Kornimate/medical-research-clean huggingface dataset:
how reflux medications affect the microbiome of infants

Conditions: GERD; Dysbiosis

Summary: the changes in the organisms making up the gut microbiota in infants who are taking anti-acid reflux medications (histamine 2 receptor antagonists) as compared to infants who are not taking these medications is not well-studied or understood. whether these medications change the gut microbiota and microbiome, and what that change may imply for children on these medications, is the focus of this study.

gut microbiota dysbiosis is associated with diseases ranging from localized gastrointestinal disorders to neurologic, respiratory, metabolic, hepatic, and cardiovascular illnesses. the microbial colonization of the infant gut is known to play a key role in immunologic and metabolic pathways impacting on human health. disruptions during the complex process of microbial colonization have been shown to increase disease susceptibility during life. a variety of factors are known to influence the gut microbiota, including mode of delivery of neonate, host genetic factors, hose immune response, diet, xenobiotics and other drugs, infections, and environmental microbial exposures. the diagnosis of gastroesophageal reflux disease in the infant population has increased during the past two decades. acid suppression medications are used commonly in infants for gastroesophageal reflux disease and other acid-related conditions despite little evidence of their efficacy. multiple studies have shown adverse effects in pediatric patients using either proton pump inhibitors or h2 receptor antagonists, the two classes of acid suppression medications that are most frequently used in children. some of these adverse effects may result from alterations in the microbiome caused by these medications. prior studies have demonstrated significant changes in microbial composition of both gastric and intestinal microbiota with proton pump inhibitor use (5), but to the investigators' knowledge, no prior studies have looked at the effect of h2 receptor antagonists on the microbiome in healthy, full term infants.

Eligibility criteria:
inclusion criteria: * full term, at least 2 months of age * no exposure or at least 14 days of exposure to h2-receptor antagonist medication * no exposure to probiotics or antibiotics exclusion criteria: * current or recent (within the past 14 days) gastrointestinal infection (viral, bacterial, or fungal) * gastrointestinal mucosal disease, or have clinically significant constipation * any history of exposure to proton pump inhibitors * unvaccinated infants * infants with weight-for-length either below the 3rd percentile for age or above the 97th percentile for age * infants with rapid weight gain, defined as change in weight-for-length z-score exceeding +0.67 from birth to 4 months of age or birth to 6 months of age

Keywords: infant gerd h2ra medication
the effect of melatonin on cognitive function in patients diagnosed with mild cognitive impairment

Conditions: Mild Cognitive Impairment (MCI)

Summary: recent studies have described the role of melatonin as a sleep regulator and as an anti- oxidative neuroprotective agent in improving sleep quality and delaying cognitive decline in alzheimer's disease (ad). in accordance with this data, our hypothesis is that melatonin will delay the cognitive decline in mild cognitive impairment (mci) patients and reduce the conversion rate from mci to ad.


Eligibility criteria:
inclusion criteria: 1. mci assessment according to the peterson et al. (2001) criteria. 2. age 55-90 years, inclusive. 3. study informant available. 4. mini mental status examination ; mmse 24-30. 5. adequate vision and hearing for neuropsychological testing. 6. normal vitamin b12 level and thyroid function. exclusion criteria: 1. significant cerebral vascular disease (modified hachinski scale \> 4). 2. depression (hamilton depression rating scale \> 12). 3. central nervous system infarct, infection or focal lesions of clinical significance on ct or mri scans. 4. medical diseases or psychiatric disorders that could interfere with study participation. 5. pregnant, lactating or childbearing potential. 6. taking vitamin supplements or other supplements. 7. restrictions on concomitant medication usage, including those with significant cholinergic or anti-cholinergic effects or potential adverse effects on cognition.

Keywords: mild cognitive impairment melatonin antioxidant memory alzheimer
prospective biomechanical analysis of donor-site morbidity following microvascular fibula transplantation

Conditions: Postoperative Complications

Summary: pre- and postoperatively patients who underwent free fibula flap were examined regarding donor-site morbidity of the lower extremities.

