cyrilzakka/clinical-trials huggingface dataset:
The Immunogenicity and Safety of 2013-2014 Seasonal Trivalent Influenza Vaccine

The purpose of this study is to evaluate the immunogenicity and safety of Northern hemisphere 2013-2014 seasonal trivalent inactivated influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy seniors aged \> 60 years.


Eligibility Criteria:
For adults and seniors:

Inclusion Criteria:

* Healthy adults aged 18-60 years old, and healthy seniors aged \> 60 years old;
* Without vaccination history of seasonal split influenza vaccine in the recent 3 years
* No traveling plan during the study period of this trial;
* Be able to understand and sign the informed consent;

Exclusion Criteria:

* Allergic to egg products or any ingredient of the study vaccine;
* Fever, influenza or acute illness on the vaccination day;
* Acute stage of chronic illness;
* Malignant tumor;
* Immunodeficiency, includes HIV infection;
* Guillain-Barre syndrome;
* Administration of live attenuated vaccine within the previous 14 days;
* Administration of subunit or inactivated vaccine within the previous 7 days;
* Planned to participate in any other clinical trial of drug or vaccine during this study;
* Received immunesuppressive treatment within the previous month, or planned for such treatment during this study;
* Pregnant, or planning pregnancy;
* Axillary temperature \> 37.0℃;
* Any other factors that, in the judgment of the investigator, is unsuitable for this study;

For infants:

Inclusion Criteria:

* Healthy male or female aged between 6 and 35 months;
* Full-term birth, birth weight 2,500 grams or more;
* Provided birth certification or vaccination card
* Parent or legal guardian is able to understand and sign the informed consent;

Exclusion Criteria:

* Received seasonal influenza vaccine after June 30, 2012;
* Acute infection within the previous week;
* Allergy history, or allergic to any ingredient of the study vaccine, such as egg;
* History of serious adverse reaction (SAR) to vaccine;
* Autoimmune disease or immune deficiency, or administration of immunosuppressive therapy, cell toxic therapy, or inhaled corticosteroid within the previous 6 months;
* Congenital malformations, developmental disorder or serious chronic disease;
* Unstable condition of asthma and administration of corticosteroid in the most recent two years;
* Coagulation abnormalities or disorders;
* History/ family history of infantile convulsion, epilepsy, cerebropathy, or mental disease;
* Without spleen;
* Severe neurological diseases, such as Guillain-Barre syndrome;
* Administration of blood products or investigational drug within the previous month;
* Administration of live attenuated vaccine within the previous 14 days;
* Administration of subunit or inactivated vaccine within the previous 7 days;
* Received treatment for allergy within the previous 14 days;
* on-going anti-tuberculosis therapy;
* Axillary temperature \> 37.0℃ immediately before vaccination;
* any other factors that, in the judgment of the investigator, is unsuitable for this study;
Nebulized Heparin for COVID19-associated Acute Respiratory Failure

The objective of the current study is to investigate the utilization of nebulized heparin to circumvent pathologic changes in COVID-19 and prevent harmful effects possible with systemic anticoagulation.


Eligibility Criteria:
Inclusion Criteria:

Patients admitted with confirmed COVID-19 receiving mechanical ventilation for ARDS (paO2/FiO2 ratio =300) within 48 hours

Exclusion Criteria:

* Allergy to heparin
* Any history of heparin-induced thrombocytopenia
* High risk of bleeding (platelet count \< 50,000/µL or international normalized ratio \> 1.5)
* Patients with known bleeding disorders (i.e. hemophilia or von Willebrand Disease)
* Active bleeding
* Pulmonary bleeding during this hospital admission (Pulmonary bleeding is frank bleeding in the lungs, trachea or bronchi with repeated hemoptysis, or requiring repeated suctioning, and temporally associated with acute deterioration in respiratory status)
* Neurosurgical procedures during this hospital admission or such procedures are planned
* Epidural catheter in place
* Any history of intracranial, spinal or epidural hemorrhage
* Tracheostomy in place
* Cervical spinal cord injury associated with reduced long-term ability to breathe independently
* Spinal or peripheral nerve disease with a likely prolonged reduction in the ability to breathe independently
* Receiving extra-corporeal membrane oxygenation or continuous renal replacement therapy
* Usually treated with hemodialysis or peritoneal dialysis for end-stage renal failure
* Death is deemed imminent or inevitable or there is an underlying disease with a life expectancy of fewer than 90 days
* Pregnant or might be pregnant.
* Objection from the treating clinician
* Consent refused by the patient or substitute decision maker.
* History of thrombosis (VTE or cardiovascular event)
The Development and Effectiveness of Museum-Based Experiences for Individuals With Chronic Pain

Aim 1: To conduct a formative evaluation of museum-based programming to address loneliness and social isolation.

