cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Trimethylamine N-oxide (TMAO) Levels in Periodontal Disease

Salivary and serum levels of TMAO and TNF-α can distinguish between individuals with periodontitis and periodontally healthy individuals.

Trimethylamine N-oxide (TMAO), a gut flora-derived metabolite from dietary choline, has emerged as an indicator of atherosclerosis. Circulatory TMAO has been implicated in cardiovascular risks by altering enterohepatic cholesterol and bile acid metabolism, increasing macrophage scavenger receptor expression, and activating nuclear factor kappa B (NF-κB) via pro-inflammatory genes such as interleukin-1 (IL-1). The pro-inflammatory cytokine tumor necrosis factor-alpha (TNF-α), which plays a crucial role in immune responses and inflammation, has been demonstrated as a crucial participant also during the development of periodontal diseases. The aim of this study is to evaluate difference in salivary and serum levels of TMAO and TNF-α between individuals with periodontitis and periodontally healthy individuals.

The study includes two groups: systemically and periodontally healthy control subjects (n= 24), and patients with periodontitis (n=24). Periodontal parameters were recorded. TMAO levels in saliva and serum were determined by liquid chromatography-mass spectrometry (LC-MS/MS), and TNF-α levels were determined by ELISA.

Eligibility Criteria:
Inclusion Criteria:

* being over 18 and under 65 years of age;
* having at least 20 natural teeth excluding the third molars; and
* being systemically healthy.

Exclusion Criteria:

* being smoker;
* chronic use of any systemic medication
* use of antibiotics and/or anti-inflammatory steroids, nonsteroidal anti-inflammatory drugs, immunosuppressants, beta-blockers, calcium channel blockers, anticoagulants, or hormonal contraceptives within 3 months preceding the study;
* pregnancy or lactation; and
* use of orthodontic appliances
A Randomized-Control Study of Gym Tonic's Community Based Strength Training Intervention.

Launched in April 2015 , Gym Tonic is the first of its kind cross-border exercise-as-medicine partnership between research institutions, business enterprises and service providers from Singapore and Finland. What sets Gym Tonic apart from other exercise programmes is its singular focus on strength training, necessary for frailty prevention and maintenance of functional independence for the elderly.

This randomized-control trial is to validate the Gym Tonic programme and data as well measuring its effectiveness in improving physical functions and reversing frailty.

The RCT is conducted in 3 eldercare community centers. In each center, a group of elderly will be randomly sorted into 2 groups. An intervention group and a control group.

The intervention group will go through 12 weeks of Gym Tonic progressive training programme. While the control group acts as a control. After the first 12 weeks, the intervention group will be going through another 12 weeks of Gym Tonic maintenance programme, while the control group will be going through the Gym Tonic progressive training programme.

Measurements of physical functions, isometric strength and frailty will be conducted pre trial, post 12 weeks and post 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years and above
* Pre-frail or mildly frail, as measured by the 5 CHS criteria of physical frailty: unintentional weight loss, slowness, weakness, exhaustion, low activity level or FRAIL
* Able to ambulate without personal assistance
* Enrolled into the 3 sites above

Exclusion Criteria:

* Bedbound
* Terminally ill patients with life expectancy \<12 months
* Significant cognitive impairment
* Major depression
* Wear pacemaker
* Severe audiovisual impairment
* Any progressive, degenerative neurologic disease
* Participating in other interventional studies
* Unavailable to participate for the full duration of the study
Assessment of Superficial Femoral Artery Lesions With FFR From the ACIST Navvus® Catheter

This study is intended to help establish standard procedures for use of FFR in the peripheral arterial system and to evaluate the correlation of post-procedural FFR values and clinical outcomes in Superficial Femoral artery (SFA) interventions in subjects ages 18 to 79 with PAD.

The ACIST Navvus Rapid Exchange FFR MicroCatheter is a rapid exchange catheter with a pressure sensor located at the distal tip that allows the operator to use their preferred standard 0.014-inch coronary guidewire for peripheral vascular intervention (PVI), eliminating the need for a wire exchange. The fractional flow reserve (FFR) measurements obtained with Navvus represent the degree of stenosis in an artery via comparison of the distal lesion value to the proximal lesion value.

While FFR has evolved as the gold standard for identifying coronary stenoses that may cause myocardial ischemia, it remains underutilized in the diagnosis and treatment of peripheral lesions. FFR cutoff values which could guide PVI decisions are yet to be defined and accepted. Routine use of FFR in patients with peripheral artery disease (PAD) may play an important role in determining the appropriateness of interventions in the peripheral vasculature by introducing a more objective assessment. Shishehbor and Agarwal further highlighted the potential economic benefit of FFR use in peripheral vessels by stating "The Affordable Care Act and higher emphasis on quality rather than quantity should support the use of \[IVUS or FFR\] to make peripheral interventions more accurate, safer, and better".

This study is intended to help establish standard procedures for use of FFR in the peripheral arterial system and to evaluate the correlation of post-procedural FFR values and clinical outcomes in Superficial Femoral artery (SFA) interventions in subjects ages 18 to 79 with PAD (Rutherford Classification 2, 3, 4, or 5). FFR measurements will be collected using the Navvus catheter pre- and post-PVI. A subset of study subjects will also have post-intervention IVUS imaging performed with the Kodama catheter.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-79 at the time of planned SFA intervention
* SFA lesion requires intervention (according to ACC/AHA/SCAI/SIR/SVM 2018 Appropriate Use Criteria for Peripheral Artery Intervention, ABI, imaging, and/or clinical symptoms)
* Index SFA lesion is ≤150 mm
* Rutherford Classification of Peripheral Artery Disease (PAD) is Class 2, 3, 4, or 5
* Minimum two vessel run-off without a hemodynamically significant lesion below the treatment lesion (in at least one vessel to the foot) in the opinion of the treating physician

Exclusion Criteria:

* Study lesion is a Chronic Total Occlusion (CTO)
* Clinically significant (in the opinion of the treating physician) inflow disease of the aorta, common iliac, external iliac, or common femoral artery
* Presence of an additional hemodynamically significant stenosis within the SFA in the opinion of the treating physician
* Active cancer (any type)
* Life expectancy less than 1 year
* Pregnancy
Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections

This is a study to evaluate a new medication dosed once a week in the treatment of bacterial infections in the blood from intravenous catheters (CR-BSI). The primary objective is to evaluate the efficacy and safety of dalbavancin in the treatment of adults with CR-BSI relative to a standard of care treatment, vancomycin.


Eligibility Criteria:
* The patient or his/her legally authorized representative has given informed consent by means approved by the investigator's IRB/EC;
* \> 18 years of age;
* Had one or more central venous catheters at the time initial signs of infection were evident;
* Creatinine clearance \<50 mL/min;
* Bilirubin \> 2x the upper limit of normal;
* Treatment with an antibiotic effective against Gram-positive bacterial infections for more than 24 hours within 48 hours of study medication initiation,
* Prolonged antibiotic therapy for CR-BSI anticipated (i.e., \>2 weeks)
Preoperative Prediction of Flexible Ureteroscopy Outcome in the Treatment of Renal Calculi

To predict the outcome of flexible ureteroscopy in the management of renal stones based on preoperative scoring module using five preoperative parameters that have effect on stone free status postoperatively.

Although flexible ureteroscopy has been in use for decades, neither the European Association of Urology (EAU) nor the American Urological association (AUA), in their clinical guidelines, recommends flexible ureteroscopy (FURS) as a first-line procedural treatment for renal stones . Several reports showed that FURS is a suitable alternative to shockwave lithotripsy (SWL) and percutaneous nephrolithotripsy (PCNL) for the treatment of renal stones, with potentially higher stone-free rates than SWL and lower morbidity than PCNL.

Safe and effective removal by FURS of multiple and large intrarenal stones, including lower pole calculi, has been documented suggesting that FURS is effective for complex intrarenal stone removal . With the multitude of available procedures, selection of the optimal one for management of renal stone is becoming more challenging.

Established models for predicting the outcomes of SWL and PCNL exist . However, a predictive model for predicting the outcome of URS is still in development , particularly for FURS treatment of renal stones. Four scores have been developed for FURS. Two of these have been compared and validated in different cohorts: the Resolu Unsal Stone Score (RUSS) and modified Seoul National University Renal Stone Complexity (S-ReSC) score , the other two scores, the S.T.O.N.E score described by Molina et al. and Ito's nomogram.

Many studies have demonstrated that stone volume is the most significant factor predictive of stone-free status (SF) after FURS. The investigators speculate that stone volume combined with other variables might improve prediction of SF after FURS. The aim of the present study is to evaluate various preoperative parameters as predictors of FURS outcome based on the Ito's nomogram

Eligibility Criteria:
Inclusion Criteria:

1. Renal stones (≤ 2 cm)
2. Radiolucent stone resistant to SWL and oral chemical dissolution treatment (≤2cm)

Exclusion Criteria:

1. Large stones (\> 2 cm).
2. Staghorn stone (stone involving the renal pelvis and more than two calyces).
3. Patient preference of other treatment modality
Hemochromatosis--Genetic Prevalence and Penetrance

To examine the cost effectiveness of hereditary hemochromatosis (HH) screening in primary care.

BACKGROUND:

Hereditary hemochromatosis (HH) is the most common inherited disorder among Caucasians with an estimated frequency as high as 8 per 1000. Affected individuals absorb excessive amounts of dietary iron and develop progressive accumulation of tissue iron stores with consequent organ dysfunction including hepatic cirrhosis, diabetes mellitus, congestive heart failure, arthropathy and impotence. Early diagnosis and institution of phlebotomy treatments will prevent disease manifestations and normalize life expectancy. In 1996, HFE, the gene for HHC was mapped on the short arm of chromosome 6 (6p21.3). HH is therefore a natural target for the development of a routine screening strategy.

DESIGN NARRATIVE:

The investigators have demonstrated the favorable cost-effectiveness ratio of adopting a screening strategy for HH and have screened 16,031 primary care patients using serum transferrin saturation (TS) levels to confirm the prevalence of undiagnosed HH in this setting and to demonstrate the feasibility of screening. The recent description of HFE gene mutations in individuals with HH has made genetic testing for HH possible and may increase the attractiveness of general screening. However, several important questions about genetic prevalence and penetrance remain to be addressed before such a recommendation can be made. The large screened sample provides a unique opportunity to address several of these important issues. First, they will obtain population-based estimates of the prevalence of HFE gene mutations. Second, they will determine the sensitivity of serum TS testing for detecting these mutations. Third, the comparison of genotype and phenotype will allow them to draw useful inferences about disease penetrance. The results will enable them to propose an optimal screening strategy for HH and to determine the place of genetic testing in the diagnostic algorithm. This strategy may vary depending on age, sex and race. The answers to these questions will enable them to determine with greater confidence the relative effectiveness of a screening strategy for HH and will clarify for primary care practitioners which of their patients should be screened for this disorder. These questions have recently been identified as a priority by the Centers for Disease Control and Prevention and by the National Heart, Lung, and Blood Institute.

Eligibility Criteria:
No eligibility criteria
TB Screening Improves Preventive Therapy Uptake

HIV-infected people have an increased risk of developing active tuberculosis (TB). To reduce the burden of TB among people living with HIV (PLHIV), the World Health Organization (WHO) recommends systematic TB screening followed by 1) confirmatory TB testing for all those who screen positive and 2) TB preventive therapy (TPT) for all TPT-eligible PLHIV who screen negative.

The objective of the TB Screening Improves Preventive Therapy Uptake (TB SCRIPT) trial is to determine whether TB screening based on C-reactive protein (CRP) levels, measured using a rapid and low-cost point-of-care (POC) assay, improves TPT uptake and clinical outcomes of PLHIV, relative to symptom-based TB screening.

The overall objective of the TB SCRIPT trial is to evaluate the effectiveness and cost-effectiveness of POC CRP-based TB screening, which is the next step required for successful scale-up of both systematic TB screening and TPT. The study's central hypothesis is that compared to symptom-based TB screening, a TB screening strategy based on CRP levels measured at the point-of-care will improve TPT uptake, thereby reducing TB incidence and its associated mortality among PLHIV.

To test this hypothesis, the investigators will conduct an individual randomized control trial enrolling PLHIV presenting to clinics in Uganda for routine antiretroviral therapy (ART) initiation. Eligible participants will be randomized to either POC CRP-based TB screening (intervention arm) or symptom-based TB screening (control arm). In both arms, screen-positive participants will undergo confirmatory TB testing; participants found to have prevalent TB will be initiated on standard TB treatment. In both arms, screen-negative participants will be assessed for TPT eligibility; TPT-eligible participants will be initiated on standard TPT. All participants will be followed for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Confirmed HIV+ test result
* CD4 T lymphocyte count of ≤ 350 cells/μL
* Capacity to provide written (or witnessed verbal, if illiterate) informed consent

Exclusion Criteria:

* Completed treatment for active pulmonary or extra-pulmonary TB within the past 2 years
* Completed a full course of TPT within the past year
* Actively taking any internationally-approved medication for TB treatment for any reason, within 2 weeks of study entry
* Prior history of combined ART for HIV treatment for any duration (does not include single-dose ART for prevention of vertical transmission of HIV)
* Currently resides 25 km outside their enrollment site, plans to move 25 km outside their enrollment site in the next 2 years, or plans to transfer their HIV care from their current enrollment site
Study to Evaluate if Inhaled Nitric Oxide Improves Liver Function After Transplantation

This blinded, placebo-controlled study will administer inhaled nitric oxide to patients undergoing liver transplantation. The purpose of the study is to test if inhaled nitric oxide prevents liver injury associated with the restoration of blood flow. The premise of the current study is provided by previous studies which document a protective effect of inhaled nitric oxide in this clinical setting.

Specifically, presenting ischemia-reperfusion injury to transplanted livers remains a therapeutic goal in improving liver function and potentially expanding the number of transplantable livers. This study aims to assess the efficacy of inhaled nitric oxide to limit ischemia-reperfusion injury in transplanted livers and by doing so improve liver function post transplantation and decrease patient hospital length of stays.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 19 yr of age scheduled to undergo liver transplantation.

Exclusion Criteria:

* Patients \< 19 yr of age
* Patients undergoing re-transplantation or dual organ transplantation
* Patients with underlying pulmonary complications
Probiotics Effect on Mental Wellness

The goal of this clinical trial is to compare the effect of a probiotic strain on mental wellbeing in moderately stressed, healthy, adults in the general population. The main question it aims to answer is

• what is the impact of probiotic consumption on overall mental wellbeing? Participants will consume one probiotic or placebo capsule per day, answer a set of questionnaire (at 3 time points) and wear a wearable device for the total duration of the study.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 18-60 years old
* Currently living in the US.
* Have access to a smart phone, internet and computer.
* Report moderate levels of perceived stress.

Exclusion Criteria:

* Are currently taking medication for depression or anxiety
* Have had antibiotics within the previous month
* Have an allergy to coconut
Effect Mobility During Induction of Labor on Time to Delivery. A Randomized Controlled Trial

this is a andomized controlled trial the evaluates the effect of enhanced mobility, controlled via electronic pedometers, during induction of labor by extra amniotic balloon on time to delivery.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* low risk pregnancies
* singlelton
* vertex position
* undergoing labor induction with extra amniotic catheter
* no contraindication for enhanced mobility

Exclusion Criteria:

* medical recommendation for limited mobility
* status post cesarean delivery
* twin pregnancy
* premature rupture of membranes
* severe preeclampsia
* maternal comorbidity
A Pilot Study to Characterize the Household Impact of Locating Devices for Children With ASD Who Wander

This pilot study will obtain preliminary data about the impact of wearable electronic tracking devices (ETDs) as an intervention for children with autism spectrum disorders (ASD) who wander. The feasibility of all study procedures and the acceptability of the intervention will be evaluated.

Wandering, or elopement, is a life-threatening behavior that has been reported to occur in a third of all children with autism spectrum disorders (ASD). Wearable electronic tracking devices (ETDs) that are able to pinpoint a child's location have emerged as an appealing intervention for families concerned about wandering risk. However, the impact of ETD use on the families of children who wander has never been studied prospectively. In this pilot study, parents will be provided with a commercially-available ETD to use for their child with ASD for 6 weeks. Preliminary data will be obtained to evaluate the impact of ETD use on the strain experienced by families due to their child's wandering behavior. The feasibility of all study procedures will be assessed in preparation for a larger subsequent trial.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Parent of a child between the ages of 4 and 17 who currently has autism spectrum disorder (ASD), was diagnosed with ASD by a professional, and has wandered at least once in the preceding 3 months
* Currently lives in the United States
* Currently lives with child with ASD
* Has been living with child with ASD for at least 6 months
* Has reliable internet access to allow for completion of online questionnaires

Exclusion Criteria:

Current or past use of any electronic tracking device to address wandering behavior in the child with ASD
Effects of 4-AP on Functional SCI Recovery

The purpose of this study is to test a strategy to potentiate functional recovery of lower limb motor function in individuals with spinal cord injury (SCI). The FDA approved drug, Dalfampridine (4-AP). 4-AP will be used in combination of Spike-timing-dependent plasticity (STDP) stimulation and STDP stimulation with limb training.

Currently, research has shown that 4-AP has a positive effect on sensory and motor function rehabilitation in humans with chronic SCI in addition to decreasing recorded spasticity, increased sensation, and decreased pain. Utilizing limb training to promote recovery of motor function is enhanced by eliciting STDP in the limbs. An important strength of this aim is the combination of training and STDP, which aims at enhancing the beneficial effects of motor training by promoting plasticity in the corticospinal pathway. We hypothesize that introducing 4-AP into the STDP stimulation and STDP stimulation with lower-limb training will further improve motor function rehabilitation in patients with chronic SCI.

Eligibility Criteria:
Inclusion Criteria:

* Male and females between ages 18-85 years
* SCI at least 4 weeks post injury
* Spinal Cord injury at or above L2
* ASIA A,B,C, or D, complete or incomplete
* Possess the following abilities
* The ability to perform a small visible contraction with dorsiflexion and hip flexor muscles

Exclusion Criteria:

* Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
* Any history of renal impairment
* Any debilitating disease prior to the SCI that caused exercise intolerance
* Premorbid, ongoing major depression or psychosis, altered cognitive status
* History of head injury or stroke
* Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without history of seizure, and without anticonvulsant medication
* History of seizures or epilepsy
* Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold (see appendix 2)
* Pregnant females
* If a women of child bearing age is unsure of the pregnancy, and does not want to take the pregnancy test Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida, MS, or herniated disk
* Metal plate in skull
* Individuals with scalp shrapnel, cochlear implants, or aneurysm clips
* Individuals taking Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or PR Interval prolonging drugs
Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial

A novel temporary peripheral nerve stimulation system that delivers electrical stimulation therapy in a cubital tunnel release model will be evaluated for feasibility.


Eligibility Criteria:
Inclusion Criteria:

* Ulnar neuropathy at the elbow

Exclusion Criteria:

* Peripheral neuropathy outside of nerve of interest
* Patients with any active implanted device