cyrilzakka/clinical-trials huggingface dataset:
Mechanism of Decreased Iron Absorption in Obesity: Controlling Adiposity-related Inflammation

The main iron regulatory protein in the human metabolism is hepcidin. In normal weight, healthy subjects, hepcidin is regulated through the iron status of the body: low iron status results in low hepcidin concentrations, which facilitates dietary iron absorption. In obesity, which is an inflammatory state, hepcidin concentrations are increased and iron absorption is reduced despite low iron stores, leading to iron deficiency over time. Whether lowering the chronic low-grade inflammation during a limited treatment period and thereby lowering hepcidin concentration can improve iron absorption is uncertain.

In states of high hepcidin concentration, intestinal iron absorption (through enterocytes) and recycling of iron (through macrophages) is reduced. The extent to which non-heme iron is absorbed from the diet is influenced by the composition of the diet. Ascorbic acid is a potent enhancer of non-heme iron absorption. It's mechanism of action is luminal reduction of dietary ferric iron (Fe3+) to more soluble ferrous iron (Fe2+). A study in the inestigator's laboratory showed that the enhancing effect of ascorbic acid on non-heme iron absorption is reduced in overweight and obese individuals. Possible explanations for this fact are the different sites of action of ascorbic acid and serum hepcidin on the enterocytes in dietary iron absorption. Increased hepcidin reduces iron efflux into the circulation at the basolateral membrane of the enterocyte. Therefore the improved iron transport into enterocytes through ascorbic acid at the luminal side (via the divalent metal transporter (DMT)-1), by reducing Fe3+ to Fe2+ seems to be less successful. To improve iron absorption in obese subjects, an intervention at the basolateral membrane of the enterocyte would be needed.

Eligibility Criteria:
Inclusion Criteria:

* normal-weight (BMI18.5-24.9kg/m2) or obesity (BMI 29-40kg/m2)
* pre-menopausal
* no chronic illness and no significant medical conditions that could influence iron or inflammatory status other than obesity
* no-smoking

Exclusion Criteria:

* Diagnosed chronic disease or gastrointestinal disorders
* Metabolic disorders (e.g. diabetes)
* Regular use of medication (except oral contraceptives)
* Subject on a weight loss diet or planning to start a weight loss diet during the duration of the study
* Pregnancy or lactation
Combination Chemotherapy With or Without Metformin Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Metformin hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if combination chemotherapy is more effective with or without metformin hydrochloride in treating patients with metastatic pancreatic cancer.

PURPOSE: This randomized phase II trial is studying giving cisplatin, epirubicin hydrochloride, capecitabine, and gemcitabine hydrochloride together with metformin hydrochloride to see how well it works compared to cisplatin, epirubicin hydrochloride, capecitabine, and gemcitabine hydrochloride alone in treating patients with metastatic pancreatic cancer.

OBJECTIVES:

Primary

* To assess the therapeutic activity of chemotherapy comprising cisplatin, epirubicin hydrochloride, capecitabine, and gemcitabine hydrochloride with versus without metformin hydrochloride in terms of 6-month progression-free survival in patients with metastatic pancreatic cancer.

Secondary

* To assess the overall survival of patients treated with this regimen.
* To assess the response rate in patients treated with this regimen.
* To assess the duration of response in patients treated with this regimen.
* To assess the toxicity in patients treated with this regimen.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive cisplatin, epirubicin hydrochloride, and gemcitabine hydrochloride on days 1 and 15. Patients will also receive capecitabine and metformin hydrochloride on days 1-28. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive cisplatin, epirubicin hydrochloride, gemcitabine hydrochloride, and capecitabine as in arm I. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed pancreatic adenocarcinoma

  * Metastatic (stage IV) disease
* Measurable disease
* No symptomatic brain metastases

PATIENT CHARACTERISTICS:

* Karnofsky performance status 60-100%
* Not pregnant or nursing
* Adequate bone marrow, liver and kidney function
* No previous or concurrent malignancies at other sites except for surgically cured carcinoma in-situ of the cervix, basal cell or squamous cell carcinoma of the skin, or other neoplasms without evidence of disease within the past 5 years
* No multiple severe diseases which would compromise safety (i.e., cardiac failure, previous myocardial infarction within the past 4 months, cardiac arrhythmia, or history of psychiatric disabilities)
* No alcohol abuse

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy or metformin
* No other concurrent experimental drugs
French Study In ICU Patients Treated With Tigecycline

This study will describe clinical outcome and safety data collected prospectively in subjects hospitalized in an intensive care unit (ICU) presenting with an infection for which treatment with tigecycline, alone or in combination, is planned. Data will be collected only from subjects providing informed consent.

Healthcare visit.

Extension Rationale:

In order to perform the necessary corrective actions required and to secure database consistency, we request an extension for posting of Basic Results due 26-May-2011 for protocol 3074A1-4448 (B1811030), NCT00799591. Our proposed submission date is 14-Sept-2011.

Pfizer acquired Wyeth on October 16, 2009. With regard to this study, our reconciliation of data identified some discrepancies in data listed in the Project database (managed by the CRO) and the Safety Database (managed by Pfizer). We are taking corrective action which involves: sending queries to investigators, collecting corrective signed forms, and implementing changes within the database. We are requesting this extension to complete that work so that the data can be treated as final and the CSR can be completed.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women (18 years).
* Subjects hospitalized in a medical or surgical intensive care unit (ICU) (on the day of enrolment in the study).
* Subjects treated with tigecycline (first, second or third line), said treatment freely chosen by the participating physician, prior to enrollment in the study.

Exclusion Criteria:

* Subjects participating in another biomedical research study.
* Patient (or legal representative) who has not dated or signed informed consent document.
Kuopio Fall Prevention Study.

This study evaluates the 6 month exercise intervention (Taiji and gym course) combined with free use of communal recreation facilities in fall prevention.

Morbidity, use of social services and health outcomes of aging women in province of Kuopio, Finland are also monitored. The study combines a six months supervised exercise, followed by six months free, but unsupervised, use of recreational facilities and observational period of second year into total of 2 year follow up duration.

In 2016, a 2-year randomized controlled trial (RCT) will be launched to investigate the effect of exercise on fall risk, injuries and subjective well-being (SWB) in aging women (n=1078) by using municipal sport services in cooperation with the city of Kuopio. The effect of the exercise intervention on functional capacity, muscle strength, bone, body composition, cognitive function, the use of health services and its cost effectiveness will also be studied.

The trial will be carried out on women belonging to the Kuopio Osteoporosis Risk Factor and Prevention (OSTPRE) Study, which is an ongoing population-based prospective cohort study, with a follow-up of 26 years. It investigates life style factors associated with fractures falls, bone mineral density and morbidity in a target population of 14 220 women, now aged between 75-84 year.

The study combines combination of a 2-year fall prevention trial with the 26 years of life style and medical data from the previous OSTPRE follow up to provide meaningful answers whether municipal exercise program can provide cost effective health gain in elderly. In addition, the study aims to answer, who will benefit from the exercise the most and what are the underlying factors explaining efficacy in the women's previous 26 years of lifestyle and medical history. The study will help to develop strategies for societal fall prevention.

Eligibility Criteria:
Inclusion Criteria:

* Included in the previous Osteoprosis Risk Factors and Prevention (OSTPRE) study follow up protocol, conducted in Kuopio Finland, between 1989-2015.

Exclusion Criteria:

* Unstable angina pectoris, severe pulmonary disease, not self-ambulatory or institutionalized, moderate to severe dementia.
Effectiveness of the CHESS eHealth Cancer Support Intervention in Population-based Care

The study's aim is to provide information about the clinical and business cases for comprehensive interactive cancer communication systems (ICCS) in the context of real world use for cancer care.