Aim 2: To develop a consensus-derived Model Museum-Based Program (MMBP) to address loneliness among individuals with chronic pain.

Aim 3: To evaluate the feasibility of museum experiences to reduce loneliness and pain among isolated individuals with chronic pain.

Due to safety concerns related to the covid pandemic in-person museum programming could not continue and virtual versions of the interventions were created. We will publish results on both the in-person and virtual versions of the intervention as well as a pooled analysis.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* English speaking
* Chronic pain (6 months or longer)
* Moderate pain or greater (4/10 or greater on a Numerical Rating Scale, range of 0 (no pain) - 10 (worst pain imaginable), in response to the question "Over the past week what was your average pain intensity?")
* Moderately lonely or greater (Score of 4 or greater on 3 item Loneliness scale, range of 3 - 9)

Exclusion Criteria:

* Participated in an Art Rx tour
* Participated in an Artful Meditation program
* Dementia or Alzheimer's disease
Lokomat Treadmill Training Effects on MS Gait

This study is being done to test the possible benefits of gait-specific training using body-weight supported, Lokomat assisted, treadmill training in people with Multiple Sclerosis.


Eligibility Criteria:
Main Inclusion Criteria:

* Clinical diagnosis of MS
* EDSS level between 3.5-6.0
* Problems with ambulation
* able to ambulate 25 feet without an assistive device

Main Exclusion Criteria:

* Lower extremity injuries that limit range of motion or function
* Unable to demonstrate an understanding of the process of the study and or fully understand instructions in order to safely participate in the study and use study equipment
* Body weight over 150 kg

  * complete inclusion/exclusion criteria listed in consent form
A Multicomponent Intervention to Address Gender-based Violence in HIV

This project seeks to adapt and pilot a trauma-informed combination intervention named 'Kickin' it with the Gurlz' that was designed with, for, and by transgender women of color to improve HIV prevention continuum outcomes. The intervention components include a violence and gender affirmation screening tool, a peer-led adaptation of Seeking Safety, and individual-level peer navigation sessions. We will examine the feasibility, acceptability, and preliminary promise of the multicomponent by conducting a one-arm pilot with 30 transgender women of color who have a history of trauma. Participants will complete baseline, immediate post-intervention, and 3-month follow up assessments.

This project seeks to evaluate the feasibility and acceptability of the trauma-informed combination prevention intervention to improve HIV prevention continuum outcomes including the development of community-informed strategies for subsequent RCTs. We will conduct a one-arm pilot of the adapted multicomponent trauma-informed intervention named "Kickin it with the Gurlz." We will collect feasibility and acceptability data related to identifying, recruiting, enrolling, intervening with, and retaining participants (i.e. recruitment length, screening procedures, feasibility of conducting sessions, intervention acceptability, retention rates, feasibility of verifying self-reported and medical chart review data on PrEP use, and exit interviews with participants and staff at program conclusion). We will recruit 30 participants into the pilot study. Participants will complete baseline, end of program, and 3-month post-intervention follow-up surveys. Exit interviews and interviews with key stakeholders will identify strategies for implementing trauma-informed HIV prevention efficacy trials with transgender women of color within close-knit communities, such as acceptable and feasible control conditions, acceptable and feasible violence and gender affirmation screening, biomedical confirmation methods, contamination concerns, and potential changes needed within existing health care systems.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Assigned male at birth; identifies as female, transgender woman, or another feminine gender identity
* Self-identifies as a person of color (any racial/ethnic identity except non-Hispanic white)
* Self-reports as HIV-negative or unknown HIV status
* History of trauma (i.e., endorses at least 2 items on the adapted Trauma History Screener which includes IPV and experiencing or witnessing other forms of violence for transgender women
* Living or willing to travel to Detroit
* English-speaking
* Willing and able to provide informed consent.

Exclusion Criteria:

• Evidence of severe cognitive impairment or active psychosis that may impede ability to provide fully informed consent
Partners Demonstration Project of PrEP and ART

The purpose of this protocol is to determine user preferences for antiretroviral therapy (ART) for HIV-1 infected partners and pre-exposure prophylaxis (PrEP) HIV-1 un-infected partners and to optimize targeted delivery and sustained use of these interventions.

An open-label, prospective cohort study of higher-risk HIV-1 serodiscordant couples in order to determine barriers and facilitators to uptake and sustained adherence to ART for HIV-1 infected partners and daily oral PrEP for HIV-1 uninfected partners. The investigators developed a risk score tool to identify couples at highest risk for HIV-1 transmission. PrEP was offered as a 'bridge' to ART in the partnership - i.e., until ART initiation by the HIV-infected partner and for the first 6 months after ART is started; ART was recommended following national ART guidelines. A subset (up to 80 couples per site) was invited to participate in qualitative in-depth interview and focus group discussions.

