cyrilzakka/clinical-trials huggingface dataset:
Enhancing Access to Supportive Services for Women of Color with Metastatic Breast Cancer

Black and Latina women experience disparities in supportive and palliative care access and outcomes. The goal of the proposed pilot study is to evaluate the feasibility and acceptability of a community navigator delivered supportive care intervention for historically underserved populations of women with metastatic breast cancer.

Primary Objectives:

1. Establish the feasibility and acceptability of an adapted navigator delivered supportive care model called ACCESS to address supportive care needs for Black and Latina women with Metastatic Breast Cancer.
2. Determine the potential impact of ACCESS on cancer related distress, symptom burden, and utilization of supportive care services.

OUTLINE: Participants (N=60) are randomized to 1 of 2 groups:

GROUP 1/Intervention Group: Participants complete 6 individualized behavioral/educational sessions focused on social determinants of health and supportive care with a trained community navigator followed by monthly phone call check ins for 4 months. Participants complete questionnaires over the phone with a research coordinator at baseline, 6 and 9 months.

GROUP 2/Attention Control group: Participants complete 6 phone calls with a research coordinator focused on supportive care resources followed by monthly phone call check ins for 4 months. Participants complete questionnaires over the phone with a research coordinator at baseline, 6 months and 9 months.

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Eligibility Criteria:
Inclusion Criteria:

* Women ≥18 years of age
* English and/or Spanish speaking
* Self-identify as Latina and/or African American/Black
* Ability to understand and the willingness to sign a written informed consent
* Stage IV breast cancer diagnosis, no time component

Exclusion Criteria:

* Moderate to severe cognitive impairment
* receiving inpatient hospice care
* if patients were previously enrolled in Aim 1 and Aim 2
* currently working with a community navigator
Relation Among HDL Functionality, Neoatherosclerosis and Target Lesion Revascularization

The aim of this study is to evaluate the relation among cholesterol uptake capacity which measure HDL functionality, neoathrosclerosis and target-lesion revascularization.

Intracoronary stent implantation has markedly reduced the incidence of restenosis in patients with coronary artery disease. However, in-stent restenosis requiring target-lesion revascularization (TLR) occurs even with the use of drug-eluting stents. Emerging evidence suggests that among various potential risk factors, atherogenic progression within the neointima, "neoatherosclerosis" is one of the major contributors to TLR, and that patients' lipid profile is one of the key risk factors for the development of neoatherosclerosis.

Conversely, recent animal and human studies have demonstrated the importance of high-density lipoprotein (HDL) functionality, rather than of HDL-cholesterol levels, in the development of de novo coronary artery disease. Cholesterol efflux capacity, a measure of the ability of HDL to promote cholesterol removal from lipid-laden macrophages, was found to be inversely correlated with the incidence of cardiovascular events and was shown to improve cardiovascular risk prediction beyond that with the use of traditional coronary risk factors. Therefore, the investigators hypothesized that the HDL function of promoting cholesterol removal from lipid-laden macrophages could be associated with TLR through its effect on the process of neoatherosclerosis progression within stents.

Recently, the investigators developed a rapid cell-free assay system to directly evaluate the capacity of HDL to accept additional cholesterol; the measurement of this cholesterol uptake capacity (CUC) enables HDL functionality to be readily evaluated in our daily practice. Thus, the investigators performed this study in order to clarify the potential relationship among CUC, neoatherosclerosis, and TLR by using the novel cell-free assay system, CUC measurement, and optical coherence tomography (OCT) analysis.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of coronary artery disease
* Patients who had undergone percutaneous coronary intervention
* Patients who had been treated with bare-metal stents, drug-eluting stents
* Patients who had successfully undergone follow-up OCT for the target stents \>6 months after stenting.

