cyrilzakka/clinical-trials huggingface dataset:
Project Mountain - Comparing SpO2 and SaO2 for Accuracy

The main goal of this study is to look at the performance of the neonatal, infant, and pediatric Philips SpO2 sensors with the Philips FAST Pulse Oximetry technology. Oxygen saturation measurements (SpO2) will be obtained via pulse oximetry and invasive arterial oxygen measurements (SaO2) will be obtained via arterial blood samples as part of your clinical care and assessed by co-oximetry. The study will aim to enroll a diverse population to help us understand the impact of skin pigmentation.

This is a prospective, multi-center, multi-phase, unblinded, non-randomized. self-controlled, observational study. All data analyses specified below will be calculated and summarized by each of SpO2 sensors under test. Demographics and baseline characteristics, including sex assigned at birth, age, ethnicity, race, baseline height, baseline weight, BMI, skin pigmentation and sensor application site measurements will be summarized with descriptive statistics using the analysis set.

Eligibility Criteria:
Inclusion Criteria:

* Subject aged 18 years or older or parent/legal guardian of subject aged less than 18 years, willing and able to understand and provide written informed consent/assent.
* Weight and/or age within intended use of at least one SpO2 sensor under test at time of enrollment.
* Willing and able to wear study devices in addition to SoC devices and during SoC procedures.
* In-patient within a neonatal or pediatric intensive care unit (e.g. NICU, PICU, PCICU).
* Has arterial access and ability to have arterial blood samples drawn as part of their SoC and analyzed by CO-Oximetry.

Exclusion Criteria:

* Known pregnancy or lactating females (self-reported)
* Injury, wounds, physical malformation, hyperkeratosis, or compromised/non-intact skin at sensor application site (i.e. fingers, toes, hands, feet, ears, nasal ala). Note: Certain malformations may be allowed if determined it would not affect application of sensor with the pulse oximetry system.
* Self-reported severe contact allergies to standard adhesives or other materials found in pulse oximetry sensors. Note: Subject may be considered eligible if subject can wear non-adhesive sensor.
* Unwillingness or inability to remove nail polish or artificial nails from sensor application site.
* Nail fungus on sensor application site.
* Wearing and unable to remove jewelry from sensor application site.
* Dye injection within 48 hours of enrollment.
* Known dysfunctional hemoglobin levels (COHb \>3%, MetHb \>2%, and ctHb \<10g/dl)
* Undergoing phototherapy for neonatal hyperbilirubinemia during arterial blood sampling
Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia

The primary purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with non-dialysis chronic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 75 years
2. Chronic kidney disease, not receiving dialysis
3. Body weight 45 to 140 kg

Exclusion Criteria:

1. Any clinically significant infection or evidence of an underlying infection
2. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)
3. History of chronic liver disease
4. New York Heart Association Class III or IV congestive heart failure
5. Myocardial infarction or acute coronary syndrome within 12 weeks prior to randomization
6. History of malignancy
7. Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
8. History of myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia
9. History of hemosiderosis, hemochromatosis or polycystic kidney disease
10. Active hemolysis or diagnosis of hemolytic syndrome
11. Uncontrolled or symptomatic secondary hyperparathyroidism
12. Seizure disorder or receiving anti-epilepsy medication
13. Known bone marrow fibrosis
14. Any prior or scheduled organ transplant
15. Prior treatment with roxadustat or any hypoxia-inducible factor prolyl hydroxylase inhibitor
16. History of alcohol or drug abuse
Technology Interventions to Improve Outcomes After Knee Replacement

The purpose of this study is to examine the effects of two technology interventions on health outcomes (e.g., physical activity, sedentary behavior, physical function, pain) after knee replacement at 2 and 5 months .

Two 8 week technology interventions will be examined and consist of the use of an app and/or website and regular calls. Assessments to examine outcomes will be completed at baseline, as well as at 2 and 5 months.

Eligibility Criteria:
Inclusion Criteria:

* Be 40-79 years of age
* Had unilateral knee replacement within last 12 months
* Have an Android or iOS smartphone that is accessible and near them the majority of the day
* Be willing to download the study applications on their smartphone
* Spend at least 7 hours/day sitting
* Be English speaking

Exclusion Criteria:

* Have any contraindications to activity
* Have a mobility limiting comorbidity
* Have a scheduled surgery within the next 6 months
* Do not have ≥4 days of valid accelerometer (\>=10 hours) wear at baseline.
Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)

The study will investigate the efficacy, safety, tolerability and Pharmacokinetic(PK) of 3 doses of empagliflozin compared with placebo over 26 weeks in 960 patients with type 1 diabetes mellitus as adjunctive therapy to insulin


