cyrilzakka/clinical-trials huggingface dataset:
Telehealth Self-Management Coaching Sessions to Improve Quality of Life in Pancreatic Cancer Survivors and Their Family Care Givers

This clinical trial evaluates the impact of telehealth self-management coaching sessions on quality of life in pancreatic cancer survivors and their family care givers (FCGs). Patients with pancreatic cancer experience many symptoms because of the disease and treatment, which can have a negative impact on quality of life. Patients and their families have unmet needs during treatment, including a lack of quality of life programs that offer support to patients. Supporting patients and families on managing the physical symptoms, emotional well-being, social well-being and spiritual well-being with telehealth self-management coaching sessions may help improve quality of life, manage symptoms from treatment, and support families in their role as caregivers during treatment.


Eligibility Criteria:
Inclusion Criteria:

* • PATIENT: Documented informed consent of the participant and/or legally authorized representative

  * Assent, when appropriate, will be obtained per institutional guidelines

    * PATIENT: Age: ≥ 18 years
    * PATIENT: Eastern Cooperative Oncology Group (ECOG) ≤ 2
    * PATIENT: Ability to read and understand English or Spanish for questionnaires
    * PATIENT: Subjects must have histologically or cytologically confirmed diagnosis of metastatic pancreatic adenocarcinoma who are within 8 weeks of initial diagnosis
    * FAMILY CARE GIVER: Documented informed consent of the participant and/or legally authorized representative
  * Assent, when appropriate, will be obtained per institutional guidelines

    * FAMILY CARE GIVER: Age: ≥ 18 years
    * FAMILY CARE GIVER: Ability to read and understand English or Spanish for questionnaires
    * FAMILY CARE GIVER: A family member or friend identified by the patient and defined as a person who knows the patient well and is involved in the patient's medical care

Exclusion Criteria:

* • An employee who is under the direct/ indirect supervision of the principal investigator (PI)/ a co-investigator/ the study manager

  * A direct study team member
Interleukin (IL)-1 Blockade in Acute Heart Failure (Anakinra ADHF)

Anakinra ADHF is a double-blind randomized clinical trial of anakinra, recombinant human interleukin-1 receptor blocker, or placebo in patients with acute decompensated heart failure with the aim to quench the acute inflammatory response, as measured by the area-under-the-curve for C reactive protein over 14 days.


Eligibility Criteria:
Inclusion Criteria:

All 5 criteria need to be met for enrollment of the patient in the study

1. Primary diagnosis of acute decompensated heart failure within the last 24 hours as evidenced by both of the following:

   1. dyspnea or respiratory distress or tachypnea at rest or with minimal exertion
   2. evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met);

   i. pulmonary congestion/edema at physical exam OR chest x-ray; ii. plasma Brain Natriuretic Peptide (BNP) levels ≥200 pg/mL; iii.invasive measurement of left ventricular end-diastolic pressure \>18 mmHg or of pulmonary artery occluding pressure (wedge) \>16 mmHg.
2. Left ventricular systolic dysfunction (LVEF\<40%) during index hospitalization or prior 12 months.
3. Age ≥18 years old
4. Willing and able to provide written informed consent.
5. Screening plasma C-reactive protein levels \>5 mg/L.

Exclusion Criteria Subjects will not be eligible if they meet any of the following 15 exclusion criteria.

