Kornimate/medical-research-clean huggingface dataset:
intervention to support participation in regular exercise in the elderly (inspire)

Conditions: Chronic Illnesses

Summary: the investigators will conduct a 1-year prospective and randomized study to evaluate the initial efficacy of positive affect vs. an educational control to motivate physical activity in older adults with high burdens of chronic disease.

older adults with multiple chronic diseases are at high risk for both disability and adverse clinical events, outcomes that can be improved with physical activity, but there have been no trials to establish physical activity recommendations or clinical guidelines for this vulnerable population. a recent randomized controlled trial conducted by dr. peterson established the efficacy of inducing positive affect-a feeling of happiness and well-being-in motivating physical activity in older adults with cardiovascular disease. this new randomized controlled trial will pilot test the a new paire (positive affect induction for regular exercise) intervention that is specific to older adults with multiple high-risk chronic illnesses versus an educational control group. this work is innovative because it will translate the benefits of a proven intervention focused on positive affect to increase physical activity in older adults with multiple high-risk chronic illnesses, one that is tailored to the clinical and psychosocial challenges of this particularly vulnerable population. this work is significant because an effective intervention promoting physical activity will improve outcomes for older adults with multiple high-risk chronic diseases, and currently one does not exist.

Eligibility criteria:
inclusion criteria: * charlson index greater or equal to 3 exclusion criteria: 1. cognitive impairment 2. inability to walk 3. \< 12 month anticipated survival 4. enrollment in other behavioral programs 5. lack of medical approval to participate 6. substance/alcohol dependence or participation in a substance abuse treatment program within 12 months 7. major psychiatric illness.

Keywords: physical activity, positive affect, older adults, aging
is there any correlation between plasmatic zonulin and expression of intestinal tight junction proteins in ibs patients?

Conditions: Irritable Bowel Syndrome

Summary: increased intestinal permeability is one of the main pathophysiological mechanisms involved in irritable bowel syndrome. the expression of some intestinal tight junction proteins is decreased mostly in ibs-diarrhoea patients. this decrease is correlated with increased intestinal permeability. currently, no test used in clinical practice could assess intestinal permeability. we hypothesis plasmatic zonulin could reflect intestinal permeability in ibs patients.

the goal of our study is to look for a correlation between plasmatic zonulin and increased colonic permeability (assessed by the expression of intestinal tight junction proteins by western blot) in ibs patients and to look for a role of intestinal low-grade inflammation and microbiota. population : ibs patients with diarrhoea or ibs with constipation or mixed with worsening of symptoms outcomes measures : plasmatic zonulin (elisa kit) occludin expression in colonic biopsies (western blot)

Eligibility criteria:
inclusion criteria: * ibs-diarrhoea, ibs-constipation or alternating with recent worsening of symptoms, according to rome iii criteria * effective contraception since 1 month for women in childbearing age exclusion criteria: * patients with organic and/or inflammatory digestive disease * ibs with constipation or alternating without clinical warning sign * treatment such as anti-inflammatory, probiotic in the last three months * severe renal failure * hypersensitivity to normacol * patient with blood dyscrasia disorder known or identified, anticoagulant or antiplatelet treatments * anal pathology (anal fissure, hemorrhoidal thrombosis) * pregnant or breastfeeding women * person with administrative or judicial decision or under legal protection measure * patient participating in another trial in the last two weeks

Keywords: plasmatic zonulin irritable bowel syndrome intestinal permeability
migraine inducing effect of levcromakalim in patients with migraine with aura

Conditions: Headache, Migraine; Aura

Summary: to investigate the migraine inducing effect of levcromakalim in patients with migraine with aura.


Eligibility criteria:
inclusion criteria: * migraine with aura patients of both sexes. * 18-70 years. * 50-100 kg. exclusion criteria: * headache less than 48 hours before the tests start * daily consumption of drugs of any kind that investigator deems might affect study results or safety. * pregnant or nursing women. * cardiovascular disease of any kind, including cerebrovascular diseases. * tension type headache (tth) according to international classification of headache disorders version 3 more than 5 times a month on average during the past year * known cluster headache according to international classification of headache disorders version 3. * psychiatric disorder * smoking or abuse of drugs or alcohol * hypertension (systolic blood pressure \>150 mmhg and/or diastolic blood pressure \>100 mmhg) on day of inclusion. * hypotension (systolic blood pressure \<90 mmhg and/or diastolic blood pressure \<50 mmhg) on day of inclusion.

