cyrilzakka/clinical-trials huggingface dataset:
A Drug Interaction Study in Healthy Participants to Assess the Effect of Rifampin on the Pharmacokinetics of JNJ-42847922

The purpose of this study is to assess the effect of single- and multiple-dose of rifampin on the single-dose pharmacokinetics of JNJ-42847922 after oral administration to healthy male and female participants.

This is an open-label, fixed-sequence, single-center, multiple-dose study in 14 healthy adults. All participants will receive a single oral dose of 40 milligram (mg) JNJ-42847922 on 3 separate occasions: Day 1 (JNJ-42847922 alone), Day 5 (JNJ-42847922 with a single dose of rifampin), and Day 12 (JNJ-42847922 in combination with steady-state rifampin). A daily dose of 600 mg (2 \* 300 mg) rifampin will be administered from Day 5 through Day 12. Following JNJ-42847922 dosing, serial blood samples will be collected over 48 hours for the evaluation of plasma concentrations of JNJ-42847922 and its metabolites. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women of non-child-bearing potential between 18 and 60 years of age, inclusive; body mass index (BMI) between 18 and 30 kilogram (kg)/meter\^2, inclusive, and body weight of not less than 50 kg who are nonsmokers (current and for past 60 days)

Exclusion Criteria:

* History of or current clinically significant medical illness
* Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis
* Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG)
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 14 days before the first dose of the study drug is scheduled until completion of the study
* Received a known inhibitor of cytochrome P450 (CYP) 3A4 or CYP2C9 activity within 28 days or a period less than 5 times the drugs half-life; whichever is longer, before the first dose of the study drug is scheduled
Study Evaluating Safety and Efficacy of UCART123v1.2 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Phase I, open-label, dose-escalation and dose-expansion study evaluating the safety and efficacy of Universal Chimeric Antigen Receptor T-cell (UCART) targeting the Cluster of Differentiation 123 (CD123) in patients with relapsed/refractory acute myeloid leukemia (AML). The purpose of this study is to evaluate the safety and clinical activity of Universal Chimeric Antigen Receptor T-cells targeting CD123 (UCART123v1.2) and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).


Eligibility Criteria:
Main Inclusion Criteria:

* Patients with relapsed or primary refractory AML (as defined in World Health Organization \[WHO\] criteria) with ≥5% bone marrow blasts
* Patients with CD123+ blast cells (verified by flow cytometry)
* Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of ≤1
* Adequate organ function, including bone marrow, renal, hepatic, pulmonary, and cardiac function based on the last assessment performed within screening period
* (Dose-escalation) Identified donor and transplant strategy prior to lymphodepletion (LD)
* Other criteria may apply

Main Exclusion Criteria:

* Patients with acute promyelocytic leukemia (APL) or central nervous system (CNS) Leukemia
* Previous investigation gene or cell therapy (including CAR)
* \> 1 prior allogeneic stem cell transplantations (SCTs)
* Prior treatment with rituximab or other anti-cluster of differentiation 20 (anti-CD20) therapy within 3 months
* Any known active or uncontrolled infection
* Other criteria may apply
Blood microRNA Depression Change After DHCA

Collect the blood sample per-operation experience deep hypothermia cardiac arrest for aorta artery replacement surgery Collect the blood from the CPB machine and from intravenous injection tube which already set at different time point.

Collect the blood sample per-operation experience deep hypothermia cardiac arrest for aorta artery replacement surgery Collect the blood from the CPB machine and from intravenous injection tube which already set at different time point Test the blood sample of DHCA, analysis the correlation between miR-194 and temperature.

Eligibility Criteria:
Inclusion Criteria:

* aortic dissection patients

Exclusion Criteria:

* other organ disorder
Advantage of Tramadol in Local Analgesia Post-Sternotomy

Sternotomy, the reference approach for heart surgery, may induce profound and intense post-operative pain. One method of analgesia used is patient-controlled intravenous morphine.

The analgesic efficacy of continuous wound infiltration at the sternum following heart surgery has been demonstrated.

