cyrilzakka/clinical-trials huggingface dataset:
A Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels

A pharmacokinetic study evaluating naproxen and esomeprazole blood levels in 4 treatments, each containing one or both components.

This study is being conducted to assess the relative bioavailability of naproxen and esomeprazole from a single dose of PN 400 (delayed-release naproxen 500mg / immediate-release esomeprazole 20mg), enteric-coated naproxen 500mg co-administered with enteric-coated esomeprazole 20mg, enteric-coated naproxen 500mg administered alone, and enteric-coated esomeprazole 20mg administered alone.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and non-pregnant, non-lactating females who are either of non-childbearing potential or using an acceptable method of birth control.

Exclusion Criteria:

* Standard exclusion criteria for a study of this nature - no significant medical conditions that might affect the interpretation of the PK data or compromise the safety of the subject.
Correlation of Serum Level of Perampanel (PER) Level to Cerebrospinal Fluid (CSF) Levels of PER

Perampanel is a drug used to treat patients with epilepsy/seizures. This study is designed to determine how much perampanel actually crosses the blood brain barrier into the cerebral spinal fluid when the drug is taken.

Perampanel is a drug used to treat patients with epilepsy/seizures. This study is designed to determine how much perampanel actually crosses the blood brain barrier into the cerebral spinal fluid when the drug is taken.

During a routinely scheduled neurosurgical procedure, one to two mL of cerebral spinal fluid will be obtained from the subarachnoid space of the brain. Five mL of arterial blood will also be drawn from the patients arterial line during their procedure. The blood samples and cerebral spinal fluid samples will be compared to see how much perampanel is in the blood versus the cerebrospinal fluid.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years-old) who are scheduled to undergo brain surgery and need antiepileptic medication for prophylaxis or treatment of seizures
* Able to provide informed consent

Exclusion Criteria:

* Patient unable to provide informed consent
* Allergy to PER or its component
* Patient with significant renal (creatinine clearance 35 ml/min) or hepatic impairment
* Pregnant or lactating females will be excluded from the study.
A Study of Inhalation of 20,000 EU CCRE and Mucociliary Clearance (MCC) in Otherwise Healthy Individuals Who Are Current Cigarette Smokers

The purpose of this Phase 1 research study is to identify a dose of inhaled endotoxin that is safe (does not cause prolonged cough, shortness of breath or other problems), but causes changes in sputum cell samples that the scientists can measure. The investigators are also interested in seeing if the exposure to the endotoxin decreases the body's natural ability to clear mucus from the lungs.

The purpose of this study is to determine the range of neutrophil response (influx of PMNs to the airways as determined in sputum) after inhalation of CCRE (20,000 EU), shown in previous studies of healthy, nonsmoking volunteers as well as in a limited number of otherwise healthy smokers to be well tolerated. This dose induces measurable increases in neutrophil content of induced sputum that can be employed to screen large populations for susceptibility to the inflammatory effect of inhaled endotoxin. Limitations of the understanding of actions of inflammatory stimuli on airway function are likely due to the fact that functional assessments of dynamic airway response /in vivo/ have generally been limited to those based on spirometry and examination of airway samples for assessment of cells and mediator content. Slowing of mucociliary clearance (MCC), a key component of airway defense, can be induced by inflammation and almost certainly contribute to mucus plugging and decreased clearance of inhaled irritants. Measures of mucociliary clearance (MCC), by inhalation of radiolabeled particles to label airway surface liquid, suggest that clearance of secretions is impaired to a mild degree in smokers and more severely in patients hospitalized for acute exacerbations.

Eligibility Criteria:
Inclusion Criteria:

* Must be current cigarette smokers
* Must be otherwise healthy
* Must be good sputum producers

Exclusion Criteria:

* Any acute illness any chronic illness which would impact results
Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess

The aim of this study is to compare two different preparation


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* cephalic presentation
* gestation of more than 37 Weeks confirmed by ultrasound
* Bishop score less than 7
* Informed consent

Exclusion Criteria:

* previous cesarean section (scarred uterus)
* polyhydramnios
* multiple pregnancy
* fetal malformation
Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO

This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO.

A randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal CLS-TA in conjunction with intravitreal aflibercept in subjects with retinal vein occlusion

Eligibility Criteria:
Inclusion Criteria:

* Has a clinical diagnosis of RVO in the study eye
* Has a CST of ≥ 300 µm in the study eye
* Has an ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye;
* Is naïve to local pharmacologic treatment for RVO in the study eye;

Exclusion Criteria:

* Any active ocular disease or infection in the study eye other than RVO
* History of glaucoma, intraocular pressure \> 21 mmHg or ocular hypertension requiring more than one medication
* Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
* Any evidence of neovascularization in the study eye
EMPOWER 3: Improving Palliative Care Health Literacy and Utilization

Through this award, Michael Hoerger, PhD, MSCR, a psychologist at the Tulane Cancer Center in Louisiana, will lead a study called EMPOWER 3 designed to test an educational intervention to help patients understand palliative care, use it, and feel better emotionally and physically. Participants will be adults with serious cancer diagnoses. Participants will be randomized into two groups. Patients in the control group will get enhanced usual care, meaning standard cancer care and several additional healthcare-related brochures. Patients in the intervention group will get enhanced usual care plus an educational video developed by the investigators and other materials designed to increase understanding and use of palliative care. Family members of patients in the intervention group may also attend if desired. The investigators will track participants' understanding of palliative care, attitudes toward palliative care, symptoms over 6 months of follow-up, and palliative care utilization.


Eligibility Criteria:
Inclusion Criteria:

1. Adult, age 18 or older
2. Meets criteria for 2a or 2b. 2a) The patient's doctor believes they may be appropriate for palliative cancer care OR 2b) The patient has a new diagnosis, recurrence, or progression of cancer in the past 90 days AND any of the following:

   * Advanced cancer, such as:

     * Lung Cancer: Stage IIIB or IV non-small cell, or extensive stage small cell
     * Breast Cancer: Stage IV
     * Gastrointestinal (GI) Cancers: Unresectable stage III or stage IV
     * Genitourinary (GU) Cancers: Stage IV
     * Melanoma: Stage IV
     * Hematologic Malignancies

       * Leukemia (e.g., acute myeloid leukemia \[AML\], acute lymphoblastic leukemia \[ALL\], chronic myeloid leukemia (CML), chronic lymphocytic leukemia \[CLL\]): advanced stage, treatment refractory, poor prognosis cell type or chromosomal abnormalities, older age
       * Lymphoma: Stage IV or treatment refractory Hodgkin's disease or non-Hodgkin's lymphoma Multiple Myeloma: elevated β2-microglobulin, albumin \<3.5, PCLI \>1%, CRP \>6µg/mL, elevated LDH, plasmablastic morphology, or abnormal chromosome 13
   * Advanced heart, lung, renal (kidney), or liver disease
   * Two or more severe symptoms (≥7 on 0-10 scale): pain, tiredness, drowsiness, nausea, bad appetite, shortness of breath, depression, or anxiety
3. Patient can understand spoken or written English
4. Patient receives care in southeast Louisiana

Exclusion Criteria:

* Known history of receiving specialty palliative care or hospice
* Significant psychiatric or other co-morbid disease that would prohibit informed consent or participation in the study
* Unlikely to complete any follow-up surveys
Individualization of Ganciclovir and Valganciclovir Doses Using Bayesian Prediction in Renal Transplant Patients.

The objective of the present study is to optimize intravenous ganciclovir(GCV) and oral valganciclovir (VGCV)doses, advised by the drug exposure, indicated by the area under the concentration time curve (AUC), in renal transplant patients receiving oral VGCV or intravenous GCV for CMV prophylaxis or treatment. The initial doses will be calculated according to population pharmacokinetic model. Subsequent doses will be adjusted according to plasma GCV concentrations, using the Bayesian approach. This method of dose adjustments could lead to increase the percentage of patients achieving a therapeutic exposure.

The area under the concentration time curve of serum concentrations of GCV is an indicator of systemic exposure to the drug and is related to the effectiveness and safety. According to the population model developed by our group, less than 16% of patients treated achieve the therapeutic goal of AUC (40 to 50 mcg • h / L) after drug dosing according to summary of product characteristics (SPC). Especially, patients with impaired renal function values (creatinine clearance (CrC)l \<30 ml / min) or high (CrCl\> 70 ml / min) would be overdosed and underdosed, respectively, with the risk of more adverse effects or therapeutic failure.

Therefore, the individualization of the dosage of GCV, can contribute greatly to achieve optimal exposure to the drug in transplant patients, especially in the cases of extreme values of renal function (CrCl decreased and high). As a consequence, minimize adverse effects, ensure greater efficiency in the target population and reduce associated costs.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 18 or older, weigh more than 34kg and may be of either sex and race.
* Subjects must be willing to give informed consent (IC) in writing and be able to do and follow the study. If a subject cannot give informed consent in writing , a legal representative could sign in his place.
* Women of childbearing potential should perform a pregnancy test at the time of entry and accept the use of a medically acceptable contraceptive method during the study.

