cyrilzakka/clinical-trials huggingface dataset:
A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the Pharmacokinetics and Safety of EDP-323.

The primary aim of the study is to assess the effect of itraconazole, carbamazepine, quinidine, and fluconazole individually on the pharmacokinetics and safety of EDP-323 in healthy adult participants. Each participant's duration in the study will be dependent upon which study part they are enrolled.


Eligibility Criteria:
Inclusion Criteria:

* An informed consent document signed and dated by the subject.
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive.
* Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of50 kg
* Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 30 days after the last dose of EDP-323. A male participant who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease
* Pregnant or nursing females
* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection
* A positive urine drug screen at Screening or Day -1
* Current tobacco smokers or use of tobacco within 3 months prior to Screening.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy)
* History of regular alcohol consumption exceeding protocol limits
* Participation in a clinical trial within 28 days prior to the first dose of study drug
* For Part 2 and Part 3 participants, the following cardiovascular abnormalities:
* QRS duration \>110 ms
* Incomplete right bundle branch block or any complete bundle branch block
* Heart rate \<40 or \>90 beats per minute (per vital sign capture while rested)
* History of unexplained syncope, structural heart disease, or clinically significant arrhythmias
* Personal or family history of long QT syndrome (genetically proven or suggested by sudden death of a close relative due to cardiac causes at a young age) or Brugada syndrome
* PR interval \>220 ms or any 2nd or 3rd degree AV block
* Ventricular pre-excitation
* Other exclusions for Part 2 (carbamazepine) participants
* Participants of Asian ancestry with HLA allele B\*1502 in this population
* Platelets, white blood cell count or hemoglobin below the lower limit of normal, due to reported incidence of agranulocytosis and aplastic anemia with carbamazepine
Golden Age: Virtual Reality and Mindfulness

The aim of the research is to identify innovative methodologies to improve the psychological well-being of ageing people.

With regard to the objectives of the Golden Age project, a software of Immersive Virtual Reality (VR) for people over 65. The application aims to improve the psychological wellbeing of ageing people, facilitating the removal of barriers that may represent a risk factor with respect to the assumption of a healthy and correct nutrition.

In particular, the elderly will be exposed to naturalistic scenarios in Virtual Reality combined with Mindfulness audio tracks. The practice of Mindfulness in Virtual Reality will be used to prevent and intervene on depressive symptoms, stress and anxiety, which represent the main obstacles to the adoption of healthy behaviours in the elderly person.

Eligibility Criteria:
Inclusion Criteria:

* Average age over 64
* MMSE between 20 and 30
* Adequate vision and hearing to see scenarios and hear tracks
* sufficient ability to understand procedures and communicate with staff

Exclusion Criteria:

* High levels of depression combined with other psychological risk indices (such as suicidal thoughts)
* Current use of narcotics or substance abuse
Ischemic Conditioning to Enhance Function (I-C-FUN) in Children With Cerebral Palsy

The purpose of this research study is to determine if remote limb ischemic conditioning (RLIC) can increase skeletal muscle power, enhance learning of motor (dynamic balance) task, and improve walking performance in children with cerebral palsy (CP).

Ischemic conditioning is a phenomenon in which an organ exposed to a controlled, short-term, local, sublethal ischemia protects from subsequent ischemia. Remote ischemic conditioning is another more practical approach where transient ischemia and reperfusion applied to a remote organ or tissue, protects other organs or tissues from further episodes of lethal ischemia/reperfusion injury. Remote limb ischemic conditioning (RLIC) is a clinically feasible way of performing remote ischemic conditioning where alternating, brief ischemia and reperfusion is delivered with cyclic inflation and deflation of a blood pressure cuff on the arm or leg.

The overall goal of this research is to use ischemic conditioning to enhance muscle power, motor leaning, and mobility in children with CP. Our previous work demonstrated that when paired with strength training, RLIC improved muscle strength and activation in healthy, young adults and motor learning in healthy older adults. The current study extends that work to determine if RLIC enhances muscle power, dynamic balance, and walking performance in children with CP. This Phase II study will yield the necessary information to design and execute subsequent randomized controlled trials in children with CP as well as other neurological conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Children diagnosed with unilateral or diplegia cerebral palsy (CP)
2. Gross Motor Function Classification System (GMFCS) levels I-III

Exclusion Criteria:

1. Children with other developmental disabilities such as autism, developmental coordination disorders, etc.
2. Children with cognitive deficits or communication problem
3. Children with balance disorders such as vestibular disorders, posterior fossa tumors etc.
4. Children with known cardiorespiratory dysfunctions
5. Children who are receiving other adjunct therapies such as TMS, tDCS, vagal nerve stimulation
6. Presence of lower extremity condition, injury, or surgery which could compromise conditioning and training
7. Children with sickle cell disease
Heart Attack Research Program: Platelet Sub-Study (HARP)

