cyrilzakka/clinical-trials huggingface dataset:
A Study of The Excretion Balance, Pharmacokinetics and Metabolism of A Single Oral Dose of [14C]-Labeled RO4917523 in Healthy Male Volunteers

This single-center, open-label study will assess the excretion balance, pharmacokinetics and metabolism of oral \[14C\]-labeled RO4917523 in healthy male volunteers. Subjects will receive a single oral dose of \[14C\]-labeled RO4917523 and an intravenous tracer dose of \[13C\]-labeled RO4917523 on Day 1. In-clinic period will be up to 18 Days. Anticipated time on study is up to 15 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male adults, 18 to 65 years of age inclusive
* Body mass index (BMI) 18.0 to 32.0 kg/m2
* Healthy, as judged by a physician on the basis of a medical history, general physical examination, laboratory tests, vital signs and 12-lead ECG
* Medical history without major pathology
* Agree to use two effective methods of contraception with their partners, including one barrier method (e.g. condom) throughout the study and for up to 3 months after the last dose of study drug

Exclusion Criteria:

* History of relevant drug and or food allergies
* Smoking (within 60 days prior to drug administration until the follow-up visit)
* History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
* Participation in a drug study within 60 days preceding first administration of study drug; participation in more than 3 other drug studies within 10 months preceding the first administration of study drug
* Infrequent bowel movements (less than once per 2 days)
* Participation in another ADME study with a radiation burden \>0,1 mSv in the period of 1 years before the start of the study
* Positive screen for drugs of abuse
* Average intake of more than 24 units of alcohol per week
* Positive for hepatitis B, hepatitis C or HIV infection
Optical Coherence Tomography Angiography and Choroidal Osteoma

This study evaluates the vessel density of choriocapillary vascular network in eyes affected by choroidal osteoma and in eyes complicated by choroidal neovascularization, using optical coherence tomography angiography.

The choroidal osteoma is a rare benign tumor of choroid, it is bilateral in 10%-25% of cases, affecting usually young women. Previous studies evaluated the morphologic characteristics of tumor-related vasculatures, described as a seafun vascular networks, but none focused on study of vessel density of coriocapillary.

The aim of this study is to investigate the potential role of the optical coherence tomography angiography (OCTA) in evaluating the choriocapillary vessel density in order to individuate the changes of this vascular network that may influence the onset of choroidal neovasculariztion.

Therefore, OCTA could be useful in the clinical management of the choroidal osteoma

Eligibility Criteria:
Inclusion Criteria:

* age older than 50 years
* diagnosis of choroidal osteoma
* absence of history of vitreoretinal and vascular retinal diseases

Exclusion Criteria:

* age younger than 50 years
* no diagnosis of choroidal osteoma
* presence of history of vitreoretinal and vascular retinal diseases
Evaluation of Plasmatic Levels of Busulfan in Patients Undergoing Hematopoietic Stem Cell Transplantation

The purpose of this prospective study is evaluate the best dose of busulfan for each patient undergoing Haematopoietic Stem Cell Transplantation

