cyrilzakka/clinical-trials huggingface dataset:
Culturally Responsive Stress Reduction: A Mobile Mindfulness Application for African Americans (CRSR)

Over a 12-week period the investigators will test whether, compared to the Waitlist-Control (WC) condition, administration of the full CRSR intervention improves participants self-reported outcomes of stress, self-efficacy, mindfulness, use of mindfulness strategies, and knowledge. The investigators also will examine the usability, cultural relevance, and user satisfaction.

The proposed intervention, Culturally Responsible Stress Reduction: A Mobile Mindfulness Application to Support Health Promotion for African Americans (CRSR), is designed to encourage the use of mindfulness to mitigate the disproportionate amount of stress-related health disparities facing African Americans. Current mindfulness approaches have been unsuccessful in engaging this population. This proposal aims to bridge this disparity by developing an mHealth (mobile health) mindfulness application ("app") tailored specifically to the cultural values of the African American community.

Mindfulness involves meditative practices that cultivate purposeful and nonjudgmental attention to current thoughts, emotions, and physical sensations in the body. Mindfulness has been incorporated into widely-used interventions, including Acceptance and Commitment Therapy (ACT). The CRSR app will be grounded in ACT and will integrate the convenience of mobile technology with tailored content to allow users to shift from potentially harmful culturally prescribed stress-coping activities (e.g., self-reliance, emotional suppression) to adaptive mindfulness-based stress-coping activities aligned with culturally specific values. This integration of content, backed by theory and empirical evidence, effective instructional delivery, an interdisciplinary development team, and modern communication technology will produce an effective mHealth intervention.

The CRSR app features include guided meditations to connect the user to the present moment and a place of calm through culturally aligned exercises grounded in spirituality, orality, self-empowerment, and resilience; personalized notifications prompting users to reflect and engage with the app; periodic email messages on the importance mindfulness as a way increase control over physical and psychological health; and user-customized reminders.

Phase I included developing a testable prototype of the CRSR app, called Mindful You. The prototype provided functionality for participants to practice mindfulness and was used to test proof of concept, i.e., the feasibility and social acceptability of the CRSR app. Users experienced significantly decreased stress and increased self-efficacy. They also reported increased use of mindfulness behaviors and improved self-regulation. Phase II will iteratively build on the prototype to develop the final product and test its efficacy with a fully-powered randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Identifies as African-American
* Can read, write, and understand English
* Have a valid email address
* Owns an iOS or Android mobile device

Exclusion Criteria:

* n/a
OurChild: A Health IT Solution to Reduce Minority Health Disparities

Chinese American immigrant families are a fast-growing immigrant group with unmet early childhood mental health needs. The team proposes to design, build, and implement OurChild, an integrated mHealth/EHR solution to increase access to early childhood mental health knowledge and mental health services and resources for Chinese American children ages 2-6 years old and their parents in the Sunset Park Brooklyn.

The goal of this study is to reduce health disparities by designing a digital solution (OurChild) that facilitates connection and bidirectional exchange of information across the cultural, contextual, language, and setting differences that are key barriers to early childhood mental health knowledge and care access for the Chinese American community in Sunset Park, Brooklyn. The first study aim is to iteratively design, build, and test OurChild. To do this, the team will 1) collaborate with family, clinical, and community stakeholders to conduct an early childhood mental health context/needs analysis and participatory design and discovery activities; 2) build a digital library of early childhood mental health resources accessible from OurChild; and 3) pilot and assess the usability and acceptability of a beta version of OurChild in a mixed-methods, cross-sectional cohort of 12 Chinese American parents and their 2- to 6-year-old children (N=24) who receive care at the Sunset Park 7th Avenue Family Health Center; and 5) optimize the design, features, and performance to create OurChild 1.0. The second study aim is to evaluate the reach, effectiveness, adoption, implementation and maintenance of OurChild 1.0 through an implementation cohort study with 120 parent/child dyads (N=240). A mixed-methods approach using metadata collected with the OurChild app, parent-reported data from the app, EHR data, and post-implementation key informant interviews with providers and other stakeholders to determine whether use of OurChild increases referrals of young children for a mental health consultation or evaluation (Primary Aim) will be used. The secondary aims include examining whether use of OurChild increases 1) parent self-efficacy; 2) parent-provider engagement; and 3) linkage with community early childhood resources.

