cyrilzakka/clinical-trials huggingface dataset:
Interactions Between Fibre and Polyphenols on Colonic Phenolic Acid Production and Biomarkers of Health ( 6 Weeks)

The investigators have studied the acute interactions of polyphenols and NDC in a single meal in a human study containing tomatoes, lovage \& onions, with and without inulin. The investigators now wish to study the longer-term interactions of these foods over 6 weeks as well as their impact on biomarkers of human health, the gut microbiome, human proteome and markers of risk of chronic disease. This may allow better targeted evaluation of foods which influence health through the gut microbiome.

Polyphenol rich plant foods have been associated with several health benefits but their bioavailability is generally low. The majority of plant polyphenols are poorly absorbed in the small intestine and enter the colon where the colonic microbiota metabolise them to release a range of phenolic acids, which are now thought to be the main bioactive components related to the reduction in disease risk. Very little is known about the impact of other constituents of the diet on the metabolism and bacterial catabolism of these polyphenols.

Colonic bacteria are key agents in the release of the bioactive molecules from polyphenols but also ferment non-digestible carbohydrates (NDC) such as inulin to short chain fatty acids. It is likely that there are key interactions in the colonic bacterial metabolism of NDC and phenolics. The investigators hypothesize that combination of polyphenolics (in onions, tomatoes and lovage) with inulin (NDC) will increase the urinary output of bioactive phenolic acids over a 6 week feeding trial and impact on biomarkers of cardiometabolic health.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy
* BMI\>=25
* Not on antibiotics within 3 months of starting of study
* No medication likely to influence gut function, colonic bacterial activity.

Exclusion Criteria:

* Antibiotics
* Pregnancy
* lactation
QT-Logs : Artificial Intelligence for QT Interval Analysis of ECG From Smartwatches in Patient Receiving Treatment for Covid-19

This observational pilot prospective study will evaluate a new method for remote monitoring of corrected QT measurement using an artificial intelligence (AI)-based solution and ECG data collected via smartwatches (AI-QTc), in patients ambulatory treated with the HC-AZ combination, at the early stage of COVID-19 infection, at a tertiary hospital center. Daily ECGs will be performed via the smartwatches. AI-QTc will be compared to standard manual QTc reviewed by cardiologist. Correlation and agreement between measures will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* SARS-COV-2 confirmed infection by positive nasopharyngual PCR
* Prescription of association hydroxychloroquine and azythromycine for COVI-19 therapy
* Patient's smartphone able to download the smartwatches application

Exclusion Criteria:

* Presence of a pacemaker
* Pregnant or breastfeeding females
* Refusal to participate
* Incapacity
* Adult under legal protection (trusteeship, guardianship)
Maintaining Patency in Implanted Port Catheters

The purpose of this study is to determine the safest and most effective flushing solution for maintaining patency (unobstructed flow) in implanted port catheters. The complication rate in patients whose ports are flushed with saline only will be compared to the complication rate in patients whose ports are flushed with a combination of saline and heparinized saline.

The purpose of this study is to determine the safest and most effective flushing solution for maintaining patency (unobstructed flow) in implanted port catheters. The complication rate in patients whose ports are flushed with saline only will be compared to the complication rate in patients whose ports are flushed with a combination of saline and heparinized saline. These complications include partial or complete obstruction, infection of the central line, and/or the onset of heparin induced thrombocytopenia.

Eligibility Criteria:
Inclusion Criteria:

* Able to read and understand English
* Has an implanted port in place less than one (1) year
* Evidence of a patent (unobstructed) port catheter prior to enrollment in the study
* Is receiving active treatment (i.e., receiving a therapeutic drug through the implanted port)
* Current treatment protocol projected to continue for a minimum of three (3) months
* Anticipates receiving care at the identified centers for 12 months following enrollment in the study
* Does not receive care of implanted port at any other facility

Exclusion Criteria:

* Has documented heparin platelet antibody (i.e., could not be randomized to either group) or other allergy to heparin
* Receiving therapeutic dose of an anticoagulant (e.g.,warfarin, heparin, enoxaparin)
* Does not have a BioFlo port (heparinized port)
* Does not meet one or more of the inclusion criteria
Development of a Model to Predict the Risk of Venous Thromboembolic Events in Patients With Metastatic Bronchopulmonary Cancer

Venous thrombo-embolism (VTE) is a frequent and serious complication of cancer. However, predictive tools for VTE in cancer patients is lacking.

In patients with metastatic broncho-pulmonarycancer, biochemical characteristics might help to identify patients at high risk for VTE.

The aim of this study is to derive a predictive score combining clinical and biochemical variable that predict VTE in metastatic broncho-pulmonary cancer.

Venous thrombo-embolism (VTE) is a frequent and serious complication of cancer. However, predictive tools for VTE in cancer patients is lacking.

In patients with metastatic broncho-pulmonarycancer, biochemical characteristics might help to identify patients at high risk for VTE, particularly in adenocarcinoma.

The aim of this study is to derive a predictive score combining clinical and biochemical variable that predict VTE in metastatic broncho-pulmonary cancer.

Eligibility Criteria:
Inclusion Criteria:

* metastatic broncho-pulmonary cancer
* age ≥18 years
* who are eligible for chemotherapy
* non opposition obtained

Exclusion Criteria:

* age \<18 years
* pregnancy, breast feeding
* VTE in the past 6 months or at the time of cancer diagnosis
* surgery in the past 3 months
* refusal to participate
Comparison of Dexmedetomidine and Fentanyl to Prevent Hemodynamic Response to Skull Pins Application

To compare the effect between dexmedetomidine and fentanyl for controlling the hemodynamic response to skull pins application

A randomized, double-blinded controlled trial was conducted from September 2015 to September 2016 in Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Thailand. Sixty patients who underwent craniotomy with insertion of skull pin were randomly allocated into group A and B. After patients entered the operative room, blood pressure and heart rate were measured (T1) then repeated measurement again (T2) when started induction, intubation and infusion dexmedetomidine 1 µg/kg over 10 min infusion in group A whereas group B received normal saline. At 3 minutes before skull pin insertion (T3), patient in group B received a single bolus of fentanyl 1 µg/kg whereas group A received normal saline. Then hemodynamic responses were recorded and repeated again at one minute before skull pin insertion (T4). Blood pressure and heart rate were observed at the time of skull pin insertion (T5) then repeated every 1 minutes after skull pin application until 5 minutes (T6 - T10).

Eligibility Criteria:
Inclusion Criteria:

* patients who scheduled for elective craniotomy under general anesthesia
* patient with American Society of Anesthesiologists physical status classification of I and II

Exclusion Criteria:

* patients having body mass index more than 30 kg/m2, heart rate lower than 45 bpm, hypertension, ischemic heart disease, heart block, on beta adrenergic blockers, medication allergy including propofol, fentanyl, and dexmedetomidine.
Telephone-based Motivational Interviewing for Smoking Cessation in Crohn's Disease Patients

Quitting smoking unequivocally improves the course of Crohn's disease (EC), and therefore, it should be one of the main therapeutic targets in the treatment of this disease. The goal of the study was to know the effectiveness of motivational intervention 5 R for smoking cessation in patients with Crohn's disease performed by telephone by nursing, in relation to those who did not receive such intervention.

For this purpose, a controlled, randomized, parallel and open clinical trial was designed. The subjects were patients with Crohn's disease that were actively smoking EC. They were all \>18 years old and they had internet access and e-mail. Those who were already in a process of smoking cessation were excluded from the study. Experimental intervention consisted of a motivational intervention for smoking cessation through telephone every 3 months for one year.


Eligibility Criteria:
Inclusion Criteria:

* Smokers Crohn's disease patients
* \>18 age

Exclusion Criteria:

* Smokers Crohn's disease patients who are receiving treatment of tobacco cessation at the time of inclusion
* Do not have email
Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy

This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of KD025 in subjects with Chronic Graft Versus Host Disease (cGVHD) after at least 2 prior lines of systemic therapy

Phase 2, open label, randomized, multicenter study in subjects with cGVHD who have previously been treated with at least 2 prior lines of systemic therapy. Approximately 166 subjects with active cGVHD will be randomized (1:1) to receive treatment with one of two belumosudil (formerly known as KD025) regimens:

* Arm A: belumosudil 200 mg QD
* Arm B: belumosudil 200 mg BID

With Amendment 2, the sample size was increased from approximately 126 subjects, with additional subjects to be enrolled as follows:

* 20 adolescents
* 20 adults into a site-specific Companion Study to collect biospecimens

These additional subjects will also be randomized (1:1) to Arm A or Arm B.

Any adolescent taking a proton pump inhibitor (PPI) or a strong CYP3A4 inducer will begin Cycle 1 Day 1 at the escalated dose of belumosudil 200 mg BID.

