Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of dexmedetomidine added to modified pectoral's block in breast cancer patients

Conditions: Breast Cancer Patients

Summary: to evaluate the effect of addition of dexmedetomedine to ultrasound guided modified pecs block on post operative analgesia \& stress response in patient undergoing modified radical mastectomy.

60 patients (age ≥29 years) who scheduled for modified radical mastectomy surgery under general anesthesia. group i (bupivacaine group): patients underwent modified radical mastectomy were given preoperative ultrasound guided modified pecs block with 30 ml of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles on the interfasial plane, and 20 ml injected between the pectoralis minor muscle and the serratus muscle.group ii (bupivacaine + dexmedetomidine group) : preoperative ultrasound guided modified pecs block with 30 ml of 0.25% bupivacaine plus dexmedetomidine (1 µg/kg) divided into 20 ml injected between the pectoralis muscles on the interfasial plane , and 10 ml injected between the pectoralis minor muscle and the serratus muscle.

Eligibility criteria:
inclusion criteria: * asa i - ii patients * weight 50- 100 kg) exclusion criteria: * a history of bleeding diathesis, * relevant drug allergy * opioid dependence, * sepsis, * those with psychiatric illnesses
study to evaluate the safety, tolerability, and efficacy of long-term adjunctive therapy with lacosamide in adults with partial-onset seizures

Conditions: Epilepsy; Partial-onset Seizures

Summary: the purpose of this trial is to evaluate the safety and tolerability of long-term administration of lacosamide at doses up to 400 mg/day in japanese and chinese adults with epilepsy who have completed the treatment and transition period of ep0008 \[nct01710657\]


Eligibility criteria:
inclusion criteria: * subject has completed the treatment and transition period of ep0008 \[nct01710657\] exclusion criteria: * subjects who withdrew from ep0008 \[nct01710657\]

Keywords: lacosamide epilepsy partial-onset seizures
alternative treatment strategies for stenotrophomonas maltophilia pneumonia

Conditions: Stenotrophomonas Maltophilia Infection

Summary: multi center, retrospective chart review of patients admitted to mhs hospitals from april 1, 2017 to march 31, 2022. patients will be identified through the electronic medical record, and data from those that meet the study inclusion and exclusion criteria will be analyzed. minimum inhibitory concentration (mic) data will be interpreted per clinical \& laboratory standards institute (clsi) standards to determine local patterns of resistance. multivariable logistic regression will be performed to determine predictors of mortality for s. maltophilia isolates.

stenotrophomonas maltophilia is an aerobic, non-fermenting, gram-negative bacillus recognized by the world health organization as one of the leading multi-drug resistant nosocomial pathogens worldwide. the investigators aim to examine differences in clinical outcomes and failure rates between standard and alternative treatment strategies such as minocycline (or moxifloxacin, ciprofloxacin, ceftazidime) alone or in combination with tmp-smx, alternative tmp-smx dosing regimens, or variations in durations of therapy for the treatment of s. maltophilia infections within methodist health system (mhs).

Eligibility criteria:
inclusion criteria: * ≥18 years of age * s. maltophilia isolated on respiratory or blood culture exclusion criteria: * those that do not meet the inclusion criteria outlined in section 4.1.
fractionated vs single dose injection for spinal c-section in patients with pregnancy-induced hypertension

Conditions: Pregnancy Induced Hypertension

Summary: the aim of this study was to compare haemodynamic changes, total dose of ephedrin requirement, and level of sensory blockade between fractionated dose and single dose spinal anesthesia injection in obstetric patients with pregnancy-induced hypertension who underwent caesarean section