27 patients are examined before and after microsurgical fibula flap performed at the department of oral and maxillofacial surgery, university medical center hamburg eppendorf, germany.

Eligibility criteria:
inclusion criteria: * planned continuity interrupting mandible resection * planned mandible reconstruction with free fibula flap * informed consent * procedure performed at university medical center hamburg eppendorf exclusion criteria: * preexisting pathology/disease of the lower limbs or back (angiologic, neurologic, orthopedic) * musculosceletal pain at the time of study enrollment
effectiveness of pulpotomy in carious first permanent molar

Conditions: Molar Incisor Hypomineralization

Summary: pediatric dentists frequently encounter deeply carious young permanent first molars (pfm) with molar incisor hypomineralisation (mih). pulpal status of affected pfm was found to be different from that of unaffected pfms which consequently might influence the pulpal response after vital pulp therapy. the aim of this study is to evaluate the clinical and radiographic effectiveness of partial removal of pulp in deeply carious symptomatic pfm affected with mih over 24 months.

pediatric dentists frequently encounter deeply carious young permanent first molars (pfm) with molar incisor hypomineralisation (mih). pulpal status of affected pfm was found to be different from that of unaffected pfms which consequently might influence the pulpal response after vital pulp therapy. the aim of this study is to evaluate the clinical and radiographic effectiveness of partial removal of pulp in deeply carious symptomatic pfm affected with mih over 24 months. in this prospective randomized controlled clinical trial, a randomized assigned sample of 96 children each with a deeply carious young pfm, group i (n=48) diagnosed with mih and irreversible pulpitis and group ii (n=48) diagnosed with irreversible pulpitis but not affected with mih. group i will be randomly equally allocated into group ii a (n=24): partial pulpotomy (pp) and group i b (n=24): full pulpotomy (fp). group ii will also be randomly equally allocated into group ii a (n=24): pp and group ii b (n=24): fp. if pulpal bleeding cannot be controlled within 6 minutes using cotton pellets soaked in 3% sodium hypochlorite, the allocated procedure will be abandoned. the pulpotomy agent to be used will be mineral trioxide aggregate (mta) and teeth will be restored using a resin modified glass ionomer restoration (rmgic). teeth will be followed up clinically and radiographically using periapical x-rays for 24 months. cone beam computed tomographic scans will be taken initially and at 24 months. pain levels will be scored preoperatively before local anesthetic administration and postoperatively every 24 hours for 7 days using visual analogue scale. all data will be statistically analyzed and discussed considering the results obtained.

Eligibility criteria:
inclusion criteria: * 7-13-year-old children. * at least one deeply decayed first permanent molar, checked through periapical x-ray) * noncontributory medical history. * the tooth should be showing irreversible pulpitis signs and symptoms. * the tooth is restorable and probing pocket depth and mobility within normal limits. * no signs of pulpal necrosis including sinus tract or swelling. exclusion criteria: * non-restorable teeth. * negative response to cold testing. * presence of sinus tract or swelling. * no pulp exposure after caries excavation. * bleeding could not be controlled after partial pulpotomy in 6 minutes. * insufficient bleeding after pulp exposure; the pulp is judged necrotic or partially necrotic. * history of analgesic intake 3 days prior to the day of commencement of procedure.
gag-layer in the urothelium of the human upper urinary tract

Conditions: Bladder Cancer; Renal Cancer

Summary: urothelial carcinomas of the lower and upper urinary tract can be considered "twin diseases". much of the current clinical decision-making surrounding upper tract urothelial carcinoma (utuc) is extrapolated from evidence that is based on urothelial carcinoma of bladder patients. the inner wall of the bladder is coated with a substance called glycosaminoglycan (gag). gag is known to form a gel-like layer on the apical cell membrane and act as a barrier against urine and pathogens in the lower urinary tract. currently no published research on the presence of a gag layer in the upper urinary tract exists. however, literature suggests that the ureteral utothelium can be transduced without enhancers, and the ureteral urothelium may be intrinsically different from bladder, both by the presence or absence of a gag-layer, by different composition/thickness of the gag-layer. any functional differences between the urothelial layers in the bladder and in the upper urinary tract may affect the adeno-virus transduction, which again will have potential impact on future treatment of utuc patients with a current unmet medical need.

this study will include patients either undergoing radical nephrectomy or radical cystectomy. after organ removal during surgery a biopsi (1x1 cm) will be collected from the ureter and the renal pelvis or from the ureter and the bladder (depending on type of surgery). these biopsies will be examined and compared, using molecular biotechniques, for the presence of glykosamino glykan (gag) layer. there is no project related follow up for patients included, other than what is standard post-operative regime in the department.

