cyrilzakka/clinical-trials huggingface dataset:
The Effect of Aromatase Inhibitors on Cardiovascular Risk Factors in Women With Breast Cancer

This study explores how aromatase inhibitor therapy affects risk factors for heart disease in postmenopausal women with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory women (aged 60-75), with a new diagnosis of nonmetastatic, hormone-receptor positive breast cancer, having undergone lumpectomy. They will not need chemotherapy and will have been prescribed but not yet started anastrazole. All will need a course of radiation therapy as part of usual care. Participants are instructed not to change their physical activity or eating habits over the period of the study.

Comparisons are:

* Identical to the cases except they are hormone-receptor negative and don't need hormonal therapy.
* Healthy controls.

Exclusion Criteria:

* Nicotine usage
* Metastatic breast cancer
* Need for chemotherapy
* AI other than anastrazole
* Usage of steroids (equivalent of equal then or more than 7.5 mg prednisone x 3 months)
* Clinically significant abnormality of thyroid function
* Treatment with gonadal hormone replacement therapy within last 3 years
* Status post unilateral/bilateral surgical oophorectomy
* Having experienced a medical event, which may confound study outcomes \[e.g. heart attack, stroke, cancer (metastatic or newly diagnosed within last 5 years, except for non-melanoma skin cancer and breast), lupus, rheumatoid arthritis, chronic inflammatory disease\]
* Medication-dependent diabetes mellitus or hypercholesterolemia.
* Gastric surgery
* Weight loss medication (prescription or over the counter)
NEO Rehab Program for Premature Infants at Risk for Cerebral Palsy

The goal of this project is to investigate the acceptability, feasibility and fidelity of an innovative NICU rehabilitation program that will include six multimodal, gestational age (GA) appropriate, parent-administered interventions (vocal soothing, scent exchange, comforting touch, kangaroo care, infant massage and physical therapy). Using the general movement assessment (GMA) instrument, the investigators will determine the effects of this program on short-term motor outcomes (general movements (GMs), cranial nerves, posture, movements, tone, and reflexes) in premature infants (≤32 week's gestation and/or ≤1500 grams birthweight) identified as at-risk for CP. The short-term motor outcomes will be measured using the GMA, the Test of Infant Motor Performance (TIMP) and the Hammersmith Infant Neurological Examination (HINE) instruments. This novel program will be applied during the neonatal intensive care unit (NICU) hospitalization when the brain is highly plastic and actively developing with the goal to mitigate severity of brain injury and its impact on development.

The two following specific aims will be tested:

Aim 1: Enroll 60 preterm infants (\<32 weeks' gestation and/or ≤1500 grams) with abnormal GMA into a pilot randomized control trial to evaluate the acceptability, feasibility (practicality) and fidelity (adherence, exposure and engagement) of a multimodal GA appropriate rehabilitation program during NICU hospitalization compared to standard of care. The investigators will evaluate:

* Acceptability using recruitment, refusal, retention, and follow-up rates as well as weekly interviews with parental participants
* Feasibility (practicality) using direct observations and weekly interviews with parental participants
* Fidelity (adherence, exposure and engagement) using visitation data, activity logs, direct observations, and weekly interviews.

Aim 2: Examine the effect of a multimodal NICU-based rehabilitation program on short-term motor outcomes (general movements, cranial nerves, posture, movements, tone, and reflexes) of premature infants at risk for cerebral palsy (CP) at discharge from the NICU and at 3 months corrected age. The investigators hypothesize that this type of GA appropriate multimodal NICU-based rehabilitation program will positively impact short-term motor outcomes by normalizing general movements and improving TIMP and HINE scores.

Eligibility Criteria:
Inclusion Criteria:

* GA at birth: ≤32 weeks gestation and/or birthweight ≤1500 grams
* Infants 7 days or older
* Ability of parents or identified designated surrogate (e.g. grandparent) to perform the interventions
* Abnormal writhing GMs defined by the presence of a poor repertoire pattern on 2 consecutive assessments or the presence of a cramped-synchronized pattern on any assessment

Exclusion Criteria:

* Clinically unstable (requiring high frequency mechanical ventilation, vasopressor support, need for continuous intravenous pain or sedation medication)
* If their parents do not speak English
* If parental participation is hindered (e.g. incarceration).
Retrospective Study of Airway Management in Dutch ED's

Describing characteristics of the practice of airway management in Dutch emergency departments, including information about patient demographics, indications, performer characteristics, equipment and medication used and complications due to intubation.

Endotracheal intubation can be a lifesaving intervention for critically ill patients in the emergency department (ED). Endotracheal intubation is, however, a high-risk procedure with many potential complications, which seem to be even more prevalent when carried out in the ED compared to for example the operating theater. This is possibly due to multiple reasons such as a sicker population, non-elective setting, a higher variability among indications for intubation or competence of providers.

Internationally, large registries were established and multiple observational studies have been performed to gain more information about the methods, safety and complications of intubations in the ED. While in recent years these studies have added to our knowledge of ED airway management, there is still a lack of high-quality studies and there is a strong argument for increased research. To date, no studies have been published of airway management in Dutch EDs. The investigators therefore have no knowledge about any factors possibly influencing intubation outcomes and complications nor comparability with international data. Among these are factors that have been associated with preventable harm and death and insight into these factors could be used for improvement of the safety of airway management in Dutch EDs.

This study is therefore intended to provide a comprehensive review of the clinical practice and characteristics of endotracheal intubations within Dutch EDs. The results could potentially be used for comparative analysis against global datasets. Additionally, the insights gained from this study will shed light on existing gaps prevalent in the current registration processes of intubations in the Netherlands. Furthermore, these insights could act as a stepping stone for future investigations that can lead to a deeper understanding of the methodologies, safety protocols, and associated complications of endotracheal intubations within Dutch EDs

Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent endotracheal intubation between 01-01-2019 and 31-12-2023 in the participating ED's

Exclusion Criteria:

* Patients for which no information about the intubation can be found in the electronic patient chart will be excluded from the study.
hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease

The human immune system produces a protein called hCAP18 (also known as LL-37 or cathelicidin). This protein is believed to help the body to fight infections. Studies suggest that vitamin D may important in the production of hCAP18. This study is designed to test the ability of two different forms of vitamin D to affect levels of hCAP18. Vitamin D and hCAP18 levels will be measured during an initial visit. Individuals who are vitamin D deficient will be randomly assigned to receive one of two forms of vitamin D for two weeks. After this, follow-up levels will be measured.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Chronic Kidney Disease stage 3-4 (estimated glomerular filtration rate 15-60 ml/min)

Exclusion Criteria:

* 6 month history of hypercalcemia, hyperphosphatemia, or nephrolithiasis
* use of active vitamin D analog within 30 days
* functioning renal transplant
* Symptoms of active infection
* Granulomatous disorders
Assessment of Quality of Life and Social Support Gained in Patients Before and After Colorectal Cancer Surgery

* evaluation of the quality of life of patients before and after laparoscopic surgery for rectal cancer and cancer of the right part of the intestine at different stages of the disease, whether it depends on the size of the tumor, neoadjuvant treatment, type of cancer and its location
* Multidimensional assessment of perceived social support (considering three sources of support: significant person, family and friends) of patients before and after laparoscopic surgery for rectal cancer and cancer of the right part of the intestine, whether it depends on the stage of the disease, the location of the tumor lesion and the treatment undertaken

Specific scientific objectives:

* To evaluate the quality of life of patients before and after laparoscopic surgery for rectal cancer and right-sided colon cancer at different stages of disease, whether it depends on tumor size, neoadjuvant treatment, type of cancer and its location
* Multidimensional evaluation of perceived social support (considering three sources of support: significant person, family and friends) of patients before and after laparoscopic surgery for rectal cancer and cancer of the right part of the intestine, whether it depends on the stage of the disease, the location of the tumor lesion and the treatment undertaken

Scientific (research) problems:

* What is the quality of life of patients before surgery, and what is the quality of life after laparoscopic surgery for rectal cancer and cancer of the right side of the intestine at different stages of oncological disease? Does quality of life depend on the size of the tumor, location, advancement or type of treatment undertaken?
* How do patients rate the received social support both before and after laparoscopic surgery for rectal cancer and right colon cancer ?
* Did the obtained social support in the patient at each stage of the disease ( before surgery, after surgery) depend on the advancement of the oncological lesion, the location of the tumor lesion and the treatment undertaken ? 2 Methodology of the study The study will be carried out at the General Surgery Clinical Department of the John Grande Hospital of the Order of St. John of God in Krakow after obtaining permission from the facility's management.

Each patient qualified for laparoscopic surgery for rectal cancer and cancer of the right side of the intestine who simultaneously agreed to participate in the study anonymously was included in the study group.

Eligibility Criteria:
Inclusion criteria for the study:

* clinical diagnosis of rectal cancer and right colon cancer
* laparoscopic surgery

Study exclusion criteria:

- surgery by traditional method
Low-Dose Chest CT (LDCT) COVID-19 Study

The goal of our proposed pilot study is to collect low dose CT (LDCT) findings from chest evaluations of a representative sample of 120 symptomatic Caucasian and African American, and Hispanic adults (45 each), stratified by presence of acute respiratory distress syndrome (ARDS) and COVID-19 positivity or negative PCR screening results. These data will provide us with preliminary data on the type and extent of alveolar remodeling by race and by severity of recent infectious respiratory disease. Findings from our study would will help us to determine if a larger multi-site research application to NHLBI or a similar funding agency might be possible and provide critical preliminary data on variation in LDCT findings by COVID-19 attributable respiratory health, race, and other risk factors (e.g., smoking history, comorbidities, and socioeconomic status).

This is a prospective data collection study of random samples of Caucasian and African American, and Hispanic adults, who are symptomatic and recently tested with a nasal or nasopharyngeal swab test (PCR test) and by test positivity and/or evidence of recent acute respiratory distress.

Our study has 2 objectives: 1) demonstrate the feasibility of using KP electronic health records (EHR) and associated computerized data resources to identify and recruit representative samples of Caucasian and African American, and Hispanic adults with varying likelihoods of lung remodeling, and 2) identify the implementation opportunities and challenges associated with recruitment for and collection of primary LDCT findings in a representative sample of adults from a diverse urban population.

The specific aims of our study are:

Aim 1: Implement a sampling and recruitment protocol to collect representative samples of Caucasian and African American, and Hispanic adults by clinical history attributable to ARDS (e.g., hospitalization for ARDS, not hospitalized by positive/negative for COVID-19) and presenting with symptoms typical of COVID-19 (i.e. fever, cough, shortness of breath, nausea/vomiting) Aim 2: Collect LDCT findings and self-reported respiratory health at the time of LDCT from this sample.

Aim 3: Link the LDCT findings to other electronic health record (EHR) data to assess face validity of findings through associations with race, other patient demographics, and clinical risk factors associated with self-reported respiratory health.

Eligibility Criteria:
Inclusion Criteria:

* KPMAS members, primarily residing in the DCSM service area (Montgomery, Frederick or Prince George's counties),
* ≥ 18 years of age or older
* Have a recent PCR test with a positive or negative result, and/or evidence of ARDS and who were symptomatic for COVID-19 related symptoms at the time of the test.

Exclusion Criteria:

* Pregnant or intending to become pregnant in the next 1-3 months
* Cancer or other treatment involving radiation therapy at any time
* Terminally ill
* Non-English speaking
* Diminished cognitive capacity
* Developmental disabilities
Effectiveness of Supportive Housing on COVID-19 Related Outcomes for People Experiencing Homelessness

This study aims to understand the comparative effectiveness of two PSH models (PB-PSH and SS-PSH) on quality of life and COVID-19 related health behaviors by following for 6 months a cohort of 800 PEH who have been placed in either PB (n=400) or SS (n=400). In a natural observational experiment, participants will complete 6 monthly mobile-based questionnaires exploring quality of life including physical, mental, social, and housing/environmental health, COVID-19 prevention practices (i.e., handwashing, social distancing, face covering), and past-30-day healthcare utilization. A sub-sample of 40 participants living in both PB-PSH and SS-PSH will be qualitatively interviewed longitudinally to help contextualize quantitative findings. Focus groups will also be conducted with providers of PSH and qualitative interviews will be conducted with other key stakeholders to understand perspectives on the challenges of implementing and sustaining COVID-19 related prevention practices while maintaining a continuity of care.

