cyrilzakka/clinical-trials huggingface dataset:
Asprosin Level in Individuals with Periodontal Disease

The aim of this study was to investigate the levels of asprosin hormone and tumour necrosis factor alpha (TNF-α) in gingival crevicular fluids and to compare its level with those in saliva and serum in patients with gingivitis and periodontitis.

This study is investigating the level of asprosin hormone in gingival crevicular fluid of patients with periodontal diseases such as gingivitis and periodontitis, and observing the healthy patient in terms of the hormone levels, as well. 75 volunteer patients aged 18-45 years old were included in this study. These patients were divided equally to three groups: Group I; periodontal health, Group II; gingivitis, Group III; periodontitis.The body fluids including serum, saliva and gingival crevicular fluid were collected from this participants according to the proper protocol and their storage was provided under certain conditions. ELISA tests for asprosin and Tumour necrosis factor alpha were made in laboratory. Also, clinical measurements such as plaque index, bleeding on probing, probing pocket depth were recorded at first visit day of the participants. The data were analysed according to the different periodontal conditions, and correlated with asprosin hormone and tumour necrosis factor alpha level in gingival crevicular fluid, serum and saliva.

Eligibility Criteria:
Exclusion Criteria:

* Those with any systemic disease
* Individuals who take medication regularly
* Pregnant or lactating women
* Individuals with menopause and anthropause
* Those who have undergone any periodontal treatment in the last six months
* Smokers
Assess the Absorption, Distribution, Metabolism and Excretion of AZD7325 After Intravenous and Oral Administration

The purpose of this study is to evaluate the absorption, distribution, metabolism and excretion of AZD7325 after intravenous and 14C labeled oral dose


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects Day 1
* Body Mass Index (BMI) \> 18 and \< 30kg/m2

Exclusion Criteria:

* Clinically relevant disease and abnormalities (past or present) which in the opinion of the investigator, may either put the subject at risk to participate in this study or may influence the results of the study or the subject's ability to participate in the study
* Use of prescription medication within 14 days of the first dose of the investigational product
* Blood loss in excess of 200 mL within 30 days of Day-1 in excess of 500 mL within 90 days of Day-1 or in excess of 1350 mL within 1 year of Day-1 or donation of blood products within 14 days of Day -1
Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects

Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours. Dosing adjustments will be based on the review of the subject's pain scores. Oxymorphone IR 5 mg will be provided to be used as supplemental "breakthrough" pain medication (as needed). Titration Period will end when the fixed dose of study medication is tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the open-label 3-month maintenance period on the fixed dose of study medication established during the Titration Period.

An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.

Eligibility Criteria:
Inclusion Criteria:

* Have chronic cancer or non-cancer pain, currently requiring treatment of pain with a strong opioid for at least 5 days (3 of 5 days at a dose greater than or equal to 45 mg/daily (qd) oral morphine equivalent)
* Weigh at least 50 kg
* Expected to continue to require a strong opioid for pain relief for at least 4 weeks and up to 4 months.

Exclusion Criteria:

* Have a life expectancy \<4 weeks
* Plan to undergo a surgical procedure within 3 days of study entry or during the Titration Period
* Have dysphagia or difficulty swallowing whole tablets
* Have a previous exposure to oxymorphone
* Have an ileostomy
Remote Use of the Asthma Control Test (ACT) to Improve Care of Children With Asthma

This study will assess whether adaption of the Asthma Control Test (ACT) and childhood Asthma Control Test (cACT) for mobile devices improves rate of completion and improves control of asthma in children and adolescents

Asthma is the most prevalent chronic disease of childhood with an overall prevalence of 10%. While effective therapies exist to control symptoms and prevent exacerbations, many asthma patients experience significant morbidity including limitations on daily activities as well as asthma exacerbations that lead to missed school (and work for care givers) and necessitate emergency department visits and hospitalizations. Among children from lower socioeconomic statues and in black and Hispanic families, asthma incidence and severity are even greater. Reasons for this disparity included decreased access to effective asthma care, increased exposure to tobacco smoke and environmental allergens, and underutilization of controller medicines. These groups have significantly increased resource utilization due to emergency department visits and hospitalizations. Optimal care for asthma patients, especially those with at highest risk, will therefore require new strategies for evaluating ongoing control and providing direct feedback to patients.