This prospective observational cohort study, will investigate the platelet phenotype, platelet genetic composition, and role of platelets as effector cells in women and men with myocardial infarction (MINOCA or MI-CAD) and controls. This study, which will take place at NYU and Bellevue Medical Center, and participating external sites. May have concurrent enrollment with the HARP Main Imaging (NCT02914483). Additionally, a sex, group of age and race matched disease controls 'CATH-NOCA' composed of women and men with stable angina referred for cardiac catheterization, will be enrolled. Blood obtained during the initial catheterization and 2 months post-MI will be utilized for platelet testing.


Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic symptoms compatible with diagnosis of MI, such as chest pain or anginal equivalent symptoms at rest or new onset exertional anginal equivalent symptoms
* Objective evidence of MI (either or both of the following):

  * Elevation of troponin to above the laboratory upper limit of normal (ULN)
  * ST segment elevation of ≥1mm on 2 contiguous ECG leads
* Willing to provide informed consent and comply with all aspects of the protocol
* Administration of aspirin at least 1 hour before cardiac catheterization
* Administration of thienopyridine (e.g., clopidogrel, ticagrelor) at least 1 hour before cardiac catheterization
* Women and men with ≥50% of any major epicardial vessel on invasive angiography may participate

Exclusion Criteria:

* Recent use of vasospastic agents, such as cocaine, triptans, or ergot alkaloids (≤1 month)
* Alternate explanation for troponin elevation, such as hypertensive urgency, acute exacerbation of heart failure, chronic elevation due to kidney disease, pulmonary embolism, cardiac trauma
* Pregnancy
* Thrombolytic therapy for STEMI (qualifying event)
* Use of any of the following medications:
* Platelet antagonists (except aspirin and thienopyridines) within 7 days
* NSAIDs (e.g., ibuprofen, naproxen) within 3 days.
* Thrombocytopenia (platelet count \<100,000)
* Thrombocytosis (platelet count \>500,000)
* Anemia (hemoglobin \<9 mg/dl)
* Hemorrhagic diathesis
PreView PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization

The primary objective of this study is to assess the ability of the PreView PHP(study device)to detect newly diagnosed non-treated Choroidal Neovascularization (CNV)lesion associate with advanced Age-related Macular Degeneration (AMD) or Myopia and differentiate them from Intermediate AMD or Geographic Atrophy (GA)or patients with high Myopia with no CNV.

This study secondary is to enhance NotalVision normative database.

* The study is prospective, multi-center, comparative study.
* A clinical trail with FDA approval device (510K).

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed (up yo 2 months) CNV OR Intermediate AMD
* Age \>50 for AMD subjects
* Age \>18 for Myopic subjects
* VA 20/160 or better in the study eye
* Mental and physical ability to performed a PHP test

Exclusion Criteria:

* Evidence of macular disease other than AMD or high myopia in the study eye.
* Previous surgical or laser treatment within the macular erea.
* Concurrent intraocular drug therapy (within 30 days).
* Present of any significant media opacity that preclude a clear veiw of the macula.
* Any non macular related ocular surgery performed within 3 months prior to the study.
* CNV subjects inability to tolerate intravenous fluorscien angiography.
Juanbi Pill for Rheumatoid Arthritis

The purpose of this study is to determine whether Juanbi Pill combined with methotrexate are effective in the treatment of active Rheumatoid Arthritis (RA).

Rheumatoid arthritis patients are suffering from painful and swelling of joints as well as joint destruction and functional disability with the duration of disease activity. Patients and physician try to find a way to alleviate the swell and tenderness of joints to avoid irreversible joints impairment, for evidence indicating that early aggressive treatment results in greater improvement than therapy initiated later in the disease course.

As a complementary and alternative medicine (CAM), herbal medicines have the potential to achieve a clinical remission, or push the disease back to low disease activity. In traditional Chinese medicine (TCM), rheumatoid arthritis is a Bi syndrome and Juanbi decotion (notopterygium root, radix angelicae pubescentis, Gentiana macrophylla, Kadsura Pepper Stem, Mulberry Twig, Angelica sinensis, Ligusticum wallichii, frankincense, Radix Aucklandiae, shaved cinnamon barka and liquorice ) is a medicine specially for Bi syndrome and it has been used in Chinese for hundreds of years. Juanbi pill is the raw extration of Juanbi decotion for the sake of convenience of quality control and storage.