Exclusion Criteria:

* Creatinine Clearance (CrCl )\<10 mL / min.
* Subjects may not have a history of type I hypersensitivity or idiosyncratic reactions to drugs ganciclovir/valganciclovir
* Pregnancy women.
* Women breast feeding
* Subjects may not present at time of inclusion any clinically significant disease that could interfere with study evaluations.
* Previous participation in another clinical trial sponsored by pharmaceutical industry, in which the promoter and the protocol set which should be the treatment for CMV.
Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers.

This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to placebo therapy.

Experimental: ALLO-ASC-DFU, Placebo Comparator: Vehicle Sheet, Study type: Interventional, Study design: Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center Study

Eligibility Criteria:
Inclusion Criteria:

1. Subject is between 18 and 75 years of age.
2. Subject is diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit.
3. Foot ulcer size is between 1 cm2 and 15 cm2
4. Ulcer graded I or II by Wagner grade, and extended to skin, tendon, and subcutaneous tissue.
5. Free of necrotic debris at target ulcer
6. Around ulcer area blood circulation should be secured to meet one of below criteria;

   * Blood vessels around the ulcer detected by Doppler Test
   * 0.7 \< Ankle Brachial Index(ABI) \< 1.3
   * Transcutaneous Oxygen Pressure, TcPO2 higher than 30 mmHg
7. Subject is able to give written informed consent prior to study start and to comply with the study requirements during study.

Exclusion Criteria:

1. Non-diabetic pathophysiologic ulcer.
2. The ulcer has increased or decreased in size by 30% or more during one week after the screening visit.
3. Subjects requiring intravenous (IV) antibiotics to treat infection.
4. Current evidence of infection including pus drainage from the wound site.
5. Subject has a glycated hemoglobin A1c (HbA1c) level of \> 15%
6. Subject's blood sugar is \> 450 mg/dl at postprandial.
7. Subjects with severe renal failure that cannot be managed by renal dialysis.
8. Subjects with severe hepatic deficiencies.
9. Subject is Human Immunodeficiency Virus (HIV) positive.
10. Subject who has allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
11. Subject who is pregnant or breast-feeding.
12. Subjects who are unwilling to use an "effective" method of contraception during the study.
13. Subjects who have a clinically relevant history of alcohol or drugs abuse.
14. Subjects who are not able to understand the objective of this study or to comply with the study requirements.
15. Subjects who are considered to have a significant disease which can impact the study by investigator.
16. Subjects who are considered not suitable for the study by investigator.
17. Subjects who had had a history of surgery for malignant tumor within the last five years (except carcinoma in situ).
18. Subjects who are currently or are enrolled in another clinical study within 60 days of screening.
19. Subjects who have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
20. Subjects who are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening.
21. Subjects not comply with off-loading procedure
Phase 3 Study Comparing IOP Lowering in OAG or OH in Japanese Subjects C-01-98

The purpose of this study is to evaluate safety and efficacy of two different IOP lowering medications after twelve months of treatment in Japanese subjects.


Eligibility Criteria:
Adults of Japanese Ethnicity
The Effects of Coenzyme A Combined With Statin on Serum Lipids in Patients With Hyperlipidemia

The purpose of this study is to evaluate the lipid lowering effects and clinical safety of a natural hypolipidemic compound, coenzyme A （CoA） capsule, combined use with statin, in Chinese patients with moderate dyslipidemia.

Although lowering cholesterol and low-density lipoprotein-cholesterol (LDL-C) is the mainstay of medical therapy for cardiovascular event prevention, evidence from clinical trials supports a role for elevated triglyceride (TG) and low high-density lipoprotein cholesterol (HDL-C) concentrations in the residual cardiovascular risk on statin treatment. Fenofibrate is the most commonly used agent to control hypertriglyceridemia as monotherapy or combining with statin, which lowers TG and raises HDL-C through multifaceted mechanism by PPARα activation. However, safety of coadministration of statin with fenofibrate has been a great concern, especially drug-induced hepatotoxicity when they are combined used. Coenzyme A (CoA) functions as an acyl group carrier and assists in transferring fatty acids from the cytoplasm to mitochondria. It is also involved in the oxidation and catabolism of fatty acids. Animal studies have proved its lipid-lowering effects. In a previous multicenter study we conducted in 2008, it was found that oral CoA 400U/d effectively lowered serum TG levels in hypertriglyceridemia patients without increasing adverse effects when compared with placebo. So, the present study was performed to further investigate the lipid-lowing effects and safety of CoA capsule combined with statin in dyslipidemia patients.

