Kornimate/medical-research-clean huggingface dataset:
an fmri study of self-regulation in adolescents with bulimia nervosa

Conditions: Eating Disorders

Summary: the aim of this project is to use both multimodal mri and behavioral measures to investigate how changes in frontostriatal neural systems contribute to the development and persistence of bulimia nervosa (bn). findings from this study will have wide-ranging importance for our understanding of the development and treatment of bn.

patients with bulimia nervosa (bn) have difficulty regulating impulsive behaviors as suggested by their binge-eating and purging, as well as the high incidence of drug abuse and shoplifting in this population. understanding dysfunction in the frontostriatal circuitry that mediates self-regulatory control processes will aid development of new therapeutics for the impulsivity associated with bn. we are conducting a longitudinal study to better understand the development and persistence of bn. participation in this study includes 4 sections: neuropsychological tests, diagnostic interviews, pregnancy test, and mri scan. all efforts are made to coordinate procedures into one day, and they require between 4 and 5 hours of the participant's time. the option of splitting participation into two study days is also offered for participants who find it more convenient. participants are compensated with $100 in the form of a check, which is mailed to their home address. participants will be invited back for follow-up visits.

Eligibility criteria:
inclusion criteria: * current or prior dsm iv diagnosis of bulimia nervosa or sub-threshold bulimia nervosa (those who meet all dsm-iv criteria for bn, but engage in subjective binge-eating episodes and binge/purge at a frequency of at least once per week for 3 months, whereas meeting full dsm-iv criteria for bn requires binge eating and purging twice per week for 3 months) * major depression * for control adolescents, no current or past history of an eating disorder exclusion criteria: * ferromagnetic implants (e.g., pacemaker) * metal braces or retainers * iq less than 80 * any other current major axis i disorder, other than major depressive disorder (mdd) * history of concussion, seizure disorder, or other neurological illness * claustrophobia * pregnant

Keywords: eating disorders bulimia nervosa bulimia fmri magnetic resonance imaging
cohort study to determine the long-term safety and efficacy of biogeneric epoetin treatment for renal anemia

Conditions: Chronic Kidney Disease; End-Stage Renal Failure; Anaemia

Summary: the purpose of this study is to establish the long-term safety and efficacy of biogeneric epoetin, the attainability of therapeutic target for anaemia management, and the impact of epoetin treatment on long-term health outcome and its cost effectiveness.

this study protocol is an elaboration of the original study protocol titled "a randomized, multi-center, open label trial to establish the therapeutic equivalence between biogeneric epoetin and eprex and to determine the long term safety profile of biogeneric epoetin in patients on hemodialysis". in the first stage, a biogeneric epoetin shall be evaluated by a randomized trial designed to demonstrate therapeutic equivalence (te) versus an innovator product (eprex), the efficacy clinical end-point being hb at 6 to 12 weeks on treatment. when preliminary evidence of efficacy is established from above stage 1 te trial, the product may proceed to be evaluated in a stage 2 single group cohort study designed to establish the long term safety, with particular emphasis on surveillance for occurrence of pure red cell aplasia (prca) and other immunogenicity related adverse event. to establish the long term efficacy, its emphasis on the potential impact of batch to batch variation in product content and potency (bioactivity) on hb response. this practical trial also designed to investigate the cost-effectiveness by estimating the optimal dosage for combination of epoetin and iron sucrose to achieve hb target under unconstrained prescriptionas, and hence the budgetary requirement can be estimated to meet therapeutic target in this dialysis population under various pricing scenario in the presence of generic competition.

Eligibility criteria:
inclusion criteria: * patient who has chronic kidney disease with anaemia for which epoetin treatment is indicated. * patient without known hypersensitivity to the mammalian cell-derived product or human albumin products.

