Kornimate/medical-research-clean huggingface dataset:
skin cleansing with chlorhexidine to decrease hospital acquired infections

Conditions: Nosocomial Infection; Bacteremia; Sepsis; Pneumonia; Urinary Tract Infection; Clostridium Infection

Summary: patients in the intensive care unit are at risk for many infections because the severity of illness and the procedures necessary to care for them. this study is designed to look at a change in bathing procedure as a method to reduce infections. currently, patients at john h. stroger hospital are cleansed with soap and water. however, preliminary data from a previous study at rush university medical center showed that a chlorhexidine (chg)-impregnated cloth (2% chg antiseptic cloth system, sage products, inc.) decreased skin bacteria and may lessen bacteria in the blood stream. the 2% chg antiseptic cloth system is a non-irritating, no-rinse, cleansing and moisturizing product that contains 2% chlorhexidine gluconate. the goal of this proposed study is to further evaluate the effectiveness of the 2% chg antiseptic cloth system compared with soap and water in cleansing the skin and preventing bacteria from entering the bloodstream.

patients admitted to the medical intensive care unit at john h stroger hospital are randomly assigned to unit a or b. unit b was randomly selected as the intervention unit. for 6 months, all patients in unit b will be bathed with the 2% chg antiseptic cloth system and all patients in unit a will receive soap and water baths. after this 6 month period, there will be a 2 to 4 week washout period and the interventions will cross over, with unit a receiving chlorhexidine baths and unit b receiving soap and water for 6 months. each week, two randomly selected patients will have cultures of the inguinal area, neck/subclavian region, and endotracheal aspirates. a comparison of the colonization of the skin and sputum will be done between the two intervention groups. daily infection surveillance will be done on all patients in the intensive care unit. a comparison of blood stream infections, clinical sepsis, and other nosocomial infections will be done between the two intervention groups.

Eligibility criteria:
inclusion criteria: * data collection will be compiled from all the participants admitted to the medical intensive care unit (micu). * for skin cultures: one randomly selected (intubated or non-intubated) patient in each intervention group exclusion criteria: * patients with greater than 20% of body surface area disruption in skin integrity will be excluded from participation in the 2% chg antiseptic cloths arm of the study

Keywords: chlorhexidine blood stream infections central venous catheter associated nosocomial infection bacteremia sepsis pneumonia urinary tract infection clostridium difficile intensive care unit catheter nosocomial pneumonia infection control
study to compare pediacel® to infanrix®-ipv+hib when both are co-administered with prevenar® in infants and toddlers

Conditions: Diphtheria; Tetanus; Pertussis; Poliomyelitis; Haemophilus Influenzae Type b

Summary: the purpose of this study is to evaluate safety and immunogenicity of pediacel® in infants and toddlers when given at 2,3,4 and 12-18 months of age. primary objectives: * to compare the post-dose 3 immunogenicity of pediacel® to infanrix®-ipv+hib when both are co-administered with prevenar®. * to describe the post-dose 3 pertussis antibody responses. secondary objectives: * to compare the post-dose 4 immunogenicity of pediacel® to infanrix®-ipv+hib when both are co-administered with prevenar®. * to describe the safety after each vaccination following co-administration with prevenar®.


Eligibility criteria:
inclusion criteria: * infants 55 to 75 days old, inclusive on the day of first vaccination * born at full term of pregnancy (\> 37 weeks) * informed consent form signed by the parent(s) or the legal guardian * parents or the legal guardian able to read and write in the local language * parent(s) or the legal guardian able to attend all scheduled visits and to comply with the study procedures. exclusion criteria: * presence of fever (defined as rectal body temperature ≥ 38.0°c) reported within the last 72 hours * moderate or severe acute illness with or without fever * participation in another clinical trial in the 30 days preceding first study vaccination * planned participation in another clinical trial during the present study period * received diphtheria, tetanus, pertussis, poliomyelitis, haemophilus influenzae type b or a pneumococcal vaccine separately or in combination prior to study vaccination * received any vaccination in the 30 days preceding the first study vaccination and/or is planning any vaccination within 6 weeks following any of the study vaccinations * congenital or acquired humoral/cellular immunodeficiency or immunosuppressive therapy such as long-term systemic corticosteroids therapy (≥ 2 mg/kg/day prednisone equivalent for ≥ 14 days) in the previous 30 days * systemic or local hypersensitivity to any of the study vaccine components (including neomycin, streptomycin, polymyxin b and formaldehyde) * history of life-threatening reaction(s) (such as encephalopathy, hypotonic-hyporesponsive episode, rectal body temperature ≥ 40.0°c, convulsions with or without fever) to any vaccine containing the same components as the study vaccines * blood or blood-derived products (immunoglobulins) received since birth * known human immunodeficiency virus (hiv) seropositivity * known thrombocytopenia or other bleeding disorder contraindicating intramuscular vaccination * history of encephalopathy, seizures or progressive, evolving or unstable neurological condition * clinically significant findings on review of systems that might interfere with study vaccination or which, in the opinion of the investigator, would interfere with the evaluation of the study vaccine/objectives or pose a health risk to the subject.

