cyrilzakka/clinical-trials huggingface dataset:
Bioactive Phytochemicals From Wheat Bran

There is a lot of evidence to suggest that eating a diet rich in cereals such as wheat bran are beneficial in protecting us from diseases such as heart disease, diabetes and cancer. It is still not clear exactly why this happens, but it is likely that the compounds which enter our bodies when we eat such products are responsible. In this study we plan to find out what these compounds are and where they are found. The investigators will do this by asking volunteers to eat a wheat-bran meal and then measuring the compounds that appear in blood, urine and stool samples over the next twenty-four hours. Once the investigators know how much and which compounds are present, we can then find out possible reasons why they are protective, for example by looking to see whether they are anti-inflammatory. We also plan to look at whether if having a diet which contains either a lot of wheat-bran products or very low amounts of these foods effects how they are absorbed by the body.

HYPOTHESIS: Wheat bran from ready-to-eat cereal has unique phytochemical profiles which are metabolized to compounds responsible for high cellular bioactivity imparting important health benefits.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers will be healthy males or females and aged between 18 and 55 years who have a documented low (less than 1 portion per week) or high (more than or equal 5 portions per week) consumption of wheat bran and are able to give informed consent.

Exclusion Criteria:

* are taking any medicines prescribed by their general practitioner
* are taking drugs to lower high cholesterol levels or high blood pressure
* regularly take analgesics, antipyretic or anti-inflammatories
* regularly take nutritional supplements
* have taken antibiotics in the last three months
* have given a large blood donation in last three months
Pharmacokinetic and Pharmacodynamics of B12019 and Neulasta® in Healthy Subjects

Multi-centre, double-blind, randomised, 2-way cross-over study to investigate the PK and PD of B12019 as compared to Neulasta® administered as a single subcutaneous (s.c.) dose in healthy male subjects. B12019 or Neulasta will be administered by s.c. injection.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* Age ≥18 and ≤55 years
* BMI 22.0 - 28.0 kg/m2
* Non-smokers for at least 6 months prior to study start
* General good health, based on a comprehensive medical history and physical examination
* Adequate organ function and normal laboratory values (unless the investigator considers an abnormality to be clinically not relevant)
* Negative hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) tests at screening
* Signed informed consent

Exclusion Criteria:

* Known hypersensitivity to Escherichia coli derived proteins, pegfilgrastim, filgrastim or any other component of B12019 or Neulasta®
* Previous exposure to filgrastim or pegfilgrastim
* History of drug or alcohol abuse
* Blood donations in the past 3 months prior to study start, or bone marrow or stem cell donor in the past 12 months (first dose)
* Medical history of haematological disease, including sickle cell disorders
* Recent infection (within 1 week prior to first dose)
* Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, inflammatory or neurological diseases, that in the opinion of the investigator may interfere with the aim of the study
* Participation in an interventional or Phase I study in the last 3 months or is current a follow-up visit schedule for any study, or has participation in more than three studies of experimental drug products in the past 12 months prior to screening
* Subjects with ANC values outside the normal laboratory range at screening
* Use of prescription or over-the-counter drugs including vitamins within 4 weeks of first dosing
* Abnormalities in ECG
* Signs of dermatitis or skin abnormalities affecting the administration area and surroundings
* History of cancer
A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department

This was a trial comparing two commonly used medications for nausea and vomiting, ondansetron and promethazine, in the Emergency Department.

Nausea and vomiting are common complaints in the emergency department (ED). There are many pharmacologic agents used for the treatment of these complaints. None are new nor experimental. Very little research has been done in the ED setting to determine which of these agents is most effective with the least adverse effects. Our own previous research found that droperidol but not prochlorperazine and metoclopramide is more effective than placebo. Because of the recent FDA black box warning added to droperidol, the use of this agent has suddenly ceased in many EDs. Promethazine remains a very commonly used antiemetic in many EDs but one recent study found it less effective than prochlorperazine which was in turn found no more effective than placebo in our own study. As a result many physicians have turned to ondansetron, a newer and more expensive agent. Experience among anesthesiologists and oncologists has shown ondansetron to be highly effective with a minimum of adverse effects. These patient populations, however, are very different from those found in the ED. It is our hypothesis that promethazine and ondansetron are equally effective for the ED treatment of unselected patients with nausea and vomiting with similar rates of adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Chief complaint of nausea or vomiting

Exclusion Criteria:

* Age less than 18
* unable to provide informed consent
* rate nausea at \< 40 mm on 100 mm VAS
* received antiemetic within 24 hours
* pregnant or possibly pregnant
* reported allergy to either study medication
* received more than 1 liter of intravenous fluids
* their primary ED physician declined to have patient participate
Vaginal and Oral Microbiome Crosstalk

To study the vaginal and oral microbiome by swab samples. On selected cases, also papa smear will be studied.

