Kornimate/medical-research-clean huggingface dataset:
a phase i study to determine the effect of food on the pharmacokinetic profile of bpi-7711

Conditions: NSCLC

Summary: this is an open-label, randomised, single-dose, cross-over phase i study to evaluate the effect of food on the pharmacokinetic profile of bpi-7711 in chinese healthy male subjects.


Eligibility criteria:
inclusion criteria: * male, aged from 18 to 55 years. * bmi from 18.5 to 28.0 kg/m2 * medical history, vital signs, physical examination and lab tests are normal or abnormal without clinical significance. exclusion criteria: * subjects with clinical significant diseases * subjects with allergic disease history * subjects with gastrointestinal disease history that can affect study drug absorption * subjects with drug abuse history
effect of two different rye bread types in irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to evaluate if low-fodmap (fermented oligo-, di-, monosaccharides and polyols) rye bread is better tolerated in irritable bowel syndrome than commonly available traditional rye bread higher in fodmap carbohydrates. the study also aims to investigate patients' compliance to rye bread regimen, potential changes is gut microbiota and hydrogen production during the test periods (a marker of large bowel fermentation of poorly absorbed carbohydrates).


Eligibility criteria:
inclusion criteria: * ibs according to rome iii criteria. accepted sub-types include ibs-m, ibs-d and ibs-u * age 18-65 years * willing to use rye bread daily during the study periods exclusion criteria: * ibs-c (constipation dominant) * celiac disease * ibd * major gastrointestinal operations like bowel gastric resection * non-treated hypo- or hyperthyroidism * alcoholism, severe depression, dementia, cancer or other diseases likely to severly impair the participants ability to conclude the protocol * regular (almost daily) use of nsaids, antibiotics or lactulose * linaclotide and other prescription medicines targeted specifically to ibs * pregnancy and lactation * follows currently strict low-fodmap diet

Keywords: ibs, irritable bowel syndrome, functional gastrointestinal disorder, diet, bread, rye, fodmap, microbiota
safety and efficacy of autologous prp and ppp eye drops in the treatment of ocular gvhd

Conditions: Graft-versus-host Disease

Summary: the purpose of this study is to evaluate the safety and efficacy of autologous platelet rich plasma (prp) and platelet poor plasma (ppp) eye drops four times a day in the treatment of ocular graft versus host disease (o-gvhd). in addition to their current medication (except autologous serum drops), patients will receive prp and ppp drops.

ocular involvement can be quite symptomatic in patients with chronic graft-versus-host disease (gvhd). the impact of ocular gvhd on quality of life (qol) in patients with chronic gvhd has been studied in a prospective, multicenter, longitudinal, observational study and showed that ocular gvhd affects 57% of patients within 2 years of chronic gvhd diagnosis. strong evidence suggested that ocular gvhd is associated with worse overall health-related qol. significant worsening of vision-related qol in ocular gvhd has been reported. ocular gvhd is devastating and there is no effective treatment available so far. the importance of this study is that for the first time in the nation, our institute will evaluate the safety and efficacy of topical autologous blood product (prp and ppp) to treat ocular surface disease associated with ocular gvhd.

Eligibility criteria:
inclusion criteria: * age ≥18 years. * willing and able to provide written informed consent. * willing and able to comply with study assessments for the full duration of the study. * diagnosis of ocular gvhd. * minimum corneal fluorescein staining of 4 (nei grading scheme, 0-15) in at least one eye. * in good stable overall health. exclusion criteria: * remission from primary cancer in more than 5 years. * history of thrombocytopenia (platelet\<50,000) in the last 2 weeks before study entry. * ocular or periocular malignancy. * significant change, as judged by the pi, in systemic immunosuppressive regimen before 2 weeks of study entry. * any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month. * any change in frequency of preserved anti-glaucoma medications before 2 weeks of study entry. * current use of topical steroids more than twice a day. * change in frequency of topical cyclosporine and/or topical kineret within the last month. * signs of current infection, including fever and current treatment with antibiotics. * intra-ocular surgery or ocular laser surgery within the last 3 months. * has worn contact lenses, except for bandage contact lens or rigid gas permeable lens or scleral contact lens, for the last 2 weeks prior to the study or would be unable to stay off contact lenses for the study duration. * any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.

