Kornimate/medical-research-clean huggingface dataset:
hypoallergenicity to substitutive formulas in children with cow's milk allergy

Conditions: Cow's Milk Allergy

Summary: the management of children with confirmed cow's milk allergy is based on complete avoidance of cow's milk proteins and leaves the physician with several dietary options, none of which, given the prevalence, spectrum and potential seriousness of the condition, can be recommended to all patients. in the absence of an alternative to cow's milk, the management of cow's milk allergy is based on the use of safe, affordable and nutritionally adequate formulas. extensively hydrolyzed cow's milk protein formulas, which are considered as safe for most children with cow's milk allergy, are still liable to contain residual peptides, and hypersensitivity reactions may occur in infants allergic to cow's milk protein. thus, specific product allergenicity must be addressed on an individual basis before recommending a formula as a substitute for cow's milk. soy-based formula can also concomitant sensitize cow's milk allergy children to soy. amino acid-based formulas have been studied from safety and nutritional efficacy perspectives. these formulas have been proposed for subjects highly sensitive to cow's milk protein and that cannot be managed using extensively hydolyzed formula and for children with multiple food allergies. in these conditions aminoacid based formulas are able to effectively cure allergic symptoms and to improve body growth.


Eligibility criteria:
inclusion criteria: * subjects with a cow's milk allergy * age between 0 to 36 months exclusion criteria: * age more than 36 months * eosinophilic disorders of the gastrointestinal tract, * food protein induced enterocolitic syndrome, * concomitant chronic systemic diseases, * congenital cardiac defects, * active tuberculosis, * autoimmune diseases, * immunodeficiency, * chronic inflammatory bowel diseases, * celiac disease, * cystic fibrosis, * metabolic diseases, * lactose intolerance, * malignancy, * chronic pulmonary diseases, * malformations of the gastrointestinal tract.
relationship between psychosocial factors, health literacy, quality of life and satisfaction with medical visits in adults with nf

Conditions: Neurofibromatosis

Summary: this is a prospective study through the nf clinic at massachusetts general hospital that will examine the relationship between psychosocial factors, health literacy, and satisfaction with the medical visit in adults with nf1, nf2, and schwannomatosis. a total of 89 participants will be enrolled in the study.


Eligibility criteria:
inclusion criteria: 1. age 18 or older 2. can read and speak english at or above the 6th grade level 3. diagnosis of neurofibromatosis type 1, neurofibromatosis type 2, or schwannomatosis exclusion criteria: 1. severe active or untreated major mental illness that would interfere with study participation, to be determined at the discretion of the study investigator (e.g. untreated psychosis or suicidality) 2. unable or unwilling to participate 3. unable or unwilling to complete psychological assessments online via the redcap or assessment center systems.
ultrasound-guided ipsilateral transverse abdominis plane and ilioinguinal iliohypogastric nerve block.

Conditions: Liver Cirrhosis

Summary: the purpose of this study is to compare the efficacy of using tab and ilih nerve blocks versus ilih nerve block only for inguinal hernia repair in patients with liver cirrhosis.

after obtaining institutional ethical committee approval and written informed consent in 2019, 60 patients between the age of 40 and 70 year were divided randomly using a computer generated randomization table and opaque sealed envelopes into two groups (30 patients in each group) according to the type of block they received: group (t) received ultrasound guided (us) combined ipsilateral transverse abdominis plane (tab) and ilioinguinal- iliohypogastric (ilih) nerve block. group (i) received us guided ipsilateral illioinguinal- illiohypogastric nerve block only. standard monitoring was used throughout the surgery; heart rate (hr), non-invasive mean arterial blood pressure (map), respiratory rate (rr) and oxygen saturation (spo2)documented at baseline before the block then at 5-min intervals intraoperative , then during the immediate postoperative period at 15 and 30 min, and at discharge from the pacu. a nasal prong was applied and supplemental oxygen at 3 l/min of fresh gas flow was given throughout the procedure. it was explained clearly to the patients that any pain, discomfort, or anxiety would be managed by the administration of local anesthetic (la) infiltration with bupivacaine 0.25% during the operation or by conversion to general anesthesia (ga) if needed.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status classification groups ii and iii,undergoing unilateral inguinal hernia repair. * all patients have liver cirrhosis having a child-pugh classification of liver disease (3) class b with a score ≤ 8/15, * moemen modified classification of liver disease (4) class b, * an international normalized ratio (inr)≤1.5. exclusion criteria: * patients with child-pugh ≥ 8/15, * inr≥ 1.5, * grade 3 ascites, * serum sodium ≤120 meq/l, * recurrent hernia, or bilateral hernia, * body mass index (bmi) ≥ to 40 kg/m 2, * known allergy to any of the medicines used * any renal or cardiovascular dysfunction, bronchial asthma, hematological disorders (other than secondary to chronic liver disease), * patient refusal.