The analgesic catheter placed near the sternotomy wound reduces the consumption of morphine.

The aim of this study is to determine whether a bolus of tramadol associated with the continuous administration of levobupivacaine via the wound catheter could potentiate the local anaesthetic effects, thus leading to a decreased consumption of postoperative intravenous morphine, and a decrease in morphine-related side effects.


Eligibility Criteria:
Inclusion Criteria:

* Persons who have provided written consent
* Patients over 18 years old
* Patients undergoing heart surgery via sternotomy: aortic valve surgery, mitral valve surgery, tricuspid valve surgery, atrial myxoma, coronary artery bypass graft, aorta surgery
* Patients undergoing emergency or scheduled surgery

Exclusion Criteria:

* Adults under guardianship
* Persons without national health insurance cover
* Pregnant or breast-feeding women
* Patients already included in the study once
* Patients with aortic dissection
* Patients with mediastinitis or sternal nonunion
* Patients undergoing heart surgery for the second or more time
* Patients with local infection or generalized bacteraemia-type infection
* Patients with hypersensitivity to local anaesthetics or to tramadol or to opiates or to one of the excipients present in the products used
* Patients with hypersensitivity to paracetamol or to paracetamol hydrochloride (prodrug of paracetamol)
* Patients on antidepressants, gabapentin, pregabalin, neuroleptics
* Patients with a history of convulsions or epilepsy
* Patients with preoperative cognitive dysfunction
* Patients with intracranial hypertension
* Chronic use of morphines or high-dose steroid or non-steroid anti-inflammatory agents
* Patients with acute or chronic kidney failure (creatininemia \> 170 µmol/L)
* Patients with liver failure or porphyria
* Patients under 17 years old
* Patients with severe respiratory failure
* Patients treated with a non-selective MAOI (iproniazid), a selective MAOI A (moclobemid, toloxatone), selective MAO-B inhibitor (Selegiline) or linezolid (Zyvoxid®)
* Patients with acute intoxication or an overdose of products that depress the central nervous system (alcohol, hypnotics, other analgesics...)
* Patients with severe hypotension
Safety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation

The purpose of the study is to see if the Sentinel® Cerebral Protection System may prevent occurrence of stroke during an ablation procedure for atrial fibrillation (AF). The secondary purpose of this study is to study if cognitive function after AF ablation differs between those treated with the Sentinel cerebral protection device and those who do not receive the device.

If assigned to receive the device, the Sentinel® Cerebral Protection System will be placed in your heart at the beginning of your ablation procedure, and then removed along with any collected blood debris upon completion of your procedure. The study team will then call you 30 days after your procedure to assess any neurological events. Your final visit will be 90 days after your procedure to complete a second 30 minute session of cognitive testing.

Eligibility Criteria:
Inclusion Criteria:

* Men / women over the age of 18 years undergoing radiofrequency, pulsed field or cryo-balloon ablation for AF in accordance with the current AHA/ACC/HRS guideline for management of patients with atrial fibrillation. This includes patients with symptomatic paroxysmal, persistent or long-standing persistent AF not responsive to or intolerant of a Class I or III anti-arrhythmic drug or patients with symptomatic paroxysmal or persistent AF prior to the initiation of a Class I or Class III antiarrhythmic drug). The decision to perform catheter ablation for AF will be made by the treating provider and the patient in accordance with the guidelines noted above. (January et al. J Am Coll Cardiol vol. 64, No. 21, 2014, page e1)
* Able to provide informed consent.
* Patients should have acceptable aortic arch anatomy and vessel diameters without significant stenosis as assessed using pre-procedure CT angiogram.

