cyrilzakka/clinical-trials huggingface dataset:
Atracurium Mixed With Magnesium Sulfate Versus Atracurium Alone as Adjuvant to Lidocaine in IVRA

The present clinical study will be undertaken to compare study between the effect of atracurium with lidocaine versus addition of magnesium sulphate to the same doses with lidocaine administrated alone in IntraVenous Regional Anaesthesia to access motor block, sensory block, tourniquet pain and post operative analgesia .Also assessment of patient and surgeon satisfaction .

patients will be divided randomly into three groups (A, B, C) of 25 each, according to computer generated table of random numbers.

* Patients in group A will receive 3 mg/kg of lidocaine 2% diluted with saline to a total volume of 40 ml.
* Patients in group B receive 3 mg/kg of lidocaine 2% + 2 mg atracurium diluted with saline to a total volume of 40 ml.
* Patients in group C will receive 3 mg/kg of lidocaine 2% + 2 mg atracurium mixed with 10 mg /kg magnesium sulphate diluted with saline to a total volume of 40 ml.

Onset of sensory block will be assessed by a pin prick performed at 1 minute interval in the dermatomal sensory distribution of the medial and lateral ante brachial cutaneous, ulnar, median and radial nerves. Sensory block onset time will be recorded as time elapsed from injection of drug to sensory block achieved in all dermatomes.Onset of motor block will be assessed by asking the subject to flex and extend his/her wrist and fingers. Monitoring of motor block will be assessed by Modified Bromage Score . Complete motor block will be recorded when no voluntary movement will be possible.

At the end of surgery, the tourniquet will be deflated by a cyclic deflation technique and recording this :

* Sensory block recovery time
* Motor block recovery time
* Mean arterial pressure (MAP),
* heart rate (HR)
* visual analogue scale (VAS) will be recorded at 0, 15 min , 1, 6, 12, and 24 h.
* The time to first analgesic requirement will be recorded (the time elapsed from tourniquet release until first patient request for analgesic).

Patient and surgeon satisfaction

Eligibility Criteria:
Inclusion Criteria:

* Short procedures (less than 2 hours).
* Cooperative patients.

Exclusion Criteria:

* Patients with sickle cell anemia.
* History of drug allergy.
* Raynaud's disease.
* Scleroderma.
* Myasthenia gravis.
* Cardiac disease.
* Diabetes mellitus.
* Peptic ulcer.
* Gastritis.
* Liver or renal insufficiency.
* Patients with history of convulsions .
Cohort Study of Adult Patients With Down Syndrome at Risk of Developing Alzheimer's Disease (TriAL21)

TriAL21 study is an interventional, open, one arm, prospective, national and single center study.

A total of 200 patients with Down syndrome, aged 35 years and over, without diagnosis of Alzheimer's disease will be enrolled into the study.

Participating centre is Institut Jérôme Lejeune; outpatient's clinic dedicated to treating patients with cognitive deficiencies of genetic origin including patients with Down syndrome.

The aim of the study is to describe and follow a cohort of patients with Down syndrome without diagnosis of Alzheimer's disease at inclusion, in order to identify factors influencing the age of onset of the disease.

The total study duration will be approximately 4 years.

* Inclusion period : 2 years
* Follow-up period per patient : 2 years

Patients will be then followed during 10 years for routine medical follow-up. In case of Alzheimer's disease onset during this period, all data regarding diagnosis of AD will be collected for the study. Data about dementia evolution and mortality in case of AD diagnosis during the study will also be collected during this follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 35 years old and over ;
* Clinical diagnosis of Down syndrome ;
* Patient attending the geriatric outpatient clinic
* Patient without diagnosis of Alzheimer's disease;
* Patient covered by social welfare;
* Patient himself or legal guardian/representative willing and consenting to participate to the study by giving written informed consent;
* Patients must have a parent, or / and other reliable caregiver who agrees to accompany him/her to all visits, provide information about the patient as required by the protocol. The parent or caregiver must be a constant and reliable informant with sufficient contact with the patient to have detailed knowledge of the patient's adaptive functioning in order to be able to complete the assessments accurately.

Exclusion Criteria:

* Patient presenting a contraindication to MRI in particular carrier of metal implants such as pacemakers;
* Patient presenting a serious, severe or unstable pathology (left to the investigator's discretion) whose nature may interfere with the evaluation parameters;
* Patient without Alzheimer's disease diagnosis but with severe dementia;
* Participation in other clinical trials in the last 3 months prior to the study;
* Pregnant woman.
Regulation of Lipoprotein Transport in Metabolic Syndrome

The purpose of this study is to determine whether PPAR-delta agonist (GW5015156)had favorable effect on lipoprotein metabolism.

The metabolic syndrome (MetS) portends diabetes and cardiovascular disease (CVD). Dyslipoproteinaemia, reflected by elevated plasma triglyceride and reduced high-density lipoprotein (HDL) concentrations, is a cardinal feature of MetS that independently predicts CVD and is accordingly a therapeutic target for risk reduction. GW5015156 is a new PPAR-delta agonist that could be used to treat dyslipidemia in insulin resistance and obesity. However, the precise mechanisms of action of this agent on lipoprotein kinetics in MetS subjects have not yet fully been investigated. We therefore carried out a study to study the effect of GW5015156 on lipoprotein transport in subject with metabolic syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Any three of the following:

  * Waist circumference \> 102 cm
  * Triglycerides \> 150 mg/dL
  * HDL-cholesterol \< 40 mg/dL
  * Blood glucose \> 110 mhg/dL
  * Blood pressures \> 130/85 mmHg

Exclusion Criteria:

* Triglycerides \> 500 mg/dL
* Diabetes mellitus
* CVD
* Consumption of \> 30 g alcohol/day
* Use of agents affecting lipid metabolism
* APOE2/E2 genotype
* Creatinemia (\> 120 umol/L)
* Hypothyroidism
* Abnormal liver and muscle enzymes
Acne Scarring in Skin of Color: Laser vs Microneedling

Atrophic acne scars are a common and important sequelae of acne that affect up to 43-55% of patients with acne. Scarring impacts quality of life with reports of diminished self-esteem and frustration/sadness; additionally, some individuals report that their appearance even interferes with their professional lives. Though many treatments for acne scarring exist including ablative and nonablative lasers, subcision, and peels, none is without risk of adverse effects of pain, post-procedure redness or pigmentary changes. There have been no randomized studies directly comparing the effectiveness and safety profiles of microneedling (Dermapen) to 1,540nm nonablative fractional lasers (Palomar StarLux) in the treatment of atrophic acne scarring in skin of color. This clinical trial aims to determine which treatment modality -- microneedling or nonablative fractional laser -- is safer and more efficacious in the treatment of acne scarring in patients with skin of color.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred to dermatology clinic for any reason, or resident or attending dermatologists at Boston University.
* Individuals (men and women) aged 18 and older
* Patients must have atrophic facial acne scarring on the face and desire treatment to improve appearance of acne scarring
* Patients must have Fitzpatrick skin type III-VI
* Patients must be willing to receive five acne scarring treatments at monthly intervals with one follow-up visit to assess for efficacy and adverse effects
* Subjects must speak either English, Chinese, or Spanish.

Exclusion Criteria:

* Subjects who are unable or unwilling to give informed consent.
* Personal history of photosensitivity or photosensitive diseases.
* Pregnancy or breast-feeding.
* Facial surgical or laser treatment in the last 3 months.
* Patients with any active skin infection in the treatment area.
* Coagulopathies or anticoagulant therapy.
* Personal history or presence of hypertrophic scars or keloids.
Race And CPAP Effectiveness

Obstructive sleep apnea (OSA) is a major public health problem in the U.S. and more than 35% of Veterans are at high risk for OSA. OSA is associated with progression of hypertension, an important health problem in Veterans. African Americans with OSA are at increased risk for poorly controlled hypertension and its health consequences. Implementing a care plan to increase the percentage of Veterans in whom blood pressure goals are achieved has been prioritized by Veterans Administration hospitals. Recent studies show that hypertension control can be improved with continuous positive airway pressure (CPAP) treatment of OSA. The aim of this proposal is to examine and compare the effects of CPAP treatment on 24-hour arterial blood pressure and central aortic blood pressure (measured non-invasively with a cuff on the upper arm) in African American and other Veterans.

Obstructive Sleep Apnea (OSA) and hypertension are both common and severe problems in African American individuals (as noted in the International Society on Hypertension in Blacks consensus statement). CPAP treatment of OSA is effective in controlling hypertension in patients with OSA, but has not been studied in African Americans, a high-risk population with potentially large health gains. This is an area of significance because poorly controlled hypertension leads to progression of cardiovascular disease (CVD) and morbidity in this population. By identifying CPAP treatment-response and relevant moderators of this response in African Americans with hypertension and OSA, targeted treatment of OSA can be implemented, reducing the excess burden of CVD. The investigators will determine the relative magnitude of hypertension response to CPAP treatment (ambulatory blood pressure and central aortic blood pressure) in 220 African American and Veterans of other race(s) with hypertension and newly diagnosed OSA (specific aim 1). The investigators will measure changes in pathogenic biomarkers (urinary cumulative sympathetic nervous system activity and oxidative stress) that are responsive to CPAP treatment in addition to hypertension assessments. Further, the investigators will examine the role of excessive daytime sleepiness (EDS), a potentially important moderator of treatment response, in these two patient populations (specific aim 2). Finally, the investigators will adjust the outcomes assessment for the anticipated biological heterogeneity among self-identified African Americans by measuring genetic ancestry (exploratory aim). This award will provide the foundation for the goals of this research program to reduce CVD disparity in diverse populations with targeted treatment of OSA.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified African American and other Veterans (of self-identified race other than African American)
* Age: 30-70 years
* Hypertension
* Apnea hypopnea index (AHI) 15/hour on home sleep apnea test

Exclusion Criteria:

* Past/current treatment of Obstructive Sleep Apnea or other primary sleep disorders
* Active uncontrolled medical conditions
* Shift work in past 6 months
* Current drug use
* Pregnancy
Glucose Metabolism in Different PCOS Phenotypes

In the present study glucose metabolism and ectopic lipids in the liver, heart and muscle were investigated in women with the polycystic ovary syndrome (PCOS) and in healthy control subjects.

In detail an oral glucose tolerance test (OGTT) was conducted in women with the PCOS defined by the Rotterdam and the NIH-criteria, as well as in healthy control subjects. In addition 1H-magnetic resonance spectroscopy and Imaging was used for the assessment of the ectopic lipid content in the liver, heart and skeletal muscle. The aim of the present study was to compare the glucose metabolism and the ectopic lipid conent in the liver, heart and muscle between women with the PCOS defined by the NIH-criteria, Rotterdam-criteria and healthy control subjects.

Eligibility Criteria:
Inclusion Criteria:

* Women with the polycystic ovary Syndrome defined according to the Rotterdam and the NIH-criteria
* healthy control subjects

Exclusion Criteria:

* BMI\>=40kg/m²
* Diagnosis of Diabetes in the PCOS-Group
* Diagnosis of Prediabetes or Diabetes in the control group
Epidemiology of Inflammatory Bowel Disease in the Songpa-Kangdong District, Seoul, Korea.

The purpose of this study is to evaluate the incidence, prevalence, clinical characteristics and prognosis of Crohn's disease and ulcerative colitis over time in a district of Seoul, Korea.

Inflammatory bowel disease (IBD), which is comprised of Crohn's disease (CD) and ulcerative colitis (UC) is a chronic inflammatory disease of gut with uncertain etiopathogenesis. According to our previous study (Yang, et al. Inflamm Bowel Dis 2008; 14: 542-549), the incidence and prevalence of IBD in Korea are still low compared with those in Western countries, but are rapidly increasing. However, the long-term trends of epidemiology of CD and UC together with their characteristics and prognosis in Korea are uncertain yet. The investigators therefore aim to elucidate the incidence and prevalence of CD and UC over a 30-year period, from 1986 to 2017, in the Songpa-Kangdong district of Seoul, Korea. In addition, the investigators also aim to reveal the clinical features at the time of diagnosis of IBD, long-term evolution of disease and prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Definite cases of CD and UC

Patients are diagnosed with CD if they meet at least 2 of the following criteria:

1. clinical history of abdominal pain, weight loss, malaise, diarrhea, and/or rectal bleeding
2. endoscopic findings of mucosal cobblestoning, linear ulceration, skip areas, or perianal disease
3. radiologic findings of stricture, fistula, mucosal cobblestoning, or ulceration
4. macroscopic appearance of bowel wall induration, mesenteric lymphadenopathy, and "creeping fat" at laparotomy
5. pathologic findings of transmural inflammation and/or epithelioid granulomas

Only patients who meet these criteria for at least 2 months are included.

Patients are diagnosed with UC only if all 3 of the following criteria are present

1. a typical history of diarrhea or blood and pus or both in the stool for longer than 4 weeks
2. a typical sigmoidoscopic or colonoscopic picture with diffusely granular, friable, or ulcerated mucosa without rectal sparing or skip lesions or radiological signs of characteristic continuous granular or ulcerated mucosa
3. characteristic histopathological signs of inflammation on biopsy

Exclusion Criteria:

* IBD unclassified
* Ethnic groups other than Korean
MRI in Diagnosing Prostate Cancer

RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help find prostate cancer and learn the extent of disease.

PURPOSE: This clinical trial is studying the safety of MRI and to see how well it works in diagnosing prostate cancer.

OBJECTIVES:

* To determine the ability of multiparametric magnetic resonance imaging (MP-MRI) to identify men who can safely avoid unnecessary biopsy.
* To assess the ability of the MP-MRI-based diagnostic pathway to improve the rate of detection of clinically significant cancer as compared to transrectal ultrasound (TRUS) biopsy.
* To estimate the cost-effectiveness of an MP-MRI based diagnostic pathway.

OUTLINE: This is a multicenter study.

Patients undergo multiparametric magnetic resonance imaging (MRI) (T2-weighted imaging, diffusion-weighted MRI, and dynamic contrast-enhanced MRI) followed by template prostate mapping and transrectal ultrasound biopsy.

Some patients may undergo blood, urine, and tissue sample collection periodically for biomarker studies. Samples are banked for future research analysis.

Patients complete a quality-of-life questionnaire (EQ-5D) at baseline, during, and after completion of study. An economic analysis will be performed for cost-effectiveness.

After completion of study intervention, patients are followed up periodically.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Men at risk of prostate cancer who have been advised to have a prostate biopsy
* Suspected stage ≤ T2 on rectal examination (organ confined)
* Serum PSA ≤ 15 ng/mL within the past 3 months

PATIENT CHARACTERISTICS:

* Fit for general/spinal anesthesia
* Fit to undergo all protocol procedures including a transrectal ultrasound
* No evidence of a urinary tract infection or history of acute prostatitis within the past 3 months
* No contraindication to MRI (e.g., claustrophobia, pacemaker, or estimated GFR ≤ 50)
* No other medical condition precluding procedures described in the protocol

PRIOR CONCURRENT THERAPY:

* No prior prostate biopsy, prostate surgery, or treatment for prostate cancer (interventions for benign prostatic hyperplasia/bladder outflow obstruction are acceptable)
* No prior hip replacement surgery
Perfusion Assessment With Indocyanine Green-SPY Angiography After Tissue Expander Filling

The purpose of this study is to optimize the expansion pressure by compare different capsule pressures' effect, the blood supply of expanded skin is assessed by the Indocyanine Green-SPY Angiography.

This is a randomized controlled trial that designed to optimize the tissue expander expanding method. All the patients were randomly divided into five groups, patients in different groups received an expansion weekly with different capsule pressure of 60mmHg, 70mmHg, 80mmHg, 90mmHg and 100mmHg respectively. Each patient received an expanding once a week, and a hemodynamic assessment of SPY-ICG angiography every two weeks. The total follow-up for each patient is 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 to 50 years;
* Expanding skin donor site at the face, neck, anterior chest wall or back;
* Implanted silicone expander of 100 to 600 ml in size; The quantitiy of normal saline in the tissue expander is more than the original volume, and less than double original volume.
* Need for further skin expansion; with previous regular expanding in hospital;

Exclusion Criteria:

* Iodine allergy; Indocyanine green allergy;
* Not fit for soft tissue expansion treatment;
* Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy;
* Significant renal, cardiovascular, hepatic and psychiatric diseases;
* Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV)
* BMI \>30;
* History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
* History of allogenic bone marrow transplantation;
* Long history of smoking;Evidence of malignant diseases or unwillingness to participate.
Pharmacokinetics (PK) and Metabolism of FTY720 in Patients With Severe Renal Impairment and Healthy Matched Subjects.

The purpose of this study is to compare the pharmacokinetics of FTY720 and its metabolites in patients with severe renal insufficiency and in matched, healthy volunteers. This study will allow a better understanding of the effects of renal insufficiency on the disposition of FTY720.


Eligibility Criteria:
Inclusion Criteria:

Healthy Subjects:

* Subjects must have a calculated glomerular filtration rate (GFR) by Cockcroft-Gault Equation ≥80 mL/min.

Severe Renal Impaired Patients:

* Patients not on dialysis with severe renal failure with a creatinine clearance \< 30 mL/min as determined by Cockcroft-Gault Equation.
* Renal function should have been stable within the 3 months prior to study start.
* Patients with diabetes and/or hypertension who are in otherwise in good health may be included. However patients with diabetes must not have clinical evidence of gastropathy or enteropathy.

Exclusion Criteria:

All Subjects/Patients:

* History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study
* History of retinal macular edema.
* History of any significant cardiovascular events such as myocardia infarction, valvular disease, angina, ischemic heart disease, dilated cardiomyopathy, dysrhythmia.
* History of immunocompromise, including a positive HIV (ELISA and Western blot) test result.

Severe Renal Impaired Patients:

* Use of any highly potent CYP3A4 inhibitor (e.g. erythromycin, ketoconazole, itraconazole) within 2 weeks prior to dosing.
* Use of beta blocker therapy within two (2) weeks prior to dosing.

Other protocol-defined inclusion/exclusion criteria may apply
Celiac plExus Block to Reduce OpioID Consumption Following Hepato-pancreato-biliary Mini-invasive Surgery

The goal of this study is to assess the efficacy of intraoperative celiac plexus block (CPB) to reduce opioid consumption following laparoscopic hepato-pancreato-biliary surgery

A bilateral CPB is convenient and safe to perform under the direct laparoscopic vision of the surgeons during surgery; however, perspective data are warranted. The investigators hypothesize that a bilateral CPB using 0.5% ropivacaine will improve the quality of recovery following a laparoscopic hepato-pancreato-biliary surgery. The primary endpoint is the Postoperative opioid use. Secondary endpoints include acute postoperative pain, opioid consumption, the incidence of postoperative nausea or vomiting (PONV), the 15-item quality of recovery questionnaire (QoR-15), length of post-anesthesia care unit (PACU) stay, length of post-operative hospital stay, and chronic post-surgical pain at 90 d after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Over age 18
* Undergoing laparoscopic hepato-pancreato-biliary surgery

Exclusion Criteria:

* Patient refuse
* Relatively contraindications: severe heart, liver, or kidney dysfunction, coagulation dysfunction, and local anesthetic allergy history
* Intervention unlikely to be effective: drug abuse history, receiving other types of nerve block treatment
* Unlikely to complete the follow-up: alcoholism, planned to replace WeChat and phone within three months; the expected life span less than three months
* Unable to cooperate with the questionnaire and use the patient-controlled analgesia pump