Keywords: platelet rich plasma platelet poor plasma ocular gvhd
multi-center validation of a hypothermia prediction mobile application (app)

Conditions: Perioperative Hypothermia

Summary: there have been no fully validated tools for rapid screen of surgical patients at risk of intraoperative hypothermia. the aim of this study is to validate the performance of a previously established prediction model in estimating risk of intraoperative hypothermia using a prospective cohort before further implementation of the model. we hypothesize that the prediction model has helpful discrimination and adequate calibration \[1\] for clinical use.

this is a multicenter, prospective, observational cohort study to validate the property of a previously established mobile application (app) \[2\] for estimating risk of intraoperative hypothermia. patients scheduled for elective surgery under general anesthesia will be enrolled consecutively at 30 hospitals, which are randomly selected across china, between june, 2021 and december 2022. the total planned sample size is 3000 cases. eligible participants will be identified, informed to sign the consent, and flagged at preoperative interview the day prior to the operation. anesthetics and perioperative temperature management will be chosen at the discretion of the anesthesiologists without intervention. intraoperative hypothermia risk score of each participant will be calculated by a mobile application of the predictor model \[2\] before surgery. a wireless axillary thermometer \[3\] will be used to continuously measure and record perioperative core temperature as the reference standard. all participants will be followed up until 30 days after the operation.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * undergoing elective operation with general anesthesia or combined with other anesthesia * operation is expected to last more than 40 minutes exclusion criteria: * central hyperthermia (e.g., cerebrovascular disease, traumatic brain injury, cerebral operation, epilepsy or acute hydrocephalus) * impaired thermoregulation (e.g., neuroleptic malignant syndrome, malignant hyperthermia, or known hyperthyroidism/hypothyroidism with current thyroid dysfunction * infectious fever * core temperature ≥38.5 ℃ attributable to other causes within 3 days before surgery * operation with induced hypothermia (e.g. cardiopulmonary bypass) * unsuited for infrared tympanic thermometry or axillary temperature monitoring * unwilling to give signed consent
handheld ultrasound (hhus) for home use in hemophilia

Conditions: Joint Bleed; Hemophilia A

Summary: this is a study in 3 phases that will assess the feasibility and utility of handheld home ultrasound (hhus) in a patient's home to assess whether a painful episode in the elbow, knee or ankle is a bleed or not.

this is a study in 3 phases that will assess the feasibility and utility of handheld home ultrasound (hhus) in a patient's home to assess whether a painful episode in the elbow, knee or ankle is a bleed or not. phase 1 will assess whether 10 subjects with severe hemophilia a can be trained to use hhus in clinic to identify basic joint structures of the elbow, knee and ankle. it will then assess whether these subjects can identify these structures at home and transmit the images life via tele-ultrasound. phase 2 will assess whether the determination of "bleed" vs. "non-bleed" made at home via hhus can be confirmed/validated with a standard high resolution ultrasound machine in clinic. phase 3 will then utilize hhus during the emimskus study over 3 years to more objectively identify patient reported bleeding during the study.