Eligibility criteria:
inclusion criteria: * bladder cancer or renal cell carcinoma * ability to understand and sign informed consent form exclusion criteria: * previous history of cancer * immune suppressing medication * treatment with local or systemic steroids (\< 3 months prior to enrollment) * treatment with antibiotics due to urinary tract infection or pyelonephritis (\< 3 months prior to enrollment) * previous radiation therapy of the pelvic floor * ureteric stent * dilatation of the upper urinary tract detected on imaging * dilatation of the upper urinary tract detected on imaging

Keywords: glykosaminoglycan layer
brief intervention for drug misuse in the emergency department

Conditions: Substance Abuse Detection; HIV; Hepatitis B; Hepatitis C; Brief Intervention; HIV Infections

Summary: although screening, brief intervention, and referral to treatment (sbirt) approaches are effective in reducing alcohol misuse and its associated risk-taking behaviors and negative consequences, there is little research demonstrating the effectiveness of sbirt for illicit and/or prescription drug misuse. misusers of illicit and/or prescription drugs frequently seek medical care in emergency departments (eds), particularly for reasons related to their misuse. as a result, the ed is well suited as a site to conduct an analysis of the effectiveness of sbirt for this population. the brief intervention for drug misuse for the emergency department (bidmed) study is a randomized, controlled, trial that will include adult ed patients at a large, academic, trauma center (rhode island hospital) and a community hospital (the miriam hospital) who have a subcritical illness or injury and whose screening indicates illicit and/or prescription drug misuse. bidmed participants will be randomized to receive screening only (so) or brief intervention (bi) with appropriate referral to treatment. participants will complete a battery of blinded baseline assessments using standardized instruments as well as adapted instruments specific to the aims of this study. all participants will undergo blinded follow-up assessments at three, six, and twelve months post-randomization. the primary hypotheses addressed in the bidmed study are that, compared to participants in the so arm, participants in the bi arm will show a significantly greater reduction in: (1) drug misuse within the prior 30 days at three months post-randomization, (2) behaviors associated with drug misuse at six months post-randomization; and (3) negative physical health, psychosocial health, and socioeconomic consequences at twelve months post-randomization. as a secondary aim, the impact of bi compared to so will be assessed on participants contacting, enrolling in, and completing a drug treatment program. in addition, the impact of bi compared to so on increasing uptake of hiv and hepatitis b/c screening will be measured. a mechanisms of change model that addresses the expected mediators and moderators of change to explain the effects of sbirt in this setting will also be developed and tested. further, the epidemiology of illicit and/or prescription drug misuse will be assessed in a random sample of ed patients.


Eligibility criteria:
inclusion criteria: * self-report of illicit and/or prescription drug misuse in the past three-months. presenting at the emergency department for medical care. exclusion criteria: not age appropriate, in custody, medically unstable, actively psychotic, suicidal -
flexible intubation scope with or without video laryngoscope in supporting endotracheal tube placement in patients with head and neck cancer before surgery

Conditions: Head and Neck Neoplasm

Summary: this trial studies how well flexible intubation scope with or without video laryngoscope works in supporting endotracheal tube placement in patients with head and neck cancer before surgery. flexible intubation scope and video laryngoscope are devices that have a small camera to help the doctor see the patient's airway on a screen. both devices may help the doctor who gives anesthesia prevent complications from placing the breathing tube (such as pain or mouth injury).