Eligibility Criteria:
Inclusion Criteria:

* Child must be 24 to 72 months old
* Child must have been receiving pediatric primary care at the 7th Ave FHC for at least 6 months
* Child must be identified as Chinese and/or preferred language is Chinese in EHR
* Parents must be at least 18 years old
* Parents must be the child's parent/legal guardian
* Parents must be able and willing to provide informed consent

Exclusion Criteria:

* Siblings and parents of previously enrolled children
* Parents who do not have access to an iOS or Android smartphone
Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.

To compare the functional immune response 28 days after administration of one dose of Men ACWY-CRM conjugate vaccine without adjuvant (MenACWY-CRM(Ad-)) with that of a Men ACWY polysaccharide (PS) vaccine


Eligibility Criteria:
Inclusion Criteria:

* healthy 12-\<60 month old children;

Exclusion Criteria:

* subjects who have previously received any meningococcal vaccine
* subjects with any serious acute or chronic progressive disease
Real-world Efficacy and Safety of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulator Therapy in Adult Patients With Cystic Fibrosis (CF)

In this trial real-world data on the safety (side effects and medication interactions) and efficacy (evolution of lung function testing, chronic bacterial airway infection, quality of life and endo- and exocrine pancreatic function) will be collected in adult people with cystic fibrosis (pwCF) eligible for elexacaftor-tezacaftor-ivacaftor (ETI) up until 2 years after the start of this therapy.

PwCF group A: CFTR-modulator-naive pwCF eligible for ETI (based on age and CFTR genotype)

PwCF group B: pwCF already on CFTR modulating therapy (i.e. ivacaftor-lumacaftor or ivacaftor-tezacaftor) and switching to ETI.

Patients in both groups will undergo these examinations:

* Physical examination (including weight)
* Anamnesis for current and recent medication use (including dosage of pancreatic enzymes) and for acute respiratory exacerbations
* Lung function testing including spiometry, multiple breath washout testing and fractional exhaled nitric oxide
* Blood sampling: liver function tests, creatine kinase, albumin, PT, red and white blood cell count, platelet count
* Sputum/cough swab sampling
* fecal elastase measurement
* Cystic fibrosis questionnaire-revised (CFQ-R) questionnaire
* Patient health questionnaire-9 (PHQ-9) questionnaire
* General anxiety disorder-7 (GAD-7) questionnaire
* Sino-nasal outcome test-22 (SNOT-22) questionnaire

These will be performed at baseline (prior to the start of ETI, on the same day of start of ETI), and every 3 months (+/- 7 days) thereafter. A blood sample will also be performed 14 (+/- 7 days) days after start of ETI (for safety). Fecal elastase measurement will only be performed at baseline if not available in the patient's medical record, and only 6 months after start of ETI.

Eligibility Criteria:
Inclusion Criteria:

* eligible for ETI (i.e. age above 18 years and CFTR genotype F508del/any) based on reimbursement criteria in Belgium

Exclusion Criteria:

* inability to perform lung function testing
A Study Comparing Two Topicals in the Treatment of Acne Vulgaris

A Randomized, Evaluator-Blinded, Bilateral Comparison Study to Evaluate the Safety and Efficacy of Two Topicals in the Treatment of Subjects With Acne Vulgaris (Study FX2018-23).

A Randomized, Evaluator-Blinded, Bilateral Comparison Study to Evaluate the Safety and Efficacy of Two Topicals in the Treatment of Subjects With Acne Vulgaris. Eligible subjects will be randomized (1:1) to treatment with Test Article A to one side of the face versus Test Article B on the contralateral side.

Eligibility Criteria:
Inclusion Criteria:

* Has facial acne vulgaris with:

  16 inflammatory lesions (papules, pustules) The inflammatory lesion count on the right and left side of the face should be similar IGA score of moderate (3) on both the right and left side of the face

Exclusion Criteria:

* Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.
* More than two facial nodules/cysts
* Sunburn on the face
Peripheral Effects of Endotoxin on Insulin Resistance

The aim of the study is to isolate the direct effects of endotoxin on glucose, lipid and protein metabolism. Eight healthy volunteers are enrolled. The hypothesis is that endotoxin will induce insulin resistance, lypolysis and proteolysis acutely.


