cyrilzakka/clinical-trials huggingface dataset:
Wireless Assessment of Respiratory and Circulatory Distress - Continuous Glucose Monitoring

The applicant and research team partners have over the last years developed the WARD project (Wireless Assessment of Respiratory and circulatory Distress), using wireless continuous monitoring of vital signs in high-risk patients undergoing major abdominal surgery. An important perioperative indicator not currently included in the WARD project is continuous glucose monitoring (CGM), which may not only predict and identify hypo- and hyperglycemia, but also utilize the information from variations in blood glucose in combination with other changes in vital signs to predict surgical complications in all patients.

The current study involves the inclusion of 80 patients, scheduled for major abdominal, orthopedic or vascular surgery, to be monitored with CGM in addition to the currently measured vital signs. The project is a prospective, observational, clinical study, describing and analyzing variations in perioperative blood glucose levels and vital signs, and the relation to adverse clinical outcomes.

Patients scheduled for elective surgery will preferentially be recruited at the preoperative assessment at a maximum of 30 days before surgery. CGM and monitoring of the remaining vital sign modalities will commence on the day of surgery. Patients admitted for acute surgery will be recruited preoperatively and CGM as well monitoring of the remaining vital sign modalities will commence as soon as possible. The patients will be monitored with CGM for up to 10 days and with the remaining modalities for up to 5 days or for all modalities until discharge or withdrawal of consent.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years) admitted to Rigshospitalet or Bispebjerg Hospital for major abdominal surgery (e.g. colonic resections, gastrectomy, hepatic resection etc.) or major orthopedic surgery (e.g. hip-fracture, hip and knee-arthroplasty) or major arterial vascular surgery (e.g. aortic aneurysm, iliac or femoral bypass etc.)
* Estimated duration of surgery ≥1 hour and at least one expected overnight stay postoperatively

AND

● Type 1 diabetes (Clinically defined: insulin initiated at diabetes onset and treatment with multiple doses of insulin or continuous subcutaneous insulin infusion) (n=20)

OR

● Type 2 diabetes treated with insulin (Clinically defined: treatment with diet or oral antidiabetic drugs for at least 6 months before insulin was started) (n =20)

OR

● Type 2 diabetes treated with oral antihyperglycemic drugs and/or GLP-1 analogs (n=20)

OR

● No diabetes mellitus (excluded by an admission HbA1c \<48 mmol/mol) (n=20)

Exclusion Criteria:

* Patient expected not to cooperate with study procedures.
* Patient allergic to plaster or silicone.
* Patients with impaired cognitive function (assessed by a Mini Mental State Examination \[MMSE\] score \<24)
* Patients admitted for palliative care only.
* Previous or currently scheduled for pancreatectomy (complete or partial)
* Patients with pacemaker or implantable cardioverter defibrillator (ICD) device
PROactive Evaluation of Function to Avoid CardioToxicity

This study is intended to evaluate the ability of an intramyocardial strain analysis package with cardiac MRI to assist in the early detection and management of cardiotoxicity from therapeutics used to treat cancer.


Eligibility Criteria:
Inclusion Criteria:

* Participant in the SURVIVE registry
* Signed informed consent form for PROACT
* Histological diagnosis of any cancer type (patients with treated and clinically stable brain metastasis are acceptable)
* Scheduled to receive anti-cancer therapy (radiation therapy is permitted)

Exclusion Criteria:

* Contraindication to magnetic resonance imaging (MRI)
* Unable to comply with study investigations (in the judgment of the investigator)
* Life expectancy less than 1 year
* Note: If a patient develops a temporary contraindication (e.g. temporary tissue expanders in breast cancer patients) after the baseline MRI, follow up MRIs will be discontinued for safety for the duration in which the patient has the contraindication. However, once the patient is no longer contraindicated to receiving MRIs, the study schedule may resume with their next scheduled MRI time point from the date of enrollment. Therefore, some time points may be skipped during the patient's enrollment in the study.

Also, if a patient needs a repeat MRI at any time point for any reason (i.e. panic attack during the MRI causing them to not be able to continue, unreadable images, etc.), we may repeat the MRI as long as the patient is willing.
Effects of Advertising on Young Children's Perception of Taste

To test whether young children's actual taste preferences are influenced by the natural marketing environment in which they live. To do so, we tested whether preschool children would like the taste of a food more if they thought it was from a heavily marketed source. We asked preschool children to taste identical foods in packaging from this heavily marketed source and plain packaging, and to tell us if they tasted the same or if one tasted better. We hypothesized that, even among a sample of 3-5 year olds participating in Head Start, a federally-sponsored preschool program for low-income families, young children would prefer the taste of foods perceived to be from the heavily marketed source.


