cyrilzakka/clinical-trials huggingface dataset:
Comparative Evaluation of the Effectiveness of Diclofenac Sodium Versus Vitamin D on Myofascial Pain

It has been reported in the literature that there is a significant relationship between bruxism and low serum vitamin D levels. It was aimed to compare the effectiveness of diclofenac sodium treatment versus vitamin D supplementation on symptoms in individuals with myofascial pain and vitamin D deficiency.

In the current literature, it has been reported that there is a significant relationship between teeth grinding and low serum vitamin D levels. Vitamin D has been shown to play an important role in the musculoskeletal and cardiovascular systems, as well as in the control of calcium and phosphate metabolism and in maintaining adequate blood levels of these minerals. Vitamin D deficiency has been associated with poor physical performance and low muscle strength. There are also studies to understand the relationship between TMJ disorders and vitamin D level (serum 25(OH) D). These studies reported a relationship between the presence of TMJ disorder and vitamin D deficiency.

NSAIDs are a large group of drugs that inhibit cyclooxygenases and thus prevent the formation of prostaglandins. Traditionally, it has been the most commonly prescribed group of medications for pain in the orofacial area. It is recommended to use these drugs regularly for at least 2 weeks to achieve an anti-inflammatory effect in individuals with TMJ disorders.

It was aimed to compare the effectiveness of diclofenac sodium treatment versus vitamin D supplementation on symptoms in individuals with myofascial pain and vitamin D deficiency.

Eligibility Criteria:
Inclusion Criteria:

* Vitamin D deficiency,
* Myofascial pain complaint,
* Chronic pain,
* No missing teeth,
* Absence of open bite and/or crossbite.

Exclusion Criteria:

* Individuals who have undergone interventional or surgical procedures related to the temporomandibular joint,
* Temporomandibular joint pathology,
* Pregnancy or breastfeeding,
* Individuals who do not come for postoperative checks,
* Using different medications other than those recommended,
* Allergy to study drugs and materials to be used
Bone Microarchitecture in Osteopenic Postmenopausal Women

The purpose of this trial is to compare the difference in bone microarchitecture of the distal radius at month 12 in postmenopausal osteopenic women treated with risedronate 150mg taken once a month compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Female: 40 and 57 years of age inclusive
* cessation of menstruation (surgical or natural) between 12 and 36 months prior to study enrollment
* have osteopenia defines as having the following: have osteopenia defined as having the following:
* Lumbar spine (L1-L4) Bone Mineral Density (BMD) T score -1 and less than -2.5 AND a total hip T score of greater than -2.5 OR
* Lumbar spine (L1-L4) BMD T score greater than -2.5 AND a total hip T score -1 and less than -2.5;
* have a body mass index (BMI) between 18 and 30 kg/m2.

Exclusion Criteria:

* history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
* use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
* hypocalcemia or hypercalcemia of any cause
Pathobiomes in Gut of Critically Ill Patients

Despite powerful antibiotics, 50% of the intestinal tracts of critically ill surgical patients are colonized by Pseudomonas aeruginosa, whose mere presence in this site increases mortality fourfold by mechanisms that remain unknown. Many patients who survive the initial surgical trauma still succumb to multi-organ failure and septicemia secondary to an invasive nosocomial infection. The sequelae of shock, hypoxia, and parental nutrition result in injury to the intestinal mucosa, changes in gut permeability, and failure of intestinal defense mechanisms. These conditions put patients at risk for infection and multiple organ failure secondary to the translocation of enteric bacteria, initiating a systemic release of inflammatory mediators-a process that has been termed gut-derived sepsis.

