cyrilzakka/clinical-trials huggingface dataset:
Effect of Chondroitin Sulphate on Synovial Inflammation in Patients With Osteoarthritis of the Knee

The purpose of this study is to determine the effect of a chondroitin sulphate conventional treatment on the degree of severity of synovitis, as measured by magnetic resonance in patients with knee OA with clinical synovitis.


Eligibility Criteria:
Inclusion Criteria:

* Primary OA of the knee according to ACR with synovitis criteria (warmth, swelling or effusion);
* OA of radiological stages 2 and 3 according to Kellgren-Lawrence;
* Minimum joint space width ≥2 mm in the medial femorotibial compartment on standing knee X-ray;
* VAS of pain while walking ≥40 mm.

Exclusion Criteria:

* Known allergy to chondroitin sulphate;
* Progressive or serious pathologies (cancer, AIDS,...);
* Other bone and articular diseases (antecedents and/or current signs) such as chondrocalcinosis, Paget's disease, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, hemochromatosis, Wilson's disease, osteochondromatosis;
* Corticosteroids (oral, injectable), indomethacin, therapeutic dose of glucosamine or chondroitin sulphate during the 12 weeks preceding inclusion;
* Hyaluronic Acid (intra-articular pathway) during the 26 weeks preceding inclusion;
* Radioactive synovectomy during the 12 weeks preceding inclusion;
* If the patient is receiving NSAID at baseline (D0), it should be maintained at a stable dosage as much as possible from D0 to D180. In the open phase of the study (D180 to D360), NSAID will also be allowed as rescue medication along with acetaminophen.
Videolaryngoscopy During Child Intubation

We hypothesized that the video-laryngoscopes are beneficial for intubation of pediatric manikins while performing CPR. In the current study, we compared effectiveness of three video-laryngoscopes and Macintosh (MAC) laryngoscopes during pediatric resuscitation with and without chest compressions using an child manikin.


Eligibility Criteria:
Inclusion Criteria:

* Give voluntary consent to participate in the study
* minimum 1 year of work experience in health care

Exclusion Criteria:

* Not meet the above criteria
* Wrist or Low back diseases
A Study of Intravenous MK-8226 in Participants With Moderate-to-Severe Atopic Dermatitis (MK-8226-003)

This is a 3-part study to assess the safety, tolerability, efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of MK-8226 in participants with moderate to severe atopic dermatitis. Part 1 (multiple rising dose study) objectives were to find the maximum tolerated dose (MTD) of MK-8226 and to assess safety and PK. Part 2 objectives were to determine safety, PK, and preliminary efficacy. Part 3 objectives were to further define safety and PK, and explore MK-8226 PK/PD to model the optimal dose range for future studies. The study was terminated early due to business reasons on 08 May 2014; final results from an analysis for Part 1 (efficacy, PK, safety, immunogenicity) and Part 2 (safety, immunogenicity) are summarized.

Part 1 of the study is a multiple rising dose assessment of the safety, tolerability, and pharmacokinetics of MK-8226 for a period of 12 weeks followed by a 20-week off-treatment follow-up period.

Part 2 of the study is an assessment of the safety, tolerability, and efficacy of MK-8226 for 12 weeks followed by a 20-week off-treatment follow-up period.

In Part 3 of the study, participants will be treated with MK-8226 for a period of 12 weeks followed by a 20-week off-treatment follow-up period to evaluate pharmacokinetic and pharmacokinetic correlations to assist with modeling the dose range planned for further studies.

Eligibility Criteria:
Inclusion Criteria:

* Body weight \>=40 kg
* Clinical diagnosis of atopic dermatitis for at least 6 months prior
* Candidate for systemic or phototherapy (i.e., failed topical treatment)
* Moderate-to-severe disease as defined by Body Surface Area (BSA) ≥10%, EASI ≥12, and IGA ≥3
* No clinically significant abnormality on electrocardiogram
* No history of active or latent tuberculosis (TB) and no signs or symptoms suggestive of TB
* No history of active or latent TB and no signs or symptoms suggestive of TB
* History of inadequate response to a stable (≥ 1 month) regimen of topical corticosteroids or calcineurin inhibitors within 3 months before the screening visit

Exclusion Criteria:

* Concurrent significant skin disease
* Any significant organ dysfunction within 6 months prior
* History of clinically significant heart disease
* History of neoplastic disease
* Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
* Infection requiring oral antibiotics within 2 weeks prior
* Receipt of a live virus vaccine within 4 weeks prior
* Inability to refrain from topical or systemic therapy during course of the study
* Had major surgery or donated or lost \>=1 unit of blood within 4 weeks prior
* Participation in another study within 4 weeks prior
* Current or regular user of illicit drugs or a history of drug or alcohol abuse within 1 year prior
* Pregnant, breast-feeding, or anticipated to conceive during the course of the study
Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain

The purpose of this 52-week open label study is to determine the long-term safety of a new opioid molecule, NKTR-181, in patients with moderate to severe chronic low back pain or chronic non-cancer pain.

This is an open-label safety and tolerability study in which approximately 600 subjects will receive NKTR-181 for up to 52 weeks. Subjects may include newly enrolled subjects and subjects who have recently completed SUMMIT-07 study.

This study will also investigate the pharmacokinetics of NKTR-181 in patients with chronic low back pain or chronic non-cancer pain.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-nursing female aged 18 to 75 years old
* Clinical diagnosis of moderate to severe, chronic low back or non-cancer pain for at least three months
* Not experiencing adequate pain relief or have failed previous treatment with non-opioid analgesics
* Opioid analgesia is necessary
* Currently taking no less than 10 mg but no more than 60 mg of morphine sulfate equivalents (MSE) per day of opioid analgesics for at least 7 days prior to entry
* Females of child bearing potential must be using a highly effective form of birth control. All subjects must agree to use double-barrier contraception during participation in this study and for at least 2 months after the last dose of the study drug.
* Willing and able to provide informed consent

Exclusion Criteria:

* History of hypersensitivity, intolerance, or allergy to opioids
* Surgical procedures in the last 4 weeks or plans to undergo surgical procedures during the study period
* Untreated moderate to severe sleep apnea
* Chronic migraines as the primary pain condition
* Cancer related pain
Effect of Early Rest on Recovery From Pediatric Concussion

The purpose of this study is to find out if strict rest for 5 days helps children get better after concussion.

The purpose of this study is to find out if strict rest for 5 days helps children get better after concussion. This research is being done because, currently, there is no effective treatment for concussion. Physical activity (for example; running, playing sports) and brain activity (for example; homework and tests) may make concussion symptoms worse. We are studying whether strict rest after concussion may help improve symptoms. About 110 children, ages 11-22 years old will take part in this study at the Children's Hospital of Wisconsin. This study is being funded by the Injury Research Center. The research grant pays for study procedures, follow-up testing, and patient reimbursement. Research staff is not being provided incentives to enroll subjects.

Eligibility Criteria:
Inclusion Criteria:

* 11-22 years
* present to the Emergency Department within 24 hours of a head injury

Exclusion Criteria:

* patients who are being admitted,
* non-English speaking patient/family,
* mental retardation (IQ \< 70)
* Suspected intoxication
* restricted used of dominant hand or limited vision
* injury or conditions affecting balance assessment
* prior mental defect or disease (e.g., developmental delay, learning disability, or moderate to severe cerebral palsy)
* known intracranial injury (e.g., intracranial bleeding, cerebral contusion)
* patients for whom a legal guardian is not present or cannot be contacted.
* ED clinician preference
Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy

Hyper polarized Xenon-129 MRI will be directly compared to a radioactive Xe-133 scintigraphy to detect defects in lung ventilation from airflow limitation. This study is conducted as a pilot study with intention to conduct a larger clinical trial.

Hyperpolarized Xenon-129 MRI has been developed by a number of techniques for imaging the lung that provide information about various aspects of lung function and structure. The main objective of this pilot study is to test and optimize the imaging parameters for a future industry sponsored clinical trial. The goal of the future trial is to determine the concordance between hyperpolarized xenon-129 ventilation MR imaging and nuclear medicine ventilation imaging (Gold Standard). In this study we will test the imaging parameters and techniques. We will directly compare human ventilation lung images in subjects with COPD, using nuclear medicine ventilation imaging with Xenon-133 gas scintigraphy versus hyperpolarized xenon-129 gas MRI. Our hypothesis is that current Xe-133 scintigraphy, which uses a radioactive gas (Xe-133) and produces a projection image of the lungs with relatively poor resolution, will not be able to detect small lung ventilation obstructions, which can be detected using hyperpolarized Xe-129 gas MRI.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a diagnosis of COPD
* at their clinical baseline on the day of imaging
* must be clinically stable in order to participate in the study.
* COPD subjects will be categorized according to the GOLD
* Current/Former SmokerSubjects
* must have a smoking history ≥ 10 pack years

Exclusion Criteria:

* Dx of asthma
* Continuous oxygen use at home
* Blood oxygen saturation of 92% less than as measured by pulse oximetry on the day of imaging
* FEV1 percent predicted less than 25%
* Pregnancy or lactation
* Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning
* Subjects with any implanted device that cannot be verified as MRI compliant will be excluded
* Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches
* History of congenital cardiac disease, chronic renal failure, or cirrhosis
* Inability to understand simple instructions or to hold still for approximately 10 seconds
* History of respiratory infection within 2 weeks prior to the MR scan
* History of MI, stroke and/or poorly controlled hypertension.
Incidence of Pain After Craniotomy in Children

The primary objective is to assess the incidence and severity of pain after major craniotomy in paediatric patients (from 1 month to 10 years of age).

The secondary objective is to determine factors associated with significant pain following paediatric neurosurgery .

Research in the adult population has evaluated incidence and severity of post-neurosurgical pain, and effectiveness of different post-neurosurgical analgesic regimens. Several small studies report the prevalence of some period of moderate to severe pain in the first 24 postoperative hours to be from 41 to 84 % of patients. In a prospective single academic medical institution study, adult patients treated with only acetaminophen and modest amounts of opioids on an as needed basis reported moderate to severe pain for the first 2 days after surgery. These findings have supported a growing consensus that perioperative pain associated with intracranial surgery may be more significant than initially appreciated. Factors that have been associated with increased pain after intracranial surgery include sex, younger age, surgical site, and surgical approach to the site. Pain may also be a significant factor in the quality of recovery from intracranial surgery. In contrast there are few studies describing the incidence or management of pain after neurosurgery in children.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female children from 1 month to 10 years Of age
* American Society of Anaesthesiologists Classification (ASA) I-III
* Scheduled for supratentorial or infratentorial craniotomy
* Admission to an Intensive Care Unit, Neurosurgery ward or paediatric ward of one of the hospitals included
* Children whose parents (or legal tutors) have given their informed written consent

Exclusion Criteria:

* Emergency surgery for multiple trauma.
* Children requiring muscular relaxants during the postoperative period
* Children whose parents (or legal tutors) denied their own consensus
EAT: A Reliable Eating Assessment Technology for Free-living Individuals

This study utilizes a small, privacy-conscious wearable device intended to monitor human behaviors. The device is worn around the neck, capturing the wearer's head and upper torso within its field of view, and records color images without audio. Participants visit the lab for consent, device training and recording of several activities using the device. Participants will then take the device home and wear it during their normal schedules for four "active" weeks. During each active week, participants will wear the device, keep a log of all food and drink items consumed throughout the day and participate in unscheduled phone calls with a dietitian. A "washout" week occurs in between each active week in which participants do not need to complete any study tasks. Alongside the device, we have included three privacy filters (blur, edge, and avatar) capable of obscuring faces and objects seen in the device-captured images. All participants will be subject to unfiltered recording during their first week followed by a different filter each following active week in a random order. At the start of each active week, participants view an example of what their recorded images will look like that week (given the privacy filter). At the end of the seven weeks, participants will return the device and provide the lab with feedback on the design of the device and its privacy-preserving features.


Eligibility Criteria:
Inclusion Criteria:

* BMI greater than or equal to 18.5
* Chicago metropolitan area resident
* Able to speak, read and write in English
* Has a valid phone number
* Owns a smartphone
* Has access to a computer

Exclusion Criteria:

* Pregnant or breastfeeding individuals
* Experienced significant weight loss/gain in the last three months (25 lbs or more)
* Diagnosed with or has a family history of genetic obesity syndromes (e.g., Prader-Willi, Bardet-Biedl, Cohen Syndrome)
* Member of household enrolled in the study
Reliability of Subjective Assessment of the Heart by Cardiac Point-of-Care Ultrasound

The purpose of this study is to evaluate reliability of subjective qualitative assessment of the basic cardiac parameters by Point-pf-Care ultrasound.

Subjective qualitative assessment of ventricular function, diameter of the right ventricle and the size of inferior caval vein using cardiac Point-of-Care ultrasound is commonly performed by intensivists and emergency medicine physicians during the management of the patients with shock and/or acute respiratory failure. However, very little data is available to define the reliability of this qualitative examination. The presented study aims to assess this reliability.

Physicians meeting inclusion and exclusion criteria will be sent by a questionnaire consisting of 19 ultrasound cases. Participants will be asked to perform qualitative evaluation of ultrasound findings of each case. Then, the results will be compared with quantitative measurements made by conventional transthoracic echocardiography and validity testing will be performed.

Eligibility Criteria:
Inclusion Criteria:

* physician with at least basic knowledge of cardiac Point-of-Care ultrasound who agrees to complete the questionnaire

Exclusion Criteria:

* not meet the inclusion criteria
Setria Performance Blend Supplementation

The objective of this trial is to evaluate the effects of setria performance blend supplementation on endurance performance in healthy men.

This study is a randomized, double-blind, placebo-controlled crossover trial in healthy men. Subjects will take either a placebo or setria performance blend (L-citrulline + glutathione) for 8 days. At the day 8, subjects run on the treadmill to measure the time to exhaustion at 90%, 100%, and 110% of peak velocity. Arterial blood flow and blood vessel diameter (via ultrasound), blood analytes (plasma nitrate/nitrite, L-arginine, L-citrulline), subjective feelings of fatigue from a visual analog scale (VAS) and ratings of perceived exertion will be assessed. There is a minimum of a two week washout period in between trials/treatments. The same procedures are completed upon return visit.

Eligibility Criteria:
Inclusion Criteria:

* Participant is an adult male between the ages of 20-30 years
* Participant is aerobically fit, as defined by a VO2max between 42-70 ml\*kg/min (determined by the screening test)
* Participant is not obese (18.5 ≦ BMI \< 30 kg/m²)
* Participant has provided written and dated informed consent to participate in the study
* Participant is willing and able to comply with the protocol
* Participant is apparently healthy and free from disease, as determined by a health history questionnaire
* Participant agrees to refrain from strenuous exercise and alcohol consumption within 24 hours of laboratory visits, and to refrain from caffeine consumption within twelve hours of visits
* Participant agrees to refrain from using antibacterial mouthwash, chewing gum, and brushing their teeth on the morning of laboratory visits

Exclusion Criteria:

* Participant has consistently used prescription drugs or ergogenic dietary supplements that may influence study outcomes within eight weeks prior to enrollment, or begins to do so during the study. Potential drugs and supplements include but are not limited to whey protein, creatine, beta-alanine, antihypertensive medications, or anabolic steroids
* Participant has gained or lost ≥10 lbs in the previous 2 months
* Participant is enrolled in a separate clinical trial involving diet, exercise, physical activity, or the potential ingestion of an active drug or dietary supplement in the previous 2 months and during this study
* Participant has participated in a clinical trial within the previous 2 months that includes modifications to their physical and/or diet that may influence study outcomes and during this study
* Participant has a known allergy or sensitivity to the placebo or active ingredients
* Participant consumes more than 3 alcoholic drinks per day
* Participant has used tobacco more than three days per week (on average) in the previous eight weeks
* Participant has used recreational drugs within the past month, or refuses to abstain from recreational drug use for the entirety of the study
Risperidone Treatment in Dually-Diagnosed Individuals - 2

The purpose of this study is to evaluate the safety and efficacy of risperidone for cocaine dependence in individuals with schizophrenia/schizoaffective illness.


Eligibility Criteria:
Please contact site for information.
Utilization of Diagnostic Ultrasound in the Detection and Therapy of Acute Coronary Syndromes

The study will see if mechanical impulses delivered by an echocardiographic probe during a continuous infusion of MRX 801 are capable of improving blood flow in smaller heart vessels in patients with acute coronary syndromes.

Pre-clinical studies have indicated that, during a continuous infusion of intravenous perfluorocarbon-containing microbubbles, the ultrasonic power delivered from a diagnostic ultrasound transducer is capable of restoring microcirculatory flow and improving epicardial recanalization rates following acute coronary thrombotic occlusions. Since both diagnostic ultrasound and intravenous infusions of microbubbles are a Class I indication to assess regional and global left ventricular function and risk area in patients with ST segment elevation myocardial infarction (STEMI), this pilot study will examine whether diagnostic assessments of left ventricular function and risk area size impacts epicardial recanalization rates and infarct size in STEMI.

The aim of this study is to test whether guided high mechanical index impulses from a diagnostic transducer during a continuous infusion of intravenous microbubbles are capable of improving microvascular recanalization and epicardial recanalization rates in STEMI, as assessed by coronary angiography, and recovery of regional microvascular perfusion and function in the post-infarction period.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age ≥ 30 years.
2. Chest Pain occurring lasting less than six hours from onset, and EKG evidence of an acute ST segment elevation myocardial infarction.
3. Arrival in the Emergency Department with above inclusion criteria between 7 am and 7pm.

Exclusion Criteria:

1. Known or suspected hypersensitivity to ultrasound contrast agent used for the study.
2. Complicated hemodynamic instability (i.e., NYHA Class IV heart failure, unstable angina at rest despite medical therapy).
3. Life expectancy of less than two months or terminally ill.
4. Heart transplant recipient, hypertrophic cardiomyopathy, severe valvular disease, acute myo- or pericarditis.
5. Contraindication to Heart Catheterization
6. Known bleeding diathesis or contraindication to glycoprotein 2b/3a inhibitors or aspirin.
MicroRNAs in Acute Kidney Injury

Profiling of microRNAs and long noncoding RNAs (lncRNAs) in patients undergoing cardiac surgery. Analysis: Prediction of acute kidney injury by plasma expression profile of microRNAs?

In this pilot study we will include 150 patients undergoing cardiac surgery in a German university hospital. We will profile microRNA expression in plasma and urine before and at several timepoints after surgery. We will use a preselected panel of microRNAs and lncRNAs for analysis. Goal is to identify microRNAs/lncRNAs that are able to predict the occurence of AKI in these patients.

Eligibility Criteria:
Inclusion Criteria:

* cardiac surgery

Exclusion Criteria:

* preexisting chronic kidney injury
* inclusion in another study
* pregnancy
* Kidney transplantation in history
* GFR \< 30 ml/min (glomerular filtration rate)
* ECLS therapy (extracorporal life support)