Kornimate/medical-research-clean huggingface dataset:
prescription opioid effects in abusers versus non-abusers

Conditions: Opioid-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to examine the abuse liability of oxycodone in individuals with, and without, a history of prescription opioid abuse.

prescription opioid abuse is becoming an increasingly widespread and serious public health concern. the 2001 national household survey on drug abuse report revealed that the number of first-time users of prescription opioid medications for non-medical reasons reached 2 million in the year 2000, a number that has quintupled since 1984. despite this trend, little experimental research has been directed towards understanding who may be abusing these medications, and under what conditions. the study will examine the reinforcing, subjective, performance, and physiological effects of oxycodone. because it is not clear who is abusing prescription opioids, the medication effects will be compared in drug abusers and non-drug abusers.

Eligibility criteria:
inclusion criteria: * in good physical health * women reporting regular menstrual cycles lasting between 24 to 35 days * able to perform study procedures * normal body weight * use of opioids for medical purposes (cough, pain, or diarrhea) or recreational purposes at least twice in lifetime with no serious adverse effects * current opioid abuse, but not opioid dependence (drug abusers only) exclusion criteria: * on parole or probation * recently convicted of a crime of violence * history of significant violent behavior * current axis i psychopathology * significant axis ii disorder * pregnancy * women who have irregular menstrual cycles, or who are dysmenorrheic, amenorrheic, or menopausal * women who have been pregnant or breastfeeding within the past 6 months * women who have had a miscarriage or abortion within the past 6 months * women who meet dsm-iv criteria for premenstrual dysphoric disorder * women who report suffering from moderate to severe premenstrual symptoms * women seeking treatment for premenstrual problems * taking prescription or over-the-counter psychotropic medication * history of chronic pain, or routinely uses over-the-counter analgesics (more than 4 days per month) * blood pressure greater than 150/90 mm hg * reports of sensitivity, allergy, or contraindication to opioids * non-drug abusers: 1. current or lifetime history of substance abuse or dependence according to dsm-iv criteria (those requiring detoxification) 2. consumes more than 500 mg caffeine daily 3. seeking treatment for substance use

Keywords: opiate opioid abuse liability abuse potential
the tendera multicenter clinical trial

Conditions: Artery; Thrombosis

Summary: tendera is a multicenter randomized controlled trial to compare traditional entry point in the radial artery for tri and distal puncture at the anatomical snuffbox area for transradial interventions. the investigators hypothesized that novel entry point in radial artery may lessen vascular access site complication rate and especially the radial artery late occlusion rate.

the forearm access will be made using traditional technique what was well described previously in the literature. the novel puncture site is located in the snuffbox area distal to the traditional radial access point. thanks to surrounded anatomical conditions in anatomical snuffbox area vascular access site complications may be lessened comparing to forearm radial access site.

Eligibility criteria:
inclusion criteria: age 18-75 primary radial artery puncture radial artery diameter \>1,5mm by ultrasound stable coronary disease less than 6f sheath needed patient height \>185cm exclusion criteria: acs ami critically ill patients previous tri procedure raynaud's disease

Keywords: transradial intervention,radial artery,anatomic snuffbox
the application of sterile water to the skin of extremely low birth weight (elbw) infants

Conditions: Fluid Loss; Dehydration; Extreme Immaturity

Summary: extremely low birth weight infants have significant water loss through their skin immediately after birth. this significant fluid loss is because they have large amounts of fluids, have immature skin and large surface area. loss of fluids is associated with many complications. the investigators hypothesize that application of sterile water to the skin of these infants is associated with decreased fluid requirements in the first week of life , improve skin integrity and decrease some complications of prematurity.

