cyrilzakka/clinical-trials huggingface dataset:
Bioavailability of Flavonoids and Phenolic Acids From Cranberry Juice Cocktail in Healthy Older Adults

This is a single-dose, pharmacokinetic study investigating the bioavailability of flavonoids and phenolic acids from cranberry juice cocktail and their breakdown products (in vivo metabolites) in healthy, older adults. Our hypothesis is that the compounds will be poorly but rapidly absorbed from the intestines and found in plasma and urine in extensively metabolized forms. These compounds will be rapidly cleared from plasma. Substantial amounts of unabsorbed compounds will be found in the stools.

Cranberries are a particularly rich source of phenolic acids and polyphenols, particularly flavonoids. Among the 20 most commonly consumed fruits in the American diet, cranberries have the highest total phenol content. Health benefits attributed to cranberries include the prevention of urinary tract infections and stomach ulcers as well as improved oral hygiene. These benefits appear to be due principally to the ability of cranberries to interfere with the adhesion of some bacteria to select cell types and surfaces.

Cranberries and cranberry constituents, including several phenolic and polyphenolic compounds, have also been shown to possess antibacterial, antiviral, anti-mutagenic, anti-carcinogenic, anti-tumorigenic, anti-angiogenic, and antioxidant activities. Most of this evidence is derived from in vitro studies and animal models. The limited number of human studies available indicate these phytochemicals are bioavailable and bioactive. However, more information is required on the bioavailability and metabolism of cranberry polyphenols, as well as on the relationship between cranberry dose and duration of use, to better understand their impact on risk factors for chronic diseases.

Eligibility Criteria:
Inclusion Criteria:

* Men and postmenopausal women
* BMI 18.5-29.9 kg/m2

Exclusion Criteria:

* Cigarette smoking and/or nicotine replacement use
* Use of cholesterol-lowering medications
* Use of blood pressure-lowering medications
* Use of any stomach acid-lowering medications
* Cardiovascular (heart) disease
* Gastrointestinal disease
* Kidney disease
* Endocrine disease: including diabetes, untreated thyroid disease
* Rheumatoid arthritis
* Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
* Systolic blood pressure \> 150 mm Hg and/or diastolic blood pressure \> 95 mm Hg
* Regular use of oral steroids
* Regular daily intake of 2 or more alcoholic drinks
* Illicit drug use
* No fish oil supplements (including cod liver oil) for one month prior to study admission
* No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) or homeopathic remedies, for one month prior to study admission
Self-sampling Among Long-term Non-attenders to Cervical Cancer Screening

The trial will evaluate whether human papillomavirus (HPV) self-sampling may increase cervical cancer screening attendance among under-screened women in Norway, how different ways of offering self-sampling and follow-up may affect attendance, and whether self-sampling may reduce inequities in attendance.

A randomized control trial will be performed on the effect of vaginal HPV self-sampling on screening attendance, targeting women age 35-69 who have not attended screening for at least 10 years. The women will be randomly allocated to one of three interventions: (i) receive a reminder to be screened by a physician; (ii) receive a self-sampling kit; (iii) receive an offer to order a self-sampling kit. Comparisons of the screening attendance among the interventions will be made. To also address potential effects on inequities, the analyses will include comparisons by sociodemographic characteristics. The rates of cervical cancer/precancer among the interventions will also be compared. Further, to assess the feasibility of and the compliance to follow-up after a positive HPV test in this population, half of the HPV-positive women from each self-sampling arm will be referred to initial follow-up by their regular general practitioner (GP), while the other half will be referred to initial follow-up by a gynecologist. The project will be embedded in the national cervical cancer screening program, and will utilize the extensive nationwide registers describing performance and outcomes of screening collected by the Cancer Registry of Norway.

