Kornimate/medical-research-clean huggingface dataset:
pediatric integrative medicine trial pilot

Conditions: Pain; Nausea; Vomiting; Anxiety

Summary: this study will investigate if adding complementary therapies such as acupuncture, massage and reiki to inpatient pediatric care is feasible and what the effects are on outcomes such as patient symptoms, cost, safety, satisfaction and length of stay.

study objective: to determine if a pediatric integrative medicine (pim) service is effective in reducing overall symptoms of pain, nausea/vomiting, and/or anxiety (pnva), length of stay, and costs, in hospitalized children when compared to conventional care. in this context, "integrative" refers to a combined approach of complementary and conventional medical therapies in an evidence-based fashion. design: cluster trial; 2-arm controlled evaluation study in pediatric oncology, general pediatrics and pediatric cardiology. intervention will be offered during a 6-month pim period following a 6 month control period. population: inclusion criteria: (i) in-patients in participating division and (ii) informed consent/assent. exclusion criteria: (i) lack of parent participation, fluency in english, or informed consent intervention: recommendations for specific cam therapies will be determined by a staff pim pediatrician. any combination of the following cam therapies (dose, duration, amount to be based on patient need as assessed by cam provider, patient, and parent): acupuncture/acupressure, massage, reiki; all are to be offered in addition to usual care. control: usual care. outcomes: primary outcome: feasibility (i.e enrollment); secondary outcomes: (i) pnva symptom management, (ii) need for conventional pharmacotherapy, (iii) adverse events; (iv) parent and health care provider satisfaction with care provided, v) length of stay; and vi) cost-effectiveness (analysis of this outcome to be limited to patients admitted for at least 2 days and for not more than 30 days). significance: to our knowledge, this study will be the first comparative effectiveness trial to assess the impact of pim for hospitalized children with cancer.

Eligibility criteria:
inclusion criteria: * (i) all children, aged 0-16 years, who are admitted to pediatric oncology, general pediatrics and pediatric cardiology at the stollery children's hospital, edmonton, canada who * (ii) can communicate in english; and * (iii) give informed consent/assent exclusion criteria: * (i) cannot communicate in english; * (ii) lack of parent availability to participate; or * iii) lack of informed consent.

Keywords: pain nausea/vomiting anxiety complementary and alternative medicine pediatric oncology cost-effectiveness
a dose-response study with strontium malonate in postmenopausal women

Conditions: Osteoporosis

Summary: the primary objective of the study is to compare dose-response effect of three dose levels of strontium malonate to placebo on bone resorption quantified by s-ctx-1 following 12 weeks of treatment.

275 post menopausal women are treated with either 750 mg strontium malonate, 1000 mg strontium malonate, 2000 mg strontium malonate, 2 g protelos® or placebo. patients are treated for 12 weeks. a follow up period of 4 weeks is planned for the main study and a follow up period of 8 weeks is planned for approximately 20% of the patients to follow post treatment ctx-1 activity. apart from s-cts-1 also response on other bio markers are evaluated as well as bmd.

Eligibility criteria:
inclusion criteria: * postmenopausal women (at least 12 months since last menstruation). * bmd (l2-4) t-score between -1 and -3 (at least 20% of the enrolled patients must have a bmd (l2-4) t-score below -2,5). * 50 years of age. * bmi\<30 kg/m2. * total s-ca level within normal range. * ability to read and understand the information given. * the patient has signed an informed consent form according to ich e6 and local requirements before any study specific procedure is carried out. * ability to comply with study procedures. exclusion criteria: * history of prior fragility fracture (any fracture in wrist, hip or spine appearing after 40 years of age). * history of alcohol or drug abuse. * metabolic bone disease (e.g. pagets disease, bone cancer). * history of vte/dvt. * history of kidney transplant. * bilateral oophorectomy. * relevant and treated reduced kidney or liver function. * any malignancy within the last 5 years (except basal cell carcinoma) * any chronic condition likely to affect absorption (e.g. crohns disease, gluten enteropathy). * known genetic pre-disposition to vte/dvt * known hypersensitivity to any of the active substances or excipients. * 25-oh-vitamin d level below 25 nmol/l * any previous treatment with bisphosphonates, strontium or fluoride. * treatment during the last 3 months affecting calcium balance or bone metabolism (e.g. thiazides, corticosteroids, calcitonin, hrt, serms, pth, phosphorus). * treatment during the last week with tetracycline, ciprofloxacin or loop diuretics. * pth out of normal range * use of any drug known to influence the coagulation process (aspirin and other nsaid allowed) * prothrombin time out of normal range (sec or inr) * inclusion in another clinical study within 30 days before randomization or during this study

Keywords: osteoporosis bmd ctx post menopausal strontium bone turnover clinical development
neurocircuit strategy to decrease cocaine cue reactivity

Conditions: Cocaine-Related Disorders

Summary: the overarching goal of this project is to examine the effect of combining theta burst stimulation (tbs) and n-acetylcysteine (nac) on cocaine craving and brain response to cocaine-related images.


