Kornimate/medical-research-clean huggingface dataset:
: identification of non-alcoholic steato-hepatitis cases in a sample of type 2 diabetes patients, with a disruption of the liver function tests, at the pointe-à-pitre university hospital

Conditions: Non-alcoholic Steato-hepatitis

Summary: non-alcoholic steatohepatitis (nash) develops on insulin resistance, especially in patients with carbohydrate tolerance. nash may progress to more extensive fibrosis, including cirrhosis, but also to hcc with or without cirrhosis in 10 to 20% of cases. the main objective of our research is to identify the prevalence of nash in a sample of 100 patients with type 2 diabetes mellitus (t2dm), consulting in the pap hospital and having a liver function disorder

in guadeloupe, the prevalence of t2dm is estimated to be 20%, among the highest in the french departements. nash is probably present in our patients with t2dm but we do not know its prevalence. there is no data on the development of nash in the afro-caribbean population, but in the united states, it has been observed that nash was less prevalent among african-americans compared to caucasian and hispanic americans, and this could be explained by differences genetics in fat metabolism. in view of the emergence of nash worldwide as a cause of chronic liver disease, it is necessary to carry out a pilot study to determine the presence or absence of nash in t2dm patients in guadeloupe. this will necessitate a systematic evaluation of liver function, usually performed during the t2dm assessment but not necessarily followed by specialized advice to confirm or invalidate the diagnosis of nash. for each patient, an abnormality of liver function will be assessed by usual serum tests (transaminases, ggt, pal). prescription for a fibrotest / actitest + nashtest and the nafld fibrosis score, will be perfomred as well as ultrasound and blood tests to eliminate other causes of liver disease (viral b or c, alcoholic, autoimmune, hemochromatosis) will also be performed.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus patient with impaired hepatic function (transaminases and / or pal and / or gamma-gt\> norm) * age ≥18 years * free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research). * affiliate or beneficiary of a social security scheme. exclusion criteria: * pregnancy or breast-feeding * no diabetes or type 1 diabetes * chronic hepatopathy of other origin: viral b, c, alcohol, hemochromatosis, α1-antitrypsin deficiency, wilson's disease, autoimmune hepatitis

Keywords: nash, type 2 diabetes mellitus
cutaneous tolerability and safety of nvn1000 topical gel in healthy volunteers

Conditions: Acne Vulgaris

Summary: the study will assess safety and tolerability of different doses of topical gel containing a new chemical entity, nvn1000, and the vehicle (gel without drug) applied to the face of healthy volunteers with high counts of propionibacterium acnes. the test product will be applied once daily for 4 weeks. exploratory measures include whether the topical product decreases the amount of a bacteria associated with acne (p. acnes).

this is a single center, observer blinded, randomized, multiple dose study with 3 doses of nvn1000 and vehicle applied once daily for 4 weeks. there are 4 arms to the study (3 active and 1 vehicle).

Eligibility criteria:
inclusion criteria: * healthy male and female volunteers * age 18 or older * high degree of fluorescence of facial skin under wood's lamp exclusion criteria: * acute or chronic skin disorders * use of topical or systemic antibiotics within 4 weeks of study * concomitant use of nitroglycerin or other nitric oxide donor drugs * females who are pregnant, planning pregnancy or breast feeding

Keywords: acne vulgaris
rtms effects on smoking cessation and cognition in schizophrenia

Conditions: Cigarette Smoking; Schizophrenia

Summary: patients with schizophrenia have high rates of cigarette smoking and tobacco dependence, and great difficulties in quitting smoking. the development of novel and more effective treatments for tobacco dependence in this population is thus needed. this study will test the hypothesis that repetitive transcranial magnetic stimulation (rtms) may facilitate smoking cessation with the transdermal nicotine patch (tnp) in patients with schizophrenia motivated to quit smoking. a total of n=40 smokers with schizophrenia would be assigned to either active rtms (n=20) or sham rtms (n=20) as a treatment regimen of 5x/week treatments for four weeks. all subjects would receive tnp (21 mg/24h) and weekly group behavioral therapy for smoking cessation for a total of 10 weeks. the investigators predict that active rtms will be well-tolerated and superior to sham rtms for enhancing smoking cessation rates in smokers with schizophrenia.


Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of schizophrenia or schizoaffective disorder * smoking at least 10 cigarettes per day and a fagerstrom score of at least 4. * willing to quit smoking in the next 30 days. exclusion criteria: * active alcohol or illicit drug abuse or dependence in the past 3 months * a history of seizures, head trauma or space occupying lesions. * a history of alcohol or illicit drug abuse in the past 6 months. * intolerance of the nicotine patch or its excipients * evidence for psychiatric instability as judged by acute psychotic exacerbations, suicidal or homicidal ideation. * females who are pregnant.

Keywords: repetitive transcranial magnetic stimulation cigarette smoking schizophrenia randomized double-blind placebo-controlled longitudinal nicotine patch
impact of a mediator for patient intake in emergency departments

Conditions: Violent Aggressive Behavior; Mediation

Summary: violence in the workplace is becoming a serious phenomenon in the contemporary world of work. hospital staff, like any employee working in contact with the public, is particularly exposed to this violence. in emergency departments, the number of patients treated and their heterogeneity, the problems of communicating with healthcare professionals, and waiting times, favor conflict situations. in the already tense context of the emergencies, the incivilities or violent acts have an impact on the well-being of professionals. in order to prevent these situations of violence, a solution could be to integrate a professional with specific skills into the teams to perform mediation functions between caregivers and patients. the aim of the study is to evaluate the impact of the presence of a mediator in emergency services on personal (verbal or physical) attacks on professionals (caregivers, doctors, administrative staff).


Eligibility criteria:
inclusion criteria: * patient aged 18 years or older. * registered at the reception of the emergency department between 8 am and 8 pm, excluding bank holidays. exclusion criteria: * patient with psychiatric disorders or impairment of judgment related to the taking of toxic substances. * patients requiring medical care in less than 30 minutes (sort code).
effect of selenium supplementation on trace mineral antioxidant enzyme and amino acid metabolism in infants

Conditions: Preterm Infants

Summary: the objectives of the study were to assess the serum selenium, zinc, and copper status and plasma and white blood cell antioxidant enzyme activities of low birth weight infants receiving selenium supplemented and non-selenium supplemented parenteral nutrition from initiation of parenteral nutrition until discontinuation of preterm formula or hospital discharge.


Eligibility criteria:
inclusion criteria: * weight less than 1500 g at birth * not capable of receiving enteral feedings prior to 7 days postnatally exclusion criteria: * metabolic abnormalities such as inborn errors of metabolism * current viral infections * enterocolitis confirmed by diagnosis * presence of congenital anomalies, severe cardiac disease, liver disease, severe renal and neurological diseases, cholestasis, hemolytic disease and severe gastrointestinal disease * evidence of chronic white blood cell disease
infection with respiratory syncytial virus in infants

Conditions: Respiratory Syncytial Virus Infections; Respiratory Syncytial Virus (RSV); Respiratory Syncytial Virus-bronchiolitis

Summary: iris (infection with respiratory syncytial virus) is an observational, multi-center study enrolling infants with severe rsv infection and healthy controls. inclusion criteria are age below two years and hospitalization due to rsv infection at three german sites. exclusion criteria are premature birth, congenital or acquired bronchopulmonary or cardiac diseases, and immunodeficiency. blood and respiratory specimens are collected upon admission, and rsv and other pathogens are analyzed by multiplex polymerase chain reaction (pcr). further biomaterials including plasma, nasal lining fluid, blood cells, dna, and rna specimens are sampled in a dedicated biobank. detailed information on demographic characteristics and medical history is recorded, as well as comprehensive clinical data including vital signs, medication, and interventions.

