Kornimate/medical-research-clean huggingface dataset:
migraine and recurrent abdominal pain in children

Conditions: Migraine; Abdominal Pain

Summary: this study will evaluate a new model for assessing and treating migraine and recurrent abdominal pain in children. the model combines behavioral techniques such as relaxation training with biologic components such as thermal biofeedback.

recurrent pain syndromes (rps) are relatively common in pediatric populations. two of the most common types of rps are recurrent abdominal pain (rap) and migraine. similar patterns of pain are described in children with rap and migraine, and similar factors (particularly stress) may initiate both types of rps. this study will assess a new biobehavioral model for evaluating and treating children with rps. this model relates precipitating, intervening, and functional status factors in chronic and recurring pain in children. the model proposes that stress is a precipitant of pain. this study will evaluate the model in children who receive therapy for rps that is based on stress management strategies. the therapy includes relaxation training, cognitive coping skills training, thermal biofeedback, and parent education. it will be compared to a control treatment program of hand-cooling biofeedback and supportive therapy. consenting participants will be randomized to receive either biobehavioral therapy or control therapy. participants will have 6 study visits over the course of 2 months. the first study visit is an evaluation visit; the remaining five study visits are treatment visits. participants will be followed for 24 months and will be asked to complete mail-in forms at months 3, 6, 12, and 24. participants will be recruited through local pediatricians, pediatric neurologists, and pediatric gastroenterologists. brochures about the study will be sent to these physicians to pass on to their patients informing them about the study. children in the control group will be recruited through children's hospital outpatient clinics.

Eligibility criteria:
inclusion criteria * migraine or functional abdominal pain of at least 3 months duration, occurring at least weekly or 5 days per month * child assent * parental consent exclusion criteria * medical illnesses that cause similar pain symptoms (e.g., inflammatory bowel disease, brain cancer) * psychiatric diagnosis that would interfere with participation in the study (any axis i diagnosis of moderate severity)

Keywords: migraine functional abdominal pain biofeedback psychological assessment
use of a tummy time intervention and parent education in infants born preterm

Conditions: Premature Birth

Summary: the purpose of this research study is to see if tummy time and parent education helps motor development among infants born preterm. participants will be recruited from ann and robert h. lurie children's hospital of chicago neonatal intensive care unit.

the purpose of this randomized control trial will be to investigate the effects of a tummy time intervention, as compared to standard care, on motor outcomes among premature infants over a four-week period. additionally, the study will measure tummy time adherence rates between groups post intervention for an additional four weeks. to meet this purpose, the following objectives will be addressed: 1. to determine if there will be a difference in motor outcome scores on the test of infant motor performance (timp) among infants born preterm and utilizing a tummy time intervention and parent education compared to those in the standard care group receiving parent education only. 2. to determine if there will be a difference in adherence rates (average minutes/day) between groups among infants born preterm utilizing a tummy time intervention and parent education compared to those in the standard care group receiving parent education only.

Eligibility criteria:
inclusion criteria: to be eligible to participate in the study, participants must meet the following inclusion criteria: * born premature (\< 37 weeks' gestation), * require medical care within lurie children's nicu, be between 35 and 44 weeks postmenstrual age. * primary parent must have a working mobile device. * participants must be english or spanish speaking as primary language. exclusion criteria: * primary parent does not having a working mobile device and * speaking a language other than english or spanish. * unable to be placed in the prone position, * physiologically unstable for handling * orally intubated or have a tracheostomy
transapical beating-heart septal myectomy in patient with hypertrophic obstructive cardiomyopathy: a multi-center study

Conditions: Hypertrophic Obstructive Cardiomyopathy

Summary: the primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart septal myectomy for the treatment of hypertrophic obstructive cardiomyopathy. this is a prospective, single-arm, multi-center study.

surgical septal myectomy remains the gold standard for the treatment of hypertrophic obstructive cardiomyopathy. however, conventional septal myectomy is hindered by the demanding expertise that is needed to sufficient relieve the obstruction of the left ventricle outflow tract while guarantee safety. to increase the visualization and minimize the surgical injury of conventional septal myectomy, the investigators have invented a novel beating-heart myectomy device. through a mini-thoractomy, septal myectomy could be accomplished via a transapical access in the beating heart using the beating-heart myectomy device. the whole process of resection is monitored, navigated, and evaluated by real-time transesophageal and transthoracic echocardiography. left ventricle outflow tract gradient and the grade of mitral regurgitation are evaluated each time after resection. multiple resections are performed to tailor sufficient relief of left ventricle outflow tract obstruction and mitral regurgitation, while preventing iatrogenic injuries. after transapical beating-heart septal myectomy, participants is scheduled to be seen for follow-up visits at discharge (about 7 days post operation) and 3 months.