Eligibility Criteria:
Inclusion Criteria:

* Women living in the regions Hordaland, Vest-Agder, Rogaland or Sør-Trøndelag, who have been eligible for screening in Norway, but who have not attended screening for at least 10 years (2009-2018)

Exclusion Criteria:

* Women who have not been eligible for cervical cancer screening during the entire 10 year period (2009-2018)
Phase I Trial of Vorinostat (MK-0683, SAHA) in Combination With Decitabine in Patients With AML or MDS (MK-0683-055 EXT1)

This study is to evaluate the safety and tolerability of vorinostat in combination with decitabine as well as the in vivo molecular and biological effects of vorinostat in patients with refractory or relapsed Acute Myelogenous Leukemia (AML) and intermediate or high risk as defined by International Prognostic Scoring System (IPSS) Myelodysplastic Syndrome (MDS). Participants with Acute Myelogenous Leukemia or Myelodysplastic Syndrome are eligible.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years old with refractory/relapsed AML

  * If untreated AML, patient is older than 60 years old and not a candidate for standard chemotherapy
* Patient is at least 4 weeks from prior treatment and has recovered from all prior treatment side effects
* Patient has no known liver or kidney problems
* Patient knows of no reason they can not receive transfusions of blood clotting cells (platelets)
* Patient is able to swallow capsules
* Patients both male and female are willing to practice birth control during the study

Exclusion Criteria:

* Patient has received prior treatment with valproic acid, decitabine or azacitidine
* Being is less than 18 years of age or if patient has untreated AML is below 60 years of age
* Patient is a women who is pregnant or breastfeeding. Patient has an active infection that requires antibiotics
* Patient has uncontrolled illness including but not limited to the following: heart problems (congestive heart failure, unstable angina pectoris, cardiac arrhythmia), inflammation of the pancreas; a mental or social condition that may interfere with patient following study procedures
* Patient has known human immunodeficiency virus (HIV) infection or HIV-related malignancy. Patient has a known history of hepatitis B or C infection
* Patient currently has another active cancer other than certain types of skin cancer
* Patient is heterosexual and able to have a child and is unwilling to practice birth control during the study
Visible Light Study

The purpose of this study is to learn more about the potential effects of visible light on the skin. More specifically, this study will examine whether an incandescent lamp (light bulb) or LED light bulb can cause skin to become darker. Investigators will determine the minimum threshold dose required to achieve immediate pigmentation darkening (IPD), persistent pigmentation darkening (PPD), and delayed tanning (DT) for Fitzpatrick skin types IV - VI utilizing two visible light sources.


Eligibility Criteria:
Inclusion Criteria:

* Be a healthy volunteer with Fitzpatrick skin types I-VI;
* Agree to abide by the Investigator's guidelines regarding photosensitizing drugs and photoprotection;
* Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form;
* Agree to follow and undergo all study-related procedures.

Exclusion Criteria:

* Women who are lactating, pregnant, or planning to become pregnant;
* Patients with a recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post-inflammatory hyperpigmentation;
* Patients with a known history of photosensitivity disorders;
* Photosensitizing medications may be continued throughout of the study at the discretion of the investigator ;
* Patients with a known history of melanoma or non-melanoma skin cancers;
* Concomitant use of tanning beds;
* Sun exposure of the irradiated or control areas;
* Patients with serious systemic disease.
* Patients with a known history of hypersensitivity to adhesives including adhesive tape.
O-LIVE: Impact of a Portuguese Olive Oil in Health Biomarkers

This research project, approved and funded, is part of a larger project, entitled "Healthy Soil for Food", which completes several work packages, one of which is a clinical research submitted to Ethics Committee entitled "O-LIVE: Impact of olive oil Portuguese in biomarkers of healthy volunteers".

The main objective of this work is to evaluate the impact of ingestion of an olive oil rich in polyphenols on clinical biomarkers and parameters, such as anthropometric measurements, on inflammatory gene expression regulation and on the composition of the intestinal microbiota.

