cyrilzakka/clinical-trials huggingface dataset:
Evaluation of ZestiVits in Children and Adults on a Ketogenic or Restricted Therapeutic Diet

A study to evaluate the acceptability of ZestiVits; a new vitamin, mineral and trace element supplement for children aged 11 years and over and adults on a ketogenic or restricted therapeutic diet with regard to product tolerance, palatability and compliance.

To evaluate the gastrointestinal tolerance, palatability and compliance of ZestiVits in a seven-day period for 15 subjects aged 11 years and over following a ketogenic or restricted therapeutic diet.

* Qualitative assessments from subject questionnaires that allow evaluation of the acceptability and ease of use of the study product.
* Collection of daily data about the gastro-intestinal tolerance of the study product.

  * Collection of daily data about compliance with the study product i.e. actual versus prescribed intake.
  * Improve quality of life by increasing range of products available for use in a ketogenic or restricted therapeutic diet.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of condition requiring a ketogenic or restrictive therapeutic diet
2. On a ketogenic or restricted therapeutic diet with good compliance
3. Aged 11 years and over
4. Has a requirement for a micronutrient supplement
5. Written informed consent by subject or parent/carer

Exclusion Criteria:

1. Participants aged less than 11 years
2. Use of additional micronutrient supplements during the study period unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file)
Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement

The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Mitral Valve to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical effectiveness with significant improvements in clinical hemodynamic performance.

The Foldax Polymer Mitral Valve is indicated as a replacement for a diseased, damaged, or malfunctioning native mitral heart valve via open heart surgery. This is a first in human study conducted under US FDA's Early Feasibility Investigational Device Exemption and will enroll up to 15 patients. These patients will be followed up to 5 years after implantation.

Eligibility Criteria:
Inclusion Criteria:

* Is 18 years or older
* Is a candidate for mitral valve replacement with cardiopulmonary bypass
* Is a candidate for mitral valve replacement due to:
* Moderate to severe mitral valve stenosis,
* Moderate to severe mitral valve regurgitation, or
* Moderate to severe mixed mitral stenosis/regurgitation
* Able to withstand short term anticoagulation
* Willing and able to comply with protocol requirements

Exclusion Criteria:

* Prior mitral valve surgery for valve replacement or valve repair (this does NOT include percutaneous interventions i.e. Mitraclip, chordal replacement)
* Requires emergency surgery
* Requires other planned surgery within 12 months of valve replacement
* Active endocarditis or active myocarditis
* Acute preoperative neurological deficit defined as neurological deficit \< 3 months prior to enrollment
* Non-cardiac illness resulting in a life expectancy of less than 12 months
* Enrolled in another investigational device or drug study (enrolled patients may not enroll in other studies)
* Myocardial infarction, or severe cardiac adverse event which has not returned to baseline for at least 30-days prior to enrollment
* Aortic aneurysm or other medical condition that creates a higher than usual risk of surgical complications
* Renal or hepatic failure
* Hematological disorders, patients must not have a hematocrit of \<30%, hemoglobin \<10 g/dL, platelet count of \<100,000 cells/µL, or WBC \<4,000 cells/µL; coagulation profile must not be outside of normal limits
* Patients who are prisoners or mentally ill
* Patients who are pregnant or expect to become pregnant in the 12 months following implantation, or are lactating
* Has a positive test result for COVID-19 virus (baseline or preoperative)
* Patients who have withdrawn after implantation may not re-enter
* Intraoperatively it is determined that the patient anatomy is not compatible with the device.
Aging and Cellular Mechanism for Insulin Action After Exercise Training

This study will determine whether the metabolic and cellular mechanisms contributing to improved insulin action after aerobic or resistive exercise are different in older, obese, insulin resistant veterans. The hypothesis is that regular exercise, whether aerobic or resistive, will improve whole body insulin action, but the nature and magnitude of changes in skeletal muscle will differ between the two types of exercise.

Veterans will be of comparable body composition and age, and randomly assigned to either aerobic or resistive exercise. They will be instructed in a weight maintenance diet prior to beginning the exercise program, and maintain this diet throughout the study. Metabolic testing will be performed at baseline and after 6 months of exercise training. Testing will include measurement of body composition (anthropometry, dual-energy Xray absorptiometry, computed tomograph scan), maximal oxygen consumption, and muscle strength, glucose tolerance (oral glucose tolerance test), insulin sensitivity (euglycemic-hyperinsulinemic clamp), and muscle biopsies to examine skeletal muscle metabolic characteristics (fiber type distribution, capillary density, oxidative and glycolytic enzyme activities, and levels of key proteins important in insulin signaling and glucose transport). Data will be analyzed using analysis of variance to determine differences between the two exercise groups, and multiple regression analysis to determine the primary adaptations that are associated with the improvements in whole body insulin action.

