cyrilzakka/clinical-trials huggingface dataset:
Health Effects of Oats and Oat Bioactive in Human

Aim of the study is to investigate health effects of oats and oat derived components, in human intervention studies, with the purpose to build new knowledge for development of cardiometabolic protective foods.

The overall goal is to increase the knowledge which can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the primary purpose of this project is to evaluate effects in healthy humans on cardiometabolic test markers of oat and oat based product. The new knowledge will form a base for the development of oat based food products with added health values.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults
* BMI 18,5 - 25
* non smokers
* consuming a non-vegetarian diet that follows the Nordic guidances

Exclusion Criteria:

* Fasting blood glucose concentration \>6.1 mmol/l
* known cardio-metabolic disease (e.g. diabetes, hypertension, metabolic syndrome), gastro-intestinal disorders such as IBS (irritable bowel syndrome) that can interfere with the study results, food allergies. Further no antibiotics or probiotics should have been consumed within 4 weeks prior to and during the study.
Study of BCG + Aminophylline Toxicity When Used in the Treatment of Bladder Cancer

The purpose of this study is to evaluate whether a new potential treatment for non invasive bladder cancer is safe and if it leads to side effects such as irregular heart rate, agitation, or burning with urination. Patients who have early stage bladder cancer and will be receiving BCG, a bladder cancer therapy as recommended by a doctor, will be asked to participate in a study where they are given the standard BCG followed by the experimental drug, aminophylline. Although we hope this medicine may one day prove to help bladder cancer patients, at the current time we do not know if it has any benefits at all. We have data in mice that suggest that aminophylline slows the growth of tumors when coupled with BCG.

Before using the combination of BCG and aminophylline clinically, we need to first determine if aminophylline is safe, when placed directly into the bladder of patients who have bladder cancer. We will give it along with BCG (Bacillus Calmette-Guerin) - a medication put into the bladder through a catheter tube to treat bladder cancer.

We also would like to determine the maximum dose of aminophylline that can be safely given and how the drug is absorbed and used by the body as well as document side effects when aminophylline is given in the bladder.

This is a study about aminophylline instilled into the bladder. Aminophylline has not been proven to be safe or a helpful treatment for bladder cancer. It is considered an experimental drug as used in this protocol for bladder cancer. Aminophylline has not been given to anyone who has bladder cancer. Aminophylline is approved by the U.S. Food and Drug Administration (FDA ) to give directly into the bloodstream for the treatment of asthma. We intend to use it at doses much lower than that used for asthma.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female \> 40 years of age because in patients younger than that the natural history is different.
2. Histologically proven bladder cancer that is NOT muscle invasive (Ta or T1)
3. Transurethral resection of Bladder Tumor (TURBT) at least 2 weeks prior to first instillation
4. ECOG performance status of 0 or 1.
5. Informed consent obtained from patient before enrollment.
6. English is primary language
7. Patients undergoing initial 6 week BCG therapy (BCG naïve)
8. Patients undergoing 3 week BCG maintenance therapy.

Exclusion Criteria:

1. Hypersensitivity reaction or contraindication to aminophylline or theophylline
2. Pregnancy (confirmed by a serum human chorionic gonadotropin pregnancy test) or breast feeding).
3. Hepatic insufficiency as defined by an abnormal AST or ALT.
4. Known arrhythmias or heart failure as defined by class II or greater cardiovascular disease according to the New York Heart Associations functional criteria
5. Immunocompromised
6. Seizure disorder.
7. Current treatment with oral theophylline or any other methylxanthine derivative.
8. Active urinary tract infection by nitrite positive urine dip or gross hematuria
9. Reduced dosing of BCG or BCG failures who have experienced bladder cancer recurrrence.
Comparative Study Between Zirconia Crowns and Endocrowns in Pulpotomized Primary Molars

Objectives: The new approach of pediatric esthetic dentistry intended to achieve a healthy beautiful smile rather than achieving only a beautiful smile. The objective of this study was to assess the clinical performance of ceramic Endocrowns and Zirconia crowns for the restoration of pulpotomized primary molars and parental satisfaction toward these crowns. Study design: Randomized clinical trial/split mouth design compared the clinical outcomes of two coronal restorations, on patients with bilateral carious second primary molars restoring one side with Endocrown (IPS e.max Press) and the other side with zirconia crown. Children attended Nahda University; Faculty of Dentistry clinics who need restorations screened for inclusion criteria till 20 patients are recruited (20 teeth for zirconia crown restorations and 20 for Endocrowns restorations). All children fulfilled the inclusion criteria were evaluated for factors including restoration integrity, marginal adaptation, marginal discoloration, oral health and overall clinical success at 3,6,12 months while parental satisfaction at 12 months follow up..


