cyrilzakka/clinical-trials huggingface dataset:
Omega (n)-3 PUFA Enriched Beef & Health Outcomes.

Red meat is an integral component of the habitual diet among the UK and Irish population, with adults consuming an average of 71grams/day. Although typically high in saturated fatty acids (SFA), red meat is also an important dietary source of protein and essential nutrients including iron, zinc, B vitamins and long chain n-3 polyunsaturated fatty acids (PUFA) which provide numerous benefits to human health, particularly related to cardiovascular disease (CVD) risk. N-3 and n-6 PUFA are a family of fatty acids with important roles in cardiovascular health, and it is often recommended in dietary guidelines to replace SFA with unsaturated fats, such as PUFA. Owing to the social and economic burden of CVD, increasing the proportions of these unsaturated fatty acids, in combination with a reduction in SFA within meat, could have a large impact on CVD risk at the population level, whilst retaining the beneficial nutrients and n-3 PUFA which meat provides.

In this research, a total of 90 eligible and consenting participants will be randomly allocated to consume three portions per week of n-3 enriched beef (from either dietary supplemented or grass-fed cattle) or control beef (from standard supply). This beef will be offered within a lunchtime meal and served from the Human Intervention Studies Unit at Ulster University, Coleraine for a period of 5 weeks. A fasting blood sample will be taken before and after intervention to determine the effect the n-3 enriched beef on cholesterol concentrations, lipid profile, PUFA status and inflammation. Blood pressure, stiffness of the arteries and body shape, size and composition will also be assessed, and some health and lifestyle habits will be captured using questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Free-living, apparently healthy adults
* Aged 20+ years at recruitment
* Low oily fish consumers (\<2 servings/mo), or those willing to reduce their fish consumption 1 month prior to commencing the study
* Non-smokers
* Not regularly consuming plant stanols or other n-3 enriched foodstuffs

Exclusion Criteria:

* Non-free-living adults
* Adults \<20 years at recruitment
* Oily fish consumers (2 servings/mo or more)
* Current smokers
* Pregnant/lactating females (or planning to become pregnant)
* Food allergy or intolerance that would prevent consumption of the study meals
* Diagnosed with a chronic medical condition (such as diabetes; CVD; autoimmune/ inflammatory disorders; cancer)
* Prescribed cholesterol or blood pressure lowering medications
* Currently taking any fish oil-containing supplement Daily consumption of plant stanols or other n-3 enriched foodstuffs
Variability of Fluconazole Concentration in Critically Ill Patients

Fluconazole is the first-line agent in the treatment of invasive candidiasis. Studies showed inappropriate drug exposure causes high mortality in critically ill patients. Under-dosing and ineffective fluconazole trough serum concentrations were found in a recent retrospective study. Variability in fluconazole exposure can be easily measured with therapeutic drug monitoring. For patient groups who are at risk for drug underexposure, therapeutic drug monitoring can be valuable regards decreasing mortality.


Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years or older.
* Treatment with fluconazole.
* Written informed consent obtained from patient.
* Written informed consent obtained from representative of patient.

Exclusion Criteria:

* Blood sampling not possible
Study of APR-1051 in Patients With Advanced Solid Tumors

The purpose of this study is to assess the safety and effectiveness of APR-1051 through the performance of a Phase 1, open-label, safety, PK, and preliminary efficacy study of oral APR-1051 in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of advanced/metastatic solid tumor
* Measurable or evaluable disease per RECIST version 1.1 (radiographic disease progression per PCWG3 criteria for patients with mCRPC)
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 or Karnofsky Performance Status (KPS) ≥ 70%
* Patients must have recovered to Grade 1 or baseline levels from toxicity or adverse events related to prior treatment for their cancer, excluding Grade ≤ 2 neuropathy, alopecia, or skin pigmentation
* Adequate bone marrow and organ function
* Women of child-bearing potential (WOCBP) or men of child-fathering potential must agree to use adequate contraception prior to study entry

Exclusion Criteria:

* Patient has had prior systemic anti-cancer therapy (cytotoxic chemotherapy, immunotherapy, targeted therapy) within 3 weeks (6 weeks in cases of mitomycin C, nitrosourea, lomustine) or at least 5 half-lives (whichever is shorter, but no less than 2 weeks) prior to Day 1
* Prior radiation therapy at the target lesion unless there is evidence of disease progression. If patient has had prior radiation therapy for disease progression, see Exclusion Criterion 1 for allowed interval between radiotherapy and Day 1 and recovery of AEs
* Treatment with any investigational agent administered within 30 days or 5 half-lives, whichever is shorter, before the first dose of APR-1051
* Major surgery within 21 days prior to Day 1
* Concomitant treatment with other anti-cancer therapy, including chemotherapy, immunotherapy, biological therapy, radiation therapy (except palliative local radiation therapy), or other novel anti-cancer agents. Note: endocrine therapy for breast and prostate cancer is allowed along with agents to treat or prevent skeletal related events (zoledronic acid, pamidronate, denosumab)
* Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy
Digital Cognitive Behavioral Therapy for Insomnia in China

Digital cognitive behavioral therapy for insomnia (dCBT-i) is found to be effective but is rarely used in China. Hence, the investigators developed an automated Chinese dCBT-i program and examined its feasibility, acceptability, and preliminary effectiveness in individuals with insomnia symptoms.


