Kornimate/medical-research-clean huggingface dataset:
role of interferon-gamma 1-b (ifn-γ) on cells of the innate immune system: functional, biochemical and gene expression studies in patients with chronic granulomatous disease

Conditions: Chronic Granulomatous Disease

Summary: the overall goal of the study is to investigate the functional, biochemical, and gene expression effects of interferon-gamma 1-b (ifn-γ) on the neutrophils of patients with chronic granulomatous disease (cgd). the investigators hypothesize that the clinical effects demonstrated in patients with cgd treated with ifn-γ (decreased number and severity of infections) are the result of biochemical processes and upregulation of specific genes, which lead to enhanced functionality of this immune cell population.


Eligibility criteria:
inclusion criteria: * current treatment with ifn-γ or intent to treat with this drug * acute infections resolved * subject is off treatment medications * women of childbearing potential must have: * a negative urine beta-hcg, and * be willing to practice two forms of effective contraception for the duration of study participation exclusion criteria: * pregnancy, * breast-feeding, or * unwillingness to use effective contraception * recent vaccination (within the last fourteen days) * current infection or acute health condition requiring treatment * chronic inflammatory complications of cgd including: * gastric outlet or urinary tract obstruction, * pleuritis, * pericarditis, * inflammatory bowel disease, or * colitis requiring treatment. * un-associated chronic lung, liver, kidney, or cardiac disorders requiring active treatment
provision of antioxidant therapy in hemodialysis (path) study

Conditions: End-stage Renal Disease

Summary: studies have shown that end stage renal disease (esrd) patients have higher levels of blood markers which their body makes in response to increased stress and injury. an increase in these markers have been shown to be related to cardiovascular disease and death in esrd patients. this study will examine whether antioxidant therapy (vitamin e and alpha lipoic acid) may decrease these markers.

oxidative stress and acute phase inflammation are now recognized to be highly prevalent in the hemodialysis population, and several lines of evidence point to their contribution in atherosclerosis development. biomarkers of the inflammatory state such as c-reactive protein (crp) and interleukin-6 are robust predictors of cardiovascular events and mortality in the dialysis population. the uremic state is characterized by retention of oxidized solutes including reactive aldehyde groups and oxidized thiol groups. it has recently been demonstrated that initiation of maintenance hemodialysis does not improve biomarkers of oxidative stress or inflammation, suggesting that dialysis alone is inadequate to control the atherosclerotic uremic metabolic state. in this study we hypothesize that administration of antioxidant therapy will decrease biomarkers of acute phase inflammation and oxidative stress while improving the erythropoietic response in hemodialysis patients.

Eligibility criteria:
inclusion criteria: 1. patients with end-stage renal disease receiving thrice weekly hemodialysis 2. age \> 18 years 3. life expectancy greater than one year 4. ability to understand and provide informed consent for participation in the study exclusion criteria: 1. aids (hiv seropositivity is not an exclusion criteria) 2. active malignancy excluding basal cell carcinoma of the skin 3. gastrointestinal dysfunction requiring parenteral nutrition 4. history of functional kidney transplant \< 6 months prior to study entry 5. anticipated live donor kidney transplant over study duration 6. history of poor adherence to hemodialysis or medical regimen 7. prisoners, patients with significant mental illness, pregnant women, and other vulnerable populations 8. patients taking vitamin e supplements \> 60 iu/day, vitamin c \> 500 mg/day over the past 30 days 9. patients taking anti-inflammatory medication except aspirin \< 325 mg/day over the past 30 days 10. patients using a temporary catheter for dialysis access 11. more than two hospitalizations within the last 90 days or one hospitalization within the last 30 days
safety evaluation of china patients: long-term treatment outcome of conbercept ophthalmic injection in real word（stone）

Conditions: Wet Age-related Macular Degeneration (wAMD)

Summary: this is a post-marketing drug safety monitoring study in a prospective manner, and data collection will be performed in a registration-follow-up manner. safety information about patients who have received intravitreal injection of conbercept ophthalmic injection in medical institutions involved in the study during research will be actively monitored without intervening in diagnosis and treatment. all patients enrolled will be followed up for one year.


