Kornimate/medical-research-clean huggingface dataset:
clinical trial of the effect of functional orthoses in children with flat feet

Conditions: Flexible Flatfoot

Summary: the purpose of this study is to investigate the efficay of functional plantar orthoses on flatfoot in children.

there's a considerable controversy regarding the effectiveness of plantar orthoses in the treatment of flexible flat foot, despite being the most widely used treatment. several studies tried to investigate the correction of the deformity using plantar orthoses, but there are few studies with a control group of people, not enough to compare the effectiveness of the treatment. a randomized, double-blind, parallel design clinical trial was conducted with two study groups. the sample consisted of 61 children, aged 3 and 4 years old, who were randomly assigned to each study group. one group (intervention group) received treatment with functional plantar orthotics, and the other group (control group) received treatment with placebo-type plantar orthotics, to use as a reference or comparison. both groups were followed for a one-year period. before delivering the treatment, all subjects underwent dorsoplantar radiography, repeated at the end of the treatment (after one year). differences in the talus-calcaneus, tibionavicular and talus-first metatarsal angles were compared, pre and post-treatment of both study groups. test analysis of covariance (ancova) was performed as a statistical test.

Eligibility criteria:
inclusion criteria: * flexible flatfoot exclusion criteria: * congenital vertical talus * tarsal coalition * neuromuscular disease * ligamentous laxity * previous history of surgery on lower limb * previous orthotic treatment

Keywords: flatfoot orthoses children
ai health assistant and type 2 diabetes

Conditions: Health Behavior; Type2 Diabetes Mellitus

Summary: the developed health assistant has the functions of intelligent analysis of health data inside and outside the hospital, health reminder, etc. the advantages of ai health assistant management group compared with conventional management group in terms of comprehensive compliance rate, metabolic index level, hypoglycemia incidence rate was further studied.

1. the investigators have developed an ai health assistant suitable for diabetes patients, which has the functions of automatically uploading blood pressure, blood glucose data, intelligent reminder, automatic analysis of reports inside and outside the hospital, intelligent question and answer, etc. it is simple to operate, highly interactive, and maximizes the management level of diabetes patients outside the hospital. 2. through ai personal health assistant, 196 diabetes patients were managed to further improving the comprehensive compliance rate of metabolic indicators such as blood glucose and blood pressure of diabetes patients, improving the patients' self-management ability.

Eligibility criteria:
inclusion criteria: the diagnostic criteria of t2dm patients are the diagnostic criteria of the 2017 china guidelines for the prevention and treatment of type 2 diabetes hba1c 7.5-13% age: 18-65y bmi 18.5-30kg/m2 the course of disease is less than 5 years have good cognitive ability and can correctly use health assistants exclusion criteria: acute complications of diabetes (diabetes ketosis, etc.) diabetes complicating pregnancy or preparing for pregnancy hba1c \ 13% age \ 65y pre pregnancy bmi \ 30kg / m2 severe liver and kidney dysfunction (alt greater than 2.5 times the upper limit of normal, egfr less than 45 ml / min / 1.73m2) using drugs that may affect blood glucose are being used (including steroids, hydroxyprogesterone hexanoate, anti aids drugs, etc.)

Keywords: type 2 diabetes ai health assistant off hospital management
preterm functional early enteral development (feed) trial on respiratory support

Conditions: Premature Birth

Summary: the purpose of this study is to demonstrate that allowing infants that require high flow nasal cannula (hfnc)/continuous positive airway pressure (cpap) to orally feed if demonstrating oral cues will achieve full oral feeds faster.


Eligibility criteria:
inclusion criteria: * infants that require greater than 2 litres per minute (lpm) high flow nasal canula or cpap with a max setting of 6cm h20 fio2 30% or less for at least 72 hours or more * tolerating enteral feeds of 120 ml/kg/day exclusion criteria: * major congenital anomalies (pulmonary malformations, airway malformations, craniofacial defects, major congenital heart disease, combined pulmonary intestinal malformations) * metabolic disorder * major gastrointestinal surgeries * patent ductus arteriosus (pda) ligation surgery * outborn deliveries greater than 7 days old

Keywords: prematurity oral skills nasal cpap oral feeds hfnc oral feeds
role of epoxyeicosatrienoic acids in chronic allograft nephropathy - the transplant-eets study

Conditions: Kidney Transplant Recipients

Summary: endothelial lesions within the transplanted kidney are a major determinant of chronic allograft nephropathy. epoxyeicosatrienoic acids (eets) are endothelium-derived hyperpolarizing factors with anti-inflammatory, antiproliferative and vasodilator properties. the main goal of the investigators' study is to evaluate whether genetic polymorphisms of specific enzymes responsible for the bioavailability of eets are associated with post-transplant kidney function. to this end, 80 kidney transplant recipients will be included. prespecified genetic polymorphisms of cyp 2j2, cyp 2c8, cyp 2c9, cyp 2c9, cyp 2c19 and ephx2 will be determined. kidney function will be recorded 3, 6, 12 and 36 months after transplantation. flow-mediated dilatation, eets and circulating biomarkers of endothelial function will be measured in the radial artery. the expected results of this study to provide preliminary evidence supporting a beneficial role of an increase in the bioavailability of eets in kidney transplant recipients.