Keywords: biogeneric epoetin treatment renal anaemia chronic kidney disease pure red blood cell aplasia hemodialysis
immunologic responses to single and double doses of covid-19 vaccines in egyptians

Conditions: COVID-19 Vaccines

Summary: the recent coronavirus disease 2019 (covid-19), has caused a global pandemic, and development of safe, effective vaccines is mandatory to return back to pre pandemic life. many vaccines have been developed and requested by the authorities after the emergency license issued. the main mechanism of protection is through humoral and cell-mediated immune responses that might reduce the potential for disease development or severity. cytotoxic t cells clear virus-infected host cells and contribute to control of infection. preliminary data are now available indicating safty and effecacy of different vaccines . the vaccines were tolerated, with induction of neutralizing antibodies and antigen-specific t cells against the sars-cov-2 spike protein. the aim of this work is to evaluate the immune responses in adults, aged 25-65 years, up to 8 weeks after vaccination with a single and double doses live inactivated (sinopharm), mrna (pfizer/ biontech) and viral vector (oxford/az- chadox1 ncov-19) vaccines. the th1- response ( interferon-γ and tumor necrosis factor-α cytokine secretion by cd4+ t cells) and antibody production predominantly of igg1 and igg3 subclasses as well as cd8+ t cells mono, polyfunctional and cytotoxic phenotypes, will be also measured.


Eligibility criteria:
inclusion criteria: * healthy adults receiving covid-19 vaccines exclusion criteria: * any contraindication of each covid-19 vaccine as listed by who

Keywords: covid-19 safety efficacy t cell responses cytokine responses antibody responses
enhancing information management for young adults after genetic cancer risk testing

Conditions: Genetic Predisposition to Disease; Genetic Predisposition

Summary: this research is being done to develop the electronic platform nest for young adults (ages 18-39) who have had prior cancer genetic testing. the platform will give patients and their clinicians access to continuously updated information about both pathogenic variants and variants of uncertain significance (vus). the name of the intervention used in this research study is: nest portal (electronic platform for patients and clinicians)

the goal of the electronic platform nest is to help patients understand and manage genetic test results and recommended care and to help clinicians with access to results and recommendations, facilitating orders, and documentation. the portal has two parts, one for participants and one for clinicians. for the first phase of the study, participants will give their feedback on the nest portal's content and processes that will guide refinement of the portal. the pilot phase will test the feasibility and acceptability of the intervention. the research study procedures include a baseline survey, using the portal after receiving a brief orientation from the study team, a follow-up survey, and then a 30-minute interview. participants will be in this research study for up to 2 hours. it is expected that about 40 people will take part in this research study. the electronic platform is being developed by nest genomics.

Eligibility criteria:
inclusion criteria aim 1: * ya patients: * ages 18-39 years, inclusive. * has had previous cancer genetic testing, with a finding of a pathogenic variant or vus; patient has previously received results from the clinical team. * english-speaking and -reading. * receiving care at dfci. * not undergoing active cancer therapy at the time of approach. * clinicians: * cancer risk physicians (oncologists, gastroenterologists, geneticists), oncologists, nurse practitioners, physician assistants, or genetic counselors. * english-speaking and -reading. * cares for yas aged 18-39 with cancer risk syndromes. inclusion criteria aim 2: * ya patients: * ages 18-39 years, inclusive. * has had previous cancer genetic testing, with a finding of a pathogenic variant or vus; patient has previously received results from the clinical team. * english-speaking and -reading. * receiving care at dana-farber cancer institute. * did not participate in a stakeholder interview (aim 1). * not undergoing active cancer therapy at the time of approach. * clinicians: * oncologists, nurse practitioners, cancer risk physicians, or genetic counselors. * english-speaking and -reading. * caring for a participating ya.

