Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of lubiprostone in patients with irritable bowel syndrome with constipation

Conditions: Irritable Bowel Syndrome With Constipation

Summary: the primary purpose of this study is to evaluate the efficacy and safety of administration of lubiprostone in patients with irritable bowel syndrome with constipation.


Eligibility criteria:
inclusion criteria: * 18 years of age and older * stable fiber therapy * normal colonoscopy/sigmoidoscopy * able to refrain from use of medications known to treat or associated with constipation symptoms * experiences abdominal discomfort/pain associated with bowel movements * reports decreased bowel movement frequency and/or other symptoms associated with constipation exclusion criteria: * diarrhea-predominant or alternating (diarrhea and constipation cycling) irritable bowel syndrome (ibs), or constipation other than that associated with ibs * open gastrointestinal or abdominal surgery prior to ibs onset * organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, unexplained weight loss or rectal bleeding * uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests per investigator discretion * if female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study
clearance of 25-hydroxyvitamin d in chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: the goal of this study is to better understand vitamin d catabolism and how it is affected by ckd and race.

specifically, the study team will evaluate the metabolic clearance of 25-hydroxyvitamin d3 in individuals with varying degrees of ckd and among participants who self-report race as caucasian, african american or african. the long-term goal of this work is to enhance the clinical evaluation and treatment of impaired vitamin d metabolism.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * self-reported race caucasian, african american, or african * serum total 25(oh)d 10-50 ng/ml * estimated gfr: * 60 ml/min/1.73m2 (n=40) 15-45 ml/min/1.73m2 (n=40) \<15 ml/min/1.73m2, treated with hemodialysis (n=40) exclusion criteria: * primary hyperparathyroidism * gastric bypass * tuberculosis or sarcoidosis * current pregnancy * child-pugh class b or c cirrhosis (i.e. cirrhosis with ascites, hepatic encephalopathy, bilirubin \>=2 mg/dl, serum albumin \ = 4 seconds) * use of vitamin d3, or vitamin d2 supplements exceeding a mean daily dose of 400 iu, within 3 months (wash-out allowed) * use of 1,25(oh)2d3 or an analogue, calcimimetics, or medications known to induce cyp24a1 within 4 weeks (wash-out allowed) * serum calcium \> 10.1 mg/dl * hemoglobin \< 10 g/dl

Keywords: chronic kidney disease vitamin d catabolism
efficacy study of subcutaneous methyl-b12 in children with autism

Conditions: Autistic Disorder

Summary: we will be testing a specific dietary supplement, methylcobalamin (vitamin b12). follow-up assessments with our clinical team will take place over the 12-week study period so that we can record any changes in development. the main goal of this study is to determine if subcutaneous injections of vitamin b12 given every three days can positively affect behavior and development in children with autism. hypothesis: methylcobalamin injections will improve measures of executive function, speech, and socialization in children with autism, and will be associated with metabolic improvement.

autism is a complex neurodevelopmental disorder that is thought to involve an interaction between multiple and variable susceptibility genes (keller \& persico, 2003), epigenetic effects (beaudet, 2002), and environmental factors (london, 2000). the increase in the prevalence of autistic spectrum disorders from 4-5/10,000 in the 1980s to 30-60/10,000 in the last decade has raised great concern (bertrand et al., 2001; destefano et al., 2004; steinhausen et al., 1986; yeargin-allsopp et al., 2003). research into potential therapeutic interventions designed to ameliorate the metabolic and clinical symptoms of autism is urgently needed to reduce the enormous public health burden of this disorder and to improve the quality of life for affected children and their families. nutritional supplementation through subcutaneous injections of methyl b12 is a current treatment for children with autism that has anecdotal reports of remarkable clinical improvements and few side effects. however there are no published studies to support its clinical benefit. comparison: injections of methylcobalamin compared to injections of sterile saline over a six week period.