Intestinal P. aeruginosa senses host factors released during stress and responds by activating its virulence gene machinery. As such, the presence of a highly activating intestinal milieu serves to induce virulence in strains of P. aeruginosa and this correlates to the severity of a patient's illness. While the host-pathogen interaction is a dynamic process, the study expects that as a patient's illness worsens or resolves over time, the "virulence-activating" properties of their intestinal milieu will change accordingly. This study will conduct a prospective observational trial in a population of critically ill patients at the Universtiy of Chicago Medical Center. This trial will entail collecting and screening stool samples obtained from critically ill patients for their virulence inducing capabilities on laboratory strains of P. aeruginosa using in vitro and in vivo assays. The study also plans to isolate strains of intestinal P. aeruginosa from stool samples to determine the prevalence of intestinal P. aeruginosa in a population of critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* Any ethnicity
* Age \> 18 years and \< 85 years

Exclusion Criteria:

* A known history of HIV/AIDS
* Active pregnancy
* Are incarcerated will be excluded from the study.
Prevalence of Internet Gaming Addiction in Adolescent

Excessive problematic use of the internet has been a topic of discussion in the academic literature for many years and has gained more attention recently. The majority of those at risk are in early adulthood. Pathological internet use (PIU) is also termed internet addiction disorder (IAD), with both terms used to link internet use with addiction terminology.

Consistent with other psychiatric conditions such as depression symptoms, PIU prevalence rates among adolescents vary widely from as low as 0.3% to 38%. Likewise, PIU prevalence among college students (young adults) showed a wide variation ranging from 3% to 34%, worldwide. Nowadays, internet gaming addiction became a problematic issue in adolescent.

This is a case -control study, aimed to evaluate the prevalence and risk factors of internet gaming addiction among adolescents and its relationship with emotion regulation and comorbid psychiatric disorders.


Eligibility Criteria:
Inclusion criteria:

1. Both males and females were included.
2. Age ranges from 10- 18 years.
3. Willing of the parents or the caregivers to participate in the study.

Exclusion criteria:

* Children with intelligence quotient below 70.
* Children with history of substance use or psychiatric disorders.
* Children with medical or other neurological conditions.
Assess Safety and Performance of the Kronos Electrocautery Device for Electrocautery Procedures Following Coaxial Biopsy Procedures

The primary objective for this study is to assess safety and performance of the Kronos Electrocautery Device for electrocautery procedures following coaxial biopsy procedures on areas that include, but are not limited to, liver, kidney, lungs, breasts, soft tissue, etc.

The Kronos Electrocautery Device is intended to be used in electrocautery procedures to control bleeding by use of electrical current to heat the device probe tip that is applied directly to the target tissue area of treatment. Prospective, multi-center, single-arm study with consecutive, eligible subject enrollment at each site. Patients who require a coaxial biopsy procedures on areas that include, but are not limited to, liver, kidney, lungs, breasts, soft tissue, etc., will be eligible to participate in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing a scheduled, elective, coaxial biopsy procedures on areas that include, but are not limited to, liver, kidney, lungs, breasts, soft tissue, etc.,
2. Patients have signed an informed consent
3. Patients who are ≥ 18 years of age

Exclusion Criteria:

1. Patients with known bleeding disorder
2. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
3. Women of childbearing potential who are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation.
4. Active illness or active systemic infection or sepsis.
Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk

This study will test the effectiveness, implementation outcomes, and cost effectiveness of a community-tailored, harm reduction kiosk in reducing HIV, hepatitis C, and overdose risk behavior in rural Appalachia. The proposed project will take place in two counties in Appalachian Kentucky, an epicenter for the intertwined national crises of injection drug use, overdoses, and hepatitis C.

This is a Type 1 hybrid effectiveness study involving a community-level, controlled quasi-experimental trial to assess the impact of a community-tailored harm reduction kiosk on HIV, HCV, and overdose risk in rural Appalachia, and a mixed methods evaluation of implementation outcomes. The trial will compare the standard local syringe service program (SSP) design (brick-and-mortar, staffed by department of health staff) to an enhanced model involving a harm reduction kiosk + standard SSP. The kiosk, referred to as the KyOSK (Kentucky Outreach Service Kiosk) will be tailored through a community-engaged adaptation process. For evaluation of the KyOSK's impact on HCV and overdose risk behavior, the investigators will enroll 750 People Who Use Drugs (PWUD) in the intervention (n=425) and comparison (n=325) counties, collectively referred to as the kiosk trial cohort. The kiosk trial cohort will be recruited from three sources: existing cohorts of PWUD, SSPs, and peer-referral. Throughout the trial and following the implementation outcome framework (IOF) measurement model by Proctor et al., acceptability, appropriateness, fidelity, cost, penetration, and sustainability will be assessed using a combination of validated scales, qualitative interviews, checklists, invoices, and program data. Following the trial, the investigators will use data collected from the kiosk cohort and implementation outcome assessment (primarily cost and reach) in a dynamic, deterministic model of HCV transmission and overdose to examine the impact and cost-effectiveness of the KyOSK model.

Eligibility Criteria:
Inclusion Criteria:

Individuals are eligible if they are:

* age 18 or older,
* live in the intervention or comparison county, and
* have engaged in injection or non-injection illicit drug use to get high in the past 6 months (excluding marijuana, alcohol, and tobacco).

Exclusion Criteria:

Individuals are not eligible if they meet any of the exclusion criteria:

* being under the age of 18,
* not living in the intervention or comparison county,
* having not engaged in injection or non-injection illicit drug use to get high in the past 6 months (excluding marijuana, alcohol, and tobacco),
* not being able to speak or understand English,
* conviction in the past 10 years of a violent crime (i.e., murder, manslaughter, rape, robbery, and /or aggravated assault) or stalking,
* current charges of violent crime or stalking, or
* having plans to move out of the study counties in the next 6 months, or residing in an inpatient facility.
Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions

The objective of this study was to prove the bioequivalence of Oxymorphone Hydrochloride 10 mg Tablets under fasting conditions


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to oxymorphone hydrochloride or any comparable or similar product.
Dose Escalation of BCX10013 in Participants with Paroxysmal Nocturnal Hemoglobinuria (PNH)

This is a multicenter, open-label, intra-subject, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and therapeutic potential of BCX10013 in participants with PNH. Approximately 8 participants will be enrolled in this study. Participants may receive treatment for up to 52 weeks.


Eligibility Criteria:
Key Inclusion Criteria:

1. Male or non-pregnant, non-lactating female adults ≥ 18 years old.
2. Documented diagnosis of PNH confirmed by flow cytometry.
3. Body mass index (BMI) ≤ 40 kg/m\^2.
4. Are either: (a) naïve to treatment with a complement inhibitor; or (b) have received no treatment with ravulizumab for at least 12 months prior to the screening visit and have received no treatment with eculizumab or pegcetacoplan for 6 months prior to the screening visit.
5. Documentation of current vaccinations against N. meningitidis, S. pneumoniae, and H. influenzae type B \[Hib\] or willingness to start vaccination series at least 14 days prior to Day 1.

Key Exclusion Criteria:

1. Known history of or existing diagnosis of hereditary complement deficiency.
2. History of hematopoietic cell transplant or solid organ transplant or anticipated candidate for transplantation during the study.
3. Myocardial infarction or cerebrovascular accident within 30 days prior to screening, or current and uncontrolled clinically significant cardiovascular or cerebrovascular condition, including unstable angina, severe congestive heart failure, unexplained syncope, arrhythmia, and critical aortic stenosis.
4. History of malignancy within 5 years prior to the screening visit.
5. Treatment with anti-thymocyte globulin within 180 days prior to the screening visit.
6. Initiation of treatment with an erythropoiesis-stimulating agent (eg, erythropoietin), a thrombopoietin receptor agonist (eg, eltrombopag), or danazol within 28 days prior to the screening visit.
7. Receiving iron with an unstable dose (ie, increasing or decreasing) in the 28 days prior to the screening visit.
Multisite Virtual Reality Intervention for Speech Anxiety

Exposure-based cognitive behavior therapy is an efficacious treatment for speech anxiety and has been delivered effectively in a virtual reality (VR) environment. The present multicenter study (conducted through the Exposure Therapy Consortium) is designed to evaluate whether trait versus state positive affectivity is a more effective predictor of exposure therapy outcomes. Further, the investigators will examine whether the predictive significance of trait positive affectivity can be accounted for by examination of baseline levels of self-efficacy, hope, and optimism.