To study the vaginal and oral microbiome by swab samples and on selected groups, by papa smear test, to find out the constitution of normal and vaginal microbiome and the cross-talk between oral and vaginal mucosa. To find out about the impact of human papilloma virus on the microbiome and vice versa.

Eligibility Criteria:
Inclusion Criteria:

* patients coming to Turku University Hospital Dermato-Venereology or Gynaecology Departments or to family planning clinics in The wellbeing services county of Southwest Finland for previously mentioned reasons

Exclusion Criteria:

* those not meeting the criteria
Equity in Diagnostic Imaging Trial

This study will 1) Develop two interventions: a) an audit-feedback email intervention that provides clinicians with data on CT scan ordering practices by patient race; and b) a clinical decision support (CDS) message in the electronic medical record headache template; and 2) Compare the effectiveness of these 2 interventions in eliminating a previously observed Black-White disparity in CT scanning rates to rule out subarachnoid hemorrhage (SAH).

Investigators at our institution (Hwang \& Richardson)\* documented a racial disparity in the use of CT scans to diagnose subarachnoid hemorrhage, (SAH) a life-threatening form of stroke. Subsequent analyses found a similar finding in NHAMCS, a national ED Visit database\*. The investigators will compare the effectiveness of 1) an audit-feedback intervention that provides data on race-specific CT rates and 2) a clinical decision support (CDS) message in the electronic "headache" charting template in eliminating the previously observed Black-White disparity in CT rates to rule out SAH.

Study Setting: The adult section of the Mount Sinai Emergency Department, an urban academic department with an annual volume of over 70,000 adult visits and a patient population representing a diverse cross-section of race and socioeconomic groups. The adult patients are cared for by a staff that includes: attending physicians, physician assistants, emergency medicine resident physicians, and rotating resident physicians from other specialties. The department has a dedicated CT scanner that is readily available around the clock. Epic Production is used for all physician and nurse documentation and for all order entry (including CT scans).

Over a 24-month period the investigators will compare the intervention and control groups' rates of testing for SAH across races, controlling for patient acuity, age and co-morbidities. Because the close working relationships among the attending and resident physicians in our department may lead to knowledge diffusion, the intervention may change the behavior of the control group as well as the intervention group, thus leading to an underestimation of the intervention effect as measured by the between- groups difference. The investigators will use a time series design to allow us to evaluate this effect. 10 months after the implementation of the first intervention, the clinical decision support message will be implemented. The impact of each intervention will be evaluated using a repeated measures design using a mixed linear model.

Eligibility Criteria:
Inclusion Criteria:

Attending Physicians, Emergency Room Resident Physicians, and PA's will be included if:

* they provide care to adult patients in the emergency department of Mount Sinai Hospital.

Patients will be enrolled for medical record review if

* they present with a complaint of headache and charted on the headache template in the period between four years pre-intervention and the end of the study period.

Exclusion Criteria:

* anyone who does not meet the inclusion criteria will be excluded from the study
TEE 3D RV Assessment for SAVR, Mini AVR, and TAVR

Three-dimensional echocardiography has become a gold standard to assess right ventricular (RV) function, and investigators plan to use 3D transesophageal echocardiography to assess RV function in 3 types of aortic valve replacement (AVR): surgical AVR (SAVR), mini-sternotomy AVR (mini AVR), and transcatheter AVR (TAVR).

Objective: Right ventricular (RV) function is known to be a critical factor to determine postoperative outcome in cardiac surgery, and echocardiography plays an important role in RV function assessment. In the previous studies, RV function was reported to be more reduced in surgical aortic valve replacement (SAVR) than transcatheter aortic valve replacement (TAVR), but its assessment was performed by 2-dimensional echocardiography. On the other hand, three-dimensional (3D) echocardiography has been the gold standard to assess RV systolic function (EF: ejection fraction), and its intraoperative use is getting more useful in cardiac surgery given recent technological advance in echocardiography machines. However, realty is that RV function assessment is based on subjective information or traditional RV function indices, mostly due to unfamiliarity of 3D technique.