Eligibility Criteria:
Inclusion Criteria:

1. Normal health
2. 22 \< BMI \< 28
3. Written Informed Concent

Exclusion Criteria:

1. Any disease
2. Any use of medication
3. Recent immobilization of a lower extremity
Microbiological and Microscopic Evaluation of Atraumatic Restorative Treatment in Adult Dentition

Atraumatic Restorative Treatment (ART) was proposed as a new and effective method in the 1990s to provide conservative dental treatment to the people living in economically underdeveloped countries, due to lack of dental treatment facilities. In the technique, after the carious dentin is removed by excavation with hand instruments, the powder-liquid system conventional glass ionomer cement (GIC) which does not require special devices for mixing and hardening is used as a filling material. Because of these advantages of the treatment, the usage fields of ART have been expanded considering that it can be applied in the cases that working with rotary instruments is difficult or even impossible. But only a few research has been conducted on ART in adults and it must be investigated in terms of the clinical safety of ART by the studies focused on the counts and activities of the microorganisms in carious dentin left on the cavity floor. The purpose of this study is to investigate the reliability of ART in adult individuals related to the marginal adaptation of the restorations and the microbiological changes in the left carious dentin using in vitro and in vivo methods. In the in vivo part of the study, occlusal dentin carious of 25 participants at high risk of caries were removed with hand instruments and microorganisms of the last removed carious dentin were evaluated quantitatively concerning the bacterias playing a major role in caries lesions. The restorations of the teeth were carried out using ART technique with a GIC which has been proven its effectiveness in preventing the caries progression and recurrent caries in the practice of dentistry for many years. After six months, the microbiological assessment was repeated such as baseline. Marginal adaptation and the presence of the gaps in the ART restorations on the replicas created with the impression materials at the baseline and sixth month were investigated under scanning electron microscope. At the end of the study, the teeth were restored by the conventional methods and using composite material.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* 19-35 years of age;
* Good general health;
* High risk of caries;
* No evident signs of occlusal parafunctions.

Tooth:

* Molar tooth;
* 3-4 mm depth occlusal dentin caries;
* Vital;
* In occlusion;
* Proper tooth axes.

Exclusion Criteria:

Patient:

* Using regular medication;
* Pregnancy or lactation;
* Received radiotherapy or chemotherapy;
* Tooth clenching, bruxism.

Tooth:

* Spontaneous pain;
* Radiographic alterations in the periapical region;
* Presence of tooth mobility;
* Previously restored;
* Broken and/ or cracked.
F&P Toffee Full Face Mask Clinical Trial, NZ, 2020

This will be a prospective, multi-arm, randomized, and non-blinded clinical trial designed to evaluate the performance, comfort, and usability of the Toffee full face mask amongst participants who have been prescribed PAP therapy by a physician. This clinical trial will take place across three investigation sites with a sample of 45 participants.

The purpose of this clinical investigation was to evaluate the performance, comfort and ease of use of the F\&P Toffee Full Face Mask. The clinical investigation took place across three sites in order to recruit the required number of participants. The clinical investigation tested the mask on 44 participants, who were currently using a full face mask for PAP therapy.

This was a non-randomized non-blinded single intervention study. Informed consent was gathered from the 44 participants before demographic and baseline measurements were recorded. Participants were issued an appropriate fitting Toffee Full face mask for the two week at home trial.

After two weeks the participants returned the masks. At this visit device data was downloaded and participant questionnaires were completed.

Eligibility Criteria:
Inclusion Criteria:

* Persons who are ≥ 22 years of age
* Persons who weigh ≥ 66 lbs (30 kgs)
* Persons who have been prescribed PAP (APAP, BPAP or CPAP) therapy by a physician
* Persons who are compliant with PAP therapy for ≥ 4 hours per night for 70% of nights for at least two weeks prior to enrolment in the trial
* Persons who are currently using a full face mask
* Persons who have an IPAP pressure of \< 30 cmH2O
* Persons who currently use a PAP therapy device with data recording capabilities
* Persons who are fluent in spoken and written English
* Persons who possess the capacity to provide informed consent

Exclusion Criteria:

* Persons who are intolerant to PAP therapy
* Persons who are required to use PAP therapy for more than 12 hours per day or for extensive periods other than sleep or naps
* Persons using nasal or nasal pillows masks
* Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
* Persons who are pregnant or think they may be pregnant
* Persons who use a PAP therapy machine for the delivery of medicines, except supplemental O2
* Persons who currently have cold or flu like symptoms at the time of recruitment
* Persons who have tested positive for COVID-19 within the previous 28 days prior to enrolment
Comparing Manual and Neurocognitive Skills-While Sitting, Standing, Walking on a Treadmill and Using a Stepper.