This study will be conducted within the Kaiser Permanente Northwest (KPNW) healthcare system. Outcomes for this study include amount of ICCS use and women's ratings of cancer information competence, perceived social support, and emotional well being. Secondary outcomes will include healthcare utilization, cost-effectiveness, and clinician ratings of healthcare visits.


Eligibility Criteria:
Inclusion Criteria:

* All subjects must be within 2 months of their primary breast cancer diagnosis,
* All subjects must be at least 18 years of age

Exclusion Criteria:

* Illiterate
* Homeless
Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS) for Treatment of Autism Spectrum Disorder

Non-invasive vagus nerve stimulation for the symptomatic improvements in Autism Spectrum Disorder

A single arm open-label study in Autism Spectrum Disorder (ASD) for evaluating treatment effects of non-invasive VNS, specifically auricular fiber vagal nerve stimulation (afVNS). A total of 20 patients diagnosed with ASD will be recruited to evaluate the feasibility of home healthcare application of afVNS and for assessment of short-term treatment effects on symptoms and comorbidities. ASD patients will receive 1 x hour per day afVNS treatment over 14 days with a fixed neuromodulation protocol. The primary outcome measure is feasibility assessed from completion success and neurostimulation tolerance. Secondary outcome measures include changes in scores pre- and post- afVNS treatment for Clinician Global Clinical Impression (CGI-I), Clinician Global Impression Severity (CGI-S), Children's Anxiety Sensitivity Index (CASI-R), Parent-Rated Anxiety Scale for ASD (PRAS-ASD), Autistic Behavior Checklist (ABC), Cleveland Adolescent Sleep Questionnaire (CASQ), verbal fluency and biomarker measures in autonomic physiology.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age: between 7 and 26 years
* Participants and parent/ guardian must read and write English
* Diagnosis of ASD as defined by ADOS-2 and DSM-5 criteria
* Full scale IQ of \>80 from WASI
* Suffering from anxiety (total score of \>49) on CASI-R at baseline

Exclusion Criteria:

* Severe psychiatric disorders (e.g. bipolar, major depressive disorder)
* Severe neurological disorders (e.g. stroke, epilepsy)
* Bradyarrhythmia
* History of head trauma (surgery or tumor)
* Active medical implants (cochlear, VNS or pacemakers)
* Cerebral shunts
* Auricular skin disease that compromises placement of electrodes
* Pregnancy
COVID-19 Advanced Respiratory Physiology (CARP) Study

The anticipated second wave of COVID-19 cases will present healthcare system challenges, including requirement to monitor large numbers of patients for deteriorating respiratory failure. Rising respiratory rate can identify deterioration requiring escalation of care. However constant monitoring of respiratory rate can be challenging outwith critical care units due to feasibility and inaccuracy of intermittent measurements.

Wearable biosensors which allows for remote patient monitoring of RR is therefore attractive, particularly when combined in a dashboard with clinical summary data. This would establish source data and infrastructure for the training and validation of machine-learning models, with decision support risk-predictions prioritising alerts and clinician reviews.

Altair medical has developed a pre-commercial investigational wearable (chest-worn) biosensor which can measure continuous respiratory rate and respiratory events. This sensor has been verified to have good correlation with reference impedance plethysmography data.

Inclusion criteria:

All inpatients in the QEUH with respiratory failure from any cause.

Exclusion criteria:

Lack of capacity to consent

Physiology data will be correlated with event time-course data including oxygen and breathing support requirements, deterioration, hospital discharge and status at 28 days and 90 days post discharge.

A small subset of patients will have further investigations - parasternal EMG; thoracic electrical impedance tomography; forced oscillometry and post discharge Altair and Fitbit data.

Study analysis will include machine learning model development with the objective of developing risk-predictions for clinically significant deteriorations.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria

  * Adult patients with respiratory failure of any cause requiring hospital admission, oxygen therapy and routine NEWS-2 physiology observations.
  * CARP detailed sub-study Adult patients with respiratory failure who are suitable for opportunistically acquired serial detailed physiology measurements taken alongside routine clinical care by study team.
  * CARP follow-up remote-monitoring sub-study Adult patients with respiratory failure who have provided informed consent and have a smartphone to connect to Fitbit and Lenus accounts for postdischarge wearable device data capture.