Keywords: transverse aabdominis plane
therapy light rooms for improved sleep in dementia patients

Conditions: Sleep Fragmentation; Behavioural and Psychiatric Symptoms of Dementia; Dementia

Summary: this intervention study will investigate the effect of therapy light rooms on sleep, circadian rhythms, mood, behavioural problems and function in nursing home (nh) patients with dementia.

people with dementia often have fragmented night-time sleep, prolonged night-time awakenings and increased daytime sleep. behavioural and psychological symptoms of dementia (bpsd) (e.g. agitation, depression) are also common. noticeably, both sleep problems and bpsd are related to a disturbed circadian rhythm. light is the most important input to the circadian system, and exposure to sufficient daylight is important for entrainment of the circadian rhythm to the surroundings. dementia patients living in nursing homes (nh) are less exposed to daylight than dementia patients living at home. bright light therapy is a promising treatment in these patients as it may improve sleep, bpsd, and independent functioning. however, traditional bright light treatment has not been routinely employed in nh patients or patients with dementia. this may be related to difficulties in achieving adherence to the traditional treatment and thus the benefit of bright light therapy for people with dementia still remains unclear. dem.light uses modern led (light-emitting diodes) technology that enables light therapy with the least possible interference of the day-to-day life in nhs, as the treatment is not confined to a light source presupposing behavioural compliance. ceiling-mounted led-sources can be programmed in terms of timing, light intensity and colour temperature. dem.light uses this to provide therapy light rooms with a dynamic light condition that better emulates natural light throughout the day. the study is a cluster-randomized trial evaluating the effect of therapy light rooms on various measures of physical and mental health in nh patients with dementia. data will be collected at baseline, after 8 and 16 weeks of treatment, and at the end of the intervention period (24 weeks).

Eligibility criteria:
inclusion criteria: * 60 years or more of age and in long term care (longer than 4 weeks) * have dementia in accordance with dsm-v * have either sleep/circadian rhythm disturbances, bpsd as identified by npi-nh, or severely reduced adl function * provide written informed consent if the participant has capacity, if not, a written proxy informed consent from a legally authorized representative exclusion criteria: * are blind or may otherwise not benefit from light * partake in another trial * have a condition contra-indicated to the intervention * have an advanced, severe medical disease/disorder and/or expected survival of less than 6 months or other aspects that could interfere with participation * are psychotic or have a severe mental disorder

Keywords: phototherapy nursing home light therapy
pet/ct assessment of tumor perfusion in patients with renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: given the growing importance of anti-angiogenic therapies in the treatment of metastatic renal carcinoma, it is expected that this trial will establish the preliminary data needed to apply for funding of a larger clinical investigation of the potential role of pet perfusion imaging in management of renal carcinoma, and potentially other cancers.