Eligibility criteria:
inclusion criteria: * patient aged 18 to 75 yo * caucasian (because of different cyp epoxygenase polymorphisms) * first kidney transplantation performed in rouen university hospital after 2000, and at least 12 months before inclusion * patient having read, understood and approved the informed consent * efficient contraception in child-bearing aged women * regular health insurance exclusion criteria: * primary non-function, or allograft loss before 1 year * previous kidney transplantation * history of psychiatric, psychologic or sensorial disorder preventing the patient from correctly understanding the protocol * history of bilateral arm or forearm arteriovenous fistula * counter-indication to trinitrin * insufficient understanding of written or spoken french language * liberty-deprived patient * pregnancy or absence of contraception in child-bearing aged women * patient enrolled in another research protocol within 2 weeks before inclusion
feasibility study of novel prescription digital therapeutic supporting unobserved buprenorphine initiation & adherence

Conditions: Opioid Use Disorder

Summary: the purpose of this study is to assess feasibility of an at-home digital therapy designed to support buprenorphine initiation and adherence.

the purpose of this study is to develop and evaluate the acceptability of a novel feature for use with the prescription digital therapeutic reset-o. this feature aims to improve the quality of treatment for opioid use disorder (oud) patients starting buprenorphine initiation at home by providing new digital content and withdrawal symptom assessment to support them during this process. this study will evaluate the acceptability of this new feature and assess success of at-home buprenorphine initiation.

Eligibility criteria:
inclusion criteria: 1. provide written informed consent prior to any study specific assessments being performed 2. male or female ≥18 years of age, inclusive 3. english proficiency to meaningfully participate in consent process, assessment and intervention 4. meets clinical sites criteria for buprenorphine initiation (e.g. current opioid use) 5. currently receiving buprenorphine outpatient treatment for oud (part 1) or wishing to start buprenorphine treatment 6. capable of using common software applications on an internet-enabled mobile device (smart phone or tablet) 7. interested in testing or using pear-002b 8. no prior history of reset-o use 9. has not participated in any other investigational drug trials within the past 30 days (or within 5 half-lives of study drug, whichever is longer) of enrollment 10. is considered appropriate for participation by their clinician exclusion criteria: 1. diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) diagnosis of oud and on methadone or naltrexone pharmacotherapy 2. dsm-5 diagnosis of oud and already on buprenorphine 3. planning to move out of the geographic area within 2 months 4. unable to use english to participate in the consent process, the interventions, or assessments 5. inability to comply with study procedures, due to severe medical conditions or otherwise 6. currently receiving inpatient treatment for oud 7. women who are pregnant

Keywords: digital therapeutic
a study of mk-0893 on glucagon-induced glycemic excursion in healthy male participants following intravenous administration of glucagon, sandostatine® and insulin (mk-0893-002)

Conditions: Type 2 Diabetes Mellitus

Summary: this is a study to assess the pharmacokinetics, safety, and tolerability of sequential single oral doses of mk-8093 10 mg, 40 mg, 200 mg, or placebo to mk-8093 (part 1) depending on treatment assignment in young healthy male participants. in part 2 of this study, sequential single oral doses of mk-8093 200 mg, 1000 mg or placebo to mk-8093 depending on treatment assignment will be evaluated. the primary hypothesis of the study is that at least one dose of mk-0893 will produce greater reduction of glucagon-induced glycemia as compared to placebo following the infusion of glucagon, sandostatine®, and basal insulin.


Eligibility criteria:
inclusion criteria: * good health * body mass index of between 18 and 28 kg/m\^2, or up to 30 kg/m\^2 with approval of sponsor * non-smoker for at least 6 months * willing to avoid strenuous physical activity * willing to avoid alcohol, caffeine, and grapefruit juice consumption exclusion criteria: * history of renal, neurologic, gastrointestinal or respiratory disease or any gastrointestinal surgery * history of multiple and/or severe allergies to a prescription, nonprescription or investigational drug or food * history of any cardiovascular/cardiac disease * history of any hepatic disease and primary biliary cirrhosis * history of hypoglycemia or glucose intolerance, type 1 diabetes, or type 2 diabetes * requires or anticipates use of prescription or nonprescription medications, including herbal remedies * a user of any illicit drugs or a history of drug or alcohol abuse * surgery, donated a unit of blood, or participated in another clinical study within 4 weeks prior to study participation * history of hypersensitivity to insulin, glucagon, or sandostatine®.