Eligibility Criteria:
Inclusion Criteria:

1. . Free of systemic diseases.
2. Age between 4 and 7 years.
3. Takes no medication on regular basis.
4. Has bilateral lower second primary molar with deep carious lesion, indicated for pulp therapy and crown restoration. (split mouth)
5. Patient and parent compliance.

Exclusion Criteria:

* 1. Non-restorable tooth. 2. Tooth near its exfoliation. 3. Tooth with extensive root resorption or periapical pathosis.
Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy

This research study is examining a preventive skin care regimen for children diagnosed with a brain tumor and receiving anti-cancer therapy with a MEK, Pan-RAF, or BRAF inhibitor.

This prospective, single-arm phase 2 clinical trial is looking at whether gentle skin care, sun protection and dilute bleach baths might decrease the chances or the severity of skin changes that occur during treatment for brain tumors.

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

Participants will receive a study treatment regimen that involves a daily sun protection, daily gentle skin care and every-other-day dilute bleach baths for the duration of the study.

Participants enrolled in this study, will be in this research study during the course of their anti-cancer treatment and receive skin examinations and complete a survey about their skin condition at the initial visit when anti-cancer treatment is started, at six weeks after the start of anti-cancer treatment, and at twelve weeks after the start of anti-cancer treatment.

Participants will be followed for twelve weeks.

It is expected that about 20 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a brain tumor between ages 6 months old -18 years old and will undergo treatment with at least one of the following:

  1. Targeted BRAF inhibitor therapy to treat the brain tumor
  2. Targeted MEK inhibitor therapy to treat the brain tumor
  3. Targeted pan-RAF inhibitor therapy to treat the brain tumor
* Subjects may participate in other studies, including therapeutic trials.
* Ability to comply with PSCR including sun protection, gentle skin care and every other day dilute bleach baths.
* Ability to understand and/or the willingness of their parent or legally authorized representative to sign a written informed consent document.

Exclusion Criteria:

* Diagnosed with brain tumor at \> 18 years old
* No data in medical records regarding treatment exposures
* Treated with a BRAF, MEK or pan-RAF inhibitor in the last three months
* Past or present allergic reaction to bleach
* Past or present allergic reactions to sunscreen and/or creams, lotions, emollients to be utilized in this study
Observational Study of the Incidence of Pressure Ulcers on the Help Support of Prevention of Bedsores POLYAIR®

The support of help to the prevention of sores include a big diversity of devices. The clinical experiment of these support comes up against the problem of the large number of factors participants in the genesis of bedsores. Nevertheless, it seems to be interesting to estimate the incidence of bedsores in these supports, with control of other factors


Eligibility Criteria:
Inclusion Criteria:

* Norton Index \<9,
* No sores in ischiatic zone,
* Sitting position not less than 2 hours per day

Exclusion Criteria:

* Sores in ischiatic zone,
* Sitting position \>2 hours per day
Statin Adjunct Therapy Among ART-treated Adults in Sub-Saharan Africa: Atorvastatin and Rosuvastatin Equivalence Trial

This study will determine whether 36 months of daily atorvastatin or rosuvastatin have equivalent effects in reduction of immune activation, inflammation and immune aging, when given as adjunct therapy among patients receiving antiretroviral therapy in an African cohort

This is a randomized, open-label trial

Eligibility Criteria:
Inclusion Criteria:

* HIV-positive individuals 18 years and older, that have initiated three first-line drug highly active antiretroviral therapy within three months within the Infectious Diseases Institute HIV treatment cohort
* Individuals that provide written informed consent to participate in the clinical trial

Exclusion Criteria:

Individuals with dyslipidemia and eligible to receive or already receiving statin therapy

* Pregnant or lactating mothers
* Individuals with another active or controlled inflammatory condition
* Individuals with deranged liver function tests 3 fold and above
Mindfulness Meditation Training in HIV

The purpose of this study is to investigate whether Mindfulness-Based Stress Reduction (MBSR) vs a one-day MBSR seminar improves immune (CD4+ T lymphocytes) and virological (HIV viral load) status in HIV-1 infected adults. The secondary goal of the study is to determine if MBSR vs a one-day MBSR seminar improves self-reported HIV-related quality of life.

