cyrilzakka/clinical-trials huggingface dataset:
Determining Equivalence Dose for Oral Versus Sublingual Administration of Tacrolimus in Hepatic Receptors

After liver transplantation one of the most important cost, for both patients and their health insurance system, is immunosuppressive drug therapy. Tacrolimus (FK 506) is considered the cornerstone of immunosuppressive therapy in solid organ transplantation. Oral administration is the usual route, however, sublingual (SL) administration has been recently reported. This method of administration avoids first pass metabolism and allows an alternative route after transplant surgery, particularly in those patients who should extend the period of fasting (prolonged intubation, ileus, etc). Interestingly, in some studies, the dose of tacrolimus SL required to maintain similar plasma concentrations compared with oral administration, is significantly lower, even up to 50%, which can result in considerable savings in short and long term. Among these studies, only one was conducted in liver recipients. This study suggest that SL administration of tacrolimus could allow to obtain similar concentrations compared with oral administration. The design of this study did not assess the existence of differences in the dose required and only included six patients.

The patient will be scheduled fasting to liver transplant unit where the pharmacokinetic study was performed. After installation of the venous needle, blood samples will be collected on 4 ml tubes with EDTA as an anticoagulant at the following intervals of time in hours: 0 (immediately before the oral administration of tacrolimus); 0.5; 1.0; 1.5; 2; 4; 6; 9 and 12 h. post-dose. Once the blood samples taken, the tubes will be plugged, invest gently to mix with anticoagulant and stored at -20 ° C until analysis.

Subsequently, tacrolimus administration was change to sublingual route and dose was adjusted to obtain similar trough levels to those determined on per oral administration. The capsule be opened and its contents shall be deposited in the sublingual mucosa. To be ensure that drug will be absorted the patient will be instructed to insistently that after sublingual placement of the drug, should not swallow the capsule content for at least 15 minutes. The same pharmacokinetic study described for the oral route will be performed.

Breakfast will be administered 2 hours after ingesting the drug and lunch and dinner 6 and 10 hours after respectively. Fluid intake is discretionary.

Eligibility Criteria:
Inclusion Criteria:

* Outline of immunosuppression that includes tacrolimus dosing every 12 hours.
* Stable plasma levels of tacrolimus in 3 consecutive measurements.
* Stable blood tests: biochemical profile, creatinine and liver profile.
* Absence of treatment with drugs that have interaction with tacrolimus (antifungal and diltiazem) and use of grapefruit juice.
* Absence of active bacterial or viral infection and rejection episodes within 8 weeks prior.

Exclusion Criteria:

-
Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Pancreatic Cancer Patients

The purpose of the study is to assess the feasibility and participant satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides enhanced dietician access and nutrition support for participants living with pancreatic cancer who are receiving chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosed metastatic or newly recurrent pancreatic cancer or locally advanced pancreatic cancer
* Receiving chemotherapy under the guidance of Moffitt
* Able to speak and read English
* Able to provide informed consent

Exclusion Criteria:

* Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse).
* Undergoing concurrent treatment for a second primary GI cancer
* ECOG status of 2 or greater
* Use of parenteral or enteral nutrition
* Presence of malignant ascites
Adaptive Immune Response in Visceral and Subcutaneous Fat: Role in Human Insulin Resistance

The proposed study is designed to test the hypothesis that in human obesity, the balance of pro- and anti-inflammatory T cells in fat tissue is in fact related to macrophage phenotype and insulin resistance, and how it is related.

This study is needed to confirm whether conclusions based on studies of visceral adipose tissue in mice are indeed applicable to humans.

We also want to determine the relationship between insulin resistance/hyperinsulinemia and ability to lose weight in obese individuals.

Previous studies have found convincing evidence of the relationship between insulin resistance, T cell profiles, macrophage profiles and inflammation of the fat cells. This study will add human subjects to that body of evidence.

Overview Aim 1: Test the hypothesis that the balance of anti- inflammatory vs proinflammatory T cells is protective for systemic insulin resistance. T cell profiles in subcutaneous and visceral tissue and blood will be compared in IR vs IS obese humans at baseline and potentially after 12 months following weight loss. Tcell profile will be evaluated for relationships with IR and inflammation, with adjustment for total body fat. Secondarily, they will be evaluated for relationship to adipose cell size.

Overview Aim 2: Test the hypothesis that macrophage phenotype in adipose tissue is associated with T cell profile and IR. Frequency of macrophage phenotypes (M1 vs M2) will be analyzed in IR vs IS obese humans at baseline and potentially after 12 months following weight loss.