This study is being performed to evaluate the effect of different active workstations (e.g., standing, stepping, or walking stations) on work performance through the evaluation of neurocognitive function using reasoning, memory, concentration, and fine motor skills evaluation tools.


Eligibility Criteria:
Inclusion Criteria:

* Dan Abraham Healthy Living Center (DAHLC) members and non-members that have provided informed consent to participate in this study.

Exclusion Criteria:

* Unable to stand up, walk on a treadmill or use a stepper.
* Alzheimer, dementia or any memory impairment.
* Cannot attempt fine motor skills.
* Not willing to use a treadmill, stepper or standing desk.
* Not a present user of an active office.
Neoadjuvant Chemotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)

The investigators will examine whether 2-cycles of DFP chemotherapy before definitive concurrent chemoradiation therapy (CCRT) can improve progression-free survival in locally advanced (Stage III \& IVM0) hypopharyngeal and base of tongue carcinoma compared to definitive CCRT alone.


Eligibility Criteria:
Inclusion Criteria:

* Histologically/cytologically proven stage III/IVM0 hypopharyngeal or base of tongue cancer
* One or more evaluable or measurable lesion
* No prior chemotherapy, radiation, or surgery
* ECOG 0-2

Exclusion Criteria:

* Distant metastasis
* Other malignancy
The High Density Lipoprotein and Endothelial Function, Niacin and Nitric Oxide Study (The High-Ennd Study)

The aim of the present study is to characterize novel mechanisms whereby HDL may exert potent vasculoprotective effects independent of reverse cholesterol transport, in particular the effect of HDL on the regulation of the vascular NAD(P)H oxidase enzyme system, a major vascular source of superoxide, known to be important for endothelial dysfunction. In addition, the present study will characterize the effect of HDL on endothelial progenitor cell (EPC) mobilization, nitric oxide production and in vivo regenerative capacity.


Eligibility Criteria:
Inclusion Criteria:

* Statin treatment for at least 3 weeks
* Reduced HDL: \< 40 mg/dL (1.03 mmol/L) in men or \< 50 mg/dL (1.29 mmol/L) in women
* Plus TWO of the following (thereby defining the patients to have metabolic syndrome (Grundy et al.; Circulation 2005)):
* Elevated waist circumference: ≥ 102 cm (≥ 40 inches) in men or ≥ 88 cm (≥ 35 inches) in women
* Elevated triglycerides: ≥ 150 mg/dL (1.7 mmol/L
* Elevated blood pressure: ≥ 130 mmHg systolic blood pressure or ≥ 80 mmHg diastolic blood pressure or anti-hypertensive treatment
* Elevated fasting glucose: ≥ 100 mg/dL or on drug treatment for elevated fasting glucose

Exclusion Criteria:

* Hypersensitivity to niacin
* Active liver disease or impaired liver function
* Persistent elevation of transaminases
* Cholestasis
* Gastric ulcer
* Acute coronary syndrome
* Gout
* Pregnancy, lactation
* Active infections
* Cancer
* Untreated concomitant diseases
* Renal insufficiency or renal failure
* Hypothyreosis
* Alcoholism
* Myopathies
* Muscle pain under therapy with fibrates or statins
* Hereditary muscle diseases in family history
Suitable Method for Routine Diagnostics of EER in Children With Otitis Media With Effusion

The aim of the study was detection of pepsin in effusion in children with OME using Peptest as new quick and cheap method of detection and comparison results with results of other studies in which pepsin was detected by more demanding methods. Such a type of study hasn't been done so far.