Eligibility Criteria:
Inclusion Criteria:

* were aged 18 or older;
* had a positive screening result for chronic insomnia, i.e., a score of 16 or lower on the Sleep Condition Indicator (SCI);
* had stable access to the internet via a smartphone.

Exclusion Criteria:

* additional sleeping conditions except for insomnia (such as restless legs syndrome and sleep apnea);
* psychosis or mania;
* serious physical health concerns necessitating surgery or with prognosis \<6 months;
* undergoing medical or psychological treatment for insomnia with a health professional;
* habitual night shift, evening, or rotating shift-workers.
Liquid Biopsy for the Diagnosis of Intestinal-type Adenocarcinoma of the Ethmoid (BLADE)

The role of this transversal study is to assess the specificity and sensitivity of liquid biopsy to detect circulating cells tumor of adenocarcinoma of the ethmoid.

Blood sample of participants will be collected at the moment of the surgical procedure or recurrence diagnosis; immediately after surgery; at day 8-10; at month 2-3 of postoperative follow-up.

Two comparison groups will be studied: one age and gender-matched group and one professional exposure-matched group to assess the sensitivity and specificity of liquid biopsy


Eligibility Criteria:
Inclusion Criteria:

* Case group: diagnosis of adenocarcinoma of the ethmoid on biopsy or imaging recurence; age\>/= 18 years; patient consent ;
* Age and gender-matched control group: consulting patient in otolaryngology head and neck surgery department without adenocarcinoma of the ethmoid; no personal history of cancer; no familial history of colorectal adenocarcinoma;
* Exposition control group: Professional exposition to wood dust, leaver or nickel for at least 12 months; consulting patient in otolaryngology head and neck surgery department without adenocarcinoma of the ethmoid; no personal history of cancer; no familial history of colorectal adenocarcinoma;

Exclusion Criteria:

* patient presenting with another malignant tumor
* deprivation of liberty
* patient under guardianship
* Other cancer diagnosed or under treatment
* Recurrent patient previously included in the study
* Refusal to accept the monitoring described and/or to provide the information required for the study
* No affiliation or non-beneficiary of a Social Security system;
* Pregnant or breast-feeding women in accordance with article L1121-5 of the Public Health Code (CSP)
Aerobic Training on Lung Function in Fibromyalgia

Exploring the effect of aerobic exercises on lung function, chest movement, and exercise capacity in women suffering from fibromyalgia.

Eighty women with fibromyalgia will be equally randomly assigned to the experimental (EX) group and the control group (CON). The participants' age will be between 30 and 40 years and they will have mild restrictive lung affection. The Ex group will attend 3 sessions/week of aerobic training at moderate intensity combined with diaphragmatic breathing exercises for 12 weeks, the CON will only attend 3 sessions/week of diaphragmatic breathing exercises for 12 weeks. The lung functions will be assessed by the spirometry testing. The chest expansion will be determined using a tape measurement. Additionally, exercise capacity will be tested using cardiopulmonary exercise testing protocol. All the outcomes will be examined at baseline, and after 12 weeks of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Well controlled fibromyalgia.
* Mild restrictive lung affection.
* Body mass index less than 30kg/m2.
* Moderate level of physical activity.

Exclusion Criteria:

* Any chest diseases.
* Musculoskeletal/ neurological limitations to exercise.
* Smokers.
* Pregnant.
Transcranial Magnetic Stimulation in Disorder of Consciousness in Acute Severe Cerebrovascular Disease Patients

This study is aimed at evaluating the potential of transcranial magnetic stimulation in patients with acute severe ischemic stroke with DoC while assessing patients with a hybrid neural network evaluation model. This model may be the basis for initiating individualized closed-loop neuromodulation treatment in patients with DoC.

Despite continued advances in life-sustaining intensive care for severe brain injury patients, little can be done to promote behavioral recovery in patients with disorder of consciousness (DoC). Arousal is the primary task in the rehabilitation of patients with impaired consciousness. Evidence suggests that some medications and physical therapies can induce wakefulness by reactivating specific pathways that lead to impaired consciousness. However, due to the complexity of the type, degree, location, and other related influencing factors of brain injury, the current commonly used treatment options are not effective for patients with impaired consciousness, and the theoretical basis for benefit is not sufficient.

