Kornimate/medical-research-clean huggingface dataset:
probiotics in patients with moderate-to-severe distention/ bloating from systemic sclerosis

Conditions: Scleroderma

Summary: organs of the gastrointestinal tract include the mouth, throat, stomach, intestines, and anus. patients with scleroderma often have git disorders. git disorders can be severely debilitating and even life-threatening. some problems associated with git disorders may include heartburn, loss of voice or hoarseness, ulcers (open sores), difficulty swallowing, constipation, diarrhea, malabsorption (impaired absorption of nutrients from the gi tract), diminished peristalsis (decreased in the wavelike motion in the muscles of the intestines), and the inability to control your bowel movements. probiotics are the "good bacteria" normally found in your digestive tract. our group is looking at whether or not taking daily probiotics (lactobacillus) can help alleviate some of these symptoms in scleroderma patients that have git disorders.


Eligibility criteria:
inclusion criteria: 1. adult patient ≥18 years. 2. patients with ssc with moderate-to-severe distention/bloating on git 2. scale (scale score \>1.00). 3. stable immunosuppressive therapy(ies) for ≥ 1 month. 4. stable ppi and/or other anti-reflux medications for ≥ 1 month. 5. stable calcium channel blocker for ≥ 1 month. 6. stable nsaid for ≥ 1 month. 7. stable dose of pro-motility agent for ≥ 1 month. exclusion criteria: 1. recent diagnosis for small intestinal bacterial overgrowth (sibo) during last 1 month. 2. treatment with antibiotics within last 2 weeks. 3. currently receiving chemotherapy (pulse cyclophosphamide). it is acceptable to be on methotrexate, mycophenolate mofetil, hydroxychloroquine, or azathioprine. 4. severe diarrhea (diarrhea scale score of ≥ 1.01; may suggest untreated sibo). 5. history of inherited or acquired immunodeficiency -

Keywords: scleroderma gastrointestinal bloating reflux
comparison of time taken to diagnose intraoperative coagulopathies using vet and scl

Conditions: Arthritis of Knee; Arthritis of Hip; Spine; Prostate Cancer; Hepatic Cancer; Valvular Disorder; Ischemic Heart Disease; Aortic Diseases

Summary: the present study is a prospective multi-center observational trial comparing the time it takes to diagnose coagulopathies due to intraoperative bleeding using point-of-care (poc) viscoelastic tests or standard central laboratory tests (scl tests).

the present study is a prospective multi-center observational trial comparing the time for diagnosing coagulopathies due to intraoperative bleeding using poc viscoelastic tests, such as rotational thromboelastometry (rotem) and thromboelastography (teg) and standard central laboratory tests (scl test, such as pt-inr, aptt, s-fibrinogen level, platelet count). the study will be performed during surgeries that are expected to entail a moderate to severe amount of bleeding and warrant the use of either poc viscoelastic tests, scl tests, or both to determine the possible association of coagulopathy. the tests will be conducted when an intraoperative condition requires identifying possible associations of coagulopathies during and after surgical bleeding. the test results will prompt appropriate coagulation management. the primary objective is to compare the diagnosis time for intraoperative coagulopathy upon using the poc viscoelastic test or scl test. the time will be defined as the time lapsed from obtaining a blood sample for the poc viscoelastic test or scl test to acknowledging the test results. researchers hypothesized that using poc viscoelastic tests would shorten the time for diagnosis compared to scl tests.

Eligibility criteria:
inclusion criteria: * patients who will undergo elective surgery with a high risk of moderate to severe amount of intraoperative bleeding or coagulopathy (e.g., cardiac surgery, joint replacement, spine surgery, hepatectomy, radical prostatectomy) * patients who provide written informed consent * patients who may warrant the intraoperative use of poc viscoelastic test or scl test exclusion criteria: * pregnancy * withdrawal of consent * termination of surgery without performing either poc viscoelastic test or scl tests * when the study conductor deems it inappropriate to proceed with the protocol with the patient

Keywords: viscoelastic test standard central laboratory test coagulation
passive mobilization and vascular function

