cyrilzakka/clinical-trials huggingface dataset:
A Study to Compare the Effect of Omadacycline Versus Moxifloxacin in Healthy Adult Volunteers

This is a randomized (1:1), double-blind, double-dummy, phase I study to compare the effects of Omadacycline versus Moxifloxacin on gut microbiota and the resistomes in healthy adult volunteers.The study consists of 3 phases: Screening, double-blind treatment, and follow-up. Healthy volunteers aged 18-40 years, who meet entry criteria, are randomly assigned to a treatment group using an Interactive Voice Response System/Interactive Web Response System (IxRS) and receive the first dose of the study drug.

The study consists of 3 phases: Screening, double-blind treatment, and follow-up. Healthy volunteers aged 18-40 years, who meet entry criteria, are randomly assigned to a treatment group using an Interactive Voice Response System/Interactive Web Response System (IxRS) and receive the first dose of the study drug.

Eligibility Criteria:
Inclusion Criteria:

1. Sign an Informed Consent Form (ICF) prior to the commencement of any study-related procedures.
2. Chinese healthy male and female subjects aged between 18 and 40 years (inclusive).
3. Body mass index (BMI) between 18.5 and 23.9 kg/m2 (inclusive).
4. Complete the stool sample collections required during screening.

Exclusion Criteria:

1. Subjects with clinically significant medical history of cardiovascular, hepatic, renal, gastrointestinal or psychiatric conditions, or any other condition as deemed by the investigators that may potentially jeopardize subject safety or impact study outcomes.
2. Subjects who have undergone any major surgery within 4 weeks prior to the first dose of study drug administration.
3. Subjects who have previously undergone gastrointestinal surgery that may affect the absorption of the study drug (eg. Intestinal resection surgery, fistula surgery).
4. During screening, subjects with positive tests for hepatitis C antibodies, hepatitis B surface antigen, or hepatitis B virus (HBV) DNA or HBV RNA, or known positive tests for human immunodeficiency virus (HIV).
5. Subjects with Fridericia-corrected QT interval (QTcF) \> 450 milliseconds (males) or \> 470 milliseconds (females); or known to have long QT syndrome; or using medications that may cause arrhythmia or prolong QT interval, and/or experiencing tachyarrhythmia.
6. Subjects with a history of irritable bowel syndrome (with or without constipation) -
A Multicomponent Clinic-based Intervention to Promote COVID-19 Vaccine Intention and Uptake Among Diverse Youth and Adolescents

The goal of this study is to refine and test CONFIDENCE, a multi-component clinic-based intervention in pediatric or family practice clinical settings. Using a randomized control trial design, the investigators will assess preliminary effectiveness of the intervention to increase COVID-19 vaccine intention among parents of under-vaccinated children ages 5 to 17.

Participating clinics will receive a brief intervention consisting of: (1) webinar training focused on communication with vaccine-hesitant parents, (2) parent-facing educational materials about COVID-19 vaccination, (3) support to create a personalized, poster campaign featuring providers. Clinics in the control condition will receive the intervention approximately 12 months after the clinics in the intervention condition.


Eligibility Criteria:
Practice site inclusion criteria

* Pediatric or family practice clinic that serves pediatric population (ages 5 to 17)
* Affiliated with UMass Memorial Health Care and/or Baystate Health
* Serve a patient population that is at least 30% racial/ethnic minority group members.

Inclusion Criteria for Parents:

The following inclusion criteria will be applied to parents (on behalf of their children):

* Parent/guardian (referred to as parents in this proposal) of child between ages 5 and 17
* Able to read and write in English, Spanish, Portuguese or Vietnamese, which are the predominant languages in the target communities
* Parent of patient at participating clinical site/child received non-urgent care visit during study period
* Child not up-to-date for COVID-19 per current CDC guidelines at the time of enrollment.