Keywords: diphtheria tetanus pertussis poliomyelitis haemophilus influenzae type b pneumococcal infections
the ohio state university sepsis registry

Conditions: Sepsis

Summary: specific aim #1: to collect follow-up information about patients with sepsis in the osumc micu who survive to hospital discharge for future retrospective irb-approved studies. specific aim #2: to collect a registry of patients who would be interested in hearing more information about future prospective irb-approved studies for survivors of sepsis. specific aim #3: to collect a blood sample from patients with sepsis admitted to the osumc micu for future retrospective irb-approved studies.

there are several goals of the ohio state university sepsis registry and blood bank. first, we hope that, by collecting a cohort of patients with sepsis, we will provide information for future studies with data of specific relevance to sepsis (the clinical registry). second, by following survivors of sepsis for a more prolonged period than prior studies, we will better understand the disease process and the duration of recovery (the follow-up registry). we will contact hospital survivors every six months to assess their vital status, living situation and employment. furthermore, subjects will have the opportunity to find out about new studies as they arise. finally, we will ask subjects for permission to collect a blood sample (10 cc) to use for future studies analyzing genetic and protein data. there will be a step-wise consent process that will allow subjects to opt out of any or all parts of the study.

Eligibility criteria:
inclusion criteria: * admitted to osumc micu, ≥ 18 years, have consensus criteria for sepsis (infection plus two of four systemic inflammatory response syndrome \[sirs\] signs \[tachycardia, tachypnea, fever or hypothermia, leukocytosis or leukopenia\]). exclusion criteria: * consent not available or declined, prisoner, died before discharge (excluded from follow-up registry only), died before blood collected (excluded from blood bank only), onset of sepsis more than 24 hours prior to icu admission. patients who have sepsis onset more than 24 hours prior to icu admission but spent the entirety of the current admission in the osumc ed will be eligible.

Keywords: sepsis registry
the effect of dexmedetomidine on postoperative analgesia

Conditions: Colon Cancer, Rectal Cancer

Summary: the purpose of this study is to determine whether additional dexmedetomidine to patient controlled analgesia can reduce fentanyl consumption.


Eligibility criteria:
inclusion criteria: * elective surgery for colon cancer exclusion criteria: * liver disease * kidney disease * allergy for study drugs * inability to receive patient controlled analgesia
epidemiology of acromegaly in denmark 1991-2010

Conditions: Acromegaly

Summary: aim: to assess the incidence rate, morbidity and mortality of acromegaly in denmark.

background: acromegaly is a rare disease caused by gh hypersecretion from a pituitary adenoma. the annual incidence is estimated to be 3-5/million with a prevalence of 100 - 150/million. the incidence rate is however uncertain since no nationwide surveys exist. if left untreated or poorly controlled the condition is associated with progressive morbidity and an excess mortality. the primary treatment is surgery, which however only provides a cure rate of ≈ 50 -60% due to the size of the tumour. the second line treatment today is medical treatment with slow release formulations of somatostatin analogs (sa) and, more recently, a specific gh antagonist. accurate data on incidence rates and outcome of treatment are of obvious importance in order to provide optimal and evidence-based treatment for the disease. this is particularly relevant in light of the availability of new and effective treatment modalities such as the gh antagonist, the proper place of which in the treatment algorithm still remains controversial. denmark holds a unique position in terms of epidemiological studies due to the existence of well organized databases which include all its inhabitants. a recognised problem with epidemiological surveys from specialised centres is whether the figures are representative for the general population. a nationwide danish study will profit from the fact that every danish citizen holds a unique id number that makes it easy to retrieve and combine pertinent data regarding health, disease and death from different registries. the investigators have previously used this for a landmark survey of another rare endocrine disease, i.e. cushing's syndrome. this publication has been cited more than 100 times. aim: to assess the incidence rate, morbidity and mortality of acromegaly in denmark.