the iris study is designed as a multicentric, prospective, observational study initiated at hannover medical school, germany. upon enrollment, detailed data on demographic background, case histo-ry, clinical presentation, physical examination, diagnostic findings, treatment, and other patient related items is collected. data on disease course, treatment, and complications is gathered. blood and respiratory specimens are collected upon admission, and rsv and other pathogens are analyzed by multiplex polymerase chain reaction (pcr). further biomaterials including plasma, nasal lining fluid, blood cells, dna, and rna specimens are sampled in a dedicated biobank (hannover unified biobank). the study enrolls hospitalized children with confirmed rsv infection between the first month of life and second year of life. the diagnosis of rsv is evaluated by point-of-care testing (poct, sofia, quidel, kornwestheim, germany), and positive findings are confirmed by polymerase chain reac-tion (pcr). exclusion criteria are premature birth, congenital or acquired bronchopulmonary or car-diac diseases, and immunodeficiency. healthy control probands are enrolled via recruitment of patients undergoing routine surgical procedures. written informed consent is obtained from all parents and caregivers. three local study centers in northern germany (hannover, oldenburg, and hildesheim) are contributing. all study sites are secondary or tertiary care hospitals and undergo extensive training in recruitment, biosample acquisition and processing, data collection and data entry, logistics, and security.

Eligibility criteria:
inclusion criteria: * rsv infection, confirmed by polymerase chain reaction (pcr) * need for hospitalisation exclusion criteria: * premature birth * bronchopulmonary diseases * cardiac diseases * immunodeficiency

Keywords: respiratory syncytial virus (rsv) infants bronchiolitis infection cohort study
daily oral l-arginine plus tadalafil in diabetic patients with erectile dysfunction

Conditions: Erectile Dysfunction

Summary: tadalafil is an effective oral therapy in erectile dysfunction. l-arginine is a pro drug that increase the level of nitrous oxide in the smooth muscles so can increase the strength and duration of erection. this clinical trials compare the daily oral l-arginine plus tadalafil in treatment of erectile dysfunction in diabetic patients.


Eligibility criteria:
inclusion criteria: * patients with type 2 dm exclusion criteria: * patients with history of pelvic trauma, major pelvic surgical intervention, hypogonadism, hyperprolactinemia, hypertension, chronic prostatitis, chronic liver disease, smokers, history of chronic intake of cns or anti-androgen drugs and patients with peyronie's disease or any fibrotic anomalies

Keywords: erectile dysfunction diabetes tadaladil l-arginine
study of lupron depot in the treatment of central precocious puberty

Conditions: Puberty, Precocious

Summary: the purpose of this study is to determine if lupron (leuprolide acetate) is safe and effective in treating children with central precocious puberty (cpp), and to assess long term effects of leuprolide acetate treatment after therapy is discontinued.

this study includes a prestudy period; a treatment period where subjects will receive treatment every 4 weeks until the initiation of puberty (age 12 for males and age 11 for females); a follow-up period where subjects will be observed every 6 months until physical and laboratory observations are at pubertal levels, then every 12 months for 5 years; lastly a final follow-up questionnaire is given to all subjects when they are at least 18 years old. at the treatment visits, efficacy assessments are tanner staging (suppression of breast development in females and genital development in males), gonadotropins (lh and fsh), sex steroids (estradiol in females and testosterone in males), ratio of bone age to chronological age, adult height compared to a standard population and predicted mature height, and age and time to regular menses in females. this protocol will also capture data from the final questionnaire about female reproductive status at adulthood including the presence of regular menses and number of pregnancies.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of isosexual central precocious puberty with onset of tanner scores of stage ii for breast or pubic hair earlier than age 8.0 years in girls or stage ii for pubic hair or genitalia earlier than 9.0 years in boys. * confirmation of diagnosis by a pubertal response to a gonadotropin-releasing hormone (gnrh) stimulation test (lh \> 10 u/l at baseline). * chronological age less than 9.0 years in girls or less than 10.0 years in boys at time of first dosing. * bone age advanced at least 1 year beyond the chronological age at entry into the study. * the condition may be idiopathic or secondary to another lesion. if secondary, therapy of the primary condition will have been undertaken and stabilized. * no evidence of abnormal pituitary, adrenal, thyroid and gonadal function except for premature secretion of gonadotropins. exclusion criteria: * irradiation to the central nervous system. * prior therapy with medroxyprogesterone acetate and/or with any gnrh analog (including prior treatment with daily subcutaneous and depot formulations of leuprolide acetate).