In this study, the investigators plan to evaluate intraoperative RV function assessment by 3D transesophageal echocardiography (TEE). The investigators will compare 3D RV EF with other traditional RV function indices (RV size, Right Ventricular Index of Myocardial Performance (RIMP), RV fractional area change (FAC), peak systolic velocity of the lateral tricuspid annulus (S'), tricuspid annular plane systolic excursion (TAPSE), speckle tracking echocardiography (STE) in SAVR, mini-sternotomy AVR (mini AVR), and TAVR.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 18 years old
* Patients who had SAVR, mini AVR, or TAVR

Exclusion criteria:

* Patients' refusal
* Suboptimal echocardiography data for RVEF, RV size, RIMP, RVFAC, TAPSE, S', STE
Noninvasively Predicting Gene Status of Glioma

Malignant gliomas are the most common and deadly primary brain tumors in adults. The clinical outcome of patients with glioblastoma depends on key molecular genetic alteration. Specifically, Isocitrate Dehydrogenase Gene Mutation, an independent favorable prognostic factor, serve as diagnostic and prognostic markers of glioma. Thus, accurate grading of a glioma is fundamental in order to determine the treatment strategy. Amide proton transfer (APT) imaging is a noninvasive molecular MRI technique based on chemical exchange saturation transfer mechanism that detects endogenous mobile proteins and peptides in biological tissues. Preliminary studies have shown that APT-weighted (APTw) signal intensity could serve as a new imaging biomarker, by revealing significantly higher signal intensities in the high-grade gliomas compared with the low-grade gliomas. The purpose of this study was to investigate the value of amide proton transfer imaging (APT) in the noninvasive evaluation of isocitrate dehydrogenase (IDH) gene status in glioma.

Materials and Methods:

The whole brain MRI examinations were performed on a 3.0-T MRI system (Discovery MR750, General Electric Medical System, Milwaukee, WI, USA) with an eight-channel head coil (General Electric Medical System). Conventional MRI, contrast-enhanced MRI, DWI and amide proton transferimaging were performed in regular sequence during the same examination. Finally, contrast-enhanced T1-weighted spin echo sequence was acquired in the transverse, sagittal, and coronal planes after intravenous administration of 0.01 mmol/kg gadodiamide (Omniscan; GE Healthcare, Co. Cork, Ireland).

MRI data processing and image analysis:

All data were transferred to a workstation (Advantage Workstation 4.6, General Electric Medical System, Milwaukee, Wisconsin, USA) for processing.The MR imaging of all the patients were assessed independently by two experienced neuroradiologist (HYC and YLF, who have 12 and 6 years of experience, respectively, in neurologic-oncologic imaging) who were blinded to the patient's information. Next, a region of interest (ROI) was drawn manually on the solid part of the tumor with the relatively higher signal intensity on APT image.

Statistical analysis:

Categorical data obtained from image were calculated using the Fisher's exact test. Quantitative data were denoted as the mean and standard deviation. The Kolmogorov-Smirnov (K-S) test was used to assess the normality of data distribution.APT-weighted (APTw) signal intensity were tested for differences between the IDH mutation and the IDH wild-type by using independent sample t test.

Eligibility Criteria:
Inclusion Criteria:

* no hypertension or cerebral vascular diseases
* no use of corticosteroid drugs
* no MRI contraindication
* no allergic constitution

Exclusion Criteria:

* pregnant wowan
* motion cause poor image quality
Role of Adverse Childhood Events and Rejection Sensitivity on Alcohol Use in Recently Withdrawn Individuals with Alcohol Use Disorder

Low utilization of addiction treatment is a public health problem. A number of factors are associated with lack of treatment, including public stigma, self-stigma, and beliefs that people with addiction should solve their problem on their own. Stigma exposes individuals to social rejection, which may sustain the anxiety of rejection, and exacerbate certain mental disorders such as addictions. Social cognition disorders have been shown to be present in addictions, but one dimension of social cognition, emotional sensitivity to rejection (ESR), has been less studied. Rejection sensitivity could be considered a critical element in access to care and the relapse process.

The study authors hypothesize a role for emotional dysregulation in rejection situations in the relapse of alcohol use disorder in recently withdrawn patients. Specifically, they hypothesize that participants with a greater change in negative experience after a rejection situation on a Cyberball task, as measured by the negative subscale of the Positive and Negative Affect Schedule (PANAS), will have a higher percentage of days with heavy drinking during the last four weeks to three months of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to the Grau-du-Roi Follow-up and Rehabilitation Care Service.
* Patient abstinent from alcohol for at least 10 days.
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

* Other mental health disorder: bipolar disorder, schizophrenia, severe acute depression, borderline personality.
* Severe substance use disorder (SUD).
* Current suicidal ideation as judged by clinician.
* Patient unable to give consent.
* Pregnant or breastfeeding patient.
* The subject is participating in a Category 1 interventional study, or is in a period of exclusion determined by a previous study
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
A Smart, "Always -On" Health Monitoring System

This is a pilot study is to test a wireless, skin-sensor device against current technology in the NICU to monitor vitals

This is a single center, prospective, observational study that will recruit subjects from Lurie Children's Hospital and Prentice Women's Hospital to test a new wireless vitals monitor against the current vitals monitors used in the NICU. Patients will be neonates in different age brackets.

