cyrilzakka/clinical-trials huggingface dataset:
Covid-19 Messaging to Underserved Communities - 2nd Experiment

The aim of the study is to build off results from our first experiment (NCT04371419) , and test whether messages that acknowledge racial injustice on behalf of institutions affect the retention of knowledge and movement of beliefs and behavior with respect to Covid-19. The investigators will also test the effect of concordance of providers and whether highlighting the unequal burden of the disease has additional effects on knowledge, beliefs and behavior regarding covid-19. The sample will include African American and white adult Americans and oversample those with less than a college degree.

Recent data have shown that covid19 is disproportionately infecting and killing African Americans and Latinx people in the United States. Moreover, since our last experiment, the killing of George Floyd by Minnesota police has raised awareness of structural racism in the United States.

The aim of the study is to build off results from our first experiment (NCT04371419) , and test whether messages that acknowledge racial injustice on behalf of institutions affect the retention of knowledge and movement of beliefs and behavior with respect to Covid-19. The investigators will also test the effect of concordance of providers and whether highlighting the unequal burden of the disease has additional effects on knowledge, beliefs and behavior regarding covid-19.The sample will include African American and white adult Americans and oversample those with less than a college degree.

Eligibility Criteria:
Inclusion Criteria:

* adults who self-identify as African American or white.
* an oversample of individuals with less than a college education

Exclusion Criteria:
Hepatitis B Vaccination in HIV-infected Persons

In this study we compare the efficacy of two different HBV-vaccination schedules in HIV-infected persons concerning immune response and compliance. Short schedule: t=0,1,3 weeks and standard schedule: t=0,1,6 months.

It is known that HIV-infected persons are more prone to develop chronic hepatitis B infection when they get infected with this virus. After developing chronic hepatitis B these patients are more likely to get livercirrosis and hepatocellular carcinoma (Bodsworth et al.).

Hepatitis B vaccination is available and the vaccine is about 95% protective in preventing immunocompetent persons from developing chronic hepatitis B infection (Lemon). The response on this vaccin is less effective in HIV-infected persons (Carne et al.). Furthermore there is a compliance problem in the standard scheme.

In this study we compare the efficacy of two different HBV vaccination schedules in HIV-infected persons concerning immune response and compliance. A short schedule: t=0,1,3 weeks, in which there are good results concerning immune response and compliance in immunocompetent persons (Saltog et al.) and the standard schedule: t=0,1,6 months. Patients not immune at week 28 will be offered boostervaccination. This consists of double doses at t=0,1,2 months.

800 persons are needed to show non-inferiority with lower margin of 10% of the short schedule in comparison with the control group. Powercalculation is 80%. Randomization is stratified according to CD4 count(CD4 \<200, 200-500, \>500).

The hypothesis of the study is a better compliance and a comparable immune response in the short schedule, through which persons will be protected against hepatitis B in an early stage.

Eligibility Criteria:
Inclusion Criteria:

* HIV positive
* Negative for HBsAg and anti-HBc
* 18 years or older

Exclusion Criteria:

* previous Hepatitis B vaccination
* current opportunistic infection
Vale+Tú Salud: Corner-Based Randomized Trial to Test a Latino Day Laborer Program Adapted to Prevent COVID-19

The purpose of this study is to assess the extent to which LDL report increased adherence with COVID 19 mitigation practices 1 month post intervention.


Eligibility Criteria:
Inclusion Criteria:

* Self-identify as Hispanic or Latino
* Be present at the corner for the purposes of looking for work

Exclusion Criteria:

* Have not been previously hired to work at a corner
* Symptoms of COVID-19 in the previous 48 hours
Comparison of Single-Dose Efficacy of an Albuterol Breath-Actuated Inhaler (Albuterol-HFA-BAI) Versus an Albuterol Metered-Dose Inhaler (Albuterol-HFA-MDI) in Participants With Asthma

This is a research study designed to compare the single-dose efficacy of albuterol-hydrofluoroalkane-breath-actuated inhaler (HFA-BAI) and albuterol-HFA-metered-dose inhaler (MDI) in asthmatics with poor inhaler coordinating abilities.


