cyrilzakka/clinical-trials huggingface dataset:
Study of VA Combined With HAAG Regimen in Newly Diagnosed Intermediate and High-risk AML Patients

The purpose of this study is to evaluate the efficacy and safety of VA combined with HAAG in the induction treatment of newly diagnosed acute myeloid leukemia.

This is a single-center, single-arm, prospective clinical study in newly diagnosed intermediate and high-risk AML patients. The patients will receive venetoclax, azacitidine combined with HAAG regimen in the induction treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed intermediate and high-risk AML according to the WHO (2022) classification of acute myeloid leukemia (non-APL).
2. Age 18-65.
3. ECOG score: 0-2.
4. No history of previous chemotherapy or target therapy.
5. Serum total bilirubin \<= 2 times the upper limit of normal (ULN), alanine aminotransferase (ALT) \<= 1.5 times ULN, aspartate aminotransferase (AST) \<=1.5 times ULN;
6. Creatinine clearance rate \>=30 mL/min;
7. Serum lipase \<= 1.5 times ULN, amylase \<= 1.5 times ULN;
8. Capable to understand and willing to participate in this study, signed the informed consent form.

Exclusion Criteria:

1. AML transformed with chronic myelogenous leukemia.
2. Acute promyelocytic leukemia (type M3).
3. Patients with a second malignancy requiring treatment.
4. Patients with uncontrolled active infection.
5. Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
6. Patients with hepatic and renal inadequacy: total serum bilirubin \>=2.0 mg/dl, AST \>=3 times ULN, serum creatinine clearance (Ccr) \<50 ml / min.
7. Patients with arterial oxygen saturation (SpO 2) was \<95%.
8. Patients with HIV infection.
9. Patients with active hepatitis B or hepatitis C infection.
10. Patients with other commodities that the investigators considered not suitable for the enrollment.
Oxycodone (10, 20 mg) in a Postoperative Dressing

The study mainly focuses on pain management using 10- or 20mg oxycodone burn wound dressing at Poznan University of Medical Sciences.

Subjects were randomly assigned to one of the two treatment groups, A and B. Patients scheduled for burn surgery will sign written consent pre-operatively about procedural pain management. Group A received 10mg of oxycodone in wound dressing, while those in Group B received 20mg of oxycodone in wound dressing.

Eligibility Criteria:
Inclusion Criteria:

* adults scheduled for surgical burn treatment
* aged \> 18 years
* ASA physical status 1,2 or 3

Exclusion Criteria:

* opioid abuse
* ASA physical status 4, 5
Metabolomic Evaluation of the Impact of Acqua Rocchetta on the Skin of Healthy Patients.

Evaluation of changes in skin metabolism after one month of intake of Acqua Rocchetta (water A) vs bicarbonate-calcic mediomineral water (water B) (reprogramming effect on skin metabolism); Evaluation of urinary profiles after intake of Acqua Rocchetta (water A) vs bicarbonate-calcic mediomineral water (water B) and possible relation with skin metabolites.

This is a single-center, interventional, randomized controlled clinical trial conducted in healthy volunteers, in a double blind (subject and investigator).

The study will include age-matched female subjects who blindly take water A or water B, both marketed as food and not supplements, therefore evaluated annually by the relevant bodies (ASL, NAS and the Central Inspectorate for quality protection. and the repression of fraud on agri-food products (Icqrf)).

Women between 30 and 50 years old will be chosen who have a skin aging pattern very different from the male sex and governed by the oscillations of the menstrual cycle. A positive result on this population would be of crucial importance in terms of nutriceuticals and generalizability.

Eligibility Criteria:
Inclusion Criteria:

* healthy female subjects
* in good health without disease with an ICD code in compliance with the World Health Organisation definition (a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity." )
* abstemious
* individuals who agree to sign an informed consent form
* individuals who follow an omnivorous diet

Exclusion Criteria:

* subjects outside the age range considered
* smokers and/or those with chronic or acute diseases coded by the ICD-10 system
* persons who do not consent to sign the informed consent form
* subjects who follow diets that are not omnivorous or with fattening / slimming purposes
* subjects undergoing hormonal or contraceptive hormonal therapies or in general drugs that may alter the hydroelectric balance
* persons with significant alterations in the menstrual cycle (amenorrhoea or dysmenorrhoea).
* use of alcohol.
* pregnancy (verified by self-declaration) and/or breastfeeding
* allergy to the components of Leukopor
Avelumab in Combination With Gemcitabine in Advanced Leiomyosarcoma as a Second-line Treatment