Olive oil is an ancient product that is crucial for social cohesion and for local economies in the Mediterranean region, particularly in Portugal. There is ample evidence on the protective effect of olive oil in cardiovascular disease, diabetes, oncological diseases and neurological degeneration. Furthermore, olive oil has been shown to increase the rate of oxidation, inhibiting lipogenesis and stimulating lipolysis, in addition to affecting the expression of receptors involved in weight regulation and fat use.

These health benefits of olive oil derive from its specific nutritional composition, with monounsaturated fatty acids, polyphenols and phenolic compounds, which act on metabolism, modulation of inflammatory responses and gene expression. But the composition of olive oil can vary considerably depending on the type of cultivation of olive trees, soil management practices, as well as the extraction and technological processes involved in olive oil production.

In this work the investigators will use an olive oil rich in polyphenols (produced in a sustainable and local manner) and evaluate its effect on several important clinical parameters involved in chronic diseases. The investigators anticipate that the results of this work will help support the relationship between consuming higher polyphenol olive oil and improved overall health.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Current active infections
* Medications (Antidepressant medication, Antibiotics, anti-inflammatory, Angiotensin Converting Enzyme inhibitors, insulin and oral anti-diabetic medication)
* Dietary supplements (minerals and oligoelements, antioxidants, n-3 polyunsaturated fatty acids, n-6 polyunsaturated fatty acids, n-9 fatty acids)
* Presence of ant chronic/metabolic diseases:
* Diabetes
* Cancer
* Inflammatory diseases
Post-Marketing Observational Study of Safety Following Vaccination With Flublok® Compared to Licensed IIV in Adults

The primary objective of this study is to retrospectively characterize the safety of Flublok in adults 18 years of age and older, in comparison with egg-based trivalent or quadrivalent inactivated influenza vaccines (IIVs), using a methodological approach designed to query the database of electronic health records (EHR) maintained by Kaiser-Permanente, Northern California (KPNC), a large medical care organization (MCO).

The primary analysis is a nonrandomized, observational retrospective cohort study. Data on adults 18 years of age and older who were enrolled in the KPNC database during the risk intervals after vaccination analyzed for this study who were vaccinated with Flublok or an IIV (either IIV3 or IIV4) will be identified for analysis. The rates of occurrence of specific MAEs of interest in pre-specified risk intervals following Flublok and IIV will be compared.

Eligibility Criteria:
Inclusion Criteria:

Data from the EHR of all adult KPNC members 18 years of age and older, who received Flublok for active immunization against influenza as part of routine medical care within the KPNC system. The comparator cohort will include data from all adults in the same age group who received any IIV (trivalent or quadrivalent) during the period of Flublok administration.

Exclusion Criteria:

Healthcare providers are expected not to administer Flublok or IIV to individuals with known contraindication to either vaccine (see product package inserts). However, there will be no exclusions other than age and KPNC membership criteria at the time of vaccination.
Clinical Isolation Syndrome of Spinal Cord and Multiple Sclerosis

The purpose of this study was to investigate the factors that influence the progression of patients with clinically isolated spinal cord syndrome to multiple sclerosis.

This study included patients who were first diagnosed with clinically isolated spinal cord syndrome admitted to the Department of Neurology, Peking University Third Hospital between January 2010 and November 2020. According to the result of the outcome is divided into multiple sclerosis and outcome group, analyzing the characteristics of the age, sex, clinical manifestations, imaging features, evoked potential, blood immune antibody results, rate of cerebrospinal fluid routine biochemical synthesis oligoclonal band IgG, extension, nerve dysfunction score spinal cord clinically isolated syndrome and the influence factors, such as the relationship between the outcome of multiple sclerosis.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis time and place: Department of Neurology, Peking University Third Hospital from January 2010 to November 2020 Diagnosed as a patient with clinically isolated spinal cord syndrome for the first time