Keywords: genetic predisposition to disease genetic predisposition genetic testing cancer risk syndromes vus variant of uncertain significance pathogenic variant
investigation of brain oxygenation and blood flow in smokers

Conditions: Cerebral Oxygenation and Blood Flow in Tobacco Use Disorder

Summary: cerebral oxygenation and blood flow in tobacco use disorder and their relation to smoking abstinence will be measured with mri" ändern in "cerebral oxygenation and blood flow in tobacco use disorder

in this study, cerebral oxygenation and tobacco-related attentional bias in smokers and non-smokers will be measured with magnetic resonance imaging (mri). in this study, the oxygen extraction fraction (oef), the cerebral blood flow (cbf) and the cerebral metabolic rate of oxygen (cmro2) are to be measured in smokers and non-smokers using mri. on the one hand, the influence of chronic smoking (i.e. smokers versus non-smokers) and on the other hand the effect of acute nicotine administration (in smokers) on these parameters will be examined. furthermore, the influence of these parameters on fmri results is to be investigated using the example of a stimulus-reaction task. it can be assumed that the oef does not change through nicotine administration, but differs in smokers and non-smokers and is associated with the strength of tobacco addiction in smokers. cbf and cmro2 are expected to be reduced in abstinent smokers, but can be normalized by nicotine administration. in this study, 20 smokers and 10 never-smokers will be investigated. never-smokers will be examined once with mri and questionnaires, whereas smokers will be examined twice: before and after a smoking break.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 * right-handed * normal or correctable eyesight * sufficient ability to communicate with the investigators, to answer questions in oral and written form * "fully informed consent" * "written informed consent" * group 1 - smokers: occasional smoker or tobacco consumption disorder according to dsm 5 * group 2 - never-smokers: consumption of less than 20 cigarettes in life exclusion criteria: * women: pregnancy * withdrawal of the declaration of consent * exclusion criteria for an mri scan * severe internal, neurological and psychiatric comorbidities * pharmacotherapy with psychoactive substances within the last 14 days * current substance abuse * axis 1 disorder according to icd-10 and dsm 5 (except tobacco use disorder and specific phobia within the last 12 months)
light to maximize vision, minimize insomnia

Conditions: Postural Balance

Summary: the purpose of this study is to determine whether specific wavelengths of light at night can be used to improve mobile balance while simultaneously not increasing alertness.


Eligibility criteria:
inclusion criteria: * aged 55-85 * at least 20/200 corrected visual acuity * greater than 20° visual field with no lower visual field loss * stable health * male or female * normal color vision * normal hearing exclusion criteria: * extreme chronotype * sleep disorders * dementia * smoker * depression * alcohol abuse * use of illegal drugs * use of sleep/wake altering drugs on an acute or as needed basis (including nutraceuticals, antihistamines) * use of light sensitizing drugs * self-reported history of nocturia (\>3 times per night)
effect of trauma life support training programs on patient outcomes

Conditions: Trauma Injury

Summary: introduction: trauma accounts for nearly 10% of the global burden of disease. several trauma life support programs aim to improve trauma outcomes. there is no evidence from controlled trials to show the effect of these programs on patient outcomes. we describe the protocol of a pilot study that aims to assess the feasibility of conducting a cluster randomised controlled trial comparing advanced trauma life support (atls) and primary trauma care (ptc) with standard care. methods and analysis: we will pilot a pragmatic three-armed parallel, cluster randomised, controlled trial in india, where neither of these programs are routinely taught. we will recruit tertiary hospitals and include trauma patients and residents managing these patients. two hospitals will be randomised to atls, two to ptc, and two to standard care. the primary outcome will be all cause mortality at 30 days from the time of arrival to the emergency department. our secondary outcomes will include patient, provider, and process measures. all outcomes except time to event outcomes will be measured both as final values as well as change from baseline. we will compare outcomes in three combinations of trial arms: atls versus ptc, atls versus standard care, and ptc versus standard care using absolute and relative differences along with associated confidence intervals. we will conduct subgroup analyses across the clinical subgroups men, women, blunt multisystem trauma, penetrating trauma, shock, severe traumatic brain injury, and elderly. in parallel to the pilot study we will conduct community consultations to inform the planning of the full-scale trial.


Eligibility criteria:
inclusion criteria: * adults (15 years or older) who present to the emergency department at participating hospitals with a history of trauma. history of trauma is here defined as having any of the external causes of morbidity and mortality listed in block v01-y36, chapter xx of the international classification of disease version 10 (icd-10) codebook as reason for presenting.
long-term remission after ileorectal anastomosis in crohn's disease.