The goal of this multicenter clinical trial is to examine predictors of VR exposure therapy outcomes for college students with public speaking anxiety following a positive or negative mood induction. The overarching aim of the present study is to evaluate whether trait versus state positive affectivity is a more effective predictor of exposure therapy outcomes. Further, the investigators will examine whether the predictive significance of trait positive affectivity can be accounted for by examination of baseline levels of self-efficacy, hope, and optimism. State affect is manipulated at an experimental level with affect induction procedures; trait positive affectivity is measured at baseline.

The study involves three phases: (1) initial screening, (2) in-person assessment and brief exposure intervention for a subset of participants with elevated public speaking anxiety, and (3) a one-week follow-up assessment conducted online. Students who choose to participate and screen high on a public speaking anxiety scale will be assigned to a positive or negative mood induction condition prior to undergoing VR-based exposure therapy. Public speaking and social anxiety outcomes are measured immediately post-intervention and one week later. The one-week follow-up assessment represents the primary outcome.

Eligibility Criteria:
Inclusion Criteria:

* Self-report of 18 - 70 years of age
* Current student at a participating University
* Ability to read English to provide informed consent
* Familiarity with a computer keyboard and mouse or a touch screen device (e.g. phone, tablet).
* For Phase 2: speech anxiety scale score of ≥ 18 on the Personal Report of Communication Apprehension, Public Speaking Subscale (PRCA-PS)

Exclusion Criteria:

* Previous participation (i.e., no participant may take the survey more than once).
A Study of IMC-RON8 in Advanced Solid Tumors

A dose escalation study to determine the maximum tolerated dose of IMC-RON8 in participants with solid tumors. Participants can either be dosed once a week, or once every other week.


Eligibility Criteria:
Inclusion Criteria:

* The participant has histologically-confirmed advanced primary or recurrent solid tumors that have not responded to standard therapy or for which no standard therapy is available
* The participant has measurable or non-measurable disease
* The participant has not received major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy within 28 days prior to the first dose of study therapy
* The participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2
* The participant has adequate hematologic function
* The participant has adequate renal function as defined by serum creatinine ≤1.5 times the institutional upper limit of normal (ULN)
* The participant has a life expectancy \>3 months

Exclusion Criteria:

* The participant has received chemotherapy or therapeutic radiation therapy within 28 days prior to the first dose of study therapy
* The participant has ongoing toxicities of \>Grade 1 associated with any prior treatment
* The participant has a known sensitivity to monoclonal antibodies or other therapeutic agents, or to agents of similar biologic composition as IMC-RON8
* The participant has received treatment with any monoclonal antibodies within 6 weeks prior to first dose of study therapy
* The participant has received treatment with agents specifically targeting the RON ligand or receptor within 6 weeks prior to first dose of study therapy
* The participant has undergone a major surgical procedure, open biopsy, or experienced a significant traumatic injury within 28 days prior to the first dose of study therapy
* The participant has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia (well controlled atrial fibrillation is permitted), psychiatric illness/social situations, active bleeding, or any other serious uncontrolled medical disorders in the opinion of the investigator
* The participant has known or suspected brain or leptomeningeal metastases (participants with a history of brain metastases must have received definitive surgery or radiotherapy, be clinically stable, and may not be taking steroids; participants receiving anticonvulsants are eligible)
* The participant has a serious or nonhealing active wound, ulcer, or bone fracture
* The participant is currently using or has received a thrombolytic agent within 28 days prior to first dose of study therapy
* The participant is receiving full-dose warfarin (participants receiving low-dose warfarin to maintain the patency of permanent, indwelling intravenous catheters are eligible if the international normalized ratio is \<1.5)
* The participant is receiving intravenous heparin
Gardner Packard Healthy Lifestyles Program

Gardner GOALS is a 6 month program for treatment of childhood obesity that consists of twice monthly telehealth meetings with a health educator. Potential participants enter the study using a randomly ordered list of eligible patients based on BMI, age and number of clinic visits in 2020.

The Gardner GOALS curriculum focuses on healthy eating and activity. The study participants are kids 6 to 14 years old with BMI ≥95th percentile who are patients at the Gardner Packard Children's Health Center, a federally qualified health center. Lessons contain educational materials and behavioral change strategies to promote healthy eating and physical activity and reduce screen time. Patients are encouraged to continue routine clinic visits with their primary care physicians during the course of the study.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 95th percentile
* Two clinic visits in 2020

Exclusion Criteria:

* Signs of an eating disorder
* Moved out of town and not planning to return to Gardner Packard Children's Health Center
Aromatherapy for Anxiety Among Children With Autism Spectrum Disorder

This study evaluated the use of bergamot aromatherapy in the treatment of anxiety in a medical office setting among children who are diagnosed with an autism spectrum disorder. H

Bergamot aromatherapy relieves anxiety in adult populations but has not been tested in a pediatric population with autism spectrum disorder. Because autism spectrum disorders often include hypersensitivity to sensory experiences, the use of essential oils in this population should be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Between 6-11 years of age
* Diagnosed with an autism spectrum disorder

Exclusion Criteria:

* none
BinaxNOW for Evaluating Children for Infection With SARS-CoV-2 (COVID-19)

This is a study of the BinaxNOW Covid-19 Ag Card as a method to rapidly identify SARS-CoV-2 infection in asymptomatic children, teachers, and other school staff for exclusion. 240 students and 80 teachers in the Madison Metropolitan School District (MMSD) will be enrolled and can expect to be on study for up to 8 weeks.

The overall purpose and research goal of this project is to understand how the virus SARS-CoV-2 is spread in the K-8 setting, decrease secondary cases of COVID-19, improve attendance and educational opportunities for children, teachers and other school staff, and decrease time away from work for parents (with threat of loss of employment and other benefits).

The investigators hypothesize that prompt diagnostic testing for SARS-CoV-2 in symptomatic children and twice weekly surveillance of asymptomatic children (with appropriate exclusion of children with positive tests) will be effective as a strategy to achieve maximum attendance in school and minimal disruption of the associated workforce.

STEP 1: Determine feasibility of using BinaxNOW COVID-19 cards for surveillance of infection with SARS-CoV-2 in teachers, other school staff, and school children.

The specific aims are to determine:

* if it is feasible to obtain nasal samples to be used with the BinaxNOW COVID-19 for diagnosis of COVID-19 in children or teachers/other school staff.
* if it is feasible to obtain nasal samples twice weekly to be used with BinaxNOW COVID-19 for surveillance of infection with SARS-CoV-2.
* The specificity of positive tests for SARS-CoV-2 obtained for diagnosis or surveillance compared to traditional PCR diagnostic testing.

STEP 2: Determine effectiveness of prompt diagnostic testing and twice weekly surveillance for SARS-CoV-2 among children and school faculty/staff to reduce the rate of positive cases (symptomatic) of COVID-19 in an elementary school setting resulting in an ultimate decrease in absenteeism for students and an increase in attendance for their parents at the workplace.

This is a record of the pilot study (STEP 1).

Eligibility Criteria:
Inclusion Criteria:

* Children aged 5 - 15 years inclusive
* Currently attending school K-8 at one of the designated schools of the Madison Metropolitan School District
* Teachers and other school staff aged 20-65 years

Exclusion Criteria:

* Children \< 5 years or \> 16 years
* Teachers and other school staff \< 20 years or \> 65 years