Kornimate/medical-research-clean huggingface dataset:
physical activity in children with type 1 diabetes study

Conditions: Type 1 Diabetes Mellitus; Physical Activity

Summary: this study aims to test the feasibility of a physical activity intervention called the steps to active kids (stak) programme in children aged 9 - 11 years with type 1 diabetes mellitus (t1dm).

the stak programme promotes physical activity in children who have a chronic condition, low levels of physical activity, are overweight or who lack confidence to take part in physical activity. the intervention involves an activity diary, circuit training, pedometer step counting, daily physical activity monitoring and goal setting to promote long-term increases in physical activity and its associated health benefits. this randomised single-centre feasibility study will test whether the stak programme is feasible for children with t1dm, in terms of acceptability, attractiveness and compliance and a qualitative process evaluation will aid the assessment of feasibility.

Eligibility criteria:
inclusion criteria: * be aged between 9 and 11 years * have a clinical diagnosis of type 1 diabetes mellitus for at least 3 months * be willing and able to comply with the study protocol * be physically able to participate in physical activity * have a parent/carer who provides informed consent exclusion criteria: * be under the age of 9 years and over the age of 11 years * have been diagnosed with type 1 diabetes mellitus for less than 3 months * have an injury or physical health condition that precludes their participation in physical activity * have a psychiatric disorder that interferes with provision of assent, completion of measurements, intervention, or follow-up * insufficient proficiency in english to comply with treatment or provide data

Keywords: physical activity type 1 diabetes mellitus children intervention
safety and tolerability of topically applied bovine lung surfactant on intact skin

Conditions: Skin and Connective Tissue Diseases

Summary: bovine lung surfactant is used as standard therapy for reducing alveolar surface tension in preterm infants. here the drug is administered via airways. the use on skin to stimulate the wound healing has not yet been tested in humans, i.e. it is not yet approved for the treatment of wound healing disorders. in the planned clinical trial lung surfactant is used the first time for the local treatment of skin lesions in humans. no substance related side effects were observed during the application via airways in neonates. the innovative idea to use lung surfactant for skin wound healing derived from two observations. first, when the skin is injured, the barrier protecting the moist body surface from the dry environment is discontinued and in part lost. lung surfactant has several characteristics that might be beneficial for treatment of chronic cutaneous wounds.


Eligibility criteria:
inclusion criteria: * two healthy forearms, * no known chronical skin diseases, * dermatoses or allergies, * signed form of consent, * caucasian exclusion criteria: * pregnancy or nursing period, * diabetes (type i or ii), * systemic or infectious diseases, * skin disease, * known allergies against bovine products or wound dressings, * mental diseases, missing ability to consent, * addictive disorders (e.g. alcohol, drugs), * peripheral circulatory disorder, morbus raynaud, * current (or \< 4 weeks ago) participation in clinical trials

Keywords: wound healing bovine lung surfactant satosu
study of spg601 in adult men with fragile x syndrome

Conditions: Fragile X Syndrome

Summary: this phase 2 study described herein will evaluate the safety, efficacy, tolerability, pharmacokinetics and pharmacodynamics of spg601 in adult men with fragile x syndrome.

this study is a phase 2 randomized, double blind, placebo-controlled, cross over, single dose of spg601 and matching placebo in patients with fragile x syndrome. this study will entail 2 in person clinic visits to administer oral doses of spg601 or matching placebo. participants will receive a dose of either spg601 or placebo at first visit, and will cross over to receive the other product at the second visit.