extremely low birth weight (elbw) infants have significant transepidermal water loss immediately after birth. this significant fluid loss is related to proportionally large extracellular pool of fluids, the immaturity of the skin barrier, and the relatively large surface area exposed to evaporation. water depletion in this population is associated with development of significant electrolyte imbalance in the form of hypernatremia, hyperkalemia, hyperglycemia and hyperosmolarity. in order to compensate for these losses, clinicians have to progressively increase fluid intake. excessive fluid intake in the first days of life is associated with worsening patent ductus artriosus (pda), necrotizing enterocolitis (nec), bronchopulmonary dysplasia (bpd) and mortality. also skin integrity is important to protect against skin infection and secondary sepsis. based on recent studies and relevant data, the risk of sepsis in elbw is up to 40% nationwide, but only about 25% at gwuh water application is a benign treatment that is routinely applied to the skin of premature babies and was shown to decrease skin colonization. the current practice at gwuh is to clean the bodies of premature infants using a piece of damp cloth with warm water. this is performed at birth and consequently every other days. the study group will receive more frequent and standardized applications. the investigators hypothesize that application of sterile water in elbw infants is associated with decreased fluid requirements in the first week of life. as a secondary outcome, the investigators hypothesize that sterile water application is associated with improved skin integrity, decreased incidence of bpd with no increased incidence of skin or systemic infections.

Eligibility criteria:
inclusion criteria: 1. extremely low birth weight (less than 1000 grams at birth), and 2. less than 24 hours of life exclusion criteria: 1. major congenital anomalies 2. malformations or other surgical emergencies requiring immediate transfer. 3. major skin abnormalities

Keywords: elbw premature neonate skin water loss
t cell repertoire analysis of immune mediated skin diseases

Conditions: Psoriasis; Mycosis Fungoides

Summary: this study is designed to identify the cells of the immune system that cause skin disease such as psoriasis and mycosis fungoides. blood samples from many patients will be compared in hopes of finding common cells and molecules responsible for skin diseases. results of this study will increase our knowledge about immune mediated skin disease.

the aim of the study is to characterized the t cell repertoire of individuals with immune mediated skin disease (e.g. psoriasis and mycosis fungoides). peripheral blood with be collected from volunteers with psoriasis, mycosis fungoides and age matched controls. fifteen tablespoons of blood will be collected prior to the initiation of treatment and again after the patient shows a clinical response to treatment. the time between blood draws will be no less than 3 months. there will be no more than two blood draws per patient. blood samples will be used to determine the patient's hla haplotype via pcr and dna sequencing. after the patient's haplotype has been established the activated t cell repertoire will be analyzed for clonal expansions. clonal expansions in the t cell repertoire will be determined by immunoscope analysis, which is a pcr based technique.

Eligibility criteria:
inclusion criteria: * have an immune mediated skin disease, such as psoriasis or mycosis fungoides * are not taking immunosuppressive medications, which may interfere with t cell analysis. exclusion criteria: * are taking immunosuppressive medications, which may interfere with t cell analysis
the role of mitochondrial respiration in the cardioprotective capacity of ipc in diabetic and non-diabetic patients

Conditions: Reperfusion Injuries, Myocardial

Summary: the overall aim of this study is to examine the role of mitochondrial respiration in human diabetic tissue before and after ischemia. furthermore we will examine the ability of ischemic preconditioning (ipc) to preserve the mitochondrial function and hemodynamic performance of both non-diabetic and diabetic fibers after ischemia. to increase our understanding on the metabolic changes during ischemia in both non-diabetic and diabetic tissue we will use dimethyl malonate and examine the impact of this blockade on post-ischemic mitochondrial respiration.

20 diabetic and 20 non-diabetic patients undergoing elective cabg surgery or other heart surgery where extracorporal circulation is used will be included in the study. the patiens will not be given any treatment prior to the operation. during the cardiac surgery a small sample of the heart is routinely removed when the patient is connection to the heart-lung machine. from this tissue sample it is possible to isolate muscle trabeculae which will be used in an atrial strip model and randomized to one of four types of treatment. simultaneously with the isolation of the trabeculae, a fifth trabecular will be used to assess mitochondrial respiration at baseline. group 1 will serve as a sham control, group 2 will serve as ischemic control and receive an extended period of hypoxia, group 3 will be treated with ischemic preconditioning, where short periods of non lethal lack of oxygen will be given directly to the tissue (after removal from the patient) prior to the extended period of hypoxia, group 4 will receive dimethyl malonate prior to the prolonged hypoxia.