Exclusion Criteria:

* Anatomy unsuitable for use of Sentinel device:

  * Right extremity vasculature not suitable due to compromised arterial blood flow.
  * Brachiocephalic, left carotid or aortic arch not suitable due to excessive tortuosity, significant ectasia, stenosis (\>70%), dissection or aneurysm.
* Cerebrovascular accident or transient ischemic attack within six months
* Carotid disease requiring treatment within six weeks
* Unable or unwilling to provide informed consent.
* Pregnant women
* Known history of dementia.
* Known hypersensitivity to nickel-titanium.
* Presence of MRI non-compatible implanted devices including cardiac implantable electronic devices.
* The presence of left atrial thrombus. All patients routinely undergo transesophageal echocardiogram prior to ablation and / or intra-cardiac echocardiogram at the beginning of the ablation procedure to rule out the presence of left atrial thrombus.
* Patients with a reversible cause for AF such as hyperthyroidism.
Test-retest Reliability for Fatigue Assessment Scale, Short Form 6 Dimension and King's Sarcoidosis Questionnaire

This study aims to see if people's health related quality of life (how they feel about their health) changes over a 12 week period if they do not receive any change in their medicines. The investigators would like people to complete four questionnaires then repeat them after three months. The investigators need to do this to in order see what difference they should expect to detect if they give people treatment that works.

Study Design This will be a questionnaire study, which will involve administering questionnaires to patients with sarcoidosis at baseline and after six and 12 weeks.

Participants can either complete the questionnaires whilst they are attending clinic, or alternatively return the questionnaires via a pre-paid postal envelope. The questionnaires will be administered at the same time; no other study measures will be taken subsequently. Demographic and clinical information will be collected from the patients' medical records.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female aged over 18
* Diagnosed with sarcoidosis by either; biopsy confirming non-caseating granulomas consistent with sarcoidosis, or multi-disciplinary interstitial lung disease meeting diagnosis of sarcoidosis
* Significant fatigue - defined as a FAS score of greater than 21 points
* Has mental capacity to complete the questionnaires

Exclusion Criteria:

* Presence of another significant cardio-respiratory disease, major organ disease (except where related to sarcoidosis) or chronic inflammatory condition
Cenobamate Open-Label Extension Study for YKP3089C025

52 Week Open-Label Safety Study of Cenobamate for Subjects who Complete YKP3089C025 (core study)

52 Week Open-Label Safety Study of cenobamate adjunctive therapy for subjects who complete double-blind study YKP3089C025. Subjects will have a 12 week double-blind conversion phase where subjects who received placebo in the double-blind study will be converted to cenobamate. Subjects who received cenobamate in the double-blind study will continue to receive their daily dose of cenobamate. Subjects switching from placebo to cenobamate will be titrated starting at 12.5 mg and increase their dose over the course of 12 weeks as follows 12.5 mg for 2 weeks, 25 mg for two weeks, 50 mg for two weeks, 100 mg for two weeks, 150 mg for two weeks, and 200 mg for two weeks. All subjects will receive 200 mg for the last two weeks of the conversion phase to preserve the blind. After completing the double-blind conversion phase, subjects will have 40 weeks of open-label, flexibly dosed cenobamate. The dose range is 50 mg - 200 mg. Primary endpoints are all safety measures.

Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight

Eligibility Criteria:
Inclusion Criteria:

* The subject must have successfully completed the Double-blind Treatment Period in the Core study.
* Written informed consent signed by the subject or legal guardian, prior to entering the study, in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. If the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained. As required by country-specific regulations, only the subject may sign the ICF in accordance with ICH guidelines.

Exclusion Criteria:

* Subject tests positive, via urine drug screen at Visit 14 of the Core study, for illicit drugs except for tetrahydrocannabinol and Cannabinoids.
* Any significant changes to the subject's medical history that, in the opinion of the Principal Investigator, could affect the subject's safety or conduct of the study.
Compliance With Once Daily Glaucoma Medication

A study to examine patient compliance with once daily glaucoma medication


Eligibility Criteria:
Inclusion Criteria:

* Primary open angle glaucoma or ocular hypertension patients

Exclusion Criteria:

* None
Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19)

The purpose of this study is to evaluate the efficacy of vadadustat for the prevention and treatment of acute respiratory distress syndrome (ARDS) in hospitalized patients with Coronavirus Disease 2019 (COVID-19).


