cyrilzakka/clinical-trials huggingface dataset:
A Trial Assessing Feasibility of Allostatic Load Biomarkers and CVD Risk Among Black Breast Cancer Survivors

This study's overall objective is to test the effects of a culturally tailored gratitude, exercise, and mindfulness/emotional freedom techniques (GEM) psychosocial intervention on allostatic load and atherosclerotic cardiovascular disease risk in black women breast Cancer survivors. Allostatic load refers to the cumulative physiological burden of chronic stress, which is a major contributor to CVD risk, impaired immune function, and worse cancer outcomes. Atherosclerotic cardiovascular disease risk encompasses factors such as blood pressure, cholesterol, and glucose control that predict long-term cardiovascular health.

Among survivors of breast cancer in the U.S., black women have the highest rates of mortality from breast cancer, cardiometabolic disease, and all causes. These disparities are likely due to complex interactions between socioeconomic, psychosocial, and biological risk factors. A higher prevalence of cardiometabolic risk factors among black women breast cancer survivors is one critical disparity associated with poorer breast cancer outcomes and increased cardiometabolic risk, including that driven by cardiotoxicity from breast cancer treatment. Engagement in physical activity, which reduces cardiometabolic risk, is associated with significant reductions in all-cause and cancer mortality in breast cancer survivors. However, black breast cancer survivors report lower levels of physical activity compared to their white counterparts, and most interventions targeting this behavior have not effectively engaged black women. Interventions that effectively increase physical activity in black women breast cancer survivors hold promise as a means for reducing these persistent disparities in survival outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Participants must identify as Black women who have survived breast cancer
* Participants must have completed primary cancer treatment (surgery, chemotherapy, and/or radiation) at least 6 months prior to enrollment
* Adults ≥ 18 years old
* Capable of completing study requirements
* Informed consent obtained from the participant and documentation of participant agreement to comply with all study-related processes

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
* Impaired cognition (i.e., inability to follow and respond appropriately during screening).
* Participants currently enrolled in other lifestyle, exercise, or psychosocial interventions will be excluded.
Treatment Patterns and Clinical Outcomes Among Patients Receiving Palbociclib Combinations for Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2 ) Advanced/Metastatic Breast Cancer in the Arabian Gulf Region

retrospective non-interventional study (NIS) that aims to describe the demographics, clinical characteristics, clinical outcomes, and treatment patterns, among patients receiving palbociclib for the treatment of HR+/HER2- metastatic/locally advanced breast cancer (BC)


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old.
2. HR+/HER2- BC diagnosis with confirmed metastatic/locally advanced disease.
3. Patient initiated on palbociclib (regardless the line of therapy) within the period between 01st January 2015 and 01st March 2019.
4. Minimum of six months of follow up data since palbociclib initiation.
5. Received palbociclib plus aromatase inhibitor or palbociclib plus fulvestrant in line with the licensed indication(s).

Exclusion Criteria:

1. Prior or current enrolment in an interventional clinical trial for metastatic/locally advanced BC.
2. Patients who were initiated on palbociclib after 01st March 2019.
A Longitudinal Investigation of Cognitive Function in Colorectal Cancer Patients

This is a prospective, longitudinal, controlled study of cognitive function and fatigue in patients with apparently localized CRC treated with adjuvant or neoadjuvant chemotherapy. In addition to following each patient over time (i.e. acting as their own control), a separate control group will consist of patients with early stage CRC (Stage A or B) who have had surgical resection of their tumour, but who do not require adjuvant chemotherapy, or patients with stage C CRC who have declined chemotherapy.

Also included is a smaller sub-study of patients with limited metastatic CRC who are treated with more toxic chemotherapy

To compare changes in cognitive function, as compared to baseline assessment, of patients with CRC who do, or do not, receive 5FU-based chemotherapy. The primary measures of cognitive function are the High Sensitivity Cognitive Screen (HSCS) \& Coghealth™.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-70 years old
* Performance Status (PS) of 0-1 on the ECOG Performance Scale
* Life expectancy of at least 12 months
* Full recovery from any post operative sequelae
* Adequate hepatic function as documented by a serum bilirubin \< 18umol/L, and LFTs within 1.5X normal range
* Patients with histologically confirmed, stage B or C colorectal cancer (CRC), who have undergone surgical resection and are about to commence chemotherapy.
* Patients due to receive neoadjuvant chemotherapy prior to surgery are also eligible.

Exclusion Criteria:

* Any major pre-existing psychiatric history or dementia, alcohol abuse, or currently using a psychotropic medication that might lead to cognitive problems, other than short acting benzodiazepines for nausea or sleep
* Any evidence of metastatic disease. If there is clinical suspicion of CNS involvement patients must have brain imaging (MRI or CT scan) prior to recruitment.
* Ongoing sepsis or uncontrolled infection, including HIV infection
* Pre-existing neurological condition likely to interfere with ability to perform cognitive testing
* Any other severe co-morbidity which, in the judgement of the investigator, would make the patient inappropriate for entry into this study
* Active cancer within the last 5 years other than squamous or basal cell carcinoma of the skin or cervical cancer in situ (except for CRC)
* Previous history of chemotherapy
* Minimal English skills such that subjects would be unable to follow simple, written English instructions and to read questionnaires of a grade 8 standard with the help of a research assistant.
The Effect of Bone Grafts on Facial Gingival Profile in Maxillary Anterior Single Tooth Replacement

The purpose of this investigator-initiated study is to evaluate the facial gingival profile following immediate implant placement and provisionalization in conjunction with connective tissue graft with or without bone graft

Thirty subjects who are at least 18 years old with a failing upper front tooth seeking for implant treatment will be recruited at Loma Linda University School of Dentistry (LLUSD), where the consent will also take place. The subjects will be randomly divided into 3 groups. The subjects will receive immediate implant placement and provisionalization (IIPP) in conjunction with connective tissue graft (CTG) with (Group I) or without (Group II) bone graft in the extraction socket; and with bone graft in extraction socket and at the facial aspect of failing tooth (Group III). Clinical, radiographic and model assessments will be performed at different time intervals (pre-treatment to 12 months after implant placement) and statistically analyzed (α = 0.05) to evaluate peri-implant tissue response and facial gingival profile of the implants. Complications, if any, will also be recorded and appropriately addressed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be 18 years of age or older, are no longer growing and able to read and sign an informed consent.
2. Good oral hygiene.
3. A single failing maxillary anterior tooth (#6-11) with the presence of healthy adjacent teeth.
4. Adequate bone volume to accommodate an implant with minimum dimensions of 3.6 mm diameter and 10.0 mm length.
5. Presence of opposing dentition (natural teeth, fixed or removable prostheses)
6. Healthy soft tissue at the future implant site.

Exclusion Criteria:

1. A medical history that would complicate the outcome of study such as alcohol or drug dependency, poor health ,uncontrolled diabetes, immunodeficiency diseases, taking any medication that may cause gingival over growth or any other medical, physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontic treatment and required follow-up examinations.
2. Dental history of bruxism, parafunction habit, and/or lack of stable posterior occlusion
3. Smoker.
4. History of head and neck radiation.
5. Soft tissue defect (inflammation, tissue cleft, unhealthy tissue) around a future implant site.
6. Inability to achieve primary implant stability following immediate implant placement.
Impact of Adapted Mirror Therapy on Individuals With Hemiparesis of the Upper Limb Following a Stroke

Patients with upper limb hemiplegia after stroke, who were admitted in the Department of Rehabilitation Medicine, were enrolled. The study lasted 30 days for each participant. The patients enrolled were randomly divided into the experimental group and the control group, all under routine rehabilitation therapy. Additionally, the patients in the experimental group were given modified mirror therapy. On day 1 and day 30, patients' Upper Limb function were compared.