Eligibility criteria:
inclusion criteria: * patients undergoing cabg or other surgery where extracorporal circulation will be used. exclusion criteria: * raise in ischemic markers within 4 weeks * ejection fraction \<30 * atrial fibrilation * oral opioid treatment
evaluation of novel risk factors and clinical outcomes of acute myocardial infarction

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Acute Myocardial Infarction

Summary: the aim of this study is to investigate the potential novel risk factors for acute myocardial infarction. predictors of poor outcomes will be also evaluated.


Eligibility criteria:
inclusion criteria: * less than 12 hours after the onset of myocardial infarction symptoms * myocardial necrosis, as evidenced by increased creatine kinase isoenzyme (ck-mb) or troponin levels exclusion criteria: * age under 18 years-old

Keywords: myocardial infarction cardiovascular diseases heart diseases infarction diabetes
new periodontitis treatment based on hyaluronic acid and melatonin

Conditions: Chronic Periodontitis

Summary: the aim of the present study is to determine whether the association of melatonin and hyaluronic acid to the antimicrobial tm paste (3% tetracyclin and 3% metronidazole) for periodontal maintenance therapy can improve the attachment level (al) and alveolar bone support for moderate chronic periodontitis.

local drug delivery agents in periodontology has gained acceptance and popularity compared to systemic drugs due to decreased risk in development of resistant flora, opportunist infection, and side effects. in order to improve the topical treatment for chronic periodontitis, melatonin and hyaluronic acid have been added to antimicrobial topic paste commercially available. * a complex matrix composed of tetracycline, metronidazole, melatonin and hyaluronic acid have been developed for local treatment of chronic periodontitis. * microbiological, physical, chemical characterization of the newly obtained matrix and biocompatibility tests have been performed. * a randomized clinical trial will be perform on 50 patients with moderate chronic periodontitis recruited based on eligibility criteria and informed consent signed. * mechanical debridement of the pockets by scaling and root planning will be performed prior to the adjunctive therapy. * extensive clinical examination including charting the remaining teeth, clinical attachment level (cal), presence of dental plaque (pi), gingival index (gi), calculus (ci), bleeding on probing (bop), radiographic assessment and identification of periodontal pathogens with micro-ident® test will be performed at the beginning of the study and 6 month after its completion. * each patient will be randomized using sealed envelopes (according to a computer-generated randomization list) to one of the following topical administration (in the periodontal pocket of affected teeth), for 30 consecutive days: tetracycline and metronidazole paste (tm), n=25 patients and tetracycline, metronidazole, melatonin, hyaluronic acid paste (tm-mha), n=25 patients. * a statistical evaluation of data recorded during the entire follow-up period will be performed.

Eligibility criteria:
inclusion criteria: * moderate chronic periodontitis, that is, \> 2 interproximal sites with al \> 4 mm (not on the same tooth), or \> 2 interproximal sites with pocket depth (pd) \> 5 mm (not on the same tooth) (1), * at least 20 teeth present in the mouth, * no periodontal therapy during the last 6 months, * no antibiotic during the last 6 months, * good general health (no systemic condition affecting the course of periodontal disease, including malignancy), pregnancy, * no allergy to the product components, * good mental health. exclusion criteria: * patients not willing to sign consent form. * patients not agreeing with the treatment protocol.

Keywords: melatonin hyaluronic acid tetracycline metronidazole topic paste chronic periodontitis
a feasibility study of group metacognitive therapy versus mindfulness meditation therapy

Conditions: Generalized Anxiety Disorder

Summary: the study will examine the effectiveness of group metacognitive therapy in comparison with group meditation therapy, in patients with generalised anxiety disorder. individuals will be randomly assigned to either meditation or metacognitive therapy and undergo 8 group therapy sessions of their respective treatment condition.