approval from ethical committee of faculty of medicine universitas indonesia was acquired prior conducting the study. subjects were given informed consent before enrolling the study and randomized into two groups; single dose (sd) and fractionated dose (fd). all subjects will receive spinal anesthesia with 2,5 ml of 10 mg bupivacaine hyperbaric 0,5% and fentanyl 25 mcg. after iv cannulas (18 - 20 g) were properly placed, premedication with intravenous (iv) ranitidine 50 mg and metoclopramide 10 mg were given. additional iv access was added if mgso4 must been continuously administered intravenously perioperatively. standard monitor device were placed after patients had been transferred to operating room. additional premedication such as intravenous midazolam 0.02 mg/bw or fentanyl 1 mcg/bw were given if the patients were anxious or in pain. baseline haemodynamic measurement was done two minutes after premedication. spinal anesthesia was performed while patients in sitting position at l3-4 or l4-5 level with median or paramedian approach, with total dose 2,5 ml of 10 mg bupivacaine hyperbaric 0,5% and fentanyl 25 mcg. after skin wheal of lidocaine at the intended spinous interspace were placed, spinal needle (spinocanr, b braun, 27 g) were inserted and advanced until subarachnoid space were reached. in group fd, 1,5 ml of total dose followed by 1 ml remaining dose after 90 s interval were given. in sd group, 2,5 ml total dose were given with 0.2 ml/second rate, and subjects were asked to remain sitted for 90 seconds. if there were more than three injection attempts, the patients were excluded from the study. co-loading 5 - 10 ml/kg ringer lactate in 20 minutes were given for all subjects.

Eligibility criteria:
inclusion criteria: * with hypertension in pregnancy (gestational hypertension or preeclampsia) * asa ii-iii * aged 18 - 40 years * bmi 18.5 - 35 kg/m2 * singleton pregnancy * would undergo spinal anesthesia for emergency or semi-emergency caesarean section exclusion criteria: * chronic hypertension * eclampsia * pulmonary edema * cerebrovascular diseases * type-2 diabetes mellitus and gestational diabetes * placental abruption/previa/accreta * umbilical cord prolapse * gestational age \<34 weeks * estimated fetal weight \ =4.000 gram * polyhydramnios * fetal distress

Keywords: spinal anesthesia pregnancy-induced hypertension cesarean section
123i-mibg spect/ct for assessment of cardiac sympathetic innervation

Conditions: Cardiac Diseases

Summary: myocardial scintigraphy with 123i-mibg allows for visual and semi-quantitative assessment of sympathetic cardiac innervation using the hear to mediastinum ratio (hmr). impaired cardiac mibg clearance may occur in patients with congestive heart failure (chf). the purpose of present study was to develop and validate a quantitative index for the assessment of cardiac mibg uptake kinetics using spect/ct for diagnosis of chf


Eligibility criteria:
inclusion criteria: * age\>40 exclusion criteria: * none
mist ii pfo-migraine trial with biostar® bioabsorbable septal repair implant

Conditions: Migraine; Aura; Patent Foramen Ovale

Summary: the objective of the study is to investigate the safety and effectiveness of pfo closure with the biostar septal repair implant system in a population of patients that have refractory migraine (with aura) and who have failed medications.

during the last five years, transcatheter and surgical closure of pfo in the cyrptogenic stroke and tia population has grown in frequency world-wide. observational retrospective reports, from both single and multi-center experiences of over 400 patients, suggest patent foramen ovale (pfo) closure to reduce the risk of recurrent migraine events in these populations may be beneficial, particularly for those patients in the migraine with aura subgroup. although none of these reports are from prospective, randomized, controlled trials, the reports are compelling enough in their totality to support further investigation of a well defined group in a prospective manner. the patients reported in these studies were brought to pfo closure with no expectation of their procedure having any impact on their migraine. in fact, in many cases, the discovery of a history of migraine was not made until well after the pfo closure procedure. this clinical trial will prospectively compare the safety and effectiveness of pfo closure with the biostar device to a control arm. patients will be followed one year post-implant.

Eligibility criteria:
inclusion criteria: * age between 18 and 60. * migraine history prior to age 50 * must meet definition of refractory migraine with aura * must have a patent foramen ovale (pfo) within bubble study specifications. * must provide informed consent. guardian consent is not accepted. * patient's heart structure and vasculature must be compatible with biostar septal repair implant system. * patient must not be pregnant and agrees not to become pregnant during study participation exclusion criteria: * medical conditions or medications that are not compatible with protocol or that would increase the patient's risk. * patient must not have any cardiac or vascular anomalies, repaired or not, that would be incompatible with the delivery system or device for pfo occlusion. * currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current trial endpoints.