Eligibility criteria:
inclusion criteria: * adult males aged 18 to 45 years * diagnosis of fragile x as confirmed with genetic testing * patient must have caregiver * must be in good health with no significant medical history * clinical laboratory values within normal range or \< 1.2 times uln * contraceptive use by men or women consistent with local regulations * able and willing to provide written informed consent * stable dosing of psychotropic drugs for at least 4 weeks exclusion criteria: * any physical or psychological condition that prohibits study completion * uncontrolled seizures or history of epilepsy with a seizure in the past 6 months. * auditory or visual impairments that can not be corrected * history of suicidal behavior or suicidal ideation * screening vital signs that are abnormal per protocol specification * ecg that are clinically significant abnormal * history of substance abuse or dependence within 6 months * other investigational products within 30 days

Keywords: fragile x syndrome fragile x chromosome cognitive outcomes
analgesic effects of led light on temporomandibular disorders.

Conditions: Temporomandibular Disorder

Summary: low intensity laser therapy (lilt) has been widely applied in pain relief in several clinical situations. with the advent of new led-based (light emitting diode) light sources, the need of further clinical experiments aiming to compare the effectiveness between them is paramount.

aims: low intensity laser therapy (lilt) has been widely applied in pain relief in several clinical situations. with the advent of new led-based (light emitting diode)light sources, the need of further clinical experiments aiming to compare the effectiveness between them is paramount. method: this study proposes an evaluation of analgesic effect in tmd (temporomandibular disorders) using two different leds systems, one emitting at the spectral band of red (630 +/-5 nm) and the other at infrared band (850 +/-5 nm), and compare the results with a laser treated control group (780nm diode laser using 105.7 j/cm2). mandibular range of motion and report of pain were evaluated via appropriate equipment developed to do this end. power output was 150mw, tip area was 0.5 cm² for both sources. fluency or dose chosen was 18 j/cm² for each point of application, around the tmj, on both sides. five points were irradiated on tmj, temporal and masseter muscles. eight irradiation sessions were done and follow up was performed 7 and 30 days, after last session. thirty patients were enrolled and they were selected randomly for each treatment, resulting in 10 patients per group (infrared led, red led and control group using infrared laser).

Eligibility criteria:
inclusion criteria: thirty patients (from 18 to 50 years old) presenting signs and symptoms of tmd were selected to participate in the study. the patients received care at a private dental office in ribeirao preto, são paulo, brazil (nilo- integrated center for laser in dentistry). the patients´ age ranged from 18 to 40 years old, being 08 male and 22 female. the signs and symptoms evaluated by a trained professional were as follow: pain during palpation in the tmj area, pain on associated muscles (masseter and temporal), and limited or painful jaw movement with impaired oral aperture. exclusion criteria: the exclusion criteria were patients whom where currently under orthodontic and/or orthopedic treatment, degenerative joint disease, patients who were under systemic medication with anti-inflammatory drugs, analgesic treatment, muscle relaxant and corticosteroids. -

Keywords: lasertherapy ledtherapy tmjs pain relief oral aperture
functional monitoring for motor pathway in brain tumor surgery within eloquent area

Conditions: Glioma, Motor Pathway

Summary: resection of brain tumors in eloquent areas involves the risk of postoperative motor deficits. for brain tumors within or adjacent to the eloquent area, maximizing tumor resection while preserving motor function is crucially important.we used dti-based tractography to visualize the spatial relationship between brain lesions and the nearby pyramidal tract(pt) in patients with malignant brain tumors and confirmed functional connections of the illustrated pt by direct electrical stimulation. we evaluated the reliability of dti-based tractography for pt mapping using intraoperative subcortical stimulation ) and the usefulness of the combination of two techniques.

adverse effects caused by electrical stimulation during the operation were recorded. all subjects adopted early postoperative mri examinations (within 3 days) to evaluate both the extent of tumor resection and the integrity of the pts. muscle strength was assessed preoperatively and postoperatively.the karnofsky performance scale (kps) was adopted for grading functional status at the 6-month evaluation. further tumor progression interval and survival analysis was conducted for each subject with high-grade glioma (hgg)

Eligibility criteria:
inclusion criteria: * patients with an initial imaging diagnosis of single, unilateral, supratentorial primary glioma (or intrinsic neoplasm). * the lesions were involved in pts, comprising cortical regions in the motor or somatosensory areas, cortical regions adjacent to the central gyrus, subcortical regions with an infiltrative progression along the pts, and temporal or insular regions in relation to the internal capsule. * mri enabled preoperative identification of patients in whom maximal tumor resection was likely to be achieved, and close pt approach within resection cavity at the time of surgery was possible. exclusion criteria: * patients with secondary or recurrent gliomas (or intrinsic neoplasm), patients with contraindications for mri or direct electrical stimulation, and patients in whom initial muscle strength grades of the affected extremities was 2/5 or lower.

Keywords: diffusion tensor imaging, glioma, intraoperative monitoring, pyramidal tract, subcortical stimulation, tractography
non interventional study with primary open angle glaucoma and/or ocular hypertension patients treated with xalacom® after failure of previous antiglaucoma therapy.

Conditions: Glaucoma, Open-angle

Summary: this study is designed to evaluate the safety and tolerability of xalacom in patients with primary glaucoma

according to physicians decision, patients who met inclusion and exclusion criteria and sign the icd

Eligibility criteria:
inclusion criteria: * primary open angle glaucoma * ocular hypertension * age \>18 years exclusion criteria: * bradycardia * obstructive pulmonary disease * hypersensitivity to the drug

Keywords: glaucoma, open-angle, non-interventional study, safety, tolerability
effect of bio-k+ on symptoms of irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to evaluate the safety and effectiveness of bio-k+ on symptoms of ibs.

given the promising clinical results of previous trials of probiotics for ibs symptoms, the objective of this clinical trial is to evaluate the safety and effectiveness of a proprietary probiotic product, lactobacillus acidophilus cl1285®, lactobacillus casei lbc80r® and lactobacillus rhamnosus clr2® on symptoms of ibs in otherwise healthy adults.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. subject meets rome iii criteria for ibs (regardless of ibs subtype) as follows: * recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months associated with 2 or more of the following: * improvement with defecation * onset associated with a change in frequency of stool * onset associated with a change in form (appearance) of stool * symptom onset must be at least 6 months prior to diagnosis 3. agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only) 4. able to understand the nature and purpose of the study including potential risks and side effects 5. willing to consent to study participation and to comply with study requirements * abdominal pain or discomfort at least 2 days during run-in period associated with 2 or more of the following: * improvement with defecation * onset associated with a change in frequency of stool * onset associated with a change in form (appearance) of stool * completion of all study-related questionnaires exclusion criteria: 1. diagnosed gastrointestinal disease, e.g. crohn's disease, ulcer, cancer 2. prior abdominal surgery that, in the investigator's opinion, may confound study outcomes 3. any systemic disease that may confound ibs symptoms or compromise subject safety 4. life expectancy \< 6 months 5. pregnant female or breastfeeding 6. lactose intolerance 7. immunodeficient subjects 8. uncontrolled psychiatric disorder 9. current treatment with nasogastric tube, ostomy, or parenteral nutrition 10. eating disorder 11. recent (\< 2 weeks) antibiotic administration 12. history of alcohol, drug, or medication abuse 13. daily consumption of probiotics, fermented milk, and/or yogurt 14. known allergies to any substance in the study product 15. participation in another study with any investigational product within 3 months of screening
psychometric evaluation in patients with brain damage during neuroinflammation

Conditions: Multiple Sclerosis; Epilepsy; Parkinson Disease; Dementia; Stroke

Summary: the presence of a damage to the central and / or peripheral nervous system resulting from diseases of a different nature (such as, multiple sclerosis, parkinson's disease, dementia, head trauma, stroke, epilepsy or other neurological syndromes) is commonly cause of both physical than mental disability. the evaluation of certain domains may be more difficult so, specific assessment tools are necessary to analyze them.

the presence of a damage to the central and / or peripheral nervous system resulting from diseases of a different nature (such as, multiple sclerosis, parkinson's disease, dementia, head trauma, stroke, epilepsy or other neurological syndromes) is commonly cause of both physical than mental disability. the presence of cognitive deficits in the sphere of memory or language is often evident at a first clinical examination. however, the evaluation of certain domains such as mood disorders, behavior, sleep-wake cycle or eating habits, may be less evident, even if they have a very strong impact on the quality of life of patients. specific assessment tools are therefore needed such as psychometric tests, to collect information and analyze the results. the main evaluation scales we will use are the beck depression inventory-ii (bdi ii), the state-trait anxiety inventory (stai), the twenty-item toronto alexithymia scale- i (tas-20), the fatigue severity scale (fss), modified fatigue impact scale (mfis), the multiple sclerosis impact scale (msis-29), the epworth sleepiness scale (ess), the pittsburgh sleep quality index (psq1), the multiple sclerosis quality of life inventory (msqoli), the work productivity and activity impairment instrument (wpai), frailty index. these rating scales will be administered in person, by telephone and / or by sending them electronically.

Eligibility criteria:
inclusion criteria: * presence of brain damage resulting from: multiple sclerosis, parkinson's disease, dementia, head trauma, neurosurgery, stroke, epilepsy or other neurological syndromes (for the experimental group only); * be able to perform the tests to be administered for the duration of the study; * patients must be able to follow protocol directions throughout the study; * patients must be able to understand the purpose of the study; * signature of informed consent, approved by our ethics committee. exclusion criteria: * inability, even partial, to understand and want; * patients with other pathologies that in the opinion of the scientific responsible prevent their recruitment
a non-interventional, observational study for targinact® treatment in patients with severe pain.

Conditions: Severe Pain

Summary: this non-interventional, observational study evaluates the efficacy of targinact with regard to pain relief in daily clinical practice in belgium compared to the previous analgesic treatment.

patients are treated with targinact® according to daily clinical practice and are monitored during 3 study visits. parameters assessed are efficacy regarding pain relief, efficacy regarding bowel function, pain relief, use of analgesic rescue medication, bowel function, use of laxatives, safety of targinact treatment, use of concomitant medication, patient satisfaction and quality of life.

Eligibility criteria:
inclusion criteria: patients who are to be included in the study, are those who meet all of the following criteria based on the spc. 1. male or female patients at least 18 years, or older, with severe pain. 2. patients with documented history of severe pain treated with who step 1, step 2 and/or 3 analgesics with insufficient pain relief and/or unacceptable side effects that require around-the-clock opioid therapy and are likely to benefit from who step 3 opioid therapy for the duration of the study. exclusion criteria are based on the spc of targinact®.

Keywords: chronic pain severe pain oxycodon naloxon opioid-induced constipation opioid quality of life laxative analgesic rescue medication
vaginal micronized progesterone versus levonorgestrel for treatment of non-atypical endometrial hyperplasia

Conditions: Endometrial Hyperplasia Without Atypia

Summary: the purpose of this study is to compare the efficacy of the vaginal micronized progesterone and levonorgestrel-releasing intrauterine system for treatment of non-atypical endometrial hyperplasia in premenopausal women.

vaginal use of micronized progesterone in the treatment of endometrial hyperplasia can result in better than oral administration, as it will remain away from the first pass effect, and depending on the local application. in this study, we aimed to compare this local treatment with levonorgestrel-releasing intrauterine system for treatment of non-atypical endometrial hyperplasia.

Eligibility criteria:
inclusion criteria: * premenopausal patients * patients with histologically confirmed endometrial hyperplasia without atypia exclusion criteria: * endometrial hyperplasia with atypia * endometrial carcinoma * suspected pathology on physical/ultrasonographic examination e.g. fibroids, adnexal abnormality
post-radiation prostate cancer local recurrences: detection with histoscanning™ and mri

Conditions: Prostate Cancer Recurrent

Summary: inclusion criteria: * patients with biochemical recurrence (phoenix criteria: psa nadir + 2 ng/ml) after radiation therapy for prostate cancer addressed for prostate biopsy or * patients referred to our institution for biopsy-proven local recurrence after radiation therapy for prostate cancer but needing a re-assessment with biopsy (insufficient number of biopsy and/or imprecise location of positive biopsy and/or questionable diagnostic of recurrence) study design: * included patients will undergo an endorectal us examination with a histoscanning™ acquisition and a multiparametric (t2-weighted, diffusion-weighted and dynamic contrast-enhanced) mri. * two independent operators will separately define suspicious focal lesion on histoscanning™ images and on mr images. * random biopsies (at least 2 cores) will be performed in sextants negative at histoscanning™ and at mri ; in sextants positive at histoscanning™ and/or at mri, targeted biopsies will be performed in the suspicious part of the sextant (at least two cores per suspicious lesion). * histoscanning™ and mri results will be compared to biopsy results. a total of 30 patients will be included


Eligibility criteria:
inclusion criteria: * patients with biochemical recurrence (phoenix criteria: psa nadir + 2 ng/ml) after radiation therapy for prostate cancer addressed for prostate biopsy or patients referred to our institution for biopsy-proven local recurrence after radiation therapy for prostate cancer but needing a re-assessment with biopsy (insufficient number of biopsy and/or imprecise location of positive biopsy and/or questionable diagnostic of recurrence) * irb-approved informed consent signed exclusion criteria: * contraindication to mri * contraindication to endorectal examination * contraindication to prostate biopsy * history of allergy to gadolinium chelates
safety and efficacy of combination acthar gel and tacrolimus in the treatment of steroid resistant nephrotic syndrome

Conditions: Nephrotic Syndrome

Summary: the management of steroid-resistant nephrotic syndrome (srns) remains a persistent problem for investigators in part because of the wide array of pathogenic cccccccccc mechanisms that contribute to these disorders as well as the lack ofs. while glucocorticoids remain the primary therapy for many forms of protein uric glomerularxxxxxxxxx diseases, prolonged use is associated with significant morbidities including steroid induced diabetes, metabolic bone disease, and excessive weight gain.

multiple agents have been investigated in the treatment of patients with srns, but there is no consensus on what constitutes optimal therapy. previous studiesoids and have shown complete and partial response rates between 40% and 60%. more recently, calcineurin inhibitors (cni) have become an effective second line therapy with similar response rates between 50%-70%. however, both treatment regiments are limited by the risk for infection as well as the development of vvvvvvv cni-induced nephrotoxicity and progressive renal disease. acthar gel is a porcine pituitary preparation composed of acth and for treatment of idiopathic nephrotic syndrome. previous studies, as well as more current studies, have shown that acthar gel can effectively reduce proteinuriammmmmmmm in idiopathic membranous glomerulonephritis and other forms of glomerulopathy including focal segmental glomerulosclerosis (fsgs) and advanced diabetic nephropathy. while the mechanism is unknown, previous studies have shown that melanocortin 1-receptors are expressed in glomerular podocytes and thatpathway could be involved in the protein lowering effects of acthar bbbbbbbbgel. incubation of cultured podocytes with acth leads to activation of mcr-1 receptors and the subsequent stimulation of protein kinase a (pka) through a g-protein-dependent pathway. the downstream phosphorylation and stabilization of rho gtpases, synaptopodin and other cell-cytoskeletal associated proteins may stabilize podocyte function and density.

Eligibility criteria:
inclusion criteria: * refractory nephrotic syndrome secondary, defined as subjects having a urine protein/cr ratio over 3.0 while actively receiving ace inhibitors and hyperglycemic therapy (i.e., insulin or oral hyperglycemic agents). * type i or type ii diabetes * receiving combination therapy with an ace inhibitor and a second protein lowering agent (e.g., arb, non dihydropyridine ccb, or spironolactone). exclusion criteria: * known primary or secondary membranous glomerulonephritis (gn) * primary or secondary focal segmental glomerulosclerosis * other nondiabetic forms of glomerulopathy