Eligibility criteria:
inclusion criteria: 1. age 18-65 2. english fluency 4. meet criteria for cocaine use disorder (cud), as determined by dsm-v criteria, using the structured clinical interview for dsm-v. 5. enrolled in an intensive outpatient treatment program (musc center for drug and alcohol programs intensive outpatient program (cdap-iop) or currently engaged in treatment for substance related problems. 6. able to read and understand questionnaires and informed consent 7. lives within 50 miles of the study site. 8. is not at elevated risk of seizure (i.e., does not have a history of seizures, is not currently prescribed medications known to lower seizure threshold) 9. does not have metal objects in the head/neck. 10. does not have a history of traumatic brain injury, including a head injury that resulted in hospitalization, loss of consciousness for more than 10 minutes, or having ever been informed that they have an epidural, subdural, or subarachnoid hemorrhage. 11. does not have a history of claustrophobia leading to significant clinical anxiety symptoms. exclusion criteria: 1. past head injury or primary neurological disorder associated with mri abnormalities, including dementia, mci, brain tumors, epilepsy, parkinson's disease, or demyelinating diseases 2. any physical or intellectual disability affecting completion of assessments 3. any contraindication to mri 4. current or past psychosis 5. ect in last 6 months 6. among females, pregnancy at screening will be exclusionary. females of child bearing potential must agree to undergo a pregnancy test 72 hours prior to the fmri scanning session and regularly before and during the medication trial. they must further agree to notify the study physician or pa if they become pregnant during the study. 7. clinical institute withdrawal assessment (ciwa-ar) scale will be used to assess alcohol withdrawal. individuals with ciwa \> 8 will be excluded. 8. individuals with unstable medical illness (e.g., hypertension, diabetes, myocardial infarction) 9. has current suicidal ideation or homicidal ideation. 10. has the need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications and medications for adhd 11. suffers from chronic migraines 12. any physical or intellectual disability affecting completion of assessments
assessment of the oral health status of children with chronic kidney disease

Conditions: Chronic Kidney Diseases; Caries,Dental; Quality of Life; Saliva Altered; Periodontitis

Summary: the aim of this study is to compare the oral health findings, salivary parameters and disease-related quality of life of children with different stages of chronic kidney disease(ckd), those undergoing dialysis and transplantation, with healthy children, and to evaluate certain serum biomarkers in children with ckd.

chronic kidney disease (ckd) is a progressive and irreversible decline in the function of many nephrons and glomerular filtration rate due to kidney diseases. this decline leads to increased serum levels of urea and creatinine. patients with ckd often exhibit various oral manifestations, such as an ammonia-like odor, gingival enlargement due to drug therapy, enamel hypoplasia, dental calculus, dry mouth, uremic stomatitis, and oral mucosal lesions. interestingly, children with ckd tend to have a lower prevalence of dental caries, likely due to the high urea content in their saliva, which has antibacterial properties. ckd is also associated with salivary gland dysfunction and increased oxidative damage. furthermore, ckd patients have reduced bone quality, making them more susceptible to fractures. a study on the quality of life (qol) in children with ckd and their parents reported significantly lower physical and social qol scores in children undergoing hemodialysis compared to healthy controls. this study aims to comparatively evaluate and analyze children diagnosed with different stages of chronic kidney disease (ckd) and healthy children without any systemic conditions, focusing on their age, gender, and oral health habits such as tooth brushing frequency, dental floss usage, and annual dentist visits. disease-related information such as the stage of ckd, dialysis, and transplantation, as well as oral findings, will be examined using dmft/dft, icdas ii, dde, bakh, di, ci, ohi-s, and mgi indices. the study will assess general disease-related quality of life from both the child's and the parent's perspectives using the kindlr scale. additionally, salivary samples collected from children with ckd and healthy children will be analyzed for salivary flow rate, ph, buffering capacity, total oxidant and antioxidant capacities, urea, calcium, potassium, and phosphorus levels. serum urea, calcium, and phosphorus values will also be examined.

Eligibility criteria:
inclusion criteria: * not having any systemic disease. * not being on any regular medication. exclusion criteria: * having any systemic disease. * being on any regular medication.