Overview Aim 3: Testing the hypothesis insulin resistance is associated with T cell receptor phenotypes in subcutaneous and visceral tissue. IR and IS subjects will be evaluated at baseline by sequencing of expressed TCRs in paired SAT, VAT, and blood. We will determine whether TCR phenotypes are shared between different IR individuals.

Eligibility Criteria:
Inclusion Criteria:

* Current patients of Stanford Healthcare, Bariatric Surgery Clinic, scheduled to undergo bariatric surgery (sleeve or RYGB)
* BMI 30-55kg/m2
* 30-65 years of age
* good general health, no major organ disease
* non-diabetic by current American Diabetes Association (ADA) criteria (fasting glucose \<126mg/dl)

Exclusion Criteria:

* Subjects with any clinical or biochemical evidence of significant anemia, gastrointestinal, cardiac, hepatic or renal disease will be excluded.
* Subjects with other medical problems may participate as long as the problems are stable.
* Subjects with active psychiatric disorders or past history of bariatric surgery
* Pregnant or lactating women will also be excluded from the study, due to possible risk to the fetus or infant.
Modifying Virtual Reality Analgesia With Low-Dose Pain Medication

The purpose of this study is to determine how pain relief is modified when the investigators combine the Virtual Reality based Snow World game with certain pain medications.

This is a randomized, double-blind, placebo-controlled, within subject 2x2 factorial, repeated measures study. Research participants will play two versions of the Virtual Reality based video game "Snow World" and be given thermal and electrical stimulus. Each of two study visits will be identical with the exception of whether or not the participant will receive an iv infusion of a low dose pain medication or a saline placebo.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and females between the age of 18 and 60 years
* Ability to communicate orally
* Ability to read and understand English
* Body Mass Index between 20-35

Exclusion Criteria:

* Women who are pregnant, trying to become pregnant, or who are breastfeeding
* History of alcohol or substance abuse
* Major medical illness; including history of migraine headaches, seizures, brain injury, or peripheral neuropathy
* Current use of analgesics including acetaminophen, non-steroidal anti-inflammatories, or opioids
* Predisposition to severe motion sickness
* Unusual sensitivity or lack of sensitivity to pain
* Urine toxicology positive for opioids or benzodiazepines
Evaluation of Efficacy and Safety of Single and Multiple Therapy of Herbal Medicine/Chuna Therapy on Non-specific Chronic Low Back Pain: A Study Protocol for Multicenter, 3-arm, Randomized, Single Blinded, Parallel Group, Incomplete Factorial Design, Pilot Study -

The Purpose of this trial is to investigate the efficacy and safety of herbal medicine with manipulation therapy on Korean Patients with Chronic Low Back Pain


Eligibility Criteria:
Inclusion Criteria:

* Inpatients with chief complaint of low back pain in oriental rehabilitation medical center
* Age 19 - 65
* Patients who have 4 \~7 cm of VAS pain score;
* Ability to have normal communication
* Ability to give informed consent

Exclusion Criteria:

* Patients with pain duration of 3 months or less
* Patients with progressive neurologic deficit or severe neurologic symptoms by SLR test
* Patients diagnosed with serious pathology(s) which may cause low back pain (e.g. spinal metastasis of tumor(s), acute fracture, etc)
* Patients with spondylolisthesis or spondylolysis(diagnosed with grade II or higher level)
* Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results
* Patients with history of spinal surgery
* Patients with more severe pain than pain caused by low back pain
* Those who do not (cannot) abide by treatment and follow up due to the mental illness such as behavior disorder, depression, anxiety neurosis etc.
* Patients with history of Medical Malpractice Case
* Patients with treatment history of low back pain within 1 month either KM or WM
* Patients participating in other clinical studies within 3 months
* Pregnant patients or patients with plans of pregnancy or lactating patients
* Patients disagree to sign the informed consent form
* Patients deemed unsuitable for participating the trial by the researchers
Therapeutic Alliance is it Associated With Better Compliance Amongst Children With Juvenile Idiopathic Arthritis ?

to evalute if therapeutic alliance is related to adherence in JIA

The therapeutic alliance is the agreement that is being built between doctor and patient during the construction process of care. So active collaboration based on a shared assessment of issues and agreement on possible solutions. Initially described in psychiatry, this analytical concept has been extended to several chronic diseases in particular requiring more often a strong link between doctor and patient. His measure is important since it has been demonstrated by several previous studies that the therapeutic alliance is predictive of the therapeutic effects of treatment. This alliance, however, was little studied in juvenile idiopathic arthritis, its connection with the observance or the quality of life has never been evaluated.

The chronic nature of juvenile idiopathic arthritis (JIA) requires a strong ability of the child to follow his treatment, where the role of parents going to be important and where the relationship built with the caregiver is also essential.