Conditions: Endothelial Dysfunction; Aging; Bed Rest

Summary: with aging, vascular function (vf) declines. inactivity and sedentary life style have been shown to contribute to the worsening of vf. furthermore, bed rest, a condition commonly used for the management of many chronic conditions, has been proven to lead to even more deleterious consequences, including vf decline. this study evaluates the effect of passive mobilization of the lower limbs on vf in bedridden oldest-old. half of the participants will undergo passive mobilization treatment in addition to standard therapies, while the other half will receive only standard therapies. we hypothesize that passive mobilization may improve nitric oxide (no)-mediated endothelial function.

normally, cardiovascular function declines with age. furthermore, cardiovascular function declines with immobility, promoting other adverse effects such as postural hypotension, impaired cardiac function, and thrombogenic events. bed rest, a condition normally used in the management of many chronic pathologies in elderly people, leads to significant functional decline, reduction in physiologic reserve of most of the organ systems, including further cardiovascular decline. fortunately, several studies have suggested interventions that may counteract immobility-induced cardiovascular dysfunction and ensure beneficial adaptations in the aging population. for example, passive mobilization of the limbs has been shown to improve cardiovascular function in bedridden oldest-old. however, the effect of passive mobilization on no-mediated endothelial function have not been studied yet. thus, the main aim of the study is to determine whether passive mobilization is an effective strategy to counteract endothelial dysfunction in bedridden oldest-old. for this purpose, bedridden individuals will be recruited and randomly assigned to two groups: one group will undergo passive mobilization treatment (pm) in addition to standard therapies, the other group (ctrl) will undergo standard therapies only. on the basis of preliminary data on a subgroup of ten participants, a sample of eighteen individuals will be allocated in each group so to reach a statistical power \>0.80 and an alpha \<0.05. the pm treatment will include knee flexion-extension and it will be performed for 30 minutes, 2 times a day, 5 days a week for 4 weeks. before, after the 4-week treatment, and 1 month after the end of the treatment no-mediated endothelial function of all participants will be evaluated by means of flow-mediated dilation and passive limb movement tests.

Eligibility criteria:
inclusion criteria: * bedridden exclusion criteria: * neurodegenerative disease (i.e.parkinson's disease, alzheimer's disease) * heart failure * organ transplantation * liver failure * kidney failure * hemorrhage * neuromuscular diseases

Keywords: flow-mediated dilation passive limb movement
a pan-canadian, retrospective evaluation of mitraclip safety and efficacy

Conditions: Mitral Regurgitation

Summary: the premise registry is a retrospective, observational study that will evaluate the efficacy and safety of the mitraclip in real-world canadian practice. it will include all patients who have undergone mitraclip implantation in canada to date.

in addition to evaluating efficacy and safety, premise will include a description of patient demographics, etiology of mitral regurgitation, co-morbidities, medication use and functional class. it will also compare re-hospitalization for heart failure 12 months prior and 12 months after the procedure.

Eligibility criteria:
inclusion criteria: * patient has undergone percutaneous mitral valve repair with mitraclip clip delivery system in canada exclusion criteria: * none

Keywords: mitraclip degenerative mitral regurgitation
characteristics of t cells from alopecia areata scalp skin before and after treatment with aldara 5%

Conditions: Alopecia Areata

Summary: it is thought that alopecia areata occurs as the result of an inappropriate response of the body's own immune system to certain substances in or around the hair follicle. we will be examining the efficacy of aldara cream 5% in treating extensive alopecia areata and observe its affect on the hair follicle.

we will examine how the application of aldara cream 5% daily for 6 months will affect the hair follicle and the inflammation present in the skin of patients with alopecia areata. in the study we will obtain additional scalp biopsies to examine how the drug affects the quality and state of activity of the immune cells in the biopsy specimens. this type of information will provide data about the behavior of these inflammatory cells in mediating the hair loss associated with alopecia areata and how this behavior may be effected by aldara cream 5% treatment. such information may be valuable to the successful management of alopecia areata.