Exclusion Criteria for Parents:

°Parent under age of 18
Multicenter Investigation of the Glaukos® Suprachoroidal Stent Model G3 In Conjunction With Cataract Surgery

Evaluate the safety and efficacy of the Glaukos® Suprachoroidal Stent Model G3 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

This is an IDE trial to evaluate the safety and efficacy of the Glaukos® Suprachoroidal Stent Model G3 (hereinafter referred to as G3) in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate open-angle glaucoma
* Characteristics consistent with mild to moderate glaucoma
* Use of one (1) to three (3) medications at time of screening exam

Exclusion Criteria:

* Pigmentary or pseudoexfoliative glaucoma
* Prior incisional glaucoma surgery
Computer-Based Cognitive Training and Sleep Quality in Older Adult Insomniacs

The purpose of this study is to investigate the effect of computerized, home-based cognitive training on sleep quality of older adults with insomnia.

Participants in the cognitive training group train in a computer-based cognitive training program over a period of 12 weeks. An active control group train in a program involving tasks that do not engage high-level cognitive functioning over the same period.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of chronic insomnia
* able to use a home personal computer
* have healthy dominant hand functioning
* Hebrew speakers

Exclusion Criteria:

* have any significant visual or hearing impairment
* have any significant medical, neurological or psychiatric illness that might bring about cognitive change
* have sleep disorders other than insomnia
* have any significant medical disease (including cancer, diabetes, liver, kidney, heart or lung disease)
* alcoholism or other drug abuse
* taking any medication known to affect central nervous system functioning other than sleeping pills
* historical evidence suggesting significant psychiatric conditions such as depression, psychosis or neurologic disease
Hand Hygiene Intervention Study in Finnish Garrison

In this study the investigators aim to elucidate the possibility to reduce occurrence of infectious diseases in a garrison with enhanced and guided hand hygiene. The investigators will study occurrence and transmission of infections. In addition, the investigators will find out the causative agents of infections in a garrison with virological analyses of naso-pharyngeal and fecal specimens. The costs of lost service days and other expenses due to infectious diseases will be evaluated with a cost analysis study.


Eligibility Criteria:
Inclusion Criteria:

* willingness to attend to the study

Exclusion Criteria:

* skin diseases which prevent using hand disinfectants
X-396 (Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases

To assess efficacy and safety of oral X-396 (Ensartinib) capsule in Chinese ALK-positive NSCLC patients with brain metastases, eligible patients will be enrolled with objective responses being primary outcome measures.

In this phase Ⅱ, open-label, single arm, multicenter study, efficacy and safety of oral X-396 capsule (Ensartinib) in 37 Chinese ALK-positive NSCLC patients with brain metastases will be assessed. Eligible patients will receive 225mg X-396 capsules once daily and objective responses of brain metastasis based on investigator assessment according to Response Assessment in Neuro-Oncology (RANO) are primary outcome measures.

Eligibility Criteria:
Inclusion Criteria:

1. Female or male, 18 years of age or older
2. Histologically or cytologically confirmed locally advance or recurrent/metastatic NSCLC that was positive for ALK mutations.
3. Contrast-enhanced MRI or CT confirmed parenchymal brain metastases with at least one measurable lesion (according to RANO and RECIST 1.1), which was not previously treated with radiotherapy.
4. At most once treated with chemotherapy, which must have been completed at least 4 weeks before the initiation of study treatment. Any adverse events related to previous chemotherapy treatment have disappeared.
5. A Karnofsky Performance Status score of at least 60.
6. An expected survival time of at least 12 weeks.
7. Adequate organ functions.
8. Drug related toxicities has been relieved to grade 1 (based on NCI CTCAE v4.03), except for hair loss.
9. Being willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
10. Signed and dated informed consent.

Exclusion Criteria:

1. Currently under treatment of other systemic anti-cancer therapies.
2. Evidence of active malignancy within last 5 years.
3. Patients who participated in other clinical trials within last 4 weeks before the initiation of study treatment.
4. Patients who received surgery or immunotherapy within last 4 weeks before the initiation of study treatment.
5. Patients who need to receive drugs which are potent CYP3A4 inhibitors or inducers within last 2 weeks before the initiation of study treatment and during the study.
6. Patients who previously received organ transplantation or stem cell transplantation.
7. Patients with clinically significant cardiovascular diseases.
8. Patients with active gastrointestinal diseases or other conditions that will interfere significantly with the absorption, distribution, metabolism or excretion of study medication.
9. Patients with interstitial lung disease history or signs of active interstitial lung disease.
10. Patients with known allergy or delayed hypersensitivity reaction to study drug or its excipients.
11. Pregnant and lactating women.
12. Patients with other illness or medical conditions potentially interfering with the study treatment.
LAMA2-related Muscular Dystrophy Brain Study