Exclusion Criteria:

* The stent was implanted in the left main trunk
* OCT images were of insufficient quality
Tuberculosis in a Multiethnic Inner City Population

To determine the incidence of tuberculosis in an inner city population, identify risk factors for TB, describe the natural history in adults and children, evaluate the effect of Mycobacterium tuberculosis (Mtb) co-infection on the progression of human immunodeficiency virus disease, and determine factors that contribute to compliance and non-compliance with prophylaxis and treatment.

BACKGROUND:

The research provided urgently needed information regarding incidence, risk factors, natural history, molecular epidemiology, treatment, and prevention of tuberculosis in an especially vulnerable multi-ethnic inner-city population with a high HIV seropositivity rate.

The study was part of a collaborative project on minority health, The Epidemiology, Drug Resistance, and Therapy of Tuberculosis in a Multi-Ethnic Inner City Population with a High HIV Seropositivity Rate. The 1993 Report of the Committee on Appropriations, House of Representatives, encouraged the NHLBI to establish minority centers to facilitate the diagnosis and treatment of cardiovascular diseases. The concept for the initiative was developed by the NHLBI staff and approved by the September 1992 National Heart, Lung, and Blood Advisory Council. The Request for Applications was released in October 1992.

DESIGN NARRATIVE:

The study was conducted prospectively and retrospectively in three groups of patients: intravenous drug users and their sexual contacts in an already-recruited cohort; children who received their primary care at Bellevue Hospital Medical Center; and Bellevue Hospital Center inpatients with TB and outpatients who underwent prophylactic treatment. In addition to environmental risk factors (e.g., hopelessness, cohabitation with tuberculosis patients and injected drug use), host factors were investigated, including: HIV infection; immune status among HIV- seropositive persons, as indicated by quantitative p24 antibodies; CD4, CD8, and gammadelta T cell counts; and race, age, and nutritional status. Incidence and risk-factors in the cohort were assessed by interview, blood draw, PPD screening, medical record review, and anergy panel. Natural history and impact on HIV disease in adult and pediatric populations were assessed by interviews, clinical screening and laboratory measures. Drug sensitivity testing and RFLP typing of specimens from the two populations were conducted, respectively, at the Bellevue Mycobacteriology Lab and the Public Health Research Institute. Factors affecting treatment compliance were assessed by self-administered questionnaire.

Eligibility Criteria:
No eligibility criteria
ELO Water In Diabetes Care For Enhancement Of Blood Sugar Control

This double-blinded, randomised and controlled trial evaluates the efficacy of oxygen-enriched ELO drinking water as an adjuvant modality in diabetes care for enhancement of glycemic control in patients with Type 2 diabetes mellitus. Adults with type 2 diabetes will be randomized to drink 1.5 L of either ELO water or normal drinking water for 24 weeks. The primary outcome is improvement in glycaemic control.

Global diabetes mellitus prevalence is rapidly increasing. In 2015, IDF reported that Singapore has 12.8% of its population diagnosed with diabetes mellitus, of which more than 90 percent are type 2 diabetes with underlying insulin resistance. With the aging population and increasing prevalence of obesity and sedentary lifestyles, the prevalence is expected to continue to rise.

In vitro studies demonstrated that hypoxia creates a state of insulin resistance through HIF (Hypoxia Inducible Factor) transcription factor expression in adipocytes. Insulin sensitivity was shown to improve in type 2 diabetes patients and overweight non diabetic patients placed in a hyperbaric oxygen chamber.Increased water intake has been associated with lower HbA1c in the general population , and also with lower post-prandial glucose in type 2 diabetic individuals.

This study aims to evaluate the effects of 1.5 L daily of ELO water, a drinking water enriched with molecular oxygen in a stable form, with a similar volume of bottled drinking water, on glycaemic control in adults with type 2 diabetes in Singapore.

Eligibility Criteria:
Inclusion Criteria:

Type 2 diabetes mellitus with HbA1c 8.0% to 11%, within the last 6 months

Exclusion Criteria:

1. Type 1 diabetes patients
2. Pregnant or lactating women
3. Comorbid conditions requiring fluid restriction to below 1.5 L daily
4. Terminal illness with life expectancy less than 1 year
Phase III Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia

This study is to determine whether once-per-cycle DA-3031(PEG-G-CSF) is not inferior to daily G-CSF in chemotherapy-induced neutropenia.