* Busulfan is an alkylating antineoplastic agent used commonly during the conditioning regimen in patients undergoing Haematopoietic Stem Cell Transplantation (HSCT). Due to the fact that this drug has a variable metabolism in different individuals, the investigators performed the plasmatic dosage of chemotherapy before starting the conditioning regimen (test dose) as a way to predict the best dose to them during the conditioning. Busulfan toxicities depends on the "Area Under Curve" and Concentration Steady State (CSS).
* The investigators randomized in groups according to the route of drug administration: per oral and intravenously. Dose test will be performed before conditioning and othe pharmacokinetics (Pk) study will be made in the first day of conditioning. The test dose of P.O busulfan will be 1 mg/Kg/dose and 32 mg/m2 for I.V busulfan. The target dose of busulfan during the conditioning will depends on the Pk obtained during the test dose. In the first day of regimen, other samples will be analysed and the new AUC will be adjusted. We will have a control group who have never performed monitoring before (retrospective group)
* Test Dose for oral busulfan will be performed with peripheral blood samples at the time: 0h (before taking busulfan), 30', 1h, 1,5h, 2h, 3h, 4h, 5h and 6h. In the first day of conditioning other samples will be collected again in the same moments.
* Test dose for I.V busulfan will be performed on time 0h, 30', 45', 1h, 2h, 3h, 4h, 5h, 6h and 8h after receiving I.V busulfan. If the patients will receive I.V busulfan during conditioning, the blood samples should be collected on time 0h, 30', 1h, 2h, 3h, 4h, 5h, 6h, 7h and 8h after taking busulfan. The blood samples will be centrifuged (4º C/ 3200 rpm/10 minutes) and analysed.
* Patients will be monitored with pharmacokinetic's drug and clinical outcomes. The investigators will evaluate acute and chronic toxicities after Stem Cell Transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hematologic or non-hematologic pathology using as part of the conditioning regimen busulfan;
* Men, women and children regardless of age;
* Performance Status\> 80 or ECOG \<2;
* Total bilirubin \<2 mg / dl and transaminases \<3 times the upper limit of normal;
* Creatinine \<1.5 mg / dl;
* LVEF\> 50% by echocardiogram or MUGA at rest;
* Pulmonary function test with FEV1\> 70%;
* Consent form signed before the start of any specific procedure.

Exclusion Criteria:

* Presence of infectious process in uncontrolled activity;
* Presence of psychiatric disorder;
* Pregnancy;
Validation of Wrist Type Oscillometric Blood Pressure Monitorings

Since the wrist devices have the advantage of being smaller, lighter, and more inexpensive than the upper arm devices, wrist devices become increasingly popular. However, it is of utmost importance to ensure that the BP measuring device can measure BP accurately. This study will be aimed to validate a wrist type oscillometric blood pressure monitoring with reference to the brachial blood pressure measured by auscultatory method with a mercury sphygmomanometer.

High blood pressure (BP) is one of the major cardiovascular risk factors in adults. Home blood pressure monitoring is superior to office-based measurements for prediction of the future development of cardiovascular diseases and is recommended by major guidelines. To monitor BP at home, patients can use devices that measure BP either at the arm or at the wrist.

Among BP monitors, the wrist device is relatively easy to use, as the cuff can be used with one hand easily and correctly around the wrist than around the arm, and undressing is not necessary. Since the wrist devices have the advantage of being smaller, lighter, and more inexpensive than the upper arm devices, wrist devices become increasingly popular. However, it is of utmost importance to ensure that the BP measuring device can measure BP accurately. To make sure the performance of these devices, several guidelines have proposed protocols to validate these devices. This study will be aimed to validate a wrist type oscillometric blood pressure monitoring with reference to the brachial blood pressure measured by auscultatory method with a mercury sphygmomanometer.

Eligibility Criteria:
Inclusion Criteria:

* above 12 years old

Exclusion Criteria:

* unclear Korotkoff sounds
* wrist circumference outside of the designated range (13.5-23 cm)
* arrhythmias
WILSTIM - DBS (WILson STIMulation - Deep Brain Stimulation)

Dystonia in Wilson's disease represent a major issue. The persistence of disabling motor symptoms despite medical treatments justifies conducting a study on deep brain stimulation (DBS) in Wilson's disease (WD). For bradykinetic patients, subthalamic nucleus (STN) could be considered as a better target than the globus pallidus (GPi). For patients with hyperkinetic dystonia, the internal globus pallidus (GPi) will be chosen as the target of DBS.

The investigators hypothesize that STN DBS will improve Wilson's disease patients, who, despite copper chelators drugs, are still impaired by severe dystonia and akinesia (more or less associated with other movement disorders).

The investigators primary objective is to demonstrate the efficacy of STN/GPi DBS on dystonia associated with Wilson's disease.