Laminin alpha-2 (LAMA2)-related muscular dystrophy (LAMA2-MD, Merosin Deficient CMD) is a form of congenital muscular dystrophy (CMD). A person with LAMA2-MD will have changes on brain imaging (MRI), a decrease or absence of the protein merosin (laminin 211) on muscle or skin biopsy and changes in the LAMA2 gene that are inherited from both parents. Several studies have described the changes on brain MRI. Brain changes on MRI do not correlate with the partial reduction or absence of merosin on muscle or skin biopsy. 8-30% of people with LAMA2-MD develop seizures. The types of seizures, electroencephalogram changes and common treatment regimens have not been characterized. This study will review the magnetic resonance imaging (MRI) changes, determine whether certain brain MRI changes are linked to seizures and define the common seizure treatment regimens.

LAMA2-MD is a congenital muscular dystrophy (CMD) subtype caused by mutations in the laminin alpha 2 gene. LAMA2-MD may present clinically as an early onset, severe phenotype or a late onset limb girdle phenotype. The early onset form is most commonly associated with a complete absence of merosin on muscle biopsy with profound neonatal hypotonia, possible respiratory distress and feeding difficulties while the late onset form presents with proximal muscle weakness, contractures and is able to achieve walking. In both early and late onset forms, brain white matter abnormalities have been described on brain MRI and approximately 8-30% develop a seizure disorder. On magnetic resonance (MR) spectroscopy, white matter changes are shown to be due to increased water content rather than areas of demyelination. Both, non-ambulant and ambulant patients may develop respiratory insufficiency requiring non-invasive ventilation and scoliosis.

Although several studies have evaluated the correlation between brain MRI white matter changes and cognition, no studies to date have provided a systematic evaluation of brain imaging, electrophysiologic testing and seizures in patients identified by molecular or immunohistochemical testing to have LAMA2-MD.

Eligibility Criteria:
Inclusion Criteria:

* Genetic confirmation of 2 variants in LAMA2 gene OR muscle biopsy with complete absence of merosin
* Complete authorization to obtain medical records for Congenital Muscle Disease International Registry
* Complete authorization to obtain medical records for National Institutes of Health (NIH)
* Reside in United States or Canada
* Complete registration and intake survey in the Congenital Muscle Disease International Registry

Exclusion Criteria:

- Individuals with LAMA2-MD who have not had a brain MRI
Long Sleep Duration and Vascular Function

Sleep duration has received much attention in recent years due to strong evidence that not enough sleep can increase risk for a number of diseases and disorders. Research is emerging that too much sleep also has a negative impact on health, particularly higher risk for myocardial infarction and stroke. The investigators hypothesize that long duration sleep has the ability to impair peripheral and cerebral vascular function in middle-aged to older adults.

The aim of this study is to compare the effect of long duration sleep (\>9 hours) to recommended levels of sleep (7-8 hours) in a crossover designed study requiring adults to maintain each prescribed sleep duration for one week. Ambulatory brachial and central aortic blood pressure will be measured during sleep, while cerebrovascular reactivity, carotid artery hemodynamics (e.g., flow pulsatility), aortic pulse wave reflections, cognitive function, and peripheral vasodilatory function will be measured before and after each sleep protocol. A secondary objective of this study is to understand whether aerobic exercise can improve vascular function under conditions of different sleep durations. This information will shed light upon the impact of sleep parameters on exercise-induced improvements in vascular function.