This study will aim to understand the comparative effectiveness of PB-PSH and SS-PSH on patient-centered quality of life, health care utilization, and health behaviors that will reduce COVID-19 risk by following a diverse sample of 800 PEH who are placed in PB-PSH (n = 400) or SS-PSH (n = 400) for 6 months. Barriers and facilitators will also be identified that may affect PSH implementation during the pandemic and its aftermath. The specific aims are:

Aim 1: To test the comparative effectiveness of PB-PSH and SS-PSH on COVID-19-related health behaviors (COVID-19-related personal health practices including social distancing) for PEH over time.

Aim 2: To test the comparative effectiveness of PB-PSH and SS-PSH on patient-centered quality of life (i.e., general life satisfaction; physical, mental, social, and environmental health) for PEH over time.

Aim 3: To test the comparative effectiveness of PB-PSH and SS-PSH on health care utilization health behaviors and unmet need for care for physical health, mental health, substance use disorders, for PEH over time.

Aim 4: To contextualize quantitative findings through longitudinal qualitative inquiry with 40 participants, purposively sampled from PB-PSH and SS-PSH, based on whether they are following social distancing guidelines.

Aim 5: To understand service providers, policy makers, and other stakeholders perspectives on challenges of implementing and sustaining COVID-19-related prevention practices and continuity of care in PSH.

Eligibility Criteria:
Inclusion Criteria:

* adults (aged 18+) with recent (past 12 months) lived experience with homelessness
* approved for PSH
* proficient in English
* able to provide informed consent

Exclusion Criteria:

* aged younger than 18
* not approved for PSH
* not proficient in English
* unable to provide informed consent
Stepped Care Model for the Wider Dissemination of Cognitive-Behavioural Therapy for Insomnia Among Cancer Patients

Insomnia is very common in cancer patients. When left untreated, insomnia can lead to numerous serious consequences (e.g., psychological disorders) for the individual and significant costs for society (e.g., increased medical consultations). Cognitive-behavioural therapy (CBT), a form of psychotherapy, is now considered the treatment of choice for insomnia and its efficacy has been demonstrated in clinical studies conducted in cancer patients. Unfortunately, CBT for insomnia (CBT-I) is not widely accessible as only a few cancer clinics have mental health professionals formally trained in the administration of this treatment. Innovative models of treatment delivery are therefore needed to make sure that every cancer patient with insomnia receives the care he/she needs. A stepped care approach in which patients only receive the level of treatment that they need, beginning with a minimal, less costly, intervention followed by more intensive treatment if required, has shown some promises for other psychological disorders (e.g., depression). Although its relevance has been emphasized to make CBT-I more accessible, its utility has never been investigated. The main goal of this randomized non-inferiority study is to assess the efficacy and costeffectiveness of a stepped care CBT-I as compared with standard care. Our hypothesis is that a stepped care approach will not be statistically inferior in terms of efficacy as compared to usual care, while being much less costly (better cost-effectiveness ratio). Three hundred cancer patients (mixed cancer sites) with insomnia symptoms will be assigned to: (1) stepped care CBT-I (n = 118) or (2) standard care (n = 59), consisting of 6 weekly sessions administered individually by a professional.