Eligibility Criteria:
Males between 50 years and 80 years

Overweight

Non-smoker

Sedentary (no regular exercise for one year)
The Role of FGF23 and Asymmetric Dimethylarginine (ADMA) in Chronic Kidney Disease

In chronic kidney disease calcium (Ca) and phosphate (P) metabolism disorders are very common and also they are one of the leading causes of morbidity in these population. FGF23 is a novel factor that contributes Ca-P disorders. It has been hypothesized that FGF 23 increase is mediated by asymmetric dimethylarginine (ADMA). The aim of the study is to evaluate this hypothesis.


Eligibility Criteria:
Inclusion Criteria:

* between ages of 18 - 65 years old
* chronic kidney disease of stage 2-4

Exclusion Criteria:

* presence of diabetes mellitus or ischemic hearth disease
* taking vitamin d therapy
U-500R Insulin In Type 2 Diabetes With Severe Insulin Resistance Via Omnipod

Patients with Type 2 diabetes and severe insulin resistance with very large insulin requirements who have failed all previous insulin regimens using non-concentrated forms of insulin (U100 insulin formulations) will receive 5X concentrated insulin (U500 regular insulin)infused via insulin pump.

Patients with Type 2 diabetes who have severe insulin resistance and very large insulin requirements (over 1.4 units of insulin /kg/day) often fail insulin regimens with persistent poor blood glucose control when standard U-100 insulin formulations are used. This is due in part to poor absorption of the large insulin volumes required using these less concentrated standard insulin preparations. The hypothesis that using a concentrated form of insulin called U-500 Regular insulin and delivering it by infusion via insulin pump will lower the volume of insulin required and therefore improve insulin absorption, which will lead to improved blood glucose control, will be tested.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes on stable insulin regimen with or without oral agents for at least 3 months
* HbA1c \> 7%
* No significant cardiovascular, renal or other serious medical diseases

Exclusion Criteria:

* HbA1c \< 7%
* Chronic renal, hepatic, cardiovascular, or other serious medical illness
* Females of childbearing age not using adequate contraception
* Use of GLP mimetic
A Study of Patients Hospitalized With Acute Heart Failure With Reduced Ejection Fraction (HFrEF)

A study of participants hospitalized with acute heart failure with reduced ejection fraction


Eligibility Criteria:
Inclusion Criteria:

* An average left ventricular ejection fraction (LVEF) \< 40% over the entire index hospitalization
* Age 18 years or older on the index date
* At least 6 months of activity in the databaseprior to the index date

Exclusion Criteria:

* Any code for myocardial infarction (ICD-9 diagnosis code: 410.xx, ICD-10 diagnosis code: I21.xx) or related terms such as "myocardial infarction", "mi", "infarct" or "heart attack" occurring during the index hospitalization

Other protocol defined inclusion/exclusion criteria could apply
Diacutaneous Fibrolysis on Carpal Tunnel Syndrome

Diacutaneous Fibrolysis is a manual method of treatment, addressed to mechanical pain of the neuromusculoskeletal system. In the clinical practice a favorable effect is observed in patients with carpal tunnel syndrome, but there is no published studies evaluating the results os this technique.

The objective of this trial is to evaluate if Diacutaneous Fibrolysis is more effective in symptoms, function, grip, mechanosensitivity and neural conduction velocity compared to a placebo.

For this purpose the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of carpal tunnel syndrome (low to moderate intensity) with a neurophysiological test.

Patients included are randomized into 2 groups one receive Diacutaneous Fibrolysis and the other placebo. Both groups receive 5 treatment sessions.

The variables are measured at the beginning and end of treatment. And also some variables are measured before and after each session. Patients who participated in placebo group, when the intervention finish the investigators will be given the opportunity to receive the actual technique

The investigators selected patients diagnosed with carpal tunnel syndrome with electroneurogram, if they meet the inclusion criteria are offered to take part in this study.

When the patient agree to participate and signed informed consent, the investigators collected dependent variables considered (symptoms, mechanosensitivity, functional capacity with upper limb, tractor speed of neural conduction ...) and the patient is assigned to an intervention group: real or placebo. Each patient receives treatment 5 sessions trascurriendo intersessional 2- 5 days. After 5 sessions the investigators remeasured the same variables. In addition, a month later they remeasured again symptoms and functional capacity with upper limb. Finally, they were shown the technique they have received. If the patient has received the technical placebo he/she is given the opportunity to receive 5 sessions of the actual technique.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed medically with neurophysiological test of carpal tunnel syndrome (low and moderate intensity)

Exclusion Criteria:

* Severe carpal tunnel syndrome
* Previous surgery on the hand
* hormonal factors: diabetes, thyroids pathologies, pregnant
* cervical disfunctions
* ulcerations or skins disorders
A Safety Study to Assess the Effects of Therapeutic and Supratherapeutic Exenatide Concentrations on QT Interval in Healthy Subjects

Compare the effect of exenatide (therapeutic and supratherapeutic concentrations), moxifloxacin and placebo on the QT interval.