Eligibility Criteria:
Inclusion Criteria:

* Neonates in different age cohorts from ages 25 weeks gestational age to fullterm infants or infants up to 6 months of age, selected with assistance of NICU staff
* Currently in NICU and requiring monitoring for heart rate, ECG, respiratory rate, temperature, and pulse oximetry
* Parents able to understand and provide informed consent for study
* Infants enrolled in the Pre-Vent study (sub-study only)

Exclusion Criteria:

* Over 6 months of age
* Hemodynamic or other instability precluding testing of new monitoring with concurrent standards
* Infants at imminent risk of death and neonates with a skin abnormality that precludes assessment
An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Participants With Osteoarthritis

The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants with moderate (medium level of seriousness) to severe (very serious, life threatening) pain of osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff).

This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), single-arm, prospective (study following participants forward in time), study of TTS-fentanyl in participants with moderate to severe pain of osteoarthritis. The study will consist of 2 phases: screening phase up to 7 days before starting the treatment and treatment phase of 30 days. The first patch will be applied by investigator then by participants until 30 days. The dose of TTS-fentanyl can be increased, if needed, by 12.5 microgram per hour until adequate (reasonably good) pain control is achieved and taking into account the daily dose of supplemental paracetamol required by the participant. Other concomitant (given at the same time) analgesics (drug used to control pain) will not be used during this phase. Efficacy with regard to pain control will be recorded principally by the participant through questionnaires in a daily diary. This record will be used to support more detailed assessments at study visits on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. Participants' safety will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Chronic (lasting a long time) primary osteoarthritis pain for more than 3 months with Visual Analog Scale (VAS) greater than or equal to 5
* Participants having moderate to severe pain (VAS greater than or equal to 5), which was not adequately controlled by weak opioids such as tramadol or codeine at optimal doses (at least 150 milligram \[mg\] per day for tramadol or 200 mg per day for codeine) for at least 7 consecutive days
* Participants who failed from other treatments such as operation or lack of efficacy of current treatment

Exclusion Criteria:

* Skin disease that prevents the use of the transdermal system or which could affect the absorption of fentanyl or local tolerability
* History or suspicion of alcohol or drug abuse within the past 5 years
* History of cardiac, nervous system or respiratory disease which in the investigator's judgment precludes participation in the study because of the potential for respiratory depression
* Confusion, reduced level of consciousness, or concomitant (given at the same time) psychiatric disorder which, in the opinion of the investigator, could prevent participation in the trial
* Pregnant or breast-feeding female; female participants of child bearing potential without adequate contraception
WPMDE1 - Whey Protein Milk-Derived Exosomes Among Healthy Subjects

This phase 1, single-center, open-label study aims to evaluate the tolerability and usability of WPMDE1, a whey protein milk-derived exosome (EV) nutritional supplement, in healthy adults. The study will assess dose tolerability and determine the appropriate dosage for future studies targeting patients with Irritable Bowel Syndrome (IBS) and Inflammatory Bowel Disease (IBD).

WPMDE1 is a nutritional supplement derived from cow's milk using a novel production process designed to preserve extracellular vesicles (EVs) and their biological functions. This single-arm, unblinded trial will explore the effects of ascending doses of WPMDE1 on tolerability and usability in up to 30 healthy adults aged 18-60. Participants will be divided into five groups to test incremental doses over 7-30 days.

The study includes blood sampling, vital sign measurements, and daily symptom tracking via validated gastrointestinal symptom questionnaires. The outcomes will inform the design of future clinical trials targeting IBS and IBD patients. The trial will be conducted at Hadassah University Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants who have not undergone any major surgeries or hospitalization 6 months prior to entering the study
* All genders
* Participants aged 18-60
* Participants with no underlying known health or mental conditions
* Participants who are not participating in another clinical study simultaneously or taking any other nutritional supplements or chronic drugs.
* Participants must pre-sign the informed consent form.

Exclusion Criteria:

* Participants who violate one or more of the inclusion criteria
* participants with chronic diseases, particularly those that are related to the GI tract
* Participants with cow milk allergy/ intolerance or history of such.
* Participants suffering from constipation or diarrhea
* Participants who use drugs or drink alcohol on a regular basis (more than one glass per week)
* Pregnant or breastfeeding women
* Participants with a BMI over 30