A Phase 2 trial of avelumab plus gemcitabine in advanced leiomyosarcoma as a second line treatment


Eligibility Criteria:
Inclusion Criteria:

1. Unresectable, advanced or metastatic histologically confirmed leiomyosarcoma
2. Progression during or after first-line doxorubicin-based chemotherapy (relapse within 6 months of completion of adjuvant/neoadjuvant chemotherapy containing doxorubicin-based regimen could be considered as first-line therapy.)
3. ECOG PS 0-2
4. At least one measurable lesion according to RECIST v1.1
5. Adequate organ function
6. Life expectancy \>= 3 months
7. Negative serum or urine pregnancy test at screening for women of childbearing potential

Exclusion Criteria:

1. Prior treatment history of anti-PD-1/PD-L1 or anti-CTLA4 treatment
2. Receipt of 2 or more prior systemic treatments for advanced leiomyosarcoma
3. Active or untreated brain metastases or spinal cord compression
4. Prior treatment with gemcitabine
5. History of major surgery within 4 weeks prior to enrollment
6. Chemotherapy or radiotherapy within 3 weeks prior to the study drug commencement
7. Previous malignant disease other than leiomyosarcoma within the last 5 years with the exception of basal or squamous cell carcinoma of skin or carcinoma in situ (bladder, cervical, colorectal, breast)
8. Pregnant or lactating women
9. HIV, HBV, or HCV infection
10. Severe hypersensitivity or anaphylaxis to monoclonal antibody, or uncontrolled bronchial asthma
11. Current use of immunosuppressive agent (exclusion : less than prednisone 10 mg/day or equivalent)
12. Active autoimmune disease
13. Clinically significant cardiovascular disease
14. Clinically significant interstitial pneumonitis or pulmonary fibrosis
15. Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines
VitalScan MCG Rule-out Multi-centre Pivotal Study - US

A prospective multi-centre observational study to validate the diagnostic accuracy of a transportable magnetocardiograph device for acute coronary syndrome (ACS), focusing on rule-out capability, in patients who present to the emergency department with chest pain symptoms consistent with ACS.


Eligibility Criteria:
Inclusion Criteria:

* Patient presents to the ED with chest pain syndrome of suspected cardiac origin (i.e. symptoms consistent with ACS)
* 18+ year old male or female
* Patient is willing and able to give written informed consent

Exclusion Criteria:

* ST-segment Elevation MI (STEMI)
* Clear non-ischemic cause for symptoms (e.g. trauma)
* Hemodynamic instability on admission (e.g. BP\>220mmHg systolic \& \>110mmHg diastolic, \<80mmHg systolic \& \<40mmHg diastolic, HR\>160bpm)
* Ventricular tachycardia or fibrillation that cannot be treated effectively
* Atrial fibrillation
* Thoracic metal implants
* Pacemaker or internal defibrillator
* Pregnancy (if after 20-week period)\* or lactation
* Patient unable to lie down (i.e. supine position) or stay still on the examination bed
* Patient unable to understand the informed consent process and/or has a poor understanding of English (e.g. English- speaking relative/translator not available)
* Patient unable to comply with the requirements of the protocol
The Management of Pilonidal Wounds With ACell MicroMatrix® and Cytal® Wound Matrix: A Case Series

A case series involving the concomitant use of MicroMatrix® and Cytal® Wound Matrix 2-Layer with standard of care negative pressure wound therapy (NPWT) during the management of pilonidal wound healing.

This is a prospective case series examining the concomitant use of MicroMatrix® and Cytal® Wound Matrix 2-Layer with standard of care negative pressure wound therapy (NPWT) during the management of pilonidal wound healing. Wound healing will be evaluated at 2 weeks, 6 weeks, and 3 months. If subjects heal prior to the 3 month visit, wound healing will be documented at that visit. A maximum of ten subjects will be included in this series.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has a clinical diagnosis of pilonidal disease.
2. Subject is being scheduled for surgical excision of pilonidal disease.
3. Subject is at least 18 years of age.
4. Subject is willing and able to adhere to protocol requirements and agrees to participate in the study program and comply with the study follow-up regimen.
5. Subject is willing to provide written informed consent.