Eligibility Criteria:
Inclusion criteria:

* Signed and dated written informed consent
* Male or female patient receiving insulin for the treatment of documented diagnosis of type 1 diabetes mellitus (T1DM) \> 1 year
* C-peptide value of \< 0.7 ng/mL
* Use of Multiple Daily Injections (MDI) of insulin or insulin pump user with total daily insulin \>= 0.3 and \<= 1.5 U/kg
* Glycated haemoglobin (HbA1c) \>= 7.5% and \<= 10.0%
* Good understanding of T1DM
* Age \>= 18 years
* Body Mass Index (BMI) \>= 18.5 kg/m2
* Estimated glomerular filtration rate \>= 30 mL/min/1.73 m2
* Women of child-bearing potential must use highly effective methods of birth control
* Compliance with trial medication administration between 80% and 120% during placebo run-in period Further inclusion criteria apply

Exclusion criteria:

* History of type 2 diabetes mellitus, maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis
* Pancreas, pancreatic islet cells or renal transplant recipient
* T1DM treatment with any other antihyperglycaemic drug except subcutaneous basal and bolus insulin within last 3 months
* Occurrence of severe hypoglycaemia within last 3 months and until randomisation
* Occurence of diabetic ketoacidosis within 3 months prior to Visit 1 and until Visit 6
* Irregular sleep/wake cycle
* Acute coronary syndrome, stroke or Transient Ischaemic Attack (TIA) within last 3 months
* Severe gastroparesis
* Brittle diabetes
* Liver disease
* Eating disorders
* Treatment with anti-obesity drugs, weight-loss surgery or aggressive diet regimen
* Treatment with systemic corticosteroids
* Change in dose of thyroid hormones within last 6 weeks and until randomisation
* Cancer or treatment for cancer in the last five years
* Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells
* Women who are pregnant, nursing, or who plan to become pregnant whilst in the trial
* Alcohol or drug abuse
* Intake of an investigational drug in another trial within last 30 days Further exclusion criteria apply
Anxiety in Black Men With Prostate Cancer: Validation of the Memorial Anxiety Scale for Prostate Cancer in an Sample of Black Men

This study is being done to see if a standard tool used to check anxiety in white men works well for Black men. The tool is used only for men who have prostate cancer. It is meant to see how the cancer affects men. If the investigators have a good tool, it is more likely that the investigators can help those who have high levels of anxiety. This test is known as the Memorial Anxiety Scale for Prostate Cancer (also called the MAX-PC).


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Patients who are being monitored by PSA tests, who will have a PSA test done on the day of their current clinic visit or prior to their clinic visit, but prior to being informed of the results
* Diagnosis of prostate cancer
* Ethnicity: Black, African-American, or of African descent (and will include those men who identify as Black and Hispanic).
* Ability to comprehend and complete questionnaires in English

Exclusion Criteria:

* Major psychopathology or cognitive impairment likely, in the judgment of the research staff, to interfere with the participation or completion of the protocol
* Other non-Black or non-African-American ethnic groups
CBD-Microglia PET Study

This study aims to examine the effect of cannabidiol (CBD) pre-treatment on brain microglial activation in healthy human subjects. Secondarily, this study aims to examine the effect of cannabidiol (CBD) pre-treatment on central pain-sensitization in healthy human subjects.

This study aims to examine the effect of cannabidiol (CBD), pre-treatment, as Epidiolex, on brain microglial activation in healthy human subjects using \[11C\]PBR28 PET imaging. Secondarily, this study aims to examine the effect of cannabidiol (CBD) pre-treatment on central pain-sensitization in healthy human subjects. Lastly, this research study will also examine the relationship between brain microglial activation and central pain sensitization with CBD pre-treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged 18- 55 years
2. No significant medical or neurological illness
3. No implanted metal devices that may pose a risk during MRI scanning
4. Within the annual permissible radiation exposure
5. Able to provide written informed consent.

Exclusion Criteria:

1. Current use of any medications
2. Presence of metal in the body
3. Pregnancy or lactation
Children's Aid Societies: Differential Response and Wraparound Prevention Trial

The purpose of this study is to assess the cost-effectiveness of this Differential Wraparound model, in 5 Children's Aid Societies within Hamilton-Niagara Region, in preventing maltreatment cases from either becoming ongoing protection cases, or the children ending up in out-of-home of out-of community placements, as well as reducing the amount of time in Children's Aid Society care as compared to usual Children's Aid Society risk assessment and protection service alone.

