cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Intervention of Eriocitrin in the Reduction of Hyperglycemia in Pre-diabetic Individuals

Supplementation with citrus bioflavonoids (hesperidin, naringin, diosmin and eriocitrin, among others) has been associated with an improvement in the glycidic and lipid profile, reduction of insulin resistance and systemic inflammation, and reduction of endothelial damage. This study aims to evaluate the effects of eriocitrin supplementation on the metabolic parameters of pre-diabetic individuals. Participants will be adults with pre-diabetes who will receive 200 mg / d of eriocitrin. Before, during and after treatment, anthropometric measures (weight, body composition and circumferences), biochemical (lipid and glucose profile, inflammatory parameters, endothelial markers, liver function, renal function) will be evaluated. Metabolic parameters that constitute risk factors for diabetes and associated chronic diseases are expected to be improved by supplementation with eriocitrin.

Individuals aged 35-60 years and who present at least one of the following criteria: (1) increased fasting blood glucose from 6.1 to 7.0 mmol / L, (2) decreased glucose tolerance of 7 , 8 to 11.1 mmol / L, and (3) glycated hemoglobin with values between 5.7 and 6.4% 10 will be eligible to participate in this study. The exclusion criteria will be to use hypoglycemic, hypolipidemic drugs, dietary supplements (vitamins, minerals, bioflavonoids, prebiotics, probiotics or other bioactive compounds), exercise intensely (more than 10 hours per week), history of cardiovascular diseases , diabetes mellitus, liver and kidney disease.

The selected individuals will be distributed randomly in 2 groups through random number generator program. Group A (n = 20) will receive 200 mg / d of eriocitrin for 12 weeks, with washout for 2 weeks and then receive 200 mg / d of placebo for 12 weeks; group B (n = 20) will receive 200 mg / d placebo for 12 weeks with washout for 2 weeks and then receive 200 mg / d placebo for 12 weeks.

The primary endpoint will be fasting blood glucose, blood glucose 2 hours after oral glucose tolerance test (GTTO), and HbA1c. The secondary endpoint will be insulin, HOMA-IR, total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, ALP, yGT, AST, ALT, TNF-α, IL-6, CRP, body weight, body mass index BMI), muscle mass, fat mass, body fat and waist-hip ratio, and macronutrient intake.

Eligibility Criteria:
Inclusion Criteria:

* 35-60 years
* Increased fasting blood glucose from 6.1 to 7.0 mmol / L or,
* Decreased glucose tolerance of 7 , 8 to 11.1 mmol / L or,
* Glycated hemoglobin with values between 5.7 and 6.4%

Exclusion Criteria:

* Use hypoglycemic, hypolipidemic drugs,
* Use dietary supplements (vitamins, minerals, bioflavonoids, prebiotics, probiotics or other bioactive compounds),
* Exercise intensely (more than 10 hours per week)
* History of cardiovascular diseases , diabetes mellitus, liver and kidney disease.
Longitudinal Analysis And Sample Collection To Evaluate PML Risk Host Markers for PML Risk Host Markers for PML Risk

The purpose of the study is to develop an improved understanding of the long term pharmacokinetics and pharmacodynamics of natalizumab with both standard dosing and extended dosing, and collect additional samples to explore cell-based biomarkers of natalizumab treatment and PML risk.