Exclusion Criteria:

1. Subject has a known allergy to porcine-based materials.
2. Subject is pregnant
Gastric Volume in Paralyzed Obese Patients After High-flow Nasal Oxygen Therapy

Preoperative preoxygenation is performed using High-flow nasal oxygen therapy, and the gastric volume before and after High-flow nasal oxygen therapy is measured by ultrasound and compared in obese patients undergoing surgery under general anesthesia.

Preoperative preoxygenation is performed using High-flow nasal oxygen therapy, and the gastric volume before and after High-flow nasal oxygen therapy is measured by ultrasound and compared in obese patients undergoing surgery under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a BMI of 30 kg/m2 or more, undergoing surgery under general anesthesia

Exclusion Criteria:

* Nasotracheal intubation
* History of a surgery or anatomical anomaly in the head and neck
* History of Inability to breathe through nose
* History of difficult airway
* Severe cardiac or respiratory disease
* Gastric reflux disease, diabetes, pregnancy
* Previous gastric surgery
Effect of Oral Magnesium Therapy on Constipation on Cerebral Palsy Children

The aim of this study is to study the therapeutic and adverse effects of oral magnesium sulfate therapy on constipation in children with spastic cerebral palsy suffering from chronic constipation in neuro pediatric unit at Assiut University Hospital.

Children with cerebral palsy (CP) often experience many comorbidities such as constipation,which is considered a frequent problem in spastic (cp)children .It occurs due to reduced mobility, difficulties in feeding and as a side effect of many muscle relaxing medications.It is estimated that 74% of children with cerebral palsy suffer from constipation ,which necessitates use of laxatives. Magnesium sulfate has a famous role as being an osmotic laxative,which is the first step in the pharmacological treatment of constipation

• Mechanism of action of mg sulphate: They are poorly absorbed by the intestinal wall, which leads to intraluminal accumulation of hyperosmolar particles. This stimulates retention of water in the intestinal lumen, softening the stools and increasing peristalsis through intestinal distension. It acts by accelerating small intestinal transit both in fasting and in fed state and it tends to increase the frequency and weight of stools, compared with placebo.In addition ,It increases intraluminal secretion of cholecystokinin and increases nitric oxide (NO) release.

• Side effects of mg sulphate: Reducing the intestinal absorption of fat, protein and carbohydrates following solid meal ingestion

• other drugs used as laxative in cp and there side effects:

* Lactulose: it can lead to distention, bloating and excess flatus. In some individuals these side-effects may limit the use of this product.
* Glycerin: is another small molecule that can exert osmotic activity in the colon. It is not absorbed by the colon and is used as a suppository to draw water into the rectum to produce a bowel movement. It is well absorbed by the small intestine, and hence cannot be taken by oral route.

  * The aim of this study is to study the therapeutic and adverse effects of oral magnesium sulfate therapy on constipation in children with spastic cerebral palsy suffering from chronic constipation in neuro pediatric unit at Assiut University Hospital.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed as cerebral palsy
2. Age below18 year
3. Presence of constipation according to ROME criteria

Exclusion Criteria:

1. Patients with cardiac problem
2. Patients with renal problem
3. Patients with GIT problem or chronic diarrhea
An Irritation Study With New Calcipotriol Ointment Formulations in Healthy Subjects

The purpose of this trial is to compare the skin irritation potential of eight different formulations of vitamin D analogues after repeated applications on intact skin of healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects having understood and signed an informed consent form.
* Either sex
* Healthy subjects, 18 to 65 years of age
* Subjects with skin types I to IV according to Fitzpatrick Scale
* Subjects without erythema on test areas on the mid back skin (visual irritation score = 0) at baseline (Day 1), before randomisation.

