Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of long limb roux-en y reconstruction

Conditions: Diabetes Mellitus Type 2 in Nonobese; Gastric Cancer

Summary: we grafted the concept of metabolic surgery (long limb roux-en y reconstruction) into gastric cancer surgery. this study aimed to investigate the safety and efficacy of long limb roux-en y reconstruction after gastrectomy in non-obese type ii diabetes with gastric cancer.

type ii diabetes in the world is increasing rapidly, and it is known that patients with type ii diabetes with morbid obesity that underwent bariatric surgery have resolution of impaired glucose metabolism. in asia, most type ii diabetes are not morbidly obese and still, it is controversy whether metabolic surgery is effective or not in non-morbid obese patients. as life expectancy is increased, the number of patients with gastric cancer and t2dm is increased as well. recently, we studied the outcome of t2dm after gastrectomy and conventional reconstruction in non-obese gastric cancer patients.(kim jw et al, world j gastroenterol 2012;18:49) the study was a large-series retrospective study including about 400 patients and the result regarding dm improvement was not satisfactory. based on our previous results, it is needed to find more effective way to resolve the type ii diabetes in gastrectomized patients with gastric cancer.

Eligibility criteria:
inclusion criteria: * pathologically confirmed gastric cancer with potentially curable state * non-obese (body mass index: less than 30 kg/m2) * have a history of type 2 dm over 6 months (diagnosed by ada criteria) 1. hba1c: more than 6.5 %, or fasting glucose: more than 126 mg/dl (7.0mmol/l) or 2-h plasma glucose: more than 200mg/dl during an ogtt or classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose: more than 200mg/dl 2. anti-gad antibody (-), anti-islet antibody (-) * c-peptide level: above 1ng/ml exclusion criteria: * patient who receive non-curative operation * patient who have less than one year life expectancy * pregnant patient * acute inflammation status patient * chronic renal disease patient (serum creatin level: more than 1.5mg/dl) * chronic liver disease patient (serum ast or alt level: more than twice of upper limit of normal range) * have a history of receiving medications such as dipeptidyl peptidase iv(dpp- iv) inhibitor or glucagon like peptide-i (glp-i) analogue

Keywords: type ii diabetes gastric cancer long limb roux-en y
pain and bleeding in subjects with acute anal fissure: comparative evaluation of three treatments

Conditions: Acute Anal Fissure

Summary: starting from the observation that acute anal fissure (aaf) in 6-8 weeks can heal spontaneously and that some of the commonly used commercial products in clinical practice would seem to be useful, the rationale of the comparative study is to try to identify, in compliance with the protocol of helsinki (2013), the most effective short-term treatment for the disappearance of pain in defecation and cessation of bleeding, shortening the duration of the healing process and favoring the patient's rapid return to his / her activity, respect for patient safety.

starting from the observation that anal fissure in 6-8 weeks can heal spontaneously and that some of the commonly used commercial products in clinical practice would seem to be useful, the rationale of the comparative study is to try to identify, in compliance with the protocol of helsinki (2013), the most effective short-term treatment for the disappearance of pain in defecation and cessation of bleeding, shortening the duration of the healing process and favoring the patient's rapid return to his / her activity, respect for patient safety. the comparative study will be conducted by comparing the following products: * centella® complex 1 cps 60 mg per os after meals twice a day for 15 days; * proctocella® complex cream to be applied in anal area and anal canal after hygiene treatment for 4 weeks; * flavonil® 1 cps 300 mg per os after meals twice a day for 15 days; * flavonil® cream cream to be applied in anal region and anal canal after hygiene treatment for 4 weeks; * rectalgan mousse cleansing cleanser for anal and perineal region for 4 weeks. our approach attempts to blend, based on the evidence of the most recent scientific literature, the experience of decades of colonproctologic clinical practice that has a predominantly surgical approach, with the clinical evidence of the science of nutrition which has a conservative vision in the treatment of ailments and constipation, a predisposing factor in the pathogenesis of anal fissure, in order to obtain healing without surgery. the control group will receive the traditional basic treatment consisting in the application of lubricated anal dilators of increasing gauge according to predetermined pattern, hygiene and diet. the two groups with which they will be compared for the results will receive, in addition to the foregoing (for controls), or flavonoids (protflav) or asian centella extract (protcent), in the form of local mouth and cream tablets to be applied at the perianal level and possibly in the anal canal with gloved finger, containing the same active principles also administered by mouth.

