cyrilzakka/clinical-trials huggingface dataset:
Sonazoid-Enhanced Ultrasound in Detecting Sentinel Lymph Node in Patients With Cutaneous Melanoma

This pilot phase I trial studies how well sonazoid-enhanced ultrasound works in detecting sentinel lymph node in patients with cutaneous melanoma. Sonazoid is a contrast agent that may make it easier to see if the tumor cells have spread to the sentinel lymph node using an ultrasound.

PRIMARY OBJECTIVES:

I. To study the imaging feasibility of peri-tumoral administration of sonazoid ultrasound contrast agent for assessment of sentinel lymph node (SLN) detection in melanoma.

II. To compare SLN detection between sonazoid ultrasound and standard of care (SOC) technique.

SECONDARY OBJECTIVES:

I. To assess the sonazoid ultrasound (US) imaging appearance of lymph nodes which are shown to be involved with metastatic disease.

OUTLINE:

Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging. Patients also undergo standard of care sentinel lymph node biopsy (SLNB).

After completion of study treatment, patients are followed up at 24 and 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* Cutaneous melanoma with Breslow depth \> 1 mm or melanoma Breslow depth of 0.76 - 1.00 mm in setting of ulceration, extensive regression
* Mitotic rate \>= 1/mm\^2
* Presence of angiolymphatic invasion
* Deep positive margin
* No known allergies to contrast material

Exclusion Criteria:

* Pregnant or nursing
* Patients with known cardiac shunt
* Patients with class II heart failure or worse, per New York Heart Association (NYHA) classification
* Patients who have experienced an acute coronary syndrome or angina in the past 6 months
* Patients who have undergone coronary artery bypass grafting (CABG) or coronary stenting in the past 3 years
* Patients with evidence of moderate or severe cardiac valvular disease on echocardiogram
* Patients with evidence of moderate or severe pulmonary hypertension on echocardiogram
* Patients with stage II chronic obstructive pulmonary disease (COPD) or worse, per Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification
* Patients with hypersensitivity to sonazoid or one of its components
* Patients with hypersensitivity to egg or egg products, because sonazoid contains a chicken egg-derived surfactant (hydrogenated egg phosphatidylserine sodium)
* Patients who cannot consent for themselves
Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients on Diet and Exercise

The primary objective of this study is to assess the efficacy of Rimonabant (SR141716) compared to placebo on change in HbA1c and on relative change in body weight over 36 weeks in obese type 2 diabetic patients inadequately controlled with diet and exercise alone.

The secondary objectives are:

* To evaluate the effect of Rimonabant compared to placebo on other parameters related to the glucose control, waist circumference, Body Mass Index and metabolic parameters;
* To evaluate the safety and tolerability of Rimonabant compared to placebo;
* To evaluate the pharmacokinetics of Rimonabant.

The total duration per patient will be approximately 53 weeks including a 36-week double-blind treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus patients inadequately treated with diet and exercise alone (not drug treated)
* HbA1C ≥ 7.0 % and ≤ 10.0 %
* Body Mass Index ≥ 25 kg/m²

Exclusion Criteria:

* Type 1 diabetes
* Within 12 weeks prior to screening visit: use of oral antidiabetic drugs and/or insulin, of anti-obesity drugs or other drugs for weight reduction
* Within 4 weeks prior to screening visit: administration of systemic long-acting corticosteroids or prolonged use (more than one week) of other systemic corticosteroids, change in lipid lowering treatment
* Secondary obesity
* Primary hyperlipidemia
* Positive serum pregnancy test in females of childbearing potential

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Association of Circulating Chemerin Levels and Arterial Stiffness

Chemerin is a novel adipokine that might provide a link between chronic inflammation and obesity. Pulse wave velocity(PWV) is a useful method for examining arterial stiffness, meaning early-stage atherosclerosis. Therefore, in the present study, the investigators examined the relationship between circulating chemerin and arterial stiffness measured using PWV in obese persons.


Eligibility Criteria:
Inclusion Criteria:

* Self referred persons for visiting routine medical check in our clinic

Exclusion Criteria:

* Malignancy
* Severe renal or hepatic disease
Improving Delivery of Mental Health Services for Patients With Drug Use and Other Behavioral and Emotional Problems

This research is being done to:

* identify any emotional, behavioral or other troubling psychological problems that some people have who are seeking and receiving treatment for heroin or other drug use problems,
* learn if providing additional psychiatric treatment services in the ATS drug abuse treatment program is as beneficial for and acceptable to patients as referring them to the Bayview Community Psychiatry Program to get help for their emotional, behavioral and other psychological problems.

This study will rigorously and systematically evaluate an integrated service delivery approach using a design that reduces many of the methodological limitations in earlier work. Study participants will include opioid abusers with a current psychiatric disorder. All study participants will receive comprehensive drug abuse treatment that includes adequate daily doses of methadone. Study participants will be randomly assigned to either an onsite and fully Integrated Substance Abuse and Psychiatric Care condition (ISAP-Integrated) or an offsite and non-integrated Parallel Substance Abuse and Psychiatric Care condition (PSAP-Parallel). Patients assigned to the ISAP condition will receive all of their ambulatory psychiatric care in the ATS treatment program; those assigned to the PSAP condition will be referred for matched "doses" of psychiatric care to the Community Psychiatry Program, which is located on the same campus as the ATS program. All drug abuse treatment services will be provided in the ATS program. Patients will be evaluated for 12 months on a range of outcome measures, including psychiatric medication and therapy adherence, drug abuse treatment adherence, changes in psychiatric symptoms, including posttraumatic stress disorder (PTSD), drug use, exposure to traumatic events, psychosocial functioning, and retention in both psychiatric and drug abuse treatment.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for current opioid physical dependence
* SAMSA Center for Substance Abuse Treatment - CSAT guidelines for maintenance on methadone or another approved opioid agonist
* have a current DSM-IV psychiatric disorder that is eligible for reimbursement in the Health Choice, Public Mental Health System (e.g., schizophrenia, mood disorders, anxiety disorders, personality disorders, adjustment disorder)
* express an interest in receiving psychiatric treatment for the problem.

Exclusion Criteria:

* pregnant
* acute medical problem that requires immediate and intense management (e.g., AIDS defining illness, tuberculosis, other serious and unstable medical disorder)
* delirium, dementia or mental retardation
* already receiving standard outpatient psychiatric care
The Effect of Aerobic Exercise on Mild Traumatic Brain Injury

The current project will examine the effects of aerobic exercise on cognition among a group of veterans who have suffered a mild traumatic brain injury.

There is substantial evidence that a large number of individuals who experience TBI will demonstrate life-long deficits in cognitive or social functions. An estimated 80-90,000 Americans with TBI suffer life-long impairment of physical, cognitive, and psychosocial skills to the degree that they are unable to return to school or work. Research on rehabilitation for mTBI has been minimal and typically has focused on speech, pain management, dizziness, fatigue, irritability, and sensory disorders. The results of the few studies that have examined long-term cognitive effects of mTBI have offered conflicting results. The current research will investigate the efficacy of an aerobic exercise intervention among individuals with mild traumatic brain injury (mTBI). This project will examine changes in fractional anisotropy (FA) values and cognitive functioning among individuals diagnosed with mTBI in a monitored aerobic exercise regimen, versus a low impact stretching and toning control group.

Eligibility Criteria:
Inclusion Criteria:

* Anyone between 18 and 50 years of age,
* from the geographic region served by the Malcolm Randall-North Florida-South Georgia VAMC,
* who have sustained a TBI and demonstrate impairment on neuropsychological assessment (criteria for mTBI will be defined as a loss of consciousness for not more than 30 minutes and post-trauma amnesia of not more than 24 hours).

Exclusion Criteria:

* TBI occurring less than 6 months or greater than 5 years prior to enrollment,
* any metal implants or shrapnel that may put them at risk for injury during an MRI scan,
* significant cognitive impairment (MMSE\<24),
* history of stroke,
* B-12 deficiency,
* hypothyroidism,
* organ failure (renal, hepatic, cardiac, or lung),
* substance abuse,
* seizures,
* or any limitation that would preclude them from safely engaging in the aerobic exercise regimen.
Fusion Rates of 3D Printed Porous Titanium Cages in Three and Four Level ACDFs

The purpose of this trial is to assess fusion rates in 3 and 4 level ACDFs in patients implanted with DePuy Conduit 3D printed titanium cages supplemented with SKYLINE Anterior Cervical Plate System and 1 CC DBM. This will be a non-inferiority study, looking to show that Synthes Conduit 3D printed titanium cages fuse as well as cages.

This is a prospective, single arm study of clinical and radiological outcomes from anterior cervical discectomy and fusions for cervical spondylosis. 58 Patients undergoing 3 to 4 level ACDF procedures from C2-T1 will be enrolled. Patients will be implanted with DePuy Conduit Titanium ACDF cage (DePuy Synthes, Raynham, MA). A retrospective comparision group will be used. The retrospective group will include 58 consecutive patients undergoing 3-4 level ACDFs with milled allograft.

This single-centered study will enroll up to 58 subjects, with subjects followed for 24 months post-surgery. All subjects enrolled in the study will be recruited from a pool of subjects eligible for three or four level anterior cervical fusion surgeries. The inclusion/exclusion criteria are listed below.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Symptomatic multi-level degenerative cervical spondylosis necessitating anterior cervical arthrodesis in the subaxial cervical spine (between C2-T1).
* Surgery performed within the Department of Neurological Surgery at The Ohio State University Wexner Medical Center (OSUWMC)
* Cervical x-rays at 24 months (±60 days; retrospective comparison group only)

Exclusion Criteria:

* Traumatic spinal fractures or spinal cord injury
* Previous cervical fusion surgery
* Co-morbidity requiring medication use that may interfere with bone or soft tissue healing (i.e., high dose oral or parenteral glucocorticoids, immunosuppressive agents, methotrexate) - at discretion of investigator
* Severe co-morbidities (e.g., heart, respiratory, or renal disease)
* Recent (\<3 yrs) or co-incident spinal tumor or infection
* Concurrent involvement in another investigational drug or device study that could confound study data (prospective exclusion only)
* History of substance abuse (recreational drugs, prescription drugs or alcohol) that could interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up
* Subjects who are pregnant or plan to become pregnant in the next 24 months
* Prisoner
* Other contraindications for DePuy Conduit 3D printed titanium cage implant (prospective exclusion only)
Potential Therapeutic Implications of Laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women

Potential Therapeutic Implications of laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women

All the patients fitted the inclusion criteria, will be given explanation of the treatment protocol in their understandable language.

Treatment procedures. Group (A): will receive laser acupuncture in addition to traditional treatment (low calorie-diet and physical activity) Group (B): will receive traditional treatment only

Laser acupuncture technique:

Application of laser acupuncture on 10 acupuncture procedure for each woman which will be detected by therapist according to Acupuncture points Will stimulate St 25 (Tianshu), St 36 (Zusanli), Liv 3 (Taichong); P 6 (Neiguan), H 7 (Shenmen) for the psychical aspect of the therapy and Auriculothera- py: 55 (Shenmen) and 87 (Stomach) Each point stimulating will be Stimulation time, 30 s/point two sessions per week for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women
* Woman with visceral obesity
* with age ranges from 50-65years
* Body mass index (BMI) more than 30 kg/m2
* WHR more than 0.8

Exclusion Criteria:

* Endometrial cancer

  * Insulin resistance
  * Or metabolic disorders
* Diabetes
* Hypertensive •NOT receiving any medication of obesity
A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments (0653A-121)

To evaluate the percentage of patients with either established cardiovascular disease (CVD), at "high risk" of developing CVD or with diabetes who are on simvastatin 40mg, with fasting LDL-C \> 2mmol/l, who are able to attain the recommended LDL-C target of \< 2mmol/l following 6 weeks treatment with either ezetimibe/simvastatin 10/40mg, atorvastatin 40mg or rosuvastatin 10mg.


Eligibility Criteria:
Inclusion Criteria:

* Patient Is Male Or Female And Aged Over 18
* Patient Provides Written Informed Consent
* Patient Has A Fasting Ldl-C Level \>2mmol/L At Both Visit 1 And Again At Visit 2
* Patient Has Established Cvd, Diabetes Or At "High Risk" Of Cvd (\>20 % Risk Over 10 Years, Framingham Scale)
* Patient Has Taken Simvastatin 40mg Continuously For The Past 6 Weeks
* Patient Has A Fasting Triglyceride Level Of \<3.7mmol/L
* Patient Has Hba1c \<9% At Visit 1
* Patient Is 75% Compliant With Medication Between Visit 1 And Visit 2

Exclusion Criteria:

* Patient Is Hypersensitive To Any Of The Study Medications Or Their Components
* Patient Has A History Of, Or Active Liver Disease (Persistent Elevation Of Alt / Ast (\>3xuln)
* Patient Is Pregnant, Lactating, Or A Female Patient Of Childbearing Potential Not Using Adequate Contraception
* Patient Has Severe Renal Impairment: Creatinine Clearance \<30ml/Min (Cockcroft-Gault Equation) (In Patients With Moderate Renal Impairment: \<60ml/Min, The Dose Of Rosuvastatin Will Be 5mg In Line With The Spc)
* Patient Has Uncontrolled Endocrine Or Metabolic Disease Known To Influence Serum Lipids Or Lipoproteins (I.E. Secondary Causes Of Hyperlipidaemia Such As Hypothyroidism Or Hyperthyroidism)
* Patient Has A Recent History Of, Or Current, Alcohol Abuse
* Patient Has Ck \>10 X Uln At Visit 1 Or Visit 2
* Patient Has Fasting Ldl-C \>4.2mmol/L
* Patient Has Any Acute Or Serious Condition, Or History Suggestive Of Myopathy Or Predisposing To The Development Of Renal Failure Secondary To Rhabdomyolysis (E.G. Sepsis, Hypotension, Major Surgery, Trauma, Severe Metabolic, Severe Endocrine And Electrolyte Disorders Or Uncontrolled Seizures)
Ultrasound Confirmation of Endotracheal Tube Location Using a Saline Filled Cuff

The purpose of this research study is to help determine if the cuff of an endotracheal tube ( ETT) ( also known as a breathing tube)can be seen by ultrasound and to determine if visualization of this tube corresponds with correct tube depth. You are being asked to participate because you will be undergoing a cardiac catherization procedure which will involve endotracheal intubation.

Ultrasound is a safe technology that your doctor could possibly use to see the breathing tube. Right now, x-rays, which come with their own risks, are being used for this purpose. We are trying to see if we can avoid using x-rays.

This is a local study with 1 location. The study will enroll a total of 71 people. There is no sponsor for this study.

If you enter the study, in the cardiac catheterization lab, after the anesthesiologist has done his part (placed the breathing tube while you are asleep and obtained the x-ray), we will use the ultrasound to check the position of the breathing tube. To help us see the breathing tube better, we will put some fluid in the cuff ( the balloon at the tip of the breathing tube). The tube may be repositioned as needed based on the chest x-ray. The entire procedure is estimated to take no more than 10 minutes.

Eligibility Criteria:
Inclusion Criteria:

* English and Spanish-speaking patients
* Age 0-21 years
* Elective cardiac catheterization procedure
* Endotracheal intubation with a cuffed ETT

Exclusion Criteria:

* Abnormal neck/tracheal anatomy
* Emergent cardiac catherization procedure
* Endotracheal intubation with an uncuffed ETT
* Inability to consent
Team Approach to Polypharmacy Evaluation and Reduction

In an aging population, most seniors suffer from multiple chronic conditions. When the number of medications taken is ≥5 (polypharmacy), the burden of taking so many together can do more harm than good. This study will test a program focused on medication reduction involving patient, pharmacist and physician using current technology aimed at reducing the harms of polypharmacy. Reducing the risk of adverse effects from drugs or the interactions between them involves prioritizing the most important ones according to the patient's preference and stopping those which may no longer be necessary. Reducing the dose also reduces the risk of drug side effects. Patients, aged over 69 years taking ≥5 medications, will randomly receive the program immediately or at 6 months. The program involves information gathering from the patient, medication review with the pharmacist and then a consultation with the family doctor focused on discontinuing/reducing the dose of medications where possible using a 'pause and monitor' framework to assess the need for restart. An electronic program that detects drug adverse effects and flags potentially inappropriate medications will be integrated into a clinical pathway incorporating monitoring and follow up systems. This study will examine effects on patient and health relevant outcome measures as well as patients' and clinicians' experiences of the program. The results will be used to determine whether this system can be implemented as part of routine preventative care in older adults.

Patients will be randomized 1:1 to receive the intervention at study start or delayed appointment 6 months later. The intervention includes initial baseline data collection from the patient including data on demographics, medications, and illness characteristics. The patient will then attend an appointment with a pharmacist to review medications appropriate for discontinuation/dose reduction, after which the patient will meet with his/her family physician to discuss patient preferences for discontinuation/dose reduction. Follow up appointments will take place at one week, 3 months and 6 months (study end). Questionnaires and a semi-structured interview will take place at the 6 month appointment. After six months, the control group will be offered the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Aged 70 years of age or older
* Participating family doctor as most responsible provider
* Patient of McMaster Family Health Team
* Currently taking 5 or more medications
* Have not had a recent comprehensive medication review
* Patient consents

Exclusion Criteria:

* English language or cognitive skills inadequate to understand and respond to rating scales
* Terminal illness or other circumstance precluding 13 month study period
Nomacopan (rVA576) in Transplant Associated Thrombotic Microangiopathy

Multicentre Study of nomacopan in Paediatric Haematopoietic Stem-Cell Transplant Associated Thrombotic Microangiopathy

This is an open-label, multi-centre study of two-parts, Part A and B, includes 24 weeks of treatment, safety follow up after 30 days.

Part A: dose algorithm, safety and efficacy

Part B: safety and efficacy

Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 0.5 and \< 18 years at the time of diagnosis of TMA.
2. Undergone allogeneic or autologous HSCT.
3. TMA diagnosis within a year of their allogeneic or autologous HSCT.
4. Clinical or histological diagnosis of TMA
5. Provision of written informed consent.
6. Provision of informed assent

Exclusion Criteria:

1. Patients weighing less than 5 kg.
2. Patients with a positive direct Coombs' test.
3. Patients who do not receive nomacopan within 21 days of the initial diagnosis of TMA.
4. Patients having an active systemic or organ system bacterial or fungal infection or progressive severe infection at the time of diagnosis of TMA
5. Grade 4 Acute GVHD
6. Received eculizumab or any other complement blocker therapy at any time.
7. Known hypersensitivity to the active ingredient or excipients

If an enrolled patient has a positive ADAMTS13 test (\<10%) returned from their screening assessment, the patient should be withdrawn from the study
Multihormonal Deficiencies and miRNA Profile in Chronic Heart Failure: Effects of Combined Hormonal Replacement Therapy

The results from this study will be useful to gain detailed information on the correlation related to pathophysiological aspects between endocrine system and clinical status of patients with heart failure, and to identify factors correlated with the progression and prognosis of ICC


Eligibility Criteria:
Inclusion Criteria:

* ischemic or idiopathic dilated cardiomyopathy, stable medications for at least three months including ß-blocker that must be started at least 6 months before entering the study, fraction of left ventricular ejection less than or equal to 49%

Exclusion Criteria:

* Age \< 18 years, Inability to perform a bicycle ergometer exercise test. Diabetes mellitus in poor glycometabolic control and/or proliferative retinopathy or nonproliferative retinopathy severe grade. Severe renal failure; Hepatic cirrhosis advanced. Active neoplastic disease or history of malignancy. Patients with severe acute illness caused by complications from open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure. Active infection or sepsis. Any allergies to growth hormone, testosterone, vitamin D, or other excipients such as benzyl alcohol, sucrose, phosphoric acid, sodium hydroxide, or methacresol. Acute Coronary Syndrome within the previous 6 months