cyrilzakka/clinical-trials huggingface dataset:
Emergency Care at Home

This study will assess the efficacy of receiving emergency care at home versus in the brick-and-mortar emergency department.

Care in an emergency department has many benefits. It delivers high-intensity critical care on demand to large populations and serves as an efficient gateway to hospitalization. However, some populations may not be well-served by the traditional emergency department, particularly older adults, adults with serious illness, and those who are homebound. Many harms may come to older adults in the emergency department, including delirium, pressure injuries, infections, anxiety, and others. Emergency department crowding secondary to hospital capacity constraints may also lead to suboptimal care, as patients wait many hours for their inpatient bed even after a disposition decision is made.

As a result, the investigators will evaluate in a randomized controlled trial the efficacy of emergency care delivered at home instead of in the emergency department

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Resides within Home Hospital geographic area
* Lives in permanent housing (i.e., not in temporary housing such as a shelter)
* Patient of a Mass General Brigham primary care provider
* Primary care provider attests that their triage recommendation is the emergency department
* Emergency care at home nurse triages the participant to the emergency department or urgent care
* Patient attests that they intend to go to the emergency department

Exclusion Criteria:

* Insurance: workers compensation and motor vehicle accident
* Lives in a healthcare facility (Skilled Nursing, Rehab, long term acute care)
* Patient/caregiver cannot answer phone or door
* Active substance use
* Acute psychiatric concerns (e.g., suicidal ideation, even if passive)
* Home safety concerns (e.g., intimate partner violence)
* High-risk features:

oHigh Risk Signs, if available: Heart rate \> 120 Systolic blood pressure \< 90 Shock Index (heart rate divided by systolic blood pressure) \> 1 Oxygen \< 93% on ambient air Increase in oxygen requirement new or \> 2 liters Respiratory rate \> 28 Diaphoresis oHigh Risk Symptoms: Active chest pain Severe work of breathing Syncope Hemoptysis Seizure Other concerning symptom per nurse triage

* Requires inpatient-level care
* Requires specialty consultation
* Requires physical, occupational, or speech therapy
* Requires blood transfusion
* Requires internal physical exam maneuver (e.g. rectal exam, genitourinary exam)
* Requires imaging that is not available at home
* Requires monitoring that is not available at home
* Troubleshooting wound vacs
Full Bladder IUD Insertion Without Vulsellum Under Ultrasound Guidance

The aim of this study is to determine whether full bladder IUD insertion without vulsellum or uterine sound under ultrasound guidance is associated with less pain compared with the standard technique of IUD insertion .

The intrauterine device (IUD) is an effective method of contraception. Pain experienced during IUD insertion is one of the main causes that limits its widespread use.

Pain during IUD insertion is caused by insertion of cusco vaginal speculum, sounding the uterus, application of vulsellum to grasp the cervix, the passage of the inserter tube through the cervical canal and uterine cavity..

In order to minimize the pain associated with IUD insertion , several studies reported that the use of ultrasound to guide the insertion of IUD into uterine cavity was associated with less pain and more accurate placement of IUD, other studies reported that filling the bladder during IUD insertion minimized the pain associated with IUD insertion.

Eligibility Criteria:
Inclusion Criteria:

* Women requesting IUD insertion

Exclusion Criteria:

* Active pelvic infection
* Viable intrauterine pregnancy
* Uterine anomalies
* Uterine fibroid
* Wilson disease
Evidence-Based Practice (EBP) Awareness Project: Peer-to-Peer Dissemination

The purpose of this study is to evaluate the effectiveness of the introduction of an EBP text for Nursing Research Council (NRC) members to use with RN staff to increase staff belief in, knowledge of and implementation of EBP in providing patient care. The theory that will drive this study is Disciplined Clinical Inquiry (DCI).

The current study will use a quasi-experimental design plus DCI to engage unit RN staff in deciding how they might learn about EBP in a feasible, useful way. After collection of baseline data, the NRC member will introduce the text + solicit staff input into a plan for using the text to increase understanding of EBP and use of evidence to make practice changes on her/his own unit. Another unit in that service line or under the same Service Line Administrator will serve as a comparison unit. Data collection will be conducted again after 4 and 12 weeks. At the 12 week point, the NRC member will introduce the text + solicit staff input for a plan on the comparison unit. Data collection will be conducted on the comparison unit at 16 weeks, and again on both units at 24 weeks. At the 24 week point, additional units will be added and the process repeated until all units represented on the NRC have been included.