Upper limb hemiparesis is a motor and sensory disorder that occurs after stroke, with an incidence rate of up to 55% to 75%. This was a Randomized controlled trial. Patients with upper limb hemiplegia after stroke, who were admitted in the Department of Rehabilitation Medicine, were enrolled. The study lasted 30 days for each participant. The patients enrolled were randomly divided into the experimental group and the control group, all under routine rehabilitation therapy. Additionally, the patients in the experimental group were given modified mirror therapy. On day 1 and day 30, patients' Upper Limb function were compared.

Eligibility Criteria:
Inclusion Criteria:

* Meeting the diagnostic criteria of stroke.
* The first-onset stroke.
* Presenting with unilateral upper limb dysfunction, within Brunnstrom stage Ⅱ to Ⅳ on the affected side, and Ash-worth score ≤2.
* No obvious cognitive impairment, with Mini-Mental State Examination (MMSE) score \>21 points.
* National Institutes of Health Stroke Scale (NIHSS) score \>4 points.
* Stable vital signs, no severe diseases such as cancer, liver or kidney disorders.
* Aged 35-70 years.
* Courses of diseases 2-6 weeks.

Exclusion Criteria:

* Presence of aphasia, apraxia, or hemispatial neglect.
* Presence of hearing, vision, or comprehension impairments that hinder diagnosis and treatment.
* Complicate with traumas, fractures, or other progressive neuro-muscular system diseases.
* Severe spasticity in the upper limbs.
* Severe bone, joint, or muscle deformities or lesions.
* History of mental illness.
Study of Heparin Prophylaxis of Hereditary Angioedema Exacerbations

OBJECTIVES:

I. Determine the safety and efficacy of inhaled and subcutaneously administered heparin in the treatment of hereditary angioedema.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, 3 way crossover study.

All patients complete diary cards for the first month of the study in order to determine compliance in providing a daily record of symptoms and medication taken. All compliant patients receive subcutaneously injected heparin twice daily, inhaled heparin daily, or matched saline placebo in a random order. Each of the three drug administration periods lasts 2 months, for a total of 6 months of treatment. Patients who have a flare in disease activity that requires hospitalization are terminated from that drug administration period of the study.

Patients are followed biweekly during the first month and again at the end of the second month for each of the three 2 month drug administration periods.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Confirmed diagnosis of hereditary angioedema (HAE) based upon C4 antigenic level, positive family history, and C1 inhibitor (C1INH) antigenic level (Type I HAE) or functional level (Type II HAE)
* Functional C1 within normal levels if diagnosis of acquired C1INH is possible
* Negative family history will not exclude as long as patient meets all other criteria, has normal C1 level, and has no evidence of acquired C1INH deficiency
* History of symptoms of HAE including episodic swelling, abdominal pain, and/or respiratory difficulty
* Experiencing a minimum of 1-2 HAE episodes within 6 weeks

--Prior/Concurrent Therapy--

* Endocrine therapy: Anabolic steroids allowed as long as dose has not been changed in at least 30 days
* Other: No concurrent and at least 1 week since prior aspirin, nonsteroidal antiinflammatory agents, dipyridamole, Coumadin-like drugs, or any other medication having an effect on coagulation or platelets

--Patient Characteristics--

* Hematopoietic: No clinically significant history of hematologic disease
* Hepatic: No clinically significant history of hepatic disease
* Renal: No clinically significant history of renal disease
* Cardiovascular: No clinically significant history of cardiac disease or hypertension
* Pulmonary: No clinically significant history of pulmonary disease
* Other: No contraindication to the use of inhaled or subcutaneous heparin No drug allergy that would interfere with the study No clinically significant history of: Malignancy Diabetes mellitus Neurologic disease Immunologic disease Bleeding disorder Infirmity No history of drug abuse, alcoholism, psychosis, or other psychological/psychiatric disorder
Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm

The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of Essential blepharospasm.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged above 18
* Subjects who was diagnosed with Essential Blepharospasm
* Subjects who voluntarily Signed written informed consent
* Subjects who can adhere to protocol and study requirements

Exclusion Criteria:

* Subjects with known history of allergy considered due to Botulinum toxin type A
* Subjects who have received botulinum toxin A type within 3 months
* Any disease that might affect neuromuscular function (e.g.. Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis ect.)
* Subjects who are participating in other clinical trials
* Pregnant or lactating female Subjects
* Subjects who are not eligible for the study at the discretion of the Investigator.
Caring for Caregivers and People Living With Dementia Under Home-Based Primary Care

The goal of this clinical trial is to develop a dementia care intervention for persons receiving home-based primary care (HBPC) and living with dementia (PLWD) and their caregivers, and test the feasibility of implementing the intervention in HBPC practices to ultimately improve outcomes of PLWD and their caregivers.

The main aims are to:

* Develop and refine HBPC Dementia Care Quality at Home
* Establish feasibility (primary outcome), acceptability, and fidelity of HBPC Dementia Care Quality at Home through an open-pilot trial involving two HBPC practices. Trained clinicians and staff at two HBPC practices will implement the intervention

Relevant stakeholders (caregivers of PLWD, and HBPC clinicians and staff) will participate in qualitative focus groups to provide feedback on the intervention.

The overarching goal of this project is to develop a dementia care intervention for PLWD and their caregivers, Dementia Care Quality at Home, and test the feasibility of implementing the intervention in two HBPC practices to ultimately improve outcomes of PLWD and their caregivers.

The investigators will evaluate the feasibility, acceptability, and fidelity in implementing HBPC Dementia Care Quality at Home in two practices for persons living with dementia and their caregivers through an open pilot. Hypothesis: HBPC Dementia Care Quality at Home will meet benchmarks of feasibility, acceptability, and fidelity by the HBPC practices implementing it and by caregivers of PLWD who experience the intervention. The investigators will assess feasibility of caregivers of PLWD to engage with the intervention, the acceptability of the intervention to caregivers, and the impact of the intervention on caregiver well-being by surveying caregivers at the conclusion of the pilot. In addition, the investigators will assess feasibility, acceptability, and fidelity of the intervention in the practices.

Eligibility Criteria:
Inclusion Criteria:

Caregiver participants will:

* be adults (18 years or older)
* have English fluency and literacy
* live in the United States
* live with and care for an individual with Alzheimer's Disease and Alzheimer's Disease Related Dementias (ADRD)
* anticipate providing care for the next 6 months
* provide an average 4 hours of supervision or direct assistance per day for the care recipient and
* have been identified by the practice as experiencing caregiver stress.

Staff participants will:

* be 18 years or older
* have English fluency and literacy and live in the United States and
* be part of a HBPC primary care program or closely connected to the practice.

Exclusion Criteria:

* Participants under the age 18.
* Participants who have no English fluency and literacy and do not live in the United States.
* For caregiver participants, not caring for and living with a patient that is part of a HBPC primary care program or closely connected to the practice.
Early Diagnosis of Alzheimer-like Dementia: Benefit of MRI and PET Imaging

The physio-pathology of Alzheimer's disease (AD) remains unknown and there is no cure. Thus, the search for objective markers of preclinical first signs of cognitive impairment, is currently a major public health issue. Early detection of the disease is a major challenge to hope to slow or even stop the neurodegenerative process before the stage of dementia.

In AD the investigators observe:

* A reduction in the volume of brain hippocampi associated with an alteration of the diffusion of water molecules in the white matter.
* A structural brain degeneration coupled with a decrease in cerebral glucose metabolism.

