Kornimate/medical-research-clean huggingface dataset:
efficacy of oral tolerance induction to raw apple

Conditions: Oral Allergic Syndrome; Allergic Reaction Caused by Food (Disorder)

Summary: the aim of the study was to describe an intensive ultra rush (ur) protocol of raw golden apple (rga) reintroduction in 28 in-patients, show the protocol's tolerance and the patients' follow-up at 2 months and 1 year. patients with oral allergic syndrome (oas) having resulted in raw fruits eviction were admitted to day hospital between june 1 2016 and october 31 2017.

the aim of this study was to describe an intensive ultra rush (ur) protocol of raw golden apple (rga) reintroduction in 28 in-patients, show the protocol's tolerance and the patients' follow-up at 2 months and 1 year. patients with oral allergic syndrome (oas) having resulted in raw fruits eviction were admitted to day hospital between june 1 2016 and october 31 2017. methods : patients were included during the first consultation, ur was performed with rga in day hospital performed in two institutions, the charcot clinic and the polyclinic of beaujolais. starting with 1 gram (g) of food, then by regularly doubling dose from 2g to 128g, to reach a 255g cumulative dose in a 3 hour period. during the the post hospitalization period, patients back home had to eat ½ rga a day during one month, then 1 rga a day during one month, together with other rosacea fruits resumption at the end of the 5th week if ur were performed between april 15th and july 15th. a synthesis consultation was made at two months and a telephone interview at one year.

Eligibility criteria:
inclusion criteria: * no longer eat raw rosacea for at least 6 months due to oral allergic syndrome * with allergic rhinitis or asthma due to betulaceae pollen (spt+ and/or ige + to bet v 1 \> 0,10 kua/l) * with reduced quality of life exclusion criteria: * with severe allergic reaction to rosacea (\>grade 3 according to ring and messmer's classification) * pregnant woman * uncontrolled asthma (fev1 \< 70%) * immunosuppressed patient or having malignant disease, current infectious disease, or serious cardiovascular disease * opposed to use data

Keywords: food allergy apple allergy oral allergic syndrome ultra-rush tolerance induction cross-allergy
effectiveness of spot-on ™ to prevent inadvertent perioperative hypothermia and their consecuences

Conditions: Hypothermia

Summary: using the spot-on device for monitoring core body temperature during colon laparoscopic surgery and prevent non-therapeutic hypothermia.

take active measures to prevent non-therapeutic hypothermia during the laparoscopic colon surgery. we improve these measures using heat conductive air warm blankets placed under and o over the patient. perform monitoring core body temperature every 15 minutes by spot-on device compared with standard nasopharyngeal probe.

Eligibility criteria:
inclusion criteria: * all patients that need a colorrectal laparoscopic surgery exclusion criteria: * use of antagonist of calcium * alergy to medications * history of malignant hipertemia * laparosocopy surgery ≥ 120 min * temperature previous surgery over 38ºc * taking chronic steroids

Keywords: spot-on; perioperative hypothermia.
99mtc-rhannexin v-128 in diagnosis of spondyloarthritis

Conditions: Spondyloarthritis

Summary: this single center, open-label, proof of concept (poc) phase ii study aimed to assess the investigational imaging agent 99mtc-rhannexin v-128 in detecting spondyloarthritis (spa) lesions. overall, it was planned to recruit 20 adults with suspected or confirmed spa. first, 5 patients were enrolled into a "proof of concept" phase, to assess the imaging potential of 99mtc-rhannexin v-128 in terms of imaging quality, disease-lesion radiotracer uptake and medical relevance. based on these results the data monitoring committee (dmc) was to decide whether to terminate the study or whether to continue and enroll the next 15 planned patients.

the study was prematurely terminated by the sponsor after the first 5 patients completed the poc phase based on strategic considerations. novartis acquired advanced accelerator applications sa.