The underlying etiology for the association of natalizumab therapy to an increase risk of progressive multifocal leukoencephalopathy (PML) remains unknown. It is possible that persistently high natalizumab levels lead to sustained immune-modulation or suppression resulting in an increased PML risk. Since 2010 we have conducted three investigator initiated trials (IITs) at our center to measure serum natalizumab concentration, lymphocyte alpha 4 integrin saturation, and other biomarkers to understand the association of these markers to PML risk. A number of the patients who participated in these clinical trials are still infusing. These studies have demonstrated that plasma natalizumab concentrations continue to rise over time with a plateau effect not yet clearly delineated. Improved drug clearance in patients with higher body weight is described in the prescribing information. We have accumulated preliminary data suggesting that patients with lower body weight may be at higher risk for PML and that this may relate to higher drug concentrations and saturations seen in this group. Dose extension may be a viable option to lower drug concentration (pharmacokinetic, PK) and saturation (pharmacodynamic, PD) in patients with lower body weight to potentially impact PML incidence. In addition to the PK/PD of natalizumab, host related biomarkers may allow for more specific PML risk stratification. Further validation of these biomarkers is critical for our understanding of their utility.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand the purpose and risks of the study and provide signed and dated consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
2. Must be enrolled in the TOUCH Prescribing Program for Tysabri® (natalizumab) prior to informed consent.
3. In the opinion of the Principal Investigator, must be able and willing to comply with all study directions
4. ≥ 18 years of age at the time of informed consent

Exclusion Criteria:

1. In the opinion of the Principal Investigator, subject is unwilling or unable to comply with study directions.
2. Subject who is pregnant, breastfeeding, or likely to becoming pregnant during the course of the study. Women of child-bearing potential must be practicing an acceptable form of birth control.

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Voriconazole Trough Plasma Levels : Genetic Polymorphism, Efficacy, Safety in Patients With Hematologic Malignancy

Multiple factors are associated with a large variability in voriconazole exposure following standard dose administration, such as non-linear saturable pharmacokinetics, drug-drug interactions, liver disease, patient age, and genetic polymorphism of the metabolic enzymes.

Voriconazole is extensively metabolized by the human hepatic enzymes, primarily mediated by CYP2C19. The polymorphisms account for a relatively large portion of inter-individual variance observed in voriconazole plasma concentrations.

However, there are limited data on the relationships between voriconazole blood levels and clinical outcomes or safety in Asian populations.

The purpose of this study is to investigate the relationships of voriconazole blood levels with genetic polymorphism, safety, and clinical outcomes in immunocompromised patients with invasive pulmonary aspergillosis.

The investigators are trying to establish that routine clinical practice for voriconazole therapeutic drug monitoring can improve the efficacy and safety outcomes.

In Korean patients with hematologic malignancy, the investigators also want to propose the optimal dosing guideline of voriconazole with different genetic polymorphisms.

Eligibility Criteria:
Inclusion Criteria: all items below

* male or female ≥ 15 years of age
* immunocompromised patients with hematologic disorders
* patients received voriconazole due to treat proven, probable invasive (pulmonary) aspergillosis

Exclusion Criteria:

* severe hepatic dysfunction (t.bil, AST, ALT, ALP \> 5 x upper normal limit)
* who experienced hypersensitivity to azoles
* pregnant women
Point of Care Echocardiography Versus Chest Radiography for the Assessment of Central Venous Catheter Placement

A prospective study to compare the use of point of care echocardiography versus routine chest radiography for the assessment of central venous catheter placement.


Eligibility Criteria:
Inclusion Criteria:

* patients who require central venous catheterization in critical care environments (ICU, IMC)
* patients (or legal guardian) who provide written informed consents
* patients aged 18 years or older

Exclusion Criteria:

* patients who are unable/unwilling to give informed consent
Evaluation, Psychological Intervention and Follow-up Study of Anxiety and Depression in Stable COPD Patients

This study expect to investigate psychological intervention (Baduanjin qigong) in COPD patients combined with anxiety and/or depression.

Anxiety and depression is one of the most common complications of COPD patients.This research use psychological questionnaires to evaluate the stage of COPD patients with anxiety and/or depression(asymptomatic, subclinical，clinical). The subclinical type will divided into the treatment group of Baduanjin qigong，and the control group. Two groups are all receive the same psychological counseling, the treatment group also receive further treatment of Baduanjin qigong under the guidance of medical staff. The treatment along for 1 year. Two groups were followed up for 2 years, dynamically observe the stage of anxiety and depression,the number of exacerbations,lung function,etc.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed of COPD
* In stable phase
* FEV1%predicted \<80.