Eligibility criteria:
inclusion criteria: 1. the condition that informed consent has been freely given prior to research-related procedures; 2. patients who have received at least one intravitreal injection of conbercept ophthalmic injection after informed consent has been given. exclusion criteria: 1. patients who have been on any of other anti-vegf drugs systematically or locally, including but not limited to bevacizumab, ranibizumab and aflibercept, 90 days before enrollment; 2. those who are on other study drugs or have been on other study drugs 30 before informed consent is given.
study of acamprosate in autism

Conditions: Autistic Disorder

Summary: recent pharmacotherapy research in autism spectrum disorders (asd) has successfully focused on treatment of co-occurring symptoms, including inattention, hyperactivity, and irritability that commonly occur in persons with asd. despite over two decades of significant pharmacotherapy research, to date no medication has been shown in controlled trials to enhance the core social deficits of asd. based upon findings describing the neurobiology of asd combined with our preliminary results, we believe the novel drug acamprosate will show evidence of reducing social skills deficits associated with asd.

each subject with asd will receive 10 weeks of blinded treatment with acamprosate or matching placebo. after completion of the double-blind phase, all subjects will have an opportunity to receive acamprosate as part of the study procedures for 16 weeks.

Eligibility criteria:
inclusion criteria: * 5-17 year-old outpatients * diagnosis of asd * general good health (determined by exam, history, and laboratory work up) * use of up to two concomitant psychotropic drugs (stable dosing for \>60 days) not impacting glutamate or gamma-aminobutyric acid a (gaba) neurotransmission is allowed * stable seizure disorder (no seizures in 6 months; on same anti-convulsant dose for \>60 days) * clinical global impression scale severity score (cgi-s) of 4 (moderately iii) * score of 13 on the social withdrawal subscale of the aberrant behavior checklist (abc-sw) at screen and baseline exclusion criteria: * potential subjects with a creatinine clearance \< 50 ml/min or evidence of a previous trial of acamprosate will be excluded
special drug use surveillance of leuprorelin for injection kit 22.5 mg in "premenopausal breast cancer"

Conditions: Premenopausal Breast Cancer

Summary: the purpose of this survey is to evaluate the safety in patients with premenopausal breast cancer receiving leuprorelin in the routine clinical setting.

the drug being tested in this survey is called leuprorelin for injection kit 22.5 mg. leuprorelin is being tested to treat people who have premenopausal breast cancer. this survey will look at the safety in patients with premenopausal breast cancer receiving the drug in the routine clinical setting. the survey will enroll approximately 300 patients. - leuprorelin this multi-center survey will be conducted in japan.

Eligibility criteria:
inclusion criteria: - participants with premenopausal breast cancer will be included. exclusion criteria: * participants with a history of hypersensitivity to any ingredients of leuplin pro, synthesized lh-rh, or lh-rh analogues * pregnant or potentially pregnant participants and breastfeeding participants
natural history of hypereosinophilia and hypereosinophilic syndromes

Conditions: Eosinophilia; Hypereosinophilic Syndrome

Summary: unexplained chronic hypereosinophilia (he) and hypereosinophilic syndromes (hes) are heterogeneous regarding the organ involvements (heart, lungs, skin, .. or none), the evolutionary profiles, the response to treatments. underlying mechanisms are largely unknown and may associate genetic predisposing factors (germinal ? somatic?), environmental factors (alimentation, tobacco use, hormones, infections, ..) the cohesion study aims to study all clinical and biological characteristics of he/hes patients and their evolutionary profiles, with a focus on genetic factors and the mechanisms supporting transitory or persistant chronic he/hes (in absence of any well identified extrinsic trigger like drugs, parasitosis, ..)