Eligibility Criteria:
Inclusion Criteria:

* Is overtly healthy, as determined by medical history and physical examination
* Has body mass index (BMI) between 25 and 35 kg/m2
* Has fasting serum glucose \<110 mg/dL
* Has no clinically significant blood pressure or heart rate readings as judged by the investigator at study start
* Has electrocardiogram (ECG) results judged as not clinically significant by the investigator at study start

Exclusion Criteria:

* Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being
* Has an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk of participating in the study, such as a Bazett's corrected QT (QTcB) interval \>450 ms.
* Family history of sudden death
* Personal history of unexplained syncope within last year, or family history of Long QT Syndrome, or significant active cardiac disease, or symptoms of angina pectoris or transient ischemic attacks within the previous 6 months
Study on Hypertension and Frailty in the Older People

To estimate the linear association between daytime systolic blood pressure variability evaluated as standard deviation (SD) and frailty evaluated as Frailty index according to the Rockwood's accumulation of deficits model


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hypertension according to the criteria of the European Society of Cardiology guidelines
* Consent of the patient (or legal representative) to participate in the study

Exclusion Criteria:

* Refusal of the patient or his/her legal representative
* Life expectancy of less than 6 months
Chlorhexidine Bathing to Prevent Hospital-acquired Infections: the CLEANS Study

Hospital-acquired infections (HAI) have been shown to increase length of hospital stay and mortality. Infections acquired during a hospital stay have been shown to be preventable. The skin of patients is considered a major reservoir for pathogens associated with hospital-acquired infections, and has been suggested as a potential target for interventions to reduce bacterial burden and subsequent risk of infection. The use of daily Chlorhexidine (CHG) bathing in intensive care patients has been advocated to reduce many of the infections in critically ill patients. However, the effectiveness of CHG bathing to reduce ICU infections has varied considerably among published trials, making the effectiveness of CHG bathing in ICU patients uncertain.


Eligibility Criteria:
Inclusion Criteria:

* adults (≥ 18-years old)
* anticipated SICU stay for 48 hours or more
* APACHE II \>15

Exclusion Criteria:

* Braden Scale for Predicting Pressure Sore Risk score more than 9 (highest risk)
* pregnancy
* skin irritation
* chlorhexidine allergy
* SICU stay of more than 48 hours prior to screening
Safety and Pharmacokinetics Study in Adults for the Prevention of S. Epidermidis Infection in Low Birth Weight Infants

The purpose of this Phase 1 study is to evaluate the safety and pharmacokinetics of BSYX-A110 in a small number of healthy adult volunteers. Following the demonstration of safety in adults, this anti-Staphylococcal monoclonal antibody will then be evaluated in the target population of hospitalized low birth weight neonates.

This study will evaluate the safety of three doses of BSYX-A110 in adults before initiating studies in the target population of low birth weight infants. This will be an open label, dose-ranging study of BSYX-A110 in 12 adults. The dose levels to be evaluated are 3, 10 and 20 mg/kg. Each dose level will enroll 4 adult volunteers who will receive one dose of BSYX-A110 intravenously. The primary endpoint of this study is safety and tolerability. The secondary endpoints include the pharmacokinetics of the rise in anti-LTA antibody and opsonic activity against S. epidermidis.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be 18 years of age or older.
2. Subjects must in good general health, without significant medical history, physical examination findings or clinical laboratory abnormalities.
3. Negative screening pre-treatment pregnancy test for female subjects.
4. Subjects of childbearing potential must agree to use an acceptable method of contraception throughout the course of the study.
5. All aspects of the protocol explained and written informed consent obtained.

Exclusion Criteria:

1. Known or suspected immunodeficiency (e.g. HIV infection, significant risk factors for HIV, primary immunosuppressive disorder), use of immunosuppressive or antineoplastic drugs except corticosteroids used for indications other than immunosuppression.
2. Clinically significant laboratory abnormality (greater than 1.5 upper limit of normal.).
3. Serology positive for HIV, hepatitis B surface antigen or hepatitis C antibody.
4. History of leukemia, lymphoma or other malignancy.
5. Clinically significant cardiac, respiratory, renal, hepatic, neurological disorder
6. Pregnant or lactating females (women of childbearing potential will undergo a pregnancy test).
7. Receipt of any vaccine within 30 days.
8. History of drug or alcohol dependence, or significant acute or chronic medical or psychiatric illness which would limit the subject's ability to complete the study and/or compromise the objectives of the study.
9. Fever or acute illness within 3 days prior to treatment. (These subjects can be rescheduled for treatment at a later date).
10. Participation in another investigational drug or vaccine trial within 30 days.
To Estimate Relative Bioavailability of 5 Formulations of Ronacaleret Given to Healthy Postmenopausal Females

This study will examine the effects of formulation on the relative bioavailability of SB-751689 (400 mg) administered to healthy postmenopausal women. Subjects will receive a single oral dose of each formulation, with five formulations of SB-751689 tested in total. Blood samples will be taken up to 24 hours postdose after each dose administration. This study will provide information for future possible formulation development of SB-751689 for Phase III.