Outcome measures will include: EBP belief and EBP implementation scales (Melnyk \& Fineout-Overholt, 2003); EBP knowledge cognitive test; # of lit searches conducted by unit RN staff ; # of requests for library support for lit searches or to obtain search-related articles: # of unit clinical policies with documented levels of evidence \& research references. EBP belief, EBP implementation and EBP knowledge variables will be analyzed at both individual and unit levels of analysis. All other variables will be measured at the unit level of analysis. Additional unit level variables will include the following data collected annually as part of the National Database for Nursing Quality Indicator (NDNQI) RN satisfaction survey: satisfaction with RN-RN interaction, satisfaction with autonomy, satisfaction with practice decision-making, perceived quality of care delivered on the unit.

The primary statistical procedures for analysis will be ANCOVA, ANOVAwith repeated measures, and logistic regression.


Eligibility Criteria:
Inclusion Criteria:

* over 18 yrs of age
* employed by Upstate
* full or parttime on unit represented on Nursing Research Council

Exclusion Criteria:

* employed by an agency other than Upstate
* working on a unit not represented on the Nursing Research Council
Study to Evaluate STI-1499 (COVI-GUARD) in Patients With Moderate COVID-19

Randomized, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARD™) in hospitalized patients with moderate COVID-19

This study is a randomized, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARD™), a COVID-19 targeting monoclonal antibody, in hospitalized patients with moderate COVID-19. Four dose levels will be tested: 10 mg, 30 mg, 100 mg, and 200 mg.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of moderate COVID-19, diagnosed standard RT-PCR assay or equivalent testing
* Willing and able to comply with study procedures and follow-up visits
* Subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating in any study related activity. However, if obtaining written informed consent is not possible, other procedures as provided in the March 27th, 2020 FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, Question 10, may be used.

Exclusion Criteria:

* Clinical signs indicative of severe COVID-19
* Rapidly progressive COVID-19 which is likely to progress to "severe" within 24 hours
* Documented infection other than COVID-19
* Any medical condition that, in the Investigator's opinion, could adversely impact safety
* Pregnant or lactating women
* Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit. Note: Participants who have been prescribed hydroxychloroquine or chloroquine with or without azithromycin or other approved products for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents so long as the dose remains stable. Additionally, any approved or authorized treatment (e.g., remdesivir, dexamethasone or treatments approved under an Emergency Use Authorization) is allowed.
Clinical Research Plan for Human Myopia Models

Collect optical biological parameters, refractive index data, and other related parameters of myopia and refractive errors in children and adolescents, and establish an optical model of myopia in children and adolescents.

Experimental research purpose:Collect optical biological parameters, refractive index data, and other related parameters of myopia and refractive errors in children and adolescents, and establish an optical model of myopia in children and adolescents.

Case selection: This study requires the inclusion of children and adolescents aged between 4 and 18 years who have been diagnosed with myopia and refractive errors through medical examination of dilated pupils.

Plan: Collect eye parameters such as refractive power, whole eye aberration, corrected visual acuity, pupil diameter, axial length, anterior and posterior corneal surface curvature, and corneal thickness of all subjects under 9 non dilated stimuli.

Eligibility Criteria:
Selection criteria:

1. Gender unlimited
2. Age 6-16 years old
3. Through medical optometry with dilated pupils, the spherical equivalent refractive index is within the range of -0.5DS\~-8.0DS, and the cylindrical lens is ≤ -0.75DC

Exclusion criteria:

1. Patients with corneal diseases such as corneal ulcers, corneal opacities, and corneal leukoplakia
2. Patients with refractive media opacity, such as cataracts and vitreous hemorrhage
3. Glaucoma patients
4. Patients with nystagmus
5. Patients with strabismus and amblyopia
6. Patients with fundus diseases
7. Patients with a column mirror range greater than -0.75DC
8. Patients with binocular anisometropia ≥ 1.0D
9. Corneal contact lenses (such as corneal reshaping lenses, multifocal contact lenses, and RGP) with a history of wearing
10. Long term history of low concentration atropine and other ocular medications
11. Wearing history of functional lenses such as asymptotic multifocal, multi-point myopic defocus, peripheral defocus, etc
12. Patients participating in other eye clinical trials
13. Individuals with mental illness or cognitive impairment who are unable to cooperate

    * Researchers believe that other reasons are not suitable for clinical trial participants, such as poor physical condition on the day of the trial
Effect of 10-day Overnight Hypoxia Treatment on Whole Body Insulin Sensitivity (SLEEP HIGH Study)

