cyrilzakka/clinical-trials huggingface dataset:
An Expanded Access Program of Pegfilgrastim (Neulastim) in Participants With Non-Hodgkin's Lymphoma (NHL)

This study will assess the prophylactic effect of pegfilgrastim (Neulastim) on febrile and/or Grade IV neutropenia in participants receiving chemotherapy (CT) or immunochemotherapy (ICT) as first or second line treatment for NHL. Pegfilgrastim will be administered at a fixed dose of 6 milligrams (mg) subcutaneously 24 hours after the last dose of CT or ICT in each treatment cycle.


Eligibility Criteria:
Inclusion Criteria:

* NHL supported by an Immunohistochemical report
* Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to (\>/=) 2
* Total serum bilirubin less than (\<) 2 times upper limit of normal (ULN)
* Absolute neutrophil count (ANC) greater than (\>) 2 x10\^9 per liter (/L)

Exclusion Criteria:

* Bone marrow compromised \> 10 percent (%)
* Any malignant myeloid condition
* Active infections requiring systemic anti-infectious therapies (antibiotics, antifungal drugs, antiviral drugs) within 72 hours prior to CT or ICT initiation
* Known hypersensitivity reactions to Escherichia coli derived products
* Pregnant or nursing participants. Women with childbearing potential should use a safe contraceptive method
Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool

More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic eye disease (DED), the leading cause of vision loss and blindness in working-age adults. Annual eye screening is recommended for all diabetic patients since vision loss can be prevented with laser photocoagulation and anti-VEGF injections if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is orders of magnitude smaller than that needed to screen the large, growing diabetic population. Therefore, to meet this large unmet need for DR screening, a fully-automated computerized DR screening system is necessary. This study is designed to assess the performance of EyeArt, an automated DR screening tool.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older;
* a diagnosis of diabetes mellitus; and
* understanding of study and provision of written informed consent.

Exclusion Criteria:

* Persistent visual impairment or sudden vision loss in one or both eyes;
* History of uncorrected media opacity in one or both eyes;
* History of retinal vascular disease other than diabetic eye disease;
* History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract;
* Subject has contraindications for mydriatic medications or is unwilling or unable to dilate;
* Subject is currently enrolled in an interventional study of an investigational device/drug; or
* Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or result in ungradable 4-wide field stereoscopic mydriatic fundus photographs.
Attitudes and Understanding of Plant Sterol Claims on Food Labels

Daily consumption of plant sterols have been demonstrated to lower blood cholesterol. The Canadian government has recently allowed plant sterols to be added to certain foods and has also approved a disease risk reduction claim to be allowed on products containing plant sterols. However, it is unknown how Canadian consumers respond to plant sterol claims.

The objective of this study was to evaluate the attitudes and understanding of different types of plant sterol claims on food labels


Eligibility Criteria:
Inclusion Criteria:

* Primary grocery shoppers
* Canadian adults between the ages 20 to 69 years

Exclusion Criteria:

* Did not have an active email address or access to internet
Methadone Maintenance Outcome Study in Taiwan: 5-year Follow-up

Methadone maintenance treatment (MMT) has been one of the most effective treatment choices for opioid addicts to reduce their heroin use, criminality and spread of HIV. In Taiwan, MMT has been introduced since 2006. To date, more than 30,000 opioid addicts have ever participated in MMT, but only around 10,000 retains in treatment. Outcomes of the ever-treated MMT patients remain unclear. It is crucial to trace the opioid addicts' treatment career, outcomes and unmet treatment needs for the service providers to modify treatment strategy to help these individual to maintain abstinence. Moreover, understanding of the determinants for these subjects' long-term outcomes is important for policy makers to implement realistic policies to motivate the service providers and patients.