Eligibility Criteria:
Inclusion Criteria:

* TG 2.3～7.0mmol/l
* 18-80 years of age
* combined use with statins

Exclusion Criteria:

* pregnancy
* acute liver disease or hepatic dysfunction, as determined by levels of alanine aminotransferase (ALT) or aspartate aminotransferase levels (AST) more than 2-fold the upper normal limit
* nephrotic syndrome or serum creatinine (Cr) ≥2-fold the upper normal limit and creatine phosphokinase (CK) more than 3-fold the upper normal limit
* primary hypothyroidism
* psychiatric patients
* poorly controlled hypertension, as indicated by a Systolic Blood Pressure \>180 mmHg or Diastolic Blood Pressure \>110 mmHg
* using contraceptive agent
* using immunosuppressive drugs, prohibited medication or other non-statin lipid-lowing drugs
Concurrent DBS Local Field Potential Analysis and Stimulation in a Closed-Loop Neuromodulation Device

The purpose of this clinical study is to allow the investigation of local field potential (LFP) signals in patients treated with DBS of the STN. This study will identify common LFP biomarkers observed as a function of disease symptoms, medication effect, fluctuations in disease, and changes resulting from adjustments from current standard practices of DBS programming. The data collected and LFP markers identified will serve as guidelines for future stimulation predicted programming.

The goals of this study are to evaluate local field potentials (LFP) and associated beta, gamma and other band oscillations and their correlation with disease pathophysiology and clinical status of the patients, and to potentially determine a more objective biomarker of response to deep brain stimulation (DBS) treatment. This study aims to find evidence that changes in the power and coherence of the beta and gamma bands can be consistently linked to DBS adjustment and associated clinical effects. This approach can be of significant potential benefit to provide a foundation for closed loop DBS therapy in patients with continuous DBS adjustments.

This study will use a novel bi-directional neural interface system that can chronically and simultaneously record, sense, process and telemeter LFP signals from DBS electrode (Rouse et al. 2011) to study the stability and subsequent change to LFP linked to the clinical state relevant to the present disorder, and DBS stimulation at rest and during motor and cognitive tasks. This investigation will be conducted at the Ohio State University.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are candidates for DBS surgery.
* Age 22-90 years of age
* Participant is willing to comply with all follow-up evaluations at the specified study time points.
* Participant is able to provide informed consent prior to enrollment in the study.
* The participant is fluent in English.

Exclusion Criteria:

* Significant cognitive impairment or dementia.
* Uncontrolled depression, anxiety or other mood disorder.
* Medical contraindications for general anesthesia, craniotomy, or DBS surgery.
* Diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months.
* Condition requiring diathermy after DBS implantation.
* Subjects with any type of destruction and/or damage to the STN as determined by brain imaging.
* Co-morbid conditions that would interfere with study activities or response to treatment, which may include:
* Life expectancy \< 3 years
* Severe Chronic pulmonary disease
* Intractable seizure disorders
* Local, systemic acute or chronic infectious illness
* Life threatening cardiac arrhythmias
* Severe collagen vascular disorder
* Kidney failure or other major organ systems failures
* History of a neurological ablation procedure.
* Labeled contraindication for MRI.
* History of hemorrhagic stroke.
* History of HIV infection or ongoing chronic infection (such as tuberculosis). Participation in another FDA device or medication trial that would interfere with the current study.
A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet Formulation

The purpose of this study is to evaluate BMS-986165 tablet formulation versus BMS-986165 capsule formulation. This study will also evaluate the effect of a high-fat/ high-calorie meal and increased gastric pH on the BMS-986165 tablet formulation.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be willing and able to complete all study-specific procedures and visits
* Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations
* Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening
* Normal renal function at screening

Exclusion Criteria:

* Women of childbearing potential not using an effective contraceptive method or are breastfeeding
* Any significant acute or chronic medical illness
* History of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months
* History of headaches related to caffeine withdrawal, including energy drinks
* History of syncope, orthostatic instability, or recurrent dizziness
* Active TB requiring treatment or documented latent TB within the previous 3 years

Other protocol defined inclusion/exclusion criteria could apply.
Bioavailability of Ibuprofen Enantiomers Compared With Standard Brufen Sirup in Healthy Male Volunteers

Pharmacokinetics (relative bioavailability), safety and tolerability


Eligibility Criteria:
Inclusion Criteria:

* Healthy males from 21 to 50 years and within +-20% of their normal weight (Broca index)
* Written informed consent

Exclusion Criteria:

* Any findings of the medical examination or laboratory tests deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory (especially bronchial asthma and chronic obstructive pulmonary disease), cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of a drug with a long half-life (\>=24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
* Use of any drugs which might influence the results of the trial within seven days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to the start of the study
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse
* Drug abuse
* Blood donation (\>100 ml) within four weeks prior to administration
* Other disease or abnormality of clinical relevance
* Excessive physical activities within two weeks prior to administration or during the trial