Eligibility criteria:
inclusion criteria: for the first 5 patients enrolled in the poc part: 1. patients with clinical suspicion or confirmed diagnosis of spa, based on the asa criteria with active symptoms including back, hip or buttock pain prior to: * a change in nsaid therapy or * a change in non-biologic dmard or * a start of non-biologic dmard. for the next 15 patients enrolled in the phase ii part: 1. patients with clinical suspicion or confirmed diagnosis of spa, based on the asas criteria with active symptoms including back, hip or buttock pain prior to: * a change in nsaids therapy * a change in non-biologic dmard * a start of non-biologic dmard * a start of biologic dmard for all patients: 2. age over 18 years old. 3. signed informed consent form exclusion criteria: 1. pregnancy or lactation 2. liver impairment (alt, ast or bilirubin \> 2 uln) at screening visit or baseline 3. kidney impairment (serum creatinine \> 1.5 mg/dl) 4. history of any disease or relevant physical or psychiatric condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment 5. known hypersensitivity to the investigational drug or any of its components 6. contraindication(s) to the mri procedure (claustrophobia, prosthetic valve, pacemaker, inability to lie still in a supine position) 7. participation to another clinical trial within 4 weeks before study inclusion except for patients who have participated or who are currently participating in an interventional study without any study drug administration.

Keywords: suspicion or confirmed diagnosis of spondyloarthritis ankylosing spondylarthritis ankylosing spondylitis ankylosing spondyloarthritis rheumatoid spondylitis spondylarthritis ankylopoietica spondylitis ankylopoietica spondyloarthritis ankylopoietica autoimmune systemic rheumatic disease inflammatory bowel disease psoriatic arthritis undifferentiated spondyloarthropathy.
a trial evaluating concurrent whole brain radiotherapy and iniparib in multiple non operable brain metastases

Conditions: Brain Metastases

Summary: recent pre-clinical and clinical data have indicated that bsi-201 does not possess characteristics typical of the parp inhibitor class. based on the results from in vitro and in vivo studies, this trial aims to evaluate the combination of bsi-201 concomitantly with radiotherapy in patients who present with multiple non operable brain metastases. as radiotherapy is a local treatment targeting only the tumor, and because the molecule bsi-201 has shown no major toxicity against tissues without dna alterations, the proposed combination is expected to provide tumor-selective therapy and leading to a clinical benefit improvement. primary objective is to determine the recommended phase ii dose (rp2d) and evaluate acute toxicity (ctc-ae v4.0 grading scale) of concurrent administration of whole brain radiotherapy (wbr) and a small molecule bsi-201 in non operable brain metastases.


Eligibility criteria:
inclusion criteria: * non operable brain metastases from any type of cancer (≥ 2) * at least one measured brain target available ≥ 1 cm (t1-weighted sequences with contrast application mri) * no stereotaxie indication * any anterior treatments for systemic disease (any chemotherapy at any line) are accepted but have to be interrupted at least 15 days before and up to 30 days after the present protocol * no extra-brain disease or stabilized since at least 1 month * aged ≥ 18 years old * kps \> 70 (rps class i or ii) * adequate bone marrow function: wbc ≥ 3.5 x 109/l, anc ≥ 1.5 x 109/l, platelets ≥ lln, hb \> 10g/dl, * adequate renal function: serum creatinine ≤ 1.5 × uln and blood urea nitrogen ≤ 25 mg/dl * male or female patient using adequate contraceptive method * women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to the start of treatment * informed and signed consent * able to be followed according to the terms of the protocol * affiliated to the french national social security exclusion criteria: * anterior treatment for brain metastases (surgery, radiosurgery, stereotaxie) * leptomeningeal metastases * inclusion in another protocol within 30 days * brain metastases with severe intracranial hypertension clinical signs * other cancer except the known primary tumor or in situ cervix cancer or basocellular carcinoma
effect of abdominal massage on patients in intensive care unit

Conditions: Intensive Care Unit Patients; Physiotherapy and Rehabilitation; Abdominal Massage