Eligible subjects are randomly assigned to receive once-per-cycle DA-3031(PEG-G-CSF) or daily G-CSF(up to 10 days). This study is conducted for 6 cycles of chemotherapy, that each cycle is repeated every 21 days.

Eligibility Criteria:
Inclusion Criteria:

1. Age : ≥18, ≤70
2. Diagnosis of stage II, III or IV breast cancer
3. ANC≥1,500/mm3, Platelet≥100,000/mm3, ECOG : 0 or 1
4. Creatinine \< 1.5 x ULN
5. Total bilirubin/AST/ALT \< 1.5 x ULN, ALP \< 2.5 x ULN
6. Have given a written, informed consent

Exclusion Criteria:

1. Prior chemotherapy
2. Prior bone marrow or stem cell transplantation
3. Other malignancy history within 5 years
4. Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors
5. Received any other investigational drugs within 30 days of informed consent date
6. Radiation therapy within 4 weeks of informed consent date
7. Infective symptom before chemotherapy into this study
8. Received systemic antibiotics within 72 hours of randomization into this study.
9. HIV positive
10. Pregnant or lactating women
CEV With/Without Periocular Carboplatin Chemotherapy for Extraocular Retinoblastoma

This study will evaluate a uniform chemotherapy protocol for nonmetastatic extraocular retinoblastoma

This study will be a phase 4 open label interventional case series. Patients with retinoblastoma will be receive chemotherapy with or without periocular injections of carboplatin at a dose of 20mg/2 ml. Patients will receive chemotherapy on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 18 months .

Eligibility Criteria:
Inclusion Criteria:

* IRSS stage II or stage IIIa RB patients.
* for patients with IRSS stage II disease, if scleral surface invasion alone was observed, only systemic chemotherapy was administered, whereas other IRSS stage II and IIIa patients received systemic chemotherapy plus additional local chemotherapy.
* no tumor-related treatment was given prior to this chemotherapy regimen.

Exclusion Criteria:

* metastasis, including lymph node metastasis.
* the diagnosis of IRSS stage I or above in the non-target eye.
Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy

EDG-5506-203 MESA is an open-label extension study to assess the long-term effect of sevasemten (EDG-5506) on safety, biomarkers, and functional measures in adults and adolescents with Becker muscular dystrophy

This is an open-label, treatment extension study to evaluate the safety, tolerability, and durability of effect in long-term dosing of sevasemten. EDG-5506-203 MESA will provide continued access to sevasemten treatment to participants with Becker muscular dystrophy who were previously enrolled in EDG-5506-002 ARCH, completed EDG-5506-201 CANYON and GRAND CANYON, or completed EDG-5506-202 DUNE.

Eligibility Criteria:
Key Inclusion Criteria:

1. Males with a diagnosis of BMD and participation in EDG-5506-002 ARCH, EDG-5506-201 CANYON and GRAND CANYON, or EDG-5506-202 DUNE. Participants are eligible if they complete the respective prior study visits as follows:

* EDG-5506-002 ARCH: Complete the final study Visit 27 \[Month 24\]; or, completion of the ET visit prior to Visit 27 \[Month 24\]
* EDG-5506-201 CANYON and GRAND CANYON: Complete the final study visit (Cohorts 1, 2, 4, and 5: Visit 12 \[Month 12\]; Cohort 6: Visit 11 \[Month 18\])
* EDG-5506-202 DUNE: Complete at least 36 weeks of open-label treatment (Visit 14 \[Week 52\])

Key Exclusion Criteria:

1. Any clinically significant changes during or following participation in EDG-5506-002, EDG-5506-201, or EDG-5506-202 that would affect the potential safety of the participant to receive sevasemten.
2. Receiving moderate or strong cytochrome P450 CYP3A4 inhibitors or inducers.
3. Receipt of an investigational drug other than sevasemten within 30 days or 5 half-lives (whichever is longer) of dosing in the present study.