Although the long term usage of Juanbi decotion, there is no high quality evidence about the decotion on rheumatoid arthritis. Using a well-designed clinical trial, the investigators will survey the effectiveness of concurrent use of this decotion in relieving disease activity. Therefore, the present study is to examine effectiveness and safety of Juanbi Pill, a compound traditional Chinese herbal medicine on rheumatoid arthritis in a randomized, double-blind, placebo-controlled trial. Results of this study will provide evidence regarding the value of the Juanbi pill as an intervention to lower the disease activity and protect the affected joints from deformity.

Eligibility Criteria:
Inclusion Criteria:

* Adults with rheumatoid arthritis (score more then 5 of ACR (American College Of Rheumatology) /EULAR (European League Against Rheumatism), 2009 )
* moderate-to-severe disease activity (Disease Activity Score for 28-joint counts (DAS28) of more than 3.2
* an onset of symptoms within 12 months before enrollment, no prior exposure to more than 10mg oral glucocorticoids or biologic agents
* paid employment or unpaid but measurable work (e.g., caring for a family and home)

Exclusion Criteria:

* combined with other disease such as adjuvant arthritis, lupus arthritis, osteoarthritis and et al.
* abnormal liver and my kidney function
* pregnancy or have a plan of pregnancy,breast feeding women
* severe chronic or acute disease interfering with therapy attendance
* alcohol or substance abuse
Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Elderly Subjects

To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over


Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or older

Exclusion Criteria:

* any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time
* hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine - - history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
* known or suspected (or high risk of developing) impairment/alteration of immune function within the past 7 days
* any acute disease or infections requiring systemic antibiotic or antiviral therapy fever within the past 3 days
Comparison of Telemedicine to Usual Care for HCV Management for Methadone-maintained Individuals

To compare the effectiveness of a patient-centered, opiate agonist treatment (OAT)-integrated telemedicine-based approach for management and delivery of hepatitis C virus (HCV) treatment to persons with substance use disorders (PWSUD) versus usual care, which we anticipate in most cases will be referral to an offsite location for HCV management. The effectiveness will be expressed through the primary patient centered and clinical outcome, achievement of viral eradication, defined as undetectable HCV RNA 12 weeks post-treatment cessation.

The study is a non-blinded stepped wedge cluster randomized controlled trial with two arms: onsite HCV management through telemedicine versus HCV management through usual care, referral to an offsite hepatitis specialist (Referral). The arm assignment is at the cluster (clinic) level. After an initial period (9 months) in which all clinics implement the control intervention (usual care), at regular intervals (i.e., the "steps") of 9 months duration each, one group of clinics is randomized to cross over from the Usual Care arm to the Telemedicine arm. The process continues until all clinics have crossed over to implement telemedicine, and thus all clinics contribute data to both interventions. In addition, patients cured of HCV are followed for two years post-treatment cessation to assess for reinfection or relapse of HCV RNA.

Eligibility Criteria:
Inclusion Criteria:

1. HCV antibody detected
2. Ability and willingness of subject or legal representative to provide written informed consent.
3. 18 years of age
4. A minimum of 12-month enrollment in the opiate agonist treatment program
5. Likely to be adherent to the therapeutic regimen
6. Covered by medical insurance

Exclusion Criteria:

1. Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain.
2. \<18 years of age
3. \< 12 months enrolled in an opiate agonist treatment program.
4. Non-compliance with therapeutic regimen defined as three consecutive missed appointments that will result in a discussion between the principal investigator at the site and the study participant to determine the reason for the missed appointments. Continuation in the study for the participant will be assessed on a case-by-case basis between the study PI and the site PI.
5. Lack of medical insurance coverage
6. Ineligibility for HCV treatment
7. Active treatment for HCV at the time of the study enrollment
Efficacy and Safety Assessment of T4090 Ophthalmic Solution Versus Rhopressa® Ophthalmic Solution in Patients with Open-angle Glaucoma or Ocular Hypertension

The main purpose is to compare the ocular hypotensive efficacy and safety of two concentrations of T4090 (Kinezodianone R HCl 0.2% and 0.3%) ophthalmic solution with Rhopressa® ophthalmic solution


Eligibility Criteria:
Main Inclusion Criteria:

* Patient (male or female) ≥18 years old
* Patient with Open Angle Glaucoma or Ocular Hypertension in both eyes
* Informed consent dated and signed.

Main Exclusion Criteria:

* Secondary Open Agle Glaucoma (ex. Pseudoexfoliation, Pigmentary glaucoma)
* Advanced stage of glaucoma
* History of ocular trauma, eye infection, or/and ocular clinically significant inflammation within the 6 previous months.
* Known or suspected hypersensitivity to one of the components of the IMPs or other product used in the clinical study
* Pregnancy (confirmed with a positive urine pregnancy test) or breast-feeding.
Study of Absorption, Metabolism and Excretion Following a Single Oral Dose of [14C]KWA-0711 to Healthy Male Subjects

The purpose of this study is to evaluate the absorption, metabolism and excretion following a single oral dose of \[14C\]KWA-0711 to healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are male, caucasian, and between 35 and 55 years of age, inclusive.
* Subjects who have a body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive.
* Subjects who have a body weight between 50 and 100 kg, inclusive.
* Subjects must have regular bowel movements.