Eligibility Criteria:
Inclusion Criteria:

* Laboratory-confirmed diagnosis of COVID-19 by detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA by Reverse transcription polymerase chain reaction (RT-PCR) from any specimen respiratory
* Admitted to the hospital within 36 hours
* Oxygen saturation of hemoglobin by pulse oximetry at room air ≤94%
* For patients admitted WITH respiratory symptoms, enrollment must occur within 36 hours of hospital admission. If the patient is admitted to the hospital with normal saturations, but develops respiratory symptoms DURING their hospital stay, enrollment may occur within 24 hours of desaturation to 94% or less on room air
* Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

* Hypersensitivity to vadadustat or any of its excipients
* Placed on mechanical ventilation before randomization
* Hemoglobin above the gender-specific upper limit of normal (ULN) at randomization: 16 g/dL for females and 18 g/dL for males
* Patients who have erythrocytosis or polycythemia vera
* Patient taking Probenecid, lopinavir or ritonavir
* Women who are pregnant or breastfeeding, or positive pregnancy test before randomization
* Patients not on maintenance dialysis with eGFC \< 31 ml/min
* Patients who have received a solid organ transplant, heart, kidney, liver or lung
* Patients who are prisoners
* Patients who are currently Do Not Resuscitate (DNR) or Do Not Intubate (DNI)
* Patients with modified Rankin scale of 3 or greater
* Patient who are currently enrolled in any other interventional clinical trial
Deep Brain Stimulation (DBS) of the Globus Pallidus (GP) in Huntington's Disease (HD)

The aim of the study is to prove the efficacy and safety of pallidal DBS in HD patients and to show superiority of DBS on motor function in the stimulation group compared to stimulation-off group

In this study the efficacy and safety of pallidal Deep Brain Stimulation (DBS) in HD patients shall be investigated and superiority of DBS on motor function in the stimulation group compared to the stimulation-off group shall be shown. This study is a prospective, randomised, double blind, parallel group, sham-controlled, multi-centre trial. Patients in the stimulation group will be stimulated for three months while the stimulator in the sham-group will be turned off for three months. After three months the primary endpoint will be assessed. Afterwards the stimulator will be turned on in all patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinically symptomatic and genetically confirmed HD (number of CAG repeats ≥ 36)
* Age ≥18 years
* Moderate stage of the disease (UHDRS motor score ≥ 30)
* Chorea despite best medical treatment (UHDRS chorea subscore ≥ 10)
* Mattis Dementia Rating Scale ≥ 120 (or \> 80% of items testable independently from motor impairment)
* Patient has stable medication prior six weeks before inclusion
* Signed informed consent

Exclusion Criteria:

* Juvenile HD (Westphal variant) or predominant bradykinesia
* Postural instability with UHDRS retropulsion score \> 2
* Severe comorbidity compromising operability and/or life expectancy and/or quality of life during the trial duration (e.g. cancer with life expectancy \< 6 months, NYHA 3 and 4 rising the anaesthetic risk according to the anaesthesiologist)
* Acute suicidality
* Acute psychosis (symptoms within previous 6 months)
* Participation in any interventional clinical trial within 2 months before screening
* Cortical atrophy grade 3
* Patients with risk of coagulopathies and/or increased risk of haemorrhage
* Patients with an implanted pacemaker or defibrillator
* Pregnancy
* lactation
Right-sided Colon Tumor, Laparoscopic Versus Open Surgery, in an ERAS Protocol

Register study. Patients who had been operated for right-sided colon tumor or benign adenoids between year 2011 to 2012. The study compare open surgery with laparoscopic surgery in an ERAS (Enhanced Recovery After Surgery) protocol.

Hypothesis:

Operation of right-sided colon tumor and large benign adenoids, a better selection of patients for open or laparoscopic surgery can improve short term results.