The number of children in child welfare care has increased from 10,000 in the early 1990s to over 18,000. Ontario spends over $1.1 billion a year on direct child welfare services, more than twice as much as spent in the late 1990s, with the majority of these resources spent on investigation instead of treatment. In response to this situation, Differential Response models, sometimes called alternative, multiple or integrated system responses, have been implemented in the US, Australia and Canada and are all at the beginning stages of systematic evaluation. These models will help prevent maltreatment cases from becoming ongoing protection cases, or the children ending up in out of home or community placements, and reduce the amount of time in Children's Aid Society care. This research will show the benefits and costs of a Differential Response approach to Children's Aid Society care, specifically in the Hamilton-Niagara Region

Eligibility Criteria:
Inclusion Criteria:

* Parent of children and youth, living in Hamilton and surrounding areas.
* Newly referred substantiated cases going on to protective services.
* English \& non-English speaking.

Exclusion Criteria:

* Safety threat
* Non-substantiated cases not going to protective services.
Human Intervention Study of Egg Protein Derivative on Cardiovascular Risk

Heart disease and stroke are the most common cause of death in Ireland today.One of the main risk factors for heart disease and stroke is high blood pressure or hypertension. Research has found that certain specific proteins or peptides found in foods such as dairy, meat, fish and eggs may promote heart health reducing blood pressure in adults with hypertension. The aim of this study is to investigate the potential beneficial effects egg peptides may have on heart health, in particular, effects on blood pressure.

Poor dietary habits of Irish adults has been accompanied by epidemics of obesity and metabolic disorders such as type II diabetes leading to a substantial predicted increase in the prevalence of chronic diseases such as cardiovascular disease.Hypertension is a major contributing factor to the development of cardiovascular and metabolic diseases. Dietary factors play a significant role in the prevention and/or treatment of hypertension and therefore the development of foods with antihypertensive properties could prove beneficial.

Eligibility Criteria:
Inclusion Criteria:

* Male and female
* Non-diabetic
* Aged 50-65
* BMI 25-35kg/m²
* Mild hypertensive: Blood pressure 130-149 mmHg

Exclusion Criteria:

* Current smoker
* Diagnosed hypertensive
* History of cardiovascular disease
* Diabetic
* Chronic kidney disease
* Gastrointestinal disease
* Currently on anti-hypertensive medications
* Allergic to eggs
Effectiveness of Pilates in Patients With Subacute Low Back Pain

This study aims to evaluate the effectiveness of Pilates exercises in patients with subacute low back pain, which typically lasts between 4 and 12 weeks. Subacute low back pain is longer-lasting than acute pain and can negatively impact daily activities and quality of life. Pilates is an exercise method that strengthens core muscle groups, improves flexibility, and supports body balance.

This research is designed as a comparative study between two groups. One group will participate in Pilates exercises, while the other group will follow a standard home exercise program. The study will assess outcomes such as pain level, mobility, and quality of life. Through this, the study aims to provide more insights into the potential of Pilates as a treatment method for subacute low back pain.

This study investigates the role of Pilates exercises in managing subacute low back pain, a condition defined as lasting between 4 and 12 weeks. Subacute low back pain often disrupts daily functioning and lowers quality of life, and effective interventions during this stage are crucial to prevent the transition to chronic pain. Pilates has been suggested as a beneficial exercise approach due to its focus on core stability, flexibility, and balanced body mechanics, which may reduce pain and improve functional outcomes in low back pain patients.

Participants in the study will be divided into two groups: a Pilates group and a home exercise group. The Pilates group will participate in a structured Pilates program designed to target core muscle strength and flexibility over a set period, while the home exercise group will follow a standard exercise program tailored for general low back pain relief. Both groups will perform their respective exercises for eight weeks.

The primary outcome measures will include pain intensity, physical function, and quality of life, assessed at baseline, post-treatment, and follow-up periods. The findings from this study will contribute to understanding whether Pilates can be a valuable addition to conservative treatment approaches for subacute low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 18 and 65 years.D
* Diagnosis of subacute low back pain, defined as pain lasting between 6 and 12 weeks
* No previous Pilates experience.