Eligibility criteria:
inclusion criteria: * ability to understand and willingness to sign a witnessed, informed consent and authorization for the release of health information. * patients with a diagnosis of relapsed stage iv renal cell cancer that are medically unresponsive to prior treatment or surgically unresectable and with metastases that fall within the pet/ct field-of-view that can include the heart. * being considered for systemic therapy with sunitinib exclusion criteria: * women who are pregnant, breast-feeding, or of childbearing potential and not using birth control * having no telephone or a reliable way in which study personal can contact them * subjects who are claustrophobic and cannot tolerate imaging procedures * subjects who weigh \> 350 lb. (upper weight limit of scanner beds)
measuring effectiveness in sleep apnea surgery

Conditions: Obstructive Sleep Apnea

Summary: the goal of this research is to improve our understanding of the effectiveness of surgical osa treatment by evaluating its impact on these health-related and functional outcomes and comparing these effects to the changes in respiratory physiology achieved after surgery. to achieve this goal, we will examine key health-related (c-reactive protein, homocysteine, leptin, the homeostasis model of insulin resistance, and heart rate variability) and functional (sleep-related quality of life and vigilance) measures among a surgical group of osa patients who do not tolerate non-surgical treatment (positive airway pressure, pap) and a comparison group of matched osa patients who tolerate pap.

the goal of this research is to improve our understanding of the effectiveness of surgical osa treatment by evaluating its impact on these health-related and functional outcomes and comparing these effects to the changes in respiratory physiology achieved after surgery. to achieve this goal, we will examine key health-related (c-reactive protein, homocysteine, leptin, the homeostasis model of insulin resistance, and heart rate variability) and functional (sleep-related quality of life and vigilance) measures among a surgical group of osa patients who do not tolerate non-surgical treatment (positive airway pressure, pap) and a comparison group of matched osa patients who tolerate pap. we propose to measure the impact of surgical osa treatment on these health-related and functional outcomes measures with the following three analyses: (1) to assess the changes seen with surgical treatment; (2) to compare changes seen with surgical and pap treatment; and (3) to evaluate the association between changes in respiratory patterns during sleep and changes in health-related and functional outcomes measures for both surgical and pap treatment.

Eligibility criteria:
inclusion criteria (surgical group) * unable to tolerate pap, supported by statement from sleep physician * multilevel airway obstruction * elect to proceed with surgical osa treatment (uvulopalatopharyngoplasty +/-tonsillectomy, genioglossus advancement, and hyoid suspension) inclusion criteria (comparison group-pap) * tolerance of pap during titration study and indication of willingness to use * no previous treatment of pap except during titration study * washout period of two weeks between pap titration study and study assessment * matched to surgical group patient on age, gender, race, body mass index, and osa disease severity (apnea-hypopnea index) exclusion criteria: * pregnant women * primary snoring or mild osa (apnea-hypopnea index \< 15) * known neurologic, cardiac, hepatic, or renal disorder * acute illness or infection * co-existing sleep disorder other than primary snoring * unable to fast overnight prior to blood draw

Keywords: obstructive sleep apnea leptin homocysteine c-reactive protein
arms: the arm rest and support study

Conditions: Hypertension

Summary: primary objectives 1. determine the effect of an unsupported and poorly positioned arm on initial and average triplicate blood pressure done according to clinical practice guidelines with an automated device. a. hypothesis: compared to blood pressure measurements obtained with the arm supported with mid-cuff positioned at heart level, blood pressures measured with an unsupported arm and/or with mid-cuff below heart level will be significantly higher. secondary objective 1. to determine if the effects differ based on the following patient characteristics: * hypertensive blood pressure (sbp≥130 mmhg vs. \<130 mmhg). * age (≥ 60 years vs. \ lesser vascular stiffness * regular health care (last bp measured \>1 year ago vs. ≤1 year ago) * arm length:cuff width

the investigators propose a cross-sectional study of adult participants recruited from the community. enrolled participants will have four sets of three automated blood pressure measurements, with each set taken with the arm positioned and supported as follows: * arm supported on a desk, with mid-cuff at mid-heart level (4th intercostal space) * desk1 * reference measurement * arm supported on the participant's lap * lap * arm hanging at the participant's side, unsupported * side * the last period of triplicate bp measurements will always have the arm supported and mid-cuff positioned at mid-heart level * desk2 in the prior 3 periods, the arm position and support conditions are randomly ordered. each participant will undergo a total of 12 systolic and 12 diastolic bp measurements

Eligibility criteria:
inclusion criteria: * age ≥ 18 years exclusion criteria: * presence of the following on both arms: rashes, gauze dressings, casts, edema, paralysis, tubes, open sores or wounds, a-v shunts. * being mentally impaired * being pregnant * arm circumference exceeding 55 cm. * \>80 years of age

