cyrilzakka/clinical-trials huggingface dataset:
Predictive and Prognostic Value of Inflammatory Markers and microRNA in Stage IV Colorectal Cancer

This study investigates the predictive and prognostic values of inflammatory markers and microRNA in stage IV colorectal cancer. The expression of inflammatory markers and microRNA in plasma will be correlated with tumor location, with dietary patterns and with survival during treatment.

Colorectal cancer (CRC) is responsible for 10% of the world-wide cancer incidence and mortality. Recent data have shown that tumors arising from different regions of the colon differ in their molecular characteristics which causes translate into a differential clinical outcome.Several studies described the role of microRNA expression in the initiation and progression of CRC and its response to different therapeutic strategies. Other studies have shown that systemic inflammation is a key determinant role of clinico-pathological outcomes in patients with CRC. We therefore aim to evaluate the expression of selected microRNA and inflammatory markers in patients with stage IV colorectal cancer and assess their correlation with tumor location, dietary patterns, survival rates, response to systemic chemotherapy and other clinic-pathological parameters. We believe that identifying a predictive and prognostic panel made up of circulating microRNA and inflammatory markers may perhaps explain the difference in outcome between right and left colon and perhaps impact the clinical practice in patients with stage IV colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed Stage IV colorectal cancer
2. Treatment naïve
3. For the control group: adult individuals (above 18 years) with no cancer disease

Exclusion Criteria:

Any disease or condition that may alter the inflammatory and immune status of subjects at baseline, such as:

1. Diagnosis of inflammatory bowel disease such as ulcerative colitis and crohn's disease.
2. Diagnosis of active systemic autoimmune disease
3. Chronic / recent use of corticosteroids
4. Use of immunosuppressant drugs
Effects of Additional Fentanyl to Epidural Bupivacaine for Post-Thoracotomy Pain in Neonates

The study exams whether adding an opioid to the epidural infusion of a local anesthetic in neonates will significantly improve the quality of the postoperative analgesia.

The purpose of this study is to evaluate the best pain medication to be infused in the epidural catheter. At CHOP, the medication infused in the epidural catheter following a chest operation in neonates is a local anesthetic (bupivacaine). However, even with this continuous infusion, neonates still require multiple doses of intravenous opioids (i.e. morphine) because of persistent or constant pain. The administration of intravenous opioids in neonates can have many side effects, such as respiratory depression (reduced breathing rate), sedation, urinary retention (inability to pass urine), itching, nausea and vomiting It has been well documented that by adding a small dose of any opioid to a local anesthetic given through an epidural catheter, the feeling of postoperative pain can be significantly improved in older children and in adults. It is not known whether the addition of an opioid to a local anesthetic is beneficial in neonates. In this study, we are comparing the standard local anesthetic (bupivacaine) with a combination of bupivacaine and a small dose of an opioid (fentanyl).

This is a randomized study and the type of medication given into the epidural catheter will be chosen on the day of the operation by a random drawing (like flipping a coin). Your child could receive one of the following:

1. bupivacaine 0.1%
2. bupivacaine 0.1% with fentanyl 2mcg/ml Neither you nor your doctors will know which arm of the study your child is in. In case of emergency, the pharmacy can tell your doctor what medication your child is receiving.

Eligibility Criteria:
Inclusion Criteria:

1. Infants 0-6 months of age who require a thoracotomy for lung resection.
2. Parents accept the placement of an epidural catheter.

Exclusion Criteria:

1. Premature infants
2. Patients allergic to fentanyl and/or bupivacaine.
3. Known medical contraindications. -
Gait Modification Treatments for Knee Pathology

The objective of this study is complete a longitudinal cross-over clinical study to investigate the effect of treatments for knee pathology, including cutaneous stimulation (skin vibration and soft knee brace), on locomotion tasks (i.e. walking, jogging, stair ascending and descending), muscle function, and pain/function.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Ambulatory
* Symptomatic knee pain ≥ 3/10 on most of the past 30 days
* Prior ACL injury/surgery, meniscus injury/surgery, and/or physician-diagnosed medial compartment knee osteoarthritis (KL grade 1-3)
* Agreement and ability to use provided interventions during the study period (suggested cumulative wear time during walking of 1-2 hr/day)
* Committed to not starting any new therapies for knee condition during the trial, other than rescue pain medication.