Eligibility criteria:
inclusion criteria: * must be in good health. * no topical or systemic treatment for alopecia areata for at least 2 weeks prior to study initiation. * must be at least 18 years of age and older * will have to have extensive scalp alopecia areata (\>95% involvement) of less than 2 years duration. * willing to refrain from other alopecia areata treatments during the course of the study. * will have to agree to shampoo their scalp daily with free and clear shampoo. participant in "aldara for the treatment of extensive alopecia areata" study. exclusion criteria: * history of any illness or condition that in the opinion of the investigator might confound the results of the study or pose additional risk to the patient * significant abnormalities on screening clinical evaluation. * previous use of aldara cream 5%. * a history of drug or alcohol abuse. * use of uv radiation including tanning beds and puva therapy for treatment of acne, psoriasis, or any other skin condition within 2 months prior to study initiation. * use of systemic or topical glucocorticoids, corticosteroids, estrogenic, progestogenic, androgenic or antiandrogen drugs, cyclosporine, fk506 or immunotherapy with dncb,sadbe or dcp within 6 months of study initiation. * alterations in thyroid medication within 6 weeks of study initiation. pregnant or nursing females. not participating in the "aldara for the treatment of extensive alopecia areata" study.
trial of direct home delivery of colorectal cancer screening kit without pre-ordering

Conditions: Colorectal Cancer

Summary: the effect of mailing fit with the invitation on participation and colonoscopy rates will be evaluated in a randomized controlled trial conducted in the centre-val de loire (cvl) region, involving 64,000 people from the population eligible for colorectal cancer population-based organised screening program (crc-pbosp). in the "c" control group, invitations, test delivery and reminders will be carried out in accordance with the crc-pbosp rules at the time of the study. intervention group "b" will evaluate two experimental modes of invitation with direct home mailing of the test: * method "b1": invitation with test sent to home without prior information letter * method "b2": information letter followed by invitation with test sent home, designed to optimize participation by first-time subjects (aged 50-51) invited to the crc-pbosp for the first time. ancillary studies will focus 1/ on acceptability of this intervention (qualitative study on a few general practitioners, gastroenterologists and invitees), 2/ on social and geographical inequalities of participation on a subsample of individuals included in expedit study using ecological indices (edi, scale).


Eligibility criteria:
inclusion criteria: * 50 to 74 years old * resident of centre val de loire french area * eligible for crc screening invitation within the biennal crc-pbosp during the inclusion period * affiliated to the health insurance scheme exclusion criteria: * crc screening exclusion criteria notified to crcdc-cvl in a previous screening round (family or personal history of crc/adenoma, inflammatory bowel disease) * colonoscopy in the previous 5 years) subjects refusing data transmission to research team will be excluded from statistical analyses.

Keywords: screening participation
comparison of solifenacin and oxybutynin in the treatment of overactive bladder

Conditions: Overactive Bladder

Summary: null hypothesis of the trial is that there is no difference between solifenacin and oxybutynin with respect to efficacy, side effects, patient satisfaction and quality of life measures in patients with overactive bladder.

in this two-month follow-up study, the patients with overactive bladder will be randomly assigned into two groups (solifenacin or oxybutynin in their usual doses) and will be assessed with respect to baseline characteristics and complaints before treatment. after initiation of the treatment at first and second months follow-up visits the patients will be reassessed with respect to compliance, satisfaction, degree of improvement, reasons for dropouts, number and severity of side effects.

Eligibility criteria:
inclusion criteria: women between 18-70 years of age, diagnosed to have overactive bladder (presence of at least two of the following three main criteria: urgency, urge incontinence, frequency and nocturia) exclusion criteria: presence of stress urinary incontinence, patients who are still using a drug for overactive bladder, pregnant women, women in postpartum period (women on lactation), patients who have closed angle glaucoma, patients with chronic constipation, having allergy to the ingredients of the drugs, patients having the contraindicated conditions listed in the printed instructions of the drugs. -

Keywords: overactive bladder solifenacin oxybutynin
effect of simethicone on eustachian tube dysfunction