Eligibility Criteria:
Inclusion Criteria:

* enrolled at participating head start sites

Exclusion Criteria:

* unable to complete the study procedures
A Study of ABT-378/Ritonavir Combination in HIV-Infected Patients Who Have Taken Protease Inhibitors

The purpose of this study is to see if it is safe and effective to give ABT-378/ritonavir combination plus nevirapine plus two nucleoside transcriptase inhibitors to HIV-infected patients who previously have taken protease inhibitors. This study also examines how the body handles this combination of anti-HIV drugs.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

- Antiretroviral regimen containing a protease inhibitor and one or two nucleoside reverse transcriptase inhibitors that has not changed in the last 12 weeks.

Patients must have:

- HIV infection with plasma HIV RNA of at least 1,000 copies/ml and less than or equal to 100,000 copies/ml at screening.

Prior Medication:

Allowed:

Naive to or has had less than 8 weeks of at least one nucleoside reverse transcriptase inhibitor and an acceptable regimen of two nucleoside reverse transcriptase inhibitors.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Medications that are contraindicated with ABT-378/ritonavir for the duration of the study, such as midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, ergotamine and dihydroergotamine.
* Over-the-counter medicine or alcohol, without knowledge or permission of the investigator.

Patients with the following prior conditions are excluded:

* Evidence of acute illness determined by vital signs, physical examination, or laboratory results.
* Clinically significant abnormal ECG results.
* Positive test result for drug abuse with the exception of cannabis, unless the investigator anticipates cannabis use will interfere with compliance with the study.

Prior Medication:

Excluded:

* Investigational drugs with the exception of Amprenavir within 28 days prior to the initiation of study dosing.
* Treatment with a non-nucleoside reverse transcriptase inhibitor.
* Treatment with a protease inhibitor different from the current protease inhibitor for more than 6 weeks prior to current regimen.
* Treatment with more than one protease inhibitor concurrently.

Risk Behavior:

Excluded:

* Active substance abuse, alcohol abuse, psychiatric illness.
* Presumption, by investigator, of poor compliance to regimen.
AZD9056 Relative Bioavailability Study

The aims of this study are to compare the blood levels achieved with a new formulation of AZD9056 to an existing formulation of AZD9056 used in previous studies.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study-specific procedures
* Healthy Volunteers, Females should not be of childbearing potential
* BMI between 18 and 30 kg/m2

Exclusion Criteria:

* Clinically significant ECG abnormality suggestive of underlying cardiovascular disease
* A history or presence of GI, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism and excretion of drugs
* Known or suspected drug or alcohol abuse or positive DOA test
The Menopause After Cancer Study

This study will recruit women with vasomotor symptoms of menopause and a prior cancer diagnosis, for whom conventional menopausal hormone therapy (MHT) is contraindicated for any reason. This study will examine if the addition of psycho-social support and digital cognitive behavioral therapy (CBT) for insomnia to standard non-hormonal pharmacotherapy can improve quality of life for these women.

Patients who are eligible and provide informed consent will be enrolled into this single arm study. Patients will be prescribed non-hormonal pharmacotherapy tailored to the timing of their predominant symptoms. They will be given access to an evidence based platform for digital CBT for insomnia and asked to identify a partner or other companion who will commit to providing psychosocial support to the research participant throughout the study period.

Eligibility Criteria:
Inclusion Criteria:

1. Females over 18 years of age at the time of recruitment and onboarding.
2. Vasomotor symptoms of menopause
3. Previous or current cancer diagnosis
4. Conventional menopausal hormone therapy contraindicated for any reason
5. Can speak and read English proficiently
6. Competent using the internet and has access to smartphone or similar device

Exclusion Criteria:

1. ECOG performance status \>3
2. Use of study medications to manage menopausal symptoms in the preceding 6 months
3. Use of CBT for insomnia in the preceding 6 months
4. Any contraindication to study medications
5. No internet access or competency issue with internet use
6. Unable to complete questionnaires or give informed consent
7. Current major mental illness
Acellular Dermis in Rotator Cuff Repair

To determine if an acellular dermal graft (ADG) will incorporate into the rotator cuff and subsequently improve outcomes without an increase in risk to the patient

Rotator cuff healing poses a significant clinical problem with re-tear rates between 20-50%. The final functional outcome following surgery correlates with healing, with those that completely heal performing best. Failure of repair is mainly due to tendon failure both mechanically and biologically. If the healing and the structural properties of the tendon can be improved then significant functional gains may be achieved. This study will therefore utilise acellular dermal grafts to determine whether they could be used for to improve patient outcomes following surgery

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic rotator cuff tear that warrants operative intervention.
2. A Tear measuring between 1-5cm at arthroscopy.
3. An arthroscopic rotator cuff repair.
4. Written consent.