This study is aimed at evaluating the potential of transcranial magnetic stimulation in patients with acute severe ischemic stroke with DoC while assessing patients with a hybrid neural network evaluation model. This model may be the basis for initiating individualized closed-loop neuromodulation treatment in patients with DoC.

Before and after a course of treatment (20 days), activation and connectivity of patients' arousal centers will be assessed through a hybrid neural network evaluation model, which consists of comprehensive cortical connectivity parameters (perturbational complexity index and evoked high-frequency oscillations) and region-specific cortical connectivity parameters (short-latency afferent inhibition and mismatch negativity). Each parameter is clinically used to assess a patient's level of cortex connectivity. This hybrid evaluation model may give a comprehensive evaluation of a patient's degree of awareness, and enhance our understanding of the mechanisms underlying these conditions.

Eligibility Criteria:
Inclusion Criteria:

* 7-28 days after ischemic stroke
* behavioral profile consistent with a UWS or MCS as assessed with the Coma Recovery Scale Revise
* prestroke Modified Ranking Scale(mRS) ≤2

Exclusion Criteria:

* history of vascular malformation or aneurysmal SAH or untreated aneurysm prior to stroke
* disorder of consciousness prior to stroke
* impairment of hearing
* metal implants, e.g. stenting, pacemaker, etc.
* contraindications to MRI, such as claustrophobia
* history of epilepsy or epileptic episodes
* suffering from serious diseases such as malignant tumors, etc., with expected survival time \<1 year
* patient is currently involved with other trials
COVID-19 and Chilblains

Chilblains (inflammatory lesion of the feet or hands) have been reported with an unusual frequency during the confinement period, most commonly in children, teenagers and young adults. The aim of the ECCES study is to find out whether these manifestations of chilblains can be linked to the SARS-CoV-2 coronavirus.

For this, an epidemiologic study will compare two types of family (or more precisely people who were confined together in March-April-May):

* "case family" in which at least one of the members had chilblains
* "comparator family" in which none of the members had chilblains Environment (home lockdown) of the two types of family will be analyzed. Each member of the "family" will be suggested doing a serological test.


Eligibility Criteria:
Inclusion Criteria:

* "case family"
* at least one of the members with chilblains
* diagnosis of chilblains (anamnesis and pictures) written informed consent
* "comparator family"
* none of the members with chilblains
* one member matched on age (+/- 1 year) to a patient with chilblains
* written informed consent

Exclusion Criteria:

- Subject legally protected (under judicial protection, guardianship), persons deprived of liberty
Use of Knotless Suture for Closure of Total Hip and Knee Arthroplasties

Barbed sutures offer several potential advantages in layered wound closure of hip and knee replacement surgeries. It use is gaining increased acceptance across many of the other surgical disciplines at this time. The purpose of this study is to evaluate the use of Quill as part of our layered closure compared to using our traditional sutures. The study timeline begins at the time of the surgical procedure and continues through the routine follow-up of total joint replacements at 2, 6, and 12 weeks, and will conclude at the six month post-operative office visit.

Primary Objectives:

* To evaluate the safety and efficacy of wound closure in primary hip and knee replacements using a bidirectional barbed suture (knotless) compared to a traditional layered (vicryl) wound closure.

Secondary Objectives:

* Establish the all around (intra-operative and post-operative) cost-savings potential in using a knotless wound closure compared to that of a layered vicryl closure (our standard suture protocol).
* Assess the overall cosmesis of the wound/scar as well as perceived presence of subcutaneous surgical knots, when using the knotless wound closure versus our traditional layered suture closure.

We performed a prospective, randomized clinical trial to evaluate the efficacy of using a bidirectional barbed suture compared with traditional sutures in the deep closure of primary total hip (25) and knee (35) arthroplasties. Complications, time to closure, and length of surgery were evaluated. Closure was noted to be significantly faster (9.3 vs 13.6 minutes, P b .005) in the barbed suture group. Wound-related complications were similar (3 cases) in both groups at 3-month follow-up. Although this study supports the use of barbed technology as a functionally comparable and more efficient modality of wound closure with the potential for costs savings based on reduced operative time, the cost-effectiveness of its adoption is institution dependent and will rely on the optimization of all other perioperative factors.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be male or female of any race
* Ages 18-80 years old
* Patients must be undergoing a primary hip or knee arthroplasty
* Patients must be able to understand and willing to cooperate with study procedures
* Able to provide written and verbal informed consent

Exclusion Criteria:

* Allergy or intolerance to the study materials
* Surgical intervention during the past month for the treatment of the painful joint or its underlying etiology
* History of previous surgeries on the affected joint other than arthroscopy (open surgeries)
* History of any substance abuse or dependence within the last 6 months
Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System.