Mindfulness meditation, which is described as a process of bringing awareness to moment-to-moment experience, has been receiving substantial scientific attention as a process that can be stress and health protective (Brown, Ryan, \& Creswell, 2007). Recent reviews by Baer (2003), Bishop (2002), and Grossman et al (2004) support the effectiveness of the standardized and manualized MBSR program in reducing stress and functional disability in a variety of chronic illnesses, although no studies have tested if MBSR impacts clinical markers of HIV, although some evidence suggests that MBSR improves some markers of innate immunity and quality of life in HIV-infected adults (see Robinson, Mathews, \& Witek-Janusek, 2003). In this study, we propose to extend this work by investigating the impact of this intervention on biological and functional health status in HIV-positive adults.

We propose to determine whether the 8-week MBSR program is more effective than a one-day MBSR seminar in: (1) maintaining immune resistance in HIV infection (i.e. maintaining counts of CD4+ T lymphocytes and reducing HIV viral load), and (2) improving HIV-related quality of life. Additional analyses will test for a dose-response effect of MBSR by examining if MBSR class attendance and daily meditation practice are associated with the primary and secondary outcomes. These aims will be tested in a sample of 50 HIV-positive adults that is diverse with respect to ethnicity, gender and sexual orientation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed HIV for \> 6 months
* English speaking
* 18 years old or older
* Indicate some distress (\>4 on the Patient Health Questionnaire-9)
* Willing to be randomized

Exclusion Criteria:

* Any substance abuse or treatment for a psychiatric disorder in the past 30 days
* Currently diagnosed with AIDS or had CD4+ T lymphocytes \<200 cells
* Hepatitis (A, B, or C)
* Indicate a regular mind-body practice (e.g., yoga, meditation) in the past six months
Metabolic and Immunological Phenotyping in Patients With Cancer

An observational study to investigate cachexia in participants with non-haematological cancer.

A single-centre, non-randomised, observational study. This study will investigate the systemic metabolic and immunological changes that occur in cachexia. The aim is to better understand the mechanism(s) underlying weight loss in people with non-haematological cancer. This will help to facilitate future research to generate treatments to reverse weight loss and improve outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent to participate
* Be aged 18 years or over at the time of signing the informed consent form
* Have a histological or cytological diagnosis of a non-haematological cancer
* Are willing and able to comply with study procedures and visits

Exclusion Criteria:

* Active infection, as determined by the investigator based on clinical symptoms and / or fever and / or requirement for antibiotics
* Current treatment with chemotherapy, oral steroids or other immunosuppressive drugs (within 7 days of baseline investigations or during the study phase)
* Significant acute, chronic or psychiatric condition or laboratory abnormality which in the judgment of the investigator would place the patient at undue risk or interfere with the study.
* Intolerance to dairy products
* Women, who are pregnant, plan to become pregnant or are lactating
Change in Coronary Heart Disease Risk Factors in Young Adults

To prospectively examine changes in lipids, lipoproteins, and blood pressure among 295 young adults who had been followed for sixteen years in the Beaver County Lipid Study. The Beaver County Lipid Study tracked the cholesterol values of 295 children, ages 11 to 14 at baseline.

BACKGROUND:

Epidemiologic studies of coronary risk factors have been performed primarily in populations of middle-aged adults, children, and adolescents. Relatively little is known about these risk factors in men and women 20-29 years of age.

This study provided important insights into the determinants of coronary heart disease risk factors in young adults and bolstered the argument of those who favor the early identification of and intervention in the young coronary candidate.

DESIGN NARRATIVE:

Three cross-sectional examinations had been carried out: 1) 1972-1973; 2) 1980-1981; and 3) 1988-1989. The study examined the predictors of change in total cholesterol (from examination 1 to examination 3, and change in LDL-C, HDL-C, and triglycerides between examinations 2 and 3. It also investigated the stability in several health habits and behaviors such as cigarette smoking, alcohol use, adherence to a low fat/low cholesterol diet, and physical activity. Weight gain and oral contraceptive use had been shown in previous analyses to be strong predictors of several lipids and lipoproteins.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Multi-omics Approach of Risk Stratification for Patients With de Novo Acute Myeloid Leukemia

The investigators will use machine learning to identify features on bone marrow smears and select features that are related to gene mutations, gene expression, or prognosis. The investigators will then use genome-wide transcriptomic profiling to investigate gene expression that is associated with patients' outcomes. The investigators will design a next-generation sequencing panel with unique molecular index and assess its feasibility and robustness in detecting measurable residual disease and optimize the panel/platform/bioinformatic pipeline. Finally, The investigators will use machine learning to integrate bone marrow smear features, gene mutations, gene expression, and measurable residual disease to construct a comprehensive risk assessment system that is based on multi-omics data. The investigators believe that such a platform will help physicians to design the most appropriate treatment strategies for individual patients, not only advancing the concept of precision medicine but also improving patients' prognoses.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with acute myeloid leukemia at the National Taiwan University Hospital
2. Ever enrolled in 201802021RINC、202109078RINB、201709072RINC

Exclusion Criteria:

Nil
Aligning Pulse Oximetry With Guidelines

The primary objective is to measure the feasibility, acceptability, and appropriateness of audit and feedback with educational outreach as a strategy to align continuous pulse oximetry use in stable bronchiolitis patients with evidence and guideline recommendations.