From the results of previous research, the research team found that early dropout, defined as stayed in-treatment less than one month, of MMT participants were 14.4%. The rate of maintaining in treatment at 3rd , 6th, and 12th month were 65.7%、51.3% and 33.8%, respectively. Average treatment days for 12-month is 186.9±141.2. This result showed that the effectiveness of the MMT was varied among different facilities. On the other hand, the quality of the MMT can be improved largely through different dimensions. Besides, if one participant can enhance its motivation in staying in-treatment, it could reduce 15% early dropout. Above all, the result also showed that though the quality of life was recorded as improved after MMT, it appeared to be significantly lower than their healthy counterparties. The assessments of health outcomes after participating MMT are rare, but in need. It is necessary to make some modification to improve the effectiveness. Moreover, the evaluation of the needs shall not limit to patients, but also extend to their family members.

Therefore, in this study, the research team plans to probe the dimensions from physical, psychiatric, to social conditions by assessing patients and their family members after treated by MMT for five years. The research team would like to know more about the outcomes of those who attended MMT five years ago, their physical and mental health conditions, also health status of their family members.


Eligibility Criteria:
Inclusion Criteria:

* Attended EC0980203, EC0980209, EC1010102 projects
* Nationality: Taiwan
* 20-year-old and above
* Match the diagnosis of heroin dependence from DSM-IV
* Able to fill out the informed consent

Exclusion Criteria:

* Acute major physical or mental illness (need immediate health care)
Prospective Endoscopic Follow-up of Patients With Submucosal and High Risk Mucosal Esophageal Adenocarcinoma

Aim of this prospective multicenter study is to evaluate the safety of an endoscopic follow-up strategy in patients treated with endoscopic resection (ER) for submucosal or high-risk mucosal esophageal adenocarcinoma (T1bN0M0 or HR T1aN0M0 EAC).

Traditionally, the risk of lymph node metastasis associated with submucosal EAC was considered too high to offer patients endoscopic follow-up. Only in elderly patients with comorbidity, more often an endoscopic protocol is selected. However, the risk of lymph node metastasis associated with submucosal EAC is mainly based on surgical series. Recently a number of studies, which included patients treated endoscopically, were published indicating that the risk of lymph node metastasis may be much lower than generally assumed (1-5). Therefore, a less invasive and organ preserving approach may not only be an option in the frail and elderly, but for all patients with submucosal EAC's.

Yet, no data exists on the risk of lymph node metastasis in high risk T1a EAC. The risk is assumed to be lower than for EACs invading into the submucosal layer. However, a recent retrospective analysis from our own research group shows that this risk may be higher than previously assumed (6). In this nationwide retrospective study, we analyzed lymph node metastasis rates and EAC related mortality rates concerning patients with high risk T1a, low risk T1b or high risk T1b EAC who received endoscopic treatment. The study was performed in 9 Barrett Expert Centers in the Netherlands (2008-2019). 120 patients were included in the analysis, and results showed the highest lymph node metastasis risk in the high risk T1a patient group.

Aim of this multicenter study is to prospectively evaluate the safety of endoscopic follow-up in patients treated by endoscopic resection for submucosal (T1bN0M0) and high risk mucosal (T1aN0M0) EAC.

High-resolution upper endoscopy with white-light endoscopy and narrow-band imaging supplemented with an EUS are performed every three months during the first two years after ER. After 1 year, a CT-thorax/abdomen will be performed to check for distant metastasis. During the third and fourth year of follow-up, EUS and upper endoscopy are performed every six months. From the fifth year on, EUS and upper endoscopy are performed annually.

Eligibility Criteria:
Inclusion Criteria:

* Patients with submucosal or high-risk mucosal EAC diagnosed in an ER specimen, by an expert gastrointestinal (GI) pathologists.
* Signed informed consent.

