Kornimate/medical-research-clean huggingface dataset:
intraosseous vancomycin in primary total hip arthroplasty - designing a protocol

Conditions: Prosthetic Joint Infection; Vancomycin; Joint Diseases

Summary: the objective of this study is to evaluate a novel vancomycin intraosseous administration protocol vs a standard iv vancomycin administration protocol for primary total hip arthroplasty patients.

patients are randomized to one of two groups. group a - will receive iv antibiotics (cefepime \& vancomycin) are started in pre-op approximately 1 hour prior to incision vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 milliliters (ml) normal saline (ns). group b - will have iv cefepime started in pre-op within 1 hour of incision. intraosseous (io) administration of vancomycin (500mg in 250 milliliters ns) will be administered in the or after sterile prep and draping has occurred. injection will take place into the greater trochanter (within a pre-specified region). both groups will be monitored during surgery and immediately post-operatively for adverse injection reactions (i.e. red man syndrome). both groups will otherwise follow identical post-operative protocols (including post-operative antibiotic administration). tissue samples five (5) tissue samples will be taken from each patient, 2 soft tissue samples and 3 bone samples will be taken throughout the course of the procedure. one blood sample will be taken in both groups intraoperatively at the time of initiation of closure. these samples will immediately be sent to a lab for analysis.

Eligibility criteria:
inclusion criteria: * patient is undergoing a primary total hip arthroplasty * patient gives informed consent to participate in the study. * age range \>18 exclusion criteria: * previous surgery on the hip (including hip scopes) * bmi above 35 * contraindication to receiving vancomycin or cefepime (allergy, medical issue, etc) * inability to locate the greater trochanter or administer the io infusion * refusal to participate * diabetes * immunocompromised or immunosuppressed patients (hiv, hep c, end stage renal disease, dialysis, transplant, chemo/radiation treatment in last 6 months, medications).

Keywords: total hip arthroplasty vancomycin intraosseous vancomycin
a phase 1b/2a, open-label single ascending doses and multiple ascending doses study in participants with pi*zz aatd

Conditions: Alpha-1 Antitrypsin Deficiency

Summary: the purpose of this open-label study is to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of wve-006 in participants with alpha-1 antitrypsin deficiency (aatd) following period 1 single ascending dose (sad) and period 2 multiple ascending doses (mad), respectively.


Eligibility criteria:
inclusion criteria: * healthy as determined by the investigator, based on a medical evaluation, or has mild to moderate aatd-induced lung disease (fev1 ≥50%) and/or stable mild aatd-induced liver disease (≤f2 (≤10 kpa) on fibroscan. * genetic testing confirming pi\*zz. * participant has been a non-smoker for at least 1 year prior to screening. exclusion criteria: * • participant has a history of multiple drug allergies or of allergic reaction to an oligonucleotide or to n-acetylgalactosamine (galnac). * participant has a history of intolerance or any medical condition that might interfere with subcutaneous injections. * any ongoing or recent infections. * any recent or planned vaccinations during the study. * participant has a history of regular alcohol consumption exceeding 14 standard drinks/week. * unwilling to abstain from alcohol for 48 hours prior to dosing at each of the dosing visits. * any recent or planned major surgery during the study. * participant has any medical condition or social circumstance that, in the opinion of the investigator, would make the participant unsuitable for participation in the study or for dosing on day 1, or could interfere with the assessments of safety, pharmacodynamics, or pharmacokinetics, or completion of the study. * participant currently on aat augmentation therapy, planned to be on augmentation therapy anytime during the study, or has been on augmentation therapy within 30 days prior to screening visit. * donation of blood or blood products in excess of 500 ml within 12 weeks prior to screening visit and/or unwilling to refrain from blood donation for the duration of the study. * participant has received an investigational agent within 3 months of the screening visit.
connecare-assuta-case study 1