Exclusion Criteria:

none
Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study was designed to investigate the efficacy and safety of NVA237, a long-acting muscarinic antagonist, in patients with moderate to severe COPD.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients age 40 years or more
* Diagnosis of Chronic Obstructive Lung Disease (COPD) (moderate to severe as classified by the Global Initiative for COPD (GOLD) Guidelines, 2008
* Smoking history of at least 10 pack-years
* Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) \<80% and ≥30% of the predicted normal value
* Post-bronchodilator FEV1/Forced Vital Capacity (FVC) \<0.7
* Symptomatic patients, according to daily electronic diary data between visit 2 (Day -8) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to visit 3

Exclusion Criteria:

* Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to the first visit
* Patients who have had a respiratory tract infection within 4 weeks prior to the first visit
* Patients with concomitant pulmonary disease
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular co-morbid conditions
* Patients with a history of asthma or a blood eosinophil count \>600/mm3 or onset of symptoms prior to 40 years
* Patients with eczema, known high IgE levels or a known positive skin prick test
* Patients participating in the active phase of a pulmonary rehabilitation programme
* Patients contraindicated for the treatment with anticholinergics, long and short-acting beta-2 agonists or sympathomimetic amines
* Patients with a history of alpha-1 anti-trypsin deficiency
* Patients on long term oxygen therapy (\>15hr per day)
* Other protocol-defined inclusion/exclusion criteria may apply
Prophylactic Use of Entecavir for HBsAg Negative/HBcAb Positive/Hepatitis B Virus DNA Negative Patients With Lymphoma

The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Negative/HBcAb Positive/hepatitis B virus DNA Negative patients with lymphoma.

The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Negative/HBcAb Positive/hepatitis B virus DNA Negative patients with lymphoma are randomized into entecavir prophylaxis group or observation group. In entecavir prophylaxis group, entecavir 0.5 mg/day orally is initiate on day 1 of the first course of antitumor therapy, and will be continued until at least 6 months after completion of antitumor therapy. In observation group, entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.

Eligibility Criteria:
Inclusion Criteria:

* treatment-naive patients with lymphoma
* HBsAg negative/HBcAb positive/hepatitis B virus DNA negative at baseline
* treated with chemotherapy and/or immunosuppressive therapy
* life expectancy of more than 3 months

Exclusion Criteria:

* younger than 18 years old
* HBsAg positive or HBcAb negative or hepatitis B virus DNA positive at baseline
* pregnant or lactating women
Evaluation of the EZ Blocker

In anesthetized patients the airway needs to be secured due to lack of protective reflexes. Golden standard is the endotracheal intubation. In patients undergoing lung surgery single lung ventilation is essential. In these cases a double lume tube is commonly used. The double lume tube has a proximal tracheal and a distal bronchial end reaching into the left or the right side of the lung dependant of the model of the tube. Thus it is possible to operate on one collapsed side of the lung while ventilating the other side.

Due to length and stiffness resulting of the construction of the device more side effects than after intubation with a conventional single lumen tube is expected. Possible side effects may be bleeding, swelling, sore throat or croakiness.

The EZ-Blocker is a new device promising to overcome these side effects. The EZ-Blocker is a device placing a balloon into one bronchus to be able to provide single lung ventilation like the double lume tube. However, the EZ-Blocker is a catheter pushed through a conventional single lume tube after intubation with a hook on one and a balloon on the other distal end. The hook prevents the device from being pushed too far to be able to harm the lung. Inside the EZ-Blocker is a small lumen able to deflate the lung which is blocked with the balloon. The device is easily positioned using a bronchoscope and when the anaesthesiologists confirmed the correct position of the device, the balloon can be inflated and deflated as needed.

