Kornimate/medical-research-clean huggingface dataset:
analgesic contribution of the suprazygomatic maxillary nerve block for cleft palate surgery in children

Conditions: Cleft Palate; Surgery

Summary: this is a monocentric prospective randomized simple-blind designed study evaluating the superiority of the suprazygomatic maxillary nerve block in analgesia after cleft palate surgery compared with a control group. every two hours, nurses systematically reassess the patient's pain and adjust the analgesic medications. analgesic requirement, incidence of respiratory complications, re-feeding time and the duration of hospitalization are evaluated.

cleft palate is the most common congenital malformation and requires early surgery given the complications it generates. the surgical site involving the upper airways and the use of morphine are providers of respiratory complications. the suprazygomatic maxillary nerve block could considerably reduce the use of morphine in the postoperative period and thus the respiratory complications in addition to an optimal comfort for the patient. the primary endpoint was to evaluate morphine consumption during the first postoperative 48 hours after cleft palate surgery.

Eligibility criteria:
inclusion criteria: * children between 5 months and 12 years old * weight \>5kg * children undergoing cleft palate repair surgery with or without upper lip surgery exclusion criteria: * inappropriate age * weight \<5kg * abnormal blood coagulation * local anesthetic contraindication (including levobupivacaine, as well as any other associated treatment administered in this clinical study, including opioids, general anesthetics such as ketamine or propofol, paracetamol or corticosteroids) * local infection

Keywords: cleft palate surgery maxillary nerve block local anesthetic loco regional anesthesia face nerve block
autologous bone marrow for lower extremity ischemia treating

Conditions: Lower Extremity Ischemia

Summary: the purpose of this study is to determine whether autologous bone marrow derived cells and isolated cd133+ fraction are effective in the treatment limb ischemia

the number of patients with low limb obliterating atherosclerosis steadily grows and compounds more than 20-25 % from all kinds of a cardiovascular pathology. at conservation of this tendency to 2020 the amputation percentage executed due to vessel diseases, can reach 45 %. hemodynamics improvement in an extremity by surgery is possible at 40 - 70 % of patients even with the widespread and plural lesion of arteries, but results are not always satisfactory. the most actual is the problem of angiosurgical help to patients with distal forms of arterial occlusions, due to the difficulty or impossibility performing reconstructive interventions. in these cases the operations of an indirect revascularization referred on stimulation of a collateral blood flow are carried out. however, despite the reached successes, in some cases results of such interventions do not give desirable effect, search of new methods of treatment therefore is necessary. to date the most perspective methods of neoangiogenesis stimulation are a cellular therapy and gene-engineering technologies. experimental researches on a model of local limb ischemia showed possibility of use of various cells for neoangiogenesis stimulation. a number of clinical researches at patients with obliterating limb diseases has shown efficacy of cellular therapy even at a critical ischemia. however randomized, the placebo-controlled researches based on principles of evidence based medicine while it is not enough for the convincing conclusions.

Eligibility criteria:
inclusion criteria: * an obliterating lower extremity atherosclerosis iib a stage (on fontaine classification) * a painless walking distance of 10-50 m * pulse absence on аа. dorsalis pedis, tibialis posterior, poplitea * absence of a ischemia in a rest and necrotic changes * mainly distal form of disease (a lesion of a superficial femoral artery, a popliteal artery, anticnemion arteries) according to an angiography that testifies to impossibility of reconstructive operation performance * patients after a lumbar sympathectomy and a tibial bone osteoperforations executed previously * heavy smokers exclusion criteria: * insulin depended diabetes * myocardial infarction or a stroke within last year * an idiopathic hypertensia iii stage * anaemia and other diseases of blood * decompensation of the chronic diseases which are contraindications to any surgical operation * hiv infection * a virus hepatitis * oncologic diseases * chemotherapy in the anamnesis

Keywords: lower extremity ischemia bone marrow progenitor cells neoangiogenesis
trial of 2% chlorhexidine bathing on nosocomial infections in the surgical intensive care unit

Conditions: Cross Infection; Pneumonia, Ventilator-associated; Catheter-related Infections; Infection Due to Indwelling Urinary Catheter; Surgical Wound Infection

Summary: this prospective, randomized, controlled trial will compare the incidence of nosocomial infections (composite of primary bloodstream infections, catheter-associated urinary tract infections, ventilator-associated pneumonia, and surgical site infections) that occur in intensive care unit (icu) patients bathed with 2% chlorhexidine solution versus patients who receive standard bathing (soap and water or non-medicated cloths).

upon study enrollment, patients will be randomized to one of two study arms. patients in study arm one will receive standard bathing (soap and water or non-medicated cloth) daily. patients in study arm two will receive a 2% chlorhexidine bath on study day 1 and every 48 hours and a standard bath (soap and water or non-medicated cloths) on study day 2 and every 48 hours. patients will be followed until icu day 28 or discharged from the surgical icu. hypothesis: compared to standard daily bathing, chlorhexidine-based bathing on icu admission and every 48 hours will decrease the incidence of nosocomial infections.

Eligibility criteria:
inclusion criteria: * admission to the surgical intensive care unit at the methodist hospital (houston, tx) * anticipated surgical intensive care unit length of stay of 48 hours or more exclusion criteria: * pregnancy * age less than 18 years old * braden score of less than 9 upon admission to the surgical intensive care unit * known allergy to chlorhexidine gluconate * active skin irritation upon admission to the surgical intensive care unit

Keywords: nosocomial infection hospital acquired infection chlorhexidine pneumonia, ventilator-associated catheter-related infections urinary tract infections, catheter-related surgical site infection
a comparison between intravenous iron sucrose to its combination with oral iron supplements for the treatment of postpartum anemia

Conditions: Postpartum Anemia

Summary: this study is aimed to compare the efficacy of two mode of iron administration to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement.

anemia is common following delivery. it is associated with disturbing symptoms such as fatigue, cognitive impairment and syncope in severe cases. international guidelines recommend to use intravenous iron sucrose to treat intermediate and severe anemia until the target hemoglobin is achieved. however, patient's compliance after delivery is low, making the administration of several doses difficult. in those cases oral iron supplements might be used. in the present study the investigators will compare the efficacy of two iron administration protocols to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement.

Eligibility criteria:
inclusion criteria: * women above 18 years old after giving birth * women who suffer from iron deficiency anemia, defined as hemoglobin\< 9.5 g/dl without one of the conditions that are described in the exclusion criteria exclusion criteria: * women who suffer from known allergy for iron supplements * women who suffer from anemia not due to iron deficiency * women who suffer from acute infection * women who suffer from liver failure or viral hepatitis * women who suffer from thalassemia or hemoglobinopathies * women who suffer from renal failure * women who suffer from unbalanced thyroid disorder
helicobacter pylori and body iron in adults

Conditions: Helicobacter Pylori Infection

Summary: this study is an etiologic trial to test the hypothesis that predicts that helicobacter pylori eradication in asymptomatic/mildly dyspeptic adults will result in an increase in body iron. the study will assign and aims to complete the follow-up of 240 subjects half of them assigned to a highly effective fda approved 14-day course of a 3-1 capsule containing bismuth subcitrate, metronidazole and tetracycline plus omeprazole which is now otc. we have tested the effectiveness of this therapy in the study population and it seems to yield almost 100% eradication on pp analysis. we need the best possible, near 100% eradication rate, which we have already obtained in a pilot, to make comparisons on itt basis and safely conclude that h pylori leads to a deficit of body iron.

this etiologic double-blind randomized trial in non-anemic mostly asymptomatic/mildly dyspeptic hp-infected adults will assess whether hp eradication results in improvements in the levels of iron stores. iron stores will be assessed by (i) sf as primary outcome, and the following secondary outcomes: (ii) serum transferrin receptor (stfr), (iii) the ratio of stfr to sf or r/f, which will be used to estimate body iron, (iv) transferrin saturation (ts), (v) zinc protoporhyrin (zpp) and (vi) hemoglobin (hb) at baseline and at 6 months of follow-up. this study is a double-blind randomized clinical trial (rct) of hp eradication allocating 400 hp-infected asymptomatic/mildly dyspeptic adults 18-65 years of age of el paso, texas, to receive either (i) a 14-day quadruple hp eradication therapy described above or (ii) placebo. we expect that at least 240 will complete the study medications and follow-up.

Eligibility criteria:
inclusion criteria: * adults 18-65, men and women, residents of the geographic target area in el paso, texas, who consent to participate and complete at least 10 days of the study medication. exclusion criteria: * unsure if they stay in the area, have a history of allergic reactions to any antibiotic, lack adequate specimen for culture, phenylketonurics, women who are pregnant or unwilling to use 2 modern contraceptive methods during the 2-weeks they take the medications, with a history of heavy menses, anemic, history of peptic ulcer disease or had received helicobacter eradication therapy or have abnormal lab results for kidney and liver functions tests. will hold the enrollment for 4 weeks to those taking ppi, bismuth salts and antibiotics, and for 3 months since last blood transfusion or receiving intravenous iron preparations.

Keywords: h. pylori infection
phase ii study of il-11 (neumega) in von willebrand disease

Conditions: Von Willebrand Disease

Summary: this study is testing the use of rhil-11 (recombinant interleukin 11, neumega) in individuals with von willebrand disease. the purpose is to evaluate: 1. if rhil-11 corrects vwf (von willebrand factor) levels to normal 2. if rhil-11 and ddavp together will boost vwf levels even higher 3. the onset, peak, and duration of rhil-11 effect 4. if rhil-11 is safe in individuals with von willebrand disease

this is a prospective, single center, open-label, escalating dose phase ii comparison study of interleukin-11 (rhil-11, neumega) in subjects with type 1 von willebrand disease (vwd). the purpose is to establish the clinical safety and hemostatic efficacy of rhil-11 in individuals with type 1 von willebrand disease. study subjects will include the following subjects: 1. age \>= 18 years of age 2. diagnosis of vwd confirmed by: 2a) at least 2 of 4 abnormal vwd-related coagulation tests; 2b) a past bleeding history a total of 10-16 subjects are anticipated to be enrolled and complete the study. the specific aims of the study are: 1. to compare the hemostatic efficacy of three escalating doses of rhil-11 2. to determine the biologic effects of rhil-11 3. to determine whether ddavp, when given after the seventh daily dose of rhil-11, enhances hemostatic efficacy or rhil-11 4. to compare the safety of three escalating doses of rhil-11 efficacy will be based on the number and percent increase of vwd-related coagulation tests into the normal range, or at least to 2-3 times baseline. safety will be based on the number and frequency of adverse reactions, including fever, headache, fatigue, arthralgias, myalgias, fluid retention, and edema. the study will last up to 4 weeks per subject, and for 24 months for the entire study.

Eligibility criteria:
inclusion criteria: * males and females 18 years of age or older * confirmed vwd by 2 of 4 vwd coagulation tests abnormal * a past bleeding history * no hormone, oral contraceptive, estrogen use in past 8 weeks * willingness to have blood drawn * willingness to sign informed consent exclusion criteria: * presence of other bleeding disorder, e.g. acquired vwd, thrombocytopenia * use of estrogens, hormones, oral contraceptives in past 8 weeks * use of immunomodulatory or experimental drugs or diuretics * pregnant or lactating women * past cardiac disease, congestive failure, arrhythmia (e.g. atrial fibrillation, atrial flutter), hypertension, mi, stroke, or thrombosis * past allergic reaction to neumega or ddavp * surgery within the past 8 weeks * inability to comply with study protocol requirements * concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin, or nsaids * treatment with ddavp, cryoprecipitate, whole blood, plasma, and plasma derivatives containing fviii, vwf within 5 days of study

Keywords: von willebrand disease bleeding coagulation hemostatic agent
effect of fentanyl on emergence delirium (ed) on children undergoing adeno-tonsilectomy at kenyatta national hospital (knh)

Conditions: Emergence Delirium

Summary: this study will be a randomized double blind placebo controlled clinical trial among children undergoing adeno-tonsillectomy in knh. the intervention arm will comprise fentanyl given at a dose of 1ug/while the placebo arm will be given normal saline at a volume equivalent to fentanyl dose, treatment will be administered approximately ten minutes to the end of surgery determined by the time when the mouth gag will be removed. the main outcome will be incidence of ed at the recovery room using watcha scale and secondary outcomes will be delay in emergence time from anaesthesia and effectiveness of fentanyl in preventing ed.


Eligibility criteria:
inclusion criteria: * american society of anaesthesiologists classes (asa) 1 and 2 children. * asa 1 - normal healthy child scheduled for adeno-tonsilectomy. * asa 2 - child with mild systemic disease without functional limitations. * children aged 1 to 12 years. * children undergoing elective adeno-tonsilectomy. * those children whose parents/guardians have given a written informed consent. exclusion criteria: * children with genetic syndromes. * children with psychological/neurological behavioural disorders. * children with allergies to fentanyl. * children with psychiatric disorders/ use of psychiatric medications. * use of sedative medications one hour prior to surgery. * children with developmental delay. * children coming in as day case. * children with airway problems not related to the surgery-sleep apnoea. * children less than 1 year and those above 13 years.
clinical decision support tool for improving the adequacy of anticoagulant therapy in non-valvular atrial fibrillation

Conditions: Atrial Fibrillation; Anticoagulants; Clinical Decision Support Systems

Summary: atrial fibrillation (af) is the most common cardiac arrhythmia and increases the risk of ischemic stroke 4-5-fold. the prevention of complications is based on oral or antiplatelet anticoagulant treatment. the first choice of anticoagulant therapy (at) is the vitamin k antagonist (vka). contraindication to vka or poor control of the international normalized ratio leads to the administration of direct-acting oral anticoagulants (doacs). there is a trend towards inadequate at in non-valvular af (nvaf) patients. the objective of the study is evaluate the impact of the implementation of a decision support tool linked to digital clinical history on the adequacy of at, the incidence of complications and the mortality in patients with nvaf in primary health care of the catalan institute of health (ics).


Eligibility criteria:
inclusion criteria (all criteria must be met): * patients diagnosed with nvaf one year prior to the implementation of the computerized tool; * patients receiving anticoagulant treatment with doacs or vkas; * patients followed in primary care (with at least 6 inr controls during the year prior to the intervention). exclusion criteria: * patients with inr control in the reference hospital; * patients with valvular af (mitral stenosis); * patients with a prosthetic heart valve; * change to another primary care center.

Keywords: non-valvular atrial fibrillation time in therapeutic range primary care
a study to evaluate abp 938 and aflibercept (eylea®) in participants with chorioretinal vascular disease (cvd)

Conditions: Chorioretinal Vascular Disease

Summary: the primary objective of this study is to is to assess the ability of retina specialists to successfully administer, via an intravitreal (ivt) injection, a 2 mg dose of abp 938, using the abp 938 aflibercept prefilled syringe (pfs), compared to a 2 mg dose of aflibercept using the aflibercept pfs.


Eligibility criteria:
inclusion criteria * must sign an irb approved informed consent form before any study-specific procedures are initiated. * men or women ≥18 years old. * treatment-naïve or previously treated neovascular age-related macular degeneration, diabetic macular edema, macular edema following retinal vein occlusion, or diabetic retinopathy in the study eye. exclusion criteria * active intraocular or periocular infection or active intraocular inflammation in either eye. * uncontrolled intraocular pressure greater than (\>) 25 mmhg in the study eye. * deemed legally blind in one or both eyes. * history of or any current indication of excessive bleeding or recurrent hemorrhages, including any prior excessive intraocular bleeding or hemorrhages after ivt injection or intraocular procedures in either eye. * current systemic infectious disease or on a therapy for active infectious disease. * history of any medical, ocular or non-ocular conditions that, in the opinion of the investigator, may interfere with the injection procedure or pose a safety concern. * history of stroke or transient ischemic attacks or myocardial infarction within the last 6 months. * treatment with anti-vegf ivt injection in the study eye within 28 days. * any use of intraocular corticosteroids in the study eye within 3 months. * receipt of any systemic anti-vegf within the last 6 months. * any invasive intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation in the study eye within the past 3 months. * for women: pregnant or breast feeding, or planning to become pregnant while enrolled in the study and for 3 months after ip administration. * sexually active participants and their partners who are of childbearing potential who refuse to use adequate contraception while on-study and for 3 months after ip administration. male participants must agree not to donate sperm during study and for 3 months following dose of ip. * allergy or hypersensitivity to the ip, to any of the excipients of abp 938 or aflibercept, or to other study-related procedures/medications. * previously enrolled in this study. * participation in any interventional clinical study within 3 months prior to screening.

Keywords: chorioretinal vascular disease cvd abp 938 eylea® aflibercept
study to evaluate nvc-422 for urinary catheter blockage and encrustation

Conditions: Urinary Catheter Blockage and Encrustation

Summary: nvc-422 is a topical, non-antibiotic, fast-acting, broad-spectrum anti-microbial, which exhibits the potential to prevent the growth of urinary pathogens, including proteus and others. the use of a catheter irrigation solution that can prevent biofilm formation and encrustation leading to blockage may keep the catheter patent longer, resulting in fewer catheter changes, potentially lower incidence of utis, and better patient quality of life. the study population will include male and female spinal cord injury (sci) and other neurogenic bladder patients with chronic indwelling transurethral urinary catheters who have a recent repeated history of urinary catheter encrustation and/or blockage. subjects will receive two treatment regimens: one treatment regimen with nvc-422 sterile irrigation solution and one treatment regimen with sterile saline irrigation solution. each treatment regimen will consist of a total of 8 treatments, with a washout period between treatment regimens.


Eligibility criteria:
inclusion criteria: * spinal cord injury (sci) or other neurogenic bladder patient requiring a chronic indwelling urinary catheter with history of catheter blockage and/or encrustation * screening within 30 days of first treatment exclusion criteria: * systemic antibiotics within 7 days of first treatment * investigational drug or device within 30 days of enrollment * current infection that requires treatment with systemic antibiotics * recent history of significant autonomic dysreflexia (requiring intervention or treatment)

Keywords: blockage encrustation catheter spinal cord injury sci
effect of gabapentin on postoperative opioid analgesic use and pain in adolescents undergoing tonsillectomy

Conditions: Pain, Postoperative

Summary: this study aims to determine if administration of gabapentin preoperatively followed by a standing postoperative course is effective in reducing and possibly eliminating the use of opioid analgesics following this procedure. as a secondary outcome, it will evaluate the possible improvement in post tonsillectomy pain control with the use of a standing dose of gabapentin.

this is a prospective, randomized, non-blinded control trial designed to determine if administration of gabapentin postoperatively is effective in reducing and possibly eliminating the use of opioid analgesics following tonsillectomies in the adolescent population.

Eligibility criteria:
inclusion criteria: * patients aged 12-18. * patient scheduled for elective tonsillectomy +/- adenoidec-tomy, +/- bmts. * asa physical status i and ii. exclusion criteria: * severe upper respiratory tract infections. * patients who are actively on gabapentin or pregabalin, pre-existing with pain syndromes, chronic use of opioids, allergy to gabapentin, acetaminophen, and or nsaids * patient who lacks of fluency in english or inability to communicate pain. * patient who has severe asthma, bleeding disorders, and history of gastrointestinal bleeding, epilepsy, renal impairment or any other medical problem that in the opinion of the investigator would interfere with study population.

Keywords: tonsillectomy gabapentin postoperative pain