 60% on the SpO2 sensor, which is displayed by a red or orange colour bar)
* Severe acidosis (pH ≤ 7.25)
* Pregnant woman
* Patients deemed at high risk for the need of non-invasive mechanical ventilation within the next 5 hours
* Patients deemed at high risk for the need of transportation from PICU to another ward, diagnostic unit or any other hospital
* Diseases or conditions which may affect transcutaneous SpO2 measurement such as chronic or acute dyshemoglobinemia: methemoglobinemia, carbon monoxide (CO) poisoning, sickle cell disease
* Formalized ethical decision to withhold or withdraw life support
* Patient included in another interventional research study under consent
* Patient already enrolled in the present study in a previous episode of acute respiratory failure
Study in Schizophrenic In-patients Treated With Quetiapine Prolong or Oral Risperidone at Flexible Dose

This pilot trial in Finland is designed to evaluate in a randomized fashion change of agitation in acute schizophrenic patients (Schizophrenia or Schizoaffective psychosis or Schizophreniformic psychosis)Diagnostic and Statistical Manual (DSM - IV) with the first visits on days 1, 2, 4 or 5 and 7 ± 1.


Eligibility Criteria:
Inclusion Criteria:

* In the opinion of the Investigator, requirement for treatment for an acute episode of schizophrenia, schizoaffective disorder or schizophreniformic psychosis (according to DSM-IV diagnostic criteria), Positive and Negative Symptoms Scale (PANSS) ≥ 65, CGI ≥ 4

Exclusion Criteria:

* Pregnancy or lactation
* In-patients/hospitalized \> 7 days before enrollment
* Known intolerance or lack of response to quetiapine fumarate or risperidone, as judged by the investigator
Parasitic Infections and Ulcerative Colitis: Combining Anti-parasitic and Immunomodulatory Treatments May Achieve Remission

The study aimed to explore the link between parasitic infections and the severity of ulcerative colitis (UC). 120 UC patients were divided into three groups: those without infection, those with Giardia lamblia infection treated with metronidazole, and those with Giardia infection treated with a combination of metronidazole and E. purpurea. The results revealed that patients with Giardia infections exhibited more severe UC symptoms. All groups experienced improved symptoms following treatment, but the combination therapy group demonstrated the most significant improvement. Remission rates were highest in the group without infection and the group receiving combination therapy. Additionally, the study identified E. purpurea therapy and a substantial reduction in SCCAI score as significant predictors of higher remission rates.


Eligibility Criteria:
Inclusion Criteria:

* Ulcerative Colitis patients had active disease,
* Patients had parasitic infection by G. lambellia,
* Patients free of parasitic infection,
* Patients free of exclusion criteria..

Exclusion Criteria:

* Patients had Inflammatory Bowel Disease other than Ulcerative Colitis,
* Patients had multiple parasitic infections,
* Patients had infection by parasites other than G. lambellia,
* Patients who were maintained on immunosuppressant therapy,
* Patients who were in remission and patients refused to sign the written consent to participate in the study.
Effect of Electrostimulation on Denervated Muscles in Individuals with Spinal Cord Injury

The aim of the study is to investigate whether there is an effect of electrical stimulation on the denervated gluteus muscle (buttocks) in individuals with chronic spinal cord injury. The expected outcome is an increase in muscle volume and a better pressure distribution during sitting. The stimulation of the gluteus muscle is performed daily for 35 minutes over a period of six months. The muscle volume and the pressure distribution are measured before stimulation, three months after having started stimulation and after six months.


