cyrilzakka/clinical-trials huggingface dataset:
Improving End-of-life Care by Continuing Medical Education and Electronic Decision Making Support for General Practitioners

Background: Optimizing the basic palliative care has been shown beneficial to patients in end-of-life care, the general practitioner (GP) having a pivotal role in the health care system, providing comprehensive and continued medical care.

The aim of the study is to investigate the effect of a complex intervention in general practice on GPs' awareness of and confidence in providing end-of-life care.

Method: A follow-up study among 404 general practices in Central Denmark Region. The participating general practices will get the opportunity to receive education in palliative care and access to an electronic support, which provides advice on palliative care and an overview of the palliative population in each medical practice. The education and the support will focus on patients suffering from either metastatic cancer or chronic obstructive pulmonary disease (GOLD stage 4).

The end-of-life care delivered by the GPs to their deceased patients will be analysed, based on questionnaires to GPs and register data related to the deceased patients before and after the intervention, .

Primary outcomes: Place of death of deceased patients, time spent at home, and number of hospital admissions in the last three months of the patients' lives.

Secondary outcomes: Number and kinds of contacts between GPs and patients, use of relevant medicine and of the 'Safety Box'. Finally GPs' confidence concerning palliative care will be assessed in questionnaires.


Eligibility Criteria:
Inclusion Criteria:

Working as General Practitioner in the Central Region of Denmark in 2013 and onwards

-

Exclusion Criteria:

-
Effect of Diet on Gulf War Illness

Fermentable Oligo-, Di and Mono-saccharides And Polyols (FODMAPs) are carbohydrates that are poorly digested in intestines. The undigested carbohydrates are fermented in the colon by gut bacteria. Fermentation of these carbohydrates can lead to diarrhea, gas and distension of the colon. Low FODMAP diet effect may be mediated by changing the gut bacteria and/or by production of chemicals that influence Veteran's intestines which then result in reduced disease symptoms.

The goal of this study is to compare a low FODMAP (modified healthy) diet to a high FODMAP (typical healthy) diet for effect on Veterans with IBS and symptoms of Gulf War illness.

Study Design This will be a prospective, blinded randomized clinical trial with two parallel groups. There will be 1-week screening period, 3-week diet treatment and, follow-up one month later while Veterans choose their own diet.

Veterans who were deployed and served in Operation Desert Storm and Desert Shield will be recruited to participate.

The two study diets to be provided to the Veterans and compared are:

Low FODMAP (modified healthy) diet:

High FODMAP (typical healthy) diet:

The FODMAP content of this diet will be higher than low FODMAP diet.

All questionnaires will be answered and measurements performed at baseline, end of treatment and at follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Gulf War Veterans
* Men and women age 25-90 years
* Gulf War Illness: Veterans will have Rome III criteria for IBS and two or more of the non-intestinal symptom groups (chronic-once a week or more often-fatigue, insomnia, joint pains, general stiffness, and headache, neurological an mood, respirator and skin symptoms)
* Symptoms of \> 6 months duration
* No significant findings on physical examination, complete blood count and clinical chemistry panel
* Normal gross appearance of the colonic mucosa (small colon polyps not an exclusion criteria)
* Veterans with psychological disorders will not be excluded but will be identified for sub-group analysis.

Exclusion Criteria:

* Current evidence of any lower gastrointestinal disorder such as celiac disease or inflammatory bowel disease
* Clinically significant chronic disease: HIV, cardiac, pulmonary, hepatic or renal dysfunction
* Presence of Giardia antigen, and Clostridium difficile toxin in stool
* Current history of drug or alcohol abuse
* Investigator perception of patient's inability to comply with study protocol
* Recent change in gastrointestinal medications
* Subject is currently participating in another research protocol. These subjects will be allowed to enroll after a washout period of one month.
Study to Assess OCT: RNFL and GCL in MS Patients

The purpose of this study is to collect preliminary data on retinal nerve fiber layer and ganglion cell layer damage in multiple sclerosis (MS) patients, using optical coherence tomography (OCT). For this study the Zeiss Cirrus OCT Imaging System will be used. The same system will be used consistently for the duration of the study.

Hypothesis: Multiple sclerosis results in axonal degeneration which can be assessed objectively and non-invasively by serial OCT measurements of the RNFL and GCL.

This will be a prospective cross-sectional, non-interventional study; total recruitment will be 200 subjects. Recruitment will be stratified to enroll at least 50 subjects currently taking Lemtrada and 50 subjects with a documented diagnosis of ON. The study will enroll subjects primarily from practices in the Tampa Bay Area and adjacent counties. It is a planned non-interventional study; subjects will be followed by their neurologist and the study ophthalmologist and will receive standard of care. All subjects will have the ophthalmological examination and diagnostic measures, by the Principal Investigator, Dr. Grace Levy-Clarke, at Tampa Bay Uveitis Center.