Eligibility criteria:
inclusion criteria: * individual's score on the gad-7 \& phq-9 * individuals who meet the dsm-iv (diagnostic and statistical manual) criteria for generalized anxiety disorder exclusion criteria: * individuals with major depressive disorder * individuals who report suicidality * individuals with a brain injury or neurological insult * individual who currently engage in substance abuse * individuals with bipolar disorder * individuals with psychotic symptoms * individuals who cannot converse or read english

Keywords: metacognitive therapy mindfulness meditation therapy group therapy generalized anxiety disorder group based metacognitive therapy group based mindfulness meditation therapy
a phase 1 study of arc-001 in participants undergoing third molar extraction

Conditions: Acute Post Operative Pain; Third Molar Extraction Surgery

Summary: the study will test the investigational product gel against placebo (which contains no active ingredient) to determine if it is safe after wisdom tooth extraction. the main questions the study will answer are: 1. how much of the investigational product is absorbed in the blood? 2. are there side effects?


Eligibility criteria:
inclusion criteria: * able to provide informed consent * in generally good health * bmi 18 to 38kg/m² * scheduled to undergo wisdom teeth extraction exclusion criteria: * serious medical condition * clinically significant abnormal lab values * blood donation in the last 60 days, or plasma donation in the last 7 days.

Keywords: wisdom teeth surgery
the effect of ablation depth on dry eye after lasik treatment of myopia

Conditions: Incidence and Severity of Dry Eye After Myopic LASIK

Summary: the study tried to find the relation between ablation depth and degree of dryness after lasik treatment of myopic patients


Eligibility criteria:
inclusion criteria: * patients with age ≥ 21 years * normal pentacam maps * myopia with spherical equation less than 12 d * corneal thickness ≥ 500 microns * calculated residual stromal bed ≥ 280 microns * no signs or symptoms of dry eye. exclusion criteria : * keratoconus and forme fruste keratoconus * auto-immune diseases * history of dry eye or previous use of tear substitutes * previous ocular surgery * pregnant or lactating women.
evaluate the shade matching of polychromatic versus monochromatic composite layering techniques in fractured class iv maxillary central incisors using universal , layering & one shade composite in-vivo on patients

Conditions: Class IV Dental Caries

Summary: the goal of this clinical trial is to evaluate shade matching ability of different techniques of application and different materials of resin composite restorations in class iv carious lesions

shade matching cabability of different resin composite materials and different techniques for restoration application, layering versus conventional incremental

Eligibility criteria:
inclusion criteria: 1- fractured class iv upper central incisors. exclusion criteria: 1- cracked teeth

Keywords: universal resin composite monoshade resin composite polychromatic composite
bridge device for surgical pain for rotator cuff surgery

Conditions: Pain; Rotator Cuff Injuries

Summary: the objective of the trial is to investigate the efficacy of the bridge device in reducing post-operative pain and post-operative opioid consumption in patients undergoing rotator cuff surgery with the typical mode of anesthesia, nerve block plus propofol sedation.

the interscalene block is the gold standard for postoperative pain management following rotator cuff surgery. however, the duration of the block does not cover rehabilitation. therefore, in most cases, patients are discharged from the surgical center with an opioid prescription. there is a growing need to investigate complementary, non-pharmacologic pain-management methods. the bridge device, which provides auricular neuromodulation of various cutaneous nerves near the ear, is manufactured by masimo and previously fda-approved to reduce symptoms of opioid withdrawal. it is a promising technology that could help relieve post-operative pain without exposing patients to the adverse effects of opioids or other pain-relieving medications. the objective of the trial is to investigate the efficacy of the bridge device in reducing post-operative pain and post-operative opioid consumption in patients undergoing rotator cuff surgery with the typical mode of anesthesia, nerve block plus propofol sedation. those enrolled will be assigned to a study group and compared to historic cohort (control group). historic control group involves patients that underwent same surgical procedure performed at the surgical center involved in the study, by the same surgical operator, between 2020 and 2023.