Keywords: diabetes mellitus diabetes mellitus, type 2 glucose metabolism disorders metabolic diseases endocrine system diseases therapeutic uses pharmacologic actions molecular mechanisms of pharmacological action physiological effects of drugs
effect of nasal cpap on cardiopulmonary exercise testing in patients with overlap syndrome

Conditions: Obstructive Sleep Apnea; Chronic Obstructive Pulmonary Disease

Summary: nasal cpap will improve cardiopulmonary exercise test (cpet) performance in patients with overlap syndrome(copd and osa). nasal cpap is proven to improve cardiopulmonary exercise testing in patients with osa. the investigators hypothesis is that patients with overlap syndrome will have a greater improvement in their cardiopulmonary exercise testing besides a possible improvement in their lung function test and airway resistance.

patients presenting to the oklahoma city va sleep clinic with obstructive sleep apnea syndrome and a desire to initiate cpap treatment will be included if they have overlap syndrome. patients will undergo a spirometry and cpet before being started on cpap as part of standard clinical care. the cpet will be repeated after 8-12 weeks of cpap use. patients will be excluded if they have any contraindication to mild exercise or they cannot perform an exercise test due to limited mobility.

Eligibility criteria:
inclusion criteria: * obstructive sleep apnea (osa) * copd exclusion criteria: * inability to perform exercise test due to musculoskeletal limitation * cardiac condition preventing patient from mild exercise * continuous oxygen supplement
collaborative mental health care model: an evaluation of the implementation of a pilot in four primary care organization

Conditions: Psychological Disorder

Summary: frequent mental disorders (anxiety or mood disorders), an important part of primary care patient care, remain insufficiently detected and treated. improving their care requires better coordination between general practice and specialized care. the collaborative care model developed in washington state with the introduction of a care manager is recognized. about 100 randomized controlled trials have established its effectiveness and efficiency, in terms of improving the progression of disorders (remission rate), adherence, quality of life, professional and patient satisfaction, and cost savings. however, the possibility of implementation of these validated care remains to be explored. a dozen collaborative care implementation studies exist, all conducted in the usa and not having considered all the dimensions of the indicators of penetration, acceptability/adoption, feasibility, fidelity and cost. a first implementation in france is implemented since september 2021 in the yvelines department on four sites of different size, organization and environments: the multi-professional health centers (msp) of mureaux and celle st cloud, the chevreuse medical house and mg in isolated practice in versailles. the main objective of the research project is to evaluate the first implementation in france of collaborative care for frequent psychic disorders according to the indicators of penetration, acceptability/adoption, fidelity, relevance, feasibility and cost.


Eligibility criteria:
inclusion criteria: * healthcare professionals involved in the collaborative care system * patients who have been referred for collaborative care by their family physician exclusion criteria: * patient refusal to participate in research * adults protected by law
egcg modulate the cytotoxic effects of chemotherapeutic agents in human urothelial carcinoma cells

Conditions: Urothelial Carcinoma

Summary: urothelial carcinoma (uc) is the most common cancer of urinary tract. patients with metastatic uc are usually treated with systemic chemotherapy. there still existed 30% to 50% of advanced uc not responsive to cisplatin-based chemotherapy; the prognosis for patients with metastatic uc remains poor.

(-)-epigallocatechin -3-gallate (egcg) is the most abundant polyphenol compound from green tea, representing \~16.5% of the water-extractable fraction. egcg have various bioactivities and can bind and regulate a wide range of molecular involved in cell cycle, signal transduction, and protein degradation. however, the anticancer effects of egcg on uc have not been thoroughly explored. our preliminary data show that egcg alone can inhibit cell proliferation and induce apoptosis with the activation of caspases and parp in a time dependent manner. moreover, egcg can enhance the cytotoxicity of several chemotherapeutic drugs in vitro. the underlying mechanism seems to be associated with akt and erk pathway. we will also check the akt and erk protein level by immunohistochemical staining in clinically chemoreistant bladder urothelial carcinoma specimens to further prove our in vitro findings. we will further confirm the effect of chemotherapeutic drugs combined with egcg on uc in vivo via xenograft model. the specific aims of the study are: 1. to explore the anti-tumor effects of egcg on human uc cells and elucidate the possible mechanisms. 2. to study the combinative cytotoxic effect of egcg with other chemotherapeutic agents such as cisplatin, doxorubicin and gemcitabine on uc cells; moreover, to investigate the underlying mechanisms. 3. to investigate the expression level of phospho-akt and phospho-erk in clinically chemoreistant bladder urothelial carcinoma specimens to further confirm our finding in clinical events. . 4. to prove the in vitro findings and confirm the combinative efficacy of egcg with chemotherapeutic agents in vivo by using the xenograft animal model. 5. to establish a novel therapeutic strategy for treatment of uc.