Conditions: Chronic Disease; Old Age; Debility

Summary: the european union's horizon 2020 project issued a call for action \[1\] in december 2013 to design, develop, disseminate and evaluate new it technologies for use in integrative treatment processes, with emphasis on complex adult patient. assuta hospital submitted a proposal for this call, as part of a broad consortium of 10 participants from various european countries. the connecare consortium has formulated a general model for integrative treatment, and is currently in the technological development stages, to create a smart (supportive decision) and adaptive system that supports integrative treatment processes both in the hospital and in the community for personalized treatment in complex chronic patients. the development includes a significant integrative component of self-care management by the patient and / or the primary caregiver. following the completion of the technological development, clinical trials will be held in four organizations throughout europe - assuta hospital in ashdod in cooperation with the maccabi community in ashdod, two centers in catalonia and the groningen region in the netherlands. the purpose of the studies is to assess the impact of the implementation of the model, processes and digital tools that will be built during the project.

the intervention in this study consists of two parts: 1. integrative treatment in the community, which includes a close follow-up with a coordinating nurse for three months after discharge from the hospital. 2. empowering the patient to self-manage his or her health by using applications for smart devices. the study protocol: 1. recruitment of participants during the patient's hospitalization after the patient is identified as a complex patient, explanation of the study and signing the consent form. 2. evaluation process for the patient, using valid questionnaires, in order to determine the baseline level at the entrance to the study. 3. distribution of research kit and related accessories and training. 4. close monitoring for three months in the community after discharge from the hospital and use of the research kit. 5. reassessment of the patient at the exit of the study.

Eligibility criteria:
inclusion criteria: * all maccabi members who arrive at the er in an unplanned manner * age over 65 * living in a home and not in a nursing home * lace\> 7 * at least three of the following conditions: * multiple drugs - regular use of four or more drugs * more than one case of hospitalization or visit to the er in the past year * malnutrition * elements of low socio-economic status * the patient and / or the main caregiver speak hebrew, english or russian * the patient or primary caregiver has a password to the maccabi online website * the patient and / or the primary caregiver have basic technological knowledge in the use of the applications * the patient has wireless internet access at home (via wifi or through a cellular connection) exclusion criteria: * patients with cognitive or dementia problems
a randomized trial of coartemether and artekin for the treatment of uncomplicated malaria in papua, indonesia.

Conditions: Falciparum Malaria; Vivax Malaria

Summary: this open randomized, parallel group, 6 week trial in two rural outpatient clinics will compare the safety and efficacy of a six dose coartemether regimen with 3 dose artekin regimen for the treatment of acute, uncomplicated falciparum and vivax malaria in adults and children (\>10kg).

with the emergence of species of multi drug resistant p.falciparum across the archipelago the indonesian centre for disease control (cdc) now recommends amodiaquine plus artesunate in areas of high chloroquine and sulfadoxine-pyrimethamine resistant strains of p. falciparum. high levels of chloroquine resistance to p.vivax has also emerged in the eastern provinces. this trial sets out to assess two fixed dose artemisinin combination regimens: artekin (dha-piperaquine) and coartemether (artemether-lumefantrine) against both p.falciparum and p. vivax and their safety profiles. patients who present to an established rural outpatient clinic in timika, papua with symptoms of acute, uncomplicated infection with p. falciparum, p.vivax or both species, will after laboratory confirmation of the diagnosis and having given informed consent to participate in the trial, be enrolled in the study. drug administration will be supervised once per day. patients will be treated as out-patients and then seen daily for the first week until aparasitaemic and thereafter at weekly visits to the clinic. the data used from this trial will be used to make a public health decision to determine a suitable alternative first line antimalarial in the timika region. in order to ensure that the data gathered will be relevant to the clinical setting in which the drugs will be used, drug administration of medication will be deliberately designed to mimic conditions that will be experienced with widespread deployment (eg once daily supervision).

