Kornimate/medical-research-clean huggingface dataset:
endoscopic balloon dilation vs surgery to treat short strictures in fibrostenosing crohns disease: an rct

Conditions: Crohn Disease

Summary: there is currently no standard management to guide the clinicians in treating patients with fibrostenotic disease. european crohns and colitis organization \[ecco\] recently developed a topical review on prediction, diagnosis and management of fibrostenosing crohns disease. the review suggests endoscopic balloon dilation, strictureplasty, and intestinal resection as reasonable treatment options for short strictures based on the low grade of evidence.

study population all patients with crohns disease and a short stricture (\<5 cm) within the reach of upper or lower gi endoscopy study timeline 1. pre-recruitment phase including proposal, irb approval, staff training, budget transfer - 9 months 2. recruitment of patients: 2 years 3. follow up: 2 years 4. analysis and preparing report: 6 months study design single blind randomized controlled trial the data will be blindly analyzed. double blinding is not possible due to the nature of the study. study methods please see the study flow diagram below. randomization will be done using computer software generating random numbers. outcome measures - a research associate will contact patients on weeks 1,2,4 and months 3,6,12,18 and 24 to record the items mentioned as secondary objectives of the study. - an interim analysis will be performed after 20 cases complete the study sample size 40 patients randomized to two arms undergoing tts dilation or surgical managements statistical analysis comparisons between groups will be done using student's t-test. qualitative variables will be summarized as a percentage of the group total and comparisons between groups will be based on the chisquared test. the cumulative relapse rate of each treatment group will be estimated by the kaplan±meier method and the difference between treatment groups will be tested by the log rank test. time to relapse will be compared betweens two groups using a cox proportional hazards regression analysis. a p value of less than 0.05 is considered to be signicant.

Eligibility criteria:
inclusion criteria: * 40 patients with crohns disease and a short stricture (\<5 cm) within the reach of upper or lower gi endoscopy exclusion criteria: * abscess or phlegmon * fistula * high-grade dysplasia * malignancy * previous intervention * pregnant women
bioequivalence study of sparc147609 in patients with ovarian cancer

Conditions: Ovarian Carcinoma

Summary: bioequivalence study of sparc147609


Eligibility criteria:
inclusion criteria: * subjects meeting all of the following criteria will be considered for enrollment in the study: * availability of subject for the entire study period and willingness to adhere to protocol requirements. * patients with documented diagnosis of ovarian cancer and eligible for receiving a dose 50mg/m2 of doxorubicin liposome(preferably on no other concomitant medication, however, if considered necessary, to be documented and given). * patients at least 18-years of age or older. iv. subjects who have no evidence of underlying disease (except ovarian cancer) during screening medical history and whose physical examination is performed within 21 days prior to commencement of the study. * patients with performance ≤ 2 on the ecog performance scale. vi. subjects whose screening laboratory values are within normal limits or considered by the clinical investigator/co-investigator to be of no clinical significance. * informed consent form given in written form. exclusion criteria: * history or presence of significant: * allergy or significant history of hypersensitivity or idiosyncratic reactions to doxorubicin hydrochloride and/or any related compounds etc. * cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. * alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year. * clinically significant illness (except ovarian cancer)within 4 weeks before the start of the study v. positive result to hiv, hcv, rpr and hbsag. * use of enzyme-modifying drugs (like phenytoin, carbamazepine, barbiturates, gresiofulvine etc.) in the previous 30 days before day 1 of this study and during the study. * donation of 350 ml or more of blood in the previous 90 days before day 1 of this study. * participation in another clinical trial within the preceding 90 days of study start * subjects who have: * systolic blood pressure less than 90 mm of hg or more than 140 mm of hg * diastolic blood pressure less than 60 mm of hg or more than 90 mm of hg * pulse rate below 60/min. or above 100/min

Keywords: carcinoma ovary carcinoma ovary
proving hemodilution in a human model for class i hemorrhage

Conditions: Hemodilution; Hemorrhage; Shock; Wounds and Injuries

Summary: this study is a randomized control trial in volunteer blood donors to quantify the effect of blood loss and subsequent crystalloid infusion on hemoglobin and markers of resuscitation such as base deficit and lactate.

blood donors were randomized to one of three arms after donation of 500cc of blood. the control group received no intravenous fluids, while donors in the two intervention arms wither received two liters normal saline or lactated ringers. chemistries and blood gases were obtained before donation, after donation and after resuscitation. donors hemoglobin levels were then compared over time and between study arms. additionally, lactate and base deficit, which are markers of shock, will be collected at the time points as well to measure their response to resuscitation. standard statistical tests were used to compare the laboratory values between groups.

Eligibility criteria:
inclusion criteria: * blood bank inclusion criteria for donation * able to donate 500cc blood * age \> or = 18 exclusion criteria: * unable to obtain iv access * multiple blood draws fail to run on laboratory assays

Keywords: hemodilution hemorrhage trauma lactate base deficit randomized control trial
impact of a process intervention on screening and testing outcomes for common hereditary cancer syndromes

Conditions: Hereditary Cancer

Summary: a prospective, non-interventional study to evaluate the impact of a process engineering intervention on screening and testing outcomes for common hereditary cancer syndromes in community-based ob/gyn settings.

this is a prospective process intervention study that will compare historical pre-process intervention data to post-intervention data from study providers within participating community obstetrics and gynecology practices. this study will begin with a process intervention at the participating practices during which myriad genetics personnel experienced in implementation of hereditary cancer risk assessment programs will provide training to practice providers. the training will be followed by a 4-week practice period to allow for incorporation of the recommendations of the intervention process into the practice. during a subsequent 8-week observation period, women who present for an office visit (new patient visit, well women visit, or problem visit) will be screened for common hereditary cancer syndromes following the process established during the process intervention. patients who meet nccn/acog testing guidelines will be offered genetic testing. patients and study providers will be surveyed about their satisfaction with the hereditary cancer risk assessment process.

Eligibility criteria:
inclusion criteria: * patient who presents for a new patient gynecologic visit, well woman exam, or problem gynecologic visit and meets guidelines (hboc-nccn guidelines; lynch syndrome-sgo/acog guidelines) for genetic testing * patient who is 18 years of age or older * able to understand informed consent and agrees to participate exclusion criteria: * patient who has previously undergone brca1/2, lynch syndrome genetic testing, or multi-gene, pan-cancer, or panel testing * patient who is not pregnant * patient who is unwilling or unable to provide informed consent.

Keywords: screening hereditary cancer
tui na for peripheral neuropathy among people with hiv

Conditions: Hiv

Summary: peripheral neuropathy (pn) is a common neurological complication in people with human immunodeficiency virus (phiv) with no food and drug administration-approved treatment. medications commonly used to treat hiv-related pn are not effective and have many side effects. hiv-related pn symptoms may be alleviated or treated with therapeutic chinese foot massage (tcfm), a non-invasive, relatively safe, non-pharmacological intervention.

this is a prospective, two-arm, double-blinded, randomized controlled trial. aim: this trial aims to assess the effectiveness of tcfm on hiv-related pn in people with hiv (phiv).

Eligibility criteria:
inclusion criteria: 1. have confirmed hiv diagnosis 2. self-report pn-related symptoms in their lower extremity, such as sharp, jabbing, throbbing, or burning pain, numbness, decreased sensation to pinprick, prickling or tingling feeling, lack of coordination and falling muscle weakness, and extreme sensitivity to touch 3. are not taking any medications, including pain medicine, to alleviate pn 4. age 18 years and older 5. can communicate with researchers in english or mandarin chinese 6. are not pregnant or lactating 7. are not concurrently enrolled in other clinical trials. exclusion criteria: 1) people who have received any non-pharmacological interventions, including massage to treat their pn symptoms in the past six months
evaluation of an innovative tuberculosis diagnostic test

Conditions: Tuberculosis; HIV

Summary: diagnosis of tuberculosis (tb)in young children is a challenge due to atypical non-specific symptoms, difficulty to expectorate mucus, paucibacillary nature of pulmonary tb and low sensitivity of available diagnostic tools. this project aims at evaluating two innovative immunological methods for diagnosing of active tb among hiv-infected and uninfected children.

the study is designed as a prospective study for the evaluation of diagnostic tests. children admitted with probable tb based on clinical and radiological symptoms are recruited. gastric lavage or sputum on two to three consecutive days will be collected as per routine practise. active tb will be defined as a positive genexpert diagnostic test or mtb culture. in addition, children with no sign of tb will be recruited to estimate the specificity of the diagnostic tests. these children will be recruited from the surgical ward of the hospital, and matched for age group and hiv status. in all children, blood samples will be drawn and stored to perform quantiferon (r) and the new tests under evaluation. the analysis will evaluate the sensitivity and specificity of the tests against the current gold standard (detection of mycobacterium tuberculosis (mtb) in any specimen obtained from the patient). identification of diagnosis algorithms, including these tests if they prove to be informative, will be elaborated and evaluated.