Eligibility Criteria:
Inclusion Criteria:

For couples

* Risk score defining higher HIV-1 risk (≥6)
* Sexually active (defined as having had vaginal intercourse at least 6 times in the previous three months)
* Willing to enter the study as a couple and intending to remain as a couple for the next 12 months
* Did not participate in the Partners PrEP Study

For HIV-1 uninfected members of the couple (partner participants)

* Age ≥18
* Able and willing to provide written informed consent
* HIV-1 uninfected based on negative HIV-1 rapid tests, both at study screening and at the enrollment visit
* Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance \>60 mL/min
* Not infected with hepatitis B virus, as determined by a negative hepatitis B surface antigen test
* Not currently pregnant or breastfeeding
* Not currently enrolled in an HIV-1 prevention clinical trial
* Not currently using PrEP
* Enrollment of individuals with active and serious infections or active clinically significant medical problems will be at the discretion of the site investigator

For HIV-1 infected members of the couple (index participants)

* Age ≥18
* Able and willing to provide written informed consent
* HIV-1 infected based on positive rapid HIV-1 tests, according to national algorithm
* No history of WHO stage III or IV conditions
* Not currently using ART
* Not currently enrolled in an HIV-1 treatment study
* Note: current pregnancy and breastfeeding are permitted for HIV-1 infected partners

Exclusion Criteria:

* Otherwise not eligible based on the above inclusion criteria
A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis (Liberty-AD-HAFT)

The primary objective of the study is to assess the efficacy of dupilumab on skin lesions in patients with atopic hand and foot dermatitis.

The secondary objectives of the study are:

* To assess the efficacy of dupilumab on various other domains (pruritus, pain, sleep loss, health related QoL, work life impairment) in patients with atopic hand and foot dermatitis
* To evaluate the safety and tolerability of dupilumab administered to patients with atopic hand and foot dermatitis
* To evaluate systemic exposure and immunogenicity of dupilumab in patients with atopic hand and foot dermatitis


Eligibility Criteria:
Key Inclusion Criteria:

* Patients with involvement of at least 2 anatomical areas at screening and baseline
* Patients need to have an IGA hand and foot score of 3 or 4 (moderate-to-severe disease) at screening and baseline
* Patients with documented recent history (within 6 months before the screening visit) of inadequate response of atopic hand and foot dermatitis to topical medication(s)
* Patients meet the diagnosis criteria for atopic dermatitis (AD)
* Provide informed consent/assent signed by study patient or legally acceptable representative
* Patients need to have been compliant with the skin protection measures through the entire duration of the screening period

Key Exclusion Criteria:

* Treatment with dupilumab in the past
* Patients with a positive patch test reaction that are deemed to be clinically relevant as the current cause of the hand and foot dermatitis
* Patients with documented exposure to irritants believed to be a predominant cause of the current hand and foot dermatitis
* Treatment with systemic corticosteroids or non-steroidal immunosuppressive drugs within 4 weeks prior to baseline
* Known history of HIV/HBV/HCV infection
* Pregnant or breastfeeding women or planning to become pregnant or breastfeed during the patient's participation in this study
* Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment and during the study

NOTE: Other protocol defined inclusion / exclusion criteria apply
A Seven-year Follow-up Study of Patient Satisfaction With Three-Implant-Retained Mandibular Overdentures

Purpose: This study aimed to compare patients' satisfaction with mandibular overdentures retained by three-splinted implants and conventional complete dentures during a seven-year follow-up period. Materials and Methods: Thirty edentulous male patients (mean age: 60 years) were carefully selected and divided into two equal groups. All patients received a new set of complete dentures. (Group I) patients received three implants in the anterior mandible and were connected after three months with bars, clips and loaded. (Group II) patients' received conventional complete dentures. Patients' satisfaction was recorded for both groups at three weeks (baseline) and after 1, 3, 5 and 7 years. Patients were then asked to grade their overdentures/dentures on a visual analog scale and written questionnaire to evaluate their overall satisfaction. Results: satisfaction scores of Group I patients was found to be statistically significantly higher than that of Group II patients (p \< .05) at 3, 5 and 7 years follow-up, meanwhile no statistically significant difference was found at baseline or after 12 months. Conclusions: The long-term results suggest that three implants-retained mandibular overdenture with a clip-bar attachment appears to be a successful rehabilitation strategy which is superior to conventional dentures for patients with advanced ridge resorption.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria stipulated that patients must have been wearing dentures on a regular basis, have been edentulous for a minimum of 3-years, and are capable of reading and writing.