Eligibility criteria:
inclusion criteria: * in january 2008 to december 2012 at the national taiwan university hospital for surgery (radical resection of kidney and ureter or bladder removal) of urothelial carcinoma histopathology specimens of patients willing to participate in this study and the subjects described in the consent book signer. exclusion criteria: * in january 2008 to december 2012 at the national taiwan university hospital for surgery (radical resection of kidney and ureter or bladder removal) of urothelial carcinoma histopathology specimens of patients are reluctant to join the researcher

Keywords: urothelial carcinoma (uc), (-)-epigallocatechin-3-gallate(egcg), chemotherapy, cytotoxicity, drug resistance, xenograft.
viper: veterans integrated pain evaluation research

Conditions: Pain

Summary: the purpose of the study is to learn about the causes of different types of pain that can occur in people who have had an amputation. by gathering information through blood tests, photographs, a nerve test, and questionnaires, we hope to de-code how each individual's special characteristics affect the type and amount of pain they experience in their amputated limb.

studies have already shown that pain following amputation might be caused by differences in a person's genes. this study may help us find out how genes affect the way you feel pain and why you may feel more or less or different kinds of pain than another person with a similar amputation. what we learn in this research study may lead to discoveries as to why some painkillers work better for some people than others.

Eligibility criteria:
inclusion criteria: * male and female active duty military personnel age 18 years and older undergoing treatment at wramc and future wrnmmc with the diagnosis of post injury amputation of 1 limb, more than 3 but less than 18 months prior to enrollment. in particular, phantom limb pain patients will be included exclusion criteria: * severe traumatic brain injury (primary major head trauma and diagnosis of traumatic brain injury resulting in documented, permanent or prolonged cognitive deficits that would preclude participation in the study (i.e. decreased intellectual capacity, marked memory deficits, or inability to communicate verbally or in writing) * significant cognitive deficits that would preclude participation in the study. * substantial hearing loss without alternative means of communication. * documented spinal cord injury with permanent or persistent deficits. * diagnosis of fibromyalgia or other chronic pain syndrome such as chronic headaches. * evidence of ongoing tissue damage pain, infection, bone spur, or poorly fitting prosthesis.

Keywords: proteomics study biomarker study of pain
chiropractic manual therapy and neck pain

Conditions: Chronic Mechanical Neck Pain

Summary: eligible subjects with chronic neck pain will be randomly allocated to one of two intervention groups: real vs control spinal manipulation. they will receive three intervention sessions. h1: chronic neck pain patients treated longitudinally over a series of three encounters in one week by random assignment to treatment group with either of the dual delivery procedures (intervention 1=typical-control or intervention 2=control-control) will have a 50% error rate of self-report of group allocation at exit interview. h2: patients treated by the typical-control dual procedure over a typical sequence of encounters (3 times in one week) will show statistically significant improvement in clinical outcomes; defined quantitatively by visual analogue pain scale (vas), neck disability index (ndi), range of motion and pressure algometry; compared to those treated by the control-control dual procedure. h3: patients stratified by 'a priori' patient expectation for treatment outcome will show no significant difference in self-report of group allocation or clinical outcome measures. a total of 372 subjects will be recruited.


Eligibility criteria:
inclusion criteria: * male or female * 21 to 60 years of age * chronic neck pain * neck pain duration greater than 6 weeks * numeric rating scale greater than 30, less than 65 * pain distribution between nuchal ridge and spine of the scapula * pain aggravated by local provocation maneuvers at single motion segment * antero-posterior glide * paraspinal tenderness * negative provocative maneuvers at adjacent segment * able to tolerate neck movement to 50 percent normal in all directions exclusion criteria: * worker's compensation or other medico-legal claim * cervical spine surgery or fracture or dislocation * uncontrolled hypertension (blood pressure over 140 over 90) * stroke or transient ischemic attack * upper respiratory infection within 4 weeks * severe degenerative disease of the cervical spine * new or significantly altered pattern of headache complaint * connective tissue disease * primary fibromyalgia * metabolic or metaplastic bone disease * whiplash injury within 12 months * high cholesterol levels not well-managed medically * cardiovascular surgery in the past 6 months or planned * use of narcotic analgesic, prescription anti-inflammatory, or muscle relaxants, anti-convulsants * angina pectoris * dizziness * tinnitus * blurred vision, vertigo, undiagnosed sensory and motor disturbances * radicular symptoms and signs * current use of anticoagulant therapy * upper respiratory infection * neck pain on provocation greater than 7 out of 10 * provocation of radicular pain or sensory disturbance * hypermobility of multiple peripheral joints, * physical or mental impairment precluding following instructions or participating -in supine recumbent postures

Keywords: neck pain chronic manipulation control randomized trial