Exclusion Criteria:

* Prior history of high-risk mucosal or ≥T1sm.
* Synchronous esophageal squamous cell carcinoma.
* Suspicion on lymph node metastasis or distant metastasis on EUS, ultrasound of the neck or CT-thorax-abdomen performed six weeks after ER during baseline measurement.
* Tumor-positive deep resection margin (R1) in ER specimen.
* Patients unable to give signed informed consent.
Implementation of a Self-Help Depression Program Among Orthopedic Patients

The proposed study addresses the potential utility of providing an accessible self-help intervention for patients in a medical setting with an estimated diagnosis of MDD. Specifically, the study will explore whether a) such an intervention can be effectively implemented in a primary care setting and b) patients originally seeking medical attention for an orthopedic problem will be willing to seek psychological treatment and, c) improvement in depression symptoms will lead to improvement in upper and lower extremity functioning.

The present project will be an open-label trial to assess the feasibility and acceptability of a self-help intervention among a sample of orthopedic patients. In addition to monitoring the effectiveness of the Deprexis program on depressive symptoms, the proposed project will assess whether a reduction in depressive symptoms will be associated with improvement on patient reported orthopedic impairment. The investigators will enroll 50 adults and the participants will be given the opportunity to participate in 8 weeks of the web-based online Deprexis program.

Eligibility Criteria:
Inclusion Criteria:

* All patients older than 18 years who present to a surgeon with an upper or lower extremity injury or disability at a participating center (see attached list)
* A level of clinical depression more than minimal symptoms as defined by a score ≥ 10 on the Patient Health Questionnaire-9 (PHQ-9)
* Willing and able to provide informed consent and comply with the protocol

Exclusion Criteria:

* Injury or illness best treated with prompt surgery
Repeated Cannabis Administration on Experimental Pain and Abuse Liability

Chronic pain is a significant public health concern in the U.S., for which prescription opioids have historically been the standard treatment. This has resulted in striking rates of opioid use disorders and fatal overdoses. Identifying non-opioid medications for the management of chronic pain with minimal abuse liability is a public health necessity, and cannabinoids are a promising drug class for this purpose. More than 80% of medicinal cannabis users report pain as their primary medical indication. These patients tend to seek products that are low in delta-9-tetrahydrocannabinol (THC; the primary psychoactive, and thus intoxicating, component of cannabis), and high in cannabidiol (CBD), a cannabinoid that purportedly has therapeutic benefit for pain but does not produce intoxicating effects. However, there are few well-controlled human laboratory studies assessing the efficacy of high-CBD cannabis for pain in the context of abuse, and even less is known regarding the effects of daily repeated use of cannabis on pain and its relationship to abuse liability.

The proposed randomized, within-subjects, placebo-controlled 16-day crossover inpatient human laboratory pilot study (N = 16 healthy cannabis users; 8 men, 8 women) will address important gaps in our understanding of the potential therapeutic utility of cannabis for pain: 1) If repeated cannabis use can result in hyperalgesia; 2) If tolerance to the analgesic and abuse-related effects of cannabis develops and is reversible. Two distinct modalities of experimental pain will be assessed: The Cold Pressor Test (CPT) and Quantitative Sensory Testing Thermal Temporal Summation (QST-TTS), and participants will smoke cannabis 3x/day. Throughout the study, experimental pain and abuse-related effects will be assessed, as will sleep and subjective mood assessments.

This protocol is currently suspended due to the NYSPI human subjects research pause and results cannot currently be analyzed and posted. Upon un-suspension, we will analyze the data and post results immediately.


Eligibility Criteria:
Inclusion Criteria:

* Males/non-pregnant females, 21-60 years old
* Current cannabis user
* Able to perform all study procedures

Exclusion Criteria:

* Use of other illicit drugs
* If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process reveal any significant illness that the study physician deems contraindicated for study participation
* Insensitivity to the cold-water stimulus of the Cold Pressor Test or the heat stimulus of Quantitative Sensory Testing
Effect of in Situ Simulation on Quality of Work Life and Multiprofessional Team Effectiveness in the Intensive Care Unit

The lack of specific, personalized training for intensive care workers can lead to a deterioration in quality of life at work, and can result in burnout, absenteeism or wanting to leave the service. The aim of this study is to assess the impact of in situ simulation on quality of work life and the effectiveness of multi-professional teamwork in intensive care.