Exclusion Criteria:

* insufficient bone volume to install three 13mm. interforaminal implants (Group I), insufficient interarch space. Patients with diabetes, osteoporosis, smokers, psychological problems of removable denture acceptance, gag reflex, absence of a maxillary complete denture and medical or physical considerations that would seriously affect the surgical procedure (Group I) or the follow-up period were also excluded
Subfoveal Choroidal Thickness After Surgery for Age-related Cataracts

To compare the effects of femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification surgery (CPS) on subfoveal choroidal thickness (SFCT) in age-related cataracts.

It is not clear whether femtosecond laser-assisted cataract surgery (FLACS) alters retinal and choroidal thickness. The goal of the present study was to determine the changes of retinal and choroidal thicknesses in patients who have undergone FLACS compared to patients who have undergone conventional phacoemulsification surgery (CPS).

Eligibility Criteria:
Inclusion Criteria:

* The cataract stages of the patients were between N2 and N4 according to the LOCS III.

Exclusion Criteria:

* eyes with histories of ocular surgery, trauma, and ocular diseases, including diabetic retinopathy, age-related macular degeneration (AMD), high myopia, psudoexfoliation, uveitis, retinal vein occlusion, and other inflammatory and vascular retinal disorders.
Revisional Versus Primary Roux-en-Y Gastric Bypass: a Case Matched Analysis

This study compared revisional malabsorptive laparoscopic very very long limb gastric bypass (VVLL RYGB) with primary VVLL RYGB and tested the hypothesis that one staged revisional laparoscopic VVLL RYGB is a safe and effective procedure after failed restrictive gastric banding.


Eligibility Criteria:
Inclusion Criteria:

* Primary Gastric Bypass according to SMOB (Swiss group for the study of morbid obesity) Guidelines
* Revisional Gastric Bypass after failed Gastric Banding

Exclusion Criteria:

* According to SMOB Criteria
Occupational/Physical Therapy to Reduce Morbidity Post-Operative Bilateral Breast Reconstruction

The purpose of this study is to demonstrate the benefits of a structured occupational/physical therapy program on upper extremity morbidity for patients who have received bilateral breast reconstruction in comparison to a home therapy program and no post-operative therapy.

Hypothesis: Patients who engage in therapist-supervised occupational therapy following bilateral breast reconstruction have less upper extremity morbidity than those patients who complete a home therapy program or no therapy program.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age
* Women who have had bilateral breast reconstruction
* All cancer stages will be included
* Physically and mentally able to participate in the study within the required time-frame
* Able to voluntarily give full informed consent to participate in the study

Exclusion Criteria:

* Women undergoing unilateral breast reconstruction
* Unable to provide informed consent in English
* Physically unable to engage in the protocol
Safety and Retention Rate of the JAK and TNF Inhibitors in Rheumatoid Arthritis: a Real-life Experience

This study aims to extract data from the Hong Kong Biologics Registry for retention rate of the JAK inhibitors in rheumatoid arthritis and review other adverse events by looking at the medical record retrospectively. These real life data are important as they cannot be provided by randomized controlled trials which are limited by the duration of observation and fixed protocols in research settings. Moreover, data will represent our local experience of the JAK inhibitors in Chinese patients with RA. The retention rate and adverse effects of the JAK inhibitors are compared with conventional TNF inhibitors.

This study aims to extract data from the Hong Kong Biologics Registry for retention rate of the JAK inhibitors in rheumatoid arthritis and review other adverse events by looking at the medical record retrospectively. Efficacy data and adverse events, in particular major adverse cardiovascular events (MACEs) and malignancy will be looked at and compared with the TNF inhibitors. Retention / withdrawal rates of the drugs will be studied by statistical analyses.

Eligibility Criteria:
Inclusion Criteria:

* All RA patients in our biologics registry treated with the JAK inhibitors (N=411)
* All RA patients in our biologics registry treated with the TNF inhibitors (N=1392)

Exclusion Criteria:

- RA patients in our biologics registry treated with other biologic/targeted DMARDs
Impact of Sleep Workshops in College Students

The purpose of this pilot study is to assess the impact of sleep workshops on sleep, mood, anxiety and well-being measures in a sample of college students. College students have a high prevalence of sleep problems including poor sleep hygiene, volitional sleep deprivation, and insomnia. Sleep disorders in college students negatively affect mood, social functioning, physical safety, and academic performance. Rarely recognized by the students themselves, these conditions are therefore often untreated. Participants in this study will be randomly assigned to receive the College Sleep Improvement Plan (C-SIP) or a control session. Participants will be asked to track their sleep as well as complete questionnaires; a subset of participants will be asked to wear an activity monitor.


Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled in classes at the NYU Washington Square campus

Exclusion Criteria:

* Students previously enrolled in the "While You Were Sleeping" course at NYU