cyrilzakka/clinical-trials huggingface dataset:
PERfusion CT in the FOXFIRE Trial to Study Blood Flow to Liver Metastases

The PERFORM study is a pilot study investigating the feasibility and usefulness of performing a novel CT (Computed Tomography)scanning technique called Perfusion CT(CTP) as an addition to normal CT scanning in patients recruited to the FOXFIRE trial. All patients recruited to FOXFIRE at the Oxford Radcliffe Hospitals and University Hospitals of Leicester will be invited to take part. FOXFIRE is a national randomised controlled trial in which patients with unresectable liver tumours secondary to colorectal cancer will receive treatment with standard chemotherapy alone, or with chemotherapy in combination with an internal radiotherapy treatment which delivers radioactive particles(SIR-spheres) to the liver via its own blood supply (radioembolisation). In the FOXFIRE study a normal CT scan would usually be performed prior to the start of treatment and also three months after the commencement of treatment to assess the cancer's response to treatment, particularly whether the tumour has changed in size as a result of treatment. Perfusion CT gives the normal information on changes in tumour size but also assesses whether the blood flow to the cancer has changed, which may allow earlier identification of treatment success compared to normal CT scans. All patients consenting to participate in the PERFORM study will undergo four perfusion CT scans: one before the treatment starts, and one at the start of each of the second, third and fifth cycles of chemotherapy. The aim is to determine the feasibility of measuring tumour perfusion for data analysis using perfusion CT and to establish if the tumour perfusion pattern at baseline or shortly after the start of therapy can predict response to radioembolisation or chemotherapy. This research is funded by the National Institute for Health Research Biomedical Research Centre in Oxford and Oxfordshire Health Services Research Committee.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have given written informed consent to participate in the FOXFIRE clinical trial and have not yet started chemotherapy treatment in the trial.
* Serum creatinine and calculated glomerular filtration rate are less than the upper limit of normal (ULN) in blood tests performed up to 29 days before entry into the FOXFIRE clinical trial.
* Liver metastasis 1.0 to4.0 cm in cranio-caudal diameter on imaging performed up to 29 days before entry into the FOXFIRE clinical trial

Exclusion Criteria:

* True allergy to intravenous iodinated CT contrast
* Active medical or psychological illness that would render the patient unsuitable for the additional imaging proposed in this pilot study, at the discretion of the investigator
Micropulsed Laser in Association With Anti-VEGF for the Treatment of Macular Edema in Diabetic Patients (LAMED).

Diabetes is a major cause of blindness in adults in the developed countries. The retinal damages associated with diabetes lead to gradual loss of vision, which is accentuated when the macula is affected. This results in macular edema.

Currently, intravitreal injections of anti-VEGF have demonstrated their effectiveness and are the first line treatment of macular edema.

Subthreshold micropulsed laser photocoagulation is an alternative to conventional grid photocoagulation. By delivering pulsed impacts under the thermal lesion threshold of the pigment epithelium, it would not cause the side effects of conventional photocoagulation. Micropulsed photocoagulation combined to anti-VEGF injections, could be the most effective treatment with a minimum injection number and without epithelial lesions.

The main objective of this study is to show that the subthreshold micropulsed laser photocoagulation, in association with intravitreal injections of anti-VEGF, allows to reduce the number of anti-VEGF injections during the first year of treatment.

In this randomized, double blind study, eligible patients will be randomized between a micropulsed laser photocoagulation arm and a sham micropulsed laser photocoagulation arm.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or more
* macular edema associated with a 1 or type 2 diabetes with a hemoglobin A1C level over 5.5% and under \<13%
* indication for a treatment with intra-vitreal injections of ranibizumab

Exclusion Criteria:

* treatment with anti-VEGF during the previous 2 months
* treatment by intra-vitreous implant of dexamethasone during the previous six months
* previous history of vitrectomy or glaucoma
* photocoagulation during the previous 3 months
* patient's opposition to participate to the study
A Randomized Trial of Effects of Parent Mentors on Insuring Minority Children

The Kids' HELP trial rigorously documented that a Parent Mentor intervention results in multiple benefits: more children are insured faster, children's access to healthcare and parental satisfaction improve, quality of well-child care is enhanced, thousands of dollars are saved per child, jobs are created, disparities are eliminated, and the intervention potentially could save our nation billions of dollars.