Eligibility criteria:
inclusion criteria: * diagnosis of dsm iv defined autism and meets cut off on autism diagnostic inventory-revised (adi-r) and the autism diagnostic observation scale (ados). * age 3 to 8 years * iq of 50 or above * willingness of parents to administer subcutaneous methyl b12. * parental agreement to continue present dietary, behavioral or psychotropic drug treatment but not change treatment during 12 week intervention or wait list. exclusion criteria: * clinical evidence of seizure disorder * cancer * recent surgery * active infection with fever * fragile x or other known genetic cause of autism * bleeding disorder * perinatal brain injury (e.g. cerebral palsy) * current use of any methyl b12 product * evidence for malnutrition seen in abnormal albumin level

Keywords: autism placebo b12 controlled complementary alternative medicine vitamin supplement
randomized phase ii study of dce-mri-based dose escalation for poor-prognosis and neck cancer

Conditions: Squamous Cell Carcinoma of the Head and Neck

Summary: this study aims to improve locoregional control of poor prognosis head and neck cancer (hnc) patients by selectively escalating the radiotherapy dose to subvolumes of tumor likely to be resistant to standard radiation therapy (rt) using dce-mri (dynamic contrast enhanced magnetic resonance imaging). standard doses of radiotherapy to the rest of the tissues and surrounding normal tissues will be maintained.


Eligibility criteria:
inclusion criteria: * patients must have pathologically-confirmed, non-metastatic locally/regionally advanced squamous cell carcinoma of the head and neck, stage iii/iv, referred for definitive chemo-rt, and meet one of the following six criteria: 1. primary tumor (t4) with or without metastatic lymph nodes. tumor or nodes are: unresectable, resection is considered by the treating surgeon or patient to result in unacceptable functional or oncological results, patient refuses surgery, or surgery is not possible due to comorbidities. 2. hpv(-) (human papillomavirus) or p16(-) locally/regionally advanced (t3-4 or n2-3) oropharyngeal cancer. 3. hpv(+) or p16(+) locally/regionally advanced (t4 or n3) oropharyngeal cancer. 4. t3 or t4 laryngeal or hypopharyngeal cancer that is locally advanced, bulky (\>40 cc\*), unresectable, or patient declines surgery. 5. stage iii/iv oral cavity or paranasal sinus cancers in patients who refuse surgery or are unfit for surgery. 6. locally/regionally advanced (stage t3-4 and/or n3) nasopharyngeal cancer which is ebv (-) (epstein-barr virus). * kps (karnofsky performance status: a measure of general well being and activities of daily living; scores range from 0 to 100 where 100 represents perfect health) \>70 (see appendix a) within two weeks of enrollment. * pre-treatment laboratory criteria within four weeks of enrollment: * wbc (white blood cell) \> 3500/ul, granulocyte \> 1500/ul. * platelet count \> 100,000/ul. * total bilirubin \< 1.5 x uln. * ast (aspartate aminotransferase) and alt (alanine aminotransferase) \< 2.5 x uln. * estimated creatinine clearance \>30cc/min. * patients must be able to receive protocol chemotherapy in the judgment of the treating medical oncologist. * patients are adults (age ≥18). * all patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines. exclusion criteria: * ebv (+) nasopharyngeal carcinoma in the protocol treated tumor. * prior head and neck radiation. * documented evidence of distant metastases. * patients with active infection. * pregnant women. * patients should have no contraindications to having a contrast enhanced mri scan. these contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the institutional standard practice.
retrograde colonic irrigation to manage spina bifida functional digestive sequelae: a multicenter, prospective, randomized controlled trial

Conditions: Spina Bifida

Summary: spina bifida is a developmental congenital disorder caused by the incomplete closing of the embryonic neural tube, leading to serious malformations of the nervous system. caudal neuropore malformations almost always lead to sensory-motor deficits (including complete paraplegia) with orthopedic deformations, pressure sores, and pelvic/perineal neurological dysfunctions (affecting the bladder-sphincter, anorectal, and genital sphere). the purpose of the study is to assess the efficacy of retrograde colonic irrigation associated with usual care (medical treatments, patient education) on anorectal dysfunction (incontinence and/or constipation), compared to usual care only.

sphincter dysfunctions impair the quality of life and patients' self-esteem. however, defecation disorders are important issues the spina bifida national reference center has to deal with. indeed, more than half of patients are concerned. these disorders are mainly due to fecal stasis. treatments include laxatives and hygiene recommendations. colonic irrigation can also be useful, especially to achieve colonic vacuity and improve continence. the use of intra-rectal balloon inflation probes and the control of instillation flow improved retrograde colonic irrigation efficacy. nevertheless, this technique is currently not evaluated in young adults suffering from spina bifida functional digestive sequelae, who are mainly concerned by malone enema. the purpose of the study is to assess the efficacy of retrograde colonic irrigation associated with usual care (medical treatments, patient education) on anorectal dysfunction (incontinence and/or constipation), compared to usual care only.

Eligibility criteria:
inclusion criteria: * patients aging at least 15 years old with spina bifida neurological pelvi-perineal sequelae, objected by neurologic exam , functional urinary and/or anorectal and/or neurophysiological data, * patients with nbd score above 9, * written and informed consent (minor children may be included with the consent of the two parents). exclusion criteria: * patients with psychiatric disorders, cognitive or intellectual disabilities compromising the assessment of primary outcome measure, * patients using currently irrigation colonic technique, * patients with functional colostomy, known anal or colorectal stenosis, colorectal cancer, acute or chronic inflammatory disease, recent anal or colorectal surgery for less than 3 months, polyp removal for less than 4 weeks, ischemic colitis. * patients with urinary trophic or orthopedic disease with planned surgery during inclusion or follow-up periods, * patients with progressive anal disease (suppuration, hemorrhoid or rectal prolapse) * patient with a hard follow-up ( judged by the investigator) * person involved in another clinical trial * pregnant women * person with a measure of legal protection (guardianship)

Keywords: faecal incontinence spina bifida enema constipation myelomeningocele human
a comparison of language intervention programs

Conditions: Language Disorders

Summary: brief summary: nearly 7% of elementary school children present with difficulties learning and using language. unfortunately, language impairments are often long lasting and may have serious social, academic, and vocational ramifications. more than 1 million children receive language intervention in the public schools each year, and many more are seen in hospitals and other clinical settings. this randomized clinical trial compares the language outcomes of fast forword to two other interventions (computer assisted language intervention without acoustically modified speech and individual language intervention) and to the outcomes of an academic enrichment (control) condition. each year for 3 years, children will be randomly assigned to each of the four conditions at three regional sites (austin, texas, dallas, texas, and lawrence, kansas). the treatments will be administered in special summer programs. the primary research question is which intervention results in the most improvement in the composite language score from the oral and written language scales. secondary questions include which intervention results in the greatest gains in conversational language,which intervention results in the greatest gains 3 and 6 months after training, which intervention results in the greatest improvement in auditory perception, and which intervention is the most cost effective. the results of the study will have theoretical and practical value. theoretically, the study tests the temporal processing hypothesis of language impairment. practically, the study will describe and compare the language, communication, auditory processing and academic outcomes of different language interventions. the study will help clinicians and administrators choose the most effective and least expensive treatment for the children they serve.


Eligibility criteria:
inclusion criteria: * age 6 to 9 years * score between 75 and 125 on the matrices subtest of the kaufman brief intelligence test * speaking quotient of 79 or lower on the test of language development: primary: 3rd edition exclusion criteria: * previous participation in 8 or more hours of language intervention or classroom activities using any of the fast forword, laureate, or earobics speech-language or reading software and/or the lindamood-bell auditory discrimination training * failure of a hearing screening test * an episode of otitis media in the previous 12 months * evidence of focal brain lesion, traumatic brain injury, cerebral palsy, or seizure disorder * abnormality of oral structure or function impeding normal language production

Keywords: specific language impairment fast forword language therapy auditory processing
effects of riboflavin in mitigating muscle soreness in ultra-marathon athletes

Conditions: Muscle Soreness

Summary: the aim of this project is to investigate the effects of riboflavin, also known as vitamin b2, on preventing delayed onset muscle soreness (doms) in ultramarathon athletes through a randomized placebo-controlled study.

the riboflavin 100 mg capsules will be self-dosed by the participant, one capsule prior to the long stage of the race followed by a second dose at the end of the long stage. historically, long-stage finish times have ranged between 8 and 24 hours. the placebo will also be dosed as one capsule on the morning of the long stage, prior to the race start, and one capsule at the end of the long stage.

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, aged 18 or over 4. in good general health as evidenced by readiness to participate in an ultramarathon 5. ability to take oral medication and be willing to adhere to the study regimen 6. for females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening. exclusion criteria: 1. unable to read or understand english 2. under 18 years of age 3. pregnancy or lactation 4. known allergic reactions to components of the investigational drugs

Keywords: delayed onset muscle soreness ultramarathon
coolsculpting in the abdomen using applicator with and without cci

Conditions: Body Fat Disorder

Summary: evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the abdomen using an applicator with the crown cooling insert.

evaluation of coolsculpting treatment in the abdomen using a vacuum applicator with an accessory insert.

Eligibility criteria:
inclusion criteria * male or female subjects \>22 years of age and \< 65 years of age. * subject has clearly visible fat on the abdomen, which in the investigator's opinion, may benefit from the treatment. * subject is a candidate for a standard coolsculpting treatment with a coolmax applicator. * no weight change exceeding 5% of body weight in the preceding month. * subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in their diet or exercise routine during the course of the study. * subject has read and signed the study written informed consent form. exclusion criteria * subject has had a surgical procedure(s) in the area of intended treatment. * subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment. * subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months. * subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month. * subject has a known history of cryoglobulinemia, cold urticaria, cold agglutinin disease or paroxysmal cold hemoglobinuria. * subject has a known history of raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin. * subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising. * subject is taking or has taken diet pills or supplements within the past month. * subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion). * subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system or any other metal containing implant. * subject is pregnant or intending to become pregnant during the study period (in the next 5 months). * subject is lactating or has been lactating in the past 6 months. * subject has a history of hernia in the areas to be treated. * subject is unable or unwilling to comply with the study requirements. * subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. * subject is prone to severe claustrophobia (during mri scans). * any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
luks-leads registry on long-term performance of icd leads

Conditions: Defibrillators; Electrical Shock

Summary: all patients having an implantable cardiac defibrillator (icd) implanted and having follow-up at the cantonal hospital lucerne (luks), the investigator center, are included in this retrospective icd lead registry from 2006 onwards. data is collected prospectively from december 2016 onwards. after certain icd-leads tended to fail early the investigators aimed for a registry monitoring our patient population with defibrillator leads and evaluating their long-term performance.

all patients having an icd implanted and having follow-up at the investigators center are included in this retrospective icd lead registry from 2006 onwards. data is collected prospectively from december 2016 onwards. after certain icd-leads tended to fail early the investigators aimed for a registry monitoring our patient population with defibrillator leads and evaluating their long-term performance. the following parameters will be measured during regular clinical controls: electronic impedances, threshold values, sensing values, battery performance, inadequate/adequate shock release und software problems

Eligibility criteria:
inclusion criteria: * all patients being implanted with a defibrillator lead from 2006 onwards exclusion criteria: * documented refusal of data collection for scientific purposes
mirvaso soolantra association in the treatment of moderate to severe rosacea.

Conditions: Rosacea

Summary: the main objective of this study is to evaluate the efficacy of ivermectin 1% cream (ivm) associated with brimonidine 0.33% gel (br) compared with the association of their respective vehicles in the treatment of moderate to severe rosacea.


Eligibility criteria:
main inclusion criteria: 1. male or female subjects age 18 years or older; 2. subjects with a minimum of 15 but not more than 70 inflammatory lesions (papules and pustules) of rosacea on the face; 3. subjects with moderate or severe diffuse persistent facial erythema of rosacea (scored 3 or 4 according to clinician's erythema assessment \[cea\]); 4. subjects with moderate or severe papulopustular rosacea (scored 3 or 4 according to the investigator's global assessment \[iga\]); 5. female subjects of childbearing potential with a negative urine pregnancy test (upt); 6. female subjects of childbearing potential must practice a highly effective method of contraception during the study; 7. females subjects of non-childbearing potential; main exclusion criteria: 1. subjects with particular forms of rosacea or other concomitant facial dermatoses that may be confounded with rosacea; 2. subjects with more than 2 nodules of rosacea on the face; 3. subjects with any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or with optimal participation in the study or would present a significant risk to the subject; 4. subjects with known or suspected allergies or sensitivities to any component of the investigational and non-investigational products, including the active ingredients brimonidine or salts of brimonidine like brimonidine tartrate and ivermectin;