Keywords: levcromakalim
large-bore mechanic thrombectomy for the treatment of symptomatic portomesenteric vein thrombosis

Conditions: Thrombosis; Thrombectomy; Portal Vein

Summary: a single site study evaluating the safety, feasibility, and effectiveness of percutaneous large-bore mechanical thrombectomy using the inari triever aspiration catheter for the treatment of portomesenteric vein thrombosis (pmvt).

this is a single center, prospective, investigator-initiated observational study of adults undergoing mechanical thrombectomy as part of clinical care for portomesenteric vein thrombosis (pmvt).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years, * pmvt diagnosed on cross-sectional imaging such as contrast-enhanced ct or mri abdomen * symptomatic pmvt (persistent symptom, worsening abdominal pain after initiation of anticoagulation, development of peritonitis, complication of portal hypertension in cirrhosis (variceal bleeding or worsening ascites), and poor surgical candidates * speaks and understands english language exclusion criteria: * age \< 18 years * no pmvt diagnosed on cross-sectional imaging such as contrast-enhanced ct or mri abdomen * malignant pmvt * chronic pmvt including presence of cavernoma and network of prominent collateral vessels in porta hepatis on cross-sectional imaging. * asymptomatic pmvt * life expectancy \< 6 months * does not speak or understand english language
exposure to potential cytochrome p450 pharmacokinetic drug-drug interactions among osteoarthritis patients: incremental risk of multiple prescriptions

Conditions: Chronic Low Back Pain

Summary: using a retrospective analysis of a large commercial claims database and a medicare database, the investigators evaluated ddes that have the potential to cause ddis among chronic low back pain (clbp) patients on long-term opioid analgesia, which metabolizes through the cyp450 enzyme system, concomitant with other cyp450-metabolized drug(s).


Eligibility criteria:
inclusion criteria: * chronic low back pain exclusion criteria: * pregnancy

Keywords: retrospective chronic low back pain
mesalazine and/or lactobacillus casei in the diverticular disease of the colon

Conditions: Diverticular Disease of the Colon

Summary: this is a multi-centre, randomised, double blind, double-dummy, parallel groups, placebo-controlled trial was conducted in a population of patients suffering from symptomatic uncomplicated diverticular disease in order to investigate which is the best treatment in preventing relapses of the disease. patients were randomly divided in double-blind fashion in one of the following groups: group a. active mesalazine 800 mg, 2 tablets/day for 10 days/month plus lactobacillus casei placebo, 1 sachet/day for 10 days/month; group b. active lactobacillus casei, 1 sachet/day for 10 days/month plus mesalazine 800 placebo, 2 tablets/day for 10 days/month; group c. active mesalazine 800 ng, 2 tablets/day plus active lactobacillus casei, 1 sachet/day for 10 days/month; group d. mesalazine 800 mg placebo, 2 tablets/day and lactobacillus casei placebo, 1 sachet/day for 10 days/month. the main objective was to assess the safety and the efficacy of mesalazine and/or lactobacillus casei in maintaining remission of symptomatic uncomplicated diverticular disease


Eligibility criteria:
inclusion criteria: * diagnosis of diverticular disease diagnosed for the first time or established by previous colonoscopy * symptomatic episode of uncomplicated diverticular disease no more than 4 weeks prior to study entry * patients who have given their free and informed consent. exclusion criteria: * acute diverticulitis (both complicated and uncomplicated) * diverticular colitis * active or recent peptic ulcer * chronic renal insufficiency * allergy to salicylates * patients with intended or ascertained pregnancy, lactation * women of childbearing age not using contraceptives * lactulose-lactitol use in the two weeks before the enrolment and during the study * presence of diverticulitis complications (fistulas, abscesses, and/or stenoses) * use of probiotic preparations either prescribed or over-the counter within two weeks prior to study entry * inability to give a valid informed consent or to properly follow the protocol * patients with active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment were also acceptable) * recent history or suspicion of alcohol abuse or drug addiction * any severe pathology that can interfere with the treatment or the clinical or instrumental tests of the trial * use of nsaids for one week before and throughout the study period (only paracetamol was permitted).
small intestinal submucosa graft for repair of anterior urethral strictures

Conditions: Urethral Stricture, Male

Summary: the field of research for this study is tissue engineering and the utilization of a small intestinal submucosa graft as a substitute biomaterial for conventional buccal mucosa in substitution urethroplasty of anterior urethral strictures.

urethral stricture refers to the abnormal narrowing of the urethral lumen resulting from fibrosis that affects the urethral epithelium and underlying corpus spongiosum. the management of urethral stricture longer than 2 cm a major therapeutic challenge in clinics. currently available surgical techniques require harvesting of grafts from autologous sites. however, there are numerous disadvantages associated with autografts, such as limited availability and variable quality, donor site morbidity, increased risk of surgical complications; thereby the application of this method is especially limited for large defects. the hypothesis of this study is that the small intestinal submucosa graft can be used as an alternative biomaterial to buccal mucosa for substitution urethroplasty in urethral stricture patients. the aim of this study is to assess safety and efficacy of surgical treatment of patients with anterior urethral stricture using a small intestinal submucosa graft. the follow-up time for all patients in this study was 5 years. the follow-up regimen includes retrograde and pericatheter urethrography, voiding cystourethrography, uroflowmetry, cystoscopy, and voiding symptoms monitoring. telephone follow-up will take place in between these assessments.

Eligibility criteria:
inclusion criteria: * patients signed informed consent form * patients with a single, longer than 2.0 cm and shorter than or equal to 7.0 cm anterior urethral stricture * patients undergoing substitution urethroplasty for urethral stricture. exclusion criteria: * patients without surgical indication * subtotal and total urethral strictures * radiation therapy to the abdomen or pelvis * lichen sclerosis related strictures * patients with previous hypospadias repair * neurogenic urinary tract disorders * mental disorders * patients with a known biologic sensitivity or a cultural aversion to the use of porcine materials. * patients with severe dysfunction of heart, lung, liver, kidney and other important organs , endocrine system and blood system. * patient with malignant tumor * patient who cannot be regularly examined due to any circumstances * any clinical state which does not ensure the safe implementation of study procedure (investigator's view)

Keywords: urethral stricture
a pilot study using rocuronium to prevent intermediate syndrome after organophosphorus insecticide poisoning

Conditions: Organophosphate Poisoning

Summary: organophosphate pesticide poisoning causes close to 300 000 deaths per year worldwide. many patients who ingest organophosphates require ventilation; of these patients approximately 50% die. much of the mortality in these ventilated patients is secondary to intermediate syndrome. this is because op pesticides inhibit acetylcholinesterase, causing an excess of acetylcholine at nerve synapses and the neuromuscular junction (nmj). at the nmj, the excess acetylcholine causes overstimulation and damage, which may lead to sudden respiratory arrest or prolonged ventilation and its associated complications. the investigators believe that blocking these receptors using a neuromuscular blocking agent such as rocuronium will protect the nmj from damage and thus prevent intermediate syndrome and reduce number of intubated days and mortality. in this pilot randomised controlled trial rocuronium, a competitive nicotinic receptor antagonist, will be used to bind to the receptor at the neuromuscular junction and to block the effects of the accumulated acetylcholine. the effects of op pesticide on cholinesterase in the blood will then be monitored and rocuronium withdrawn using sugammadex as the op is eliminated from the body.

primary outcome: number of days intubated

Eligibility criteria:
inclusion criteria: * male or female * age over 16 * clinical diagnosis of op insecticide poisoning * admission to intensive care unit for ventilation * informed consent from family * train of four measurement \> 50% exclusion criteria: * age 16 or under * pregnant * consent not obtained from patient or patient's family

Keywords: organophosphate poisoning intermediate syndrome rocuronium
growth and tolerance of cow milk-based infant formulas

Conditions: Body Weight

Summary: this clinical trial will assess growth, tolerance and adverse events of cow milk-based infant formulas in healthy, term infants.


Eligibility criteria:
inclusion criteria: * singleton, 12-16 days of age at randomization * term infant with birth weight of minimum of 2500 g * solely formula fed * signed informed consent and protected health information exclusion criteria: * history of underlying metabolic or chronic disease or immunocompromised * acute infection * feeding difficulties or formula intolerance
safety and efficacy of sbrt in the reirradiation for ultra-central thoracic malignant tumors

Conditions: Stereotactic Body Radiation Therapy; Irradiation; Reaction; Thoracic Tumor; Recurrent Cancer

Summary: the reirradiation of thoracic tumor is difficult. the possibility of surgery or re course radiotherapy is very small. in the nccn guideline, only systemic treatment is recommended. however, the effective rate of systemic treatment is low. sbrt has the characteristics of high dose in tumor target area and low dose in surrounding normal tissues. in theory, sbrt is more conducive to the protection of normal tissues and can potentially be used in the salvage treatment of recurrent lesions after radiotherapy. even so, sbrt is still controversial in the rescue treatment of recurrent lung cancer after radiotherapy, especially for "ultral-central" lesions close to mediastinal structures (such as bronchus, esophagus and large blood vessels), which have a high probability of fatal side effects. however, a few studies on the application of sbrt in the reirradiation for ultral-central lung cancer have shown acceptable safety and efficacy. generally speaking, there are few studies on sbrt in the treatment of recurrent ultral-central tumor with limited data. the purpose of this study is to further evaluate the efficacy and toxicities of sbrt in the treatment of recurrent ultral-central tumors after radiotherapy.


Eligibility criteria:
inclusion criteria: * pathological diagnosis is malignant tumor. * the location of the target lesion belongs to the ultra-central type of chest. * the target lesion had a history of radiotherapy, and the lesion diameter is ≤ 5cm. * there is no extensive systemic metastasis or although there is metastasis, the metastasis have been controlled by previous treatment. * kps\>70, no serious or uncontrolled underlying diseases, such as severe or uncontrolled hypertension, diabetes, cardiovascular and cerebrovascular diseases and organ dysfunction, and patients are expected to be tolerated by radiotherapy. exclusion criteria: * poor basic pulmonary function or symptom correlation caused by various reasons, unable to lie flat or cooperate with treatment. * the general condition is poor, and the expected survival time is less than 3 months. * psychiatric patients or poor compliance, unable to cooperate to complete treatment. * for other reasons, the researcher believes that it is not suitable to participate in this trial.
a study to evaluate the effect of atg-f on engraftment, graft versus host disease (gvhd) and graft versus leukemia (gvl) effect in haplo-identical sct

Conditions: Allogeneic Haplo-Stem Cell Transplatation (SCT); Graft Versus Host Disease

Summary: this study is planned to evaluated whether atg is needed in haploidentical stem cell transplantation


Eligibility criteria:
inclusion criteria: 1. patient age 3-70 years old with a disease necessitating allogeneic sct. 2. patients must have a mismatched donor willing and capable of donating peripheral blood stem cells and/or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (mismatched defined as 3/6-4/6 hla matching). 3. each patient / patient's guardian must sign written informed consent. 4. patients must have an ecog ps ≤ 2; creatinine \ 40%; dlco \>50% of predicted; serum bilirubin \ 3 x normal values. exclusion criteria: 1. not fulfilling any of the inclusion criteria. 2. active life-threatening infection. 3. overt untreated infection. 4. known hypersensitivity to atg. 5. hiv seropositivity, hepatitis b or c antigen positivity with evidence of active hepatitis. 6. pregnant or lactating women. 7. donor contraindication (hiv seropositive confirmed by western blot hepatitis b antigenemia; positive hcv antibodies with positive hcv pcr; evidence of bone marrow disease; unable to donate bone marrow or peripheral blood due to concurrent medical condition). 8. inability to comply with study requirements.

Keywords: mismatched stem cell transplatation bone marrow transplantation t cell depletion engraftment patients undergoing allogeneic haplo-sct
antioxidant effects of pomegranate juice versus placebo in adults with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: this is a research study designed to look at how pomegranate juice (or a placebo juice) affects the body through the measurement of specific biomarkers, which are indicators of health.

this research study will evaluate how pomegranate juice (or a placebo juice) affects the body. participants will be asked to drink 8 oz. of juice daily for 12 weeks. biomarkers, which are indicators of health, will be measured throughout the study. they are present in blood and urine. the placebo is a juice that is not made from pomegranates, but resembles pomegranate juice in color and taste. eating pomegranates has been shown to have a positive impact on certain biomarkers. recent studies have shown that biomarkers can be indicators of general health. the investigators want to know if drinking pomegranate juice daily for 12 weeks is effective at improving a variety of biomarkers in diabetic adults.

Eligibility criteria:
inclusion criteria: * able to speak and read english * have a diagnosis of type ii diabetes mellitus and currently being treated with oral medication * have an hba1c level ≤9.0% at screening * have an hscrp level ≥ 1.0 at screening * 35 - 70 years old (inclusive) * non-smokers * willing to maintain his/her normal activity and eating patterns for the duration of the study * willing to maintain his/her normal diet for the duration of the study but avoid anti-oxidant rich foods and pomegranate juice (other than what is dispensed to them) exclusion criteria: * allergy to pomegranates * currently using insulin * currently taking steroidal drugs * hiv positive or aids * chronic infectious disease * recent (within 2 weeks of screening) cold/flu, inflammatory illness, or flare-up of gout * cancer treated within the past two years * participation in a therapeutic research study within 30 days of baseline * women who are pregnant, lactating, or planning to become pregnant during the study period

Keywords: diabetes pomegranate biomarkers antioxidant
fluid balance study in sick neonates

Conditions: Very Low Birth Weight Infant

Summary: the purpose of this study is to determine if routinely recording fluid balance in sick neonates admitted to the pediatric ward is reliable and useful. the investigators' hypothesis is that it is not useful and reliable.

fluid balance charts are commonly used, in the netherlands, to assess patient fluid volume status. some disadvantages of recording fluid intake and output are that it is time-consuming and complex. if it would give reliable and accurate information about the fluid volume status there would be a good reason for all this effort. in the few researches that have investigated this subject a low correlation has been found between the fluid balance and the weight changes of an adult patient. own experience gives reasons to doubt about the reliability of the fluid balance in children, not rarely there is a discrepancy between the fluid balance and the weight measurement. we are interested in the relevance of recording fluid balance in neonates.

Eligibility criteria:
inclusion criteria: * sick neonates admitted to the neonatal ward exclusion criteria: * admitted elsewhere before admission to the neonatal ward * indication for recording fluid balance * impossibility to measure the weight every day * no consent parents

Keywords: recording fluid balance reliability utility sick neonate fluid balance inpatient sick