Exclusion Criteria:

* Exclusion criteria • Lack of capacity or inability to comprehend informed consent.
Glucobrassicin-Brussel Sprout Effect on D10 Phe Metabolism

To determine whether glucobrassicin-rich Brussels sprouts can favorably modify the metabolism of the polycyclic aromatic hydrocarbon deuterated phenanthrene (\[D10\]phe) in current and former smokers

Subjects will be given 1 microgram of \[D10\]phe, and all urine will be collected for 6 h afterwards to quantify baseline levels of \[D10\]phenanthrene tetraol (\[D10\]pheT) and \[D10\]phenanthrols (\[D10\]HOP). Within 3 days of this baseline measurement, subjects will consume 200 micromoles of glucobrassicin in the form of raw Brussels sprouts (\~200-300 grams) at the study center once daily for 7 consecutive days. Urine will be collected for 24 h after vegetable consumption on days 3 ± 1 and 6 of the feeding intervention for 3,3'-diindolylmethane (DIM) quantification. On day 7 of the feeding intervention, a second dose of 1 microgram of \[D10\]phe will be administered at the study center after vegetable consumption, followed by another 6 h urine collection.

Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 18 years old
* Current or former smoker by self-report
* Willing to abstain from cruciferous vegetable consumption other than the study vegetable during the study period
* Able to understand the experimental nature of the study and provide informed consent
* Negative urine pregnancy test for women of childbearing potential within 7 days of baseline \[D10\]phe dosing

Exclusion Criteria:

* Chronic proton pump inhibitor, H2-blocker (i.e., ranitidine, famotidine), and/or calcium carbonate use
* History of gastric bypass surgery, gastric banding, bowel resection, malabsorption syndromes such as celiac sprue or pancreatic insufficiency, or other conditions that may affect gastric absorption
* Current use of tobacco products other than cigarettes (i.e. snuff, snuz, smokeless tobacco, cigars, pipes) or use of these products within 3 months of study registration
* Major or chronic medical disease, including heart disease, poorly controlled diabetes, etc., to be adjudicated by the principal investigator
* Women who are pregnant, intend to become pregnant within 3 months of the study period, or who are breastfeeding
* Current or recent (within 12 months) problems with drug use or alcohol dependence by self-report Antibiotic use within 2 months of study enrollment or during the study by self-report Alcohol dependence, abuse, or history of dependence/abuse by self-report Vegetarians
* History of respiratory tract cancer
* Use of metronidazole or antabuse during the study
* Taking ibuprofen, naproxen, other NSAIDs, steroids (except inhaled steroids) within 14 days of study registration
* Allergy to Brussels sprouts
Healthy Effects of an Innovative Probiotic Pasta

The aim of the project was the evaluation of the antioxidant and anti-inflammatory effects of a whole grain pasta, enriched in barley β-glucans and fortified with strains of Bacillus coagulans, versus a control wheat pasta on healthy volunteers, using a parallel randomized controlled trial.

Epidemiological evidences indicate that consumption of whole grains products is associated to a decreased risk for common chronic diseases, as cardiovascular diseases, diabetes, obesity, hypertension and metabolic syndrome. In the present study a whole grain pasta was supplemented with prebiotics and probiotics 'ad hoc' formulated. In detail, pasta was industrially developed after the identification of particular cultivars of wheat and barley, rich in carotenoids, β-glucans (2.6 g/100g pasta), not soluble fibers and antioxidants. Further, pasta was supplemented with spores of Bacillus coagulans, a putative probiotic microorganism, belonging to Lactobacillus family. It is well demonstrated the ability of this microorganism to survive to technological processes and to upper gastro-intesinal tract, in order to exert beneficial effects in the lower gut, as anti-microbial activity, increasing immunological defences as well as improvements in intestinal regularity. Conversely, the control pasta was made from the same cultivar of grain and by the same technological process, but without any supplementation.