Keywords: cpp central precocious puberty pediatrics suppression of lh lupron leuprolide acetate depot formulation gnrha gnrh agonist gnrh analog lh tanner staging
cognis and teligen 100 he and reliance quadripolar defibrillation lead (4-site) field following

Conditions: Ventricular Tachycardia, Ventricular Fibrillation; Heart Failure

Summary: the cogent-4 field following study will evaluate the clinical performance of the boston scientific teligen 100 he implantable cardioverter defibrillator (icd), the cognis 100 he cardiac resynchronization therapy icd (crt-d) systems and the reliance 4-site defibrillation lead (when available). an optional sub-study will also evaluate the clinical performance of the reverse mode switch (rms) feature in the teligen 100 he dr icd.


Eligibility criteria:
inclusion criteria: * icd indication according to normal clinical practice (for those patients receiving a teligen 100 he) * crt-d indication according to normal clinical practice (for those patients receiving a cognis 100 he) * willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational centre and at the intervals defined by this protocol * geographically stable patients who are available for follow-up at a study centre * age 18 or above, or of legal age to give informed consent specific to national law exclusion criteria: * documented life expectancy of less than six months or expected to undergo heart transplant within the next six months * patients currently requiring dialysis * women who are pregnant or plan to become pregnant. method of assessment per physician discretion * enrolled in any concurrent study * patients implanted with the following leads which will not be abandoned: * atrial or right ventricular unipolar leads * patch defibrillation leads * non-compatible defibrillation leads (e.g. 5/6mm)
solyx single-incision slingdynamic intraoperative standing sling technique (disst) as an office-based procedure

Conditions: Stress Urinary Incontinence

Summary: this study will assess the feasibility and success of performing the solyxtm simus in the office using the dynamic interactive standing sling technique (dissttm). study endpoints will be feasibility, composite success, complications, and patient and physician acceptance.

the single-incision midurethral sling (simus) is a procedure where there are no exit incisions. there is a 15 mm suburethral incision with the sling being attached with anchors to the obturator muscle on each side. this procedure has potentially lesser side-effects compared to the longer slings however, the literature has not found the simus to be as effective as the long slings. in our recently published study, the dissttm technique has significantly improved the success of the simus procedure as the sling can be tested for proper application in vivo. as we have performed several of these procedures in the operating room entirely under local anesthesia, we have decided to perform this procedure in an office setting using the same safety precautions as in a hospital operating room. performing this procedure in the office has significant benefits for the patient, the healthcare industry, and the economy overall. moving away from a hospital setting has significant psychological benefits. this will increase patient acceptance and therefore will become appealing to many more women who may be shying away from treatment. it would also eliminate the risk of nosocomial infections for the patient and family members, improve efficiency as the wait time would be negligible, and would reduce the expense of the entire treatment as hospital costs would not feature in the equation. this study will assess the feasibility and success of performing the solyxtm simus in the office using the dynamic interactive standing sling technique (dissttm). study endpoints will be feasibility, composite success, complications, and patient and physician acceptance.

Eligibility criteria:
inclusion criteria: * sui with hypermobility of the urethrovesical (uv) junction * american society of anesthesiologists (asa) classes i or ii * ages ranging 21-89 years * have the ability to stand for cst during the procedure * have failed behavioral therapy * completed childbearing exclusion criteria: * asa classes iii or iv * need for concomitant surgery * poor compliance for office-based approach * demonstrate concomitant urgency incontinence on urodynamic testing
perioperative methadone use to decrease opioid requirement in pediatric spinal fusion patients

Conditions: Scoliosis; Pain

Summary: acute pain management following major surgical procedures in pediatric patients continues to be a challenge, especially after extensive posterior spine fusions. spine surgery is particularly traumatic, initiating pain in both peripheral and central pathways. while the standard management of post-surgical pain involves a multimodal approach, opioids provide the predominant benefit. however, opioid use is associated with many adverse effects, including nausea, constipation, and pruritus. perioperative methadone may decrease total opioid consumption and adverse effects as well as improve satisfaction with pain management after scoliosis repair.

this study is a double blind comparison, evaluating the benefits of intraoperative methadone in extensive posterior spine fusion surgery for idiopathic scoliosis. methadone 0.2 mg/kg will be given to the treatment group. postoperative evaluation for narcotic use, pain control, and adverse effects will be compared to a standard treatment approach used at children's hospital of wisconsin.