Summary: bowel motility can be affected by many factors such as immobilization, lack of fiber in the nutritional formula, inadequate fluid intake, and lack of privacy for toileting in patients hospitalized in the intensive care unit. abdominal massage, which is one of the effective methods to increase intestinal motility, is accepted as an intervention that can be safely applied in patients. the aim of our study was to investigate the effect of abdominal massage applied to patients hospitalized in the intensive care unit on sepsis, survival, discharge time from intensive care unit, amount and duration of antibiotic use. hypotheses h0: abdominal massage application has no effect on sepsis, survival, discharge time from intensive care unit, amount and duration of antibiotic use in patients hospitalized in intensive care unit. h1: abdominal massage application has an effect on sepsis, survival, discharge time from intensive care unit, amount and duration of antibiotic use in patients hospitalized in intensive care unit. in this randomized controlled study, the data of patients who received abdominal massage for 5 days during routine physiotherapy applications and those who did not will be recorded. randomization will be performed in a 1:1 ratio using a computer generated randomization schedule. the effect of abdominal massage on sepsis, survival, discharge time from intensive care, amount and duration of antibiotic use will be examined by using the data of 2 groups with and without abdominal massage in a randomized controlled trial.


Eligibility criteria:
inclusion criteria: * patients aged between 18 to 80 years * patients hospitalized in the intensive care unit for more than 3 days * body mass index less than 30 kg/m² * patients who are not mobilized out of bed * patients without any intervention contraindicating abdominal massage exclusion criteria: * history of abdominal surgery * active gastrointestinal bleeding * patients discharged from icu within less than 5 days after enrollment

Keywords: intensive care unit patients physiotherapy and rehabilitation abdominal massage sepsis
united states pharmacovigilence retapamulin-prescribing

Conditions: Skin Infections, Bacterial

Summary: retapamulin, a topical pleuromutilin antibiotic, is the first in a new class of topical antibiotics approved for human use. in the united states (us), retapamulin is approved for the treatment of impetigo in persons nine or more months of age and was launched on 12 april 2007. this five-year study is designed to examine use of retapamulin in the pediatric population less than nine months of age. we will conduct an annual assessment of prescription sales claims for retapamulin using the integrated health care information services (ihcis) national managed care benchmarked database. for each year of reporting, the observed frequencies of the exposure, with or without same-day, co-prescribed sales claim of mupirocin, will be identified. the study objectives are to determine the frequency of retapamulin sales in a representative us population stratified by the designated age group and to determine the frequency of same-day sale of the topical agent, mupirocin.

the ihcis is health insurance portability and accountability act (hipaa) compliant with encrypted member and provider identifiers; date of birth is restricted to year of birth. based on year of birth and the prescription sales claim date, age at the time of the prescription(s) will be categorized as less than 9 months (definitive) and less than 9 months (uncertain).

Eligibility criteria:
inclusion criteria: * the study population will consist of all 'eligible members' in the ihcis database with a valid gender and age record who have at least 1 month enrolment and eligibility of pharmacy benefits. exclusion criteria: * membership in ihcis without a valid gender or age record, enrolment less than 1 month, or ineligibility for pharmacy benefits will be excluded.

Keywords: altabax united states topical mupirocin retapamulin bactroban
efficacy and safety of montelukast in non alcoholic steatohepatitis (nash)

Conditions: Non Alcoholic Steatohepatitis

Summary: the current study is to evaluate the efficacy and safety of montelukast in the treatment of patients with non-alcoholic steatohepatitis (nash).

this is a randomized, prospective placebo-controlled study that will be conducted on 44 patients who fulfill the selection criteria and will be classified randomly into two groups. group 1 (control group n= 22): patients will receive placebo once daily at bedtime. group 2 (treatment group n= 22): patients will receive montelukast 10 mg daily at bedtime. the treatment duration will be 12 weeks. patients will be recruited from national liver institute and fever, liver and git disease shebin el-kom hospital, egypt. all participants will be informed about the nature of the study. the patients will give their informed consent.the study will be approved by research ethics committee of faculty of pharmacy -tanta university. data of all patients will be private and confidential. any unexpected risk will be reported to patients and ethical committee on time