1. The primary diagnosis for admission is NOT decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy- or brady-arrhythmias.
2. Concomitant clinically significant comorbidities that would interfere with the execution or interpretation of the study including but not limited to acute coronary syndromes, uncontrolled hypertension or orthostatic hypotension, tachy- or brady-arrhythmias, acute or chronic pulmonary disease or neuromuscular disorders affecting respiration.
3. Recent (previous 3 months) or planned cardiac resynchronization therapy (CRT), coronary artery revascularization procedures, or heart valve surgeries.
4. Previous or planned implantation of left ventricular assist devices or heart-transplant.
5. Chronic use of intravenous inotropes.
6. Recent (\<14 days) use of immunosuppressive or anti-inflammatory drugs (not including Non-Steroidal Anti-Inflammatory Drugs \[NSAIDs\]).
7. Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus).
8. Active infection (of any type);
9. Chronic/recurrent infectious disease (including Hepatitis B virus \[HBV\], Hepatitis C virus \[HCV\], and HIV/AIDS).
10. Prior (within the past 10 years) or current malignancy.
11. Any comorbidity limiting survival or ability to complete the study.
12. End stage kidney disease requiring renal replacement therapy.
13. Neutropenia (\<2,000/mm3) or Thrombocytopenia (\<50,000/mm3).
14. Pregnancy.
15. Angina, arrhythmias, or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing obtained during the baseline testing.
Prevention of Osteoporosis in Men With Prostate Cancer

The purpose of this two year study is to examine the safety and effectiveness of alendronate (Fosamax) for the prevention of bone loss in men with prostate cancer who are on therapy to lower their testosterone levels. All men will receive appropriate calcium and vitamin D supplements and one to two years of alendronate therapy. Bone density tests will be done every six months.

Prostate cancer is the most common visceral malignancy and second leading cause of cancer death in men. While androgen ablation therapy is the cornerstone of treatment for more advanced stage disease, recent studies suggest the advantage of introducing androgen deprivation much earlier. Because androgens are essential in maintaining skeletal integrity in men, androgen deprivation therapy constitutes a major risk factor for male osteoporosis. We have previously demonstrated that men on chronic androgen deprivation therapy have up to 20% loss of bone. Our hypotheses are that: 1) chronically increased bone resorption induced by long term androgen deprivation therapy in men with prostate cancer can be reversed with once weekly bisphosphonate; 2) the improvement in bone mass with bisphosphonate therapy will be reflected by changes in biochemical markers of bone turnover and will allow us to predict who will respond to therapy; and 3) following termination of bisphosphonate therapy, bone mass will be maintained despite the absence of antiresorptive therapy. To address these hypotheses, we will enroll 84 men with stage D0 prostate cancer who have been on chronic androgen deprivation therapy in a two year, double blind, placebo controlled, randomized, modified crossover clinical design. During the first year, subjects will be randomized to bisphosphonate therapy or placebo. During the second year, all subjects who were on placebo will receive active treatment and all subjects who were on active treatment will be randomly assigned to continue therapy or change to placebo. To evaluate the effect of bisphosphonate on preventing bone loss, we will assess bone mass of the spine, total hip, total body, and forearm by dual-energy X-ray absorptiometry. For hypothesis 2, we will assess markers of bone resorption and formation to determine if early changes in markers are associated with long term changes in bone mass. For hypothesis 3, we will continue to follow bone mass and biochemical markers of bone turnover between months 12 and 24 to examine rates of change when antiresorptive therapy is terminated. Few data are available on the prevention of bone loss in men on androgen deprivation therapy. This study will examine a preventive strategy, the potential mechanism of bone loss, the ability of biochemical markers to predict bone mass, and skeletal outcomes when antiresorptive therapy is withdrawn.

Eligibility Criteria:
Inclusion Criteria:

* Men age 50-85
* Stage D0 prostate cancer
* On androgen deprivation therapy

Exclusion Criteria:

* Renal failure
* Hyperthyroidism
* Cushing's syndrome
* Metabolic bone disease
* Use of glucocorticoids
* Use of certain anticonvulsants
* On osteoporosis therapies
* Nonprostate cancers
HoPE (Hospice Preparation and Education)

The investigator will conduct a two-site, randomized, controlled study of the HoPE (Hospice Preparation and Education) web-based tool versus usual care to assess: Technology usability (primary), study feasibility (secondary), user acceptability (secondary), and hospice service conversion rate (exploratory). Technology usability will be assessed through a one-time quantitative survey using established instruments. Study feasibility and user accessibility will be assessed through trial enrollment and retention alongside analytics assessing tool usage (e.g. time spent on each page of the website). Conversion rate is the percent of patients introduced to hospice who eventually enroll. The investigators will evaluate in an exploratory manner the differential effect of HoPE versus usual care.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for and referral made for home hospice services (Note: this excludes home palliative care, home infusion, home nursing, home physical therapy, and bridge services)
* Aged between 21 and 89
* Capacity to give consent
* Ability to speak and understand English
Antihypertensive Therapy in Patients With Comorbidities