Eligibility criteria:
inclusion criteria: 1. patients whose resting or provoked left ventricular outflow tract gradient \> 50 mmhg, and maximal ventricular septal wall thickness ≥ 15 mm. 2. patients with heart function of new york heart association ≥ class ii. 3. patients with drug-refractory symptoms or intolerable to pharmaceutical therapies. 4. patients who was informed the nature of the clinical trial, consented to participate in all of the activities of the clinical trial, and signed the informed consent form exclusion criteria: 1. patients who were pregnant. 2. patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-heart surgery. 3. patients who had severe heart failure with left ventricle ejection fraction \< 40%. 4. patients whose estimated life expectancy \< 12 m. 5. patient who were non-compliant. 6. patients under circumstances which were considered not suitable or prohibitive for participating the clinical trial at the discretion of the attending medical team and the researchers.

Keywords: hypertrophic obstructive cardiomyopathy septal myectomy systolic anterior motion left ventricle outflow tract obstruction mitral regurgitation transapical off-pump minimally invasive
a study to determine the effect of multiple doses of bms-955176 on the electrocardiograph of healthy subjects

Conditions: Infection, Human Immunodeficiency Virus

Summary: the purpose of the study is to determine the effect of multiple doses of bms-955176 on the qt interval corrected with fridericia's method (qtcf) in healthy subjects.


Eligibility criteria:
inclusion criteria: 1. written informed consent 2. healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, 12-lead ecg measurements, physical measurements, and clinical laboratory test results 3. body mass index (bmi) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening and day 1. bmi = weight (kg)/\[height(m)\]2 4. women must have a negative serum pregnancy test, must not be breastfeeding, and women of child bearing potential (wocbp) must agree to follow instructions for method(s) of contraception for the duration of treatment with bms-955176 in addition to a post-treatment completion period 5. males who are sexually active with wocbp must agree to follow instructions for method(s) of contraception for the duration of treatment with bms-955176 in addition to a post-treatment completion period exclusion criteria: 1. any significant acute or chronic medical illness 2. any gi disease or surgery that can affect absorption of the study drug 3. a personal history of clinically relevant cardiac disease, long qt syndrome, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure) 4. evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecg or clinical laboratory determinations beyond what is consistent with the target population 5. history of allergy to moxifloxacin, hiv maturation inhibitors, or related compounds
a study to evaluate efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 3 through 5 years who have a specified cftr gating mutation

Conditions: Cystic Fibrosis

Summary: to evaluate the efficacy of ivacaftor treatment, as measured by lung clearance index (lci), in subjects with cystic fibrosis (cf) who have a specified cf transmembrane conductance regulator (cftr) gating mutation


Eligibility criteria:
inclusion criteria: * male or female with confirmed diagnosis of cf. * must have 1 of the following cftr gating mutations on at least 1 allele: g551d, g178r, s549n, s549r, g551s, g1244e, s1251n, s1255p, or g1349d. * hematology, serum chemistry, and coagulation at screening with no clinically significant abnormalities or concomitant diagnosis that would interfere with the lci and ct scan study assessments, as judged by the investigator. exclusion criteria: * an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before day 1 * any clinically significant laboratory abnormalities at the screening visit that would interfere with the study assessments or pose an undue risk for the subject (in the opinion of the investigator) * abnormal liver function, at screening, defined as ≥3 × upper limit of normal (uln), of any 3 or more of the following: serum aspartate transaminase (ast), serum alanine transaminase (alt), gamma-glutamyl transpeptidase (ggt), serum alkaline phosphatase (alp), and total bilirubin * history of solid organ or hematological transplantation * any clinically significant "non-cf-related" illness within 2 weeks before day 1 * use of any moderate or strong inducers or inhibitors of cytochrome p450 (cyp) 3a within 2 weeks before day 1 * participation in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 terminal half-lives (whichever is longer or as determined by the local requirements) before screening
study to evaluate safety, tolerability and pharmacokinetics of idb-011

Conditions: Rift Valley Fever

Summary: phase 1 randomized, double-blind, placebo-controlled trial to evaluate safety, tolerability, pharmacokinetics (pk) and immunogenicity of idb-011 following intramuscular (im )administration of single ascending doses to healthy adult participants.

this is a randomized, double blind, placebo-controlled, dose escalation, first-in-human, phase i clinical trial to assess the safety, tolerability, pk and immunogenicity of idb-011 in healthy volunteers aged 18-64. idb-011 is comprised of idb-774 and idb-898, which will be administered as separate, consecutive intramuscular injections. volunteers will be recruited into sequential dosing cohorts. within each cohort, eligible volunteers will be randomly allocated (6:2) to receive either idb-011 or placebo (0.9% normal saline). a sentinel dosing scheme will be employed for the first 2 volunteers in each dosing cohort. volunteers will stay in a clinical research unit for up to 4 consecutive days and be followed for up to 1 year.