Eligibility criteria:
inclusion criteria: * age 10-18 years * idiopathic scoliosis * fusion levels planned for 10 or greater * english speaking * american society of anesthesiology (asa) class 1 - 3 exclusion criteria: * current narcotic use / history of substance use disorder * morphine, hydromorphone or methadone allergies * pregnancy * seizure disorders * bleeding disorders * neuromuscular scoliosis * history of renal or hepatic disease * long qt syndrome * obstructive sleep apnea * body mass index \> 40 * inability to tolerate standard analgesic medications (gabapentin, ketorolac, acetaminophen) * non-english speaking

Keywords: methadone gabapentin postoperative pain posterior spinal fusion pediatric
a study of three different anti-hiv drug combinations in hiv-infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to compare the safety and effectiveness of three anti-hiv drug combinations. the three combinations are: (1) efavirenz (dmp 266) plus indinavir; (2) dmp 266 plus zidovudine (zdv) plus lamivudine (3tc); and (3) indinavir plus zdv plus 3tc. this study also examines the resistance hiv may have to these drugs and if these drugs are effective over a long period of time.


Eligibility criteria:
exclusion criteria concurrent medication: excluded: * terfenadine, astemizole, cisapride, triazolam, or midazolam (competition for the enzyme cytochrome p-450 3a4 \[cyp3a4\] by indinavir could result in inhibition of metabolic breakdown of these drugs and create the potential for serious and/or life threatening events \[i.e., cardiac arrhythmia, prolonged sedation\]). * rifampin or rifabutin (prohibited because of potential drug interaction with indinavir). * ketoconazole, itraconazole, and clarithromycin. * concomitant systemic therapy for acute opportunistic infection or malignancy. excluded: life expectancy less than 12 months. prior medication: excluded: * prior treatment with efavirenz, 3tc, an nnrti, or an hiv protease inhibitor. * prior antiretroviral agent within 14 days of initiating study treatment. * prior treatment (within 30 days of initiating study treatment) with any other experimental drug for any indication. patients must: * have a diagnosis of hiv infection. * have cd4 counts greater than or equal to 50 cell/mm3. * have a life expectancy greater than or equal to 12 months. * be post-pubescent.

Keywords: hiv-1 drug therapy, combination zidovudine drug resistance, microbial hiv protease inhibitors lamivudine indinavir genotype reverse transcriptase inhibitors efavirenz
usefulness of serum pepsinogen and gastrin as the predictive biomarker of atrophic gastritis, intestinal metaplasia and gastric cancer in korea

Conditions: Atrophic Gastritis

Summary: it is well-known that atrophic gastritis is a major risk factor for gastric cancer, which leads to variations in the serum levels of gastrin, pepsinogen (pg) i, and pgii. we want to assess the effects of age, sex, and helicobacter pylori status on pepsinogen (pg) level for atrophic gastritis and whether gastric atrophy based on the pg test would be improved after h. pylori eradication.


Eligibility criteria:
inclusion criteria: 1. over 19 years 2. the patients who have gastrointestinal discomfort or get esophagogastroduodenoscopy (egd) for health check up 3. the patients who got the procedure, endoscopic submucosal resection (esd) for early gastric cancer exclusion criteria: 1. gastrectomy history 2. advanced gastric cancer (impossible to get the gastrectomy) 3. helicobacter eradication history 4. the patients who have chronic disease 5. cancer patients except gastric cancer within 6 months 6. who cannot perform this study according to research's decision 7. who have bleeding tendency (ex. taking antiplatelet agent, low platelet count or abnormal coagulation time)

Keywords: atrophic gastritis, pepsinogen, helicobacter pylori