Exclusion Criteria:

* History of spinal surgery or significant spinal deformities (e.g., scoliosis).
* Presence of serious medical conditions such as cardiovascular disease, uncontrolled hypertension, or neurological disorders.
* Pregnancy or planned pregnancy during the study period.
* Use of pain-relief medications that could interfere with the results of the study.
* Participation in any structured physical therapy program in the last three months.
Intellectual Enrichment to Build Cognitive Reserve in MS

Cognitive problems are a primary concern for people with multiple sclerosis. In many cases, people with MS report these issues to be more debilitating than the motor symptoms that are targeted by most treatment strategies. For people with MS, impaired memory and thinking skills can interfere with the ability to function efficiently in multiple professional and personal roles. Finding ways to decrease, slow, or reverse declines in memory and thinking skills is a vitally important research priority. We now know that engaging in intellectually enriching activities helps protect against the negative impact of MS disease-related declines in memory and thinking. Such activities contribute to something called 'cognitive reserve,' which serves as a protection against disease-related declines in memory and thinking. Thus far, no one has created a treatment that aims to provide a concentrated 'dose' of intellectual enrichment to build cognitive reserve. The present intervention aims to do precisely this. Here, we have developed a program of enriching activities that are delivered via a personal iPad. This allows for a 12-week 'treatment' that is entirely home-based, while also providing close personal contact between participants and our study personnel, who will communicate daily via emails. Week by week, participants choose from a menu of intellectually enriching activities such that their treatment is dynamic and customizable to fit their interests. The intervention is designed to be fun, as we hope the activities will be incorporated into people's lives beyond the period of the study itself. Given what we already know about the striking benefits of cognitive reserve to protect against disease-related declines in cognitive functioning, we expect to show that treatment with a daily, intense, intellectually enriching schedule of activities results in improved thinking and memory for people with MS. We will also investigate the positive impact of our treatment on the brains of people with MS through brain scans. We expect to see evidence for a shift toward more efficient processing in the brain, changes that translate to improved memory and thinking skills.


Eligibility Criteria:
Inclusion Criteria:

* age 25-65
* MS duration \>5 years
* read and speak English fluently

Exclusion Criteria:

* currently experiencing an MS exacerbation
* MS exacerbation within 6 weeks of study start
* left handed
* non-MRI compatible: metal in body, claustrophobic
* history of neurological disorder other than MS
* history of head injury
* history of schizophrenia or bipolar disorder
* pregnant
* currently taking steroids, benzodiazepines, and/or neuroleptics
* do not speak English as primary language
Efficacy and Safety of Rapid Titration Protocols of Lacosamide

Three different dose titration schedules are tested to find a way to reduce the titration period of lacosamide

The investigators intend to find a way to reduce the titration period of lacosamide. Dosage of lacosamide is increased from 100-200 mg/d to 400 mg/d by three different titration schedule. Safety of lacosamide administration is primary endpoint. 50% responder rate (seizure reduction) and blood level of lacosamide are investigated for secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-85 years old
* Patients diagnosed with focal epilepsy
* Patients subjected to the addition of lacosamide to treat focal onset seizures according to physician's judgement
* Subjects provided informed consent

Exclusion Criteria:

* Subjects who changed other antiepileptic drugs at the beginning of lacosamide treatment
* Subjects with unstable physical, mental or other disease condition that can impede with accurate evaluation or treatment
* Subjects with terminal illness or general medical condition that can impede with the participation of the clinical trial
* Subjects who do not agree with prior consent
Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of LC350189

This will be a dose block-randomized, double-blind, active and placebo controlled, single and multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic / pharmacodynamic characteristics. Adverse events, physical examinations, vital signs, ECG and laboratory tests will be conducted for safety/tolerability evaluation and serial blood samples and urine collections for pharmacokinetic and pharmacodynamic evaluations will be conducted at specified time points.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects between the ages of 20 and 50 years at screening
2. Subjects with Body Mass Index (BMI) between 18.0 (inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive). ☞ BMI (kg/m2) = body weight (kg)/ {height (m)}2.
3. Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures.
4. Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests
Novel Metabolites of Beta-Carotene and Lycopene

The study (n = 36) will be a parallel design and will be 6 weeks in duration. Participants will start with a 2-week free-living wash-in period where they will be asked to avoid certain carotenoid-rich foods, followed by 4 weeks of a completely controlled diet. In addition to the controlled diet, participants will consume one of three beverages (300 mL/day; n = 12/group): placebo beverage (control), high beta-carotene tomato juice, and high-lycopene tomato juice. Blood, urine and feces will be collected throughout the study.


Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:

* Age less than 21 or greater than 75 years
* Glucose \> 126 mg/dl
* Triglycerides \> 300 mg/dl
* Known allergy or intolerance to tomatoes or tomato products
* Pregnant, lactating, or intend to become pregnant during the study period
* History of bariatric surgery or nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring special diet recommendations
* Smoker or use of tobacco products
* Presently have cancer
* Use of certain medications (prescription or over-the-counter) that may interfere with the study objectives
* Type 2 diabetes
* Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol, or Miradon (anisindione)
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol