Kornimate/medical-research-clean huggingface dataset:
treatment of opioid/heroin dependence: comparison of three medication dosing regimens

Conditions: Heroin Dependence; Opioid-Related Disorders

Summary: heroin dependence remains a major addiction problem in the united states. the purpose of this study is to determine the effectiveness of levoacetyl methadol (orlaam) in treating heroin dependent individuals.

heroin is a highly addictive drug, and its abuse has both medical and social consequences. orlaam is approved to treat both opiate and narcotic dependence. the purpose of this study is to determine the efficacy of orlaam in treating heroin dependent individuals. in addition, this study will determine the most effective dosing regimen of orlaam. this study will last 20 weeks. participants will be randomly assigned to receive one of three dosing conditions: 1) standard fixed dose, 2) dose-by-weight, and 3) dose effect. the dose effect condition will include a dose of orlaam dependent on opiate use and withdrawal symptoms associated with opiate use; doses may be adjusted throughout the study. all participants will receive cognitive behavioral therapy throughout the study.

Eligibility criteria:
inclusion criteria: * current opiate dependence * provides acceptable proof of identity * history of 5 or more years of regular heroin use or dependence * reads and writes english exclusion criteria: * significant suicidal or homicidal ideation, intent, or plan * current axis i psychotic, depressive, or anxiety disorder * meets dsm-iv criteria for dependence on any drug other than nicotine * impending legal complications or incarceration * on parole or probation that requires reports of drug use or research data * currently receiving treatment for opiate dependence * currently participating in a 12-step substance detoxification program * medical condition that contraindicates administration of orlaam * plans to leave houston, texas within the year following study entry * pregnant or breastfeeding * history of heart problems, including heart arrhythmias * requires psychotropic medications (e.g., antidepressants, antipsychotics, anxiolytics)

Keywords: heroin dependence
assessment of functional independence and quality of life in adolescents with spina bifid

Conditions: Spinal Dysraphism

Summary: the purpose of this study is to investigate the level of functional independence and the quality of life of adolescents and young adults with spina bifid in an italian population.

we submitted the quality of life in spina bifid questionnaire to subjects who participated in the study and the spinal cord independence measure to the parents of subjects.

Eligibility criteria:
inclusion criteria: * recurrence of clinic control in unit for spina bifid in parma * 14-21 years old exclusion criteria: * subjects unable to understand the items of the questionnaire (mental retardation and need for help at school ) * subjects without any caregiver

Keywords: quality of life functional independence spina bifid
effect of laser acupuncture augmented by abdominal exercises on abdominal fat

Conditions: Obesity, Abdominal

Summary: the aim of study is to investigate the effect of laser acupuncture and abdominal exercises on abdominal fat in breast feeding women

forty breast feeding women aged between 20 and 35 years will recruited to the study in the women health department faculty of physical therapy clinic, kafr el sheikh university , egypt. the evaluation procedures will explained to each participant. participants will be divided into two groups group a : received laser acupuncture, diet modification and abdominal exercises group b: received diet modification and abdominal exercises only out come measurement bw, bmi, body fat mass (bfm), body fat percent, waist girth, hip girth, and waist-to-hip ratio (whr) were measured at baseline and the end of treatment. bw, bmi, bfm, and body fat percent were measured using the body composition analyzer (model inbody 3.0, republic of korea).

Eligibility criteria:
inclusion criteria: * all participants are free from any medical problems such as diabetes mellitus, hypertension and thyroid dysfunction. all participants do not use any hormonal contraceptive method. exclusion criteria: * participants will be excluded if they had diabetes, hypertension, cardiac diseases, patients who had endocrine disease or digestive tract disease and patients with neurological or musculoskeletal disorder.

Keywords: obesity laser acupuncture abdominal exercises
evaluation of patients with lupus nephritis using kidney mri (magnetic resonance imaging)

Conditions: SLE (Systemic Lupus)

Summary: this study is being done to find out if a non-invasive magnetic resonance imaging (mri) examination of the kidneys may be helpful in patients with systemic lupus erythematosus (sle).


Eligibility criteria:
inclusion criteria: * male and female adults over the age of 18 who have been diagnosed with sle and are able to undergo a kidney mri. exclusion criteria: * any patient that has undergone a renal transplant. * any patient that is receiving renal dialysis
a comparative study of the healing of chronic ulcers of recessive epidermolysis bullosa : dressing vs amniotic membrane

Conditions: Epidermolysis Bullosa Dystrophica, Recessive; Ulcer

Summary: skin wounds of recessive epidermolysis bullosa dystrophica (rebd) involve pain, superinfection, protein-losing, inflammation, and joint contractures are the bed of squamous cell carcinoma. there is no precise data on the kinetics of healing post-bullous erosions but clinical experience suggests that most epidermise in less than a month. some, however, for unknown reasons, persist for several months. these chronic ulcers (uc), arbitrarily defined for this study as lasting more than three months are a source of major discomfort and could play a decisive role in the morbidity and mortality of the disease. the aim of this study is to evaluate the efficacy of the amniotic membrane on the healing of chronic ulcers rebd on the percentage ulcerated surface re-epithelialised at 12 weeks (m3) from the start of treatment.


Eligibility criteria:
inclusion criteria: * age between 2 years and 60 * rebd clinically evident with immunohistological confirmation and / or genetic * rebd with at least two chronic ulcers (\> 3 months) comparable * signing the informed consent of the patient and / or (children) of parents holding parental authority * affiliation to a social security scheme (beneficiary or legal) exclusion criteria: * epidermoid carcinoma on the target or chronic ulcers * budding excessive requiring the application of a topical corticosteroid on the target or chronic ulcers * skin bacterial superinfection clinically overt requiring oral antibiotics * herpes simplex virus superinfection * major evolutionary and malnutrition defined as a bmi \<12 or more than 2 variant between screening and randomization or a serum albumin \<20 g / l or more ranging from 5 g / l between screening and randomization * major and progressive anemia defined by a hb \<6 g / liter or variant more than 4 g / l between screening and randomization * life expectancy estimated at less than 3 months * pregnancy * inability to understand or observance of the rules of protocol * participation in another interventional therapeutic biomedical research whose treatment is not yet completed or the primary endpoint is not yet measured at the time of inclusion in mabul
post marketing surveillance study to observe safety and effectiveness of crysvita® in s. korean patients

Conditions: FGF23-related Hypophosphataemic Rickets and Osteomalacia

Summary: the objective of this post-marketing surveillance (pms) study is to assess the safety and effectiveness of crysvita injection 10, 20, and 30mg, equivalent to in routine clinical settings


Eligibility criteria:
inclusion criteria: 1. patients who have been started on crysvita® in accordance with the approved label in korea 2. those (or his/her legal guardian) who have agreed in writing to participate in the survey. children who have obtained a written consent of his/her legal guardian about participation in this survey. in case of pediatric patient, explain sufficiently what you think the patient can understand. in this case, the legal guardian may provide supplementary explanations of the survey. exclusion criteria: 1. patients for whom burosumab is contraindicated according local label of crysvita® 2. patients who intend to use this drug for other purposes 3. patients who participated in pre-market clinical trials with crysvita® (consecutive investigation method only) 4. patients who have been taking this drug before the starting day of this study (consecutive investigation method only)
safety and efficacy evaluation of s (+) - ketamine in children

Conditions: S-ketamine; Esketamine; Acute Pain; Postoperative Pain; Analgesia; Hyperalgesia; Delirium; Depression, Anxiety; Children

Summary: a multicenter, randomized, open-label, active controlled pragmatic clinical trial that evaluates the safety and efficacy of s (+) -ketamine for postoperative acute pain in children in perioperative settings.

children often suffer acute pain,awakening delirium, anxiety and depression after operation which may affect the recovery of children. s (+) - ketamine has been described to decrease acute pain and opioid consumption,but it needs to confirm for chinese children undergoing surgery. objective: to evaluate the analgesic effect of perioperative administration of s (+) - ketamine on postoperative acute pain in children undergoing surgery, and explore the effects of s (+) - ketamine on postoperative awakening delirium, postoperative anxiety and depression mood ,as well find the best usage, including dose, timing, compatibility, and type of operation.

Eligibility criteria:
inclusion criteria: 1. age ≤17 years; 2. scheduled for elective digestive tract surgery, orthopedic surgery, urological surgery , ear surgery or other surgeries under general anesthesia; 3. asa physical status i～ⅲ; 4. the informed consent form was signed by the patients or the guardians. exclusion criteria: 1. the expected length of hospital stay of the patient is less than 48h; 2. patients expected to be admitted to the icu after surgery; 3. patients expected to return to the ward with tracheal catheter after surgery; 4. be allergic to s (+) - ketamine; 5. patients with severe disorder of consciousness or mental system diseases (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction; 6. patients with congenital heart disease or severely developmental retardation; 7. patients with any of the following contraindications of s (+) - ketamine: 1. patients with risk of serious rise of blood pressure or intracranial pressure; 2. patients with high intraocular pressure (glaucoma) or penetrating ocular trauma; 3. patients with poorly controlled or untreated hypertension (resting systolic blood pressure greater than 180 mmhg, or resting diastolic blood pressure greater than 100mmhg); 4. patients with untreated or undertreated hyperthyroidism.
collection of blood and bone marrow from healthy volunteers and patients for research purposes

Conditions: Bone Marrow Diseases; Healthy Volunteers

Summary: this study is designed to provide bone marrow and/or blood cells for other research studies. patients participating in this study will be asked to provide small amounts of medical information and undergo a limited physical examination designed to detect the presence of any obvious blood disease. a blood and bone marrow sample will be obtained to verify that the patient has normal blood cell production. researchers plan to obtain bone marrow samples to be used in laboratory studies directed toward understanding the formation of blood cells. bone marrow samples will be taken from the hip bone of patients and healthy volunteers. these samples are valuable to many research studies within the hematology branch of the national heart, lung, and blood institute, including studies of normal and abnormal production of blood cells, the viral causes of blood diseases, and the role of the immune system in bone marrow failure and related conditions....

this protocol defines in general terms the purposes for which blood and bone marrow specimens will be collected by members of the hematology branch and the conditions under which the sampling will be performed. samples of blood and bone marrow from healthy volunteers and from patients are indispensable for many research projects, including studies of normal and abnormal hematopoiesis, the viral etiology of blood diseases, and the role of the immune system in marrow failure and related conditions.

Eligibility criteria:
* inclusion criteria: healthy volunteers age greater than or equal to 18 years. subjects with hematologic disease age greater than or equal to 2 (for subjects less than 18, blood and bone marrow specimens will be obtained concurrently with clinically indicated sampling). exclusion criteria: history of a significant bleeding disorder. abnormal host-defense mechanisms.

Keywords: bone marrow hematopoiesis dna rna viruses
a study of patients with chronic disease

Conditions: Asthma; Chronic Obstructive Pulmonary Disease; Idiopathic Pulmonary Fibrosis; IPF; COPD; Respiratory Disease

Summary: target-rwe is a 10-year, international, longitudinal, observational study of patients with chronic disease designed to specifically address important clinical questions that remain incompletely answered from registration trials. the protocol will follow a master protocol design in which a shared study infrastructure supports progressive development of the registry across the spectrum of chronic diseases.

the target-rwe master protocol design allows shared study parameters and operational components to be organized within a centralized platform. utilizing this platform, therapeutic area-aligned communities with associated disease-specific cohorts (dsc) can be added according to scientific merit and need to address specific research questions in patients diagnosed with chronic diseases. this design capitalizes on a shared, sustainable infrastructure across a diverse patient population, which allows for more efficient coordination and conduct than can be achieved in traditional stand-alone, independently-conducted research studies with narrowly-focused target patient populations. this master protocol design will ultimately support a dynamic program that adapts to the changing landscape of chronic disease management and allows for rapid enrollment and collection of retrospective and long-term prospective data from participants in specific disease areas of interest. target-rwe currently includes the target-rwe.lung community, with open dscs for asthma, copd and idiopathic pulmonary fibrosis.

Eligibility criteria:
inclusion criteria: * adults and children being managed or treated for a chronic disease under study. diagnosis is based on the clinical judgement of the care provider. * patient is anticipated to have continued management of their chronic disease at the participating site. exclusion criteria: * inability to provide informed assent/consent.

Keywords: ipf copd respiratory disease asthma
effect of naltrexone on counterregulatory mechanisms in hypoglycemia

Conditions: Hypoglycemia

Summary: insulin treatment often causes the blood glucose levels to fall too low. the body usually responds to low blood glucose levels by releasing hormones which act against the insulin to help correct the low blood glucose levels. however, this hormone response can be altered in people with diabetes. currently there are no therapeutic agents that can be used to improve the recovery from hypoglycemia (low blood sugar). naltrexone is a tablet used to help people who are addicted to alcohol or morphine-based drugs to remain drug and alcohol-free but it can also affect the levels of the hormones which are released during hypoglycemia. the aim of this study is to determine whether naltrexone can be used to improve and accelerate the recovery from hypoglycemia in patients with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes (well controlled, 2-3 hypoglycemic episodes/wk) age 18-55, bmi 18-35 exclusion criteria: * pregnancy * significant diabetes complications * liver disease, cirrhosis * cardiac disease * neurological disorder * autonomic neuropathy * kidney disease * lactose intolerance

Keywords: hypoglycemia type 1 diabetes
effect of single vs repeated cycles of a combination of granulocyte colony stimulating factor and darbepoetin vs standard medical treatment on immunometabolic profile in patient with early decompensated cirrhosis.

Conditions: Decompensated Liver Cirrhosis

Summary: exogenous growth factor-mobilized bone marrow (bm) stem cells(g-csf) and darbepoetin use have shown a differential response in the management of decompensated cirrhosis (dc) with improved survival, ctp and meld scores. this study was designed to evaluate potential clinical benefit of repeated cycles of granulocyte-colony stimulating factor (g-csf) and darbepoetin versus single cycle on delta change in immunometabolic profile of patients at 6 months assessed in terms of -change in innate immunity -monocyte, neutrophils -distribution , function and bioenergetic adaptation .

aim: to study the efficacy of single vs repeated cycle of granulocyte colony stimulating factor+ darbopoetin vs standard medical treatmenton immunometabolic profile in patient with early decompensated cirrhosis study population: * age 18-70 years * early decompensated cirrhosis meld \< 16 , ctp \< 9b * uncomplicated ascites * a prospective randomized controlled trial. * single centre. * open label. * block randomization will be done , it will be implemented by iwrs method. * the study will be conducted in department of hepatology, ilbs.

Eligibility criteria:
inclusion criteria: 1. age 18-70 years 2. decompensated cirrhosis patients 3. uncomplicated ascites, 4. ctp ≤ 9b and meld \<16 5. bm hematopoietic stem cell reserve \> 0.4 6. given informed consent exclusion criteria: 1. patients with age less than 18 years or more than 65 years 2. lack of informed consent 3. patients with a history of serious allergic reactions to the active component, filgrastim, other human granulocyte colony-stimulating factors, or any of the ingredients 4. evidence of alcoholic hepatitis/active alcohol abuse last intake ≤ 3 months 5. suspected autoimmune hepatitis (ana/asma-positive in titers 1:80 and/ or igg 1.5 times upper limit of normal), 6. hemolytic anaemia -sickle cell disease or thalassemia 7. patients with grade iii ascites /complicated ascites 8. patients with large spleen (size ≥ 15cm) 9. recent variceal bleeding in less than 42 days 10. patients with any focus of sepsis as proven by culture positivity or presence of spontaneous bacterial peritonitis (sbp) 11. h/o seizures 12. hepatocellular carcinoma (hcc) or other malignancy 13. acute kidney injury (aki) with serum creatinine \>1.5 mg/ dl, 14. multi-organ failure, 15. hepatic encephalopathy or prior history of he in less than 6months 16. hiv seropositivity, 17. uncontrolled essential hypertension, cad /stroke 18. massive hydrothorax 19. pregnancy 20. viral etiology of liver disease 21. chronic kidney disease 22. portal vein thrombosis 23. planned for lt 24. bone marrow hematopoietic stem cells \< 0.4
naldebain for pain management after knee arthroplasty

Conditions: Arthropathy of Knee Joint

Summary: naldebain, a long-acting analgesic injection, obtained a license from the taiwan food and drug administration (tfda) of the ministry of health and welfare on march 6, 2017 to approve a sustained-release long-acting analgesic on the market in taiwan. this study hopes to use a rigorous double-blind randomized controlled experiment to understand whether the new sustained-release analgesic naldebain can achieve effective pain relief for patients undergoing knee replacement surgery, and to evaluate the patient's functional recovery status .

naldebain, a long-acting analgesic injection, obtained a license from the taiwan food and drug administration (tfda) of the ministry of health and welfare on march 6, 2017 to approve a sustained-release long-acting analgesic on the market in taiwan. at present, it is the only analgesic injection that has an efficacy of up to seven days. the currently approved drug indication is to relieve moderate and severe acute pain after surgery. pharmacological mechanisms and experiments show that its analgesic effect is equivalent to morphine, but its side effects are much lower than morphine. because of its special pharmacological mechanism, it has extremely high potential to improve patients undergoing knee replacement surgery. therefore, this study hopes to use a rigorous double-blind randomized controlled experiment to understand whether the new sustained-release analgesic naldebain can achieve effective pain relief for patients undergoing knee replacement surgery, and to evaluate the patient's functional recovery status .

Eligibility criteria:
inclusion criteria: * age at least 50 years old, not exceed 100 years old * diagnosed primary knee osteoarthritis accepted knee arthroplasty exclusion criteria: * diagnosed inflammatory arthritis、rheumatoid arthritis * accepted revision knee arthroplasty * patients with head injury, intracranial injury, increased intracerebral pressure and liver insufficiency * patients who are allergic to nalbuphine sebacate, nalbuphine, sesame oil or benzyl benzoate drugs
plasma and lung tissue concentrations of linezolid in septic shock patients

Conditions: Septic Shock

Summary: the study measures the plasma and bronchoalveolar lavage fluid concentrations of linezolid in septic shock patients comparing with non-septic shock patients to confirm the impact of septic shock on pk/pd of linezolid.

a wide array of pathophysiological changes occurring in severe sepsis and septic shock patients may influence antibiotics' pharmacokinetic (pk) properties. the pharmacokinetics and tissue distributions of linezolid achieving effective concentrations are key factors of successful clinical outcomes. to the best of our knowledge, no observational clinical studies are available on the plasma and bronchoalveolar lavage fluid concentrations of linezolid in septic shock patients. severe pneumonia patients known or suspected to be caused by gram-positive pathogens will be considered eligible for the study when the attending physician prescribed linezolid as treatment. the plasma and bronchoalveolar lavage fluid concentrations of linezolid are measured in each group at steady state. in an in vitro pk model, concentration-time curve is drawn to calculate %t\>mic or auc0-24h/mic. linezolid pharmacodynamics evaluation should be based on bacterial eradication and clinical outcomes.

Eligibility criteria:
inclusion criteria: 1. between 18 years old and 75 years old; 2. admitted to the icu; 3. expectation, in the opinion of the investigator, that the patients' infection will require icu stay more than 3 days; 4. patients diagnosed as severe pneumonia requiring mechanical ventilatory support; 5. severe pneumonia known or suspected to be caused by gram-positive pathogens; 6. expected to treat with linezolid. exclusion criteria: 1. unable to take bronchoalveolar lavage via bronchofiberscopy; 2. allergy, hypersensitivity or a serious reaction to linezolid; 3. treatment with linezolid during the previous 72 hours; 4. pregnancy.

Keywords: linezolid; pk/pd; septic shock