Exclusion Criteria:

* Females who are pregnant, or who wish to become pregnant during the study, or who are breast feeding
* Any topical or systemic corticosteroids or immuno-suppressors within 3 weeks prior to randomisation
* Any other medication which may interfere with the study results, in particular topical drugs applied on the test area within 2 weeks prior to randomisation
* Any other products which may interfere with the study results, in particular emollients, creams, gels, lotions and body powders applied on the test area within 24 hours prior to randomisation
* Any systemic or cutaneous disease that may confound interpretation of the study results (e.g., atopic dermatitis, eczema, psoriasis)
* Scars, moles, sunburn, or other blemishes in the test area which may interfere with grading
* Exposure to excessive or chronic UV radiation (i.e., sunbathing, solarium, phototherapy) within 2 weeks prior to randomisation or is planned during the study period
* Known or suspected hypersensitivity to any component of the investigational products
* Participation in any other interventional clinical trial within 4 weeks prior to randomisation or during the study period, based on interview of the subject
Investigating the Impact of Indocyanine Green Titration on Fluorescent Intensity in Free Flap : An Exploration of Alternative Indicators

This study is a randomized clinical trials that aim to determine the effect of Indocyanine Green (ICG) titration dose on the intensity degree of ICG fluorescence imaging results. In addition, this study will also determine the relationship of other indicators such as flap surface temperature, transcutaneous pressure of carbon dioxide (TcPCO2), transcutaneous pressure of oxygen (TcPCO2), HIF - 1 alpha expression, and flap histopathology morphology to the intensity degree of ICG fluorescence imaging results with titrated doses.

The ICG contrast solution will be evaluated with Near-Infrared (NIR) camera that being fixated 20 cm above the flap after the injection. The imaging result will be analyzed using ImageJ Application to assess the grey value. The fluorescent intensity of ICG will be compared with other tests.

Drop Out Criteria :

* Patients who are unable to complete the research procedure due to various condition, such as death
* Patients who experience complications or worsening, during and after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Free flap operation that being performed by researchers.
* Free Flap must have a skin paddle located on the body skin area with intraoperative ischemic time of at least 60 Minutes
* Free flap should be in a viable/vital condition judged from the clinical examination of the flap, which includes color, temperature, turgor, capillary refill time (CRT), and skin prick test, immediately post surgery
* Body area that will be a flap-free donor area has no history of trauma or operation
* Patient with blood albumin value \>3 gr / dL
* The patient/family sign the informed consent sheet stating willingness to become research sample

Exclusion Criteria:

* Patients have increased sensitivity to iodine or ICG
* Free Flaps that being transported undergo trauma or damage due to external factors during treatment
* Patient with high urea and creatinine level
* Patient with high Alanine transaminase (ALT) and Aspartate transaminase (AST) level
* Patients who receive injectable heparin treatment containing natrium disulfite preoperatively
* Patients who regularly take anti-seizure drugs, haloperidol, heroin, meperidine, Metamizole, methadone, morphine, nitrofurantoin, opium, phenobarbital, and phenylbutazone.
A Primary-Secondary Care Partnership to Prevent Adverse Outcomes in Chronic Kidney Disease

Chronic kidney disease (CKD) is a major public health problem with a UK prevalence of 8-10%. The study hypothesis is to ascertain if intensive primary care led disease management programmes for CKD, supported by input from secondary care specialists will slow progression of CKD, improve blood pressure control and reduce cardiovascular events in patients on CKD registers.

The investigators have partnered with Nene commissioning, a practice based commissioning group representing approximately 80 GP practices in Northamptonshire, to run this study. This will be a cluster randomised trial of an intensive, secondary care supported, CKD management programme in primary care vs normal CKD care. Randomisation will be at the level of the individual general practice. All general practices associated with Nene commissioning will be invited to participate. Randomisation of practices will be performed by the University of Leicester Clinical Trials Unit and the study will adhere to guidelines for undertaking randomised cluster trials.

The aims of the study are:

1. To determine whether reinforcement of best practice in the management of key aspects of CKD care by clinical nurse specialists based in primary care, but with close links to colleagues from secondary care, improves clinical outcomes.
2. To foster excellence in CKD care
3. To improve coding of CKD and prevalence on chronic disease registers.
4. To increase interest in, and capacity for primary care research in Northamptonshire.
5. To implement and evaluate a new model of partnership working between primary and secondary care.