We propose to transform the way asthma care is provided through the use of an innovative patient centered technology -Trivox Asthma - to improve quality of care and outcomes for asthma patients while reducing the cost of care. Specifically we will extend Trivox Health to facilitate closer monitoring of patients with asthma through the existing web platform and a new mobile interface. This will allow asthma patients, their parents and school nurses to remotely input data on asthma control through smartphones and/or tablets. We will use the ACT+, an expansion of a validated measure currently utilized in both primary care and specialty clinics, to measure both asthma control and risk.

Effectiveness of this intervention will be measured by examining resource utilization and ongoing asthma control.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma
* Cared for at Boston Children's Hospital (Primary or secondary care)

Exclusion Criteria:

* Age \<4 or \>21
Correlation of Carotid Flow Time and Cardiac Output.

Assessment of common carotid artery flow is more easily done and can be taught more broadly than transthoracic echocardiography, providing a greater number of clinicians a tool to assess volume responsiveness. These assessments are of great importance to patients with COVID-19, who often present with hypotension requiring fluids, which must be balanced against limiting fluid administration to minimize pulmonary edema.

Optimizing volume status for patients in shock is of critical importance to their outcomes, both in the provision of helpful, and avoidance of harmful fluid volumes. As such, much work has been done to develop and assess measures of volume responsiveness; that is, tests that indicate whether additional fluid administration will increase cardiac output by at least 10%. The passive leg raise (PLR) providing a reversible "auto-bolus" has been demonstrated to be the most predictive assessment of fluid responsiveness.

Recent studies of changes in carotid artery blood flow suggest it can be used as a surrogate for changes in cardiac output with moderate reliability. This has been assessed in several populations with anticipated changes in volume status (e.g. before/after blood donation), and more recently assessed by Sidor et al. against several preload augmenting maneuvers. Interestingly, while decreasing preload resulted in a decrease in cardiac output and systolic carotid blood flow, it did not result in a decrease in corrected carotid flow time, although a PLR produced an expected increase in all measures.

In our study we seek to validate these results, questioning if there is a lower limit of corrected carotid flow time that de-couples the relationship between carotid systolic flow and corrected carotid flow time.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient admitted to hospital with diagnosed COVID-19, on up to 6L oxygen, and able to undergo leg compression testing and passive leg raise.

Exclusion Criteria:

* known cardiac disease, carotid atherosclerosis, prior right-sided neck surgery, chest wall deformity, or deep-venous thrombosis identified on admission
Study Using Combined Virtual 4-D Electromagnetic (EM) Tip-Tracked Devices & EBUS in Diagnosis of Lung Nodules

The purpose of this study is to determine the safety and biopsy yield of EM Tip Tracked devices compared to standard bronchoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Any adult patient aged 18 and older, able to sign an informed consent and is scheduled for flexible bronchoscopy with biopsies of peripheral nodules. Patient needs to have a recent chest CAT scan within last 4 weeks or will obtain a chest CAT scan prior to bronchoscopy.

Exclusion Criteria:

* Pulmonary nodules less than 1.0 cm
* patients must be able to tolerate general anesthesia
* patients with significant coagulopathy having International Ratio (INR)\>2.0 or Prothrombin Time (PTT) \>2x normal
* patients unable to tolerate bronchoscopy
* pregnant patients or patients who believe they are pregnant
* patients with implantable devices susceptible to Radio Frequency (RF) fields
* severely obese patients
Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)

This is a three arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.

Participants with chronic tinnitus will be provided with a CE marked neuromodulation device. Devices will be programmed with one of 3 stimulation parameter settings. After 12 weeks of use, differences in tinnitus severity scores will be compared between the 3 arms and within the arms for patient subtype analysis.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years of age
* The ability to read and understand English/German
* Willing and able to provide informed consent
* Willing to commit to the full duration of the study
* Have been experiencing tinnitus 3 months to 5 years
* Experiencing subjective tinnitus
* Baseline Tinnitus Handicap Inventory (THI) score of 28 to 76 points
* Baseline Minimum Masking Level (MML) of 20 to 80 dBHL
* Maximum AC pure-tone audiometry hearing loss of 80 dB HL at any test frequency in the range of 2 to 8 kHz or of 40 dB HL in the range of 250 to 1000 Hz either unilaterally or bi-laterally

Exclusion Criteria:

* If participant has been diagnosed with objective tinnitus
* Commenced usage of hearing aid within the last 90 days
* Cases where pulsatility is the dominant feature of tinnitus
* Patients whose tinnitus cannot be masked during MML assessment
* Meniere's disease
* Significantly severe Loudness Discomfort Level (LDL), \<30 dB SL
* Depression or neuro-psychological condition, previously diagnosed or identified from the State-Trait Anxiety Inventory (STAI) scores greater than 120
* Diagnosed with somatic tinnitus resulting from head or neck injury
* Temporomandibular Joint Disorder (TMJ)
* Current or previous involvement in medico-legal cases
* Pregnancy
* Oral piercings
* Neurological conditions that may lead to loss of consciousness (e.g. epilepsy) or is considered to be the dominant feature of the tinnitus, as assessed by audiologist or ENT consultant
* Severe cognitive impairment based on Mini Mental State Examination (MMSE), less than 20
* Pacemakers or other electro-active implanted devices
* Have used Neuromod Devices products in the past
* Participants currently prescribed drugs for a Central Nervous System pathology, i.e. epilepsy, Multiple Sclerosis (MS), Parkinson's, bi-polar disorder.
* The site Principal Investigator does not deem the candidate to be suitable for the study for other reasons not listed above
* Self-reporting episodes of Auditory hallucinations
* Abnormal Otoscopy as assessed by the Audiologist, including active Otitis Media, perforation and hearing loss that is identified as completely conductive
* Abnormal Tympanometry as assessed by the Audiologist
Biological and Behavioral Outcomes of Community Nature Walks

The investigators will test the efficacy of our proposed intervention to reduce embodied stress in four racial/ethnic groups (Black, Latinx, Pilipinx, and Pacific Islander) as a preventative intervention for health disparities found in these communities. The intervention is comprised of two phases. The first consists of community nature walks in a pristine redwood forest for six months. This is followed by chosen nature activities with family and/or friends for three months. The investigators will test the ability of these activities in nature to reduce chronic stress that underpins many health disparities using validated biological, behavioral, and sociocultural measures. The use of these measures is in alignment with the National Institute of Minority Health and Health Disparities (NIMHD) Research Framework, and will increase understanding of individual, interpersonal, community, and social level factors that lead to, and that can eliminate health disparities.

The investigators will test the efficacy of our proposed intervention to reduce embodied stress in four racial/ethnic groups (Black, Latinx, Pilipinx, and Pacific Islander) as a preventative intervention for health disparities found in these communities. The intervention is comprised of two phases. The first consists of community nature walks in a pristine redwood forest for six months. This is followed by chosen nature activities with family and/or friends for three months. The investigators will test the ability of these activities in nature to reduce chronic stress that underpins many health disparities using validated biological, behavioral, and sociocultural measures. The use of these measures is in alignment with the National Institute of Minority Health and Health Disparities (NIMHD) Research Framework, and will increase understanding of individual, interpersonal, community, and social level factors that lead to, and that can eliminate health disparities.

Eligibility Criteria:
Inclusion critieria:

* 18 years or older
* able to commit to a 9-month Nature Intervention (6-month walks; 3-month chosen nature activity)
* spoken languages: English, Spanish, or Tagalog
* able-bodied as in must be able to walk.

Exclusion criteria:

* pregnant women (and other gender identities who are pregnant)
* prisoners
* cognitively impaired
The Influence of Different Food Componente on Zinc Absorption in Young Adults Consuming Zinc Fortified Porridges Prepared From Maize, Beans and Sorghum: a Series of Six Similar Randomized, Single-blind Studies

The influence of different food componente on zinc absorption in young adults consuming zinc fortified porridge's prepared from maize, beans and sorghum: a series of six similar randomized, single-blind studies.


Eligibility Criteria:
Inclusion criteria:

1. Male or female of 18 to 45 years old
2. Body Mass Index in the range of 19 to 25
3. No mineral and vitamin supplements two weeks prior to the study and during the whole duration of the study

Exclusion criteria:

1. Any metabolic, gastrointestinal or chronic disease (according to the subjects own statement)
2. Long-term medication during the whole study (except for contraceptives)
3. Smoking
4. Pregnancy
5. Lactating
6. Earlier participation in any other clinical study within the last 30 days

   * Subject Withdrawal:

     * Incomplete consumption of test meal
     * Missing of test meal Missing of iv dose
     * Incomplete urine collection (studies 2-6); exceptions to be discussed for study 1
     * No blood sample at start of study
     * Consumption of food within 3 hours after iv dose - to be evaluated
     * Vomiting within 3 hours after test meal administration - to be evaluated
     * Sick subjects and subjects taking any medication during study - to be evaluated (postponement of test meal possible)
Gait in Low Back Pain Patients After Spinal Mobilization

Introduction: patients with chronic back pain as a result of degenerated disc disease, besides pain also present with impaired gait. The purpose of this study is to evaluate both the clinical data using clinical rating scales, such as Oswestry Disability Index Greek version (ODI), Numerical Pain Rating Scale for low back pain and leg pain (NPRS) and the Roland Morris Disability Questionnaire Greek Version, and kinetic and kinematic characteristics during gait analysis in patients with chronic low back pain as a result of the degenerated disc disease (Disc Degenerative Disease), before and after application of manual therapy techniques.

Methodology: for the purposes of the study, 75 patients suffering from chronic low back pain were randomly divided into 3 groups of 25 each. Each group received five sessions with the first group receiving manual therapy treatment (spinal mobilisation), the second a sham treatment and the third, classic physiotherapy (stretching exercises, TENS and massage). To evaluate the effectiveness of each treatment, the visual analog pain scale, two questionnaires (Oswestry and Roland Morris) and also an optoelectronic system for recording and analysis of gait (kinetic and kinematic data) were utilized.

This was a randomized controlled trial comparing the efficacy of spinal mobilization with other physiotherapy interventions (stretching, TENS application and Swedish type massage) and sham treatment in a group of chronic low back pain patients. The outcome measures included three dimensional gait analysis (kinetic and kinematic data) as well as clinical indicators (numerical pain rating scale, Oswestry disability index, Roland-Moris Disability questionnaire).

Eligibility Criteria:
Inclusion Criteria:

* low back pain for over 3 months
* recent lumbar MRI (up to 12 months)
* able to walk without the need of walking aids

Exclusion Criteria:

* leg length discrepancy of over 2 cm
* history of spinal surgery
* history of autoimmune disease
* history of spondylolysis and spondylolisthesis
* spinal fractures
* pregnancy
* respiratory and/or cardiac disease
* history of stroke
* hip, knee or ankle osteoarthritis
* cauda equina syndrome
* spinal inflammation
* spinal tumor
* steroid drug use in the last month
* osteoporosis
Observational Safety Study of Rituximab in Patients Diagnosed With Rheumatoid Arthritis (RA) Who Did Not Respond Adequately to TNF-alpha Blocker

This multi-center, observational, retrospective-prospective cohort study will investigate the safety of rituximab (MabThera) by collecting data from daily clinical practice on the use of rituximab and its relative clinical impact, particularly with regard to adverse events. Data from each patient will be collected over 24 months after enrolment in the study. Target sample size is up to 325 patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with RA who did not respond adequately to anti-TNF-alpha and who started rituximab (RTX) treatment in the 12 months before site initiation and were still under treatment when enrollment starts

Exclusion Criteria:

* Patients with serious infections
Home Food Delivery for Diabetes Management in Patients of Rural Clinics

Our long-term goal is to transform rural residents' management of T2DM. This study's objective is to determine the effectiveness of an intervention that is scalable and sustainable and promotes patient adherence by mitigating rural food insecure participants' difficulties associated with completing existing interventions. Our specific aims are:

1. Compare the effectiveness of the Healthy Food Delivery Intervention (HFDI) plus standard care and standard care alone to improve diabetes-related outcomes among rural food insecure patients with T2DM. Hypothesis: Compared with standard care alone, patients receiving the HFDI plus standard care will demonstrate improved: H1 glycemic control as measured by HbA1c; H2 cardio-metabolic risk factors: blood pressure, fasting glucose, fasting lipids, and BMI; H3 self-management: self-efficacy, adherence to self-management behaviors, and medication adherence; H4 patient-centered outcomes: diabetes-related distress, diabetes-related quality of life, and diabetes-related complications.
2. Compare the effectiveness of the HFDI plus standard care and standard care alone to improve diet quality among rural food insecure patients with T2DM. Hypothesis: Compared with standard care alone, patients receiving the HFDI plus standard care will demonstrate improved: H1 Healthy Eating Index 2015 (HEI-2015) scores; H2 fruit and vegetable consumption.
3. Compare cost-effectiveness to understand HFDI plus standard care costs in relationship to outcomes in relation to standard care alone. Hypothesis: The HFDI will be cost-effective based on traditional cost per additional quality-adjusted life year gained.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* report food insecurity
* report T2D (confirmed by having an HbA1c equal to or greater than 6.5 at initial data collection immediately following consent)
* Speak English or Spanish
* Currently lives at a rural address

Exclusion Criteria:

* conditions making it unlikely the participant will be able to follow the protocol, such as terminal illness, severe mental illness, severely impaired vision or hearing, eating disorder, or plans to move out of the geographic region
* Pregnant