Study Duration: The study duration will be 24 months, with an interim analysis at 50% recruitment status.

There are two primary aims of this longitudinal observational study:

1. To determine whether atrophy within specific retinal layers over time is associated with clinical neurological progression of MS
2. To determine whether an ON history affects the relationship described in aim # 1

Eye Exam: Subject will have an eye exam, including:

Visual Acuity Testing Color Vision Testing Automated perimetry/Peripheral Vision Testing Completing the National Eye Institute Visual Functioning Questionnaire (NEI/VFQ) Slit Lamp Examination Measurement of Intraocular Pressure (IOP) Dilated Fundus Examination (Ophthalmoscopy) Fundus Photography Optical Coherence Tomography: RNFL and Macular OCT

Neurologic Assessments: Must be performed no more than 60 days prior to screening/assessment Day 0 Ophthalmic Assessments

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Pregnant women will be excluded by self declaration
* Male or female
* A diagnosis of MS, that meets the 2010 Revised McDonald Diagnostic Criteria
* A visual acuity of 20/400 or better in at least one eye

Exclusion Criteria:

* Any ocular disease than prevents assessment of the optic nerve and macula by OCT
* Advance glaucoma with optic nerve damage
* Any optic neuropathy not diagnosed as ON associated with MS
* A diagnosis of Macular Degeneration
* Any previous ocular trauma
* Any medical history of a cerebrovascular accident
* Any planned ocular or systemic elective surgery during study duration
* Any contraindication to a comprehensive dilated ophthalmic examination
* Inability to give informed consent
Paracetamol and Pharmacogenetic

Recent works has emphasized that the mechanism of action of paracetamol analgesic depend on its metabolism in the body, since a breakdown product of paracetamol, the AM404 is now considered the analgesic metabolite of paracetamol suggesting as paracetamol may be a pro-drug.

Indeed, it has been shown that paracetamol may have a deleterious effect, especially in vulnerable populations (hepatic insufficiency, elderly). First results showed a very significant decrease in sulfatation and gluthatione and increased phase 1 metabolism of acetaminophen, which involves enzymes such as cytochrome P450.

Multifactorial causes, combining nutrition (depletion of sulfur amino acids), increased detoxification of toxic metabolites of paracetamol, stress or trauma are discussed to explain the results.

Clinical studies showed a great variability of pain assessment by patients and variability in the metabolic response of paracetamol. Genetic factors probably play a role remains largely unknown.

The review of the literature on genetic polymorphism shows the involvement of a number of enzymes that are well known, predominantly on the metabolism of acetaminophen liver, but without connection with its analgesic effect. This is a critical missing link in the understanding of the analgesic effect of paracetamol.

Randomized, single-center, placebo-controlled, double-blind, cross-over in 100 healthy volunteers meeting the inclusion criteria and receiving 2g of paracetamol orally or placebo on two study periods separated by one week.

The evaluation criterion is the difference in areas under the curve of pain thresholds to thermal and mechanical stimulations test

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Males
* Aged between 18 and 30 years

Exclusion Criteria:

* Subject without cons-indications of paracetamol
Effects of Physical Activity Counseling After an Exacerbation in COPD

Severe exacerbations are prevalent in a subgroup of patients with COPD and generally warrant a hospitalization. During the hospitalization, patients are extremely physically inactive with only a limited recovery one month after discharge. Physical inactivity is associated with negative health benefits. Therefore intervening in the period after and exacerbation seems useful to improve the levels of physical activity. Physical activity counseling and real-time feedback have already been applied in stable patients with COPD, with beneficial effects.The present study will investigate whether this specific intervention will help to improve the activity level in patients after an acute exacerbation. Further we investigated the effects of the intervention on improvements in functional exercise capacity.

After signing the informed consent, the patients will be randomized into a control group, receiving usual care, or the intervention group receiving real-time feedback and physical activity counseling.

Intervention: Physical activity counseling will be provided by 3 weekly telephone contacts based on the step count from the Fitbit Ultra. In agreement with the patient and based on the step counts a patients provided, a new goal for the next week was set. The goal was to strive for the highest possible level of physical activity during one month.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Chronic Obstructive Lung Disease (Tiff\<70%)
* Hospitalized because of exacerbation
* Capable of working with electronic devices

Exclusion Criteria:

* Orthopedic/Neurologic problems making it difficult to be active
* Participation in a rehabilitation program
Combined Antibody Screening for Celiac and Diabetes Evaluation

The CASCADE Study (Combined Antibody Screening for Celiac and Diabetes Evaluation) is an observational study whose primary goal is to show that population-based screening for advanced prediction of type 1 diabetes (T1D) and celiac disease (CD) is feasible to prevent diabetic ketoacidosis (DKA), improve celiac disease diagnosis, and ultimately gain public health acceptance to facilitate future prevention. It has two arms, a Birth Cohort and a Kids (cross sectional) Cohort.