Eligibility Criteria:
Inclusion Criteria:

* Asthma of a minimum of 6 months duration
* Participants who demonstrate poor inhalation/actuation coordination when evaluated at screening utilizing the Aerosol Inhalation Monitor (AIM, Vitalograph) prior to any training and following training in 3 consecutive attempts
* Reversible bronchoconstriction of \>12% increase in FEV1 with a cumulative dose of 450 mcg of albuterol
* The reversibility (FEV1) of ≤70% following administration of the initial 90 mcg of albuterol
* Ability to perform spirometry reproducibly
* Ability to self-perform peak expiratory flow (PEF) determinations and report scores on diaries
* Can tolerate withdrawal of applicable medications for qualification at screening
* Otherwise healthy individuals
* Non-smokers for at least 2 years prior to the screening visit

Exclusion Criteria:

* Allergy or sensitivity to albuterol
* Exposure to investigational drugs within 30 days prior to the screening visit
* Continuous treatment with beta-blockers, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, and/or systemic corticosteroids
* Treated with oral or injectable corticosteroids within the 6 weeks prior to the screening visit
* The prescribed dose regimen of any required antileukotrienes, inhaled corticosteroids and/or inhaled cromolyn and/or nedocromil had not been stable for at least 4 weeks prior to the screening visit
* Inability to tolerate or unwillingness to comply with required washout periods for all applicable medications
* Hospitalization for acute exacerbation of asthma more than twice in past year
* Treatment in an emergency room or hospitalization for asthmatic symptoms within 3 months prior to the screening visit
* An upper respiratory tract infection and/or sinusitis associated with exacerbation of asthma that is unresolved 3 weeks prior to the screening visit
* History and/or presence of any clinically significant non-asthmatic acute or chronic disease
* Known or suspected substance abuse
* Previous enrollment in an IVAX Research-sponsored Albuterol-HFA asthma study Note: Other inclusion and exclusion criteria may apply.
Immunogenicity After Revaccination With 23-valent Pneumococcal Polysaccharide Vaccine: Healthy Elderly People Versus Diabetic Patients

Pneumococcal disease causes thousands of infections, such as meningitis, bloodstream infections, pneumonia, and ear infections in US annually. As pneumococcal vaccines provide serotype-specific protection, it is important to induce sufficient immune responses for the most clinically relevant serotypes. All adults aged 65 years or older are recommended to receive PPSV23 vaccination irrespective of underlying medical conditions. Thus, since May 2013, South Korea introduced PPSV23 in the national immunization program for elderly individuals aged ≥65 years. Following PPSV23 vaccination, serotype-specific IgG concentrations and OPA titers increase and then decline over time thereby decreasing protective efficacy, although these might remain above pre-vaccination levels until 5 years from PPSV23 administration. The decline of pneumococcal immunity may be more prominent among chronically ill patients, including those with diabetes. Currently however, revaccination is not recommended. In this study, we aimed to evaluate the serotype specific immunogenicity between healthy elderly people and old adults with diabetes after revaccination with PPSV23 at the age of 70-75 years. Serotype-specific IgG concentrations and opsonophagocytic killing activity (OPA) titers will be assessed.


Eligibility Criteria:
Inclusion Criteria

* Elderly people aged 70-75 years
* Had received PPSV23 in the previous 5-7 years

Exclusion Criteria:

* Immunocompromised patients
* Subjects receiving immunosuppressive agents
* Subjects with a history of vaccination with pneumococcal conjugate vaccine
* Subjects with a history of pneumococcal disease (positive culture from blood or other sterile fluid)
* Fever (defined as an oral temperature \>37.5℃) within 24 h before PPSV23 vaccination
Radiation Therapy in Treating Women Undergoing Lumpectomy for Stage I or Stage IIA Breast Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving intraoperative radiation therapy after lumpectomy followed by external-beam radiation therapy may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying the side effects and how well radiation therapy works in treating women undergoing lumpectomy for stage I or stage IIA breast cancer.

OBJECTIVES:

* To determine the feasibility and acute patient tolerance of intraoperative electron irradiation (IOERT) and hypofractionated external-beam irradiation (HYPORT) after lumpectomy for patients with stage I-IIA breast cancer treated with breast conservation therapy.
* To determine the local tumor control and distant tumor control rates for patients with stage I-IIA breast cancer treated with breast conservation therapy using IOERT and HYPORT after lumpectomy.
* To determine the long-term side effects and cosmetic outcome of IOERT to tumor bed and HYPORT after lumpectomy for patients with stage I-IIA breast cancer.

OUTLINE: Patients undergo lumpectomy per standard procedures. Patients undergo intraoperative electron irradiation (IOERT) to the tumor bed right after completion of lumpectomy with axillary lymph node dissection or sentinel lymph node biopsy.

Beginning 2-6 weeks after lumpectomy with axillary lymph node dissection/sentinel lymph node sampling and IOERT, patients receive hypofractionated external-beam irradiation once daily for 16 days.