Eligibility Criteria:
Inclusion Criteria:

* have received a diagnosis of non-metastatic cancer (any type) in the past -18 months
* to have an ISI score \> 7
* to be aged between 18 and 75 years old
* to be readily able to read and understand French

Exclusion Criteria:

* having a life expectancy \< 1 year
* having a severe psychiatric disorder (e.g., psychotic, substance use, severe depressive disorder)
* having severe cognitive impairments (e.g., diagnosis of Parkinson's disease, dementia, or Mini-Mental State Examination score \< 24)
* having received a formal diagnosis for another sleep disorder (e.g., obstructive sleep apnea, periodic limb movement disorder)
* shift work in the past 3 months or in the next 12 months
* to have received a CBT for insomnia in the past
Randomized Comparison of Radiological Exposure With TRIPTable® in Patients With Acute Coronary Syndromes

Excessive radiation received by the operator has been described as a possible drawback of the radial catheterization technique when compared with the femoral access.

The study hypothesis is that the use of radial access device dedicated radioprotective TRIPTable ® (Transradial Intervention Table Protection) is not inferior to standard femoral technique and superior to standard radial technique as radioprotection strategy to the operator in patients with acute coronary syndromes acute and submitted to cardiac catheterization.

This study is prospective, 1:1:1 randomized, unicentric, comparative between femoral and radial radial technique with and without dedicated TRIPTable ® device.

The TripTable device is a polycarbonate support table anatomically-designed to facilitate the radial technique, facilitating the puncturing, positioning, support to work material and providing further radioprotection from a lead layer without obstruction in viewing the fluoroscopic images.

Eligibility Criteria:
Inclusion Criteria:

* Unstable angina with an indication for invasive stratification
* Acute coronary syndrome without ST-segment elevation
* Acute coronary syndrome with ST-segment elevation
* Patient informed of the nature of the study and have signed the Informed Consent
* Patient suitable for coronary angiography and / or percutaneous coronary intervention either by radial access as the femoral

Exclusion Criteria:

* Below 18 years of age
* Pregnancy
* Chronic use of vitamin K antagonists, or direct thrombin inhibitors or antagonists of factor Xa,
* Active bleeding or high risk of bleeding (severe hepatic insufficiency, active peptic ulcer disease, creatinine clearance \<30 mL / min, platelet count \<100,000 mm3);
* Uncontrolled hypertension;
* Cardiogenic shock;
* Previous coronary artery bypass graft surgery with the use of ≥ 1 graft
* Patients not candidates for the use of any of the specified vascular access
* Concomitant severe disease with life expectancy less than 12 months life;
* Medical, geographical, or social conditions that impede study participation
* Refusal or inability to understand and sign the informed consent form.
Tailored Intervention to Promote Positive Airway Pressure Adherence

The purpose of this study is to examine the feasibility of a tailored (i.e., individualized) intervention to promote adherence to continuous positive airway pressure therapy (CPAP) in adults with newly-diagnosed, CPAP treated, obstructive sleep apnea.

Poor adherence to CPAP is a significant problem among OSA patients resulting in suboptimal health and functional outcomes. Intervention studies to promote CPAP adherence have shown relatively small effects in selected samples and were costly. The overall objective of this research is to examine the effect, feasibility, and acceptability of a tailored intervention on CPAP adherence among adults with newly-diagnosed, CPAP treated OSA. The central hypothesis is that critically timed tailored interventions that focus on sociocultural aspects and cognitive perceptions of the individual experience with OSA diagnosis and treatment will improve overall CPAP adherence rates. The pilot randomized controlled trial will examine CPAP adherence outcomes at 1wk, 1mo, and 3mo among those randomly assigned to the tailored intervention or usual (standard) care and examine specific feasibility and participant acceptability outcomes in order to design and conduct a subsequent larger randomized controlled trial testing the overall efficacy of the tailored intervention.

Eligibility Criteria:
Inclusion Criteria:

* males and females \>/= 18 years of age
* newly diagnosed with apnea/hypopnea index \>/= 10 events/hr
* CPAP naive
* able to read and speak English

Exclusion Criteria:

* previous diagnosis and/or treatment of OSA
* major new psychiatric diagnosis within 6 months of study enrollment
* require supplemental oxygen or bilevel positive airway pressure on CPAP titration polysomnogram
* diagnosis of co-existent sleep disorder on polysomnogram, including periodic limb movements \>/= 10 events/hr with arousal, central sleep apnea with \>/= 5 central events/hr, insomnia, sleep hypoventilation syndrome, or narcolepsy