Eligibility criteria:
inclusion criteria for tuberculosis cases: * one of 4 clinical signs * persistent and unexplained cough * unexplained weight loss or failure to thrive * persistent and unexplained fever * persistent and unexplained lethargy or reduced playfulness * chest x-ray consistent with a tuberculosis infection * an adenitis compatible with non-pulmonary tuberculosis among these children only those with confirmed tb will be analysed for the primary outcome inclusion criteria for controls: * children without any of the signs and symptoms quoted above

Keywords: immunology diagnosis test children zambia
efficacy, safety, and pharmacokinetic profiles of regn3500 administered to adult patients with moderate-to-severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the primary objective of the study is to assess the efficacy of regn3500 monotherapy in atopic dermatitis (ad), as well as understand the dose-response relationship, compared with placebo treatment, in adult patients with moderate-to-severe ad. secondary objectives are to: * assess the safety and tolerability of subcutaneous (sc) doses of regn3500 monotherapy in adult patients with moderate-to-severe ad * assess the pharmacokinetics (pk) of regn3500 in adult patients with moderate-to-severe ad * assess the immunogenicity of regn3500 in adult patients with moderate-to-severe ad


Eligibility criteria:
key inclusion criteria: 1. chronic ad, according to american academy of dermatology consensus criteria (eichenfield, 2014), that has been present for at least 3 years before the screening visit 2. eczema area and severity index (easi) score ≥16 at the screening and baseline visits 3. iga score ≥3 (on the 0 to 4 iga scale, in which 3 is moderate and 4 is severe) at screening and baseline visits 4. ≥10% body surface area (bsa) of ad involvement at the screening and baseline visits 5. documented recent history (within 6 months before the screening visit) of inadequate response to topical ad medication(s) or for whom topical treatments are medically inadvisable key exclusion criteria: 1. participation in a prior anti-interleukin (il)-33 medication clinical study 2. treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit 3. having used any of the following treatments within 4 weeks before the baseline visit or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment: 1. immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon-gamma (ifn-γ), janus kinase inhibitors, azathioprine, methotrexate, etc) 2. phototherapy for ad 4. regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit 5. treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit 6. active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit 7. known or suspected history of immunosuppression 8. history of human immunodeficiency virus (hiv) infection or positive hiv serology at screening 9. positive with hepatitis b surface antigen (hbsag), hepatitis b core antibody (hbcab), or hepatitis c virus antibody (hcv ab) at the screening visit 10. pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study note: other protocol defined inclusion/exclusion criteria apply

Keywords: moderate severe
dexamedatomidine vs. dexamethasone in rhomboidal intercostal plain block and subserratus block in breast surgery

Conditions: Postoperative Pain, Acute

Summary: the aim of this study is to evaluate the analgesic efficacy and safety of adding dexmedetomidine and dexamethasone to bupivacaine in rhomboidal intercostal and subserratus (riss) block for patients undergoing modified radical mastectomy compared to bupivacaine only.

rhomboid intercostal block (rib); a new interfascial plane block involves the triangle of auscultation that's bounded medially by inferior a part of the trapezius, inferiorly by the superior border of latissimus dorsi, and laterally by the medial border of the scapula. the local anaesthetic spreads between the rhomboid major and therefore the intercostal fascia at the extent of t6-t7 and provides analgesia of t3-t8 dermatomes. aiming to expand dermatomal coverage, a new modification of rhomboid intercostal and sub-serratus block (riss) is performed by advancing the ultrasound probe caudally and laterally distal to the inferior angle of the scapula, the second injection apply between the serratus and intercostal muscle fascia. the riss block is a novel ultrasound-guided block that has been shown to provide analgesia from t2-t11 dermatomes. dexmedetomidine is a potent selective α 2 adrenoceptor agonist that was reported in many previous studies as an adjunct to regional and general anesthesia, with significant prolongation of the duration of sensory block, motor block and analgesia, and accelerate the time to onset of sensory and motor block when added to a local anesthetic. dexamethasone is a potent long-acting steroid that has shown efficacy as an adjuvant to local anesthetics in various studies. it enhances peripheral nerve blocks when added to local anesthetics, providing better quality of anesthesia as well as postoperative analgesia. the mechanism by which dexamethasone prolong the duration of local anesthetics are not completely understood; however, some studies demonstrated that dexamethasone exerts its action through reducing the release of inflammatory mediators and by inhibiting discharge of c-fibers.

Eligibility criteria:
inclusion criteria: * adult female patient * type of surgery; modified radical mastectomy (mrm). * physical status asa ii, iii. * age ≥ 21 and ≤ 65 years. * body mass index (bmi): \> 20 kg/m2 and \< 35 kg/m2. exclusion criteria: * patient refusal. * patients suffering from coagulation disorders. * patients with histories of allergic reactions to local anesthetics or dexmedetomidine. * patients suffering from neuropsychiatric disorders. * pregnancy.
prospective cohort study of neurogenetic diseases

Conditions: Genetic Disease; Nervous System Diseases

Summary: neurogenetic diseases (ngd) represent rare and hereditary forms of neurological diseases. the goal of cngd is to create a one-window approach for ngds, to facilitate and accelerate participation in research projects through deep phenotyping and the availability of low-cost biological samples for research teams. it is positioned as a true hub allowing new connections between clinical and basic research teams and ultimately as an incubator for translational projects for ngds, in order to be able to initiate therapeutic trials, the ultimate objective of clinical and translational research.