After completion of study treatment, patients are followed at 3 months, every 6 months for 5 years, and then annually thereafter for 8 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed primary invasive breast carcinoma

  * Stage I-IIA disease (T1, N0, M0 or T2, N0, M0)
  * Pathologically determined single, discrete, and well-defined primary tumor ≤ 5 cm in diameter

    * Pathologically negative surgical margins
* No multicentric disease and/or diffuse malignant appearing microcalcifications

  * Micro-calcifications must be focal

    * Specimen radiograph is required after lumpectomy for tumors associated with malignant appearing calcifications to assure removal of all malignant appearing calcifications
    * Specimen radiograph is optional if the tumor appears as a discrete mass on mammogram
* No axillary lymph node involvement
* No evidence of metastatic breast cancer
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Menopausal status not specified
* No pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

* No prior irradiation to the area of planned radiation field
* No prior placement of breast prosthesis in the treated breast
* Concurrent hormonal therapy with external-beam irradiation allowed
Effects of Neostigmine-dose on Diaphragmatic Dynamics

The goal of this Randomized Clinical Trial is to compare the postoperative diaphragmatic excursion between patients receiving half-dose neostigmine (0.04 mg/kg) and those receiving full-dose neostigmine (0.08 mg/kg) for neuromuscular blockade reversal.

The main questions it aims to answer are:

* Does half-dose neostigmine result in similar postoperative diaphragmatic excursion compared to full-dose neostigmine?
* Does half-dose neostigmine result in similar diaphragmatic thickening fraction compared to full-dose neostigmine? Researchers will compare patients receiving half-dose neostigmine to those receiving full-dose neostigmine to see if there are differences in postoperative diaphragmatic function, respiratory complications, and recovery.

Participants will:

* Undergo elective laparoscopic cholecystectomy.
* Receive either half-dose or full-dose neostigmine for neuromuscular blockade reversal.

Fifty patients from both genders scheduled for elective laparoscopic cholecystectomy were enrolled in this study to compare diaphragmatic assessment parameters.

Enrolled participants were randomly assigned to group A (patient receiving full dose of Neostigmine (0.08 mg/kg) plus Atropine (20 mic/kg)) or group B (patient receiving half dose of Neostigmine (0.04 mg/kg) plus Atropine (20 mic/kg)).

This is a prospective study that will be conducted at Aswan University Hospital.

Eligible participants will be adult patients (age ≥ 18 years) scheduled for elective laparoscopic cholecystectomy, with American Society of Anesthesiologists (ASA) physical status I or II, and a body mass index (BMI) \< 35 kg/m². Patients with pre-existing diaphragmatic or respiratory disorders, ASA physical status III or IV, BMI \> 35 kg/m², chronic opioid use or abuse, pregnancy, or breastfeeding will be excluded.

Eligibility Criteria:
Inclusion Criteria:

* Adults scheduled for elective laparoscopic cholecystectomy.
* Age: \< or = 18 years.
* Both genders.
* American Society Of Anesthiologists (ASA) I/II patients.
* BMI \<35

Exclusion Criteria:

* Pre-existing diaphragmatic or respiratory disorders.
* ASA III/IV
* BMI \>35
* Chronic opioid use or abuse
* Pregnancy or breastfeeding
Comparing 6-Minute Walk Tests for Ambulatory Oxygen Assessment

Patients with lung disease who report breathlessness on exertion are often referred for a 6MWT. Due to the nature of the 6MWT (hereon referred to as a Max-6MWT), patients are required to walk as far as they can in 6 minutes. This may lead to an inaccurate assessment of their requirement for ambulatory oxygen as this form of exercise may not correspond to their normal daily activities.

In this study, patients who are routinely referred for a Max-6MWT to investigate possible exercise-induced hypoxaemia will be invited to perform an additional walking test which is performed at their normal walking speed, referred here on in as a Nor_6MWT. We hypothesise that performing a Nor_6MWT will provide a more accurate assessment of a patients' oxygen requirement, primarily from their oxygen desaturation during the test.

Patients with lung disease who report breathlessness on exertion are often referred for a 6MWT. During this test patients are asked to walk up and down a corridor (or other flat area) for six minutes whilst their blood oxygen levels and heart rate are non-invasively measured using a pulse oximeter (finger probe) and the distance walked is measured. In addition, a questionnaire that obtains a Borg Score measures the patients perceived breathlessness and leg muscle fatigue both before and immediately following the test.

Due to the nature of the 6MWT (hereon referred to as a Max-6MWT), patients are required to walk as far as they can in 6 minutes. This may lead to an inaccurate assessment of their requirement for ambulatory oxygen as this form of exercise may not correspond to their normal daily activities. It may also not accurately measure the normal changes in oxygen saturation (or desaturation) that occurs in these patients during their normal daily activities (such as walking to the shops, walking up the stairs, gardening).