Eligibility criteria:
inclusion criteria: * severe hemophilia a * male * over 18 years of age * able to read, write and understand english * willing to come to the center for an 8 hour training session * lives in proximity of the htc and is willing to come in for acute joint episodes in phase 2 * willing and able to follow study procedures * willing and able to keep hhus at a safe place * have the dexterity to operate a hhus unit exclusion criteria: * unable to follow study instructions * physically or mentally unable to operate a hhus unit

Keywords: joint bleed hemophilia a handheld ultrasound
vitamin d supplementation and neurocognition

Conditions: Vitamin D Deficiency; Neurocognitive Dysfunction

Summary: this study will evaluate the effect of vitamin d supplementation on the neurocognitive function of older people with lower than normal levels of vitamin d at baseline

background: ageing is associated with an increased risk of cognitive decline. vitamin d plays an important role in many of the symptoms and conditions related to advanced age, including impaired balance, falls and osteoporosis. vitamin d also has a physiological effect on the function of the central nervous system, and studies have suggested a relationship between this vitamin and changes in cognitive function of older people. the investigators propose a pilot study to evaluate the effect of vitamin d supplementation on the neurocognitive function of older people. methods: a total of 30 subjects of both genders older than 65 years with levels of 25-oh vitamin d lower than 30 ng/ml on routine laboratory screening will be included in the study. exclusion criteria will include any unstable medical condition as determined by the treating physician, a diagnosis of dementia, the use of supplements containing vitamin d in any dose, significant visual or hearing impairment not corrected by spectacles or hearing aids, and a level of literacy that limits the performance of computerized neurocognitive testing. following provision of written informed consent for inclusion in the study, subjects will answer a questionnaire providing demographic details, undergo cognitive screening by use of the moca test, and computerized cognitive assessment using the neurotrax battery. all subjects will undergo repeat testing for level of 25-oh vitamin d, and where below-normal levels are confirmed patients will receive a supplemental monthly oral dose of 60000 units vitamin d administered by a nurse for a period of 3 months. levels of serum calcium will be repeated monthly (end of month 1, 2, 3). at 3 months subjects will undergo repeat testing for level of 25-oh vitamin d, and repeat computerized cognitive assessment using the neurotrax battery.

Eligibility criteria:
inclusion criteria: * adults aged 65 years and older. * level of vitamin d (25-oh vitamin d) is less than 30 ng / ml. * stable health status as assessed by the treating primary care physician. * do not take supplements containing vitamin d. * normal cognitive function as determined by moca test screening and clinical assessment * adequate literacy to enable the performance of cognitive assessment instruments * provide informed consent as required by the ethics committee. exclusion criteria: * age younger than 65 years * health status not stable as determined by the treating primary care physician * a diagnosis of dementia * taking supplements containing vitamin d * significant visual or hearing impairment not corrected by spectacles or hearing aids * impaired competency limiting the subject's ability to provide informed consent
study of effectiveness of liraglutide added to high dose insulin in type ii diabetics

Conditions: Diabetes Mellitus, Type II

Summary: the purpose of this study is to determine the effect of adding liraglutide to high dose insulin therapy compared to high dose insulin therapy alone in patients with insulin-treated type 2 diabetes with insulin requirements of \> 100 units of insulin per day.

40 subjects with type 2 diabetes using \> 100 units of insulin per day with or without metformin with hba1c \> 6.5% will be randomized into 2 treatment groups: treatment group will have liraglutide added to insulin and control group will have insulin uptitration only for 6 months. primary endpoint to be compared between groups will be hba1c at 6 months. secondary endpoints will include weight, total daily insulin dose, percent time in euglycemic, hyperglycemic, and hypoglycemic ranges by continuous glucose monitor (cgm), and effect on glycomark and hs-crp. safety endpoints will include incidence of hypoglycemia and incidence of gastrointestinal side effects.