neurogenetic diseases (ngds) represent rare inherited forms of neurological diseases. they constitute a constellation of different diseases, affecting neurodevelopment (syndromic or non-syndromic intellectual disabilities (id), with or without autism spectrum disorders (asd), epileptic encephalopathies, neurodevelopmental disorders (ndd) with or without id... ) or leading to early neurodegeneration (huntington's and huntington-like disease, hereditary ataxias, hereditary spastic paraplegias (hsp), primary dystonias, neurodegeneration due to intracerebral iron accumulation (nbia), neurometabolic diseases, etc.). progress in the knowledge of the genetic causes of ngds is unceasing, with the discovery of new genes involved in their determinism being continuous. as a result, the boundary between routine care and clinical research is extremely narrow and blurred, and the two activities are totally intertwined and interdependent in the care of patients. for patients with ngds already characterized by molecular genetics, at an early, intermediate or presymptomatic stage, we will perform a comprehensive annual standardized clinical and paraclinical evaluation for deep phenotyping as part of routine care; collection of biological samples (annual blood and urine sampling, optional skin biopsy and optional cerebrospinal fluid (csf) sampling), for functional analyses and better understanding of the pathophysiological mechanisms involved. this study will last 3 years

Eligibility criteria:
inclusion criteria: * patient-specific inclusion criteria * age ≥ 6 years * patient with a molecularly identified ngd o specific inclusion criteria for controls * for the 10 controls with lumbar puncture (lp): person who performed an lp for medical reasons and who consented to participate in the collection of biological samples * age ≥ 18 years * person matched in age (+/- 5 years) and sex to adult patient with ngd at the time of collection exclusion criteria: * participation in an interventional clinical trial that may interfere with our study * refusal of blood collection * pregnant and breastfeeding women * only for patients performing lp: contraindication to lp * specific non-inclusion criteria for controls: criterion of a neurodegenerative or inflammatory pathology of the central nervous system

Keywords: hub translational research neurogenetics disorders biocollection
breathe-peds pilot - i focus group interviews

Conditions: Asthma; Asthma in Children

Summary: the overall aims of this study are to develop and pilot test brief intervention to evaluate asthma therapy (breathe)-peds, a dyadic shared decision-making intervention, to improve asthma by supporting self-management among racial and ethnic minority early adolescents receiving care for uncontrolled asthma in federally-qualified health centers (fqhcs) in urban communities. aim 1 (phase i) involves developing the intervention through focus groups with early adolescents and caregivers. aims 2 and 3 (phase ii) involve preliminary testing of the intervention through a pilot randomized controlled trial. this record is for phase i only.

despite high asthma prevalence and morbidity among adolescents (highest among black and hispanic youth and early adolescents aged 10-14), there is a lack of developmentally appropriate interventions for this at-risk group. racial and ethnic minority early adolescents have sub-optimal asthma self-management. critical health behaviors that emerge during early adolescence affect lifelong patterns; therefore, early adolescence offers a unique opportunity to intervene. additionally, successful self-management requires the right division of responsibility between adolescents and their caregivers. thus, intervening simultaneously with early adolescents and their caregivers who can help support the adolescent's growing autonomy to self-manage their condition has the potential for a synergistic effect. prior studies have demonstrated the effects of improved asthma control of breathe, a brief one-time shared decision-making intervention for black adults with uncontrolled asthma that utilizes motivational interviewing delivered by primary care providers. this study (i.e., phase i) attempts to build on these promising results by adapting breathe to caregiver-early adolescent dyads. phase i of the study will involve conducting up to 6 focus groups to identify components of breathe that are relevant to racial and ethnic minority early adolescents with uncontrolled asthma receiving care at fqhcs in urban communities and their caregivers. focus groups will be composed of \~10 participants each: (a) two groups of early adolescents aged 10-14 with asthma; (b) two groups of the caregivers of the youth in group a; and (c) two groups of adolescent-caregiver dyads who did not participate in group a or b. investigators will use the focus group results to write breathe-peds, making modifications based on feedback from two primary care providers and two pediatric pulmonologists.

Eligibility criteria:
inclusion criteria (adolescents): * aged 10-14 years * physician-diagnosed persistent asthma (defined as being prescribed a controller medication) exclusion criteria (adolescents): * serious mental health conditions * developmental delay inclusion criteria (caregivers): * informal caregivers (e.g., parent, grandparent) of adolescents aged 10-14 years with physician-diagnosed persistent asthma exclusion criteria (caregivers): * serious mental health conditions

Keywords: asthma adolescents dyads shared decision-making minority health