Eligibility Criteria:
Inclusion Criteria:

* recreationally active
* reporting no recent history of sleep problems
* not taking sleep-inducing medication
* not diabetic (fasting blood glucose \<126 mg/dL)

Exclusion Criteria:

* show symptoms of insomnia
* smoke
* have a personal history of stroke or diabetes
* take birth control pills
Evaluation of the Resection of Adenoma and Colic Adenocarcinoma by EMR Piecemeal or EMR/ESD Hybrid Technique

For tough colic resection, evaluation of our practice for these lesions unresectable in monoblock and evaluation of the contribution of the hybrid technique EMR (mucosectomy dissection) /ESD (submucosal dissection)


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years,
* Patient with colorectal adenoma or intramucinous adenocarcinoma

Exclusion Criteria:

* Contraindication surgery
A Study of Time Restricted Eating in Obese Adults

The purpose of this pilot study is to understand the difference between early and late time-restricted eating on weight and body mass index (BMI), and evaluate the barriers encountered and the effect on quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Ability to read and understand English
* BMI ≥ to 25.

Exclusion Criteria:

* Regularly skip meals.
* Are unwilling or unable to limit eating to an 8-hour window.
* Have a current Melanoma or cancer diagnosis.
* Currently breastfeeding.
* Pregnant, or planned to be pregnant within 3 months.
* Are taking insulin or sulfonylurea drugs.
* Are taking weight loss medications or had weight loss surgery within the last year.
* Have a history of eating disorders.
Sequential Treatment With BELKYRA® Then Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour

This study has been designed to evaluate the safety and effectiveness of sequential treatment with BELKYRA® (for the treatment of convexity and fullness associated with submental fat) and VOLUMA™ (to restore volume along the mandibular border) to enhance the overall contour of the jawline.

Participants may be treated with up to 6 treatments with Belkyra, followed by treatment with Voluma. Participants will have opportunity to participation in a skin biopsy sub-study.

Eligibility Criteria:
Inclusion Criteria:

* Grade 2 or above on Allergan Loss of Jawline Definition Scale (ALJDS)
* Grade 2 or 3 on reported Clinician-Rated Submental Fat Rating Scale (CR-SMFRS)
* Stable body weight for at least 26 weeks
* Accept the obligation to forego any treatment or behavior (e.g., unshaven facial hair; significant changes to dietary or exercise habits) during the participants participation in the study that may affect the assessments of the submental area

Exclusion Criteria:

* Grade 4 on Submental Skin Laxity Grade (SMSLG)
* Grade 4 on Allergan Jowl Fat Rating Scale (AJFRS)
* Body mass index (BMI) \>35 kg/m\^2
* History of, or current symptoms of dysphagia
* History of temporary, semi-permanent or permanent facial or neck dermal filler injections below the medial canthi at any time prior to treatment, or within 52 weeks before Screening for treatment above the medial canthi
* History of facial and/or neck plastic surgery, tissue grafting or permanent facial implants anywhere in the face or neck
* History of any intervention (e.g., liposuction, surgery, or lipolytic agents) to treat submental fat (SMF)
* Evidence of any cause of enlargement in the submental area other than localized SMF
* History of mesotherapy or ablative procedures to the face and/or neck 52 weeks before Screening
* History of skin resurfacing in the neck or submental area within 26 weeks before Screening
* Treatment with botulinum toxin injections in the neck or submental area within 26 weeks before Screening
* Participants on prescription topical retinoid therapy and/or topical hormone cream applied to the face, who have not been on a consistent dose regimen for at least 26 weeks before Screening and who are unable to maintain regimen for the study
* Systemic retinoid therapy within 52 weeks before Screening
* Current use of oral corticosteroids
* Is on a regimen of anticoagulation therapy (eg, warfarin, clopidogrel)
* Has current injection site inflammatory or infectious processes, abscess, an unhealed wound, or a known cancerous or precancerous lesion in chin, masseter, or submental region
* Planned oral surgery or other dental procedures (e.g., tooth extraction, orthodontia, or implantation) within 2 weeks prior to and after VOLUMA™ treatment
Oral 6R-BH4 for the Treatment of Isolated Systolic Hypertension and Endothelial Dysfunction

This study is designed to assess the safety and efficacy of twice-daily oral dosing of 6R-BH4 to improve endothelial function, reduce systolic blood pressure and reduce arterial stiffness.