Background: Six million US children are uninsured, despite two-thirds being eligible for Medicaid/Children's Health Insurance Program (CHIP), and minority children are at especially high risk. The most effective way to insure uninsured children, however, is unclear.

Methods: We conducted a randomized trial of the effects of parent mentors (PMs) on insuring uninsured minority children. PMs were experienced parents with \>=1 Medicaid/CHIP-covered child who received 2 days of training, then assisted families for 1 year with insurance applications, retaining coverage, medical homes, and social needs; controls received traditional Medicaid/CHIP outreach. The primary outcome was obtaining insurance 1 year post-enrollment.

Eligibility Criteria:
Inclusion Criteria:

1. The parent/guardian is a primary caretaker of a least one child 0-18 years old who currently has no health insurance
2. The parent/guardian self-identifies the uninsured child as Hispanic/Latino, African-American/Black, or both
3. The uninsured child is eligible for either Medicaid or CHIP
4. The parent/guardian is willing to be contacted monthly by telephone, or in the form of a home visit (if no functioning telephone is present in the household).
Investigate a Interaction of Candesartan and Atorvastatin in Healthy Male Sugjects

primary object : Evaluate pharmacokinetic drug-drug interaction of Candesartan and Atorvastatin


Eligibility Criteria:
Inclusion Criteria:

* Adult healthy males 20 to 45 years at screening.
* BMI 18-29 kg/m2

Exclusion Criteria:

* History of cardiovascular, respiratory, hepatic, renal, neuropsychiatric, endocrine, hematologic disease
* Hypersensitivity reactions to drugs or significant hypersensitivity reactions in the history of Candesartan and Atorvastatin
* Hypotension (DBP ≤ 100 mmHg or SBP ≤ 95mmHg) and hypertension (SBP ≥ 150 mmHg or DBP ≥ 95 mmHg)
* Gastrointestinal disease affected the absorption of medications
* Genetic disease of Galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
* AST or ALT \> 2 x normal range
* Total bilirubin \> 2.0 mg/dl
* CK \> 2 x normal range
* eGFR \< 60 mL/min/1.73m2
* Subject who have drunken habitually (alcohol more than 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) or who are unable to quit drinking during this study
* Subject who have smoke habitually more than 10 cigarettes/day or who are unable to quit smoking during this study
* Subject who treated with any investigational drugs within 90 days before the administration of investigational drug
* Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days
* Subject who treated with any drug within 30 days can affect absorption, distribution, metabolism, excretion of candesartan or atorvastatin
* Subject who treated with any Rx only drug or herbal drug within 14 days and any OTC within 7 days
* History of drug abuse
* Genetic neuromuscular disorder or family history of neuromuscular disorder
* Unusual diet affected the absorption, distribution, metabolism, excretion of medications
* Subjects deemed ineligible by investigator based on other reasons
PROSAIC-DS Study (PROState AI in Cancer - Decision Support)

Around 375,000 cancers are diagnosed in the UK annually, with this figure expected to reach 500,000 by 2035. As the number of different cancer treatment options and our scientific understanding continue to grow rapidly, it can be difficult for clinicians to keep up-to-date with best practice, causing unjustified variations in the quality of care and clinical outcomes for patients.

Currently, when a patient has been referred to and seen by a clinician, their treatment is then discussed in a Multi-Disciplinary Team Meeting (MDTM). MDTM is a meeting of medical experts, including Surgeons, Oncologists, Nurses, and specialists in cancer, imaging and diagnosis. This is the case even if a treatment decision is straightforward.

A nationwide review published by CRUK in 2017 highlighted the demands on cancer teams and the MDTM process:

* Increased caseloads are causing dramatic increases in the time spent by clinicians in MDTMs, leading to an unsustainable rise in costs: the cost in England has increased from £88m to £159m in 4 years;
* There is not enough time in the MDTM to discuss complex cases;
* There is a failure to involve patients in the decision-making process: around 75% of patients feel their views are unrepresented in MDTMs; In our study we are looking at the potential of technology - particularly Clinical Decision Support Systems (CDSS) - to improve MDTM decision making.