Adherence is a complex concept for which there is no ideal measure. Direct evaluation criteria such as bioassays prove still incomplete and difficult to implement in observational studies. Indirect measures have been developed through self-administered questionnaires and literature showed their relatively good correlation with actual catches. The innovative hypothesis of this research is that a better therapeutic alliance is associated with better adherence child in JIA.

Eligibility Criteria:
Inclusion Criteria:

* Patients with JIA (see classification above)
* Aged at least 8 to 18 years.
* Having already seen more than 2 times in consultation with the referring physician will even include the child in the study so that the alliance could build process
* Children can read, understand and complete questionnaires
* No opposition made

Exclusion Criteria:

* Systemic form of JIA;
* Children aged under 8 years old or over 18 years;
* Child or parent does not understand French
* Refusal of participation
Side Pole Static Ankle Foot Orthosis in Children With Neurological Disorders

Transverse-plane foot deformities are a frequently encountered issue in children with neurological disorders. They are the source of many symptoms, such as pain and walking difficulties, making their prevention very important. It is thus important to prevent the occurrence of transverse-plane foot deformities and limit their development regarding the high risk of morbidity. In order to prevent such deformities, in the department of pediatric physical medicine and rehabilitation department of Lyon, since 2001 the investigator use a side pole static ankle foot orthosis (SPS AFO) in children with a neurological disorder predisposing such deformities. The aim of the study this study is to describe the use, tolerability and potential side effects of this orthosis in children with neurological disorders from the investigator's department


Eligibility Criteria:
Inclusion Criteria:

* regularly follow-up in the department of physical medicine and pediatric rehabilitation L'Escale (Lyon, France)
* presenting at least unilateral transverse-plane foot deformity within the context of a neurological disorder
* having a first prescription of SPS AFO between December 2001 and December 2011.

Exclusion Criteria:

* None
NUtraceutical TReatment for hYpercholesterolemia in HIV-infected Patients

The effects of a nutraceutical combination (NC) containing low-dose monacolin K and berberine on lipid profile, proprotein convertase subtilisin/kexin type 9 (PCSK9), subclinical inflammation and arterial stiffness were investigated in human immunodeficiency virus (HIV)-infected patients receiving stable antiretroviral therapy (ART).

This is a crossover interventional study of 26 HIV-infected patients on stable ART with low density lipoprotein cholesterol (LDL-C) \>100 mg/dL, not receiving any lipid-lowering treatment. After a 3-week lipid stabilization period with a standardized diet regimen, the effect of a 3-month oral NC containing red yeast rice-derived monacolin K 3 mg, berberine 500 mg, policosanol 10 mg, astaxanthin 0.5 mg, folic acid 0.2 mg and coenzyme Q10 2 mg vs no active treatment (noNC) was tested on plasma total cholesterol (TC), LDL-C, high density lipoprotein cholesterol (HDL-C), triglyceride, lipoprotein(a), PCSK9, high-sensitivity C-reactive protein (hsCRP) levels and aortic pulse wave velocity (aPWV).

Eligibility Criteria:
Inclusion Criteria:

* LDL-C \>100 mg/dL
* no history of cardiovascular disease
* stable ART for at least 6 months

Exclusion Criteria:

* current or recent (≤6 months) treatment with lipid-lowering drugs
* chronic kidney disease \[estimated glomerular filtration rate (GFR) \<60 ml/min\]
* liver impairment (AST and/or ALT \>3 times upper limit of normal)
* current pregnancy
* opportunistic infections within the past 3 months,
* having received an organ transplant/immunosuppressive therapy
A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial

To compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy to an assigned open label antidepressant therapy (ADT) in the proposed subject population with MDD.

This is a trial designed to assess the safety and efficacy of brexpiprazole (flexible dose) as adjunctive therapy to an assigned known anti-depressant in depressed subjects. The trial consists of a continuous 18-week double-blind treatment period with a 30-day follow-up. Subjects who complete all trial visits through the Week 18 visit may be offered entry into an optional open-label rollover trial.

Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
* Subjects with both a diagnosis of MDD, and in a current major depressive episode, as defined by DSM-IV-TR criteria
* Subjects willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts prior to and during the trial period.