A retrospective analysis

This retrospective study will be performed using all-Russian nationwide database of anonymized medical health claims and administrative data. The database holds information on diagnoses, patient data, medications, results of examinations, laboratory values, and genomic information, visits, follow up and outcomes. Participating health care organizations include a mix of hospital, primary care, and specialty treatment providers spanning a wide range of geographies, age groups, and income levels.

This study will analyze of outcomes according to comorbidity and antihypertensive drug prescriptions. The study will include patients who were first diagnosed with hypertension, attended the hospital as an outpatient due to hypertension, and received their antihypertensive prescription as an outpatient. To be eligible for inclusion, patients must have had comorbidities and outpatient visits or hospitalizations (for any indication) during the 3-years. The study will focused on comorbidities for choice of antihypertensive drug therapy: diabetes mellitus, dyslipidemia, gout/hyperuricemia, heart diseases, cerebrovascular diseases, and renal diseases.

We going to analyze the EMR of patients who had hypertension and comorbidities by CDSS (MedicBK) utilizing a core laboratory.

Eligibility Criteria:
Inclusion Criteria:

patients who were first diagnosed with hypertension, attended the hospital as an outpatient due to hypertension, and received their antihypertensive prescription as an outpatient. To be eligible for inclusion, patients had to have comorbidities and outpatient visits or hospitalizations (for any indication) during the 3-years.

Exclusion Criteria:

No
Open-label Study to Investigate Systemic Exposure in Adult and Pediatric Atopic Dermatitis Patients Treated 8.5 Days With Pimecrolimus Cream 1% Under Occlusion

This study will access the degree to which pimecrolimus is absorbed from pimecrolimus cream 1% into the blood when applied repeatedly under occlusion (i.e. areas treated wrapped in a plastic film) over 8 days in patients with moderate to severe atopic eczema.


Eligibility Criteria:
Inclusion Criteria:

* Patients 2 - 18 years of age
* Patients with a diagnosis of moderate to severe atopic dermatitis, assessed by a score ≥ 3 at the Investigator's Global Assessment. AD to involve at least 30% of their body surface area as determined by the rule of nine or the Lund and Browder chart.

Exclusion Criteria:

* Erythrodermic patients with Netherton's syndrome
* Patients with known serious adverse reactions or hypersensitivity to any of the excipients of the study medication
* Patients with a history of cancer, skin malignancy or lymphoproliferative disorders or of immunocompromise, including a positive HIV (ELISA and Western blot), Hepatitis B surface antigen (HBsAg) or Hepatitis C test result

Other protocol-defined inclusion/exclusion criteria may apply
Role of Salbutamol and Furosemide in TTN

to see the effects of slabutamol and IV furosemide in the treatment of transient tachypnea of newborn


Eligibility Criteria:
Inclusion Criteria:

* all newborn babies with clinically diagnosed TTN

Exclusion Criteria:

* babies less than 34 weeks babies with congenital malformations and CHD
Telemonitoring of Activities of Daily Living in Home Care Services of Older Adults with Cognitive Deficits

In Canada, it is estimated that two million people are users of publicly funded home care services, with more than half of them being 65 years and older. Although home care services are considered a priority by Canadian provinces, in Québec alone, more than 46 000 people were waiting for those services in 2022. The provision of home care services is hampered by limited funding and growing demand from among an aging population, among other factors. These challenges have led to urgent calls to better support home care in Canada to ensure optimal use of scarce human and financial resources. One of the key strategies to achieve optimal use of resources may be remote monitoring of activities of daily living (ADLs), a type of telehealth. ADL telemonitoring can remotely recognize ADLs such as preparing meals and moving around the home. Past studies have shown that ADL telemonitoring can help in better understanding older adults' home care needs, thereby allowing for more personalized ADL interventions. Previous projects have also allowed for the developement of NEARS-SAPA, a telemonitoring system for ADLs. In these past projects, it was identified how NEARS-SAPA was used by home care services and its ease of use was tested in real environments. In the present project, the benefits of ADL telemonitoring will be tested and its technological capabilities expanded, hence preparing the system for the next big step, i.e. large-scale adoption by home care services. Ultimately, ADL telemonitoring may help the healthcare system determine which service is more appropriate for which person and at what time, thereby optimizing interventions and resource management.