Deontics has a CE marked AI-based CDSS that integrates individual patient data and preferences with evidence-based clinical guidelines. This dynamically and transparently generates best-practice, individualised treatment recommendations which can help determine treatment. Deontics' AI tool has already been shown to provide personalised recommendations concordant with UK best practice while incorporating patient values, and can be used to safely triage less complex patients straight to treatment with minimal clinical oversight. Our project partners with Deontics to develop PROSAIC-DS - A CDSS for prostate cancer.

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Eligibility Criteria:
Inclusion Criteria:

* All patients referred to the GSTT and KCH Prostate MDT meetings where sufficient information is available for the MDT to make a treatment decision (approximately 40-50 per week) will be eligible for the study.

Exclusion Criteria:

* If data available for patients is not adequate to make any treatment decisions they will be excluded. Non-consenting patients will be excluded.
A Human Clinical Study to Collect Calibration and Performance Data for the RBA-1 and KBS-1

The purpose of the Kaligia Biosciences KBS Systems 1.0(b) analyte monitoring device is to measure the blood analyte levels in patients. The KBS Systems 1.0(b) device avoids the common practice of accessing the vein to draw blood for conventional laboratory analysis. Instead, the KBS Systems 1.0(b) device uses Raman Spectroscopy to acheive the measurement of various blood analytes through the use of only approximately 40µl of blood. Such a small volume of blood can be sampled via a finger prick procedure rather than needing a larger volume of blood sampled via a venipuncture. The spectra contain information of all the molecules present in the blood (RBCs, hemoglobin, glucose, sodium, potassium, etc.). From these spectra, the system is able to analyze the blood and provide results in a matter of minutes, rather than hours or even, in some cases, days.


Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 yrs of age.
* Willingness and ability to provide informed consent
* Hospital patients with a physician-prescribed laboratory blood test

Exclusion Criteria:

1. People with clotting factor disorders and/or currently taking anticoagulation medication.
2. Has any other medical condition that, in the opinion of the Investigator, would interfere with the person's participation in this study (i.e. double arm amputee).
3. Any skin abnormalities or tattoos located on the palm(s) of the hand(s). The left palm is preferred for this study; however, the right palm can be used if the left palm is excluded.
4. Parkinson's disease, dyskinesia, tremors, or similar that may make it challenging for said person to hold their hand on the device in a still and stable manner.
Mobile Health to Enhance Exercise in Type 2 Diabetes

Being physically active and exercising is important for the treatment of Type 2 diabetes as it helps control blood sugar and improve physical function. Lots of people find it hard to be physically active and sticking with exercise is difficult for most people. In this project we will investigate two strategies to support people with Type 2 diabetes to increase and then maintain a physically active lifestyle, which includes exercising regularly. Participants in one group (Exercise Counselling) will complete a 6-month structured exercise and physical activity programme supported by regular (virtual) contact with an exercise specialist. Participants in the second group (Mobile health technology (mHealth)) will receive the same 6-month exercise and physical activity programme supported by an exercise specialist, but participants in this group will also receive a fitness watch that links to a mobile phone application (App). The fitness watch and mobile App will allow the exercise specialist to provide greater support and feedback throughout the programme.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with T2D within the previous 5-24 months
* Male or Female
* Aged 40-75
* Treat diabetes with only Metformin or lifestyle modifications (diet and exercise)
* For those prescribed Metformin: have used a stable dose for 3-months or more

Exclusion Criteria:

* Aged under 40 or over 75
* Glycated hemoglobin level (HbA1c) more than 10% (\>86mmol/mol)
* Blood pressure higher than 160/110 mmHg
* Treat diabetes with an antidiabetic drug other than Metformin (Sulfonylureas, Thiazolidinedione, dipeptidylpeptidase-4 inhibitors, sodium glucose co-transporter 2 inhibitors, glucagon-like peptide-1 receptor agonist, Acarbose, meglitinides)
* Prescription of Insulin
* Unstable angina (frequent chest pain)
* Myocardial infarction (heart attack) within the previous 3 months
* Transient ischemic attack (TIA) within the previous 6 months
* Heart failure ≥class 2
* Arrhythmia
* Inability to increase activity
* Pregnancy or planning to become pregnant
* Less than 6 months post childbirth or stopped breastfeeding less than 1 month ago
* Not owning a smartphone/ or having no data plan or access to WiFi
* currently meeting the recommended exercise guidelines (150 min of moderate intensity exercise per week).
The Acceptability and Feasibility of an Alternative to Routine Follow-up Visit After Medical Abortion in Vietnam

This trial will compare the efficacy and acceptability of post-medical abortion follow-up by assigning women to either 1) alternative follow-up via routine semi-quantitative pregnancy test and a self-administered follow-up questionnaire, or 2) the standard of care: a routine follow-up visit including a bimanual exam and vaginal ultrasound.

The goal of the study is to provide answers to the following questions:

1. Is a follow-up protocol that employs a self-administered questionnaire and at home use of a semi-quantitative pregnancy test effective at identifying women with ongoing pregnancies?
2. Is an innovative follow-up protocol more acceptable to women and providers than the current standard of care?
3. Is an innovative follow-up protocol feasible to implement in abortion services in Vietnam?


Eligibility Criteria:
Inclusion Criteria:

* Reproductive age women seeking medical abortion services
* Intrauterine pregnancy less than or equal to 63 days gestation on the day of mifepristone administration
* Hold a working, personal phone number
* be willing and able to sign consent forms and agree to comply with study procedures

Exclusion Criteria:

* Pregnancy greater than 63 days gestation on the day of mifepristone administration
Biomarker Predictors of Memantine Sensitivity in Patients With Alzheimer's Disease

The effects of the medication, memantine, on brain functions and the symptoms of Alzheimer's Disease will be tested


Eligibility Criteria:
Inclusion:

1. Alzheimer's Disease Research Center-confirmed diagnosis of AD
2. Mini-Mental State Examination (MMSE) score 10-22 OR a Montreal Cognitive Assessment (MOCA) score of 15-24
3. Age 50-83 y
4. Knowledgeable caregiver
5. Ambulatory
6. Medically stable;
7. Audiometric testing (detection \< 40 db(A) at 1000 Hz)
8. Informed consent

Exclusion:

1. Active systemic illness (e.g. heart disease, liver failure, renal insufficiency, cancer, HIV, tuberculosis, Hepatitis C)
2. Current psychiatric or neurologic illness other than AD
3. History of vascular disease, myocardial infarction, cerebrovascular accidents, transient ischemic attack, seizure, head injury with loss of consciousness; substance dependence (including alcohol and Opioid)
4. Past treatment with memantine; unable to tolerate acetylcholinesterase inhibitor
5. Investigational drug treatment \< 30 d of screening
6. Current meds: amantadine, riluzole, other pro-cognitive medication, opioids
7. Positive urine toxicology for non-prescribed psychoactive substance
8. Actively enrolled in cognitive remediation therapy
Pressure Ulcer Prevention in Ventilated Patients Using Two Repositioning Regimens

The purpose of this study is to compare a 2-hour versus every 4-hour turning regimen on the incidence of grade \> II pressure ulcers (PU) in patients in ICU on mechanical ventilation ≥ 24h that use alternating-pressure air mattresses (APAMs).

Pressure ulcers (PUs) pose a major healthcare challenge and are associated with an increased risk of infection and sepsis, longer hospital stay, and higher hospitalization costs. Their reported incidence in critical care patients varies widely from 1% to 56%. Therefore it is important to take appropriate preventive measures, which can often be successful and less costly than the treatment of established ulcers. Among these measures are the use of pressure-reducing surfaces and repositioning strategies in a protocolized way. Though there is general agreement that critical care patients, including those under mechanical ventilation must use pressure-reducing surfaces, there is no enough evidence in the literature about what is the best repositioning schedule when new, high technology mattresses are used. The use of this new technology has lead to propose that repositioning can be less frequent. In the only clinical trial where this subject (time interval turning) has been addressed (Vanderwee et al, Journal of Advanced Nursing), it is concluded that a turning regimen every 4 hours is equally effective than a 2-hour turning, using this kind of mattresses. Nonetheless this study is not made in critically ill patients, that have more risk factors for developing PUs, the reason we don´t share this findings and recommendations cannot be generalized.