The main aim is to evaluate the safety and efficacy of the iD-System™, One-handed Disposable Internal Defibrillation System The device is made for manual defibrillation during intra-thoracic procedure, by transferring a shock from a defibrillation device to the patient's heart, in combination with the iD-Electrode. The device will be used when the patient reaches a stage of ventricular fibrillation or rapid ventricular tachycardia during cardiac surgery.

The main aim is to evaluate the safety and efficacy of the iD-System™, One-handed Disposable Internal Defibrillation System The device is made for manual defibrillation during intra-thoracic procedure, by transferring a shock from a defibrillation device to the patient's heart, in combination with the iD-Electrode. The device will be used when the patient reaches a stage of ventricular fibrillation or rapid ventricular tachycardia during cardiac surgery.

In case ventricular fibrillation occurs and the iD-system is not effective to restore the sinus trythm, the conventional approach with use of the two paddels spoons will be performed immediately.

the following will be assessed:

* Ease of use of the device
* Safety of the device
* Efficacy of the device

Eligibility Criteria:
Inclusion Criteria:

* All races and ethnicity (\>18 years)
* Written informed consent form (ICF) has to be obtained from the patient.
* Elective surgery: cardiac surgery on pump (CPB)

  * Coronary artery bypass surgery
  * Heart valve repair and/or replacement

    * Mini sternotomy
    * Median sternotomy
  * Redo surgery

Exclusion Criteria:

* Patients without cardiopulmonary bypass (referred to as heart-lung machine or pump)
* Emergency surgery without a sufficient amount of time to explain and ask for ICF
Efficacy of the Chronic Application of Tear Formulations

The purpose of this study is to determine the therapeutic effect of the chronic application of eye-drops on tear evaporation rate in dry eye and normal subjects exposed to a condition of environmental stress. The effect will be studied in terms of changes in tear physiology and the inflammatory biomarkers on the ocular surface.

Environmentally induced dry eye is a condition which occurs in otherwise asymptomatic individuals in certain situations, for example with the use of computers, in overheated or air conditioned workplaces and in conditions of low humidity. The most common ocular complaints associated with these environments are burning, dryness, stinging, and grittiness. Although the exact cause of these symptoms is unknown, it is thought that increased tear evaporation rate due to low humidity plays a vital role. The changes in tear film physiology, which occurs in these environments, have traditionally been dealt with by the use of eye drops (particularly the highly viscous variety), which have been shown to be an effective therapeutic option in the treatment of environmental dry eye disease. Previous studies of the use of eye-drops of various formulations has shown improvements in tear physiology in mild to moderate dry eye patients with their use in both acute and chronic application protocols. In this study, an attempt was made to relate the effects on tear physiology induced by variations in environmental conditions to the beneficial effect produced by the use of eye-drops.

Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 18 and 79 years of age.
* Must understand and be able, willing and likely to fully comply with study procedures and restrictions.

Exclusion Criteria:

* Active ocular allergy
* Current contact lens wear
* Any topical ophthalmic drops within 1 week of initial screening visit.
* Started or changed the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of initial screening visit.
* Systemic disease known to affect tear production or loss including, but not limited to thyroid eye disease, that has been diagnosed or has not been stable within 30 days initial of screening visit.
* Known hypersensitivity to any of the agents used in testing.
TROLLEY Study - TRansit Opportunities for HeaLth, Livability, Exercise and EquitY

The researchers are evaluating longitudinal changes in multiple health, economic, and environmental outcomes over a 3-year COVID recovery period and in the context of a new light rail transit (LRT) line, called the Mid-Coast Trolley, among 465 UC San Diego (UCSD) staff. The primary aim is to evaluate change in objectively measured total and moderate to vigorous physical activity (MVPA), travel mode, and vehicle miles traveled (VMT).


Eligibility Criteria:
Inclusion Criteria:

1. are 18 years of age or older;
2. are a full or part-time employee at UC San Diego
3. Prior to COVID-19, you used to commute to La Jolla at least 2 days per week;
4. have lived in the neighborhood selected for the study for at least one year;
5. are able to walk without human assistance;
6. are comfortable reading and writing in English or Spanish;
7. have a reliable phone where you can be reached;
8. spend most of your time in San Diego County;
9. don't plan on moving in the next year;
10. are able to give informed consent and comply with the protocol;
11. are willing to complete all assessments and wear all devices for 7 days at 3 different time points in the next 2 years.

Exclusion Criteria:

1) pregnant, 2) mental state that would preclude understanding the protocol, 3) medical condition that would affect physical activity, 4) taking part in another physical activity related research study, and 5) live or regularly travel outside of San Diego County.