Eligibility criteria:
inclusion criteria: * male and female patients at least one 1year of age and weighing more than 10kg. * microscopic confirmation of p. falciparum and /or p.vivax infection (any parasitaemia). * fever (axillary temperature \>37.5c) or history of fever in the last 48 hours. * able to participate in the trial and comply with the clinical trial protocol * written informed consent to participate in trial; verbal consent in presence of literate witness is required for illiterate patients, and written consent from parents/guardian for children below age of consent exclusion criteria: * pregnancy or lactation * inability to tolerate oral treatment * signs/symptoms indicative of severe/complicated malaria or warning signs requiring parenteral treatment (see appendix ii) * known hypersensitivity or allergy to artemisinin derivatives * serious underlying disease (cardiac, renal or hepatic) * parasitaemia \>4%

Keywords: coartemether artekin papua uncomplicated malaria
new hydroxyethyl cellulose hydrogel for the treatment of the pain of knee arthrosis

Conditions: Osteoarthritis, Knee; Pain

Summary: prospective, multicenter study, unmasked, single-arm, to study the safety and efficacy of a new hydroxyethyl cellulose hydrogel for the treatment of the knee pain caused by osteoarthritis.

prospective, multicenter study, unmasked, single-arm, to study the safety and efficacy of a new hydroxyethyl cellulose hydrogel for the treatment of the knee pain caused by osteoarthritis. the working hypothesis is that the effect of hydrogel use on the study population will result in a reduction in pain in the knees affected by symptomatic oa. the general objective of this study is to generate clinical evidence of the safety and efficacy of the new hydrogel used as a treatment of symptomatic knee osteoarthritis. the patient's perception of the pain caused by osteoarthritis in the knee joint before and after the treatment under evaluation will be quantify. subjects' quality of life before and after treatment will also be evaluated. monitoring of the adverse events associated with the use of the device under evaluation will be determined. subjects will be follow-up for 12 months.

Eligibility criteria:
inclusion criteria: 1. subjects diagnosed with osteoarthritis of unilateral or bilateral knee osteoarthritis who meet the criteria defined by the american college of rheumatology for at least 4 months prior to the study. in bilateral knee osteoarthritis, only the knee with more symptoms will be treated. 2. arthrosis grade 2 or 3 according to the kellgren - lawrence classification system (radiological classification) 3. persistence of symptoms despite conservative treatment (nsaids, physical therapy, lifestyle changes, etc.) for more than 4 months 4. subjects aged between 40 and 70 years 5. bmi (kg/m²) 20-32 6. for female subjects: postmenopausal women with at least 1 year documented in the medical record. exclusion criteria: 1. arthrosis grade 0 or 4 according to the kellgren - lawrence classification 2. history of allergy to any of the hydrogel components 3. history of previous treatment with corticosteroid injections less than 4 months prior to entry into this clinical study 4. history of previous treatment with hyaluronic acid viscosupplementation 5. history of open or arthroscopic surgery in the knee to be treated less than 9 months 6. severe chronic progressive disease 7. insulin-requiring diabetes 8. rheumatic diseases (rheumatoid arthritis, psoriasis, gout, pseudo-gout, fibromyalgia) 9. history of septic arthritis 10. history of psychiatric illness that makes it impossible to understand and sign the informed consent 11. history or presence of severe peripheral vascular disease 12. deseje over 15° valgus or varus movement 13. pregnant or breastfeeding women 14. bmi (kg/m²)\> 32

Keywords: osteoarthritis pain knee
the effect of soy isoflavones on non-alcoholic fatty liver disease and the level of fgf-21 and fetuin a

Conditions: NAFLD

Summary: in this research, the investigators tested the effect of 12-week supplementation with soy isoflavones on non alcoholic fatty liver disease (nafld) management and the level of fibroblast growth factor-21 (fgf-21) and fetuin a as markers of nafld progression.

non-alcoholic fatty liver disease (nafld) accounts as a crucial health concern with a huge burden on health and economic systems. the aim of the present study was to investigate the effect of soy isoflavone intake on hepatic outcomes and the level of fibroblast growth factor-21 (fgf-21) and fetuin a in patients with nafld. fifty patients with nafld were randomized to either receive two tablets of soy isoflavone (100 mg/d) or placebo. dietary intakes, anthropometric parameters, the serum levels of liver function tests including alanine amino transferase (alt), aspartate amino transferase (ast) and gamma glutamyl transferase (ggt), fgf-21, fetuin a and hepatic histological features by fibroscan assessed at study initiation and after week 12.