Conditions: IBD - Inflammatory Bowel Disease

Summary: single-center, retrospective, observational study. the medical records of patients who underwent colectomy and ileorectal anastomosis (ira) for refractory crohn's colitis between 1996 and 2016 were reviewed.

several studies show that, although the type of disease changes in a statistically significant way after 5 years from diagnosis, overall, a follow-up of more than 10 years indicates that the disease remains unchanged in about 85% of patients. studies show that up to 70% of patients with crohn's disease (cd) undergo surgery at least once in their lifetime. in colon crohn's disease, the cumulative risk of surgery 10 years after diagnosis is lower compared to ileal crohn's disease. for patients with extensive colitis who do not respond to medical therapy, total colectomy with ileorectal anastomosis (ira) is a safe and effective approach. several studies in the literature have retrospectively evaluated the recurrence rate after colectomy and ira in crohn's disease-related colitis, showing reasonable recurrence rates. furthermore, several studies have highlighted that rectal involvement and the presence of perianal disease may be predictive factors for recurrence in crohn's colitis treated with colectomy and ileorectal anastomosis (ira). ileal involvement in colectomy in patients with crohn's colitis appears to be associated with a higher risk of recurrence in the small intestine and failure of the ira. our study is based on the hypothesis that, in patients with extensive and refractory crohn's colitis but without rectal involvement or perianal disease, colectomy and ira could instead drastically reduce the recurrence rate.

Eligibility criteria:
inclusion criteria: * patients with crohn's colitis who underwent colectomy and ileorectal anastomosis exclusion criteria: * none

Keywords: ibd cd ira
effect of an integrase inhibitor on the latency and reservoir of hiv-1

Conditions: HIV-1; HIV Infections

Summary: the presence of a pool of cells latently infected by hiv-1 in patients taking haart and with a viral load below 50 copies/ml is the main limitation to eradication of the virus from the body. this viral reservoir prevents antiretroviral therapy from being interrupted; therefore, patients are obliged to continue with treatment for a period calculated to be greater than 60 years. despite the important advances in knowledge of the biology of this reservoir, we still have no real knowledge about its dynamics. the opportunity to carry out a clinical trial for the first time with an integrase inhibitor is exceptional, since the results could provide important information on the nature of this reservoir. if maintenance of the reservoir is a dynamic process, inclusion of an integrase inhibitor is expected to lead to a reduction in the size of this reservoir. this effect could be critical when including iat (viral reactivation), since, in theory, it would be necessary to act on a smaller reservoir. current consensus is that it would be necessary to act on almost 100% of the viral reservoir (approximately 1,000,000 cells). the study has also been designed to enable us to understand the biochemical and molecular mechanisms by which certain drugs can induce viral reactivation in vitro as a previous step to a clinical trial aimed at reactivating viral latency and eradicating hiv-1 from the body.


Eligibility criteria:
inclusion criteria: * after receiving information on the design and objectives of the study, the possible risks involved, and the fact that they can refuse to collaborate at any time, patients will give their informed consent to participate in the study and agree to provide material for the cellular and molecular studies. * aged over 18 years. * chronic hiv infection * antiretroviral therapy with at least 3 drugs for at least 2 years and with no modifications expected during the study. antiretroviral drugs can be switched due to intolerance as long as plasma viremia remains controlled. * undetectable viral load determined by ultrasensitive techniques (\<50 copies hiv rna/ml) for at least 2 years. * cd4+ t lymphocyte count above 350 cells/mm3. * understand the objective of the study and be available to make frequent visits to the hospital. exclusion criteria: * previous failure of antiretroviral therapy, understood as a rebound in viral load that can be detected after having reached undetectable levels. low-grade increases (\<200 copies of hiv rna/ml) and transitory increases (blips) resolved without modifying antiretroviral therapy are excluded. * proven resistance against the antiretroviral drugs under study. * planned interruption of antiretroviral therapy. * taking immunosuppressive or immunostimulating medication of any type, including valproic acid. * taking a fusion inhibitor (enfuvirtide). * pregnancy or intention to become pregnant during the study.