3. Receipt of oral corticosteroids for the treatment of BMD in the previous 6 months.
Relationship Between Symptoms, Retinal Morphology, and the Nigrostriatal Dopamine System in Parkinson's Disease

The purpose of this study is to examine if a correlation exists between findings from brain imaging studies of the status of the dopamine system in the brain using DaTscan and SPECT imaging, clinical symptoms of Parkinson's disease, and changes in the structure of the retina as detected by optical coherence tomography (OCT) in recently diagnosed and more advanced Parkinson's disease patients.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to give informed consent.
2. Between the ages of 50-80 years old.
3. Male or female with idiopathic PD who fulfill UK PD Society brain bank criteria for diagnosis of Parkinson's disease.
4. Early stage subjects will need to have Unified Parkinson's Disease Rating Scale (UPDRS) motor scores of \< 10, be within 3 years of diagnosis, and not requiring dopaminergic therapy
5. Later stage subjects will need to have Unified Parkinson's Disease Rating Scale motor scores of \> 20 and be \> 5 years from diagnosis
6. If female, one of the following three scenarios must apply:

   * at least two years post-menopausal
   * surgically sterile
   * negative urine pregnancy test, and following a reliable method of birth control (oral contraceptive, intrauterine device, contraceptive implant, barrier, or abstinence) for at least two months prior to entry, and agreeing both to follow a reliable method of birth control, and (if relevant) to desist from breast feeding during, and for two weeks following tracer administration.

Exclusion Criteria:

1. Abrupt onset of Parkinsonism
2. 'Other Parkinson-like syndromes (e.g. progressive supranuclear palsy, multiple system atrophy)
3. Any condition that would preclude successful completion of SPECT scanning
4. Use of anti-coagulant therapy
5. Any clinically significant eye disease that would complicate interpretation of OCT data
6. Use of any drugs that would alter or interfere with tracer binding for SPECT imaging studies (ex., cocaine, amphetamines, methylphenidate, ephedrine, phentermine, bupropion, fentanyl, selective serotonin reuptake inhibitors).
7. Known sensitivity to the imaging agent or to Lugol's solution or to potassium perchlorate.
8. History or presence of severe renal disease.
Wound Healing and Pain Management in Partial Thickness Burns

the aim of the study is to compare between two advanced wound dressing and conventional dressing for the primary ER treatment of superficial partial thickness burns


Eligibility Criteria:
Inclusion Criteria:

patients with minor superficial partial thickness burns

Exclusion Criteria:

co-morbidities, pregnancy
The MAGiC™ Cardiac Ablation European Study

The purpose of the first phase of this feasibility study is to gather safety and performance data on MAGiC to support European marketing approval.

The purpose of the first phase of this feasibility study is to gather safety and performance data on MAGiC to support European marketing approval. After MAGiC obtains European approval, the study will be amended and expanded to collect Post-Market Clinical Follow-up data.

Eligibility Criteria:
Inclusion Criteria:

* Adult (aged 18 or older at time of consent);
* Eligible for ablation procedures of an atrial or ventricular arrhythmia per European Heart Rhythm Association (EHRA) guidelines, with at least one (1) documented episode of the tachyarrhythmia to be treated within the previous six (6) months;
* Able to be safely exposed to magnetic fields;
* Willing and capable to attend scheduled follow up visits at the investigational site for the study duration (up to 12 months)
* Willing and able to provide informed consent.