Exclusion Criteria:

* Females who are breast-feeding and/or who have a positive pregnancy test result during screening prior to receiving trial medication
* Subject has a current Axis I (DSM-IV-TR) diagnosis of: dementia, Schizophrenia, Bipolar, Eating disorder , Obsessive-compulsive disorder, Panic disorder, Posttraumatic stress disorder
* Subjects experiencing hallucinations, delusions or any psychotic symptomatology in the current major depressive episode.
* Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days
* Subjects currently treated with insulin for diabetes.
* Subjects with uncontrolled hypertension
* Subjects with known ischemic heart disease or history of myocardial infarction, congestive heart failure, angioplasty, stenting, or coronary artery bypass Surgery
* Subjects with a positive drug screen for cocaine, marijuana, or other illicit drugs
* Inability to swallow tablets or tolerate oral medication
* Abnormal laboratory test results, vital signs and ECG results
* Subjects who previously participated in any prior brexpiprazole clinical trial.
Longitudinal Pattern of Streptococcus Pneumoniae Nasopharyngeal Carriage and Antimicrobial Susceptibility in Healthy Children Aged Less Then 5 Years, in the Area of Milan and Surroundings, Lombardy, Italy.

The objective of this active surveillance study is to make available crucial data about epidemiology, serotype distribution, and longitudinal pattern of antibiotic susceptibility of nasopharyngeal strains of Streptococcus pneumoniae carried in the population of healthy children aged less than years and living in the area of Milan and surroundings, Lombardy, Italy.

* To estimate the nasopharyngeal carriage rate and longitudinal pattern of Streptococcus pneumoniae in healthy children aged less than 5 years living in the area of Milan, Italy;
* To describe the circulation of antimicrobial non-susceptible Streptococcus pneumoniae strains in healthy children aged less than 5 years

Secondary objectives:

* To describe the nasopharyngeal carriage distribution of Streptococcus pneumoniae strains in healthy subjects less than 5 years old;
* To examine the role of risk factors in the Streptococcus pneumoniae carriage rate in healthy children;
* • To evaluate the possible impact of vaccination policy in the referenced population.


Eligibility Criteria:
Inclusion Criteria:

* To estimate the nasopharyngeal carriage rate and longitudinal pattern of Streptococcus pneumoniae in healthy children aged less than 5 years living in the area of Milan, Italy;
* To describe the circulation of antimicrobial non-susceptible Streptococcus pneumoniae strains in healthy children aged less than5 years

Exclusion Criteria:

* To describe the nasopharyngeal carriage distribution of Streptococcus pneumoniae strains in healthy subjects less than 5 years old;
* To examine the role of risk factors in the Streptococcus pneumoniae carriage rate in healthy children;
* To evaluate the possible impact of vaccination policy in the referenced population..
Metabolic Adaptation to Diabetes

Hypoglycemia or low blood sugar is a very serious complication that diabetics experience. This is of great concern because there is a lack of available information of how Non Insulin Dependent Diabetic Mellitus patients (NIDDM) defend themselves against a low blood sugar. This is particularly disturbing since NIDDM patients are likely to require intensive treatment, and as a result, the risks of severe hypoglycemia to the NIDDM patient increase. The current proposal aims to provide information on how NIDDM patients can defend themselves against hypoglycemia, thus decreasing their risks for this severe complication.

There is very little data available on the neuroendocrine response to hypoglycemia in intensively treated (sulfonylurea or insulin) NIDDM patients. The data that are available on the neuroendocrine response to hypoglycemia in NIDDM patients were obtained under conditions following a single IV bolus of insulin or single SQ regular insulin injection. The neuroendocrine response following a large IV bolus of insulin differs greatly from the clinical paradigm of a slow progression into hypoglycemia. Therefore, clinically relevant data cannot be obtained from short experiments involving rapid changes in plasma glucose levels and insulinemia. Furthermore, a comparison between neuroendocrine responses to hypoglycemia in NIDDM and normal man is not available due to the fact that glycemia has never been equally controlled. In short, virtually nothing is known about the neuroendocrine response to hypoglycemia in these subjects. This is of great concern as following the positive outcome of the Kumamato study, large numbers of NIDDM subjects are going to receive intensive therapy with all its altendent risks of severe hypoglycemia. The Kumamato study was a trial in NIDDM patients to determine if intensive therapy reduces tissue complications of diabetes. Similar to the results of the Diabetes control and complications trial in IDDM patients the Kumamato study proved that intensive therapy in NIDDM patients also prevents diabetic tissue complications. Therefore, the goals of this study are 1) to define in greater detail how the body defends itself against hypoglycemia in NIDDM patients and 2) to determine if differing levels of insulin affect hypoglycemic counterregulation in NIDDM patients.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects aged 30-65 years
* Male and female non-insulin-dependent diabetic patients, sulfonylurea and/or Metformin aged 30-65 years

Exclusion Criteria:

* Prior or current history of poor health
* Abnormal results following screening tests
* Pregnancy