Kornimate/medical-research-clean huggingface dataset:
effect of minigo as add-on to oral laxatives for children with constipation and fecal incontinence

Conditions: Functional Constipation; Fecal Incontinence in Children

Summary: the goal of this clinical trial is to compare combination therapy with low volume trans anal irrigation (tai) and oral laxatives to monotherapy with oral laxatives in children with functional constipation and fecal incontinence. the main questions it aims to answer are: * can more efficient treatment be achieved with aforementioned combination therapy? * does the well-being of the children change, when they are well treated for their symptoms? * is low-volume trans anal irrigation a tolerable treatment method for children? participants will be randomized into 2 groups, where one group is treated with current standard treatment of peg (oral laxatives), and the other group is treated with peg + daily low volume tai.

functional constipation and retentive fecal incontinence is a prevalent health issue in children. the current standard treatment regimen in denmark consists mainly of behavioral interventions and oral laxative treatment. this treatment leaves a large group of non-responders. suffering from constipation and fecal incontinence has a negative impact on well-being in children, wherefore treatment of this condition should be improved. earlier literature shows that trans anal irrigation (tai) is an effective means of managing these symptoms, both in children and adults. however, conventional high volume tai is time consuming (up to 45 minutes-an hour daily) and a cause of discomfort, or even pain. this can lead to low compliance and treatment failure. low volume tai has the potential of bringing about all the positive effects of tai, but with less time consumption (only few minutes daily) and less discomfort. in this clinical trial, we will compare how children with functional constipation and fecal incontinence respond to treatment with 1) oral laxatives (peg) alone versus 2) peg and low volume tai with the minigo-irrigation system. the intervention period is 6 weeks, and the treatment takes place at home.

Eligibility criteria:
inclusion criteria: * age 4-14 years * medical history with fecal incontinence \>1/week on a non-neurogenic but retentive basis (fulfills rome-iv-criteria) * non-responsive after min. 2 months treatment with polyethylene glycols and behavioral interventions (set times for toilet use) exclusion criteria: * hirschsprungs disease * anorectal malformations * use of medications known to cause constipation (eg. anticholinergics) * former use of low or high volume tai or enemas contraindications for use of minigo-irrigation device: * known stenosis of the rectum or intestinal tract * colorectal cancer prior to surgical removal * acute inflammatory bowel disease * acute diverticulitis * within 3 months of surgical procedures in the rectum or intestinal tract * within 4 weeks of endoscopic polypectomy * ischemic colitis

Keywords: trans anal irrigation retentive fecal incontinence low volume tai
the effect of the erchonia gvl low level laser therapy on neck and shoulder pain

Conditions: Musculoskeletal Pain

Summary: this study is to see if applying green and violet low level laser light to the neck and shoulders can help to reduce pain in the neck and shoulders.

it is the goal of this single (active) group study to evaluate the efficacy of the erchonia® gvl which simultaneously emits both green (520 nano-meter (nm)) and violet (405 nm) diodes, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

Eligibility criteria:
inclusion criteria: * subject presents with one or more of chronic neck or shoulder pain. * subject is diagnosed with of one or more of osteoarthritis, chronic muscle spasms or cervical and thoracic spine sprain strain. * pain is chronic, having persisted for longer than the past 30 days * self-reported pain rating on the 0-100 visual analog scale (vas) of 50 or greater. * willing and able to refrain from consuming any over-the-counter and/or prescription medication(s) and/or herbal supplements intended for the relief of pain and/or inflammation, including muscle relaxants throughout the course of study participation. * willing and able to refrain from engaging in any non-study procedure therapies throughout the course of study participation, including conventional therapies such as physical therapy, occupational therapy and hot or cold packs, as well as alternative therapies such as chiropractic care and acupuncture * 18 years of age or older exclusion criteria: * current active chronic pain disease: such as chronic fatigue syndrome and fibromyalgia * use of analgesics or muscle relaxants within 7 days prior to study procedure administration. * use of systemic corticosteroid therapy (inhaled and topical corticosteroids permitted), narcotics or botulinum toxin (botox®) injection in the neck/shoulder region within 30 days prior to study procedure administration. * active cancer or treatment for cancer within the last 6 months. * unstable cardiac disease, such as recent cardiac arrhythmia, congestive heart failure or myocardial infarction. * prior surgery to the neck/shoulder region. * known herniated disc injury. * active infection, would or other external trauma to the areas to be treated with the laser medical, physical or other contraindications for or sensitivity to light therapy. * serious known mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years. * pregnant or breast feeding. * participation in a research study within the past 30 days.
effect of acute exercise on cognitive functions and blood markers of brain plasticity in regular chronic cannabis users

Conditions: Cannabis User

Summary: the endocannabinoid system (ecs) is a complex endogenous signaling system made up of transmembrane cannabinoid receptors (cb1 and cb2 receptors), their endogenous lipid-derived ligands (the endocannabinoids - ecbs), and enzymes for ligand biosynthesis and degradation. interestingly, exercise increase plasma aea, one of the most famous endocannabinoid. this increase could be involved in exercise-induced neurogenesis and other beneficial exercise adaptations. chronic cannabis use is associated with alteration of ecs activity. the aim of the study is to compare ecs response to exercise between chronic cannabis users and non-users.


Eligibility criteria:
inclusion criteria: cannabis consumer group: * cannabis consumption \> 100 times in lifetime, last exposure \ 10 times in the month. * positive toxicological urine test for ∆-9-thc. * having a cannabis use disorder according to the cast. healthy group: * negative urine toxicological test for cannabis. * no regular cannabis use for more than 6 months once in a lifetime. * no cannabis consumption in the 6 months preceding the study. exclusion criteria: for all subjects : * disorders of use of other substances (alcohol, cocaine, opioid, or synthetic drugs). * alcohol consumption greater than 30g per day (averaged over one week) and/or alcohol abuse the week preceding the visit. * under medical treatment. * presence of diagnosed neurological disorders. * diagnosis of a psychotic picture entering axis i, dsm-5. * chronic progressive disease or in remission. * body mass index \> 30 kg/m2 (i.e. presence of obesity).
efficacy and safety of vildagliptin compared to rosiglitazone in drug naive patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.


Eligibility criteria:
inclusion criteria: * blood glucose criteria must be met * not currently on drug therapy for type 2 diabetes * body mass index (bmi) in the range 22-45 exclusion criteria: * pregnancy or lactation * type 1 diabetes * evidence of serious diabetic complications * evidence of serious cardiovascular conditions * laboratory value abnormalities as defined by the protocol * other protocol-defined exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin
study of genetic determinants in alcoholic hepatitis and establishment of a multicenter prospective cohort of patients with alcoholic liver disease

Conditions: Alcoholic Liver Disease; Severe Alcoholic Hepatitis; Alcoholic Cirrhosis

Summary: alcoholic hepatitis carries a risk of high mortality at short term, especially in its severe form. its diagnosis is confirmed by liver biopsy. the prevalence of alcoholic hepatitis, severe or not severe, is poorly known and prospective data are needed. the present observational study aims to define the prevalence of alcoholic hepatitis among patients admitted for jaundice and determine their outcome according to the severity. survival and markers of liver dysfunction will be assessed. a biobank including genetic samples will be created to identify the disease profile in terms of inflammation and regeneration. the performance of non-invasive criteria for diagnosis will also be studied.


Eligibility criteria:
inclusion criteria: for sah group: * alcohol consumption : * on average\> 40 g / day for women and 50 g / day for men * duration:\> 5 years * recent jaundice episode (less than 3 months) * bilirubin\> 50 mg / l (85μmol / l) for nsah group: - alcohol consumption : * on average\> 40 g / day for women and 50 g / day for men * duration:\> 5 years for cirrhosis (control) group: * alcohol consumption : * on average\> 40 g / day for women and 50 g / day for men * duration:\> 5 years * unambiguous presence of cirrhosis criteria, including: * clinical signs (ascites, stellar angiomas ...) and / or * radiological signs (scanner or mri: signs of hepatic dysmorphism and / or portal hypertension) and / or * biological signs (increased inr, thrombocytopenia) and / or * endoscopic signs (oesophageal / gastric varices) exclusion criteria: for nah and nsah groups: * presence of another hepatic pathology: evidenced by blood biology, imaging or histology (viral or autoimmune hepatitis, hemochromatosis, wilson's disease) * presence of hepatocellular carcinoma * hiv infection for cirrhosis (control) group: * history established / suggestive of haa (clinical, biological and / or histological criteria) in particular absence of jaundice episode * presence of another hepatic pathology: evidenced by blood biology, imaging or histology (viral or autoimmune hepatitis, hemochromatosis, wilson's disease) * presence of hepatocellular carcinoma * hiv infection

Keywords: cohort alcoholic hepatitis alcoholic cirrhosis pathophysiology bio bank pan-genomic study
randomized study comparing both latest generation self-expanding valves and a minimalist approach vs. standard of care in transcatheter aortic valve implantation

Conditions: Aortic Valve Stenosis

Summary: open-label, 2 x 2 factorial, prospective, randomized, national, multicenter study to compare latest-generation self-expanding valves and a minimalist approach versus standard of care in transcatheter aortic valve implantation.

the purpose of the doubel-choice study is to demonstrate non-inferiority of a latest-generation self-expanding valve (sev) (acurate neo2, boston scientific, marlborough, ma, usa) in comparison to another latest-generation sev (evolut pro, pro+ and fx, medtronic inc., minneapolis, mn, usa) and of a minimalist approach vs. standard of care with respect to safety and efficacy in patients with severe symptomatic aortic stenosis undergoing transfemoral tavi.

Eligibility criteria:
inclusion criteria: * severe symptomatic aortic valve stenosis (ava ≤1 cm² or 0.6 cm²/m²) with indication for transcatheter aortic valve implantation according to heart team consensus * perimeter-derived native aortic valve annulus diameter measuring 21-27 mm * heart team consensus that the patient is anatomically suitable for both device types * suitability for transfemoral vascular access * written informed consent exclusion criteria: * life expectancy \<12 months due to comorbidities * native aortic valve annulus \ 27 mm * bicuspid aortic valve * cardiogenic shock or hemodynamic instability * active endocarditis * contraindications for transfemoral access * active peptic ulcer or upper gastro-intestinal bleeding \<2 weeks * hypersensitivity or contraindication to aspirin, heparin or clopidogrel * contraindication for a specific treatment strategy (minimalist approach vs. standard of care) as judged by the heart team * clear patient-specific clinical or anatomic reasons to prefer one treatment strategy or valve type over the other * active infection requiring antibiotic treatment * age \<18 years * participation in another interventional trial where the primary endpoint has not been reached

Keywords: tavi acurate neo2 evolut pro local anesthesia conscious sedation monitored anesthesia care minimalist approach
vascular effects of high-salt after preeclampsia

Conditions: Preeclampsia; Preeclampsia Postpartum

Summary: women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life, even if they are otherwise healthy. importantly, women who had preeclampsia have an exaggerated vascular responsiveness to hypertensive stimuli, such as high-salt intake, compared to women who had a healthy pregnancy. the reason why this occurs is unclear but may be related to impaired endothelial function and dysregulation of the angiotensin system that occurs during the preeclamptic pregnancy and persists postpartum, despite the remission of clinical symptoms. while the association between a history of preeclampsia and vascular dysfunction leading to elevated cvd risk is well known, the mechanisms underlying this dysfunction remains unclear. the purpose of this study is to examine the role of vascular mineralocorticoid receptor, the terminal receptor in the angiotensin system that contributes to blood pressure regulation, in mediating exaggerated microvascular endothelial dysfunction before and after a high-salt stimulus. this will help us better understand the mechanisms of microvascular dysfunction these women, and how inhibition of these receptors may improve microvascular function. in this study, we use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) we examine the blood vessels in a nickel-sized area of the skin.


Eligibility criteria:
inclusion criteria: * women who had preeclampsia and women who did not have preeclampsia * 12 weeks to 5 years postpartum * 18-45 years old exclusion criteria: * history of hypertension or metabolic disease before pregnancy * history of gestational diabetes * history of gestational hypertension without preeclampsia * skin diseases * current tobacco use * current antihypertensive medication * statin or other cholesterol-lowering medication * currently pregnant * body mass index less than 18.5 kg/m2 * allergy to materials used during the experiment.(e.g. latex), * known allergy to study drugs or salt-supplement
real-world experience on using nemolizumab in the treatment of moderate-to- severe prurigo nodularis in adults

Conditions: Prurigo Nodularis

Summary: the main aim of this study is to assess real-world effectiveness of nemolizumab in prurigo nodularis (pn) as measured by investigator and patient reported outcome (pro) in clinical practice at month 6.

this prospective, multicenter, non-interventional study (nis) seeks to evaluate pn treatment with nemolizumab (nemluvio®) in adults over an approximately 12 month period using physician assessments in routine clinical practice and pro measures. treatment with nemolizumab will be determined solely by the participant's physician prior to study enrollment. no additional visits, procedures, or laboratory tests are required outside of routine clinical practice. the visit structure is not defined by the study protocol but is determined by routine medical practice. the visit schedule is intended to facilitate a systematic data assessment according to clinical routine. a sub-study will be completed in germany and the uk at selected sites in which participants will complete the peak pruritus (pp) numerical rating scale (nrs) and sleep disturbance (sd) nrs on a daily basis from day -1 to day 14. data collection will occur remotely and no clinic visits will be required.

Eligibility criteria:
inclusion criteria: * participants who, according to the treating physician's decision and in line with the local package label, are newly initiated on nemolizumab (nemluvio®) for the treatment of pn. * participants greater than or equal to (\>=) 18 years of age. * participants who signed the written informed consent form (icf). exclusion criteria: * have contraindication(s) for the use of nemolizumab (nemluvio®) according to the local package label; * participants who received treatment with a drug under clinical development/ investigation within 3 months prior to baseline. * participants who received nemolizumab previously. * participants who are mentally, physically, or linguistically unable to understand the content of the icf and/or to complete the study questionnaires.
3d ultrasound breast imaging

Conditions: Breast Tumor

Summary: the purpose of this research is to study the efficacy of a new ultrasound imaging method for diagnosis of breast mass.


Eligibility criteria:
inclusion criteria: * adult women ≥ 18 years of age. * solid breast lesion and ultrasound guided biopsy (either as part of their clinical care or through participation in other irb-approved studies) * lesion size of 3mm or larger exclusion criteria: * \< 18 years of age. * lacking capacity to consent * pregnant or lactating * receiving cancer therapy such as chemotherapy or radiation therapy
prospective acute myocardial infarction data bank

Conditions: Acute Myocardial Infarction

Summary: in order to accelerate border crossing between basic research and clinical research in acute myocardial infarction, it is necessary to easily use clinical and biological data. that is the reason why it is very important to create a clinical, biological and pathologic database of acute myocardial infarction, mainly prospective. all data are from patients treated in 5 centers in shanghai，including zhongshan hospital of fudan university, shanghai renji hospital，shanghai tenth people's hospital，shanghai first people's hospital, and shanghai tongji hospital.


Eligibility criteria:
inclusion criteria: * acute myocardial infarction was diagnosed based on the fourth universal definition of acute myocardial infarction criteria. the term acute myocardial infarction should be used when there is acute myocardial injury with clinical evidence of acute myocardial ischaemia and with detection of a rise and/or fall of ctn values with at least one value above the 99th percentile url and at least one of the following: symptoms of myocardial ischaemia; new ischaemic ecg changes; development of pathological q waves; imaging evidence of new loss of viable myocardium or new regional wallmotion abnormality in a pattern consistent with an ischaemic aetiology; identification of a coronary thrombus by angiography or autopsy. exclusion criteria: * life expectancy of less than 12 months * malignant tumor * pregnancy or plans of pregnancy in the one year * any anticoagulation therapy such as heparin within 24 hours of baseline blood sampling
non-inferiority study of zk-a03 in treatment of herpes zoster before and after the alteration of the active ingredient manufacturer

Conditions: Herpes Zoster

Summary: the goal of this clinical trail is to demonstrate the non-inferiority of recombinant human interferon α-2b gel (zk-a03) after changing the manufacturer of the active ingredient in patients with herpes zoster. this double-blind study will enroll approximately 368 adult patients with herpes zoster in china. eligible patients will be assigned randomly at a 1:1 ratio. for each patient who is included, treatment may last up to 10 days. during the study, subjects will be treated with recombinant human interferon α-2b gel (either before or after the alteration of the active ingredient manufacturer), at a frequency of four times a day, together with a background therapy of valaciclovir hydrochloride.


Eligibility criteria:
main inclusion criteria: 1. men and women aged between 18 and 70 years old. 2. diagnosed as herpes zoster. 3. time to appearance of lesions ≤ 72 hours prior to the first dosing (lesions may represent as: erythema, papules or blisters), lesion area ≤ 3% body surface area (bsa). 4. self-rated numerical rating scale (nrs) in pain ≤ 6. 5. negative serum pregnancy test for women of reproductive age. birth control from first dosing until 1 month after last dosing for all men and women of reproductive age. 6. subjects must have signed an informed consent form (icf). main exclusion criteria: 1. diagnosed as herpes zoster on face, visceral herpes zoster, herpes zoster meningitis, disseminated herpes zoster, zoster sine herpete or blood blisters and necrosis. 2. the lesion is complicated with other skin diseases that may affect the evaluation of efficacy, 3. skin lesions combined with severe bacterial or fungal infections. 4. use of antiviral or analgesic therapy for herpes zoster within 2 weeks prior to the first dosing. 5. known allergies to recombinant human interferon α-2b and chemical structure analogs, valaciclovir or history of any drug, food or other allergy. 6. liver and/or renal disfunction，ie. alanine aminotransferase (alt), aspartate transaminase (ast) \> 2 times of upper normal limit（uln）; creatinine clearance rate (ccr) \< 50 l/min. 7. combined with immunodeficiency disease or require long-term glucocorticoid or immunosuppressive drugs. 8. combined with severe cardiovascular, respiratory, gastrointestinal or neurological disorders and remains unstable after treatment. 9. history of psychiatric illness or inability to fully comply to the protocol. 10. use of another investigational product within 4 weeks prior to the first dosing. 11. pregnant or lactating women. 12. other conditions deemed by the investigator to be inappropriate for participation in this trial.
closing the gap in care in seronegative inflammatory arthritis

Conditions: SpA; PsA

Summary: rheumatologists treating patients with seronegative arthritis will be randomized to treat their patients to a target or to treat their patients under their usual standard of care. all physicians will perform an initial chart audit. following the initial chart audit, all physicians in the treat-to-target group will receive accredited educational training. six months after the initial chart audit, all physicians will perform a repeat audit to see if patients are assessed more systematically and treated to a target of low disease state.


Eligibility criteria:
inclusion criteria: * canadian rheumatologist exclusion criteria:

Keywords: seronegative inflammatory arthritis spa psa randomized behavioural change