Keywords: migraine aura patent foramen ovale (pfo) cardiac defects heart septal defects, atrial cephalalgia
oral aromatase inhibitors modify the gut microbiome

Conditions: Breast Cancer

Summary: the purpose of this research is to study the bacteria in participants' gut before receiving a medicine called an aromatase inhibitor for breast cancer and after participants receive medicine for breast cancer.

primary objective: to describe the microbiome shift of gut microbiome from baseline after 4-weeks and 12-weeks of oral aromatase inhibitor treatment. secondary objective * to correlate gut microbiome populations with circulating sex hormone metabolite concentrations at baseline and 12 weeks. * to describe the correlation of change in the microbiome populations with change in circulating sex hormone metabolite concentrations from baseline to 12 weeks.

Eligibility criteria:
inclusion criteria: * pathologic diagnosis in situ or invasive breast cancer for which initiating aromatase inhibitors therapy is recommended or initiating aromatase inhibitors for risk reduction. * ecog performance status 0,1, 2, 3. * age ≥ 18 years * her2+ breast cancer is allowed if patients are on a monoclonal antibody therapy for which a change is not anticipated while on study (12 weeks) and they have been on the monoclonal antibody therapy for at least 4 weeks. * ability to read, understand and evaluate study materials and willingness to sign a written informed consent document. exclusion criteria: * have been on antibiotics within 4 weeks of enrollment. * administered chemotherapy less than 4 weeks prior to enrollment. * hormone replacement (defined as only estrogen and/or progesterone replacement) or anti-estrogen therapy within 4 weeks of starting aromatase inhibitors * use of antibody drug conjugate (her2+ breast cancer) * male breast cancer * any serious and/or unstable pre-existing medical, psychiatric, or other existing condition that would prevent compliance with the trial or consent process

Keywords: gut microbiome circulating sex hormone metabolite concentrations
impact of erythropoietin administration during definitive cervix cancer radiotherapy on treatment outcome

Conditions: Cervix Cancer

Summary: the purpose of this study is to determine whether an increase of blood haemoglobin levels through the substitution of erythropoietin during radiotherapy treatment of cervix cancer patients results in improvement for disease specific survival, tumor response and local control.

definitive radiotherapy is the treatment of choice for patients with locally advanced cervix cancer. low pre-therapeutic values of the intratumoral po2 are associated with significantly worse therapeutic outcome and the blood hemoglobin levels correlate positively with the intratumoral po2. successful augmentation of hemoglobin levels by way of transfusion leads to improvement of therapeutic results. therefore, a pre-therapeutic transfusion therapy is carried out routinely at a number of hospitals; however this therapy is due to its cost and risks limited to patients with an initial hemoglobin level of \ 12 g/dl) or rather an upper-normal (\>14 g/dl) hemoglobin level is reached, then the tumor oxygenation and thus also the response to radiation could be positively influenced. the objective of this study is to improve the response and control rates as well as the disease free survival rates in female patients with primary carcinoma of the cervix within the scope of the curative radiation therapy. the test hypothesis is that by administering erythropoietin the hemoglobin levels are increased and through this increase the response of the tumor to radiation therapy will be improved. comparison(s): a prospective, randomized, multi-centric group of female patients treated with erythropoietin is compared to a parallel stratified control group receiving no treatment.

Eligibility criteria:
inclusion criteria: * histologically proven cervix cancer (figo stage i-iva) * age of 19-80 years * initial blood level of hemoglobin \<= 14 g/dl * patients who gave their informed consent exclusion criteria: * karnofsky-index \< 50 % * known intolerance of erythropoietin * figo stage ivb * blood transfusion within the last four weeks * neoadjuvant chemotherapy * previous radiation therapy of the abdomen

Keywords: radiotherapy clinical trial erythropoietin cervix cancer phase iii 2 arms
comparison of lithotripsy urolithiasis machines

Conditions: Kidney Stone; Kidney Calculi; Ureteral Calculi; Ureterolithiasis; Urolithiasis

Summary: a comparison on the outcomes of patients undergoing shockwave lithotripsy using the storz machine versus the dornier machine.

this is a single institution, prospective randomized controlled clinical trial comparing two lithotriper machines (the storz modulith lx-f2 and dornier delta iii) in patients who are undergoing shockwave lithotripsy (swl) as the primary management of their urinary stone. patients record pain score on day of operation and post-operative day 1, and are followed for 1 month until they receive standard of care imaging at 1 month post-operatively.