Secondary objectives:

* To evaluate the impact of STN/GPi DBS on other movements disorders (tremor, Parkinsonism, chorea) observed in Wilson's disease.
* To describe cognitive status of patients and to evaluate the consequences of STN/GPi DBS on cognition and behavioral aspects of the disease.
* To evaluate the consequences of the stimulation on speech and swallowing.
* To evaluate the social impact of STN/GPi DBS in Wilson's disease.
* To evaluate the safety of STN/GPi DBS in the specific context of Wilson's disease.

4 periods of stimulation on and off, sequence randomized at Day 0.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 and \< 60 years.
* Severe neurological form of Wilson's disease with predominant dystonia and akinetic-rigid syndrome, despite optimized treatment stabilized for at least 6 months.
* Important disability due to abnormal movements (Rankin score=2 to 4).
* Absence of dementia (MMS \> 24 and BREF \> 15).
* Stable psychiatric status and absence of severe depression (BDI \<28).
* Social security coverage.
* Signature of informed consent. (signature of legal guardian for subjects under protection)

Exclusion Criteria:

* Severe hepatopathy with coagulation disorders (Platelet count \< 100 G / l; INR \> 1.5; V factor deficit; low level of fibrinogen \< 1g/dL; increased of fibrin degradation products; low level of antithrombin).
* Liver transplanted patients \< 2 years
* Patients under immunosupressive drugs and corticoids regimen.
* Participation to another biomedical research involving any drugs.
* Severe and uncontrolled psychosis or depression.
* Major atrophy on brain MRI that could represent a problem for leads implantation.
* Necrosis of the STN/GPi on brain MRI.
* Female subjects who are pregnant or lactating.
Outcomes From an Asthma Disease Management Program

Disease management is used to manage patients who have asthma and who are enrolled in a managed care health plan. To understand the effect of disease management on asthma severity and utilization, the investigators at Children's Mercy Hospitals and Clinics, will review data from a Medicaid Health Maintenance Organization (HMO) to determine the number of health plan members with different asthma severities and what their outcomes are. This will help us to improve the service provided to these patients. The investigators wish to publish this so that other health plans can benefit from the investigators experience.

Disease management is used to manage patients who have asthma and who are enrolled in a managed care health plan. To understand the effect of disease management on asthma severity and utilization, we will review data from a Medicaid HMO to determine the number of health plan members with different asthma severities and what their outcomes are. This will help us to improve the service provided to these patients.

Data on subjects already exists in the Health Management database. We will use data that has been collected between January 1, 2000 and August 18, 2005. We will use a convenience sample consisting of available subjects meeting the program criteria. The total FHP database includes approximately 50,000 members from which approximately 6,000 have been identified as having asthma.

We will create a research database that will not contain any patient-specific data. Instead, an intermediate workstation will be programmed to query the health management database and send the resulting aggregated and de-identified data to the research database for analysis on another workstation. The research database will never contain any patient identifiers nor will it contain individual patient data. It only will contain aggregated data provided by the intermediate query workstation.

Here is a complete list of variables that will be housed in the research database for subsequent analysis:

Categorical variables: Asthma severity (intermittent, mild, moderate or severe persistent), Provider office, Quarter when seen, Medication type (controller or reliever), Age category (0-4, 5-9, 10-17, \>17years), active status (active or inactive), Location (ER, Inpatient, Routine visit), Case managed (yes, no), Gender, Psychosocial issues, Diagnosis (asthma, not asthma)

Continuous variables: Cost of care, Number of visits, Number of prescriptions, Number of members in the above categories, Mean Quality of life

Eligibility Criteria:
Inclusion Criteria:

* Health plan members who have undergone disease management and who have a diagnosis of asthma (ICD9 code of 493.xx)
Study of Combined Therapy of Aspirin and "IVIG-SN" in Kawasaki Disease

The purpose of this study is to evaluate the safety, efficacy and of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with kawasaki diseases.

This clinical trial was designed as a multicenter, single-arm, and open-label clinical trial.

Evaluate the incidence of coronary artery lesions in the 7th week of IVIG-SN administration, compared to the incidence of coronary artery lesions among untreated Kawasaki patients, to prove the superior efficacy of IVIG-SN.