Eligibility criteria:
inclusion criteria: 1. male and female patients with type 2 diabetes with hba1c from 6.5 to 10% treated with intensive insulin therapy (mdi or csii, including u-500 insulin-treated patients) using \> 100 units of insulin, with or without a stable dose of oral insulin sensitizing medications, for at least three months. 2. aged 18 to 80 years. 3. females of child-bearing potential must be using adequate form of contraception. 4. patient willing to monitor bg four times daily, use cgm, and comply with study-related protocol. exclusion criteria: 1. type 1 diabetes. 2. use of any glp-1 receptor agonist within previous three months. 3. use of dpp-4 inhibitors or oral insulin secretagogues within the previous three months. 4. use of glucocorticoids (except inhaled). 5. use of any experimental drug within previous three months. 6. known or suspected allergy to liraglutide, novolog or levemir. 7. personal or family history of medullary carcinoma of the thyroid or men-2. 8. concomitant chronic renal disease with creatinine \> 1.5%. 9. concomitant chronic hepatic, gastrointestinal or other illness (including pancreatitis or active cardiovascular disease except stable exertional angina). 10. inability or unwillingness to monitor bg, use cgm, or comply with study protocol. 11. women of child-bearing potential unwilling to use adequate contraception, intending to become pregnant or breast-feeding.

Keywords: insulin type ii diabetes liraglutide glucagon-like peptide 1
effect of high intensity laser on hemiplegic shoulder dysfunction

Conditions: Stroke; Shoulder Dislocation or Subluxation

Summary: hemiplegic shoulder pain (hsp) is a common and disabling complication following a stroke, and it may affect the quality of life. it often occurs following two to three months of stroke. upper limb impairment is seen in 90% of patients affected by stroke. numerous causes have been implicated in developing hsp in stroke. this includes muscle flaccidity around the shoulder joint, shoulder subluxation, shoulder-hand syndrome, increased muscle tone, impingement syndrome, frozen shoulder, brachial plexus injury, and the thalamic syndrome. muscle paresis, abnormal muscle tone and loss of proprioception following stroke may render the shoulder complex unstable and therefore prone to misalignment. in recent years, high-intensity laser therapy (hilt) has been considered as a treatment option for shoulder pain. hilt increases microcirculation and tissue regeneration and lowers edema, inflammation, and pain with its photomechanical, thermal, electrical, and bio stimulating effects in deep tissues that cannot be reached with lilt. it has some advantages over lilt, i.e., having higher power, greater tissue penetration capacity to deep tissues, the short emission time, and long rest periods preventing heat accumulation. in recent studies, effectiveness of hilt has been shown in the treatment of subacromial impingement syndrome, rotator cuff tendinopathy, and frozen shoulder.


Eligibility criteria:
inclusion criteria: * disorder more than 6 months * unilateral * first time exclusion criteria: * iinflammatory rheumatic disease, * cervical radiculopathy, * diabetes mellitus, * thyroid disease, * coronary heart disease, * cardiac pacemaker, * neurological disease, * shoulder surgery, and * shoulder injection in the last 3 months

Keywords: stroke, shoulder dysfunction high intensity laser
diagnostic role of chest ultrasound in children presenting with respiratory distress in pediatric intensive care unit (picu) compared to chest x-ray

Conditions: Pediatric Respiratory Diseases

Summary: the use of pocus in pediatrics is gaining momentum, and whilst pediatric specific data remains limited when compared to adult critical care, there is growing pediatric evidence demonstrating the high sensitivity and specificity of lung pocus in the diagnosis of pneumonia, bronchiolitis, pleural effusion and pneumothorax. the american academy of pediatrics policy statement cautions that "clinicians should be aware that point of care ultrasonography is better used as a rule in and not a rule out diagnostic modality".

in recent years, the use of point-of-care ultrasound (pocus), understood as the bedside ultrasound examination of the patient by the physician in charge, has been increasing in paediatric patients for the investigation of pulmonary, pleural and diaphragmatic disease, following its use in adult patients, in whom the technique has been developing for more than a decade, and whose ultrasound semiotics can be safely extrapolated to the paediatric age group. the unossified costal cartilage and sternum and thinner adipose subcutaneous tissue in children provide ideal acoustic windows. this study aims to compare the use of bedside lung us to portable chest x-ray regarding sensitivity, specificity, safety and accuracy in identifying the etiology of respiratory distress among children admitted to the picu.

Eligibility criteria:
inclusion criteria: * age \>1month \& \<18years old * all cases with clinically respiratory distress admitted in picu assiut university children hospital either connected to mechanical ventilation or not. exclusion criteria: 1. neonate. 2. congenital anomalies of respiratory tract. 3. cardiac diseases either congenital or acquired. 4. traumatic patients.
hyperbaric oxygen therapy for optic neuropathies

Conditions: Optic Neuropathy; Glaucoma

Summary: the purpose of the study is to evaluate the neuroprotective efficacy of hyperbaric oxygen for the treatment in patients with optic neuropathy.


Eligibility criteria:
inclusion criteria: * patients must meet all of the following criteria to join the study (all eligibility criteria must be met at the screening and baseline visits unless otherwise noted): * participant must be at least 18. * participant must has the ability to comply with the requirements of the study and complete the schedule of events (soe). * participant's with clinical evidence of optic neuropathy. * participant must understand and sign the informed consent. if the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety. exclusion criteria: * participant is unable to comply with study procedures or follow-up visits. * participant has evidence of corneal opacification or lack of optical clarity. * participant is currently participating in or has within the last 3 months participated in any other clinical trial of a drug by ocular (if in the study eye) or systemic administration. * participant is pregnant or lactating. * participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments. * children and comatose patients. * participant abusing drugs or alcohol. * prior treatment with hyperbaric oxygen within the last 6 months. * participant with claustrophobia or that cannot decompress properly.
laryngeal and esophageal egf-r expression in patients with reflux laryngitis

Conditions: Gastroesophageal Reflux Disease; Chronic Laryngitis

Summary: * saliva plays an important role in the homeostasis of the digestive tract mucosa. * salivary organic components, such as the epidermal growth factor(egf) have been found in defficient concentrations in patients with gastroesophageal reflux disease (gerd) and reflux related laryngitis (lpr). * the epidermal growth factor receptor (egfr) signaling pathway is one of the most important pathways that regulate growth, survival, proliferation, and differentiation in mammalian cells * eperdermal growth factor receptor (egfr) overexpression has been linked to hyperproliferative diseases. * it is unknown if the inflammatory process in gerd is realated to difficiencies in egfr expression. * the objective of the current study was to try to establish a correlation between the expression of egfr in the laryngeal and esophageal mucosa and the severity of laryngitis in adults with gerd and lpr

objectives: the expression of the epidermal growth factor receptor (egfr) has been studied in a number of neoplastic and chronic diseases, but there are no reports in literature regarding its expression in chronic laryngitis associated to gastroesophageal reflux isease (gerd), also known as laryngopharyngeal reflux (lpr). the current study compared the expression of egfr in the esophageal and laryngeal mucosa of adults with gerd and lpr. study design: prospective based on imunohistochemical analysis of parafine embedded biopsy specimens and clinical data. methods: from august, 2004 to february 2007 a total of 24 adults with confirmed diagnosis of lpr and no other clinical conditions or habits known to cause chronic laryngitis were studied at a university hospital. biopsies of the distal esophagus and the retrocrycoid laryngeal mucosa were obtained during upper digestive endoscopy. data were analyzed statistically comparing samples in each individual and between individuals using the severity of histological signs of inflammation on hematoxacillin and eosinophillin (he) stains to immunohistochemical analysis of the expression of egfr. other independent variables were severity of symptoms and signs, gender and age. fishers´s exact test and multivariance anova tests were used with significance level established at 95%.

Eligibility criteria:
inclusion criteria: * adults with reflux laryngitis diagnosed by clinical symptoms (reflux symptom -index \>13) and videolaryngoscopic signs (reflux finding score \>7) * a positive 24-hour doube probe esophageal ph monitoring test exclusion criteria: * other known causes of chronic laryngitis or inflammatory conditions of the pharynx, larynx and upper digestive tract. * current or past history of head and neck or digestive tract tumors.

Keywords: gastroesophageal reflux disease (gerd) chronic laryngitis epidermal growth factor receptor