Paramedics in intensive care are particularly exposed to the risk of burnout, which is multifactorial (psychologically and physically challenging environment, life-threatening emergency context, etc.). Personal assistance professions require a high level of compassion, leading to a positive feeling of compassionate satisfaction, i.e. the satisfaction of helping others. Compassion fatigue leads to a reduction in job satisfaction, culminating in burnout. Factors negatively influencing compassion satisfaction are the absence of specific and adapted training, or the lack of support from the hierarchy. Among the pedagogical tools available, in situ simulation could be used to respond to a specific and personalized training request from a care department. The study will be carried out in the cardio-thoracic intensive care unit at Montpellier University Hospital, comparing 2 groups to assess the effect of simulation on paramedics. Paramedics will be randomized into 2 groups, with stratification on diploma (nursing assistant or nurse): group A benefiting from a simulation program, and group B not benefiting from it during the study.

Eligibility Criteria:
Inclusion Criteria:

* Paramedical staff (nurse and nursing assistant) in the cardiothoracic intensive care unit at Montpellier University Hospital.
* Acceptance of being filmed for direct video transcription during the intervention

Exclusion Criteria:

* Refusal of consent or inability to give consent (guardianship, curatorship)
* Paramedics intending to leave the department before the end of the study.
* Not affiliated to a French social security scheme or not a beneficiary of such a scheme
Post-discharge Early Assessment With a Video-visit

The purpose of this study is to determine if a video visit with an advanced practice provider (Nurse Practitioner or Physician Assistant) within 7 days of discharge from Hospital Internal Medicine services will increase patient compliance with medication, self-management and home supports after hospital discharge.

Prior to discharge, patients will be referred by Hospital Internal Medicine (HIM) teams to the PEARL team and screened for study eligibility. Eligible patients who provide oral consent to participate. Participants will be randomized 1:1 with comparisons between "Usual care" and "Usual care + Video-visit" arms. Participants randomized to the intervention arm will participate in a 15-20 minute Video visit (using Zoom®) with an advanced practice provider (APP; nurse practitioner or physician assistant in HIM) approximately 2-5 days after discharge. The telephone follow-up will occur 3-6 days after discharge. If a patient has a Video visit, the telephone follow-up will be scheduled for after the Video visit.

It is standard practice for HIM teams to make and coordinate outpatient appointments and activities including radiologic procedures for discharging patients. During this study, usual care will continue for patients in each arm. The intervention (Video-visit) is in addition to and not in place of the usual standard of care.

If issues/concerns beyond the scope of the video visit or telephone follow-up arise, then the PEARL APP will direct these to the discharging hospitalist team/supervising physician, or the participant's primary care provider (PCP) consistent with current standards of practice and management of post-discharge issues. Issues re-directed to the discharging hospitalist team or other providers will be documented in the Video-visit encounter. If the APP deems the clinical situation urgent or emergent, the APP will refer the patient to emergency services, or if needed ask the patient his/her location and contact 911. The APP will also immediately notify the study PI or co-PI who are both hospitalists and familiar with the practice. The APP will also notify the discharging hospitalist team.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years
* Patients discharged from a Hospital Internal Medicine service at Saint Marys Hospital
* Patients or their legally authorized representative provides consent to participate in the study
* Patients discharged home or to assisted living facility

Exclusion Criteria:

* Patients discharged from Hospital Service Meds 1-4 and Med 17
* Patient discharged with Care Transitions Program, or to Hospice, skilled nursing facility (SNF) or long-term acute care (LTAC) facility
* Post-procedure patients (i.e., elective hospital admission for planned intervention or procedure)
* Patient/legally authorized representative is Non-English speaking
* Patient leaves the hospital Against Medical Advice (AMA)
* No access to mobile technology/laptop/computer for post-discharge follow-up
* Patient with an active diagnosis Covid-19 infection
* Patients with a scheduled re-admission for a procedure, chemotherapy, or other treatment
An Enhanced Medication Monitoring Program