Eligibility Criteria:
Inclusion criteria:

* Healthy postmenopausal women
* Non-smokers
* Body weight \> or = 50 kg and BMI within the range 19-32 kg/m2
* Capable of giving written informed consent and complying with the requirements and restrictions listed in the consent form
* QTcB or QTcF \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block
* Hispanic or non-Hispanic (Caucasian) ethnicity

Exclusion criteria:

* Any clinically relevant biological or physical abnormality found or reported at screening which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study
* Positive urine drug screen at screening
* Positive urine test for alcohol at pre-dose
* Positive for HIV or hepatitis B or C virus at screening
* Urinary cotinine levels indicative of smoking at screening
* History of smoking or use of nicotine containing products within one year of the study or \>10 pack-year history of smoking overall
* History of regular alcohol consumption exceeding 7 units/week (1 unit = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening
* History of drug abuse within 6 months of the study
* Participation in a clinical study and received a drug or a new chemical entity with 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of the current study medication.
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
* Use of prescription or non-prescription drugs
* Consumption of red wine, grapefruit, grapefruit juice or grapefruit containing products within 14 days prior to the first dose of study medication
* Donation of blood in excess of 500 mL within 56 days prior to dosing
* Evidence of renal, hepatic or biliary impairment
* History of serious gastrointestinal disease
* History of sensitivity to any of the study medications or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
* History of clinically significant cardiovascular disease
* Medical conditions that might alter bone metabolism
* Serum parathyroid hormone (iPTH) test levels outside the reference range at screening
* Liver function tests, parathyroid hormone test or CPK outside the reference range at screening
Study to Assess Clinical Characteristics and Outcome of Patients with Marginal Zone Lymphomas

This is a purely retrospective and observational monocentric study

the study aimed at describing the characteristics and outcome of Marginal zone lymphoma patients who were diagnosed and treated in our Hospital between December 2012 and December 2018

Eligibility Criteria:
Inclusion Criteria:

1. Marginal zone lymphoma patients who were diagnosed and treated in our Hospital between December 2012 and December 2018.
2. Age ≥ 18 years at enrolment.
3. Written informed consent (if applicable)

Exclusion Criteria:

* none
Inspection of the Colon Using a Retrograde Viewing Device for Detection of Colorectal Polyps

During standard colonoscopy a substantial number of colorectal polyps may be missed. Previous studies have found a 12-28% of miss rate for all polyps, a 31% for hyperplastic polyps and 6-27% for adenomas. In this study it is tested whether a retro viewing endoscope can detect more colorectal polyps in comparisson to standard forward viewing endoscopy. Further, ppolyps detected, mean adenomas per Patient and withdrawal time are recorded.


Eligibility Criteria:
Inclusion Criteria:

* screening colonoscopy
* 18 years of age

Exclusion Criteria:

* inflammatory bowel disease
* inadequate bowel preparation
Dose Escalation of POL6326 in Combination With Eribulin in Patients With Metastatic Breast Cancer

POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to, on the day of and on days after treatment with eribulin. Different doses and dosing frequencies will be investigated


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive cancer of the breast.
* Presence of at least one measurable lesion per RECIST 1.1 criteria
* Stage IV disease by AJCC criteria (7th edition).
* HER2 negative (IHC 0,1 or FISH HER2:CEP17 ratio \< 2.0)
* Must have had treatment with at least 2 but no more than 3 previous regimens in the metastatic setting. Previous treatment must have included an anthracycline and taxane in either the adjuvant or metastatic setting.
* At least 21 days from the completion of any previous cytotoxic chemotherapy or biological therapy at time of initiation of POL6326.
* ECOG performance status \< 2

Exclusion Criteria:

* Previously received eribulin.
* Peripheral neuropathy \> Grade 2.
* Receipt of any other investigational agent within the 28 days prior to Day 1.
* Receipt of colony stimulating factor filgrastim, pegfilgrastim, or sargramostim within 14 days prior to Day 1.
* Radiation therapy within the 14 days prior to Day 1.
* Severe concurrent illness or psychiatric illness/social situation that would limit compliance with study requirements.
* History of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
* Pregnant or breastfeeding.
* Known HIV positivity on combination antiretroviral therapy; these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy