cyrilzakka/clinical-trials huggingface dataset:
Gastric pH and Anthocyanin Absorption

Anthocyanins are phytonutrients that provide blue, purple and red colors to fruits and vegetables. The purpose of the study is to determine whether absorption of anthocyanins occurs in the acid pH of the stomach and to determine whether altering stomach pH by use of an over-the-counter medicine, Prilosec TM, alters absorption of anthocyanins from strawberries and blackberries.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5 kg/m2 to 30 kg/m2
* Age 22 to 59 years

Exclusion Criteria:

* Plans to have MRI analysis or other contact with MRI equipment during the study
* Has implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump
* Suspected strictures, fistulas or physiological GI obstruction
* Allergy to omeprazole
* Current use of clopidogrel (Plavix) or use within the past 3 months
* Use of warfarin, prescription antifungals/anti-yeast drugs, diazepam, and digoxin
* Chronic daily use of nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen, etc.)
* History of bariatric or other gastric surgery
* Frequent use of antacids
* Use of proton pump inhibitors in past 3 months
* History of acid reflux
* History of gastrointestinal disorders or gastrointestinal surgery
* History of bezoars (packed collection of partially digested or undigested material that is unable to exit the stomach)
* Crohn's disease, diverticulitis or inflammatory bowel disease
* Inability to swallow large pills
* Dysphagia (Trouble or pain with swallowing food or pills)
* Allergy to strawberries or blackberries
* Pregnant women
* Lactating women
* Pregnancy in last 12 months
* History of kidney disease
* History of liver disease
* History of metabolic disorder
* History of some cancers
* Tobacco use in past 6 months
* Use of oral or IV antibiotics in past month
* Use of herbal supplement in past month
Neuro Biomarkers of Smoking Behavior

The purpose of this study is to evaluate cognition in smokers and nonsmokers. It involves administration of intranasal insulin (Novolin R), an investigational medication followed by a brief non-invasive cognitive test. All participants will receive both Novolin R and placebo in two separate testing sessions.

This program of research focuses on identifying neurologic biomarkers of smoking behavior in order to develop individualized smoking cessation aids. The intranasal insulin administered is an investigational drug and has been granted IND status by the FDA (IND#129432). During the times of drug effects, the investigators will evaluate a biomarker using computerized tasks. Non-smokers and smokers will participate in two testing sessions where the biomarker will be critically evaluated after administration of intranasal insulin and compared to the cognitive processes elicited by placebo administration.

Eligibility Criteria:
Inclusion Criteria:

* Age between 21-40 years
* Smokers only: Begin smoking within 5 minutes of waking (verified by carbon monoxide concentrations greater than 10 ppm).
* Non-smokers only: No self-reported cigarette use in the past 1-year period.
* Non-smokers only: Carbon monoxide concentration \< 6 ppm.
* Normal vitals (blood pressure \< 120/80 mmHg; heart rate between 60 and 100 bpm, body temperature \<37 °C)
* Point-of-care (POC) blood glucose between 80 and 140 mg/dL
* Body mass index between 18.5 and 30 kg/m2

Exclusion Criteria:

* Use of non-cigarette tobacco products, e-cigarettes, or smoking cessation treatment
* Positive urine drug screen test
* Current pregnancy (urine test-verified) or lactation, or a plan to become pregnant
* Breath Alcohol Concentration \>0.00%
* Shipley IQ (Intelligence Quotient) test \<80
* Hyposmic or anosmic individuals (identifying less than 10 of 12 smells correctly)
* Abnormal physical exam of the nares
* Lifetime DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) Axis 1 disorder (except anxiety and depression)
* Current DSM-5 Axis depression or anxiety disorder
* Prescription medications
* Over-the-counter psychotropic medications
* Use of any medications administered intranasally
* Allergies to any ingredients in intranasal insulin or placebo
* Braided hair that would cause noise in EEG recording
Individualized Treatment of Pediatric R/R AML Based on Transcriptomic Profile and in Vitro Drug Sensitivity Test

Acute myeloid leukemia (AML) accounts for about 15% to 20% of childhood leukemia, but the death rate accounts for about 50%. About 20-30% of children with AML did not achieve complete response (CR) after 2 induction treatments, and about 30% of children with CR had relapse within 3 years (including recurrence after hematopoietic stem cell transplantation).Relapsed/refractory (R/R) AML is a major cause of treatment failure and refractory survival. Reinduction chemotherapy for R/R-AML to obtain CR again, followed by hematopoietic stem cell transplantation, is the current treatment. At present, there is no recognized reinduction protocol, and the reinduction remission rate of R/R-AML varies greatly among different treatment regimens, ranging from 23 to 81%. Current guidelines recommend a new combination chemotherapy regimen consisting of new drugs without cross-resistance. This method selects sensitive chemotherapeutic drugs, and then forms a new combination chemotherapy regimen according to the characteristics of drugs, which is the choice of R/R-AML reinduction therapy.This study intends to conduct a clinical study on the individualized treatment of R/R AML patients through in vitro drug sensitivity test combined with patient transcriptomic characteristics.


Eligibility Criteria:
Inclusion Criteria:

- (1) Refractory recurrent acute myeloid leukemia (AML), and after second-line reinduction therapy, such as C+HAG did not reach complete CR.Criteria for complete response, refractory, and recurrence are as follows.

(2) \<18 years old; (3) The child had good organ function, could tolerate chemotherapy, and had a physical strength score of 0-3 (WHO standard); (4) Understand the research procedures and voluntarily sign written informed consent.

Exclusion Criteria:

- (1) Acute promyelocytic leukemia, chronic myelogenous leukemia, acute mixed cell leukemia or known central nervous system leukemia; (2) AML associated with congenital syndromes such as Down syndrome, Fanconi anemia, Bloom syndrome, Cole's syndrome, or congenital aplastic anemia; (3) secondary to immunodeficiency or positive for human immunodeficiency virus (HIV); (4) Cardiac and renal function were obviously abnormal, and left ventricular ejection fraction was \<50%.

(5) There is active systemic infection; (6) any medical history or concomitant condition that the investigator believes would impair the subject's safe completion of the study; (7) The investigator considers that the subject is medically unfit to receive the investigational drug or is unfit for any other reason; (8) a known or suspected allergy to the subject drug or to any drug administered in connection with this test;
Patients With Alzheimer Disease, Spouse Carers and Risk of Institutionalization: a Prospective Observational Cohort Study of Dyads (AID Study)

The primary objective of AID study is to identify the medico-neuropsychological, socio-economic and environmental baseline characteristics of dyads associated with the institutionalization of AD patients.

In order to reduce Alzheimer Disease (AD) adverse impacts at individual level as well as in terms of expenditures, the development of efficient strategies based on the identification and the correction of risk factors of institutionalization of AD patients proves necessary.

While it has been identified that institutionalization date depends on patients' health characteristics, the role of social, economic and environmental factors still remains few known.

The investigators hypothesized that institutionalization of AD patients could be related not only to medico-neuropsychological patients' characteristics but also to socio-economic and environmental characteristics of dyad (i.e., AD patient and spouse carer), that could modify the delay of institutionalization.

Eligibility Criteria:
Inclusion Criteria:

* Eligibility criteria for AD patients were:

  * Over age 65,
  * Diagnosis of AD according to the NINCDS-ADRDA ( National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) criteria,
  * Last memory center consultation between 6 and 12 months before the inclusion,
  * Being affiliated to the French health insurance,
  * Living at home,
  * Having a caregiver with inclusion criteria,
  * Agreement of General Practitioner (GP) of AD patient to participate in the study and affiliation of the GP to the national "Association pour le Développement de l'Information Médicalisée" (ADIM) French network.
* Eligibility criteria for spouse carers were:

  * Over age 65,
  * Being the spouse and the caregiver of AD patient,
  * Being affiliated to the French health insurance,
  * Living at home with AD patient.

Exclusion Criteria:

* Non inclusion criteria for AD patients and spouse carers were:

  * An inability to understand and speak French,
  * Acute disease in the past month of baseline assessment,
  * Expected moving outside the recruitment area during the follow-up period
  * Concomitant participation in a clinical trial.
Robot-assisted Training of the Upper Limb in Persons With Multiple Sclerosis: an Randomized Controlled Trial

With this randomised intervention study, the investigators want to investigate the training effect of an 8 week training regime, using a robot-assisted training system in persons with MS. Besides conventional therapy, study participants in the experimental group will train 3 times per week during 30 minutes, using the haptic master. Research questions focus on the effects of additional robot assisted training on range of motion, movement quality and clinical tests for the upper limb in persons with MS. Evaluation by means of questionnaires and clinical outcome measures occured at baseline, after 4 weeks, after 8 weeks and at 16 weeks of follow-


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Multiple Sclerosis (McDonald criteria), upper limb dysfunction due to muscle weakness (Motricity Index \<80), age \> 18 years

Exclusion Criteria:

* MS relapse or glucocorticosteroid treatment in the last month before the start of the study, upper limb paralysis (Motricity Index \< 18), other sever limitations, influencing participation (cognitive, visual)
Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers

To evaluate the ocular tolerance of T1225 1% and 1.5% eye drops versus vehicle after one instillation twice-daily (morning and evening), in one eye, during 3 days (from Day 0 to Day 2).

To assess azithromycin tear, conjunctiva and plasmatic concentrations, after a 3-day treatment period

The aim of the present study was to compare ocular tolerance and safety after repeated instillations of T1225 1% and 1.5% eye drops and vehicle and to assess the residual azithromycin concentrations in tear, ocular conjunctiva and plasma samples, approximately 12 hours after the last Investigational Medicinal Product instillation.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged from 18 to 45 years old;
* Written informed consent;
* Healthy volunteers without any subjective ocular symptom;
* Normal ocular examination in both eyes (corrected visual acuity \>= 6/10, normal slit lamp examination, tear prism height \> 0.1mm, tear break-up time (BUT) \>= 10 seconds, lissamine green test score \< 4);
* Registered, or agreed to be registered, in the national register of healthy volunteers

Exclusion Criteria:

* Ocular trauma, infection or inflammation within the last 3 months;
* number of corneal stained punctuations Ocular trauma, infection or inflammation within the last 3 months;
* number of corneal stained punctuations \>= 5;
* blepharitis, conjunctivitis, uveitis;
* contact lenses;
* topical ocular treatment within the last month;
* ocular laser within the last 3 months;
* ocular surgery, including LASIK and PRK, within the last 12 months;
* systemic macrolide within the last month;
* medication during the study (except: paracetamol and contraceptives).
Pharmacokinetics of Two Eletriptan Oral Formulations Given With and Without Water and the Commercial Tablet Formulation Given With Water

The study will evaluate whether the blood concentrations of eletriptan administered using two test formulations of oral disintegrating tablets are comparable to those observed with the standard commercial tablet.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* No CYP3A4 inhibitors

Exclusion Criteria:

* Clinically significant disease in any organ system
* Positive urine drug screen
Thermography in Surveillance of Ulcerative Colitis

Ulcerative colitis represents a chronic condition occurring in relapsing and remitting fashion with uncertain outcome and requires lifelong treatment with considerable side effects. Diagnostic methods currently in use, clinical (endoscopy), imaging (CT, MR) or laboratory (C - reactive protein, fecal calprotectin) give an insight into disease activity but are possibly associated with significant discomfort for the patient and / or increased risk of irradiation and potential allergic reactions on contrast agents. For that reason there is a need for a noninvasive, biologically inert method for evaluation of disease activity in inflammatory bowel disease (IBD). Thermography possesses most of these characteristics. The aim of this study is to find potential link between pathological thermographic signs and endoscopic findings, serum C reactive protein (CRP) and calprotectin in the stool of patients with active and extensive ulcerative colitis.

Hypothesis: Documenting pathological thermographic signs in patients with extensive ulcerative colitis investigators will demonstrate pathological thermography criteria that correlate with standard inflammatory markers such as Mayo endoscopic subscore (ESS), CRP and calprotectin in patients with ulcerative colitis.

Aims: The aim of this study is to record abdominal thermographic images of patients with active ulcerative colitis (UC), to create interpretational thermographic criteria for these images and to compare them to abdominal infrared (IR) images of healthy volunteers. Furthermore, investigators intend to correlate these criteria with standard markers of inflammation such as CRP and calprotectin in patients with UC at the beginning of treatment and at the end.

Materials and methods: For the purpose of this work, 36 patients with extensive UC and 30 healthy individuals will be put throe thermographic imagining, have their stool tested for calprotectin and their blood for CRP. In addition, patients with UC will receive colonoscopy evaluations.

Expected scientific contribution: The results of this paper would give an additional contribution to existing tools for pursuing ulcerative colitis activity thus demonstrating the potential of thermography as a complementary method to standard methods in assessing disease activity. Establishing diagnostic criteria for this method would be a good addition to present clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Endoscopic diagnosis of active extensive ulcerative colitis
* Stool Calprotectin \> 150 mcg/g
* CRP \> 5 mg/L
* Signed informed consent form

Exclusion Criteria:

* Inability to preform total colonoscopy
* Marked abdominal comorbidities
* Prior abdominal surgery
Study of Association Between Maternal Uric Acid , Maternal and Fetal Outcome in Pregnant Women With Hypertension

Association of maternal uric acid with maternal condition and fetal outcome in pregnant women with hypertension.

Association of maternal uric acid with maternal condition(renal function,liver function,...ect.) and fetal outcome(birth weight,APGER score) in pregnant women with hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Age:18-40 years old
* Gestational age:28-42 weeks gestation singleton pregnancy of living fetus
* Non smoker

Exclusion Criteria:

* women who refuse the study
* Any medical or obstetric disorders especially D.M.,renal disease,hepatic, cardiac disorders or gout arthritis, other than hypertension if present.
* Previously elevated uric acid level.
* Hemolytic or sickle cell anemia,urinary tract infection.
* Use of diuretics or anti-inflammatory drugs.
The Effect of Glucagon-like-peptide 1 (GLP-1) Receptor Agonism on Diabetic Kidney Disease

Diabetic kidney disease (DKD) is a devastating complication of diabetes, that in it's worst form, can lead to early cardiovascular death or kidney failure. A group of medicines used to treat diabetes, glucagon-like-peptide-1 analogues (GLP-1), may be able to protect people with diabetes from DKD by reducing inflammation in the kidney. This study aims to test this theory by studying the effect of GLP-1 on kidney function in people with diabetes.

To understand how GLP-1 can affect inflammation, the investigators will give a GLP-1 treatment (Liraglutide) to people with DKD and monitor the effect on inflammation and kidney function using blood and urine tests. The investigators will compare these results to patients with DKD who do not receive GLP-1 treatment.

If GLP-1 proves to be effective in reducing inflammation and improving kidney function, then it could be developed as a viable new treatment for people with DKD, and may significantly reduce the disease burden, or the risk of DKD, in people with diabetes. This would be a major advance in the treatment of DKD.

A randomised controlled trial for patients with microalbuminuria and type 2 diabetes. Treatment is 0.6mg of liraglutide and is compared to standard care. Treatment duration is 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes with a HbA1c of 42-75mmol/mol (6-9%DCCT)
* Male or female aged above 30 years
* Have a negative pregnancy test at screening (women of child bearing potential only)
* Body mass index (BMI) of 25kg/m2 or greater
* On a renin-angiotensin system antagonist, at a stable dose, for at least 8 weeks before inclusion into the study
* Established microalbuminuria
* Estimated glomerular filtration rate (eGFR) 30ml/min/1.73m2 or above by Modification of Diet in Renal Disease (MDRD) formula

Exclusion Criteria:

* Patients with any cognitive impediment that preclude the patient from giving free and informed consent
* Patients on dipeptidyl peptidase 4 inhibitors or thiazolidinedione treatment
* Patients with stage 4-5 renal disease, defined as an eGFR of 30ml/min/1.73m2 or less
* Patients who have used a GLP-1 agent in the last 6 months
* Female patients of child bearing potential who are pregnant, breastfeeding, or unwilling to practice an acceptable barrier and/or hormonal method of contraception or abstinence during participation in the study
* Previous pancreatitis
* Hypersensitivity to GLP-1 analogues
* Proliferative diabetic retinopathy
* Any other contraindications, as per the SmPC for liraglutide
* Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the dosing requirements
* Concurrent treatment with an investigational drug or participation in another clinical trial
* Use of an investigational drug within 4 weeks or 5 half-lives, whichever is longer, preceding the first dose of investigational medicinal product
Evaluation of Lifestyle Modification on Cardiovascular Risk

This study proposes to examine the independent and combined effects of an 8-week home-based, equipment-free HIIT exercise intervention with/without Mediterranean diet through ghrelin-mediated alteration in overweight and obese metabolic women to improve cardiovascular-risk related markers and metabolic risk factors.

This is a randomised-controlled study investigating the independent and combined effects of a home-based, equipment-free high intensity interval training (HIIT) exercise intervention with/without the Mediterranean diet (MedDiet) through ghrelin-mediated alteration on body composition, cardiovascular risk-related markers, metabolic markers and obesity-related hormones in postmenopausal women. The intervention will last for 8-weeks, with three arms comprising of 1) exercise only (Ex); 2) exercise and MedDiet (Ex+MedDiet); 3) control (no intervention).

Eligibility Criteria:
Inclusion Criteria:

* Female
* Participants \>45-65 years of age
* Body mass index (BMI) \>25.0 - 35.0
* Postmenopausal (with spontaneous amenorrhea for the last 12 months)
* Healthy (no known diseases)
* Physically inactive (IPAQ score - category I and not engaged in at least 60 min/week of structured exercise during the previous 6 months)
* Generally well enough to exercise.

Exclusion Criteria:

* Any inclusion criteria not met
* Abnormal ECG
* Current smokers
* Current or history of substance abuse and/or excess alcohol intake
* Cardiovascular disease
* Cancer
* Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
* Kidney disease
* Liver disease
* Pancreatitis
* On hormone therapy for \<6 months
* Prescribed anti-hypertensive or beta-blocker medication
Pharmacokinetic Study of Single Doses of Clopidogrel, 75 mg and 300 mg, in Healthy Subjects

The objectives of the study are to:

* Assess the within-subject variability of the pharmacokinetic profiles of the clopidogrel and its active metabolite after a replicated single administration of 75 mg of clopidogrel in healthy male and female subjects
* Assess the pharmacokinetic profiles of the clopidogrel and its active metabolite after single administration of 75 or 300 mg of clopidogrel

The total study duration per subject is 4 - 6 weeks broken down as follows:

* Screening: 2 to 21 days before the first dosing
* Period 1, 2 and 3: 4 days including 1 treatment day each
* Washout between periods: at least 7 days between 2 administrations
* End of study: 7 to 10 days after the last dosing

Eligibility Criteria:
Inclusion Criteria:

Healthy subjects:

* as determined by medical history and complete physical examination including vital signs and clinical laboratory tests
* with a body weight between 50kg and 95 kg if male, between 40.0 kg and 85.0 kg if female and a Body Mass Index (BMI) between 18 and 28 kg/m2

Exclusion Criteria:

* Evidence of inherited disorder of coagulation/hemostasis functions
* Smoking more than 5 cigarettes or equivalent per day
* Abnormal hemostasis screen
* Any contraindication to clopidogrel
* Unability to abstain from intake of any drug affecting haemostasis throughout the whole study duration.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Effects of Pregnane X Receptor (PXR) Activation on Human Glucose, Lipid and Hormone Homeostasis

This clinical trial is designed to study the effects of pregnane X receptor activator rifampicin on the glucose, lipid and hormone homeostasis in healthy volunteers. The main hypothesis is that rifampicin raises postprandial glucose studied with oral glucose tolerance test. The study is a non-randomized, one-phase, open-label trial. Twelve subjects will be given 600 mg of rifampicin a day for a week. The main outcome measures are the changes in the glucose and insulin levels during oral glucose tolerance test.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer
* Age 18-45 years
* Body mass index 19-28

Exclusion Criteria:

* Any continuous medication
* Any significant disease
* Allergy to rifampicin
* Pregnancy and breast feeding
* Fear of needles and previous difficult blood samplings
* Substance abuse
* Participation in another clinical drug trial within 1 month of enrollment
* Use of soft contact lenses