Eligibility criteria:
inclusion criteria: * 18 years or older * without any history of allergy to soy or excessive consumption of soy products * without chronic diseases including renal, liver, heart, respiratory, cardiovascular, malignancies, auto immune disorders, cushing's syndrome, thyroid dysfunction, hepatitis, cirrhosis, biliary disorders, diabetes, gastrointestinal tract diseases affecting the gut absorption and psychiatric disorders considering as an obstacle for patients to prepare written informed consent; * hepatic steatosis grade 2 and higher with fibroscan confirmation (cap \> 260 db/m); * without history of excessive alcohol drink (≥10 g/day); * without history of drug consumption with approved positive effects on nafld treatment (i.e. metformin, vitamin e, ursodeoxycholic acid, phenytoin, tamoxifen, lithium, corticosteroids and methotrexate) in last three months; * without the history of bariatric surgery or following weight loss diets within 6 months; * without history of smoking; * not being a pregnant or lactating woman exclusion criteria: * consuming less than 90% of intended supplements. * unwillingness for study collaboration

Keywords: non-alcoholic fatty liver disease isoflavones soy foods fgf21 liver steatosis
a study to confirm the efficacy and safety of different dupilumab dose regimens in adults with atopic dermatitis (ad)

Conditions: Atopic Dermatitis

Summary: the primary objective of the study was to assess the ability of different dupilumab dose regimens, administered as monotherapy, to maintain the treatment response achieved after 16 weeks of initial treatment with dupilumab monotherapy compared to placebo.


Eligibility criteria:
key inclusion criteria: 1. must have completed the treatment phase in 1 of the two 16-week initial treatment studies (r668-ad-1334 or r668-ad-1416). 2. must have achieved at least 1 of the following 2 treatment success criteria: investigator global assessment (iga) = 0 or 1 (clear or almost clear) at week 16 or eczema area and severity index \>= 75% (easi-75) (at least 75% reduction in easi score from baseline to week 16) 3. must be willing and able to comply with clinic visits and study-related procedures 4. must provide signed informed consent 5. must be able to understand and complete study-related questionnaires key exclusion criteria: 1. receipt of rescue medication for ad in the initial treatment study 2. any conditions that require permanent discontinuation of study treatment in either initial treatment study 3. planned or anticipated major surgical procedure during the participants's participation in this study 4. pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during this study 5. women unwilling to use adequate birth control, if of reproductive potential\* and sexually active. adequate birth control is defined as agreement to consistently practice an effective and accepted method of contraception, whenever engaging in heterosexual intercourse, throughout the duration of the study and for 120 days after last dose of study drug. these include hormonal contraceptives, intrauterine device, or double barrier contraception (e.g, condom + diaphragm), or a male partner with documented vasectomy. additional requirements for acceptable contraception may apply in certain countries, based on local regulations. investigators in these countries will be notified accordingly in a protocol clarification letter. (\*for females, menopause is defined as at least 12 consecutive months without menses; if in question, a follicle stimulating hormone level of \>= 25 milli units per milliliter (mu/ml) must be documented. hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented, as applicable; if documented, women with these conditions are not required to use additional contraception).

Keywords: eczema
safety and immunogenicity study of group b meningococcal vaccine to prevent meningitis.