Eligibility Criteria:
Inclusion Criteria:

1) be an older adult (\> 65 years old), 2) have cognitive deficits as reported in the medical record, 3) live alone, at home, 4) be a care recipient of home care services, 5) speak French or English

Exclusion Criteria:

* None
Impact of Intravitreal Faricimab on Renal Function in Diabetic Patients

This study aims to investigate the impact of intravitreal injection of anti-vascular endothelial growth factor (anti VEGF) Faricimab on renal function of diabetic patients. Faricimab is a new anti-VEGF drug which inhibits both VEGF-A and Ang-2 and it is used for the treatment of diabetic macular edema and neovascular age related macular degeneration. It is known that previous anti-VEGF agents has systematic absorption and may cause deterioration in renal function of the patients. However, the effect of Faricimab on kidney function has not been investigated yet. Taking into account that Ang-2 has destructive effect on kidneys, the investigation of the effect of its inhibition in diabetic patients who have already renal function deterioration may provide a valuable information in scientific community.

For the purposes of this study, 60 diabetic patients who need intravitreal injections of anti-VEGF for either diabetic macular edema or neovascular age related macular degeneration will be enrolled. 30 patients will consist the study group and they will receive Faricimab and the remaining 30 patients will receive Aflibercept 2 mg. Before the initiation of therapy, laboratory tests including HbA1c, eGFR, plasma creatinine, urine albumin to urine creatinine ratio (ACR) will be ordered to investigate the glycemic control and the renal function of the patients.The best corrected visual acuity (BCVA), the intraocular pressure (IOP) and the anterior segments will be assessed on each visit. The optical coherence tomography (OCT) will be used for the assessment of centra macular thickness (CMT). The results will be assessed at baseline and then at 6 months and 12 months from the initiation of therapy. The statistical analysis will be performed at the end of study period.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes
* Patients with DME or nAMD or macular edema secondary to retinal vein occlusion
* Patients already receiving nephroprotective drugs

Exclusion Criteria:

* Patients with end stage renal disease
* Pregnancy
* Patients with other retinal disorders
* Previous renal transplantation Patients under hemodialysis
Novel Skin Care for Chemotherapy- Related Dermatologic Toxicities

Notwithstanding the continuous progress in cancer treatment, patients with cancer still have to cope with quality of life (QoL) - impairing complications. Especially an extensive spectrum of dermatologic toxicities has been associated with cancer treatments. The number and type of cutaneous toxicities have evolved over the past 50 years, paralleling the development of new chemotherapeutic agents. The chemotherapy-related skin toxicities can significantly impede the patient's emotional, physical, social, and financial well-being resulting in a poor QoL. In rare cases of severe cutaneous reactions, treatment modifications are needed, resulting in a diminished overall survival.

Important organizations in the field of oncology and supportive care, such as the MASCC, the ASCO, and the ESMO, have developed guidelines for the management of cancer therapy- related cutaneous toxicities based on available scientific evidence. Still, for some interventions, the evidence of recommendation is moderate to insufficient. Therefore, it is essential to elucidate other new potential management strategies for dermatological complications of cancer treatment. Based on the previously mentioned supportive care guidelines for the ChemoSkin project, a novel emollient to tackle the cutaneous adverse events of chemotherapy has been developed.

The ChemoSkin project general aim is to evaluate the efficacy of a novel skincare product to manage chemotherapy-related cutaneous toxicities.