Recent publications show that cerebrospinal fluid (CSF)flow is also altered, probably due to dysfunction of the choroid plexus. Hence the potential interest to study is, in addition to conventional imaging, the imaging of CSF dynamics and choroid plexus metabolism. In that aim,the investigators use two imaging modalities:

* Magnetic resonance imaging (MRI) is used to assess blood and CSF flow in the brain
* Positron emission tomography (PET) is used to assess glucose metabolism in grey/white matter and also in choroid plexus.

The investigators expect that, because of choroid plexus atrophy in AD, CSF flow would be altered as well as glucose metabolism dynamic in choroid plexus.


Eligibility Criteria:
Inclusion Criteria:

* Age: over 65
* Participants (or representatives) gave their written informed consent
* Dementia diagnosed according to Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria
* For Alzheimer arm: probable Alzheimer based disease according to NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association ) criteria
* For vascular dementia: diagnosis based on NINDS-AIREN (National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherche et l'Enseignement en Neurosciences) criteria
* For MCI: diagnosis based on Petersen index

Exclusion Criteria:

* Claustrophobia
* Diabetes
* Cardiovascular disease
* Glycemia over 1.3 g/L
* Lumbar puncture within one week before MRI examination
* Non MR-compatible implant
* Suspected brain metastases
* No informed consent signature
Echocardiography and Peak Endocardial Acceleration (PEA) Measurements in Cardiac Resynchronization Therapy (CRT)

This study used an external endocardial acceleration sensor (sonR sensor), placed on the patient's chest, to time the closure of aortic and mitral valves, and compared its performance with echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* Every patient coming in the participating centers for an echocardiographic exam and implanted with a pacemaker or an implantable cardioverter defibrillator (ICD) can be included in the study.

Exclusion Criteria:

* Inability to understand the patient information sheet.
* Minor patient or pregnant woman.
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)

The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle


Eligibility Criteria:
Inclusion Criteria:

* Functional single ventricle patient with heart failure who is scheduled for stage 2 (Glenn) or stage 3 (Fontan) surgery
* EF(%) by echocardiography ≤ 55%
* Able to obtain written informed consent of participation in the study by a parent of the patient

Exclusion Criteria:

* Known medical history of cardiogenic shock
* Lethal, uncontrollable arrhythmia
* Complication of coronary artery disease
* Eisenmenger syndrome
* Complication of brain dysfunction due to circulatory failure
* Malignant neoplasm
* Complication of severe neurologic disorder
* Severe pulmonary embolism or pulmonary hypertension
* Severe renal failure
* Multiple organ failure
* Active infection (including endocarditis)
* Sepsis
* Active hemorrhagic disease (e.g. gastrointestinal bleeding, injury)
* Known history of hypersensitivity to anti-infective drugs
* Inability to complete the protocol treatment and baseline to follow-up examinations
3D Printed Models in Mohs Micrographic Surgery

Patients undergoing Mohs micrographic surgery (MMS) frequently experience anxiety. It has been suggested that enhanced patient education prior to the procedure may decrease patient anxiety. The purpose of the study is to investigate if optimized participant education enhances participant understanding, decreases participant anxiety and increases participant satisfaction.

1. To investigate if participant education with a 3 dimensional printed (3DP) MMS model and standardized script protocol increases participant understanding of MMS more than current standard of care (control group) at the University Hospitals Cleveland Medical Center MMS Clinics.
2. To investigate if participant education with a 3DP MMS model and standardized script protocol decreases perioperative participant anxiety during MMS more than current standard of care (control group) at the University Hospitals Cleveland Medical Center MMS Clinics.
3. To evaluate if participant satisfaction with a 3DP MMS model and standardized script protocol increases participant satisfaction during MMS more than current standard of care (control group) at the University Hospitals Cleveland Medical Center MMS Clinics.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing MMS at University Hospitals Cleveland Medical Center, Chagrin Highlands and Westlake Campus
* Capable of reading and completing all subjective questionnaires

Exclusion Criteria:

* Cannot complete the survey measures independently for any reason