Kornimate/medical-research-clean huggingface dataset:
a randomized, double-blind, placebo controlled, crossover trial to evaluate safety and efficacy of agy in celiac disease

Conditions: Celiac Disease

Summary: to assess the efficacy and safety of agy vs placebo when administered to individuals age 10 to 65 years with medically proven cd and on a gluten free diet

we propose to conduct a randomized double-blind, placebo-controlled crossover trial in 149 individuals with celiac disease proven by biopsy (or other medically documented confirmation of cd, e.g. ttg counts \> 10 times the upper limit of normal on two occasions) at least 12 months before study entry, and who are following a gluten-free diet but continue to have recurrent symptoms. agy is designed to neutralize the hidden gliadin in food, thus preventing gliadin absorption and gliadin induced pathogenesis. the study will test whether agy is safe and effective in the study population, versus placebo. primary objective: the primary objective will be to evaluate the effect of agy on celiac symptoms using the daily celiac symptom index (csi). secondary objectives: secondary objectives will be to evaluate product safety and the effect of agy on quality of life, autoantibodies, and gut permeability.

Eligibility criteria:
inclusion criteria: * history of cd * experience periodic celiac related symptoms * following a gluten free diet for at least 12 months exclusion criteria: * severe complications of cd or chronic active gi disease * type 1 diabetic * pregnant or breast feeding * daily asa/nsaid use * any condition that in the opinion of the investigator, would preclude safe participation
the neonatal hemorrhagic risk assessment in thrombocytopenia study

Conditions: Thrombocytopenia

Summary: this is a prospective longitudinal study that evaluates platelet function analyzer-100 (pfa-100) ct-adps (closure time-adp) and incidence of bleeding using the neonatal bleeding assessment tool - neo-bat in preterm neonates \<32 weeks gestational age or with a birth weight \<1500 grams and with different degrees of thrombocytopenia. the investigators hypothesized that pfa-100 ct-adp, a global in vitro test of primary hemostasis, will be a better predictor of clinical bleeding in neonates than platelet count alone. a bleeding risk assessment marker could help physicians more accurately determine the risk/benefit ratio of platelet transfusions, guiding platelet transfusion decisions in neonates with thrombocytopenia.


Eligibility criteria:
inclusion criteria: * \<32 weeks gestation or with a birth weight \<1500 grams; * have confirmed moderate-to-severe thrombocytopenia, defined as a platelet count \<100x109/l; * have a parent/guardian willing to comply with the protocol and provide written informed consent. exclusion criteria: * are not expected to survive by the attending neonatologist; * are thought to have a congenital thrombocytopenia or platelet dysfunction, based on family history or clinical presentation (e.g. associated congenital malformations, platelet morphology); * have a major chromosomal anomaly such as trisomy 13, 18, or 21.

Keywords: thrombocytopenia neonate pfa-100 neo-bat hemorrhage
the effects of white noise for adult patients' sleep quality in intensive care unit.

Conditions: Sleep

Summary: poor sleep quality is one of the most common problems among adult patients in the intensive care unit (icu). the causes of sleep disturbance are complicated. poor sleep quality can lead to negative consequences for patients' physical and mental health. non-pharmacological interventions, such as white noise, have been recommended to increase the threshold level of sound during nighttime and achieve masking effects to improve subjective sleep quality. this study is a randomized controlled trial that compared two parallel patient groups.the hypothesis of this study is that white noise can improve sleep quality in adult icu patients compared with conventional treatment group.