Keywords: hiv-1 integrase inhibitor (raltegravir) the cell reservoir of hiv-1 treatment experienced
multicentric trial comparing three therapeutical strategies in patients with acute primary hiv infection

Conditions: HIV Infections; Primary Acute Infection

Summary: treatment of acute primary hiv infection may improve long-term outcome. however, optimal treatment is still debated. the anrs 112-interprim trial evaluates three different therapeutical strategies, combining permanent or intermittent haart and a cytokine, interferon alpha, in order to determine which combination allows the best control of hiv viremia after 24 weeks of antiretroviral treatment interruption

treatment of acute primary hiv infection may improve long-term outcome. however, optimal treatment is still debated. the main objective of this multicentric randomized phase ii/iii study is to compare hiv viremia 92 and 96 weeks after acute primary hiv infection, between patients treated with 3 different strategies. in the first group, patients receive antiretroviral drugs (haart) continuously up to week 72. in the second group, patients receive haart continuously up to week 36, then intermittently up to week 72. in the third group, patients receive haart as in group ii, and pegylated interferon alpha is administered for the initial 14 weeks, then for 3 weeks at each of the 3 haart interruption between week 36 and week 72. all patients are monitored without any haart up to week 96. enrolled patients have circulating p24 antigen and/or hiv viremia, an uncompleted hiv western blot, between 18 and 65 years old, and agree to participate to the study. they should have received no antiretroviral drugs, not be pregnant, without neuro-psychological or autoimmune disorders, without chronic hepatitis. secondary objectives of the study are: the quality of immune restoration, the anti-hiv immune response, safety and adhesion to treatment. a total of 90 patients (30 in each group) have been enrolled.

Eligibility criteria:
inclusion criteria: * p24 antigen with positive neutralization or positive plasma hiv rna * negative or not complete western blot * with symptoms or not * written informed consent exclusion criteria: * previous antiretroviral treatment * pregnancy * biological abnormalities * hepatitis c or b

Keywords: hiv infections primary acute infection interferon-alpha
comparative study between millard and tennison randall techniques in complete and incomplete cleft lip repair.

Conditions: Cleft Lip, Unilateral

Summary: "the investigators will compare the quantitative and qualitative (functional and aesthetic outcomes) of these two surgical approaches for repair of the unilateral cleft lip using an evaluation protocol developed many years ago by the research council of operation smile, a non- profit organization based in virginia beach, usa. operation smile delivers charity management of cleft lip and palate cases in many different developing countries around the world. under this protocol, a dual rating system has been developed with two scores: one preoperative score concerning the severity of cleft and one score for the postoperative results.

one of the common congenital malformations in the head and neck is cleft lips. the prevalence of cleft lip is about 1:1000 of live birth; it also more common in boys and tends to present on the left side with a 6:3:1 ratio of left to right to bilateral. many facial malformations, including cleft lip, are linked with environmental, maternal, and genetic factors, such as exposure to teratogen drugs, including isotretinoin, alcohol, or anticonvulsants. similarly, some habits or diseases during pregnancy increase the risk of the cleft lip as smoking, pregestational and gestational diabetes, and specific nutritional deficiencies. the treatment begins soon after the child's birth and continues until adulthood. the purpose of cleft treatment is aesthetic and functional rehabilitation. surgical repair is important for facial growth preservation, normal speech formation and development of proper dentition. the less number of interventions, the less the scaring results and hence, growth retardation nowadays, the most commonly used techniques in managing unilateral cleft lip (ucl) are millard's rotation advancement and tennison randall's triangular flap repairs. this study aimed to use anthropometric analysis by anthropometric measurements taken pre and post operation to evaluate the quantitative assessment of the modified millard technique compared with the tennison randall technique in ucl repair.

Eligibility criteria:
inclusion criteria: * patients are generally fit * patients with unilateral with or without cleft palate * patients with compliance for follow up. exclusion criteria: * syndromic cases. * patients are generally unfit. * secondary cleft lip. * age less than 3 months, more than 4 years * bilateral cleft lip.