Exclusion Criteria:

1. Rotator cuff tears greater than 5cm and less than 1cm
2. Clinical or radiological evidence of osteoarthritis affecting the index side.
3. Patients involved in a Compensation claim related to the shoulder.
4. Inability to attend follow-up for 1 year and to a repeat MRI scan.
5. Previous shoulder surgery or proximal humeral fracture on the index side.
6. Patients that are recruited in a current study
Electronic Cardiac Rehabilitation (eCardiacRehab) Feasibility Study

In Norway, more than 11,000 patients undergo percutaneous coronary intervention (PCI) annually. However, a very recent study utilizing registry data show a national average of cardiac rehabilitation (CR) participation of only 14%, despite its proven beneficial effects on readmissions, physical capacity, psychological distress, self-management, and quality of life. CR is strongly recommended in European guidelines. However, uptake is low and is not systematically identifying those in most need of CR. The primary objective of eCardiacRehab is to meet rehabilitation needs of large patient populations regardless of their access to traditional place-based rehabilitation by developing and evaluating the efficacy and cost effectiveness of an interdisciplinary and comprehensive home-based eCardiacRehab programme. eCardiacRehab address patient- and system level challenges in order to increase access to CR. The investigators give particular attention to older patients, women, and those with comorbidities or mental health challenges. Aspects related to continuity of care between specialist and primary care services, health literacy, adherence to treatment, cost effectiveness and ethics are investigated. The investigators will 1) continue to develop the programme with patients, general practitioners, healthcare experts from both specialist and primary care services, and technology developers, 2) develop treatment modules, 3) establish information and communication infrastructure, 4) evaluate the process and efficacy of treatment modules, 5) ensure knowledge development and transfer of competence to the municipalities, and 6) contribute to fulfil the innovation potential for health service and industry partners. eCardiacRehab has the potential to improve interaction and collaboration between primary and secondary care, modernise and digitalise work processes, and develop more coherent and tailored patient pathways. The vision of the home-based eCardiacRehab is to make CR available to all.


Eligibility Criteria:
Inclusion Criteria:

* Adult Norwegian (or Scandinavian) speaking patients (≥ 18 years) who have a Norwegian national identification number,
* With coronary artery disease after percutaneous coronary intervention
* Are living at home and have internet available to them
* Providing signed informed consent

Exclusion Criteria:

* Patients with cognitive impairment that may interfere with the ability to comply with the study protocol
* Severe aortic stenosis
* Severe arrhythmias
* Expected lifetime less than one year as determined by study personnel
* Otherwise clinically unstable
* Not fully revascularized (awaits percutaneous coronary intervention or coronary artery bypass graft surgery)
* Inability to comply with the study protocol due to any physical disability, somatic disease, or mental problems as determined by study personnel
Effect of Periorbital Massage on Dry Eye Disease

This randomized controlled trial aims to investigate the efficacy of periorbital massage therapy in alleviating symptoms and improving clinical outcomes in patients diagnosed with dry eye disease.

Participants will be randomized into either a periorbital massage intervention group or a control group receiving standard care. The intervention group will receive gentle periorbital massage techniques, while the control group will receive conventional dry eye treatments. The primary outcome measure will be assessed using the Schirmer Strips and Ocular Surface Disease Index (OSDI) questionnaire. This study holds promise for providing insights into the potential benefits of periorbital massage therapy as a complementary approach for managing dry eye disease symptoms and enhancing patients' overall quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of dry eye (such as burning, dryness or foreign body sensation)
* Ocular signs of dry eye (such as tear film instability, reduced tear production or meibomian gland dysfunction)
* Patients having moderate and severe dry eye disease according to schirmer test Willing and able to comply with the study protocol

Exclusion Criteria:

* Active ocular infection
* Ocular surgery within past 3 months
* Use of contact lenses
* Use of systemic medications that can affect tear production or tear quality
* Pregnancy or lactation
Genetics of Hypertension Associated Treatments (GenHAT)

To examine whether the association between selected hypertensive genes and combined fatal coronary heart disease and nonfatal myocardial infarction in high-risk hypertensives is modified by the type of antihypertensive treatment, leading to differential risks of coronary heart disease.

BACKGROUND:

The study might shed important light on the variation in patient response to antihypertensive agents, and improve the ability to pick the right antihypertensive for specific patients. GenHAT is an ancillary study to ALLHAT (the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial). ALLHAT recruited 42,515 hypertensives and randomized them to one of four antihypertensive agents (lisinopril, chlorthalidone, amlodipine, and doxazosin); follow-up will be completed in March, 2002.