Eligibility criteria:
inclusion criteria: * greater than 18 years of age * willing and able to provide informed consent * scheduled to undergo elective rotator cuff surgery at upmc * no pre-existing medical conditions which would prevent application of the bridge device on auricle of ear (i.e., skin infection, rash) exclusion criteria: * opioids dependence * chronic pain condition with daily opioid use * anatomical malformation, which may interfere with placement of the nerve block * raynaud's disease diagnosis * vasculopathy * hemophilia or other coagulopathy, or use of active anticoagulation other than aspirin * patient refusal * pacemaker * pre-existing medical conditions which would prevent application of the bridge device on auricle of ear (i.e., skin infection, rash) * psoriasis vulgaris
effectiveness of a knowledge-based intervention for patients with cutaneous lupus erythematosus

Conditions: Cutaneous Lupus Erythematosus

Summary: studies have shown that there are significant differences in severity and outcome of lupus in patients of colored skin compared with caucasians. there are many factors that lead to this discrepancy: genetics, poverty, education level, as well as behavioral and cultural factors. cutaneous lupus erythematosus (cle) is a disease of flares and remissions with identifiable triggers. one of the most aggravating triggers in cle is sun exposure. the investigators hypothesize that there are disparities in knowledge about photoprotection, leading to poorer outcomes in minority ethnic groups. this study aims to assess knowledge of risk factors and triggers, especially sun exposure, and the effects on quality of life of caucasian and minority populations, by conducting an assessment survey and subsequent teaching intervention on appropriate skin protection techniques including appropriate sun screen application, and use of sun-protective clothing. after three months a survey to evaluate knowledge retention about and the application of the educational intervention will be conducted.


Eligibility criteria:
inclusion criteria: * subjects with a diagnosis of cutaneous lupus erythematous * subjects ages 18 years of age and older and able to give consent exclusion criteria: * that which does not fit the inclusion criteria
school-based health programs on children's wellbeing in lusaka, zambia

Conditions: Acute Disease; Morbidity

Summary: this study evaluates the impact of a new and comprehensive school-based health program implemented in lusaka, zambia.

while school-aged children in low- and middle-income countries remain highly exposed to acute infections, programs targeting this age group remain limited in scale and scope. in this study, we evaluate the impact of a new and comprehensive primary school-based health intervention program on student health outcomes and academic performance in lusaka, zambia. the intervention involved the training of teachers to become school health workers and the provision of vitamin a supplementation and deworming medication on a bi-annual basis. teachers in intervention schools were trained to deliver health lessons and to refer sick students to care. this study is designed as a prospective matched control study. students from the seven intervention schools are matched with students from control schools.

Eligibility criteria:
inclusion criteria: * children attending one of the 14 schools in the study. exclusion criteria: * children not attending one of the 14 schools in the study.

Keywords: school-aged children school-based health program zambia child and adolescent health
lifestyle intervention in morbidly obese patients

Conditions: Morbid Obesity

Summary: the long term effects of organized lifestyle intervention on weight loss, physical fitness and quality of life in morbidly obese patients have not been extensively studied. the objective of this study is to investigate whether an intensive lifestyle intervention program in a tertiary care clinic (spesialsykehuset for rehabilitating) is superior to lifestyle intervention in a primary care setting with respect to long term (4-years) changes in weight loss, physical fitness and quality of life

due to limited recruitment from gp, the study design has been changed into an observational long term study following the participants in the intensive lifestyle intervention group

Eligibility criteria:
inclusion criteria: * morbidly obese patients not planned for bariatric surgery exclusion criteria: * participation in other weight loss programs during the last 12 mths * serious psychiatric conditions

Keywords: weight loss physical fitness quality of life