Keywords: chronic kidney disease oral health salivary quality of life
dose-finding study of qge031 as add-on therapy to evaluate efficacy and safety in patients with csu

Conditions: Chronic Spontaneous Urticaria

Summary: this is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and safety of qge031 monthly subcutaneous injections as add-on therapy in patients with chronic spontaneous urticaria.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic spontaneous urticaria for at least 6 months * diagnosis of chronic spontaneous urticaria refractory to standard of care at time of randomization exclusion criteria: * clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria * evidence of parasitic infection * any other skin disease with chronic itching * previous treatment with omalizumab or qge031 * contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or epinephrine * history of anaphylaxis * history or current diagnosis of ecg abnormalities indicating significant risk of safety for patients participating in the study * history of hypersensitivity to any of the study drugs or its components of similar chemical classes * pregnant or nursing (lactating) women other protocol defined inclusion/exclusion criteria may apply.

Keywords: qge031 ligelizumab omalizumab chronic spontaneous urticaria adults csu
detection of small fiber neuropathies by the non-invasive sudoscan method during chronic autoimmune pathologies and / or unexplained pain syndromes

Conditions: Systemic Autoimmune Pathologies; Unexplained Pain Syndrome

Summary: very few studies have evaluated the prevalence of small fiber neuropathy (sfn) during pathologies that may be responsible for small fibers damage. sudoscan is a new rapid (2 minutes), automated, reproducible and non-invasive technology to assess small fiber neuropathy by sweat function. with quantitative and reproducible results, sudoscan allows physicians to early detect and follow-up peripheral neuropathy to monitor disease progression and assess treatment efficacy for a better patient management. sudoscan® could allow the identification of sfn in painful patients apart from another pathology already diagnosed responsible for sfn. the purpose of the study sudocu is to assess the prevalence of small fiber neuropathies (sfn) in patients with systemic autoimmune pathologies or unexplained pain syndrome.


Eligibility criteria:
inclusion criteria: * patient corresponding to one of the two following groups: 1. systemic autoimmune pathology known to be complicated by small fiber neuropathies. the following autoimmune pathologies will be included: lupus, sjogren, scleroderma, myositis, rheumatoid arthritis, sarcoidosis, vasculitis of small or medium vessels 2. no conditions known to be responsible at sfn, unexplained pain symptoms * aged ≥ 18 years * having given free and informed written consent exclusion criteria: * chronic alcoholism * unbalanced diabetes * chemotherapies * hiv * vitamins b12, b1, b6 deficiencies
a clinical trial of water therapy for autosomal dominant polycystic kidney disease

Conditions: Autosomal Dominant Polycystic Kidney

Summary: patients affected by autosomal dominant polycystic kidney disease (adpkd) need a safe and effective long-term treatment regimen. unfortunately, there are still no disease-specific treatment for adpkd approved in the us. a rational step towards identifying such agents is to test therapies that have a proven safety profile with mechanisms of action that can counter the disease progression. the purpose of this study is to investigate whether drinking increased amounts of water (water loading) might slow down polycystic kidney growth or kidney function decline. water loading can cause the suppression of a pathway that causes fluid buildup and cyst growth. high water intake has been safely used in the clinical setting, such as in the case of kidney stone therapy. new york state tap water is widely available and safe, making it highly cost-effective as well.

the study will involve 11 visits to the study site over 19 months. participants will need to follow specific dietary and fluid recommendations. there will be physical examinations and medical history assessments at each visit. testing will include undergoing magnetic resonance imaging (mri), blood and urine tests. study participants will be compensated for their time. detailed study procedures will be reviewed upon contact with the study team.

Eligibility criteria:
inclusion criteria: * pre-existing diagnosis of autosomal dominant polycystic kidney disease * estimated glomerular filtration rate of 40 ml/min or greater * urine osmolality \> 400 mosm/l exclusion criteria: * estimated glomerular filtration rate less than 40 ml/min * low blood sodium levels * syndrome of inappropriate diuretic hormone * use of thiazide diuretics or selective serotonin reuptake inhibitors (ssris) * use of tolvaptan, another vasopressin receptor antagonist, vasopressin agonists or ddavp * contraindications to magnetic resonance imaging (mri) (pacemakers, defibrillators, implanted electronic devices, metallic foreign body)
assessing perfusion of osteotomized scapula and lat flap

Conditions: Head and Neck Cancer

Summary: the gold standard for reconstruction of the jaw is the utilization of a bone free tissue transfer. scapula reconstruction is an excellent option for elderly patients, those with significant comorbidities and for complex defects with large soft tissue reconstructive requirements. the scapula is supplied by the angular artery and circumflex scapula arteries. no studies have shown with objective measures, the viability of the lateral border of the scapula bone supplied by either the angular artery or circumflex scapula arteries. the aim of this observational study is to demonstrate with objective clinical measures, via spy-q software analysis, that the angular artery can adequately supply the scapula tip flap including with a single osteotomy giving two bone segments, in 30 patients who will undergo reconstructive head and neck surgery at lhsc.

the aim of this follow-up observational study is to demonstrate with objective clinical measures via spy-q software analysis, that the angular artery can adequately supply the scapula tip flap including a single distal osteotomy segment. 30 patients undergoing mandible or maxillary reconstruction with the scapular tip flap will be included. an osteotomy will be performed at up to 8cm from the scapular tip. the adequacy of blood supply to the scapula tip flap after a distal osteotomy and the latissimus dorsi muscle component of the flap will be measured intraoperatively, using spy-q software analysis.