primary objectives: i. to compare the rates of difficult endotracheal tube (ett) placement using a flexible intubation scope (fis) versus a combination of flexible intubation and video laryngoscopy in difficult airway management. secondary objectives: i. to compare the ease of using a flexible intubation scope (fis) with and without the use of the video laryngoscope (vl). ii. total time for securing the airway. iii. number of attempts required for intubation. iv. rate of failure at intubation. v. incidence of desaturation. vi. assessment for hoarseness, sore mouth, neck, or jaw, dysphonia, dysphagia, lip injury, tongue injury, or tooth damage. outline: patients are randomized to 1 of 2 arms. arm a: patients undergo flexible scope intubation up to 2 attempts following induction of general anesthesia and adequate manual ventilation. in case of failed 2 attempts, patients undergo a third attempt utilizing another technique or device. arm b: patients undergo flexible scope intubation and video laryngoscopy up to 2 attempts following induction of general anesthesia and adequate manual ventilation. in case of failed 2 attempts, patients undergo a third attempt utilizing another technique or device.

Eligibility criteria:
inclusion criteria: * ages ≥ 18 years of age * all surgical patients with known or suspected difficult airways that meet at least three (3) of the difficult airway criteria \[mallampati iii-iv, neck circumference \> 40 cm, sternomental distance \< 12 cm, thyromental distance \< 6 cm, mouth opening \< 4 cm, bmi ≥ 35 kg/m2, upper lip bite test - ulbt (class iii)\] or history of radiation to the head and neck area or oral pathology obstructing the glottic view * american society of anesthesiology (asa) i-iv * has provided written informed consent exclusion criteria: * active bleeding from nasopharynx or oropharynx * trismus * oral pathology obstructing the glottic view * planned awake or nasal intubation * neuromuscular blockade (nmb) contraindicated post-induction * emergency endotracheal intubation and patients intubated pre and post-surgery * surgical procedures such as tracheostomy, laryngectomy, esophagectomy * patient refusal or inability to consent for study participation * american society of anesthesiology (asa) v * pregnant females
identifying prognostic variables for persistent upper limb dysfunctions after breast cancer treatment

Conditions: Breast Cancer

Summary: breast cancer is the most frequently occurring cancer, assuming that it accounts for 29% of all new cancers in women (european cancer information system). the number of long-term survivors is increasing rapidly due to improving accuracy of the detecting methods, the early diagnosis and advances in cancer treatment. the international consortium for health outcomes measurement initiative described upper limb (ul) function as the health outcome that matters most for breast cancer survivors (bcs). 50% of bcs at 6 months post-radiotherapy suffer from of decreased ul function, i.e. difficulties in performing activities of daily living with the upper limb. patients experiencing ul dysfunctions and other problems are less likely to be physically active. given that physical inactivity is associated with an increased risk of mortality after breast cancer, taking away the barriers to physical activity (e.g. ul dysfunctions) is very important. identifying these factors contributing to chronic ul dysfunction is important in terms of identifying targets for prospective evaluation and specific treatment approaches at specific time points during breast cancer treatment. there is a need to rethink the follow-up strategy (besides the treatment of the cancer itself) and develop a clinical care pathway consisting of multifactorial screening instruments to identify women and men who are in need of extra rehabilitation efforts and specific rehabilitation goals to alleviate symptoms and side effects experienced by breast cancer survivors. this clinical care pathway should cover all aspects of the international classification of function, disease and health (icf), a biopsychosocial framework that conceptualizes a person's level of functioning and bodily structures, activity and participation and contextual factors (including personal and environmental factors). the present study aims to identify the factors, during and after breast cancer treatment, contributing to persistent upper limb (ul) dysfunctions.