In this parallel randomized controlled one arm trial, 40 healthy volunteers were randomly allocated for the consumption of the two kind of pasta once a day, for 12 weeks. At the beginning of the study and every 4 weeks, subjects were asked to provide blood, urine and feces for the evaluation of:

* blood inflammation markers;
* blood lipid and carbohydrate profile;
* blood and urine markers of cardiovascular risk;
* feces profile of microbiota and detection of markers for the healthiness of the gut.

In addition, volunteers filled in different questionnaires regarding their dietary habits, the physical activity and the gut healthiness.

Eligibility Criteria:
Inclusion Criteria:

* Overweight / Obesity
* Lower consumers of fruit and vegetables

Exclusion Criteria:

* Antibiotic treatment within 3 months prior the pasta feeding
* Chronic diseases
* Surgeries
* Consumer of whole grain products
* Dieting
* Pregnant or lactating
Impact of Mass Zinc Fortification Programs on Plasma Zinc Concentration

The purpose of the study is to evaluate the use of plasma zinc concentration for assessing the impact of mass zinc fortification programs.

The objectives of the present study are to determine whether plasma zinc concentration changes in response to additional zinc consumption, as provided by zinc-fortified cereal-based complementary foods fed to adult men (fortified at a level consistent with currently proposed levels). The following specific steps will be completed:

1. Zinc-fortified breads prepared from zinc-fortified wheat flour will be developed with assistance from experts in food technology.
2. A four-week feeding trial will be implemented to assess the change in plasma zinc concentration among young adult men who receive: a) bread fortified with a moderate amount of zinc and a liquid vitamin preparation between meals; b) bread fortified with a large amount zinc and a liquid vitamin preparation between meals; c) non-zinc-fortified bread and a liquid vitamin preparation between meals \[negative control group\]; and d) non-zinc-fortified bread and a zinc-containing liquid vitamin preparation between meals \[positive control group\].

Eligibility Criteria:
Inclusion Criteria:

* apparently healthy males

Exclusion Criteria:

* Hemoglobin \<80 g/L
Extended Follow-Up of the ISS T-003 Trial Volunteers (ISS T-003 EF-UP2020)

A further extension of the follow-up of the volunteers of the ISS T-003 trial is being conducted in order to evaluate the persistence of vaccine immunogenicity as well as of the immunological and virological effects induced by the therapeutic immunization with Tat after about 10 years from vaccination.

The volunteers enrolled in the South African ISS T-003 trial (ClinicalTrials.gov NCT01513135; SANCTR: DOH-27-0211-3351) were recently enrolled in an observational study to extend the follow-up of the trial. The results of this study (ISS T-003 EF-UP, ClinicalTrials.gov NCT02712489; SANCTR: DOH-27-0615-4948) indicate the maintenance of anti-Tat Ab in a vast proposition of vaccinees.

The new roll-over observational study (ISS T-003 EF-UP2020; SANCTR: DOH-27-072022-7347) is to be conducted to further extend the follow-up of the participants of the ISS T-003 trial in order to evaluate the persistence of vaccine immunogenicity as well as of the immunological and virological effects induced by the therapeutic immunization with Tat after about 10 years from vaccination.

To this aim volunteers of the ISS T-003 study are included in a new 6-months study, with visits at weeks 0 and 24, during which the persistence and levels of anti-Tat antibodies (primary endpoint) and the CD4+ T-cell and HIV-1 plasma viraemia levels (secondary endpoint) will be evaluated. In addition, depending on the availability of residual specimens (PBMC, serum and plasma), further laboratory tests will be performed to investigate in-depth the immunological and virological profile of the volunteers. Clinical signs and symptoms of disease progression and AIDS-defining events will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* previous participation in the ISS T-003 EF-UP study without withdrawal of consent;
* availability to participate in the ensuing extended follow-up study;
* signed informed consent.

Exclusion Criteria:

* The absence of any of the above criteria will exclude the participants from the study.