Eligibility criteria:
inclusion criteria: * healthy male or female * body mass index (bmi) within 18.0 kg/m2 to 30.0 kg/m\^2, inclusively * female participants must not be pregnant, breastfeeding or intend to become pregnant through 1 year post-administration * male subjects must agree to not cause pregnancy or donate sperm for 1 year post-administration * non-smoker * agree to abstain from alcohol for 72 hours and caffeine for 48 hours prior to administration and during the confinement period * agree to not donate blood or plasma during study participation * agree not to travel to rift valley fever virus (rvfv) endemic areas during participation exclusion criteria: * known history of rvfv infection * previous receipt of rvfv vaccine * illness with fever within 5 days prior to administration * history of malignancy within prior 5 years * history of significant cardiovascular, pulmonary, gastrointestinal, liver, kidney, hematologic, neurological, psychiatric, endocrine, immunologic, dermatologic disease * history of hypersensitivity reaction * history or clinical evidence of alcohol abuse * human immunodeficiency virus (hiv) positive * hepatitis c virus positive * hepatitis b virus positive * received immunoglobulin or antibody product within 6 months of administration * vaccine within 28 days of administration * received investigational agent within 3 months or \< 5 half-lives (whichever is longer) prior to administration * donation of plasma, 1 unit or \> 500 ml blood donation in 56 days prior to administration

Keywords: healthy volunteer rift valley fever virus
transepithelial corneal collagen cross-linking (cxl) in treatment of keratoconus

Conditions: Keratoconus

Summary: transepithelial cxl (performed without epithelial removal) seem to have similar clinical effect on keratoconic eyes compared to the standard cxl (which includes epithelial removal). the current study attempts to prove that hypothesis. a prospective, controlled, randomized, contralateral trial, will involve one eye of the patient to be treated with transepithelial cxl, while the control eye will be treated with the standard cxl. totally 20 patients (age \>18 and \<40 years) referred by an ophthalmologist to the eye department of the university hospital north norway for cxl treatment of bilateral progressive keratoconus, will be recruited.

cxl appears to hinder the development of keratoconus by strengthening the cross-bindings in the corneal stroma with a resultant increase in corneal biomechanical strength of up to 300%. the method was introduced in the mid-nineties and has been approved for use in the eu countries since 2007. standard treatment protocol, involving the removal of the corneal epithelium before the riboflavin application, has been used. in order to avoid potential complications following removal of the epithelium (infection, delayed healing, scar formation, as well as discomfort and pain), a modified procedure where the epithelium is kept intact, so called transepithelial cxl, has been suggested. according to the preliminary results of the published retrospective studies, no significant difference in the clinical effect between the standard cxl with epithelial removal and the transepithelial cxl was found.

Eligibility criteria:
inclusion criteria: * documented keratoconus progression in both eyes during the last 12 months before the treatment - decrease in best spectacle-corrected visual acuity (bscva) and/or increase in cornea curvature or asymmetry * corneal thickness ≥400μm at the thinnest point * age range from 18 to 40 * amsler-krumeich classification graded stage i to iii exclusion criteria: * corneal thickness \<400μm at the thinnest point * history of viral keratitis * severe dry eye * concurrent corneal infections * previous ocular surgery * hard contact lens wear for ≤4 weeks before baseline examination
collecting stem cells in patients with waldenstrom's macroglobulinemia

Conditions: Lymphoma

Summary: rationale: collecting and storing stem cells to study in the laboratory may help doctors learn more about collecting stem cells from patients who have undergone treatment for waldenstrom's macroglobulinemia. purpose: this laboratory study is collecting stem cells from patients with waldenstrom's macroglobulinemia.

objectives: * harvest and store adequate cd34+ stem cells from patients with waldenstrom's macroglobulinemia (wm) for potential future use in transplantation strategies. * evaluate the ability to harvest stem cells after therapy for wm (e.g., fludarabine-based chemotherapy) by evaluating the number of days to adequate harvest. * collect aliquots of stem cells for future research analysis as part of a wm database project. outline: patients undergo collection of autologous stem cells beginning on day 4 or 5 and continuing until an adequate number of stem cells are collected. cells are then cryopreserved. projected accrual: a total of 40 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of waldenstrom's macroglobulinemia (wm) * less than 30% lymphoplasmacytoid cells in bone marrow by histopathology * received prior chemotherapy for wm patient characteristics: * ecog performance status 0-1 * wbc \> 2,000/mm³ * platelet count \> 50,000/mm³ * lvef ≥ 50% * no organ dysfunction that would preclude future transplantation prior concurrent therapy: * see disease characteristics

Keywords: waldenström macroglobulinemia
clinical performance of a transcutaneous bone conduction hearing solution (baha® attract system)

Conditions: Deafness; Hearing Loss; Hearing Loss, Conductive

Summary: the rationale behind this clinical performance investigation is to collect data regarding the usability of the baha attract system in patients with hearing impairment that are candidates for baha surgery: * to describe the expected hearing performance with the baha attract in comparison to unaided hearing thresholds or a pre-test situation using a sound processor together with a softband * which sound processor to select, i.e. bp100 vs bp110 * improve the fitting process for the sound processor * selection of sound processor magnet at time of fitting and over time


Eligibility criteria:
inclusion criteria: * conductive hearing loss in the implanted ear. bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 hz \<30 decibel (db) hearing level (hl) * single-sided sensorineural deafness (ssd). bone conduction thresholds with a pure tone average of 500, 1000, 2000 and 3000 hz \<30 db hearing level (hl) in the best ear * signed informed consent exclusion criteria: * uncontrolled diabetes as judged by the investigator * condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids * unable to follow investigational procedures, e.g. to complete quality of life scales * less than 4mm of soft tissue pre-operatively * participation in another investigation with pharmaceuticals and/or device * condition that may have an impact on the outcome of the investigation as judged by the investigator * subjects that have received radiation therapy at the same side of the skull where the baha attract will be positioned * suitable implant position for the baha bi300 implant system (4 mm and 3 mm) not found during surgery due to insufficient bone quality and/or bone thickness
a study of ly3295668 erbumine in participants with relapsed/refractory neuroblastoma

Conditions: Neuroblastoma

Summary: the reason for this study is to see if the study drug ly3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma.


Eligibility criteria:
inclusion criteria: * participants must have relapsed/refractory neuroblastoma and have active disease in at least one site: bone, bone marrow or soft tissue. participants must be able to submit an archival sample of tissue. * participants must be able to swallow capsules. exclusion criteria: * participants must not have had an allogeneic hematopoietic stem cell, bone marrow, or solid organ transplant. * participants must not have untreated tumor that has spread to the brain or spinal cord. * participants must not have a serious active disease other than neuroblastoma. * participants must not have a condition affecting absorption. * participants must not have had prior aurora kinase inhibitor exposure. * participants must not have a known allergy to the study treatment. * participants must not have symptomatic human immunodeficiency virus (hiv) infection or symptomatic activated/reactivated hepatitis a, b, or c.

Keywords: aurora kinase a kinase aurora a aurora kinase inhibitor aurora kinase a inhibitor kinase inhibitor aurka aura pediatric neuroblastoma children
tumour registry lung cancer (tlk)

Conditions: Lung Cancer

Summary: overview of treatment reality in patients with bronchial carcinoma requiring systemic treatment and being treated by office-based oncologists in germany.

the tlk is a prospective, longitudinal, nation wide cohort study that collects data on the treatment reality of patients with nsclc and sclc. at inclusion, data in patient characteristics, comorbidities, tumor characteristics, biomarker testing and previous treatments are collected. during the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. patients are followed until death or for a maximum of 3 years.

Eligibility criteria:
inclusion criteria: * histologically confirmed small cell lung cancer (sclc), non small lung cancer (nsclc) or neuroendocrine tumors receiving therapy * written informed consent * start of neoadjuvant, adjuvant or first-line therapy no longer than 4 weeks before informed consent exclusion criteria: * patients not receiving any systemic therapy

Keywords: bronchial carcinoma registry real life treatment cohort study nsclc sclc germany
effects of music therapy during endoscopy on pain, anxiety and vital signs

Conditions: Music Therapy

Summary: this study was conducted to evaluate the effect of music therapy on the vital signs, anxiety and pain of the patients during endoscopy procedure

the aim of this study was to the effects of music during the endoscopy procedure on anxiety, pain and vital signs.this study was conducted as a randomized, controlled, double-blind trial. the study population consisted of patients in the endoscopy unit of a university hospital between june and december 2023. the patients were randomly divided into the experimental group, who listened to music during endoscopy, and the control group, which did not receive any intervention other than routine nursing care. this study, data were collected via a patient information form, the state-trait anxiety inventory (stai-state), the visual analogue scale (vas), and a vital signs monitoring form.

Eligibility criteria:
inclusion criteria: * patients who have endoscopy procedure * being older than 18 years old * not having hearing problems * asa status between 1-3 exclusion criteria: * cognitive or psycological disorders * regular usage of analgesic/anxiolytic/sedaditive drugs * haemodynamic instability

Keywords: music endoscopy nursing pain vital signs