Exclusion Criteria:

* Cancer
* Severe cerebrovascular disease
* Severe arrhythmia,cardiac insufficiency
* Alzheimer's disease
* Mental illness
* Severe liver disfunction
* Severe renal disfunction
* Physical activity disable.
Compared Efficacy of Nurse-led and GP-led Geriatric Assessment in PrImary Care

Older patients account for around 10% of the population, of which 57% have a long-term illness, and 33% were admitted in the past year.

Geriatric assessment (GA) is a multidimensional assessment of general health status that can help identifying deficiencies and followed by a personalized care plan.

Assessment and management of elderly patients is a daily concern for the general practitioner (GP) but conflicting results have been reported so far relating to the clinical impact of GA when applied in the primary care setting.

This study protocol aims to assess the effect on morbi-mortality of a complex intervention in patients aged ≥70 years with chronic conditions in primary care. It aims to demonstrate that a GA adapted to primary care, followed by a personalized care plan and combined with successful interprofessional collaboration can improve clinically relevant outcomes in elderly patients with chronic conditions such as one-year overall mortality, unplanned hospital admission, emergency visits, or institutionalization.

The CEPIA study will also help addressing the issue of whether an improved benefit could be achieved from a systematic nurse-led or a case-by-case GP-led GA.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged≥70 years with a long-term illness scheme or hospital admission the past 3 months
* Visiting their preferred general practioner (GP) or another GP in the same practice
* patient oral non opposition

Exclusion Criteria:

* Patient who does not speak French
* Severe disease with a life expectancy \<12 months
* Institutionalized patients
* Patient insured under the French national health insurance system
A Study of CAR-T Cells in Subjects with Systemic Lupus Erythematosus

The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in Subjects with SLE.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, between 18 and 65 years old;
* Diagnosed with SLE according to 2019 EULAR/ACR SLE classifications;
* Positivity for ANA (titer≥1:80), and/or anti-dsDNA, and/or anti-Smith antibody at screening;
* SLEDAI-2K≥8 points (with a clinical SLEDAI-2K≥6 points) ;
* Patients who have used stable standard treatment regimen for at least 6 months in their medical history before screening, and their condition is still active for at least 2 months before screening.
* Good organ functions;
* Voluntary participates this trial and can comprehend and sign ICF.

Exclusion Criteria:

* Had or has active malignancy;
* Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
* Combined with other autoimmune disease that needs treatment;
* Pregnant or lactating women;
* Has other factors that deemed not suitable by investigator.
Single-Dose Hybrid Hyaluronic Acid and Sodium Chondroitin with Rehabilitation for Sports Adults with Knee Osteoarthritis

: This observational case-control study aims to evaluate the efficacy of a single-dose intra-articular injection of a hybrid purified hyaluronic acid with high molecular weight and sodium chondroitin of biotechnological origin, combined with rehabilitation treatment, in sports adults with moderate to severe knee osteoarthritis. Additionally, the study incorporates isokinetic testing to assess muscle strength and functional capacity.

The primary objective is to determine whether this combined treatment improves pain relief, functional capacity, and overall quality of life compared to rehabilitation treatment alone. Participants aged 18 to 50 years, diagnosed with knee osteoarthritis, will be recruited from clinics at the U.O.C. of Recovery and Functional Rehabilitation at A.O.U.P. P. Giaccone in Palermo. Participants will be divided into two groups: one receiving the hybrid hyaluronic acid and sodium chondroitin injection along with rehabilitation, and the other receiving only rehabilitation. The study will also utilize isokinetic testing to provide objective measurements of muscle strength and endurance.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 18 and 50 years.
* Radiologically confirmed diagnosis of knee osteoarthritis (Kellgren-Lawrence grade ≤3), present for at least 6 months.
* Persistent moderate to severe pain due to osteoarthritis, interfering with physical performance.
* Documented reduction in sports performance (use appropriate scales or tests to validate this).
* Lack of response to pharmacological or other conservative treatments.
* Willingness to provide written informed consent for participation.