The purpose of this study is to look at how a reduction in oxygen levels (hypoxia) influences insulin sensitivity and carbohydrate metabolism. It is expected that 10 nights of exposure to moderate hypoxia (\~ 15% O2, similar to conditions at an altitude of \~7500 feet) will improve glucose metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Aged 20-45 years
* Male
* Obese category (BMI \> 30 kg/m2)
* Healthy as assessed by a self-reported health questionnaire
* Non-smokers
* Weight stable over the past 3 months (\<2kg fluctuation)

Exclusion Criteria:

* Female
* Diabetes
* Sleep apnea
* Hypertension
* History of altitude sickness
* Individuals taking any chronic medications
* Individuals taking any stimulants
* Individuals taking beta-blockers
* Individuals with chronic alcohol consumption (\>3 drinks per day) or drug abuse.
* Individuals unable to abstain from caffeinated beverage or alcohol the days of study testing
* Individuals with history disease or history of stroke
A Double-blind, Placebo-controlled, Single-dose Study to Evaluate the PK, IM, and Safety in Japanese Subjects

A phase 1 randomized, double blind single-dose study to evaluate the PK and immunogenicity of single SC 100 and 150 mg doses of mavrilimumab in healthy adult Japanese subjects.

This is a Phase 1, randomized, double-blind, placebo-controlled, parallel group, single-dose study to evaluate the PK, immunogenicity, and safety of mavrilimumab at doses of 100 and 150 mg in healthy adult Japanese subjects. The study will be conducted at one site in Europe and subjects will be randomized in a 5:5:2 ratio to 100, 150mg mavrilimumab and placebo.

Eligibility Criteria:
Inclusion Criteria:

* Subject is of Japanese ethnicity
* No evidence of clinically significant respiratory disease

Exclusion Criteria:

* Any condition that, would interfere with the evaluation of the study drug or safety of subjects.
* Subject has a known hypersensitivity to any components of the investigational product.
* History of infection requiring hospitalization or treatment with IV antibiotics within 12 weeks before screening, or evidence of clinically significant active infection.
* Subject has a history or present condition of malignancy.
* Subject has a history or presence of drug addiction (urine test) or has alcohol consumption (breath test) of more than 21 (males) or 14 (females) units of alcohol per week.
* Any blood donation or significant loss of blood within 56 days of study initiation,
* Receipt of live (attenuated) vaccine within the 4 weeks before screening or during the study.
Effect of RAS on Balance and Gait After Stroke

A rhythmic auditory stimulation intervention may be beneficial in order to improve movement parameters after stroke. Reviews argue that more randomized controlled trials with a control group are needed. Main objective: Evaluate the effect of a rhythmic auditory stimulation on the quality of balance and gait parameters in people with stroke. Methodology: quasi-experimental study. The study has been approved by the hospital ethics committee.

A rhythmic auditory stimulation (RAS) intervention may be beneficial in order to improve the parameters of the post-stroke movement: increase of the speed of the walk, improvement in the width of the step with the affected side, improvement of the walking index dynamics (Dynamic Gait Index), improvement in cadence and improvement in the static balance.

Current systematic reviews argue that more randomized controlled trials with a control group are needed.

Main objective: To evaluate the effect of a rhythmic auditory stimulation on the quality of progress and balance in people with stroke.

Methodology: experimental group will be done between 2019 and 2020 and historical control group of the years 2017 and 2018. Experimental group will do 3 sessions in a week of RAS, and daily 2 hours of physiotherapy except of Sundays. Control group received 2 hours daily of physiotherapy, except Sundays.

The study has been approved by the hospital ethics committee.

Eligibility Criteria:
Inclusion Criteria:

* Had a stroke in the last 3 weeks
* Rankin 3-4
* Barthel before stroke: \>85
* Tinetti \< 23

Exclusion Criteria:

* Patient can walk independently (Functional Ambulation Category \>3)
* Global and/or mixed aphasia
* Glasgow \< 10
* Mini-Mental State Examination \< 24
* Posterior cerebral artery stroke
* Gait and/or balance disorders before stroke (parkinsons disease, neurodegenerative diseases)
Results of an Interferon-Gamma Release Assay After Treatment for Tuberculosis

New blood tests have become available to detect either latent or active tuberculosis. These tests - which according to the CDC can replace the tuberculin skin test - measure the production of gamma-interferon (a cytokine) by peripheral lymphocytes (white cells) when exposed to antigens which are highly specific of mycobacterium tuberculosis (the bacteria responsible for tuberculosis). Our hypothesis was that the production of gamma-interferon would be much higher at the beginning of treatment than at the end, and that decline in gamma-interferon secretion could be an indicator of clinical response to treatment.