The study hypothesis is that in patients using APAMs, a turning regimen every 2 hour compared to a 4-hour is most effective in the prevention of PUs and could be equally safe.

The objective of this study is to investigate the effect of postural turnings every 2 hours compared to every 4 hours on the incidence of grade \> II pressure ulcers (PU) in patients in ICU on mechanical ventilation (MV) ≥ 24h that use alternating-pressure air mattresses (APAMs) The study is an open label, randomized, controlled clinical trial. The main variable is the incidence of Pus grade ≥ II. As secondary variables measures of efficacy and safety of patients will be registered. The study will take place in a 26 bed medical-surgical ICU with APAMs. Randomization will be done between 24h-48h from the beginning of MV. The final analysis will be by intention to treat.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the medical-surgical ICU, requiring more than 24 hours of mechanical ventilation.
* Patients on alternating-pressure air mattresses.
* Patients or their legal representative able to provide written informed consent to participate in the study
* Patients whose weight are within the limits accepted by the mattresses (45-140 Kg)
* Over 18 years

Exclusion Criteria:

* Patients with pressure ulcer at ICU admission.
* Pregnant patients
* Patients in which informed consent is not obtained in the first 48 hours of mechanical ventilation
Evaluation of the MORENO Score for the Regulation

The main objective of this work is therefore to evaluate the safety and feasibility of the MORENO score for the regulation of secondary transfers to the SAMU 29 compared to current practices.

Today, there is an increase in the number of secondary transfers and paramedical transport between the different hospitals in a territory. They have been promoted by the SFMU (French Society of Emergency Medicine) since 2012.

The sharp increase in the number of calls for SAMU regulation means that decisions must be made quickly and safely regarding transport requiring or not requiring a medical presence. The development of a decision support tool for the level of medicalisation of a transfer therefore seems necessary. However, there is currently no recommendation in France.

The MORENO score has already been used in a hospital in the Var, as well as in Spain and Greece. Prior validation of this score in our health territory is essential before setting up an operational procedure. Using a list of simple clinical items, this score enables us to assess whether or not it is necessary to medicalise a transfer.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients having benefited from a transfer regulated by the SAMU 29 of adult patients on the Finistère territory over a predefined period of time

Exclusion Criteria:

* Pediatric patient transfers
* Maritime transfers
* Transfers for which the collected information does not allow to establish the MORENO score.
* Patients under judicial protection (guardianship, curatorship,..)
* Opposition
Assess the Safety, Tolerability, and Pharmacokinetics of HL-1186 in Healthy Participants

This single-center, randomized, double-blind, placebo-controlled, two-part study is designed to assess the safety, tolerability and PK of oral HL-1186 Tablet in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy participants, males and females.
2. Between the ages of 18 and 45 years old (inclusive).
3. Weighs no less than 50 kg (for males) or 45 kg (for females) and body mass index (BMI) within 19.0 to 26.0 kg/m2 (inclusive).
4. During the screening period, vital signs, physical examination, blood routine, blood biochemistry, coagulation function, urine routine, virology examination, chest X-ray, and pregnancy blood test (female) were examined, and the results did not show abnormalities or abnormalities without clinical significance.

Exclusion Criteria:

1. Females who are pregnant or breastfeeding; females/males who are prepared for having children.
2. History or presence of neurological, cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematological, endocrine, or osteoarticular disorders, or any laboratory abnormalities that pose a potential danger to constitute a risk when taking the study intervention or interfere with the interpretation of data.
3. Active infectious diseases which need anti-infection treatment.
4. Significant surgery within three months and not fully recovered per investigator's judgments.
5. Significant allergies per investigator's judgments, e.g., food allergies, allergies, or atopic reactions to any components of the investigational drug or placebo, asthma attacks, etc.
6. Immunosuppressive diseases, e.g., immunodeficiency, etc.