Exclusion Criteria:

* Subjects who have an abnormality in heart rate, blood pressure , temperature or 12-lead ECG.
* Subjects who are still participating in a clinical study or who have participated in a clinical study involving administration of an investigational drug in the 3 months prior to dose administration.
* Subjects who have had a clinically significant illness within 4 weeks of dose administration as determined by the Investigator.
* Subjects who have any clinically significant abnormal laboratory safety findings.
* Subjects who have had an X ray or who have participated in any clinical trial involving a radiolabelled investigational product or have been exposed to radiolabelled substances within 12 months prior to dose administration.
Study Of Circulating Multiple Myeloma Cells As A Biomarker of MGUS And SMM

This is a prospective study to collect blood and bone marrow samples from patients with SM and MGUS. About 100 subjects will be enrolled at the University of Pennsylvania and followed for 2 years. The primary objective of this study is to evaluate CMMCs as a biomarker to detect patients at high risk of progression to multiple myeloma in patients with MGUS and SMM.

The primary objective is to evaluate CMMCs as a biomarker to detect patients at high risk of progression to multiple myeloma in patients with MGUS and SMM. The secondary objective are to correlate CMMCs with the Mayo Clinic prognostic models in MGUS/SMM, to compare bone marrow genomic findings with genomic findings in CMMC (utilizing multiple myeloma FISH panel), to perform immunophenotyping of bone marrow plasma cells, to perform gene expression profiling on CD138+bone marrow plasma cells and correlate with progression, to perform serum microRNA profiling and correlate with progression, to correlate bone marrow immunohistochemical studies evaluating the microenvironment with CMMC, to perform proteomic profiling on peripheral blood to evaluate serum biomarkers of progression and to establish a biorepository of samples of peripheral blood for future studies.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or greater
* Capable of informed consent
* A monoclonal gammopathy detected in the serum, including intact immunoglobulin (IgG and IgA) and light chain only gammopathies. Light chain only gammopathy is defined as an abnormal light chain ratio and increased involved light chain).44, 45
* Absence of myeloma related organ or tissue impairment ("CRAB") as defined by:

  * Hypercalcemia (calcium greater than or equal to 11)
  * Renal failure (creatinine \>2.0)
  * Anemia hemoglobin \<10 gm/dl)
  * Bone disease (Osteolytic lesions, fractures)

Exclusion Criteria:

* A secondary B-cell neoplasm or other active malignancy aside from non-melanoma skin cancer or localized prostate cancer. An active malignancy is any malignancy requiring therapy within the past 3 years. Patients with monoclonal B-cell lymphocytosis are not excluded.
* IgM monoclonal gammopathy
* Inability to comply with follow-up
A Study of SI-6603 in Patients With Lumbar Disc Herniation

The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in patients with lumbar disc herniation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with lumbar disc herniation (L1-L2, L2-L3, L3-L4, L4-L5 or L5-S1) as assessed by MRI and clinical symptoms corresponding to position of the impaired nerve root.
* Patients assessed as positive in the Femoral Nerve Stretching (FNS) test for L1-L2, L2-L3, or L3-L4 and Straight Leg Raising (SLR) test.
* Patients with sciatica in either leg.
* Patients with no improvement from conservative treatment

Exclusion Criteria:

* Patients who have 2 or more lumbar disc herniations as assessed by MRI.
* Patients in whom a rupture into the posterior longitudinal ligament is identified by MRI.
* Patients who have undergone lumbar operation, or lumbar percutaneous nucleotomy or lumbar intradiscal therapies
Heart Rate Variability in Children Conceived Via Assisted Reproductive Technologies

This is a proof of principle study that investigates heart rate variability differences in fetal and neonatal life in a longitudinal study design and compares two subject groups, offspring conceived using in-vitro fertilization and conceived naturally.

This is a proof of principle study that investigates heart rate variability differences in fetal and neonatal life in a longitudinal study design and compares two subject groups, offspring conceived using in-vitro fertilization and conceived naturally.

Eligibility Criteria:
Inclusion Criteria:

* Fetus or newborn
* Delivery at University of Utah Medical Center, Latter Day Saints Hospital or Intermountain Medical Center

Exclusion Criteria:

* Twins
* Genetic anomaly
* Congenital malformation
* Need for special care