there is currently no data on the natural history of unexplained chronic hypereosinophilia (he) and hypereosinophilic syndromes (hes). clinical practice shows that he/she patients can present 4 evolutionary profiles: a. a single flare-up of their disease, with favourable evolution spontaneously or under corticosteroid therapy, without further recurrence b. recurrent flare-ups with a variable free interval of several months to several years, with or without persistent eosinophilia between flare-ups c. a chronic disease requiring the continuation of a substantive treatment d. chronic asymptomatic he for years: the mechanisms involved in the occurrence of possible organ damage are unknown the primary objective of the study is to describe the frequency of the different clinical manifestations during the diagnostic and follow-up of the hypereosinophilic syndrome (hes). the primary endpoint is the frequency of the different clinical manifestations and/or organs damage related to eosinophilia.

Eligibility criteria:
inclusion criteria: * men or women of any age : * with the diagnosis criteria of hyperosinophlia or hypereosinophilic syndrome or specific organ eosinophilic disease according to the consensus conference of the international cooperative working group on eosinophil disorders (icog-eo) * with an aec \> 1500/mm3 or organ damage related to the presence of eosinophils in the tissues or organs whatever the context (idiopathic, clonal or reactive, including drug-related, parasitic or allergic) * hes diagnosis since 2005/01/01 * patients socially insured * patient who agreed to participate to the study, its proceedings and duration. exclusion criteria: * known hiv infection * not socially insured * person unable to receive a enlighten information * person who refuse to sign the consent * persons deprived of their liberty * persons benefiting from a system of legal protection (tutelage / guardianship)

Keywords: eosinophilia hypereosinophilia hypereosinophilic syndrome
treatment of cutaneous ulcers with a novel biological dressing

Conditions: Venous Ulcers

Summary: the aim of the study is to evaluate the effect of a biological dressing on the healing process of venous ulcers. the dressing is a reconstructed skin substitute made with the patients own cells.

the hypothesis of this trial is that the cutaneous model sass, a dermal epidermal skin substitute, created by the loex could be as high-performant, or even better, than the one's already existent in north america for the wound care. we anticipate showing on 6 patients that ulcer that did not close with conventional treatment, will heal or at least improve with this treatment.

Eligibility criteria:
inclusion criteria: 1. men or women from 18 to 85 years old 2. have a venous ulcer or a mixed ulcer exclusion criteria: diabetes mental deficiency hepatitis holder (a-b-c) hiv positive pregnancy or lactation corticosteroids therapy radiotherapy chemotherapy

Keywords: tissue engineered wound dressing; autologous skin substitute; biological dressing; wound care
this study aims to determine the incidence, of hepatitis b diagnosis among diabetes mellitus patients of 0-80 years of age

Conditions: Hepatitis B

Summary: this study is being conducted to assess the risk of hepatitis b (hepb) diagnosis among diabetes mellitus (dm) and non-dm patients of 0-80 years of age with in a large population-based cohort in united kingdom (uk) using data from the cprd database.

the study is a retrospective, observational, descriptive, cohort study, in dm and non-dm patients of 0-80 years of age. as a first step the eligible baseline population from cprd will be defined as per the data quality qualifiers, which include subjects aged 0-80 years, "acceptable for research" registered in practices classified as "up to standard" by the cprd for the time period 2000- 2012. the following cohorts will be defined from the baseline population: * dm cohort: patients diagnosed with type 1 or type 2 dm, as confirmed by diagnosis medical codes with or without a dm related drug or monitoring devices prescription. * non-dm cohort: patients with the absence of personal history of dm diagnosis or antidiabetic drug or monitoring devices prescriptions. from the above defined cohorts, hepb cases will be identified based on clinical diagnosis codes, hospital episodes statistics (hes) or positive diagnostic laboratory tests results.