Keywords: blood pressure
asthma & exposure to peaks in particulate air pollution

Conditions: Asthma

Summary: we are testing the following two hypotheses: 1) peaks in hourly exposures to airborne particulate matter (pm) of outdoor origin will be more closely associated with acute asthmatic responses to particles than 24-hour average exposures in susceptible individuals; 2) personal exposure to pm, and estimated particle dose to the lungs, will be more closely associated with daily asthma severity than standard outdoor particle concentrations measured as 24-hour averages at governmental monitoring sites.

we are testing the following two hypotheses: 1) peaks in hourly exposures to airborne particulate matter (pm) of outdoor origin will be more closely associated with acute asthmatic responses to particles than 24-hour average exposures in susceptible individuals; 2) personal exposure to pm, and estimated particle dose to the lungs, will be more closely associated with daily asthma severity than standard outdoor particle concentrations measured as 24-hour averages at governmental monitoring sites. toxicological data for asthma exacerbations from particulate matter (pm) suggests that particle deposition in the lower respiratory tract can cause inflammatory and lung function changes suggestive of asthma pathology. there is now a scientific need to explain epidemiological findings of ambient pm effects on asthmatics at mass concentrations below what is expected (from toxicological data) to be harmful. one possibility is that study participants are encountering unmeasured short-term excursions of particle mass levels capable of inducing adverse reactions in the lung, but this effect is only captured somewhat by the regulatory standard of 24-hour averages. our research in southern california is vital to the current controversy regarding regulatory standards given that a health-based scientific rationale for any specific pm averaging time is not established.

Eligibility criteria:
1) physician-diagnosed asthma, at least a 1 yr. history, including episodic symptoms of wheezing, cough and dyspnea; 2) mild to moderate severity of asthma: i) a history of at least several weeks during the warm seasons (mar-oct) during which the subject required regular daily use of prescribed prophylactic asthma medications; \& ii) asthma exacerbations at least 2 days/week requiring as-needed bronchodilators during an extended period of 1-2 warm season months; 3) age from 9-18; 4) home, school or work addresses in alpine, ca area; 5) no history of smoking by the subjects and no person smoking in the subject?s home.

Keywords: asthma particulate matter
detrusor underactivity and bladder outlet obstruction in women with cystocele

Conditions: Cystocele

Summary: women with cystocele may be associated with detrusor underactivity (du) or bladder outlet obstruction (boo). however, the impact of cystocele repair on the rates of du and boo remained obscure. thus, the aim of this study was to elucidate the prevalence of du and boo in each age group and elucidate the impact of cystocele repair on the rates of du and boo.

between november 2010 and september 2018, all women with ≥ pop-q stage ii cystocele who visited the urogynecological department of a medical center for urodynamic evaluation were reviewed. those women who have no complete data of maximum flow rate (qmax), voided volume, post-void residual volume (pvr) and detrusor pressure at a maximum flow rate (pdetqmax) were excluded from this study. the du was defined when the pdetqmax was less than 20 cmh2o, the qmax was less than 15 ml/s, and the bladder voiding efficiency (bve) was less than 90 %. the boo was defined when the pdetqmax was not less than 40 cmh2o, and the qmax was less than 12 ml/s. bve = voided volume / (voided volume+ pvr) x 100%. those women without du or boo were allocated to the non-du/boo group. stata software was used for statistical analysis. wilcoxon signed-rank test or mcnemar's test was used for statistical analysis as appropriate. p \< 0.05 was considered statistically significant.

Eligibility criteria:
inclusion criteria: * ≥ pop-q stage ii cystocele * female exclusion criteria: * those women who have no complete data of maximum flow rate (qmax), voided volume, post void residual volume (pvr) and detrusor pressure at maximum flow rate (pdetqmax) were excluded from this study.