Eligibility Criteria:
Inclusion Criteria:

* Child must be between 0 to 8 months in age or between 4 to 7 years in age. Child must be born in the state of Washington.

Exclusion Criteria:

-
A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers

This study is designed to assess the safety and preliminary activity of SBT6050 in combination with trastuzumab deruxtecan (Part 1) or tucatinib plus trastuzumab +/- capecitabine (Part 2). Participants will be enrolled into each Arm based on cancer diagnosis and prior therapies.


Eligibility Criteria:
Inclusion Criteria:

* Advanced or metastatic HER2-expressing (IHC 2+ or 3+) or HER2-amplified solid tumors
* Measurable disease per the the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria
* Tumor lesion amenable for biopsy or able to submit an adequate recent archived tumor tissue for baseline testing, as follows:

  1. Breast cancer and colorectal cancer (CRC): archival biopsy tissue obtained after the last HER2-directed therapy (excluding trastuzumab and pertuzumab), or a fresh biopsy
  2. Gastric cancer and non-small-cell lung cancer (NSCLC): archival biopsy tissue taken within the past 12 months and after completion of last HER2-directed therapy, or a fresh biopsy
* ECOG Performance Status of 0 or 1
* Adequate hematologic, hepatic, renal, and cardiac function

Exclusion Criteria:

* History of allergic reactions to certain components of study treatment therapies
* Untreated brain metastases
* Currently active (or history of) autoimmune disease
* Taking the equivalent of \>10 mg / day of prednisone
* Taking a medication that moderately induces CYP2C, strongly inhibits CYP2C8, or interacts with both enzymes (CYP3A and CYP2C8)
* Uncontrolled or clinically significant interstitial lung disease (ILD) / pneumonitis that requires systemic corticosteroid treatment or suspected ILD / pneumonitis
* HIV infection, active hepatitis B or hepatitis C infection
Mat Pilates Exercise Program in Patients With Axial Psoriatic Arthritis

The aim of this study is to investigate the effectiveness of mat Pilates exercises on spinal mobility, spinal muscle endurance, disease activity, fatigue, emotional well-being, physical performance, and overall quality of life in Psoriatic Arthritis (PsA) patients with axial involvement.

Psoriasis is a chronic inflammatory skin disease commonly accompanied by joint involvement known as psoriatic arthritis (PsA) \[1\]. PsA is a subgroup of spondyloarthritis and is characterized by peripheral arthritis, dactylitis, enthesitis and spondylitis. Axial involvement, which occurs in approximately 40% of PsA patients may affect the entire spine, particularly the sacroiliac joint, leading to reduced cervical rotation, lateral flexion and anterior flexion of the spine \[2,3\]. Exercise interventions in PsA primarily aim to relieve pain, improve mobility and enhance functional capacity \[4\]. Mat Pilates exercises have been demonstrated as a safe and beneficial intervention in various rheumatic diseases, exhibiting significant improvements in functional status, fatigue, disease activity, pain, and overall quality of life \[5-7\]. Additionally, Pilates has been reported as effective in maintaining and enhancing spinal mobility \[8,9\]. However, despite these favorable outcomes, the efficacy of Pilates exercises in PsA remains unexplored.

The aim of this study is to investigate the effectiveness of mat pilates exercises in psoriatic arthritis patients with axial involvement.

Eligibility Criteria:
Inclusion Criteria:

* Being classified as PsA according to CASPAR Classification Criteria
* Being between the ages of 18-65
* Volunteering to participate in the study

Exclusion Criteria:

* Any additional systemic disease other than PsA
* Any other condition that may prevent participation/continuation of the exercise program or completion of the assessments
* Regular exercise habits (following a structured exercise program at least 3 days a week)
* Being included in a physiotherapy and rehabilitation program within the last 6 months
Evaluation of the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles

The purpose of this study is to evaluate the efficacy and safety of the treatment of wrinkles using the picosecond 755nm Alexandrite laser.


Eligibility Criteria:
Inclusion Criteria:

1. Is a healthy non-smoking (must have quit 1 year prior) male or female between 18 and 65 years old.
2. Is willing to consent to participate in the study.
3. Is willing to comply with all requirements of the study including biopsies, being photographed, following post treatment care and attending all treatment and follow up visits.