Eligibility criteria:
inclusion criteria: * • adult patients (18 years and older) seen at the head and neck clinic at london health sciences centre (lhsc) * planned to undergo a maxillary and/or mandibular reconstruction surgery with a scapular tip flap exclusion criteria: * • younger than 18 years of age * history of failing microvascular flaps * hypersensitivity toward icg or related substances (e.g., imaging agents), defined as (based on icg product monograph): possibly life-threatening dizziness, severe itching, hives, nausea, difficulty breathing, rash, low blood pressure) * pregnant * breastfeeding * clinically apparent cognitive impairment

Keywords: head and neck cancer scapular free flap blood perfusion
characterizing inflammatory bowel disease with 68ga-fapi pet/ct

Conditions: Inflammatory Bowel Disease

Summary: 68ga-fapi has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation,such as inflammatory bowel disease. and it might be more sensitive than fdg in detecting a certain type of inflammations according to our preliminary research. thus this prospective study is going to investigate whether 68ga-fapi pet/ct may be superior for diagnosis, therapy response assessment and follow-up of inflammatory bowel disease than 18f-fdg pet/ct.

inflammatory bowel disease (ibd) is comprised of two major disorders: ulcerative colitis (uc) and crohn's disease(cd).cd is an autoimmune condition resulting in chronic gut inflammation that can be complicated by intestinal fibrosis and stricture formation. ulcerative colitis is characterized by recurring episodes of inflammation limited to the mucosal layer of the colon. it commonly involves the rectum and may extend in a proximal and continuous fashion to involve other parts of the colon. studies identified fap to be overexpressed in uninflamed strictures compared with nonstrictured colonic regions in biopsies taken from crohn's disease patients. but preliminary studies showed fap was not overexpressed in colonic biopsies taken from healthy individuals or individuals with ulcerative colitis.68ga-fapi has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and inflammation. recently we have published an article of the application of 68ga-fapi in igg4-related disease which showed it was more sensitive than fdg in detecting a certain type of inflammations. thus this prospective study is going to investigate whether 68ga-fapi pet/ct may be superior for diagnosis, therapy response assessment and follow-up of ibd than 18f-fdg pet/ct.

Eligibility criteria:
inclusion criteria: * suspected or confirmed untreated inflammatory bowel disease patients; * 18f-fdg pet/ct within two weeks; * signed written consent. exclusion criteria: * pregnancy; * breastfeeding; * known allergy against fapi * any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
evaluation of an electronic health record-based screening tool for peripheral artery disease

Conditions: Peripheral Artery Disease; Peripheral Vascular Disease

Summary: this protocol represents a pilot randomized-controlled trial evaluating the effect of an electronic health record (ehr)-based peripheral artery disease (pad) screening tool on rates of new non-invasive testing, diagnosis and treatment of pad over a 6-month period. an ehr-based pad screening tool will be applied to the stanford ehr, which will generate a group of patients of varying risks of having undiagnosed pad. patients with the highest risk of having undiagnosed pad will then be evaluated for inclusion in this study. 1:1 randomization will be performed on a consecutive basis until study enrollment is completed (25 patients per arm). physicians of patients randomized to the intervention arm will be sent notification via an ehr message detailing the patient's risk of undiagnosed pad and suggestions for referral to vascular medicine for risk assessment and/or non-invasive ankle brachial index (abi) testing. the primary outcome is number of patients receiving abi testing for pad at 6 months, with secondary outcomes including number of new pad diagnoses, number of new referrals to cardiovascular specialists (vascular medicine, vascular surgery, and/or cardiology) and number of patients receiving initiation of new cardiovascular medications (anti-platelet agents, statins, and/or antihypertensive agents).


Eligibility criteria:
inclusion criteria: * are 50-85 years old * currently an outpatient, actively obtaining care at stanford * have at least 1 year of data within the stanford ehr (including at least 2 clinical visits) * have no prior diagnosis of peripheral artery disease as determined by no chart term mentions or icd-9/10 codes in their ehr data exclusion criteria: * have less than 1 year of data available or less than 2 clinical visits at stanford * enrolled in a previous related study * receiving treatment for a potentially terminal condition * prior diagnosis of peripheral artery disease by icd code or term mention in their ehr data.