Exclusion Criteria:

* Unable to be safely exposed to magnetic fields due to Magnetic Resonance Imaging Unsafe device (implanted device or device that cannot be safely removed for the procedure)
* Unable to remain comfortable or hemodynamically stable in the supine position for an extended period of time
* Weight exceeding 200 kg (the weight limit of the table)
* For female patients of childbearing potential: pregnancy at the time of the procedure or unwilling to take a pregnancy test
* Presence of intracardiac thrombus at the time of the procedure
* Where MAGiC would need to cross a prosthetic valve
* Use of MAGiC in the coronary arteries
* A history of sensitivity to foreign objects or extreme allergies
* Acute illness or active systemic infection
* Histological or anatomical abnormalities that may lead to post-operative complications including diminished resistance to infection
* Hemodynamic instability
* Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
* Acute myocardial infarct (within the previous 30 days)
* Recent cardiac surgery (within the previous 60 days)
* Unstable angina
* History of embolism (cerebrovascular accident, transient ischemic attack, systemic embolism) in the previous 30 days
* Previous cardiac ablation within the previous 30 days
* Concomitant arrhythmia(s) requiring active treatment at this time or in the 90 days prior to enrollment (Day -90 to Day 0)
* Currently or in the 30 days prior to consent, participation in an interventional clinical trial
* Significant uncontrolled or unstable medical problems which, in the opinion of the Investigator, would preclude enrollment in and completion of the study (limitation on survival).
* Any reason or condition that, in the judgement of the investigator, makes the patient ineligible for the investigation.
* For Atrial Fibrillation only: persistent Atrial Fibrillation (continuous Atrial Fibrillation lasting longer than 7 days)
* For Atrial Fibrillation only: Presence of any device that would interfere with planned access: Patent Foramen Ovale occlusion/closure device, patch
Web-based CBT for Symptoms of Mild-to-Moderate Anxiety and Depression in Youth With Chronic Illness

Symptoms of anxiety and depression are common in adolescents and young adults with chronic illnesses and are associated with decreased adherence to medical regimens. However, many young patients go untreated for anxiety and depression. The purpose of this study is to evaluate an online cognitive behavioral therapy (CBT) program in young adults with chronic illness. Prior research has shown online CBT to be effective in multiple other populations, but to the investigators' knowledge, this is the first study to examine web-based CBT for young adults with chronic illnesses.

Emotional problems such as anxiety and depression commonly surface during adolescence and are even more common among youth with chronic illness compared to other children. Emotional comorbidities are associated with decreased adherence to medical regimens in children and adults as well as poorer clinical outcomes for medical conditions and increased medical expenditures. It is widely accepted that cognitive behavioral therapy is an effective treatment for anxiety and depression and in-person CBT has been shown effective for young people with inflammatory bowel disease (IBD). However, despite the presence of this effective treatment, the majority of those with anxiety and depression are untreated.

Offering mental health services in an acceptable, feasible and low cost fashion remains a challenge.

Research suggests that web-based CBT is a promising candidate for offering effective and feasible treatment for anxiety and depression to young people. It has been shown effective for mild to moderate symptoms of depression and anxiety in adults and adolescents with a primary diagnosis of depression. In adults, studies comparing face-to-face CBT treatment to web-based CBT with low level therapist support showed comparable clinical outcomes and a 15% cost savings for online treatment. Furthermore, an online treatment format may be especially appealing for younger populations who spend much of their time online as well as for people with chronic illness, who may be home-bound due to symptoms. Despite the well-established evidence base for web-based CBT in other populations, the greater affordability of web-based CBT compared to face-to-face treatment, and the appeal of the online format for young adults, the investigators are aware of no published studies examining the use of web-based CBT for young adults with chronic illness. The innovation of the proposed project is to study low- cost, web-based CBT in a new population of adolescents and young adults with inflammatory conditions that constitute serious chronic illness.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic illness
* Language: English
* Computer and Internet access
* Symptoms of mild-moderate depression and/or anxiety

Exclusion Criteria:

* Existing mental health diagnosis
* Psychoactive medications initiated in past 2 months
* Severe depression
* Suicidal ideation (refer to on-call psychiatrist and/or social worker for urgent intervention) or history of prior suicide attempt