In this study, patients who are routinely referred for a Max-6MWT to investigate possible exercise-induced hypoxaemia will be invited to perform an additional walking test which is performed at their normal walking speed, referred here on in as a Nor_6MWT. We hypothesise that performing a Nor_6MWT will provide a more accurate assessment of a patients' oxygen requirement, primarily from their oxygen desaturation during the test.

Eligibility Criteria:
Inclusion Criteria:

* Referred for a standard 6-minute walk test
* Has the capacity to give informed consent
* Is aged between 18 and 90

Exclusion Criteria:

* Lack of capacity to provide informed consent
* Poor peripheral perfusion that prevents an accurate measurement of SpO2
* Contraindicated to perform a Max_6MWT as indicated in the standard HHFT 6MWT SO
Confirmatory Clinical Trial of the Evera MRI System for Conditionally-safe MRI Access

The purpose of the Evera MRI™ study is to confirm safety and efficacy of the Evera MRI ICD (Implantable cardioverter-defibrillator) System in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans without positioning restrictions (MRI scans may occur anywhere on the body).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are indicated for implantation of an ICD at the time of study enrollment.
* Subjects who are able to undergo a pectoral implant.
* Subjects who are receiving an ICD for the first time.
* Subjects who are able and willing to undergo elective MRI scanning without sedation.
* Subjects who are geographically stable and available for follow-up at the study site for the length of the study.
* Subjects who are at least 18 years of age (or older, if required by local law).

Exclusion Criteria:

* Subjects with a history of significant tricuspid valvular disease .
* Subjects for whom a single dose of 1.0mg dexamethasone sodium phosphate and/or dexamethasone acetate may be contraindicated.
* Subjects who require a legally authorized representative to obtain informed consent.
* Subjects undergoing device upgrades, change-outs, lead extractions, and/or lead or device revisions.
* Subjects with abandoned or capped leads.
* Subjects who require an indicated MRI scan, other than those specifically described in the Evera MRI™ study, before the one-month post-MRI/waiting period follow-up (approximately 4 months post-implant).
* Subjects with a non-MRI compatible device (such as neurostimulators) or material implant (e.g., non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys).
* Subjects with medical conditions that preclude the testing required by the study protocol or limit study participation.
* Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the Evera MRI™ study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
* Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within seven (7) days prior to device implant.
* Subjects with exclusion criteria required by local law (e.g., age, breastfeeding).
The Effectiveness of Adding Braun Anastomosis to Standard Child Reconstruction After Pancreatoduodenectomy

The goal of this clinical trial (REMBRANDT) is to evaluate the effectiveness of adding an extra connection (i.e. 'Braun anastomosis') after standard reconstruction in pancreatic head resection in reducing the incidence of delayed gastric emptying.

Rationale/hypothesis: The addition of Braun enteroenterostomy (BE) reduces the incidence of delayed gastric emptying (DGE) resulting in lower morbidity and healthcare costs after pancreatoduodenectomy.

Objective: To assess the effectiveness of adding BE in reducing DGE in patients undergoing open pancreatoduodenectomy.

Study design: A multicenter, patient and observer blinded, registry-based randomized controlled trial.

Study population: Patients undergoing an open pancreatoduodenectomy for all indications.

Intervention: Braun enteroenterostomy (BE), or Braun anastomosis, in addition to usual care.

Usual care/comparison: Pancreatoduodenectomy with standard Child reconstruction.

Main endpoints:

1. Incidence of DGE Grade B/C (according to International Study Group of Pancreatic Surgery (ISGPS)
2. Incidence of postoperative pancreatic fistulas (POPF) Grade B/C (according to ISGPS), anastomotic leak, complications, hospital length of stay, functional outcome at 12 months, in-hospital mortality, 30-day mortality, healthcare costs.

Sample size: 256 in total, 128 per arm

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients undergoing open pancreatoduodenectomy have an increased risk of postoperative complications such as DGE, POPF and anastomotic leak. The addition of BE, which is an anastomosis, could also result in a leak. However, this risk is diminishable compared to the risks of DGE and DGE related other complications like anastomotic leaks associated with standard pancreatoduodenectomy. Moreover, previous cohort studies involving BE do not describe an increased risk of adverse outcomes for BE.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing open pancreatoduodenectomy
* Provided informed consent
* Age over 18 years

Exclusion Criteria:

* Insufficient control of the Dutch language to read the patient information and to fill out the questionnaires in Dutch hospitals
* Previous bariatric surgery (such as Roux-en-Y gastric bypass, gastric sleeve)
* Pregnancy
* Bowel motility disorders
* Minimally invasive pancreatoduodenectomy
* Gastric outlet syndrome