Keywords: bladder outlet obstruction detrusor underactivity cystocele
68ga-psma pet/ct in prostate cancer

Conditions: Prostate Cancer

Summary: this is a single-center, multi-arm, open-label, phase iii trial in up to 500 patients with biopsy-proven prostate cancer. participants will receive regular standard of clinical care. the only study-specific procedures will the administration of 68ga-psma-11 followed by a pet/ct (positron emission tomography/computed tomography) scan. participants will be followed for two hours after the infusion for identification of any immediate adverse events (ae), and will be contacted by telephone after 7 to 14 days to enquire about any delayed aes. pet/ct images, ct-alone images and bone scans will be read by separate readers who will not be blinded to all other clinical and imaging information. the standard of truth will be a consensus of the readers based on all available clinical, imaging, and histopathological information available for up to 6 months after the pet/ct scan.


Eligibility criteria:
inclusion criteria: * male sex * age 18 years or older * previously diagnosed with prostate cancer, under referring physician's care * ecog performance status 0 - 3, inclusive * able to understand and provide written informed consent * able to tolerate the physical/logistical requirements of a pet/ct scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection exclusion criteria: * patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive) * patients who exceed the safe weight limit of the pet/ct bed (usually approximately 400 lbs.) or who cannot fit through the pet/ct bore (usually approximately 70 cm diameter) * patients with unmanageable claustrophobia
cold snare endoscopic resection for duodenal adenomas

Conditions: Duodenal Adenomas

Summary: non-ampullary sporadic duodenal adenomas (sda) are rare lesions, incidentally discovered in up to only 5% of patients during routine endoscopy. in any case, these lesions require treatment due to their potential malignant transformation because of the adenoma-carcinoma sequence, occurring in 30-85% of cases. endoscopic resection (er) of sda represents an attractive alternative to surgical resection in appropriately selected patients, with lower morbidity and mortality rates. however, most endoscopists are not keen to resect larger lesions due to the risk of complications. indeed, endoscopic resection in the duodenum has unique challenges: thin wall, high vascularity, very limited space and harmful effects of bile and acid both acting on the er defect. cold snare endoscopic resection has been shown to be a viable method for removing colorectal lesions with comparable efficacy outcomes compared to conventional polypectomy/endoscopic mucosal resection (emr) and a promising safety profile. as a matter of fact, adverse events associated with hot snare resection technique such as delayed bleeding, post-polypectomy syndrome, and perforation are all related to electrocautery-induced injury. performing cold snare piece-meal resection and avoiding the need of thermal therapy, may have a major impact in the duodenum where the risk of delayed bleeding and perforation is consistent. the aim of this pilot study is to prospectively evaluate the feasibility and the efficacy in term of safety and efficacy of cold snare endoscopic resection.


Eligibility criteria:
inclusion criteria: • patients able to give informed consent to involvement in trial. exclusion criteria: * patient's with known strictures/stenosis * pregnancy * patients who did not consent to study * bleeding diathesis * anticoagulants
study to evaluate progression free survival in cancer patients with advanced colorectal carcinoma with amt2003

Conditions: Colorectal Carcinoma

Summary: the purpose of the study is to evaluate efficacy and safety of amt2003 in cancer patients with advanced colorectal carcinoma. the primary endpoint is progression free survival rate at 18 weeks after registration

the study will include patients with advanced colorectal carcinoma that is refractory to standard therapy or for which no effective standard therapy exists. eligible patients must have had at least second-line chemotherapy.

Eligibility criteria:
inclusion criteria: * cancer confirmed by histology or cytology * at least one measurable lesion * advanced disease refractory to standard therapy or for which no standard therapy exists * life expectancy of at least 3 months exclusion criteria: * known secondary neoplasia or central nervous system (cns) metastases; acute or chronic leukemia, lymphoma or multiple myeloma * body weight below 45 kg * female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective method of birth control * confirmed diagnosis of hiv * insulin dependent diabetes mellitus / abnormal glucose tolerance test (gtt) / latent diabetes mellitus type i or ii * chemotherapy or radiotherapy less than 4 weeks prior to entry * surgery less than 2 weeks prior to entry (or not recovered from effects of surgery) * participation in a clinical trial less than 30 days prior to entry in the study

Keywords: advanced colorectal carcinoma