Conditions: Meningitis, Meningococcal, Serogroup B

Summary: the purpose of this study is to determine if the vaccine called group b meningococcal 44/76 mos nomv 5d vaccine is safe and free from side effects and if it will protect people from meningitis. this study will vaccinate three groups of people. in the first 2 groups, the study will be double-blinded. this means that neither the volunteer or the medical team will know which formulation of the vaccine was administered. the third group of volunteers and the medical team will know that they are receiving the higher dose of the vaccine.

meningococcal disease is a contagious bacterial disease caused by neisseria meningitidis that can kill children and young adults very quickly. meningococci are divided into distinct sergroups based on their polysaccharide outer capsule, which is the usual target antigen for vaccines. serogroup a is the main cause of epidemics in africa and in the united states, sergroups b, c and y predominate. in the united states, no vaccine is yet available to offer protection against serogroup b which currently accounts for 32% of all meningococcal disease in the united states. this study serves as a proof of concept for our new nomv group b single strain monovalent vaccine model which is obtained from a genetically modified parent. if successful we plan to develop a multivalent group b vaccine for routine use for military recruits at the beginning of basic training, for college students, particularly those who live in dormitories, and for use by travelers to countries recognized as having hyperendemic disease.

Eligibility criteria:
inclusion criteria: * healthy military or civilian males or non-pregnant, non-lactating females * age 18-45 * give informed consent and understand risk and benefit of study * understands and willing to comply with all protocol procedures and time commitment * females only: surgically sterilized or received a negative pregnancy test on day of first injection and agrees to practice adequate birth control, if necessary, for the next 7 months after first vaccination. exclusion criteria: * currently has or has had a history of significant organ/system disease * history of allergy to any vaccine * allergy to component of vaccine such as aluminum hydroxide * presence of significant unexplained laboratory abnormality * hiv sero-positive or any other immunosuppressive state * positive test for hbsag, or hepatitis c * ongoing drug abuse/dependence * received any live vaccine, experimental products or immunosuppressive therapy in the last 28 days or inactivated vaccine in the past 14 days, or received parenteral immunoglobulin or blood products within the past 3 months * intention to leave study area for an extended period of time during the study * females: positive urine pregnancy test prior to vaccination
could the advanced hybrid closed-loop system algorithm provide postprandial normoglycemia after a high-fat, high-protein meal

Conditions: Type 1 Diabetes Mellitus; Adolescents

Summary: ahcl systems could cover postprandial glycemic response after high fat and high protein meals

on the 1st, 2nd and 3rd day of the study, a pediatric endocrinologist from the research team will evaluate the continuous glucose measurement system data and optimize the carbohydrate/insulin ratios. on the 4th and 7th days of the study, participants with blood sugar levels between 70-140 mg/dl according to the continuous glucose measurement system, which is a component of the hybrid closed-loop insulin infusion pump system, will consume the test meal consisting of dr oetker ristorante pizza mista (340 grams) (92 g carbohydrate, 33 g protein, 41 g fat) at lunch, under the supervision of a dietician from the research team, by switching the pump to manual mode and entering the carbohydrate amount of the meal into the pump. this application will be repeated on the 11th and 14th days of the study while the participant's pump is in automatic mode. participants will not be allowed to consume food or beverages other than water or exercise for 5 hours after the meal. blood sugar monitoring will be done with a continuous glucose measurement system. the participant will leave the hospital 5 hours after the start of the meal to return to their normal life. dr oetker ristorante pizza mista, which was selected as the test meal, was chosen because it is a macronutrient content that is consumed by young people between the ages of 9-18 and that is similar to the test meals in the world literature and accepted research reports reporting the effect of high-fat and high-protein meals on glycemic response in individuals with diabetes.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study * not having a disease accompanying type 1 diabetes (celiac, cystic fibrosis, etc.) exclusion criteria: * - not volunteering to participate in the study * using psychiatric medication or any medication that may cause obesity at the time of trial * having a disease accompanying type 1 diabetes (celiac, cystic fibrosis, etc.)

Keywords: ahcls type 1 diabetes high fat, high protein adolescents