Exclusion Criteria:

* Use of walking aid (e.g. cane, crutch, walker, or wheelchair)
* BMI ≥ 35 kg/m2
* Injection in the affected knee during the previous three months
* Known neuropathy due to diabetes or other causes
* Inability to provide informed consent
Sensory-Play Based (SenPlay) Intervention for Young Children With or At Risk for ADHD

The purpose of this pilot study is to determine the effects of 15 minutes of sensory-play based (SenPlay) intervention on improving focused attention in developmentally appropriate tasks in young children with or at risk for ADHD.

After being informed about the study and potential risks, written consent will be obtained by the investigators. Twenty participants will be recruited for this randomized, experimental study with a two-group longitudinal, pre-posttest, linear association study design to measure attention levels and off-task behaviors. All participants will attend a total of four sessions. The investigator, a registered, licensed occupational therapist, will lead all intervention sessions utilizing a set protocol. Participants will complete an intake session to determine baseline fine motor skills for developmentally appropriate tasks (DAT) before being randomly assigned to either the control group or the SenPlay intervention group. The control group will engage in spontaneous, free play with the supervising only for safety within the sensorimotor gym (see image 1) for 15 minutes, prior to the assessment of off-task behaviors during 10 minutes of DAT. The intervention group will engage in 15-minutes of SenPlay intervention, followed by assessment of off-task behaviors during 10 minutes of DAT. The 10 minutes of DAT will be coded at the beginning of each 15 second interval (Wood et al., 2016) for a total of 40 observation periods. The percentage of on and off-task behaviors will be calculated. Two coders, blinded to the group assignment will code session. Prior to the study, both coders will achieve a reliability of at least 95% accuracy in training sessions.

Eligibility Criteria:
Inclusion Criteria

* Age 3-years, to 5-years, 11-months
* Diagnosis or provisional diagnosis of ADHD or overactivity by the primary care physician, psychologist or neurologist
* No diagnosis of neurological disorders other than ADHD
* Normal or corrected vision
* Cognitive skills to follow verbal instruction
* Gross and fine motor skills to engage in sensorimotor activities and school readiness tasks

Exclusion Criteria:

* Participants will be excluded if they currently take medication for ADHD or exhibit severe physical impairments that result in inability to engage in the SenPlay intervention, fine motor and visual motor activities.
Impact of OCT Imaging on Decision Making During PCI in ACS Patients

Optical coherence tomography (OCT) provides valuable information to guide percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) regarding lesion preparation, stent sizing, and stent optimization.

OCT can be used in acute coronary syndrome (ACS). ACS has more complex culprit lesion morphologies and larger extent of coronary atherosclerosis compared with stable coronary artery disease. The detailed vascular information obtained by OCT may impact PCI in ACS, and which may improve acute results and late outcomes of PCI. Stent expansion immediately after PCI is a strong predictor of late outcomes of PCI, and it is associated with late clinical outcomes in many previous trials.

Eligibility Criteria:
Inclusion Criteria:

* Patients presented with acute coronary syndrome.
* PCI was done to them with stent implantation.

Exclusion Criteria:

* Multivessel PCI at the index procedure.
* Patients with ACS due to graft failure post CABG.
* Patients treated with no stent implantation.
Supplementation Trial on Arginine With Metabolic Profiling

This study will assess effects of an acute dose of the amino acid arginine on metabolism in healthy young men.

A double - blind randomized, crossover design trial examining arginine vs. placebo beverage treatments will be performed. The primary objective is to determine the effects of arginine assessed by standard laboratory assays and metabolomics. To accomplish the objective standardized meals will be provided for 2 days preceding treatment for dietary consistency. Participants will arrive at the center following a 10-12 hr fast. Blood samples will be collected at baseline (fasting), 1.5 hrs, 3.0 hrs, 6.0 hrs, and 24 hrs post treatment. Plasma prolactin, growth hormone, amino acids, glucose, insulin, triacylglycerols, thyroid hormones (TSH, T3, and T4), sex hormone binding globulin (SHBH), testosterone, cortisol, DHEA, and citrulline will be measured. Metabolomics will be measured at 3 time points for each treatment. Peripheral arterial tonometry (PAT) will also be performed at \~2 hrs following treatment to examine endothelial function in response to nitrous oxide release. In addition, psychological status including fatigue will be assessed using a standardized mood questionnaire (POMS).

Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5 - 25 kg/m2.
* Must be physically active (exercise at least 2 days/week).
* Willing to refrain from alcohol and supplements for the duration of the study.
* Willing to refrain from supplement ingestion, nuts, watermelon, and cracklins (fatback) for the 2 weeks prior to the initial treatment diet through the duration of the study.

Exclusion Criteria:

* HIV or AIDS
* Uncontrolled CVD/arrhythmia
* Type I or type II diabetes
* Pregnancy (or breastfeeding)
* Diagnosed eating disorder
* Non-normal sleeping patterns
* Chronic neurological condition
* Altered metabolism including growth hormone disorders
* Use of nicotine or tobacco products
* Heavy caffeine use (≥ 350 mg caffeine/d)
* Whole blood donation within previous eight weeks
* Protein supplementation
* Protein wasting disease.
* Exclusionary medications include diuretics, beta-blockers, weight loss medications or diet pills, anti-inflammatory drugs (corticosteroid/ anabolic steroid/NSAID), antipsychotic medication or other medication that may affect fluid balance, metabolism, or body weight.
* Prisoners and adults who are unable to consent will be excluded from the study.
* Lastly any other medical, psychiatric, or behavioral factors in the judgement of the Principle Investigator that may interfere with study participation or the ability to follow the protocol.
Relative Bioavailability Study in Healthy Subjects Comparing 2 Dry Powder Oral Suspensions of Rivaroxaban Under Fasting and 20 mg of an Oral Suspension of Rivaroxaban Under Fed Conditions to 10 mg of an Immediate Release Tablet Under Fasting Conditions

Rivaroxaban is a substance developed for use in the treatment of blood coagulation disorders.Thrombosis (blood clots) can occur as a result of excessive coagulation activity in the blood vessels. Excessive coagulation activity can occur in children as well, and rivaroxaban is therefore being developed for the treatment of thromboembolic events in children and adolescents. As small children are often unable to swallow tablets, an oral suspension (mixture of a liquid containing finely distributed solids) has been developed which allows dosing according to body weight.The objective of this trial is to compare the bioavailability (proportion of a substance that remains available unchanged in the blood circulation) of a new oral suspension of rivaroxaban with a previously used oral suspension and with a rivaroxaban tablet approved for treatment. In order to evaluate the potential influence of food, the new oral suspension containing 20 mg rivaroxaban will be taken after consuming food. In addition, the pharmacokinetics (concentrations of the drug and breakdown products (metabolites) in blood), safety and tolerability will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* Age: 18 to 55 years (inclusive) at the first screening examination
* White
* Body Mass Index (BMI): ≥18.0 and ≤29.9 kg/m2 at the screening visit.

Exclusion Criteria

* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Known coagulation disorders (e.g. von Willebrand's disease, hemophilia)
* Known disorders with increased bleeding risk (e.g. periodontosis, hemorrhoids, acute gastritis, peptic ulcer)
* Known sensitivity to common causes of bleeding (e.g. nasal)
* Regular use of medicines and use of medication that may have an impact on the study objectives
* Clinically relevant findings in the ECG such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QTc-interval over 450 msec
* Clinically relevant findings in the physical examination
* Clinically relevant deviations of the screened laboratory parameters from reference ranges
* Participation in another clinical study during the preceding 3 months (Last Treatment from previous study to First Treatment of new study)
Leveraging mHealth and Peers to Engage African- Americans and Latinxs in HIV Care (LEAN)

This is a pragmatic randomized controlled study comparing existing linkage to care and retention (LTCR) services to an mHealth-enhanced linkage to care and retention (mLTCR) protocol.

Baltimore's HIV prevalence rate (586/100,000) is among the top 5 in metropolitan areas in the US, and disparities are profound. African Americans have an HIV prevalence that is 5 times higher than among whites, and account for 78% of all HIV cases. Latinxs also have a higher prevalence of HIV than whites and are at the highest risk for late HIV diagnosis among all racial/ethnic groups. In addition, HIV viral load suppression, which is the best predictor of long-term survival among HIV-infected patients, is substantially lower among minority populations in Baltimore.

The overall goal of this proposal is to evaluate whether mHealth-enhanced Linkage to Care and Retention (mLTCR) can improve HIV outcomes among HIV-infected African Americans and Latinos compared to standard Linkage to Care and Retention (LTCR) programs. The mHealth-enhancement consists of two smartphone applications (app), one for patients and one for patient supporters (e.g. linkage officers, patient navigators, nurses, etc.), to help facilitate communication. Communication will focus on issues related to HIV care (e.g. appointment scheduling, transportation), as well as patient-directed requests. Using HIV surveillance data (e.g. unsuppressed HIV viral load), patient supporters will be automatically alerted if a patient has a high viral load and prompted to contact the patient. In addition to appointment reminders, patients will receive positive reinforcement behavioral text messages.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Ability to provide consent
* Identified by BCHD Linkage protocol to be a new HIV diagnosis or HIV-infected and "out of care"
* Identified by participating clinics as needing patient support services

Exclusion Criteria:

* Not able to provide consent.
Preemptive Analgesia With Morphine Sulphate in Major Urological Surgery

In this study safety and efficacy of oral morphine sulphate is evaluated in order to reduce opioids administration during major urological surgery

The administration of oral morphine sulfate could be useful to reduce the use of opioids in major urological surgery. This study aims to assess the safety and efficacy of two different oral morphine sulphate doses 0,2 mg/kg vs 0,4mg/kg in major urological surgery.

Eligibility Criteria:
Inclusion Criteria:

American Society of Anaesthesiologists physical status classification I/ II, age between 18 - 75, BMI 18 -30

Exclusion Criteria:

American Society of Anaesthesiologists physical status classification III/ IV, renal and hepatic insufficiency, postoperative nausea and vomiting after oral opioids administrations, neurological and psychiatric disorders.
Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska Native Communities

This is a formative research study to test a culturally-centered, program-level implementation intervention to increase the use of medications for opioid use disorder in four healthcare and addiction specialty treatment sites serving American Indian and Alaska Native communities.

This is a formative research study to test a culturally-centered, program-level implementation intervention to increase the use of medications for opioid use disorder (MOUD) in four healthcare and addiction specialty treatment sites serving American Indian and Alaska Native communities. The study design is a cluster randomized stepped wedge implementation trial with two steps, and two sites per step (N=4 sites). Study design and methods are informed by the Consolidated Framework for Implementation Research (CFIR) and the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). The primary outcome of the trial is the number of consumers with OUD initiated onto MOUD (i.e., buprenorphine, extended-release naltrexone, or methadone) in the 6 months after intervention delivery (compared to the 6 months before intervention delivery) - capturing implementation intervention Reach. The primary outcome will be measured at the end of the six-month implementation stage and compared to the pre-intervention observation phase (prior to delivery of the implementation intervention). Primary data collection will use de-identified data from the electronic medical records (EMR) at each site beginning with data from the six months prior to intervention delivery for Step 1 sites and 12 months prior for Step 2 sites. For Step 1 sites, some secondary outcomes will also be assessed during the sustainment stage (the six months following implementation). As part of the study, consumers with OUD will be asked to participate in additional assessments and provide informed consent. Enrolled consumer participants will be asked to complete four assessment visits (baseline, week 4, week 8, and week 12) to collect comprehensive information about mental health, cultural connectedness and spirituality, social functioning, and experiences with and acceptability of OUD treatment. Providers at each clinical site will also be asked to complete surveys at three time points to assess attitudes, knowledge, and readiness related to MOUD.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent
* English comprehension and proficiency
* Receiving services at a participating study site
* Meet criteria for a current opioid use disorder
* Self-identify as American Indian or Alaska Native
* Willing to have program data linked to assessment data
* 18 years or older

Exclusion Criteria:

* participation in research assessments contraindicated
The Effect of Virtual Reality on Pulmonary Recovery and Mobility in Patients With Blunt Chest Trauma

Blunt chest trauma comprises over 10% of all trauma patients presenting to emergency departments worldwide and is the most frequent injury in polytrauma patients. It is associated with high risk (\>10%) of pulmonary complications such as pneumonia. Pillars of treatment are adequate pain relief, respiratory function exercises and rapid mobilisation through physiotherapy. Inadequate pain control can result in restricted ventilatory function and in reduced mobility, both resulting in a higher risk of particularly pulmonary complications. Virtual Reality (VR) might be an easy to use, individualized, and harmless technique that can facilitate pulmonary recovery and aid in the prevention of complications through reducing pain and promoting exercising. The investigators hypothesize that VR improves respiratory function and mobilisation in the post-acute phase of blunt chest trauma by distracting patients from pain and stress, and by stimulating pulmonary and physical exercise.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to the trauma ward with sustained blunt chest trauma
* Age≥16
* Patient is willing and able to comply with the study protocol

Exclusion Criteria:

* Neurotrauma with GCS ≤13
* History of dementia, seizures, epilepsy
* Severe hearing/visual impairment not corrected
* Head wounds or damaged skin with which comfortable and hygienic use is not possible.
* Stay at intensive care unit (ICU) during current hospital admission.
* Erect position in bed not possible/allowed.
Tdcs And cogNitive traininG cOmbined for AUD (TANGO)

The overarching goal of this project is to expand the traditional expertise in non-invasive neuromodulation at the University of Minnesota towards developing novel paired-neuromodulation approaches using transcranial direct current stimulation (tDCS) for new treatments for alcohol use disorder (AUD) that support long-term abstinence. This study will allow the investigators to discern whether the pairing of dorsolateral prefrontal cortex (DLPFC) stimulation and cognitive training can lead to improved treatment outcomes as it pertains to executive functioning and maintenance of abstinence. This paired-neuromodulation approach can potentially be used as a therapeutic intervention to decrease relapse probability in addiction. The long-term goal is to develop new addiction treatments that support long-term abstinence. The exploratory goal of this research is to associate genotypes and epigenetic changes with variations in intervention response and clinical outcome. Individual differences in baseline genetic profiles or epigenetic changes over the course of treatment could be associated with treatment response variability.


Eligibility Criteria:
Inclusion Criteria:

* Meet the Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria for AUD
* Abstinent from alcohol use
* Must have the intention to remain in the Lodging Plus program until the end of the intervention portion of the study.

Exclusion Criteria:

* Any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness\>30 min, HIV)
* A head injury resulting in a skull fracture or a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI)
* Any contraindications for tDCS or MRI scanning (tDCS contraindication: history of seizures; MRI contraindications; metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder)
* Any primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder); Participants with other treated and stable psychiatric disorders will be included
* Presence of a condition that would render study measures difficult or impossible to administer or interpret
* Primary current substance use disorder diagnosis on a substance other than alcohol except for caffeine or nicotine
* Clinical evidence for Wernicke-Korsakoff syndrome
* Left-handedness
* Entrance to the treatment program under a court mandate