Eligibility criteria:
inclusion criteria: - cleveland clinic foundation patients planned for elective swl with a preoperative ct performed * age ≥ 18 years old * male and female patients * patients of all ethnic backgrounds * stone size 5-15mm * stone location: renal or proximal ureter * stone density: \< 1200 hounsfield units * skin to stone distance: \< 12cm * primary treatment for a solitary stone (must be previously untreated) patients must be capable of giving informed consent and must be capable and willing to enroll and participate fully with the study. exclusion criteria: * prior treatment for specified stone * multiple stones on treatment side (even if only one is treated) * anticoagulated or history of coagulopathy * prior ureteral stent placement * technical problems/impossibility of localizing the stone on the day of intervention patients unable to give informed consent or unwilling to enroll or participate in the study will be excluded.

Keywords: lithotripsy extracorporeal shockwave lithotripsy
st. john's wort vs. placebo in obsessive-compulsive disorder.

Conditions: Obsessive Compulsive Disorder

Summary: the purpose of this study is to determine the effectiveness of st. john's wort as compared to placebo (an inactive substance) in the treatment of outpatients with obsessive compulsive disorder.

the objective of the proposed study is to assess the efficacy of the herbal st. john's wort (sjw) in the treatment of symptoms of obsessive-compulsive disorder (ocd). the approach is to conduct a 12-week, randomized, double blind, placebo controlled, parallel group pilot trial with 30 subjects in each of two arms. the yale-brown obsessive compulsive scale (y-bocs) will be the primary measure for evaluating ocd. an intention-to-treat analysis will be done to compare the two arms.

Eligibility criteria:
inclusion criteria * female patients: at least 2 years post-menopausal, surgically sterile, or practicing a medically acceptable method of contraception. * meets dsm-iv criteria for obsessive compulsive disorder exclusion criteria * primary diagnosis of major depression, dysthymia, panic disorder, social phobia, schizophrenia, schizo-affective disorder, bipolar disorder, or ptsd * substance abuse or dependence in the past 6 months * vascular dementia or primary degenerative dementia of the alzheimer's type * treatment with maois, tcas, ssris, venlafaxine, nefazodone, remeron, citalopram, or bupropion within 14 days of first visit. * fluoxetine within 5 weeks of first visit. * failure to respond to at least two adequate antidepressant trials for obsessive compulsive disorder * investigational drugs within 30 days of baseline * known allergy or hypersensitivity to st. john's wort * currently in behavior therapy for obsessive compulsive disorder all inquiries will undergo a phone screening to determine whether they meet eligiblity requirements.

Keywords: obsessive compulsive disorder ocd anxiety st. john's wort wisconsin psychiatric mental health
use of biodesign® otologic graft in canal wall down mastoidectomy: a prospective, randomized trial

Conditions: Otologic Disease

Summary: this is a prospective, randomized trial to evaluate canal wall down mastoidectomy (cwdm) healing outcomes using biodesign® small intestine submucosa graft compared to autologous temporalis fascia graft.

patients 18 or older will undergo primary canal wall down mastoidectomy. patients with known biologic sensitivity or cultural objection to use of porcine materials will be excluded. data will be derived from the medical record and surgeon reports as detailed on pre-op and follow-up forms. variables collected include age, gender, medical co-morbidities, body mass index, pre-operative audiometric values (including word recognition score, pure tone average, and air bone gap), side of surgery, size of operative cavity, infectious state (draining versus dry), exact surgical procedure, presence of cholesteatoma, time to dry cavity, time to complete epithelialization (as observed directly by the surgeon), and post-operative complications (such as persistent perforation, drainage, granulation tissue formation, and facial nerve outcomes). dates and patient number will be recorded. patients will be randomly assigned using randomization software, whereby patients will be assigned a sequential research number that is pre-randomized to one research arm. the study cannot be blinded, as the surgeon will be able to identify which graft will be used. de-identified photographs of the post-operative outcomes at each time point will be recorded photographically. three physicians will review these photographs without prior knowledge of the treatment arm.