The goal of the Enhanced Medication Management Program (eMMp) being developed by MedMinder Systems, Inc. is to increase the ability of frail elders to adhere to complex medication regimens for chronic conditions. Adherence will facilitate effective self-care and decrease personal and societal costs associated with disease progression and loss of independence. Multiple studies have shown that more frequent personal follow-up is the most effective way to maximize medication adherence, but such personal care is too costly to translate well to real life in a world of limited healthcare resources.

Currently available "smart pillboxes" are too expensive, too limited in the number and types of medications delivered, and too technically complex for the large majority of senior citizens. The eMMp is designed to deliver prompts and reminders to the user, to be remotely programmable by caregivers, to allow the option of using pre-filled medication trays, to provide electronic adherence reports to family/caregivers and to provide personalized reinforcing phone calls from professional caregivers, all at a modest cost. The in-home ReMinder will use a familiar pillbox layout (4 doses/day for 7 days) and allow easy removal of medication cups by elderly, rheumatic fingers. Installation will require only an electrical outlet (no modems or dedicated phone lines). Once plugged in, the built-in pager will continuously download remotely programmed visual and/or aural prompts and reminders from a central server (RemoteMind). It will continuously upload the date and time when each medi-cation cup is removed and when weekly refill is carried out, enabling remote adherence monitoring, alerts to caregivers, and follow-up intervention(s) from personal and/or professional caregivers as needed.

The hypothesis to be tested in this 2 year SBIR Phase I work plan is that the eMMp will significantly im-prove adherence and clinical outcome (blood pressure control) in a population of frail elderly who are hyper-tensive. SBIR Phase II will determine the minimum level of intervention needed to achieve sustained medication adherence and control of blood pressure in a larger group of hypertensive elders.


Eligibility Criteria:
Inclusion Criteria:

* persons aged 55 years and older who are coming in for routine outpatient visits
* speaks and reads English
* history of high blood pressure
* systolic blood pressure ≥ 130 mm Hg
* using antihypertensive medication
* using 2 or more prescription medications
* plans to stay in area for the 9 months of study

Exclusion criteria:

* receives personal help or reminders to take medication
* has moderate to severe dementia (MMSE score\<18)
* has severe hearing or vision deficiency
Brief Counseling to Reduce Injuries Among Emergency Department Patients Who Report Alcohol and Substance Use

The purpose of this study is to determine the effectiveness of two brief counseling sessions delivered to emergency department (ED) patients who report conjoint alcohol and marijuana use, in reducing injuries and other negative consequences, in comparison to an assessment only group.

Alcohol and substance use remain a significant predictor of injuries, health and psychosocial consequences.

ED patients who were not being treated for critical conditions were asked about their use of alcohol and marijuana. Patients who self-reported the use of both substances were asked to participate in the study.

Recruited participants were given a baseline assessment and then randomized a treatment or a control condition. The treatment condition consisted of two 40 minute sessions of brief counseling. The first session took place in the ED the second session occurred within two weeks of being seen in the ED.

Participants completed assessments three and twelve months after being recruited in the ED. The primary dependent variables for this study are 12 month injuries and self-reported levels of negative life consequences associated with alcohol and marijuana use.

Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients 18 years of age or older.
* Participants will have a current DSM-IV diagnosis of alcohol dependence.
* Participants will have signed a witnessed informed consent.

Exclusion Criteria:

* Participants who meet current DSM-IV criteria for bipolar disorder, schizophrenia, dementia, or a psychological disorder requiring medication.
* Participants who have had more than seven days of inpatient treatment for substance use disorders in the 30 days previous to randomization.