Due to the easier approach the investigators expect less side effects as mentioned earlier using the EZ-Blocker compared to the double lume tube. As well the stress caused by intubation may be reduced.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgery
* thoracic surgery with requiring single lung ventilation in lateral position
* ASA Status 1-3
* Oral and written consent to participation
* Age 18- 90

Exclusion Criteria:

* Contraindications against placing a double lume tube, like tracheal lesions, etc.
* Thoracic surgery within the last four weeks
* Any form of infection (Pneumonia, Pleural empyema) or suspected Tbc
* BMI higher than 45
* Patients with a previous diagnoses or suspected difficult airway
Outcome of Botulinum Toxin Treatment for Oromandibular Dystonia

Symptoms of oromandibular dystonia can be alleviated by injections of botulinum toxin. The scope of this study is to describe the efficacy of this procedure, by a retrospective systematic review of patients medical charts


Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from oromandibular dystonia
* Medical follow up in the Fondation Ophtalmologique Rothschild (Paris)
* Treatment by at least one session of botulinum toxin injection

Exclusion Criteria:

* Patient cannot assess symptoms improvement using a Likert scale
G7 Acetabular System with Vivacit-E or Longevity Liner PMCF Study

The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells when used with the Vivacit-E and Longevity HXLPE liners and instrumentation in primary and revision total hip arthroplasty.

The primary endpoint is defined by the survival of the implant system at 10 years, which is based on removal or intended removal of the study device and will be determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to either implant or instrumentation should be specified.

The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).

Eligibility Criteria:
Inclusion Criteria:

* Patient must be a legal adult who has reached full skeletal maturity.
* Patient must be treated for one of the following indications:
* Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
* Rheumatoid arthritis
* Correction of functional deformity
* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
* Revision procedures where other treatment or devices have failed
* Patient must be able and willing to complete the protocol required follow-up visits.
* Patient must be able and willing to sign the Institutional Review Board or Ethics Committee (IRB/EC) approved informed consent.

Exclusion Criteria:

* Patient presents with osteoporosis, which in the opinion of the Principal Investigator, may limit the subject's ability to support total hip arthroplasty using the study device.
* Patient has a metabolic disorder that may impair bone formation.
* Patient has osteomalacia.
* Patient has distant foci of infections which may spread to the implant site or patient with infection, sepsis or osteomyelitis.
* Patient has rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
* Patient has a vascular insufficiency, muscular atrophy, or neuromuscular disease
* Patient is a prisoner.
* Patient is a current alcohol or drug abuser.
* Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
* Patient is pregnant.
A Drug Interaction Study of SPD503 and Vyvanse Administered Alone and In Combination in Normal Healthy Volunteers

Drug-drug interaction study; to examine the pharmacokinetics of SPD503 and VYVANSE (lisdexamfetamine dimesylate) when given alone, and in combination.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be normal healthy adult volunteers (with no significant abnormalities in medical history, physical exam, vital signs or lab evaluations at screening) in order to be eligible to participate.
Anti-Xa Level With Thromboprophylactic Dosage Nadroparin in Critically Ill COVID-19 and Non-COVID-19 Patients

Primary objective The objective of this study is to compare anti-Xa levels obtained with a standard high dose thrombosis prophylaxis in COVID-19 intensive care-patients compared with anti-Xa levels obtained with a normal dose thrombosis prophylaxis in non-COVID-19 intensive care patients.

Secondary objectives

1. To determine the incidence of anti Xa levels out of range of the established target anti Xa level in both groups.
2. To determine the influence of relevant co-variates on the anti-Xa level in the COVID-19 and non-COVID-19 group.


Eligibility Criteria:
Inclusion Criteria:

* All COVID-19 patients \> 18 years admitted at the ICU using nadroparin in a high thrombosis prophylactic dosage of 1 dd 5700 IU or 2 dd 5700 IU sc
* All medical non-COVID-19 patients admitted at the ICU using nadroparin in a standard prophylactic dosage of 1 dd 2850 IU sc.
* Minimum estimated length of stay on the ICU of 4 days

Exclusion Criteria:

o (History of) Heparin Induced Thrombocytopenia and Thrombosis