Patients either treated for active culture proven tuberculosis (TB) or having completed treatment during the preceding 6 months were recruited. Exclusion criteria were : HIV infection and previous TB. Interferon gamma release assay (T-SPOT.TB, Oxford Immunotec) was sampled during the 2 first weeks of treatment, at the end of treatment and 6 months later.

T-SPOT.TB was analysed qualitatively (pos/neg) and quantitatively (Spot forming units: SFU) to determine if there was a higher rate of negative tests at the end of treatment and 6 months after treatment than initially. Paired samples were analysed to compare SFU counts between beginning of treatment and end of treatment, and SFU counts between end of treatment and 6 months later.

Clinical response to treatment was recorded, as well as treatment failures and relapses.

Eligibility Criteria:
Inclusion Criteria:

* culture proven tuberculosis

Exclusion Criteria:

* age \< 18
* prior tuberculosis
* HIV infection
Benefits Counseling to Preserve Function Among Disability Applicants

This study will address the problem that claimants with psychiatric disabilities who apply for and receive disability benefits go on to work less than those whose claims are denied.

The objective of this research is to conduct a 6-month randomized clinical trial comparing participants assigned to Benefits Counseling and to those assigned to the control condition, VA Orientation. Benefits Counseling is an adaptation of two counseling approaches to foster veterans' involvement in work and work-related activity compared to the control condition, VA Orientation. The first approach helped recipients of Social Security disability benefits for psychiatric illness return to work in part by alleviating beneficiaries' concerns that they would lose their benefits if they worked. The second approach is a Motivational Interviewing approach that showed great promise in engaging veterans with psychiatric disabilities in compensated work therapy.

Eligibility Criteria:
Inclusion Criteria:

* Has never received VBA benefits
* Able to provide valid consent
* Expresses willingness to discuss benefits with a counselor
* Difficulty working as evidenced by a "Yes" to either (a), (b), or (c) of the question below about work-related difficulties: During the past 4 weeks, have you had any of the following problems (such as feeling depressed and anxious):

  * Cut down on the amount of time you spent on work or other activities?
  * Accomplished less than you would like?
  * Didn't do work or other activities as carefully as usual?
* Expresses willingness to try Benefits Counseling if assigned to it
* An evaluation by a psychiatrist or psychologist is scheduled

Exclusion Criteria:

* Already receiving VA payments
* Already receiving SSI or SSDI payments
* Has a conservator
PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY UREAMIC PRURITIS

Patients will be randomly assigned into 2 groups:

1. Group A: (20 patients) will receive NB UVB phototherapy 3 sessions per week for 2 months.
2. Group B: (20 patients) will receive pregabalin oral therapy (50mg after each dialysis session) for 2 months.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 20-60 years.
2. End stage renal disease (the last stage(stage 5) of chronic disease which means kidneys are only functioning at 10 to 15 percent of their normal capacity and dialysis or kidney transplant is necessary to stay alive).
3. Refractory uremic pruritis.

Exclusion Criteria:

1. Other causes of pruritis (Dermatological or systemic) e.g. atopic, cholestatic liver disease.
2. Photosensitivity.
3. Contraindication or allergy to pregabalin.
4. Patients on antipruritic drugs e.g. antihistamines, steroids, emollients, opioid agonists.
A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Simvastatin in Healthy Volunteers

The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754) affect the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of a single dose of simvastatin.

This study will be an open-label (all volunteers and study staff know the identity of the assigned treatment), single-center, fixed-sequence study (all volunteers receive the same medication on the same days and in the same order) to determine how multiple doses of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) affects the pharmacokinetics and pharmacodynamics of a single dose of simvastatin (a drug used to treat raised cholesterol). The study will consist of 3 phases: a screening phase, an open-label treatment phase, and an end-of-study (or follow-up) phase. During the open-label treatment phase, each volunteer will receive a single 40 mg dose of simvastatin on Day 1, followed by 300 mg of canagliflozin once daily on Days 2 through 6. On Day 7, volunteers will receive both simvastatin 40 mg and canagliflozin 300 mg. Each volunteer will participate in the study for approximately 32 days

Eligibility Criteria:
Inclusion Criteria:

* Volunteers must have a body mass index (BMI) (weight in kg/height in m2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
* Volunteers must be non-smokers

Exclusion Criteria:

- History of, or current active illness, considered to be clinically significant by the Investigator, or any other illness that the Investigator considers should exclude the patient from the study, or that could interfere with the interpretation of the study results