Eligibility criteria:
inclusion criteria: * subjects with acute anal fissure * collaborative patients able to understand and want; exclusion criteria: * pregnancy

Keywords: anal fissure local therapy pain defecation bleeding
an observational research study of the health of joints in people with haemophilia taking the medicine esperoct

Conditions: Haemophilia A

Summary: this study will collect information on the long term health of joints in people with haemophilia a who have started treatment with esperoct within twelve months prior to participation to the study. this study is conducted to look at how joint health of people with haemophilia changes over time when they are receiving the medicine esperoct. the participants will get esperoct as prescribed to the participants by the study doctor. the participant's treatment will not be affected by their involvement in the study. every six months, the participants will be asked to answer some questionnaires about their joints, their pain and their ability to be physically active. their participation in the study will last for no more than 2 years. the participants are free to leave the study at any time and for any reason. this will not affect their current and future medical care.


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). * male, greater than or equal to 18 years of age at the time of signing informed consent, diagnosed with severe (fviii activity below 1%) or moderate congenital haemophilia a (fviii activity 1-5%). * the decision to initiate treatment with commercially available esperoct has been made by the patient and the treating physician before and independently from the decision to include the patient in this study. * switched, within two months prior to enrolment, or planned to switch, within one month post enrolment, to prophylaxis treatment with esperoct from previous therapy; the decision to initiate treatment with esperoct must be made prior to and independently from the decision to enrol in the study. * must have baseline data (hjhs, target joints, and medical history) collected in routine clinical practice within two months prior or up to one month post switch to esperoct therapy. exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study. * previous terminated treatment regimen with esperoct prophylaxis. * current or previously terminated treatment regimen with esperoct on-demand. * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. * previous participation in a clinical trial within the 30 days prior to switching to esperoct.
hiv prevention and prep intervention for sgm adolescents and parents: "hey, friend"

Conditions: HIV Infections

Summary: in this 24-month pilot study, we will conduct the preparation phase of a multiphase optimization strategy (most) to develop a culturally appropriate (for deep south contexts, to be adolescent friendly, and to be acceptable to parents or guardians) modular hiv prevention mhealth intervention, targeting behavior change related to hiv testing, hiv prevention knowledge, and pre-exposure prophylaxis (prep) uptake for sexual and gender minority (sgm) adolescents, that can be seamlessly integrated into the existing school and community environments across the deep south.

in this 24-month pilot study, we will conduct the preparation phase of a multiphase optimization strategy (most) to develop a culturally appropriate (for deep south contexts, to be adolescent friendly, and to be acceptable to parents or guardians) modular hiv prevention mhealth intervention, targeting behavior change related to hiv testing, hiv prevention knowledge, and pre-exposure prophylaxis (prep) uptake for sexual and gender minority (sgm) adolescents, that can be seamlessly integrated into the existing school and community environments across the deep south. to do so, in aim 1, we will assess stakeholders' knowledge, sentiments, and beliefs related to hiv risk, hiv stigma, and hiv prevention including preferences related to modality of prep and prep acceptability. then, in aim 2, we will use aim 1 data, applying the 4-step intervention mapping framework, to inform the development of intervention modules targeting 14-18 year old sgm adolescents (rationale for this age range presented later in this proposal). we will also, develop corollary modules for parents or guardians. after intervention modules have been finalized, in aim 3, we will conduct a 4-arm randomization to assess each module's acceptability, feasibility, and clinical signal of effectiveness as compared to a time-attention control.

Eligibility criteria:
inclusion criteria: * adolescents aged 14-18 * parental or guardian consent * sgm identity * english speaking exclusion criteria: * does not fit the inclusion criteria

Keywords: hiv prep
stop-hsp.net: a registry for hereditary spastic paraplegia as an integration tool for future therapeutic strategies

Conditions: Hereditary Spastic Paraplegia

Summary: our goal is to create a solid and harmonious disease registry of patient affected by hereditary spastic paraplegia (hsp) that facilitates the collection and management of patients' data over time encouraging the research and the development of future clinical trials. in-depth clinical phenotyping will develop significant clinical outcome measures that can be used in clinical trials and will allow the phenotypic complexity of the disease to be captured with the use of validated clinical scales, biomarkers and so-called patient reported outcomes (pros).