Eligibility criteria:
inclusion criteria: * adult (\>18 years) overweight/obese subjects who have persistently abnormal aminotransferase level in two separate occasions over the past six months. nafld will be assumed in patients with moderately elevated aminotransferase activities (\<3x the upper limit of normal). there is evidence of hepatic steatosis by imaging (increased liver echogenicity (bright), stronger echoes in the hepatic parenchyma, vessel blurring, and narrowing of the lumen of the hepatic veins) and there is no cause for secondary hepatic fat accumulation such as significant alcohol consumption, use of steatogenic medication or hereditary disorders. patients with fibroscan score \>7 kpa and \<14 kpa will be included in the study. exclusion criteria: * alcohol abusers. * presence of evidence for viral or autoimmune hepatitis. * diabetic patients. * patients with wilson's disease and patients with hemochromatosis. * patients with decompensated liver disease. * patients show hypersensitivity to studied medications. * patients taking medication known to cause steatosis. * patients with other comorbid conditions that could potentially elevate transaminase, such as congestive heart failure, malignancy. * pregnancy and lactating women.
bibx 1382 in treating patients with solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase i trial to study the effectiveness of bibx 1382 in treating patients who have solid tumors.

objectives: i. determine the maximum tolerated dose of oral bibx 1382 in patients with solid tumors. ii. determine qualitative and quantitative toxicities of oral bibx 1382 in these patients. iii. determine predictability, duration, intensity, onset, reversibility, and dose relationship of the toxicities of oral bibx 1382 in these patients. iv. determine safe and optimal doses of oral bibx 1382 for a phase ii study. v. assess the pharmacokinetics of oral bibx 1382 in these patients. vi. document any antitumor activity in these patients treated with oral bibx 1382. outline: this is a dose escalation study. patients receive bibx 1382 iv over 1 hour followed 7 days later by oral bibx 1382. beginning 3 days later, patients receive oral bibx 1382 daily for 28 days. courses of daily oral bibx 1382 repeat every 28 days in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of oral bibx 1382. the maximum tolerated dose (mtd) is defined as the dose at which dose limiting toxicity occurs in at least 2 of 6 patients. patients are followed for up to 4 weeks. projected accrual: a total of 40-80 patients will be accrued for this study over 18 months.

Eligibility criteria:
disease characteristics: histologically or cytologically proven solid tumor not amenable to standard treatment no symptomatic brain involvement or leptomeningeal disease patient characteristics: age: 18 and over performance status: who 0-2 life expectancy: at least 3 months hematopoietic: absolute neutrophil count at least 2,000/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin less than 1.5 mg/dl other liver function tests no greater than 2 times upper limit of normal (unless related to liver metastases) renal: creatinine no greater than 1.4 mg/dl other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception during and for 3 months after study no active bacterial infections no nonmalignant disease that would be incompatible with study no prior alcoholism, drug addiction, or psychotic disorders prior concurrent therapy: biologic therapy: at least 4 weeks since prior immunotherapy chemotherapy: at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) endocrine therapy: not specified radiotherapy: at least 4 weeks since prior radiotherapy (6 weeks for extensive radiotherapy) no concurrent radiotherapy surgery: not specified other: no other concurrent investigational or antitumor drugs

Keywords: unspecified adult solid tumor, protocol specific
pediatric urgent start of highly active antiretroviral treatment (haart)

Conditions: Human Immunodeficiency Virus; Immune Reconstitution Inflammatory Syndrome

Summary: design: randomized clinical trial involving hospitalized hiv-1 infected children. children will be randomized to randomized to urgent (\<48 hours) versus early antiretroviral therapy (7-14 days). this trial will be unblinded. population: hospitalized hiv-1 infected children who are antiretroviral therapy (art) naïve ≤ 12 years of age. sample size: 360 children will be randomized (180 per arm). treatment: all infants will be treated with art according to world health organization (who) and kenyan national guidelines. study duration: enrollment into the study will occur over the course of 36-48 months and each infant will be routinely followed for a maximum of 6 months. study site: kenyan hospitals. primary hypothesis: hiv-1 infected children hospitalized with severe co-infection either may be unsalvageable due to too far advanced immunosuppression/co-infection or may benefit from urgent art. secondary hypotheses: urgent art during an acute infection could potentially result in increased risk of immune reconstitution inflammatory syndrome (iris) or drug toxicities/interactions. specific aims: 1. to compare the 6 month all-cause mortality rate, incidence of immune reconstitution inflammatory syndrome (iris), and incidence of drug toxicity in hiv-1 infected children (≤ 12 years old) presenting to hospital with a serious infection randomized to urgent (\<48 hours) versus early art (7-14 days). 2. to determine co-factors for mortality, iris, and drug toxicity. potential cofactors will include: baseline weight-for-age, height-for-age, weight-for-height (z-scores), cd4, hiv-1 rna, type of co-infection, age, rate of viral load and cd4 change following art, immune activation markers, pathogen and hiv-1 specific immune responses. secondary aim: to determine etiologies of iris and to compare immune reconstitution to hiv, tb, ebv and cmv following art overall and in each trial arm.

children will be followed and compared for 6-month mortality.