Exclusion Criteria:

1. The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
2. The subject is hypersensitive to light exposure OR takes photo sensitized medication.
3. The subject has active or localized systemic infections.
4. The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
5. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
6. The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
7. The subject has used Accutane within 6 months prior to enrollment.
8. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
9. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
10. The subject has a history of keloids.
11. The subject has evidence of compromised wound healing.
12. The subject has a history of squamous cell carcinoma or melanoma.
13. The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
14. The subject has an allergy to lidocaine and epinephrine.
Suicide Prevention Intervention for Schizophrenia-Spectrum Disorders

The current project is a pilot randomized controlled trial to test the Coping Long-term with Active Suicide Program for schizophrenia-spectrum disorders (CLASP-S) for patients following a psychiatric hospitalization. Participants will be assigned to enhanced treatment as usual (ETAU) alone vs CLASP-S plus ETAU. Participants complete assessments at baseline during their psychiatric hospitalization and at 3 months (mid-treatment) and 6 months (post-treatment) following discharge. The primary aim is to assess the feasibility and acceptability of CLASP-S. The secondary aim is to estimate the effects of CLASP-S on reducing suicidal thoughts and behaviors relative to ETAU.


Eligibility Criteria:
Inclusion Criteria:

* suicidal thoughts or behaviors prior to hospital admission
* diagnosis of a schizophrenia-spectrum disorder
* receiving pharmacotherapy
* 18 years or older
* speaks/reads English

Exclusion Criteria:

* psychosis due to substance use or medical condition
* lack of phone access
* discharge to long-term facility
Analysis of Cardiac Biomarkers, ECG and CPET Results in Children With Cardiomyopathies

The aim of the study is to analyze cardiac biomarkers, electrocardiograms and cardio-pulmonary exercise test (CPET) results in children with cardiomyopathies.

The study group will consist of children that have been diagnosed with DCM, HCM or LVNC. The control group will be composed of healthy children. Examination of cardiac biomarkers (in the study group), ECG, 24-hour- ECG monitoring, CPET will be performed.

Patients in the study group will be invited for 2 consecutive visits (in 6-10 months intervals). During the first and the last visit CPET will be performed. The control group will not be invited for consecutive visits.

Eligibility Criteria:
Inclusion Criteria:

* Children with HCM, DCM, LVNC diagnosed in 2D echo.
* Healthy children with no congenital heart disease (CHD) in 2D echo.
* Patients who signed consent form.

Exclusion Criteria:

* Patients with coexisting CHD, kidney and liver disfunction, taking anti-psychotic and anti-depressant medication, or patients with bundle bunch blocks in ECG.
* no consent form signed.
Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System

The goal of this multicenter observational clinical trial is to evaluate the safety and effectiveness of the Cardiohelp System for VA-ECMO in children with cardiac failure. The main question\[s\] it aims to answer are:

* What is the safety and effectiveness of the Cardiohelp device for pediatric ECMO?
* What are the optimal performance specifications of the Cardiohelp device in children? Should the Cardiohelp device be FDA-cleared for children?

Children who are receiving the Cardiohelp device will be approached and consented to participate if interested. Participants will undergo a standardized data collection to estimate survival to 30 days and the prevalence of serious adverse events like stroke, bleeding, and hemolysis.

Outcomes will be compared to performance goals (PG) derived from the ECMO literature.

Funding Source -- FDA OOPD (Office of Orphan Products Development)

This is a multicenter clinical trial to evaluate the safety and effectiveness of the Cardiohelp System for up to 30 days of support in children with severe cardiac failure. Despite more than 50 years of use and significant mortality, no standalone ECMO device has ever been FDA-cleared for ECMO. All ECMO use in children is off-label and this may explain why there is significant center-based variation in ECMO use that is not evidence driven. This study seeks to change that by collecting systematic safety and effectiveness data on a single standardized ECMO circuit (Cardiohelp Device). The goal is to provide the data necessary to secure FDA clearance of the first pediatric ECMO system, to determine the optimal performance range of the Cardiohelp device in infants and children, and to provide the FDA with a predicate device to support FDA clearance of other ECMO systems.

Eligibility Criteria:
Inclusion Criteria:

1. Age 0 to 16 years of age
2. Body weight 3 to 80 kilograms
3. VA-ECMO use for primary cardiac failure using the Cardiohelp system.
4. First ECMO run during any hospitalization
5. Written informed consent from the parent or legally authorized representative.

Exclusion Criteria:Children must not meet any of the following exclusion criteria within 48 hours prior to device implant:

1. Gestational Age \<37 weeks
2. Bleeding or coagulopathy that is a contraindication to anticoagulation
3. Irreversible renal, hepatic or lung failure
4. Stroke or uncertain neurological status within the past 30 days
5. Severely malnourished
6. Use of an ECMO system other than the Cardiohelp
7. VV-ECMO or ECMO for primary respiratory failure
8. Goals of patient to focus on comfort measures only.
9. Failure to separate from cardiopulmonary bypass