Primary objective Evaluate the efficacy of a novel emollient for the management of chemotherapy-related cutaneous adverse events

Secondary objective 1 Evaluate patient-relevant treatment benefit of the novel emollient for chemotherapy-associated cutaneous toxicities

Secondary objective 2 Evaluate the influence of the novel emollient for chemotherapy- associated cutaneous toxicities on the patient's quality of life

Secondary objective 3 Evaluate the safety of the novel emollient for chemotherapy- associated cutaneous toxicities

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cancer of any type
* Undergoing chemotherapy at the Jessa Hospital (Hasselt, BE)
* Age ≥ 18 years
* Able to comply to the study protocol
* Able to sign written informed consent

Exclusion Criteria:

* Pre-existing skin rash, ulceration, skin infections or open wounds
* Severe psychological disorder or dementia
* Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
Web basEd soCial Media tecHnology to Improvement in Adherence to Dual anTiplatelet Therapy Following Drug-Eluting Stent Implantation

Few studies have attempt to improve DAPT adherence through social media. The investigators will explore the prevalence of DAPT discontinuation and prove the hypothesis that using social media will improve DAPT adherence among patients requiring DAPT following DES implantation.

Dual antiplatelet therapy (DAPT) is frequently discontinued after drug-eluting stent (DES) implantation, which could lead to many major adverse cardiovascular events (MACEs). Social media have been proven effective in improving lifestyles and blood pressures control, but few studies have attempt to improve DAPT adherence through social media.Therefore, eligible patients will be enrolled through scanning QR code and randomized in a 1:1 ratio to an intervention group or control group with 12 months of follow-up.The investigators will find out the prevalence of DAPT discontinuation and prove the hypothesis that using social media will improve DAPT adherence among patients requiring DAPT following DES implantation..

Eligibility Criteria:
Inclusion Criteria:

* aged ≥18 years
* diagnosed CHD and underwent DES implantation
* provide written informed consent

Exclusion Criteria:

* pregnancy
* malignant tumor or end-stage disease with a life expectancy of \<1 year;
* refusal to use social media
* refusal to provide written informed consent for this study
Predictive Questionnaire for Vitamin D Insufficiency in Healthy Adults

The purpose of this clinical study is to evaluate the metrological properties of a questionnaire that aims to identify the vitamin D status in reference to a vitamin D blood dosage.

Each subject will perform only one visit (visit V1). The study duration per subject will last about 2 hours. During this visit V1, the subjects will perform a medical exam in order to check their eligibility (general statement and check of inclusion / non-inclusion criteria). The eligible subjects will fill up a study questionnaire and will perform a blood sampling for a dosage of serum vitamin D.

Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers
* Subject able to communicate with the investigator and the study team, able to read and write and follow all study instructions.
* Written informed consent provided and signed prior screening, after receiving and understanding the subject information.
* Registered with the French Social Security, in agreement with the French law on biomedical experimentation.

Exclusion Criteria:

* Subject with diagnosed osteoporosis, osteopenia or osteomalacia.
* Subject with known disease that contributes in osteoporosis: Rheumatoid arthritis, Malabsorption syndrome, Inflammatory bowel disease, Hyperthyroidism, Hyperparathyroidism.
* Subject with known hepatic impairment.
* Subject with known liver impairment or with a history of renal transplantation.
* Subject with history of cancer.
* Subject with history of bariatric surgery.
* Subject taking or having taken osteoporosis inducing treatment, or treatment with an effect on calcium and phosphorus metabolism during the 3 months prior the visit: Corticosteroids, Enzyme inducing anticonvulsants, Heparin.
* Subject requiring vitamin D supplementation for a diagnosed pathology.
* Pregnant or breastfeeding Female.
* Subject with history of alcohol or drug abuse.
* Participation to any other clinical trial simultaneously and/or not having ended the exclusion period of another clinical trial.
* Subject of legal age unable of giving consent.
* Subject deprived of liberty by judicial or administrative decision.
* Subject of legal age under legal protection.
* Subject having received over 4500 Euros for clinical trial participation within the prior year including the indemnity for the present study.