Eligibility criteria:
inclusion criteria: * aged ≤ 12 years old (reported) * hiv-1 positive (for example, two rapid hiv-1 antibody tests for children \>18 months and not breastfeeding, or one hiv-1 dna/rna test for children ≤18 months or who are breastfeeding) * not currently receiving antiretroviral therapy (history of pmtct does not affect eligibility) * eligible to receive art, according to current who guidelines * caregiver plans to reside in study catchment area for at least 6 months (reported) * caregiver provides sufficient locator information exclusion criteria: * suspected meningitis, any other central nervous system infection, or encephalitis

Keywords: hiv-1 iris
aim 3, optimizing crc screening in patients with diabetes in safety-net primary care settings

Conditions: Colorectal Cancer Screening; Diabetes Mellitus, Type 2

Summary: this mixed methods study evaluates the effectiveness and feasibility of a multi-level (patient, team, organizations) intervention to optimize crc screening for patients with diabetes in primary care safety-net settings.

aim 3 is a hybrid type 2 effectiveness-implementation pilot study in six primary care safety net clinics. this single-arm study uses a pre-post design to evaluate the targeted implementation strategies impact on: (1) preliminary effectiveness and (2) implementation (i.e., feasibility and acceptability) and a mixed-method comparative case study learning evaluation for safety-net primary care adoption and implementation. implementation strategies that will be tested were developed through a stakeholder engaged, community-based participatory implementation planning approach. this study uses a tailored combination of implementation strategies that include but are not limited to: identification of patient and practice-level barriers, patient education matierals, patient reminders provider/clinical team education, clinical champions, and audit and feedback. the impact of this evaluation will be measure using mixed methods to assess exploration, preparation, implementation factors related to how organizational and contextual variables affect adoption and implementation for targeting crc screening among patients with diabetes in safety net clinics at 12 months post intervention. aim 3 surveys 20 clinicians and staff from 6 clinics (n=120) and conducts key-informant interviews with 8 clinic and staff members at pre- and post-implementation (who have participated in the survey; n=96) and evaluates aggregate data for 30 patients across six clinics (n=180).

Eligibility criteria:
inclusion criteria: * diagnosis of diabetes mellitus; * participants not up-to-date with crc screening based on electronic health record (e.g. fobt/fit in last year; flexible sigmoidoscopy within four years; or colonoscopy within nine years); * age-eligible for crc screening (50-74 years of age); * participants in process of undergoing screening are eligible for participation if they have a fit/fobt incomplete test ordered for more than six months or a sigmoidoscopy or colonoscopy referral not completed for greater than one year. exclusion criteria: • medical conditions not concordant with standard crc screening intervals (e.g. prior crc diagnosis, inflammatory bowel disease, renal failure, etc.).
effectiveness of the drug gsk189254 in treating patients with narcolepsy

Conditions: Narcolepsy

Summary: the purpose of this study is to assess the effectiveness and safety of the drug gsk189254 in treating patients with narcolepsy.


Eligibility criteria:
inclusion criteria: * narcolepsy patients * body mass index between 18 - 32 kg/m2 * females may be of child bearing or non-child bearing potential. * agreement to refrain from driving or operating heavy machinery for the duration of the study. * must be able to withdraw from medication for the treatment of daytime sleepiness and must not be living on their own. exclusion criteria: * history or presence of major psychiatric disorder or depression. * history of significant head trauma in the previous 12 months. * participation in a clinical trial in the previous 3 months. * patient has significant and recent (within 1 year) history of drug or alcohol abuse. * patient is pregnant or breast-feeding.

Keywords: gsk189254 h3 histamine narcolepsy