Eligibility criteria:
inclusion criteria: * subjects, 0 to 80 years of age during the study period. * subjects acceptable for research as per cprd definition: * acceptable flag for research. * subjects with at least 12 months of observation time at the time of inclusion in the study: * subjects have to be registered in the cprd database for at least 12 months at the date of inclusion in the study. * subjects have to be registered in a general practitioner practice classified as 'up to standard' for at least 12 months at the date of inclusion in the study. * particular case of new born children. * to ensure inclusion of subjects less than 1 year of age, they will be included regardless their observation time in cprd. * inclusion date * inclusion criteria will be assessed for each calendar year between the years 2000 and 2012. exclusion criteria: • for the analyses requiring the inclusion of hes data, hes records linked with more than one cprd patient will be excluded from the analyses.

Keywords: diabetes mellitus hepatitis b incidence
validation of accexible as a tool for screening and monitoring depression.

Conditions: Major Depressive Disorder (MDD)

Summary: major depressive disorder (mdd) is a chronic disease with a prevalence around 8-12% and is considered one of the most debilitating disease worldwide. a recent orientation is the analysis of language in relation to the description of images with a high and varied semantic and emotional content. it can be studied that changes in the description of an image check if these changes are associated with the evolution of a person with probable impairment both in memory and cognitive as well as emotional, psychiatric, behavioral and even in their interaction with environmental factors especially those associated with socialization and loneliness. the present study has the objective of validating accexible as a tool for screening and monitoring depression.


Eligibility criteria:
inclusion criteria: * adult 18-65 years of age. * participants must have spanish as their first language (able to speak and understand verbal messages). * participants must have mobile phone with internet. * participants must have the ability to understand accexible's basic instructions. * participants must agree to participate in the study and have voluntarily signed the informed consent. exclusion criteria for patients: * to have received a diagnosis of neurodegeneration. * to have significant vision problems that would affect the ability to perceive visual stimuli. * to have significant hearing problems that would affect the ability to understand verbal cues. * to be unable to give informed consent to participate in the study.
effect of obstructive sleep apnea syndrome on insulin sensitivity and cardiovascular risk in pcos adolescents

Conditions: Obstructive Sleep Apnea Syndrome; Polycystic Ovary Syndrome; Sleep Apnea

Summary: polycystic ovary syndrome (pcos) is one of the most common disease caused by hormonal imbalance and is also associated with overweight and obesity. it affects 5-10% of adolescent girls and women capable of having children. polycystic ovary syndrome is associated with missed menstrual periods, hormonal imbalance, being overweight, and with a form of diabetes. girls with polycystic ovary syndrome may have a breathing problem known as "sleep apnea." sleep apnea may cause a person to stop breathing for short periods of time while sleeping. people with polycystic ovary syndrome are thirty times more likely to develop sleep apnea than those who do not have pcos. if sleep apnea is not treated, it may lead to daytime sleepiness, poor school performance, high blood pressure, heart disease and diabetes. the purpose of this study is to understand how insulin function is affected in presence of sleep apnea in girls with polycystic ovary syndrome between 13-21 years of age as compared to girls with pcos without sleep apnea. insulin is one of the hormones made in your body to convert food into energy. in people with increase weight body cannot use insulin properly. the investigators also want to see if insulin action is also affected by sleep apnea.

see above.

Eligibility criteria:
inclusion criteria: * female. * ages 13-21 * pcos * bmi \>95%ile (obese group) or \<85%ile (lean group) * controls: ages 18-21, regular menses, bmi \<85%ile exclusion criteria: * breastfeeding. * pregnant. * use of any steroid preparations (including hormonal contraception), medications known to alter insulin secretion and/or action within 3 month (including metformin)

Keywords: insulin function sleep apnea girls pcos insulin action
doula combined latent phrase epidural analgesia in primiparous women

Conditions: Labor Pain

Summary: accumulating evidence indicated that neuraxial analgesia in the latent phase of the first stage of labor would be an effective and safe health care procedure for nulliparas. doulas, women with labor experience trained for parturients, is a new way to alleviate the psychological stress from the laboring pain. previous data in our study showed that doula accompany is a good method in shortening the progress of labor used in the active phrase of the first stage of labor, and decreasing the rate of cesarean delivery. investigators hypothesized that doula combined neuraxial (epidural) analgesia in the latent phrase would be a superior means for effective pain relief, decreased rate of cesarean section, and shortened duration of labor.