poor sleep quality is one of the most common problems among adult patients in the intensive care unit (icu). statistics indicate that over 50% of icu patients report sleep abnormalities, such as sleep fragmentation, arousals, frequent awakenings, and poor sleep quality. the causes of sleep disturbance are complicated, with evidence suggesting that environmental factors such as noise, from alarms and machines that are active around the clock in the icu, play a significant role. poor sleep quality can lead to negative consequences for patients' physical and mental health. sleep promotion interventions, including both pharmacological and non-pharmacological approaches, have been proposed. however, the side effects of pharmacological intervention may also lead to poor outcomes. therefore, non-pharmacological interventions, such as background noise, have been recommended to increase the threshold level of sound during nighttime and achieve masking effects to improve subjective sleep quality. this study was conducted in randomized controlled trial that compared two parallel patient groups. patients were included by convenience sampling in a medical center in taiwan. the verran and snyder-halpern sleep scale (vshss) was used to assess subjective sleep quality. the main purpose of this study was to investigate the effect of white noise intervention in sleep quality in adult intensive care unit patients.

Eligibility criteria:
inclusion criteria: * age must be greater than or equal to 20 years old. * admitted to the icu and have been intubated for at least 24 hours. * aware of people, time, and place, and without hearing impairment. * be able to communicate in writing. * the glasgow coma scale score must be equal to or greater than 11, with a vocal response of 1 in the patient post-endotracheal tube placement. exclusion criteria: * history of insomnia, alzheimer's disease, or depression. * routine use of sedative-hypnotic drugs (opioids, benzodiazepines, non-benzodiazepines, antihistamines, and melatonin) before admission. * post-operation in the operating room before icu admission. * icdsc score of at least 4 or cam-icu positive.

Keywords: sleep quality sleep disturbance intensive care unit critically ill patient
the impact of professional coaching on early career academic emergency physicians

Conditions: Development, Human; Well-Being; Professional Burnout; Goals; Leadership; Professional Role; Physician's Role; Stress; Anxiety

Summary: this research study is designed to answer the question: how does professional coaching impact early career academic emergency medicine physician goal attainment, leadership strengths, well-being, and burnout?

a recent systematic review and meta-analysis found coaching to have significant positive effects on goal attainment, well-being, coping skills, work attitudes, and goal-directed self-regulation. randomized controlled studies of professional coaching have found significant positive effects in various settings including high school teachers and students, postgraduate students in a major university, and executives in the commercial, government, and education sectors. coaching provides the participant focused time with a trained professional who facilitates that participant's self-determined and self-directed problem-solving and change. coaching helps the participant "get on the balcony" away from the action on the "dance floor" to see things from a different and broader perspective and, in doing so, enriches the participant's ability to generate options, challenge biases, understand the effects of emotions, and consider uncertainty. this study also establishes the level of adult development of academic faculty and creates an initial qualitative dataset for further longitudinal study and theory generation for physician well-being, burnout, leadership strengths, and goal attainment.

Eligibility criteria:
inclusion: * emergency physicians * academic appointment of instructor or assistant professor * work greater than 80% of their time in a residency and fellowship program approved by the accreditation council of graduate medical education (acgme), the american osteopathic association (aoa), or the royal college of physicians and surgeons of canada (rcpsc) will be invited to participate in the study. exclusion: * mayo clinic emergency physicians are not eligible for this study.

Keywords: coaching professional coaching emergency physicians emergency medicine goal attainment leadership strengths well-being burnout adult level of development group coaching instructor assistant professor academic faculty subject-object interview
the effectiveness of mindfulness practices in the recovery of burnout

Conditions: Burnout, Professional; Stress

Summary: the aim of this study is to examine the effectiveness of intervention based on mindfulness and acceptance-commitment therapy (act) in the recovery from job burnout. the 8-week intervention is delivered using jointly face-to-face group meetings and web-based program. the study hypothesizes that the muupu-program is more effective than the normal practices when promoting work well-being in finland. the participants are recruited from finland.

mindfulness-act-based interventions aren't widely used in finnish work health care a the moment. this study examines the possibility of using this kind of intervention for reducing job burnout and stress and also promoting well-being at work. muupu-program is standardized and can be administered in varying settings. if intervention is effective, it can have an impact on finnish practices when treating job burnout and work-related stress.

Eligibility criteria:
inclusion criteria: * currently working * daily internet connection available * belongs to the group of most exhausted workers in finland (bbi cut-off is set on the top 25%) exclusion criteria: * no psychological or somatic conditions or other practical reasons that hinder the possibility to participate to the program * acute medicine changes * regular psychotherapy * not willing to inform employer and/or work health care of participation to the study

Keywords: burnout stress mindfulness acceptance-commitment therapy (act) intervention effectiveness working conditions work engagement psychological well-being life situation
safety and efficacy of car t cell therapy in patients with r/r b-all

Conditions: Relapse/Refractory B-cell Acute Lymphoblastic Leukemia

Summary: the goal of this clinical trial is to evaluate the safety and efficacy of cd19 car-t cells in pediatric patients of all genders, aged 2 to 18 years, with relapsing or refractory b cell acute lymphoblastic leukemia (r/r b-all). the main questions it aims to answer are as following: 1. what is the percentage of patients with overall remission rate (orr) of complete response (cr) or complete remission with incomplete blood count recovery (cri)? 2. what is the rate of event-free survival at first month and 2-3 months after intervention? 3. what is the rate of overall survival at first month and at 3 months after the intervention?

b-cell acute lymphoblastic leukemia (b-all), as the most common type of pediatric tumor, is identified by unregulated cell proliferation of immature lymphoid cells that can infiltrate the bone marrow and blood. also, relapse and refractory b-all (r/r b-all) is the main reason of global mortality due to the constraints of combination chemotherapy. over the past few years, substantial advancements have been made in treatment of all, specifically in the r/r context. chimeric antigen receptor t (car-t) cells are a type of cancer immunotherapy treatment that function through modification of patient t cells to express car antigen on their surface. car-t cells aimed at cd19 have demonstrated promising activity in treatment of r/r b-all. in this study we aim to evaluate safety and efficacy of anti-cd19 car t cell therapy in children with r/r b-all.

Eligibility criteria:
inclusion criteria: * ages 2 to 18 years with relapsed or refractory cd19+ b-all * presence of disease in the bone marrow * able to tolerate the apheresis process * life expectancy \&gt; 12 weeks * lansky or karnofsky score \&gt; 50% * at least 7 days passed since the last chemotherapy and the last treatment with corticosteroids * informed consent * having potential donor for stem cell transplantation exclusion criteria: * presence of active malignancy other than the disease under study * chloroma and leukemic infiltration on mri or significant neurological symptoms * any cns disorder * presence of active gvhd * radiation therapy within last 14 days * history of anti-cd19 or anti-cd20 therapy * donor lymphocyte injection or other cell therapy methods within the last 30 days * presence of severe active infection * organ dysfunction
using feedback reports to improve medication adherence

Conditions: Coronary Artery Disease; Adherence

Summary: the purpose of this research study is to improve statin medication adherence among veterans with coronary artery disease with poor adherence to medications. the investigators are testing if newer technology pill bottle devices linked with individual feedback and/or social incentive strategies can improve medication taking behavior.

patients with coronary artery disease and previous poor adherence to statin medications will be recruited at philadelphia va medical center. enrolled participants will be randomly assigned to one of three arms: 1. control group 2. individual alarm device and feedback report 3. individual plus patient-selected feedback friend report patients will be given a medication-monitoring device (vitality glowcaps) to monitor the statin medication that is being currently prescribed by their primary care physician. in first group, the control arm (arm 1), the device reminders will be turned off but the device will continue recording adherence to the medications. in second group, reminder arm (arm 2), the device will be programmed as an alarm that will be activated if the patient does not take the medication at the time set by the patient. in addition the patient will get a weekly report of his/her adherence. in the third group, patient-selected family/friend/or reciprocal peer feedback arm (arm 3), in addition to the activation of the alarm function the device will be linked to a weekly report on adherence to medications. this report will be delivered to the patient and to the patient identified family/friend/ or reciprocal peer.

Eligibility criteria:
inclusion criteria: * all participants will have a diagnosis of cad * to be eligible they must be between the ages of 30-75 years of age-to ensure we are targeting those most likely to benefit from improving control to these medications * patients must have been prescribed a statin by their provider and a documented poor adherence as measured by a 16-month medication adherence rate (medication possession ratio) of \<80% exclusion criteria: * due to the use of the medication adherence reminder device, patients must speak english * have a home address * telephone number * be willing and able to identify a friend or family member * the investigators will exclude atients with active substance abuse, significant hearing loss, or reduced cognitive ability as determined from the patient's problem list

Keywords: medication adherence reciprocal peer telemonitoring
measurement of lung elastance and transpulmonary pressure using two different methods (lungbarometry)

Conditions: Acute Lung Injury

Summary: classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations i esophagus pressure divided by the tidal volume. this requires the presence of a esophageal balloon catheter which is cumbersome and costly. in this study values obtained as described above are compared to values obtained with a new method in which a stepwise increase in positive endexpiratory pressure (peep) is performed with a size of the lung volume increase which corresponds to the tidal volume which the patient is ventilated with. the measurements are performed in sedated and mechanically ventilated patients in the intensive care unit.

classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations in esophageal pressure divided by the tidal volume (method 1). this requires the presence of a esophageal balloon catheter which is cumbersome and costly. in this study values obtained as described in method 1 above are compared to values obtained with a new method (method 2) in which a peep-step is performed with a size of the lung volume increase which corresponds to the tidal volume which the patient is ventilated with. measurements using method 1 and 2 are performed in sedated and mechanically ventilated patients in the intensive care unit.

Eligibility criteria:
inclusion criteria: mechanically ventilated patients in the intensive care unit exclusion criteria: patients with chronic obstrucive lung disease
13-c urea breath test using breathid system and ppis (proton pump inhibitors)

Conditions: Helicobacter Pylori Infection

Summary: approximately 200 patients with suspected h.pylori will be tested with a 13c-urea breath test (ubt) to ascertain h.pylori positive. 100 h.pylori positive patients will tested before and after prescribed with one of the four selected proton pump inhibitors (ppis); 25 patients in each arm. this will provide information on the influence of ppis on the ubt (urea breath test). the aim of the trial is to observe the effect of different ppis on the breath test and choose the optimal protocol of when to stop ppi. the hypothesis is that there will be a minimal effect on the ubt while using selected ppis.

adult subjects with suspected h pylori infection will be recruited and will undergo a 13c -urea breath test (including citrica) with the breathid test device. those were found positive will undergo selected ppi treatment for 14 days and after 24 or 72 hours from the completion of the two weeks, will undergo a second breath test. those found to be negative (false negative), will undergo additional breath tests. * those subjects that underwent any antibiotic, bismuth or ppi therapy 4 weeks prior to the trial, are to be excluded. * furthermore, pregnant or nursing women and subjects with an allergy or sensitivity to one of the tests substrates, will be excluded from the study.

Eligibility criteria:
inclusion criteria: * adults with h.pylori infection. exclusion criteria: * pregnancy, * nursing, * antibiotic, bismuth or ppi treatment 2 weeks prior to trial, * known sensitivity to urea or citrica.

Keywords: hp ubt ppi
safety and efficacy of insulin aspart vs. regular human insulin in gestational diabetes

Conditions: Diabetes; Gestational Diabetes

Summary: this trial is conducted in the united states of america (usa). the purpose of this study is to test whether novolog (insulin aspart) is a safe and at least as effective alternative to regular human insulin for the control of blood glucose after meals in women who develop diabetes during pregnancy.


Eligibility criteria:
inclusion criteria: * subjects older than 35 years old will be considered * gestational diabetes mellitus
a study of azelaic acid (aza) 15% gel in the treatment of seborrheic dermatitis of the face

Conditions: Seborrheic Dermatitis on the Face

Summary: this study is to determine whether a medication on the market for other indications is effective and safe in treating seborrheic dermatitis of the face.

to test the efficacy and safety of azelaic acid 15% gel in the treatment of seborrheic dermatitis of the face

Eligibility criteria:
inclusion criteria: - stable or exacerbating seborrheic dermatitis in the facial area exclusion criteria: * psoriasis * atopic dermatitis * facial acne and rosacea * dermatophytic skin infections * parkinson's disease * known immunosuppression; hiv infection * any condition requiring continuous systemic or topical corticosteroid or antimycotic therapy * continuous asthma inhalation treatment requiring \> 800 mg corticosteroids * any severe disease likely to interfere with the conduct or the planned termination of the study
renal transplant injury and the renin-angiotensin system in kids (retask)

Conditions: Renal Transplant; Renin-Angiotensin System; Rejection Acute Renal; Rejection Chronic Renal; Rejection of Renal Transplant

Summary: in pediatric kidney transplant patients, rejection, medication toxicity and ischemia cause early and chronic renal allograft injury, which reduces graft lifespan and patient survival. early detection of injury would facilitate prevention and treatment. the gold standard surveillance biopsy has limitations including delayed discovery of injury. no noninvasive test identifies graft injury before it is clinically apparent. this project's goal is to develop a novel early marker of subclinical graft injury to facilitate prompt recognition and treatment.

kidney damage activates the traditional renin-angiotensin (ang) system (ras), characterized by ang-converting enzyme (ace)/ang ii/ang ii type 1 receptor. the ang-converting enzyme 2 (ace2)/ang-(1-7)/mas pathway counteracts this damage. the balance, or ratio, between levels of the ace/ang ii and ace2/ang-(1-7) pathways may be clinically important because ang-(1-7) counteracts ang ii-mediated injury. an increase in ace and ang ii expression and a decrease in ace2 and ang-(1-7) expression on tubular cells may promote renal injury. tubular damage may increase urinary loss of protective ace2 and ang-(1-7), propagating renal damage by allowing ace and ang ii to stimulate inflammation and fibrosis unopposed. the investigators hypothesis is that a shift in the urinary ace-to-ace2 and ang ii-to-ang-(1-7) ratios towards ace2 and ang-(1-7) predicts acute graft injury diagnosed on renal biopsy and predicts chronic graft damage on renal biopsy.

Eligibility criteria:
inclusion criteria: * ages 1 - 20 years * actively listed on the transplant list at lucile packard children's hospital at stanford and received a renal transplant during the study enrollment period exclusion criteria: * transplanted at a center other than lucile packard children's hospital at stanford

Keywords: pediatric renal transplant renal allograft angiotensin ii angiotensin-(1-7) ace ace2
evaluation of microbial colonisation and contamination caused by the transvaginal and transabdominal access for cholecystectomy

Conditions: Cholecystectomy

Summary: transvaginal hybrid procedures are of interest as an available notes procedure for the clinical routine. the gynaecologists' experiences and the available studies report on low morbidity related to the transvaginal access. however, little is known about the vaginal and intraabdominal microbial contamination due to the transvaginal approach. the aim of this cohort study is to evaluate the microbial colonisation and contamination in patients with transvaginal hybrid and conventional laparoscopic cholecystectomy. therefore, pre- and intraoperative microbiological evaluations will be performed in patients with transvaginal hybrid cholecystectomy and laparoscopic cholecystectomy.


Eligibility criteria:
inclusion criteria: * indication for elective cholecystectomy * informed consent for laparoscopic cholecystectomy or transvaginal hybrid cholecystectomy exclusion criteria: * cholecystitis * intraabdominal infection * existing antibiotic therapy * adnexitis * pelvic inflammatory disease * infection (crp \> 10 mg /l; lc \> 11 g/l)

Keywords: transvaginal access for cholecystectomy