the registry will involve five recruiting clinical centres (irccs fondazione stella maris in pisa, irccs eugenio medea in conegliano, irccs policlinico gemelli in rome, irccs istituto di scienze neurologiche in bologna, università degli studi di messina) and a data analysis partner (cineca). participants will be assessed annually at one of the five participating clinical sites. for each patient, at least one follow-up visit will be scheduled at an interval of 12 months in order to monitor and compare the longitudinal progression of hsp in similar groups (for example based on phenotype, age at onset, or genotype). at each visit all enrolled subjects will carry out a clinical-instrumental evaluation as per clinical practice, including: anamnestic collection, general and neurological objective examination; administration of illness scales (e.g. the sprs scale) and quality of life questionnaires. any biological samples will be collected as tissues, blood or urine and stored in the laboratories or bio-repositories of the individual centers and also reported in the electronic clinical report form (crf) of stop-hsp.net. the results of further diagnostic tests carried out such as optical coherence tomography (oct), brain magnetic resonance imaging (mri) or neurophysiology performed during diagnostic practice or clinical follow up will also be collected. any further clinical scales/evaluation questionnaires to be administered will be selected according to clinical need based on the neurological characteristics and genotype of each participant. all data relating to further instrumental and/or neurophysiological investigations carried out by the patient for clinical needs will also be collected. the data collected during the aforementioned clinical-instrumental-laboratory evaluations will be entered into the stop-hsp.net register in pseudonymized form.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of pure or complex hsp/spastic ataxia, even in the absence of a known genetic diagnosis * participants/parents/legal guardians will have to give informed consent for enrollment in the registry and privacy data management exclusion criteria: * subjects affected by secondary forms of hsp * presenting comorbidities that affect the general clinical picture according to clinical judgment * lack of informed consent
long-term safety of minocycline in patients with gum disease

Conditions: Periodontitis

Summary: this study will look at the safety of using the study medicine for a long time. it will see if the germs get used to the medicine, making it not work as well, if it's used by people with gum disease for a long time.

the objective of this study is to evaluate the changes in populations of minocycline-resistant bacteria after long-term use of minocycline hcl microspheres, 1 mg in subjects with moderate-to-severe chronic periodontitis. this will be assessed through monitoring the total number and proportion of minocycline-resistant bacteria and the identity of minocycline-resistant species within a panel of 40 representative periodontal species in saliva and subgingival plaque.

Eligibility criteria:
inclusion criteria: * generally healthy * over 25 years of age * moderate-to-severe chronic periodontitis * documented informed consent * willing to comply with contraceptive requirements * free from any significant oral soft tissue pathology exclusion criteria: * willing to adhere to prohibitions and restrictions of the study * oral health inappropriate for study inclusion * females self-reporting pregnancy or lactation, or having a positive urine pregnancy result * reporting any of the following conditions: * allergy to a tetracycline-class drug * systemic medical conditions requiring antibiotic prophylaxis prior to invasive dental procedures * active systemic infectious disease such as hepatitis, human immunodeficiency virus (hiv) or tuberculosis * diagnosed with clinically significant or unstable organic disease, or compromised healing potential, heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement * participation in a dental clinical trial or use of an investigational drug within 30 days of enrollment * employees of the investigator or study center, with direct involvement in the proposed study or other studies, as well as family members of the employees or the investigator * anyone who the investigator determines should not be included in the study for any reason that could compromise safety or the analysis of study results

Keywords: chronic periodontitis, antibiotic resistance
the effect of sitting and moderate exercise on plasma triglyceride elevation after a meal

Conditions: Atherosclerosis; Metabolic Syndrome

Summary: the purpose of this study is to investigate the effect of 4 days of sitting and moderate exercise on plasma triglyceride elevation after a meal.

subjects will undergo three weeks (two intervention, one washout) of testing during which they will participate in two conditions: 1) prolonged sitting (\~14-hours/day) with a 1-hour bout of acute exercise at 65% of pre-intervention vo2max and 2) prolonged sitting (\~14-hours/day) without an acute bout of exercise. during each intervention week, subjects will have 2 days of dietary and activity control, followed by 4 days during which prolonged sitting will occur. on the evening of the 4th day, subjects in the exercise group will perform the acute bout of exercise. on day 5, all subjects will undergo a lipid tolerance test to determine the body's ability to clear triglycerides from the blood as well as insulin/glucose response and substrate oxidation. blood samples will be assayed for the previously mentioned substances and postprandial gas collection will be analyzed via indirect calorimetry.