Eligibility Criteria:
Inclusion Criteria:

* right-sided colon tumor or large benign adenoids

Exclusion Criteria:

* none
Correlation of Gene Status and Clinical Outcomes in ESCC

The incidence of esophageal squamous cell carcinoma is highly regional and familial. The current treatment plan is based on the stage and location of the tumor.By studying the relationship between the status of different genes and prognosis, it can help doctors to develop precise and individualized treatment plans.


Eligibility Criteria:
Inclusion Criteria:

* Esophageal cancer patients who underwent surgery treatment, and postoperative pathological diagnosis was squamous cell carcinoma. Patients with ESCC have complete clinical information.

Exclusion Criteria:

* Patients who also suffering from other tumors.
Factors Related to the Number of Visits to PT in PHC

Musculoskeletal disorders can be a large burden on individuals, health care and social care systems. The aim was to assess the feasibility of performing a prospective study investigating whether self-efficacy, fear of movement, empowerment or enablement has any relation to the number of visits to physiotherapists among patients with a musculoskeletal disorder in primary health care. Design was apProspective study with consecutively selection including patients seeking physiotherapist for the first time for a musculoskeletal disorder. Primary outcome measure included operational and practical feasibility regarding recruitment of participants, use of questionnaires and key variables to be collected as part of the study.

Background: Musculoskeletal disorders can be a large burden on individuals, health care and social care systems. Patients with musculoskeletal disorders are often treated by physiotherapists in primary health care. Psychosocial variables can be a significant obstacle to recover from musculoskeletal injuries.

The primary aim of this pilot study was to assess the feasibility of performing a prospective study investigating whether self-efficacy, fear of movement, empowerment or enablement has any relation to the number of visits to physiotherapist among patients with a musculoskeletal disorder in primary health care.

Methods: Prospective study with consecutively selection including patients seeking physiotherapist for the first time for a musculoskeletal disorder. Primary outcome measure included operational and practical feasibility regarding recruitment of participants, use of questionnaires and key variables to be collected as part of the study. Secondary outcomes included correlation between self-efficacy (Exercise Self-Efficacy Scale (ESES-S)), fear of movement (Tampa Scale for Kinesiophobia (TSK-SV)), empowerment (Making Decisions Scale ), enablement (Patient Enablement Instrument (PEI)) and number of visits to physiotherapist. Statistical analysis was done using IBM SPSS statistics version 24 with analysis of correlation using Spearman's rank correlation coefficient.

Eligibility Criteria:
Inclusion Criteria:

* Patients, who seek physiotherapist for the first time for a musculoskeletal disorder, are over 18 years of age and are able to read, write and understand Swedish.

Exclusion Criteria:

* Patients, who have visited physiotherapist previous for the same musculoskeletal disorder and/or are diagnosed with malignant diseases. Patients, who suffer from dementia, severe mental illness or other conditions making them not able to understand the information about the study and not able to fill in the questionnaires.
Prevalence of Eosinophilic Esophagitis in Children With Celiac Disease

Celiac disease (CD) and eosinophilic esophagitis (EE) are distinct diseases of the gastrointestinal tract with specific clinico-pathological characteristics. In recent years, in the literature, several children who underwent upper gastrointestinal endoscopy for suspected CD, which was confirmed histologically, were also found to have coexistent EE. There are reports of coexistent CD and EE. We would like to see the prevalence of EE in children with CD and the prevalence of CD in children with EE in our population, and to do so would like to review medical records. Our objectives are to determine if children with celiac disease have a high prevalence of eosinophilic esophagitis.and to determine if children with eosinophilic esophagitis have increased risk of developing celiac disease.


Eligibility Criteria:
Inclusion Criteria:

* Seen in the Pediatric Gastroenterology clinic at St. John Hospital \& Medical Center during study time frame
* Age 2-21 years old
* Diagnosed with CD or EE or both based on the endoscopic and histopathological findings .

Exclusion Criteria:

* Gastroesophageal reflux diagnosed by PH probe.
* History of chemical ingestion