Eligibility Criteria:
Inclusion Criteria:

* chronic spinal cord injury (min. 2 years after injury)
* lesion height from T10-L5
* ASIA (American Spinal Cord Injury Association) Impairment Scale A

Exclusion Criteria:

* acute pressure sore in stimulated area (M. gluteus)
* arteriosclerosis
* skin irritation or infection in stimulated area (M. gluteus)
* \< 3 months after plastic surgery in stimulated area (M. gluteus)
Hyaluronic Acid in Counteracting Aphthous Stomatitis

Oral mucosal ulcers can determine a real worsening of the quality of life. Conventional therapy usually lasts not less than 2-3 weeks, and carries a high risk of serious side effects; furthermore, ulcers often recur. The use of hyaluronic acid applied as an adhesive gel over the lesions seems to have potential in terms of efficacy and the avoidance of side effects. Of course, hyaluronic acid-based formulations show different effects and tolerability. In this retrospective observational study, the results obtained using a hyaluronic-acid based medical device applied for 14 days to counteract ulcers in adults will be reported.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of aphthous stomatitis
* Healthy for other conditions excluding aphthous stomatitis

Exclusion Criteria:

* Taking one of the following in the 45 days prior to the beginning of the study: immunosuppressive, cytotoxic, cortisone, antibiotic, antifungal, hormone therapy (including birth control pills).
A Study to Assess the Efficacy and Safety of MNK-1411 in Duchenne Muscular Dystrophy

This is a multicenter, double blind, placebo controlled, multiple dose study to examine the safety and efficacy of MNK-1411 in male subjects 4 to 8 years of age (inclusive) with Duchenne Muscular Dystrophy (DMD).

The main purpose of this study is to determine the effect of MNK-1411 on motor function in participants with Duchenne Muscular Dystrophy (DMD). Information is collected only from caretakers who are fluent in English, using the Pediatric Outcomes Data Collection Instrument (PODCI).

The PODCI is a validated 86-question instrument completed by the parent or legal guardian of children 2 to 10 years of age to assess a variety of health outcome measures (Uzark et al, 2012). This study will only collect information for the PODCI domains of sports and physical functioning and transfer/basic mobility.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must have a documented diagnosis of Duchenne Muscular Dystrophy (DMD) confirmed by complete dystrophin deficiency (by immunofluorescence and/or immunoblot), or identifiable mutation in the DMD gene where reading frame can be predicated as "out of frame," or complete dystrophin gene sequencing consistent with DMD; AND in the opinion of the Investigator, a typical clinical profile consistent with DMD.
2. Participants taking approved treatments for DMD (by a Health Authority) that target dystrophin gene mutations (e.g., eteplirsen or ataluren) may be enrolled in the study if they have been on a stable dose for 30 days prior to the first dose of study drug, and plan to remain on that dose throughout the study.

Exclusion Criteria:

1. Participant has had previous systemic treatment with corticosteroids within 2 months prior to the Screening Visit. Exception: In subjects who were down-titrated to a physiological dose of corticosteroids (ie, 3mg/m2 of prednisone or deflazacort) a maximum of 1 month of no greater than a physiological dose followed by 1 month completely off corticosteroids prior to the Screening Visit will be acceptable for study entry. Transient previous use of corticosteroids will be evaluated on a case-by-case basis by the sponsor or designee. The use of topical or intra-articular corticosteroids is permitted during the study
2. Participant is unable to complete the 10 meter Walk/Run test at the Screening and/or Baseline Visit.
3. Participant has Type 1 or Type 2 diabetes mellitus.
4. Participant has a history of chronic active hepatitis including acute or chronic hepatitis B, or acute or chronic hepatitis C.
5. Participant has a history of tuberculosis (TB) infection, any signs/symptoms of TB, or any close contact with an individual with an active TB infection.
6. Participant has known immune compromised status (not related to disease/condition under study), including but not limited to, individuals who have undergone organ transplantation or who are known to be positive for the human immunodeficiency virus.
Pain Relief in the Emergency Department Waiting Room: a Prevalence Study

Pain in the emergency room is under documented and pain relief suboptimal. Data on nurse driven analgesia in emergency department waiting rooms is lacking. The primary objective of this study is to determine the proportion of patients in pain receiving pain therapy administered by the triage nurse (prevalence study). The secondary objectives are to 1) describe nursing practices in analgesia and adherence to the dedicated protocol; 2) to determine the factors associated with the non administration of painkillers and for these factors, to estimate the strength of the association


Eligibility Criteria:
Inclusion Criteria:

* Documented pain score on arrival by the triage nurse and
* Patients having to wait in the ER waiting room

Exclusion Criteria:

* patients directly admitted to the consultation room
* patients for whom pain was not recorded