Eligibility Criteria:
Inclusion Criteria:

1. Pediatric patients aged 6 months - 5 years
2. Case definition for complete KD: Fever (≥ 38.5°C) for ≥ 5 days (but less than 10 days), 4/5 standard clinical criteria
3. Case definition for incomplete KD: Fever ≥ 5 days(but less than 10 days) and 3 clinical criteria plus coronary artery lesion on echocardiogram.
4. Subjects whose parents or legally acceptable representative (LAR) gave voluntary written consent to participate in this clinical trial

Exclusion Criteria:

1. Those whose blood test results show abnormalities of significance as follows : Platelet count \< 100,000/mm3, WBC count \<3,000 cells/mm3,Those whose hemogloblin, hematocrit or red blood cell count exceed 30% of the upper limit of the normal range or are 30% below the lower limit of the normal range.
2. Those who have been administered other clinical product in the last 30 days after this clinical trial commenced
3. Those who have been administered TNF alpha or steroid within 48 hours after being administered the test product
4. Those who plan to be inoculated with live vaccine during the clincial trial period
5. Those considered difficult to participate in clinical trial due to serious chronic diseases(e.g., cardiovascular diseases except controllable hypertension, diseases of the respiratory system concurrent with respiratory failure, metabolic disease, kidney dysfunction, hemoglobinopathy, etc.)
6. Those who have been administered an immunosuppressant or immune modifying drug in the last 3 months before the innoculation with the test product
7. Those who are HIV-positive or have immune dysfunctions including immunodeficiency
8. Those who have previously exhibited hypersensitivity or shock to IVIG agents
9. Patients with underlying liver disease or liver dysfunction with known etiology.
10. Patients with kidney dysfunction, whose Creatinine level is found to be over 2 times higher than the upper limit of the normal ranges in a screening test
11. Those who have -- or previously had -- a malignant tumor
12. Those who have previously been diagnosed with IgA deficiency
13. Those found unsuitable for undergoing the tests
Insights Into Participating in Clinical Studies for Anorexia

Clinical trials centered on anorexia serve a pivotal function in assessing the safety and effectiveness of emerging treatments for this condition.

The primary aim revolves around meticulously scrutinizing both trial completion rates and instances of voluntary withdrawal within specific patient cohort.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* Diagnosis of anorexia
* No prior treatment for anorexia

Exclusion Criteria:

* Pregnant or lactating women
* Any serious and/or unstable pre-existing medical disorders
* Patients receiving any other investigational agents
Potassium-titanyl Phosphate (KTP) Laser vs KTP Laser and Ivermectin Cream for Facial Rosacea

Rosacea is a frequent chronic inflammatory disease affecting mainly the face but also eyes and scalp. Rosacea is classified into 3 types: erythemato-teleangiectatica, papulopustulosa and phymatosa. Treatments depend on the type and include topical and systemic antibiotics, azelaic acid, topical ivermectin, topical brimonidine, systemic isotretinoin as well as intense pulsed light (IPL) and laser therapies.

For treatment of telangiectasia and redness, laser and IPL therapies are the first choice. Vascular lasers, such as pulsed dye lasers (PDL) and potassium-titanyl phosphate (KTP) lasers as well as IPL, have demonstrated good efficacy in reduction of erythema and telangiectasias in patients with rosacea. However, these treatments are expensive and mostly not covered by the health insurance. Therefore, for patients it is important to receive the maximal effect and improvement after each single laser session.

Ivermectin is a semi-synthetic derivative of avermectin and has an anti-inflammatory effect as well as an antiparasitic effect on demodex mite. The latter is playing an important pathogenetic role in rosacea.