By comparing values measured at different timepoints, the study is expected to provide insight regarding the ability of 6R-BH4, administered along with their currently prescribed antihypertension medications, to improve endothelial function, reduce SBP, and reduce arterial stiffness in patients with ISH and endothelial dysfunction

Eligibility Criteria:
Inclusion Criteria:

* No change in prescribed antihypertension medications within the previous 30 days
* Study staff able to visualize and measure the brachial artery diameter by high resolution vascular ultrasound required for FMD measurements
* ISH with the following mean seated BP: SBP \> 145 and \< 180 mmHg. Diastolic blood pressure \< 90mmHg

Exclusion Criteria:

* Has known hypersensitivity to 6RBH4 or its excipients
* Pregnant or breastfeeding at screening
* Use of any investigational product or investigational medical device within 30 days prior to screening
* Current disease or condition that would interfere with study participation or safety such as the following: heart failure, atrial fibrillation, aortic valve disease, bleeding disorders, history of repeated syncope or vertigo, severe GERD, GI ulcer, symptomatic coronary or peripheral vascular disease, arrhythmia, serious neurologic disorders including seizures, organ transplant or organ failure
* Hypertension secondary to other medical conditions
* Any severe comorbid condition that would limit life expectancy to \<6 months
* Current use of any nicotine containing substances
* History of drug or alcohol abuse
* MI, stroke or surgery within 90 days before Screening Visit
* CABG within 6 months before the Screening Visit
* Serum creatinine \>2.0mg/dl or AST, ALT, GGT levels \>2times upper limit of normal
* Concomitant treatment with: any drug known to inhibit folate metabolism, any phosphodiesterase-5 or -3 inhibitor
* Previous treatment with any formulation of BH4
Irinotecan, Gemcitabine and Radiation Therapy for Pancreatic Cancer

The study hypothesis is that chemoradiation based on 2 drugs will improve local control and long-term survival in patients with locally advanced pancreatic cancer. That is why gemcitabine and irinotecan are combined in an induction phase of 2 months and then this IrinoGem combination is given for 3 more cycles, in reduced doses,concurently with irradiation.


Eligibility Criteria:
Inclusion Criteria:

* locally advanced pancreatic cancer
* performance status 0-2
* normal blood count and chemistry
* no previous chemotherapy or radiotherapy

Exclusion Criteria:

* serious concurrent systemic disease
Vitamin D3 in Patients With Sickle Cell Disease

There are approximately 90,000 individuals in the United States with sickle cell disease (SCD). Studies have shown that up to 98 percent of patients with Sickle Cell Disease have a vitamin D deficiency, defined as a 25-hydroxyvitamin D level (25(OH)D) less than or equal to 20 ng/mL. As a result, of low bone density, patients may develop osteonecrosis, chronic inflammation and related pain. This study will be coordinated with patients' regularly scheduled visits for medical care and will require patients to submit blood sample at the start of the study and at 3, 6, 9, AND 12 month visits. Patients will also be scheduled for a bone density measurement (DXA scan) at the start of the study and after 12 months of supplementation to assess for any bone re-mineralization. Thus, the main purpose of this study is to find the amount of nutritional vitamin D that needs to be taken by patients with sickle cell disease in order to correct vitamin D deficiency. The study will also test whether vitamin D supplements improve bone health and reduce inflammation.

This is an observational cohort study to follow vitamin D levels over time in patients with sickle cell disease receiving doses of vitamin D as part of their clinical care for vitamin D deficiency.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years and older)
* Diagnosis of sickle cell disease by hemoglobin electrophoresis (HbSS, hematopoietic blood stem cell \[HbSC\], Sickle cell b0 Thalassemia, Sickle cell b+ Thalassemia)
* Able to give informed consent
* Any race/ethnicity/socioeconomic status

Exclusion Criteria:

* Pediatric patient (less than 18 years of age)
* Unable to give informed consent
* Untreated primary hyperparathyroidism (ICD9 codes 252.01XX and 252.00XX)
* hypercalcemia (serum calcium level \> 11 mg/dl; ICD9 codes 275.42XX, 259.3XX, 252.00F)
* Pregnancy: a urine pregnancy test, or a serum pregnancy test, will be obtained at the time of enrollment in addition to reviewing the medical record; pregnant patients will be excluded because they should not undergo DXA scanning
* Patients taking atorvastatin, thiazide diuretics and digoxin, which are medications that can interact with vitamin D
* Non-English speakers