Eligibility criteria:
inclusion criteria: - exclusion criteria: * cardiovascular problems (e.g. pre-existing heart issues, coronary artery disease, hypertension, etc.) * respiratory problems * musculoskeletal problems that prevent prolonged sitting or exercise * obesity * susceptibility to fainting
a study to assess the safety and efficacy of the vegfr-fgfr-pdgfr inhibitor, lucitanib, given to patients with metastatic breast cancer

Conditions: Breast Cancer; Metastatic Breast Cancer; MBC; HER2 Positive; HER2; Estrogen Receptor Positive; ER; Triple Negative

Summary: the purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with fgf aberrant metastatic breast cancer, as well as in the treatment of patients with biomarker negative (fgf non-aberrant) metastatic breast cancer.

lucitanib is a selective, orally available tyrosine kinase inhibitor targeting fgfr1-3, vegfr1-3, and pdgfrα and β, with activity in relevant cell lines and animal models. the first in human trial of lucitanib demonstrated that daily dosing with lucitanib can provide durable clinical responses in patients with fgfr1- or 11q (fgf3, fgf4, cyclin d1, or fgf19)-amplified breast cancer. recist partial responses (prs) were also observed in patients not known to have fgf abnormalities. based on these results, this study is designed to explore the safety and anti-tumor activity of daily lucitanib in breast cancer patients with and without alterations of the fgf pathway.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed metastatic breast cancer relapsed or refractory to approved standard available treatment * prior treatment with standard first line therapy in the metastatic setting * availability of tumor tissue sufficient for confirmatory testing of fgfr1 and 11q amplification status * demonstrated progression of disease by radiological or clinical assessment (measurable disease according to recist version 1.1 is not required for enrollment) * estimated life expectancy \>6 months exclusion criteria: * current or recent treatment with biologic anticancer therapies * ongoing aes from prior anticancer therapies * active central nervous system (cns) metastases * clinically significant or uncontrolled hypertension or cardiac disease * females who are pregnant or breastfeeding

Keywords: breast cancer metastatic breast cancer mbc her2 positive her2+ estrogen receptor positive er+ triple negative fgfr1 11q fgf aberrant biomarker negative fgf non-aberrant
safety and efficacy of rifabutin in hiv patients

Conditions: Non-tuberculous Mycobacterial Diseases; Tuberculosis; Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections

Summary: the objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the lpd (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

all the patients whom an investigator prescribes the first mycobutin® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria:
inclusion criteria: * patients need to be administered mycobutin® in order to be enrolled in the surveillance. exclusion criteria: * patients not administered mycobutin®.
voriconazole pharmacokinetics in children with gastrointestinal graft versus host disease

Conditions: Graft Versus Host Disease; Stem Cell Transplantation

Summary: determine how much voriconazole is absorbed when the product is given by mouth to children with extensive graft versus host disease after a stem cell transplantation and determine the correct dosing of voriconazole in this population. hypothesis: children with gastrointestinal graft versus host disease will have decreased absorption of oral voriconazole and require higher doses of voriconazole in order to prevent or treat fungal infections.

disseminated fungal infections are a leading cause of mortality in children who receive hematopoietic stem cell transplantation (sct). therefore, children routinely receive prophylactic and empirical antifungal therapy after sct. the most commonly used antifungal agent in this population is voriconazole. voriconazole can be given via intravenous or oral routes and children who are post sct are routinely switched from the intravenous to oral formulation at the time of hospital discharge. however, the absorption and systemic exposure of oral voriconazole has not been well-described in children. furthermore, many children who undergo transplantation develop gastrointestinal graft versus host disease and this likely impacts oral absorption. the magnitude of effect resulting from graft versus host disease on absorption of voriconazole and subsequent blood concentrations in children is unknown. thus children with graft versus host disease are at a particularly high risk of inadequate absorption with subsequent sub-therapeutic levels of voriconazole. they may need higher or more frequent dosing to achieve therapeutic levels. the purpose of my research project is to define the pharmacokinetics of oral voriconazole and establish dosing guidelines in children following sct.

Eligibility criteria:
inclusion criteria: * age ≤ 18 years, sufficient venous access to permit administration of voriconazole, ability to take oral medications, written informed consent provided by the parent or legally authorized representative, and grade ii or higher (extensive) gastrointestinal graft versus host disease for those patients in the graft versus host disease patient subset. exclusion criteria: * history of anaphylaxis attributed to voriconazole or other triazole compounds, any concomitant condition, which in the opinion of the investigator would preclude a patient's participation in the study, or previous participation in this study.

Keywords: pharmacokinetics pediatric bioavailability