Children at the age between 1 to 7 years diagnosed with bilateral or unilateral OME who underwent adenoidectomy and myringotomy with insertion of ventilation tube were included in the prospective study. OME was defined as effusion in the middle ear behind intact eardrum longer than 3 months. Diagnosis was made on the basis of otomicroscopic findings, pneumatic otoscopy, type B tympanometry and audiometry (in older cooperative children). Children with no fluid in middle ear during myringotomy were revised as having tympanosclerosis and were excluded from the study. Children with craniofacial abnormities (Down syndrome, Treacher Collins syndrome, clefts etc.) were excluded from the study, as well. Demographic data and symptoms of EER disease were provided by parents, who were particularly inquired regarding the hoarseness, recurrent lower respiratory infection (bronchitis, pneumonia) and bronchial asthma of their child.

Myringotomy using microscope was done in anterior inferior part of the tympanic membrane. Type of middle ear effusion (fluid, mucous) was registered. Middle ear fluid was collected by special suction device with collecting bottle and ventilation tube was inserted in the tympanic membrane. In case of bilateral OME, effusion was collected and analysed separately. Specimen was first standardized. An amount of 0.1 ml of 10 % citric acid was added, specimen was centrifuged for 10 minutes and subsequently original migration reagent was added. Afterwards, specimen was examined using Peptest, which contains monoclonal antibodies targeted against pepsin. Result of the Peptest was stated as positive (2 lines), negative (1 line) and invalid (no line). Peptest detection limit is 16ng/ml of pepsin. Statistical analysis was done using MS Excel.

Eligibility Criteria:
Inclusion Criteria:

* signing of the informed consent
* children at the age between 1 to 7 years diagnosed with bilateral or unilateral OME

Exclusion Criteria:

* children with craniofacial abnormities (Down syndrome, Treacher Collins syndrome, clefts etc.)
Growth and Safety of a Low Lactose Milk-Based Infant Formula

The purpose of this study is to show that a low lactose milk-based infant formula supports normal growth in healthy term infants.

Infants will be fed a low lactose milk-based formula for 16 weeks. Growth and formula tolerability will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* healthy term infants
* birth weight 2500 - 4500 g
* singleton birth
* 37 - 42 weeks gestation

Exclusion Criteria:

* clinically significant abnormal findings (as determined by the investigator) on the physical examination or medical history
* receiving medications other than vitamins
Efficacy and Safety of Once-Daily Tacrolimus in Liver Transplant Recipients (SOUL)

The purpose of this study is to evaluate the efficacy and safety of conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) in patients undergoing maintenance therapy with Twice-Daily Tacrolimus after liver transplantation.

This study is a multi-center, non-comparative, and phase IV clinical trial that evaluates the efficacy and safety of conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) in patients who have undergone at least one year after liver transplantation and receive maintenance therapy with Twice-Daily Tacrolimus.

Enrolled subjects will take TacroBell slow-release cap.(Once-daily Tacrolimus) for 24 weeks and will conduct scheduled tests with four additional visits.

Eligibility Criteria:
Inclusion Criteria:

* At least one year after liver transplantation
* Over 20 years old(male or female)
* Patient taking tacrolimus twice daily as a maintenance therapy
* Patients with Tacrolimus blood levels of 3-10 at screening
* Agreement with written informed consent

Exclusion Criteria:

* Previously transplanted another organs other than the liver or at the same time
* Diagnosed and clinically treated with acute rejection within the last 6 months
* Patients who have changed the method of administering concomitant immunosuppressants or steroids within the last month
* Diagnosed with cancer in the last five years \[Patients, however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer, hepatocellular carcinoma without main vessel invasion or extrahepatic metastasis can be enrolled\]
* Patients who have positive HIV test result
* Severe systemic infection requiring treatment
* At screening

  * White blood cell count \< 1,500/mm\^3, or platelet \< 50,000/mm\^3, or Serum-C r\> 2.0mg/dl
  * Liver function test(T-bilirubin, aspartate aminotransferase, alanine aminotransferase)is over 3 times than upper normal limit
* Patients Taking HCV(hepatitis C virus) Therapeutic Drugs
* Pregnant women or nursing mothers
* Fertile women who not practice contraception with appropriate methods
* Participated in other trial within 4 weeks
* In investigator's judgment