This randomized controlled study aims to compare the effect of KTP laser in combination with ivermectin 1% cream vs KTP laser alone in patients with facial rosacea.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick skin type I-IV
* Presence of facial erythematous rosacea or mild papulopustular rosacea with permanent erythema
* Informed consent signed

Exclusion Criteria:

* History of adverse events related to KTP laser therapy
* Pregnant or breastfeeding women
* Intention to become pregnant during the course of the study
* History of intolerance or allergic reaction to ivermectin 1% cream or one of the ingredients
* Ongoing treatment for skin cancer
* Ongoing treatment with strong inhibitors of P-glycoprotein (P-gp) and CYP3A4 (e.g., itraconazole, voriconazole, posaconazole, clarithromycin, cobicistat)
* Ongoing treatment with substances with a narrow therapeutic range whose excretion depends substantially on P-gp (e.g. digoxin, ciclosporin)
* Inability to understand the study content
Study Investigating Immunological Effects of Treatment for Chronic Hepatitis C Patients.

Aim

To evaluate the effects of peginterferon and ribavirin therapy on the immune response in chronic HCV genotype 1,2 or 3 patients before, during and after treatment.

Background

Treatment of chronic hepatitis C (HCV) has shown a remarkable success. However, genotype 1 patients have reduced response rates. A better understanding and improvement of these results can now be considered the greatest challenge.

In chronically infected patients, HCV-specific immune responses are generally weak, narrowly focused, and often dysfunctional. The presence of HCV-specific cells suppressing the immune response (regulatory T-lymphocytes=Treg) are able to suppress the immune response. These Treg are possibly responsible for the impaired immune response.

Previous studies have indicated increased Treg frequency and activity of immune regulating mechanisms, locally in the liver, as a result of HCV re-infection. Hence, these Data highlight the importance of monitoring intrahepatic immune responses in addition to peripheral immune responses. Using the minimally-invasive technique of fine-needle aspiration biopsy (FNAB), it is now possible to obtain safe and frequent liver samples to monitor local antiviral immune responses in chronic HCV patients during antiviral therapy.

Rationale and hypothesis of the study

Our previous studies and current literature support the concept that Treg may contribute to HCV persistence by suppressing HCV-spec immune responses. The current study is designed to examine if peginterferon and ribavirin therapy affects the activity of Treg and DC, and if this results in enhanced HCV-specific immune responses.

Design

Single centre, translational and observational open label study with one arm of 20 genotype 1 patients and one arm of 7 genotype 2/3 patients.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between 18-70 years of age, with evidence of a chronic hepatitis C - Genotype 1,2 or 3 infection.
* No previous treatment with, peginterferon or conventional interferon plus ribavirin combination therapy.
* Indication for antiviral therapy of hepatitis C according to current clinical guidelines.
* Written informed consent.

Exclusion Criteria:

* History or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigators, unsuitable for the study.
* Presence of contra-indications for antiviral therapy with peginterferon or ribavirin.
Intestinal Barrier Function and Liver Cirrhosis

Patients with liver cirrhosis have an increased risk to develop life-threatening complications such as spontaneous bacterial peritonitis (SBP). Impairment in the intestinal barrier, changes in numbers and composition of the intestinal microbiota and alterations in immune defenses have been suggested to be involved in liver cirrhosis and its complications. Dysfunction in the intestinal barrier for example results in the ongoing passage of toxic substances from the gastrointestinal tract that may damage the liver, leading to oxidative stress, inflammation and eventually liver cirrhosis. In addition, bacterial translocation is considered a key step in the development of spontaneous infections, mainly SBP, in patients with liver cirrhosis.

The investigators hypothesize that patients with decompensated liver cirrhosis have a more impaired intestinal epithelial barrier and altered intestinal microbiota than patients with compensated liver cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis of any cause
* A score of greater-than or equal to 5 assessed according to the Child-Pugh classification
* Age between 18 and 65 years

Exclusion Criteria:

* Known gastrointestinal diseases (such as inflammatory bowel disease and celiac disease), chronic renal disease (i.e. a glomerular filtration rate of less-than or equal to 60 ml/min per 173 m2 estimated from the Modification of Diet in Renal Disease (MDRD) equation) or Diabetes Mellitus
* Major abdominal surgery interfering with gastrointestinal function (except for uncomplicated appendectomy, cholecystectomy and hysterectomy, other surgery upon judgement of the principle investigator)