Eligibility criteria:
inclusion criteria: * patients undergoing primary canal wall mastoidectomy exclusion criteria: * patients with a known biologic sensitivity or a cultural aversion to the use of porcine materials.
impact of beta-lactams on the microbiota and relative fecal abundance of mulltidrug resistant bacteria

Conditions: Enterobacterial Infection

Summary: the global spread of esbl-producing enterobacteria (eblse) poses a real public health problem. the exposure of patients to antibiotic therapy leads to an increase in resistant bacterial populations within the digestive flora. as a result, the diagnosis of digestive colonization by eblse is an event that has become common in hospitalized patients in intensive care / intensive care under high pressure antibiotics. the aim of this work is to study the impact of beta-lactams frequently prescribed on the microbiota and the emergence of multiresistant bacteria in the digestive flora and to evaluate, in colonized patients, the factors associated with the occurrence of an infectious episode. in particular, the impact of the relative fecal abundance of esbl enterobacteriaceae on the occurrence of this event will be studied.

among enterobacteria, the production of esbl is the first cause of multi-resistance. the consequences of multidrug-resistant enterobacterial infections predominantly represented by esbls are currently well known, both from the individual point of view (increase in mortality and length of hospital stay) and collective (increase in costs of care). data from the literature reveal an increased risk of esbl bacteremia in patients with rectal carriage of esbl-producing enterobacteria. it therefore appears necessary in known patients with esbl-producing enterobacteria to evaluate the impact of different antibiotics (beta-lactams) on the modification of flora, the increase of faecal abundance in multidrug-resistant bacteria such as e. coli esbl and evaluate the factors associated with infections in these patients.

Eligibility criteria:
inclusion criteria: * age\> 18 * icu admitted patient * rectal colonization of enterobacteria * accepting participation * with medical insurance exclusion criteria: * patient without bacterial colonization * under antibiotics more than 24hours * without medical insurance
safety of oral food challenge with cow's milk proteins in children with food allergy

Conditions: Food Allergy

Summary: the aim of the study is to assess the safety of an oral food challenge (ofc) with cow's milk proteins and to assess the tolerance of cow's milk proteins in children with a food allergy after introducing cow's milk into the diet.

the aim of the study is to assess the safety of an oral food challenge test with cow's milk proteins and to assess the tolerance of cow's milk proteins in children with food allergies after introducing cow's milk into the diet. the study covers children over 12 months of age diagnosed with cow's milk allergy, treated with a non-dairy elimination diet based on extensively-hydrolyzed formulas or amino acid formulas, admitted to the department of pediatrics, gastroenterology and nutrition to conduct an open oral food challenge. in all children, after appropriate assessment and qualification (interview, physical examination, skin prick tests, results of allergen - specific immunoglobulin e (ige), total blood count, fecal calprotectin and lactoferrin), an oral food challenge test with cow's milk will be performed. the oral food challenge test will be carried out in accordance with current standards and with child protection in the event of an adverse reactions. during the food challenge test (first 24 hours), after 2 weeks (phone survey) and 3 months after the test (visit to the department) the frequency, severity and type of allergic reactions and cow's milk protein tolerance will be assessed. the safety of oral food challenge with cow's milk protein in children previously fed with extensively - hydrolyzed formulas or amino acid formulas will be compared. the results of allergy tests, total blood count and intestinal inflammatory markers (fecal calprotectin and fecal lactoferrin) will also be assessed before and 12 weeks after oral food challenge. the assessment of the incidence and severity of allergic reactions and tolerance of cow's milk proteins after introduction into the diet in children challenged with cow's milk proteins may help to establish guidelines on the qualifications and how to conduct an oral challenge test.

Eligibility criteria:
inclusion criteria: * children aged from 13 months to 15 years * children diagnosed with cow's milk allergy treated with a dairy-free diet * informed consent of the child's parents/legal guardians to participate in the study exclusion criteria: * occurrence of anaphylactic reaction after ingestion cow's milk proteins less than 12 months * positive skin prick test with cow's milk proteins * milk specific serum ige values \> 17,5 ku/l * age below 13 moths * no consent of the child's parents/legal guardians to participate in the study

Keywords: oral food challenge food allergy children