Exclusion Criteria:

* Coexisting rheumatic diseases.
* History of intra-articular viscosupplementation in the target knee within the previous 6 months.
* Presence of significant venous or lymphatic stasis.
* Body Mass Index (BMI) ≥ 30 kg/m².
* Use of systemic or intra-articular corticosteroids in the target knee within the last 3 months.
* Chronic use of topical/systemic analgesics, NSAIDs, or narcotics.
* History of alcohol or drug abuse.
* Allergy or hypersensitivity to hyaluronic acid or any of its components.
* Pregnant or breastfeeding women, or those not using adequate contraception.
Collection of Patient-Reported Symptoms and Performance Status Via the Internet

This pilot clinical trial studies how well using the internet to collect symptoms and the ability to carry out daily activities works in patients with enrolled on Cancer and Leukemia Group B (CALGB) studies. A study that evaluates a patient's ability to use a clinic waiting room computer to report their symptoms and their ability to carry out daily activities may help doctors understand a patient's use of a computer to report symptoms.

This study enrolled participants who were diagnosed with breast cancer, lung cancer, colorectal cancer, leukemia and multiple myeloma and prostate cancer.

PRIMARY OBJECTIVES:

I. To assess the feasibility of collecting symptom data directly from patients at clinic visits via waiting-area computers.

II. To preliminarily assess the level of agreement between patient and clinician Common Terminology Criteria for Adverse Events (CTCAE) symptom severity scoring, and to measure whether their scores converge when clinicians are exposed to patient self-reports.

OUTLINE:

Patients are registered into the Symptom Tracking and Reporting (STAR) database, obtain a password, undergo STAR training, and complete a patient-STAR questionnaire after seeing their clinician (baseline self-report) on day 1 of course 2\* of chemotherapy. Patients are reminded to complete online STAR questionnaire before seeing their clinician on day 1 of courses 3, 4, 5, and 6\* of chemotherapy. Clinicians review these patient reports before creating their own assessment. Patients also complete a patient feedback survey on day 1 of course 4\* of chemotherapy. Clinicians complete feedback survey at study completion.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Enrolled on clinical trial CALGB-90401, CALGB-30607, CALGB-30704, CALGB-40601, CALGB-40603, CALGB-40502, CALGB-40503, CALGB-70604, or CALGB-80405

PATIENT CHARACTERISTICS:

* Able to read and comprehend English language text
* Able to see a computer screen (i.e., no visual impairments) or be accompanied at visits by someone who can read the screen for the patient

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Von Willebrand Disease.

The main objectives of the study were

* to compare the pharmacokinetics (PK) of Optivate® and Haemate P® in various types of vonWillebrand disease (VWD) using the results from the VWF: RCo, VWF:Ag, VWF:CBA and Factor VIII assays.
* to compare the clinical tolerance and safety of these two treatments after single IV infusions in subjects with VWD.


Eligibility Criteria:
Inclusion Criteria:

* Previously treated subjects of at least 12 years of age, with any type of VWD were eligible for entry into this study.

Exclusion Criteria:

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Molecular and Imaging Studies of Cardiovascular Health and Disease

Biobank is a program which collects biological samples, health information and imaging data from consented patients and stored them at the core facility. These information would be used to study the molecular, imaging and outcome studies of cardiovascular health and disease.

This program recruits patient from National Heart Centre Singapore and collects their biological sample, health information and imaging data.The donated biospecimens will be stored indefinitely and used for any future research on molecular, imaging and outcome studies of cardiovascular health and disease.The same biological samples and imaging data will be obtained from consented healthy volunteers for comparison.

Eligibility Criteria:
There is no inclusion/exclusion criteria except for the age limit as this is a repository program.

Inclusion Criteria:

•Subject aged ≥ 16 years and ≤ 90 years.

Exclusion Criteria:

•No
Verify the Safety and Effectiveness of the Cerclage Pessary in Prevention and Treatment of High-risk Preterm Pregnancy

Verify the safety and effectiveness of the cerclage pessary in the prevention and treatment of high-risk preterm pregnancy.