Eligibility criteria:
inclusion criteria: * nulliparous women * \> 18 years and \< 45 years * spontaneous labor * analgesia request exclusion criteria: * allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records * participants younger than 18 years or older than 45 years * those who were not willing to or could not finish the whole study at any time * using or used in the past 14 days of the monoamine oxidase inhibitors; * alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics * subjects with a nonvertex presentation or scheduled induction of labor * cervical dilation was 4.0 cm or greater before performing epidural puncture and catheterization

Keywords: doula patient-controlled epidural analgesia neuraxial analgesia labor analgesia
phamacological reversal of airway instability during sedation

Conditions: Upper Airway Obstruction

Summary: the investigators are attempting to demonstrate a decrease in the frequency and severity of sedation-induced respiratory arrhythmias(central and obstructive apneas) with pharmacological pre-treatment in this pilot project and then eventually to understand the mechanisms behind this decrease. the efficacy and mechanisms of these treatments, while evaluated during sleep in obstructed sleep apnea (osa) patients, have not been systematically studied during sedation in either normal subjects or osa patients. the agent to be assessed in this study in physostigmine versus placebo.

one of the most serious side effects of drugs administered for sedation is untoward respiratory events. the relative prevalence of such events is thought to be high, occurring in up to 41% of patients in some cohorts. many specific drugs and combinations have been recommended for moderate sedation, particularly when provided by a non-anesthesiologist. the use of an opioid and a benzodiazepine is the most frequent combination, partly because the availability of antagonists for both drugs may make a "rescue" easier. however, this combination results in frequent respiratory arrhythmias (combinations of obstructions, pauses and changes in respiratory patterns).there has not been a comprehensive study of the mechanisms underlying the disruptions of respiratory rhythm caused by agents commonly used for moderate sedation. this specific research, and the line of research it opens, has the potential to make the administration of anxiolytics and analgesics safer for patients at high risk for respiratory events.

Eligibility criteria:
inclusion criteria: * ages 18-45 * bmi below 25 * healthy males exclusion criteria: * psychiatric illness * substance abuse * airway disorders * bleeding abnormatlities * claustrophobia * sleep apnea.

Keywords: breathing sedation
prevention of malnutrition in children with sickle cell disease

Conditions: Sickle Cell Disease; Malnutrition

Summary: the investigators are studying how to prevent malnutrition in children with sickle cell disease (scd) in northern nigeria. community health workers will teach mothers about nutritious local foods that might help children grow better than the usual advice from doctors. the investigators will enroll 148 children with scd aged 6 to 18 months old. the investigators will determine if their weight and diet improve and check for low vitamin a levels. this information will help us find better ways to improve growth for children with scd.

despite efforts to improve nutrition, 45% of under-5 mortality is at least partially attributable to malnutrition. children with scd have high nutrient demands and energy expenditures with a risk of impaired growth. the investigators will test the hypothesis that maternal nutrition education on locally available nutrient-dense foods will lead to improved childhood growth compared to standard pediatrician-delivered nutrition counseling. the research will involve a randomized controlled trial with 148 children aged 6 to 18 months with scd, assessing changes in weight-for-age z-scores and dietary adequacy, as well as determining the prevalence of vitamin a deficiency. these preliminary findings will inform evidence-based interventions for the primary prevention of malnutrition (underweight and vitamin a deficiency) in children with scd.

Eligibility criteria:
inclusion criteria: * laboratory confirmed scd (hbss, hbsβ0 thalassemia, or hbsc) * aged 6 to 18 months. exclusion criteria: * severe acute malnutrition (weight-for-length z-score \<-3 or mid-upper arm circumference \<11.5 cm) * diagnosis of hiv or other chronic illnesses

Keywords: malnutrition malnourishment undernutrition nutritional deficiency sickle cell disease nigeria primary prevention vitamin a infant and young child feeding