DESIGN NARRATIVE:

GenHAT, a prospective study ancillary to ALLHAT, will characterize hypertension genetic variants and determine their interaction with antihypertensive treatments in relation to coronary heart disease (CHD). DNA from frozen clots stored at the ALLHAT Central Laboratory will be used to genotype variants of hypertension genes (angiotensinogen -6, angiotensin converting enzyme insertion/deletion, angiotensin type- 1 receptor, alpha-adducin, beta2 adrenergic receptor, lipoprotein lipase, and 10 new hypertension variants expected to be discovered during the course of the study). In addition to the primary aim, a number of secondary aims will be undertaken to evaluate gene- treatment interactions in relation to other endpoints, including all-cause mortality, stroke, heart failure, left ventricular hypertrophy, decreased renal function, peripheral arterial disease, and blood pressure lowering. Because of the ethnic and gender diversity of ALLHAT, an assessment will be made of the effects of these variants on outcomes in key subgroups (age \>65 years, women, African Americans, Type II diabetics), and whether the gene-treatment interactions in relation to outcomes are consistent across subgroups.

Eligibility Criteria:
* not taking anti-hypertensive medication
* use of anti-hypertensives for less than two months with a baseline blood pressure between 140/90 and 180/110
* use of anti-hypertensives for greater than two months with a blood pressure not greater than 160/100
* at least one additional cardiovascular risk factor such as previous MI, stroke, type 2 diabetes, smoking, left ventricular hypertrophy or dyslipidemia
The Predictors for Activity and Participation in Children With ASD: A Follow-up Study

Developmental function and Participation in life and school activities in patients with autism spectrum disorder: A follow-up study

Most ASD studies have explored the body functions and core symptoms in children with ASD by follow-up, but less studies explore the activities and participation by follow-up, especially the changes in different ages. Although studies explore many predictors to predict the activities and participation in children with ASD, but less studies explore sensory perception to predict the activities and participation in children with ASD.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Autism Spectrum Disorder
* Age 2-18 y/o
* Agree to sign informed consent

Exclusion Criteria:

* Active medical condition (e.g. infection)
* Concurrent progressive or degenerative disease (e.g. neurogenerative disease)
* Concurrent illness or disease not typically associated with ASD (e.g. pneumonia)
Evaluation of Sonelokimab in Patients with Active Psoriatic Arthritis and Anti-TNFα Inadequate Response

This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.

M1095-PSA-302 is a Phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm to investigate the efficacy and safety of sonelokimab 60 mg and 120 mg versus placebo in adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must be ≥18 years of age .
2. Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006 Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 months before the Screening Visit.
3. Participants have moderate to severe active disease (defined by a 68 tender joint count \[TJC68\] of ≥3 and a 66 swollen joint count \[SJC66\] of ≥3).
4. Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO.
5. Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.
6. Participants must have received 1 or 2 TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with the TNFα inhibitor(s) given at an approved dose for ≥3 months or have stopped treatment due to safety/tolerability problems after ≥1 administration of a TNFα inhibitor.

Exclusion Criteria:

1. Participants with a known hypersensitivity to sonelokimab or any of its excipients.
2. Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients.
3. Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.
4. Participants with a diagnosis of inflammatory bowel disease.
5. Participants who have experienced a period of ≥3 weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.
6. Participants who have an established diagnosis of arthritis mutilans.
7. Previous exposure to sonelokimab.
8. Participants who have ever received biologic immunomodulating agents for PsA or PsO whether investigational or approved, except for those targeting TNFα
Stop for Stress - a Randomized Controlled Trial Comparing an Online and a Group-based Format of an Intervention for Work-related Stress

Work-related stress is a major public health concern, causing sickness absenteeism and impaired health and well-being. Many afflicted with severe work-related stress will not receive evidence-based treatment due to geographical distance, stigma and unwillingness to participate in a group, creating unequality access to healthcare services. Online interventions show comparable effects to face-to-face interventions and have potential to break down some of these barriers. We have developed and pilot tested the online delivery format of the intervention for work-related stress, Stop for Stress, with promising results. In a two-armed, multicentre randomized controlled trial we aim to 1) compare the effect of the online delivery format and an evidence-based face-to-face group-based format and 2) identify markers of enhanced outcomes in each delivery format. The study will include 220 patients with severe work-related stress (110 from each of two centres) who are randomizes 1:1 to the two interventions. Outcomes consist of self-report measures of psychological symptoms, cognitive functioning, sleep, and perceived working environment and register data on ebsenteeism and return-to-work.


Eligibility Criteria:
Inclusion Criteria:

* Current employment and significant work-related stressors
* Perceived Stress Scale (PSS-10) score ≥20 and symptom duration \>4 weeks
* In case of full-time sick leave, return to work must be planned concurrent with the intervention
* Access to a computer or tablet with internet connection at home

Exclusion Criteria:

* Interpersonal difficulties, bullying, harassment, violence, threats, and traumatic events as primary stressor
* Severe stressors outside of work
* Symptoms meeting diagnostic criteria for anxiety, depression or severe psychiatric illnesses requiring specialized treatment
* Current abuse of alcohol and/or psychoactive drugs