Eligibility criteria:
inclusion criteria: * diagnosed with acromegaly in years 1991-2010

Keywords: acromegaly mortality morbidity incidence prevalence
pressure area distribution on a variety of clinical surfaces

Conditions: Pressure Ulcer

Summary: participants in the study will be adults with full mobility, with the capacity to give informed written consent. the investigators will recruit a group of volunteers in order to represent a variety of bmis, in an attempt to gain a sample of the bmis found in the population. the investigators will mimic current practices and standard equipment in order to replicate real conditions as closely as possible. participants will lay on the following surfaces in the following scenarios 1. ambulance scoop: supine (lying flat on their back) 2. a\&e trolley: supine 3. hospital bed: supine 4. theatre table: supine 5. theatre table: left lateral (lying on their left side at 90 degrees to the operating table) with pelvic binders (pads designed to keep the hip immobile). each participant will remain in each position on that particular surface for a period of 25 minutes. a pressure mapping mattress will lie between the participant and the surface assessed to generate a pressure map. following completion of data collection, data will be analysed and any areas of potential pressure damage vulnerability will be identified.


Eligibility criteria:
inclusion criteria: • subjects will be individuals aged 18 and over, with good command of spoken and written english, full mobility, and the capacity to give informed, written consent. provided there is no impairment to mobility, there is no upper age limit to participation. exclusion criteria: * inability to provide informed written consent * having a bmi that falls outside of the stated ranges for the study (\<19) * any significant impairment to mobility, for whatever reason, that prevents the patient from getting in and out of bed unaided, walking 100 metres unaided, or climbing a flight of stairs unaided. * patients who lack sufficient command of written and spoken english to allow them to give written informed consent take part.

Keywords: pressure ulcer pressure sore patient positioning
effect of creatine supplementation on physical performance in vegan subjects

Conditions: Deficiency; Diet

Summary: the primary objective of this study is to investigate the effect of creatine monohydrate supplementation on body composition, physical performance, and muscle creatine levels in vegan individuals over four weeks.

this randomized, double-blind, placebo-controlled clinical study aims to evaluate the effect of creatine monohydrate supplementation on body composition, physical performance, and plasma biomarkers in 20 vegan individuals (10 men and 10 women) over a 4-week period. participants, who will have followed a strict vegan diet for at least 6 months prior to the study's start, will be randomly assigned to one of two groups: one receiving 0.01 grams of creatine monohydrate daily and the other receiving a placebo (maltodextrin). a dietitian-nutritionist will standardize the participants' diet to ensure it is normocaloric and equivalent in macronutrient distribution. to ensure proper dietary control, 3-day dietary records (two weekdays and one weekend day) will be maintained both at the start of the study and during the last week of the intervention. assessments will be conducted before the start of the study (week 0) and at the end (week 4), and will include body composition measurements using the inbody system, physical tests (30-meter sprint, dynamometry, countermovement jump (cmj), maximum isometric force, and a 15-repeated-jumps test), as well as blood analyses for creatine, creatinine, and creatine kinase (ck) levels, and urine analyses for creatine excretion. it is expected that creatine supplementation in vegan subjects will significantly increase lean muscle mass, improve physical performance in the mentioned tests, and elevate muscle creatine levels while decreasing markers of muscle damage (ck). statistical analysis will include a repeated measures anova to evaluate changes in dependent variables between groups over time, with a significance level set at p \< 0.05.

Eligibility criteria:
inclusion criteria: * vegan diet for at least 6 months prior to the study's start. * aged between 18-40 years. * physically active according to the recommendations of the world health organization (who). * body mass index (bmi) between 18.5-24.9 kg/m2. * no tobacco use. * no or low alcohol consumption and no orthopedic limitations that would interfere with the performance of the study tests. exclusion criteria: * chronic diseases that impair athletic performance (cardiovascular, metabolic, gastrointestinal, respiratory) within the last six months. * musculoskeletal disease within the last six months. * creatine supplementation prior to the study's start

Keywords: performance vegan diet creatine strenght
an open study of foscarnet treatment of acyclovir-resistant herpes simplex virus in patients with the acquired immunodeficiency syndrome and other immunodeficiencies

Conditions: Herpes Simplex; HIV Infections

Summary: to evaluate the safety and efficacy of intermittent intravenous (iv) foscarnet in the treatment of acyclovir-resistant herpes simplex virus (hsv) infections in aids patients and other immunocompromised patients. to evaluate the necessity, efficacy, and safety of iv maintenance foscarnet therapy in preventing recurrent disease. to confirm the pharmacokinetics of intermittent induction and maintenance iv regimens.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * cyclosporine. patients must have aids as defined by the cdc or be immunocompromised (transplant patients; other hematologic malignancies with recognized cell-mediated immune deficiency). patients must also have herpes simplex virus (hsv) infection documented by culture and in vitro resistance to acyclovir by standard laboratory susceptibility or suspected resistance to acyclovir after an acyclovir treatment failure in which acyclovir was administered for at least 2 weeks intravenously at doses of 30 mg/kg/day (or a comparative dose adjusted for renal insufficiency). in vitro susceptibility data must be pending in the latter case. patients must be able to give informed consent. patients \< 18 years of age may participate with the consent of parent, guardian, or person with power of attorney, or through the provisions of state laws regarding emancipated minors. patients must have expected survival of at least 6 months. prior medication: allowed: * cyclosporin. * ganciclovir. exclusion criteria co-existing condition: patients with the following are excluded: * known allergy to foscarnet. * any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose). concurrent medication: excluded: * any potentially nephrotoxic agent (except cyclosporine). * immunomodulators. * biologic response modifiers. * investigational agents. patients with the following are excluded: * known allergy to foscarnet. * any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose). prior medication: excluded within 7 days of study entry: * any potentially nephrotoxic agent (except cyclosporin). * immunomodulators. * biologic response modifiers. * investigational agents.

Keywords: aids-related opportunistic infections immune tolerance injections, intravenous herpes simplex immunity, cellular foscarnet acquired immunodeficiency syndrome antiviral agents
evaluation of effectiveness of two dosing regimens of fostamatinib compared to placebo in patients with rheumatoid arthritis (ra) who are taking methotrexate but not responding.

Conditions: Rheumatoid Arthritis

Summary: the purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (ra) who are taking methotrexate but not responding. the study will last for 1 year.

sub-study: full title: optional genetic research date: 18 june 2010 version: 1 objectives: to collect and store, with appropriate consent ,dna samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or methotrexate; and/or susceptibility to, progression of and prognosis of ra

Eligibility criteria:
inclusion criteria: * active rheumatoid arthritis (ra) diagnosed after the age of 16 * currently taking methotrexate * 6 or more swollen joints and 6 or more tender/painful joints (from 28 joint count) and either erythrocyte sedimentation rate (esr) blood result of 28mm/h or more, or c-reactive protein (crp) blood result of 10mg/l or more * at least one of the following: documented history of positive rheumatoid factor (blood test), current presence of rheumatoid factor (blood test), radiographic erosion within 12 months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test) exclusion criteria: * females who are pregnant or breast feeding * poorly controlled hypertension * liver disease or significant liver function test abnormalities * certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders * recent or significant cardiovascular disease * significant active or recent infection including tuberculosis * previous failure to respond to a tnf alpha antagonist, anakinra or previous treatment with other biological agent * severe renal impairment * neutropenia

Keywords: rheumatoid arthritis
evaluate the safety and efficacy of hdm1002 tablets in chinese overweight and obese adults

Conditions: Overweight and Obesity

Summary: a phase 3 trial to evaluate the safety and efficacy of hdm1002 tablets in overweight and obese adults


Eligibility criteria:
inclusion criteria: * bmi≥28 but \< 40.0 kg/m2 at screening or randomization，or bmi≥24.0 kg/m2 but \< 28 kg/m2 with any of the following: 1. hypertension 2. dyslipidemia 3. obstructive sleep apnea syndrome 4. mash 5. pain in the weight-bearing joints * at least one previous failure to lose weight through lifestyle modification was defined as \< 5% weight loss after ≥3 months of lifestyle modification exclusion criteria: * weight change ≥5% as reported or documented. * previous diagnosis of type 1, type 2, or any other type of diabetes. * diagnosis of overweight or obesity due to other diseases or medications. * history or family history of medullary thyroid carcinoma, c cell hyperplasia, or multiple endocrine neoplasia type 2. * have diseases or conditions that affect gastric emptying or gastrointestinal absorption of nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, chronic pancreatitis, etc. or a history of acute pancreatitis or acute gallbladder disease within 3 months before signing icf. * glp-1r agonist use within 6 months prior to signing icf. * use of hypoglycemic drugs within 3 months before signing icf.