Randomization will be stratified according to prior cGVHD treatment with ibrutinib (Yes / No) and severe cGVHD at baseline (Yes / No). Subjects may receive treatment in 28-day treatment cycles until clinically significant progression of cGVHD. Subjects who have not achieved a response after 12 cycles of belumosudil should be withdrawn if in the Investigator's judgment there is no evidence of clinical benefit. Subjects will undergo evaluations as outlined in the Study Assessments table (Appendix A). The primary endpoint is the overall response rate (ORR) with responses as defined by the 2014 National Institute of Health (NIH) Consensus Development Project on clinical trials in cGVHD.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects at least 12 years of age who have had allogenic hematopoietic cell transplant (HCT).
2. Previously received at least 2 and not more than 5 lines of systemic therapy for cGVHD
3. Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening
4. Have persistent cGVHD manifestations and systemic therapy is indicated
5. Karnofsky Performance Score of ≥ 60 (if aged 16 years or older); Lansky Performance Score of ≥ 60 (if aged \< 16 years)
6. Weight ≥ 40kg

Exclusion Criteria:

1. Subjects has not been on a stable dose / regimen of systemic cGVHD treatments for at least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate, rituximab, and extracorporeal photophoresis (ECP) are acceptable. Systemic investigational GVHD treatments are not permitted).
2. Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
3. Current treatment with ibrutinib. Prior treatment with ibrutinib is allowed with a washout of at least 28 days prior to randomization.
Western Equine Encephalitis Vaccine, Inactivated

This study is designed to determine the safety and immunogenicity of WEE Vaccine Lot number 3-1-92.

Study Objectives:

Primary: To assess safety of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, lot 3-1-92.

Secondary: To evaluate immunogenicity of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, lot 3-1-92.

Eligibility Criteria:
Inclusion Criteria:

* 18-55 years of age
* In good health as determined by pertinent medical history, brief physical exam, vital signs, and clinical safety laboratory evaluations
* Female: has a negative urine pregnancy test and is willing to use reliable form of contraception for the study duration
* Negative HIV antibody screen, seronegative for HBsAg and Hepatitis C antibody
* WEE, EEE, VEE, and CHIK PRNT80\<1:10
* Ability to comprehend abnd a willingness to sign an informed consent, which includes the HIPAA and a separate HIV consent form
* Be willing to comply with all follow-up visits, testing, and AE reporting

Exclusion Criteria:

* Participant in the USAMRIID SIP
* Receipt of any other vaccine or investigational; drug within 30 days prior to study entry
* Anticipates receipt of other vaccines for the duration of the study (influenza vaccination will be permitted but not within 28 days of WEE vaccination
* Acute of chronic medical conditions, medications, or dietary supplements that, in the PI's opinion, would impair the subject's ability to respond to vaccination
* Hypersensitivity to any vaccine
* Allergic to any vaccine component: Human serum albumin, Neomycin
* Receipt of or anticipates receipt of blood products during the study
* Female: Pregnant or breastfeeding
* Clinically significant abnormal laboratory tests (generally greater than or equl to 2 times the upper limit of normal as determined by the PI)
A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy

This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar monotherapy compared with placebo in patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic therapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Diagnosis of diabetes mellitus, type 2 within 12 months prior to screening
* Patients who have not received a anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months in the past
* HbA1c \>/=7% and \</=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
* Fasting plasma glucose \</=240 mg/dL at pre-randomization visit
* Agreement to maintain diet and exercise habits during the study

Exclusion Criteria:

* Patients with Type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months
* Any previous treatment with thiazolidinedione or a dual peroxisome proliferator activated receptor (PPAR) agonist
* Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)
* Symptomatic congestive heart failure classified as New York Heart Association class II-IV at screening
Study of Long Non-coding RNA SNHG15 as a Novel Biomarker in HBV Associated HCC

In this study, the investigators will detect the expression of HBV-related HCC biomarker lncRNA SNHG15 in tumor tissues and peripheral blood, to explore the specific molecular markers for the early diagnosis of HBV-related HCC.

Paired hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) and adjacent liver tissues were selected, and lncRNA SNHG15 was detected by RT-PCR. At the same time, healthy subjects were selected as the control group, and lncRNA SNHG15 in blood was detected by RT-PCR. At the same time, the correlation between lncRNA SNHG15 and the clinical data of patients, such as diagnosis, pathological grading, recurrence, metastasis and survival time was statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* The age and sex of the healthy control group were matched with that of HBV-associated patient group. There was no tumor in the other parts of the body, and no tumor in the blood system. The healthy control group did not have any liver benign diseases. There are no inflammatory diseases in other parts of the body; the functions of the liver, kidney, and heart were normal.

Exclusion Criteria:

* The volunteer has tumors in the liver or other parts of the body, or blood system tumors; The volunteer has benign liver diseases; The patient has inflammatory disease elsewhere. If the volunteer has any one of the above diseases, it shall be excluded.
Using Clonidine to Improve Leg Weakness in People With Heart Failure

People with heart failure often have weakness in their leg muscles. This study will determine whether the leg weakness is due to very high adrenaline levels and whether the medication clonidine can improve leg weakness.