Eligibility criteria:
inclusion criteria: * patients scheduled for surgery (mastectomy or breast conserving surgery; in combination with axillary lymph node dissection or sentinel node biopsy) for unilateral primary breast cancer or patients with oligometastatic breast cancer. * patients with a cognitive and language functioning enabling coherent dutch communication between the examiner and the participant * patients who can comply with the protocol at baseline assessment and willing to provide written informed consent exclusion criteria: * bcs with widespread distance metastases, previous breast surgery, or planned bilateral surgery * and/or with a diagnosis of a neurological or rheumatological condition, * and/or bcs who are not available the entire duration of the study

Keywords: upper limb dysfunction
short-term impact of covid-19 lockdown on metabolic control of type 2 diabetes

Conditions: Type 2 Diabetes; Metabolic Control

Summary: the strict rules applied in italy during the recent covid-19 pandemic, with the prohibition to attend any regular outdoor activity, are likely to influence the degree of metabolic control of patients with type 2 diabetes. the aim of this observational, prospective, single centre study was to evaluate the immediate impact of the lockdown rules on the metabolic profile of a cohort of patients with type 2 diabetes.

all the patients with type 2 diabetes who were previously scheduled for a follow-up visit in our outpatient diabetes clinic during the lockdown for covid-19 (march 9, 2020-may 04, 2020) were contacted by phone. patients who accepted to take part of the study received a medical prescription for routine analysis via email. they were asked to perform blood drawing one week after the end of the lockdown period and transmitted us the results. we then compared the metabolic profile tested one week after the end of the lockdown with the last value and the mean of the last three determinations performed before the pandemic emergency.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * at least two previous clinical records in the last two years exclusion criteria: * age \>85 years * first access to the outpatient clinic * type 1 diabetes

Keywords: t2d sars-cov-2 covid-19 lockdown metabolic control sedentary
classroom study to assess efficacy and safety of mts in pediatric patients aged 6-12 with adhd

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: evaluate the behavioral effects of mts in children aged 6-12 with adhd

evaluate the behavioral effects measured by the skamp deportment scale of mts compared to placebo in children aged 6-12 with adhd

Eligibility criteria:
inclusion criteria: * primary diagnosis adhd * total score of greater than or equal to 26 on adhd-rs-iv * iq of greater than or equal to 80 * blood pressure measurements within 95th percentile for age, gender, height at screening and baseline exclusion criteria: * current controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except odd) * known nonresponder to psychostimulant treatment * bmi for age greater than 90th percentile * history of seizures during last 2 years * conduct disorder
non-proliferative diabetic retinopathy treated with runcaciguat

Conditions: Diabetic Retinopathy

Summary: this phase 2 study is conducted to investigate the safety and efficacy of runcaciguat in the treatment of diabetic retinopathy. to assess efficacy, the retinal morphology will be investigated by 7-field color fundus photography for central assessment of the diabetic retinopathy severity score, or drss. two-step drss improvement at 24 weeks of treatment will be the primary efficacy endpoint. drss assessments are repeated after completion of 48 weeks of treatment. in addition, vision threatening complications will be recorded throughout the study and assessed as secondary efficacy endpoint.


Eligibility criteria:
main inclusion criteria: * moderately severe to severe npdr in the study eye: diabetic retinopathy severity scale (drss) levels 47 or 53 * diabetes type 1 or 2 * best corrected visual acuity (bcva) early treatment diabetic retinopathy study (etdrs) letter score in the study eye of ≥69 letters (approximate snellen equivalent of 20/40 or better) main exclusion criteria: * presence or history of macular edema involving the center of the macula * any kind of neovascular growth in the study eye, including anterior segment neovascularization * arterial hypotension with systolic blood pressure \< 100 or diastolic blood pressure \< 60mmhg * alanine aminotransferase (alt) or aspartate aminotransferase (ast) above 3 x upper limit of normal (uln) or bilirubin ≥ 1.5 uln at screening, known ascites * estimated glomerular filtration rate (egfr ckd-epi) below 30 ml/min/1.73 m\^2 at screening * any prior systemic anti-vascular endothelial growth factor (vegf) treatment or ivt anti-vegf treatment in the study eye * any prior intraocular steroid injection in the study eye * any prior grid or focal laser photocoagulation within 500 microns of the foveal center or any prior pan-retinal photocoagulation (prp) in the study eye * use of nitrates or nitric oxide (no) donors (such as amyl nitrate) in any form including topical; phosphodiesterase 5 (pde5) inhibitors, nonspecific pde inhibitors within 1 week or less than 5 half-lives (whichever is longer) before first study drug administration

Keywords: non-proliferative diabetic retinopathy