Prospective Open-label Multicentre Randomized Controlled Trial. high-risk preterm pregnancy is that there are at least one history of spontaneous preterm birth and/or late abortion before 34+0 weeks, for high-risk pregnant women that meet the inclusion criteria, the early treatment with cerclage pessary at 12-18weeks compare with routine treatment. The patients will be informed of the intended therapeutic effect and possible side effects. If they agree and after obtaining their informed consent, they will be randomized to test group (cerclage pessary group) and control group (Utrogestan group).

Eligibility Criteria:
Inclusion Criteria:

* Women with a pregnancy and a history of at least one spontaneous preterm birth before 34+0 weeks and/or a history of late abortion
* 12+0 -18+0 weeks of gestation
* Minimal age of 18 years
* Informed consent signature

Exclusion Criteria:

* The previous preterm delivery is iatrogenic proterm labor
* Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
* The pregnant woman with severe cervical erosion, cervical polyp, hemorrhage and the doctors think she could not use cerclage pessary
* The pregnant woman with uterine cervicitis
* The pregnant woman that has been confirmed premature birth
* Cerclage prior to randomisation
* Cerclage prior to randomisation
* Placenta previa totalis
* Active vaginal bleeding at the moment of randomization
* Spontaneous rupture of membranes at the time of randomization
* Silicone allergy
* Painful regular uterine contractions
* The pregnant woman have the indication of operation cervical cerclage
* Current participation in other RCT
A Study of a Novel Silicone Dressing to Minimize Scar Formation

Neodyne has developed an investigational dressing for post-operative incision care. Neodyne is conducting this research to study whether the investigational dressing, called the Neodyne Dressing, can minimize scar formation in a simple manner.

It is proposed to study a dressing designed to reduce scarring in post-incision skin tissue. It is expected that by managing the incision site during the healing phase, scar formation may be minimized.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have undergone a de novo abdominoplasty.
* Appearance of subject's incision is aesthetically similar across length of incision.

Exclusion Criteria:

* Subjects with a history of collagen vascular disease, cutis laxica, connective tissue disease, psoriasis, or lupus.
* Subjects diagnosed with scleroderma.
* Subjects with known adverse reactions to steri-strip tapes, medical tapes, or adhesives.
* Subjects with oozing, dehiscence, non-closed/healed incisions at time of first application.
* Subjects with inability to maintain adequate care of incision.
* Subjects with a body mass index (BMI) \> 30.
* Subjects with a weight loss of greater than or equal to 100 lbs within 6 months from date of abdominoplasty.
* Subjects who currently smoke.
* Subjects taking steroid therapy.
Effect of One Week Self-management Program in Patients With Fibromyalgia

The purpose of this study is to explore the effect of one week inpatient self-management program (SMP) in patients with fibromyalgia. The SMP is delivered as group education/activities by allied health professionals.

This study will determine if one week inpatient SMP can reduce FM symptoms and increase patients self-efficacy, health status, quality of life and being active health consumers.

The one-week SMP is designed to help people manage their rheumatic disease and challenges in daily life. The program has the same core concepts as outpatient programmes and comprises information, discussions on how to cope with the disease and daily life, cognitive management skills, exercise, engagement in self-care and interactions with healthcare professionals. During the program, the inpatient education unit takes up to 16 patients and 5 relatives per week within one diagnostic group. Each educational session lasts for 1.5-2.5 hours and the physical activity sessions for 0.5-1 hour. In the evening group sessions, the patients are divided into small groups of approximately five participants. They talk together for one hour under leadership of one health professional who is educated in coaching. The focus is on coping with the disease and daily life.

For the intervention group there will be a one year follow up study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Fibromyalgia outlined by the American College of Rheumatology for one year or more
* Between 20 and 70 years old
* Native Norwegian speaking
* Own wishes about participating the self-management program

Exclusion Criteria:

* Participated in the hospitals' SMP before
* Cognitive dysfunction
* Problems with sight and hearing that not can be compensated
* Mental disorders except light or treated depressions