Heart failure is a common condition, affecting approximately 5 million people in the United States. People with heart failure are encouraged to exercise and lose weight. However, many people with heart failure develop weakness in their leg muscles, which can make exercise difficult. Increased sympathetic nerve activity, which involves the nerves that carry adrenaline, also occurs in people with heart failure. It is possible that the increased sympathetic nerve activity may actually cause the leg muscle weakness. Clonidine, a medication used to treat high blood pressure, has been found to decrease sympathetic nerve activity. This study will further examine the connection between leg weakness and sympathetic nerve activity. It will also evaluate the effectiveness of clonidine at decreasing leg weakness in people with heart failure. Results from this study may explain why some people with heart failure are unable to exercise and may help to identify ways in which leg strength can be increased.

This study will enroll people with heart failure. Participants will be randomly assigned to wear either a clonidine patch or a placebo patch for 3 months. Participants will wear the patch on their upper arm, and they will replace the patch each week. At study visits at baseline and Month 3, participants will undergo the following procedures:

* Sympathetic nerve activity recording, which will record nerve activity in the lower leg, using small electrodes inserted through the skin
* Muscle biopsy, in which a small piece of muscle tissue will be obtained from participants' legs
* Heart rate and blood pressure measurements
* Arterial baroreceptor measurements, in which the nerves in the body that respond to changes in blood pressure will be examined while participants receive different medications to increase and decrease their blood pressure
* Echocardiography to obtain images of the heart
* Magnetic resonance scan of the leg
* Passive exercise procedure, in which study researchers will conduct an arm exercise with participants

There will be no follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure

Exclusion Criteria:

* Currently on Coumadin therapy
* Experienced a heart attack in the 3 months before study entry
* Medically unable to receive clonidine
* Advanced kidney or liver disease
Study of Nitazoxanide Combined With Peginterferon Compared to Peginterferon Monotherapy in the Treatment of Hepatitis C

The purpose of this study is to evaluate the safety and efficacy of nitazoxanide-peginterferon alfa-2b combination therapy compared to peginterferon monotherapy in patients that are treatment naive or pre-treated for 24 weeks with nitazoxanide monotherapy in the treatment of chronic hepatitis C.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Chronic hepatitis C infection (at least 6 months) evidenced by a positive enzyme immunoassay for anti-HCV-antibodies and a positive quantitative RT-PCR amplification of HCV RNA.
* Chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis.
* HCV genotype 4.
* Patients that have not previously received peginterferon.

Exclusion Criteria:

* Patients unable to take oral medications.
* Use of ribavirin within 30 days prior to enrollment.
* Females who are either pregnant, breast-feeding or not using birth control and are sexually active.
* Any investigational drug therapy within 30 days prior to enrollment other than through Romark study number RM01-3027.
* Patients with other causes of liver disease.
* Transplant recipients receiving immune suppression therapy.
* Patient co-infected with human immunodeficiency virus, hepatitis A virus, hepatitis B virus, or hepatitis D virus based on enzyme immunoassay.
* Patients with decompensated cirrhosis, thrombocytopenia (platelet count \<80,000), neutropenia, history of variceal bleeding, ascites, hepatic encephalopathy or CTP scores \>6.
* Patients with history of alcoholism (unless abstinent for 2 years) or with an alcohol consumption of \>20 grams per day.
* Patients who are clinically unstable.
* Patients with any concomitant condition that, in the opinion of the investigator would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed.
* History of hypersensitivity or intolerance to any of the excipients comprising the nitazoxanide tablets or peginterferon alfa-2b solution for injection.
4-point vs 4-roll Canne as Walking Aids After Stroke

Stroke patients frequently necessitate walking aids such as 4-point canne. However, the 4-point canne has to be lifted by the patient which limited gait speed. The adjunction of small wheel below the 4 point of the canne (4-roll) gives the possibility to the patient to walk without having to lift the canne as it will roll over the ground.

The aim of our study is to compare gait parameters (gait speed and energy cost) with a classical 4-point canne and with 4-roll canne.

Stroke patients frequently need walking aids such as 4-point canne. However, the 4-point canne has to be lifted by the patient which limited gait speed. The adjunction of small wheel below the 4 point of the canne (4-roll) gives the possibility to the patient to walk without having to lift the canne as it will roll over the ground.

OBJECTIVE To compare the gait parameters with a 4-point canne and with a 4-roll canne METHODS The investigators will recruited stroke patients who necessitate 4 point-canne as walking aids. A 10 meters walking test, a 6 minutes walking test, an estimated energy cost and a patient's satisfaction will be monitored with a 4-point canne (day 1) and with a 4-roll canne (day 2) in a cross-over study. The first tested device will be randomized.

PERSPECTIVE The investigators hope to demonstrate that a 4-roll canne makes possible to walk faster in a safe way after stroke

Eligibility Criteria:
Inclusion Criteria:

* post stroke patient
* able to walk 10 meters

Exclusion Criteria:

* cognitive impairment limiting walking capacities
* need support when walking