The primary outcome measures will be changes in estimated glomerular filtration rate (eGFR). Secondary outcome measures will be blood pressure control, proteinuria, incidence of cardiovascular events,other biochemical parameters, referrals to secondary care and hospitalisations and mortality.

see above

Eligibility Criteria:
Inclusion Criteria:

* measurement of serum creatinine
* eGFR \< 60 ml/min/1.73m2
Quality Improvement PrecivityAD Clinician Survey (QUIP I)

There is an important unmet need for timely, non-invasive, and low-burden evaluation of patients presenting with mild cognitive impairment (MCI) and early dementia. MCI impacts 12-18% of people in the United States over age 60 and is often an initial clinical sign of Alzheimer's disease (AD) (Alzheimer's Association, 2022). The PrecivityAD test is an analytically and clinically validated blood test that aids healthcare providers in the diagnosis of AD in patients with MCI and early-stage dementia. C2N has created a quality improvement (QI) survey to gather insight from clinicians as to the clinical effectiveness of the commercially available PrecivityAD™ test, which identifies whether a patient with signs and symptoms of cognitive decline is likely to have amyloid plaques in the brain, a pathological hallmark of Alzheimer's disease.

By gathering feedback from healthcare providers on patient selection, intended use, and anticipated outcomes and continued or revised care plans as a result of the test report, C2N can better understand the impact of the test results on diagnosis and patient management.

Eligibility Criteria:
Inclusion Criteria:

1. Memory specialist actively practicing in the United States.
2. Practice includes individuals with mild cognitive impairment age \> 60 years
3. Average patient volume \> 50 visits per week (all patients seen across practice)

Exclusion Criteria:

1. Other clinicians with a specialty outside of the field of Memory Specialists
2. Principal Investigator reserves the right to not include a clinician in the survey
A Crossover Trial of Chitosan Oligosaccharide on Post Prandial Glucose Control in Subjects With Normal, IFG and IGT

It is well known that Chitosan oligosaccharide is low molecular weight and water soluble and chitosan oligosaccharide has been shown to reduce blood cholesterol and blood pressure, increase immunity, and enhance antitumor properties. the effect of chitosan oligosaccharide (GO2KA1) supplementation on glucose control in subjects with normal blood glucose, impaired fasting glucose and impaired glucose tolerance.

A randomized, double-blinded, controlled, cross-over trial was conducted to verify the effects of chitosan oligosaccharide (GO2KA1). forty healthy male and female subjects aged 20-75 years with normal blood glucose, impaired fasting glucose and impaired glucose tolerance were recruited. The subjects visited the research site twice over with a seven-day interval after an overnight fast at least 12 hr. On the screening visit, the participants were the 2-hr oral glucose tolerance test (OGTT) was conducted. And they were separated normal blood glucose, impaired fasting glucose and impaired glucose tolerance. On the first visit, the participants were randomly assigned to consume a test or placebo product \[test product: chitosan oligosaccharide powder 500mg (GO2KA1); placebo product: white egg powder 500mg\] and ingested the assigned product. On the second visit, the participants consumed the other product that they did not eat on the first visit. On both visit day, the 2-hr oral sucrose tolerance test (OSTT) was conducted and started at 8:00 in the morning; venous blood samples were collected before (0 hr) and after ingestion (0.5, 1 and 2 hr) of the products.

Eligibility Criteria:
Inclusion Criteria:

* Normal Blood Glucose (fasting blood sugar below 100mg/dl, two hours after meals below 140mg/dl)
* Impaired Fasting Glucose (fasting blood sugar 100-125mg/dl)
* Impaired Glucose Tolerance (two hours after meals 140-199mg/dl)

Exclusion Criteria:

* history/presence of diabetes mellitus (including oral hypoglycaemic agent and insulin)
* history of serious hypoglycemia
* history of serious cardiovascular, cerebrovascular disease, pulmonary, gastrointestinal, hepatic, renal and/or haematological disease
* uncontrolled blood pressure (blood pressure level more than 140/90mmHg)
* history/presence of alcoholism, drug addiction, etc.
* taking a regulation of blood glucose medications within 1 month before study
* participation other intervention studies within 1 months before study
* history of diagnosed with cancer, cancer surgery and hospitalization
* women who are pregnant or desire to become pregnant during the study period
* having any other medical condition which, in the opinion of the investigator, could interfere with participation in the study