Continuous pulse oximetry (SpO2) monitoring has revolutionized detection of oxygen desaturation in operating rooms and other high-risk areas, improving outcomes in those settings. However, research suggests that overuse of continuous SpO2 monitoring in stable children with bronchiolitis who are unlikely to benefit from it is low-value care that places some children at risk of adverse outcomes. Despite national guidelines discouraging continuous pulse oximetry use in stable bronchiolitis patients, 46% of those infants and children are continuously monitored. This pragmatic, prospective, non-randomized, single-arm feasibility pilot will be performed on non-Intensive Care Unit (ICU) hospital units that care for bronchiolitis patients. The primary subjects are hospital staff who order or manage continuous pulse oximetry monitoring for bronchiolitis patients; secondary subjects are patients age 2 through 23 months with a primary diagnosis of bronchiolitis.

Eligibility Criteria:
Inclusion Criteria:

* Primary subjects - Hospital staff

  1. Nurses, physicians, physician assistants, nursing assistants, or respiratory therapists
  2. Providing care to patients on units included in the study.
* Secondary subjects - Patients

  1. Males or females 8 weeks through 23 months old hospitalized on non-Intensive Care Unit (ICU) wards
  2. Cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine)
  3. Primary diagnosis of acute bronchiolitis according to hospital chart
  4. Not currently requiring supplemental oxygen therapy or nasal cannula flow at an fraction of inspired oxygen in the air (FiO2) of 21% (room air flow)

Exclusion Criteria:

* Primary subjects - Hospital staff

  1) None. Staff may self-exclude by choosing not to interact with the electronic communications and may choose to not attend meetings where the intervention is discussed.
* Secondary subjects - Patients

  1. Premature birth: \<28 weeks completed gestation
  2. Cyanotic congenital heart disease
  3. Pulmonary hypertension
  4. Home oxygen or positive pressure ventilation requirement
  5. Tracheostomy
  6. Neuromuscular disease
  7. Immunodeficiency
  8. Cancer
  9. Historical, current, or suspected diagnosis of heart failure, myocarditis, or arrhythmia
  10. Historical, current, or suspected diagnosis of Coronavirus disease 2019 (COVID-19)
Analysis of the Effect of Intravitreal Dexamethasone Injection on Diabetic Macular Edema After Cataract Surgery (IDDMECS)

Macular Edema (Swelling of a particular site of the retina) can become a significant problem for Diabetics undergoing Cataract surgery. And a significant number of people who undergo Cataract surgery each year are diabetics. And when you multiply these two factors together you are left with a significant number of people who do not gain as much vision as their peers. Diabetics who develop Macular Edema actually can loose some vision after surgery and when you follow them up, they don't gain as much vision. This Study aims to prevent such an event from happening and therefore allow Diabetics to gain as much vision as they can from cataract surgery. This study will use Dexamethasone injected intravitreally (into the gel of the eye) at the end of cataract extraction to control Macular edema brought about by surgery. The main outcome is the central retina thickness and retinal volume as measured by Optical Coherence Tomography. Secondary outcomes are BCVA and incidence of Laser Treatment.

Other Drugs, life Bevacizumab and Pegaptanib, have been used for this purpose but they are expensive and have potential systemic side-effects due to anti-VEGF (vascular endothelial growth factor) actions. Dexamethasone has been used in the eye for decades and is short-lived, minimizing possible systemic effects. Moreover, this drug is at least 15x cheaper than the previously mentioned ones and therefore has tremendous benefit for developing countries. We seek an alternative drug that can reduce or prevent Macular edema at a less expensive and safer way.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients for Cataract Surgery with vision of ≤ 20/50 and \> grade 3 any cataract type using the Lens Opacities Classification System III. Diabetics included must have at least one microaneurysm in the posterior pole (defined by the Superior and Inferior Arcade).

Exclusion Criteria:

* Without any diabetic retinopathy and those with active uncontrolled proliferative disease
* Retinal disease,other than Diabetes, that can affect macular edema
* Uveitis, a history of any other intraocular surgery or a history of uncontrolled glaucoma
* Eyes with cataract precluding proper OCT measurement pre-operatively
* Patients who will experience longer than usual operating time, complicated surgery, rupture of the posterior capsule, and iris or corneal burns