Conditions: Otitis Media

Summary: this study is designed to measure the effects of a chewable simethicone tablet taken by mouth on middle-ear pressure in adults with a common cold and evidence of abnormal middle-ear pressure. in children and adults, middle-ear diseases such as otitis media (the buildup of fluid within the middle ear) and a form of temporary hearing loss occur if the eustachian tube does not open, does not open often enough or is always open. simethicone, available over-the-counter under several brand names including gas-x, may help break up the bubbles that may block the opening of the eustachian tube in the back of the nose during a cold, allowing air to pass between the nose and middle ear. this study requires a single visit to the middle ear physiology laboratory in the oakland section of pittsburgh. if eligible for the study, eustachian tube function testing will be done; the simethicone tablet or placebo (a tablet that looks and tastes like the simethicone tablet but has no active ingredient) will be given and eustachian tube function testing repeated.

for the eustachian tube function testing, the subject and a technician are seated comfortably within a pressure chamber, a room-like chamber in which the air pressure can be varied much like in an airplane or submarine. middle ear pressure will be measured in each ear by tympanometry, a test done by inserting a small probe (an earplug attached to a rubber or plastic tube that measures ear pressure) half-way into the ear canal and changing the pressure in the probe. then, microphones will be placed in the ear canals and a sound source placed into one nostril. the chamber pressure is then decreased and increased to various pressures and middle ear pressure is measured at these various pressures.

Eligibility criteria:
inclusion criteria: * age 18 to 50 years * healthy subjects other than current upper respiratory tract infection ("cold") * jackson score of 6 on screening * subject reports symptom onset within 4 days of entry visit * unilateral or bilateral middle-ear pressure \<-50 mmh2o exclusion criteria: * otoscopic diagnosis of unilateral or bilateral otitis media * presence of tympanostomy tubes or tympanic membrane perforations bilaterally * asthma or any chronic medical disease or condition * use of an "over the counter" medicine within 24 hours of study or prescription within 4 weeks of the study day (except birth control) * use of an experimental drug within 3 months of study * an unusual or allergic reaction to simethicone, food dyes, or preservatives * pregnancy or breast feeding * ear surgery other than tympanostomy tube insertion

Keywords: eustachian tube otitis middle-ear pressure simethicone
randomised trial between lhm alone vs lhm with anterior fundoplication in achalasia cardia

Conditions: Achalasia Cardia

Summary: back ground: achalasia cardia (ac) manifests with major symptom dysphagia. surgery as the treatment modality relieves dysphagia in most of the patients. laparoscopic heller's myotomy(lhm) is the surgery of choice but is associated with gastroesophageal reflux. anterior fundoplication (dor fundoplication) is usually combined with lhm in patients with ac. it reduces gastroesophageal reflux following lhm. it has been observed that along with reduction of gastroesophageal reflux dor fundoplication also affects relief of dysphagia. but it has not been prospectively studied. hypothesis:the hypothesis of present study is that "frequency of dysphagia following laparoscopic heller's myotomy with dor fundoplication is more than that compared to laparoscopic heller's myotomy alone in patients with achalasia cardia". methods: from december2017 to november 2018 minimum of 20 patients with diagnosis of achalasia cardia will be randomized to receive either laparoscopic heller's myotomy (lhm) alone or lhm with dor fundoplication. symptomatic outcomes would be assessed using frequency of dysphagia and eckardt's score. . outcomes: primary outcome is frequency of dysphagia and secondary outcome is manometry pressure assessment. statistical analysis would be done using statistical package for the social sciences (spss) soft ware. p value \< 0.05 is considered significant.


Eligibility criteria:
inclusion criteria: * all adult patients (18 years or more) with achalasia cardia exclusion criteria: * patients of achalasia with axis deviation * patients with history of pneumatic dilatation * patient with other associated motility or non motility disorders * patients with pseudoachalasia prior gastric or esophageal surgery

Keywords: achalasia, lhm, anterior fundoplication
phase i/ii study of oral s-1 plus irinotecan in patients with advanced gastric cancer

Conditions: Gastric Cancer

Summary: to assess the usefulness of irinotecan plus s-1 therapy based on the antitumor effect and survival period. by performing a phase i/ii study of this combination in patients with inoperable or with postoperative gastric cancer

a multicenter open-label, single-arm, phase i/ii clinical trial is conducted on patients with histological stage iv gastric cancer given irinotecan plus s-1. the usefulness of this regimens as 1st line therapy for gastric cancer was evaluated by the disease-free survival rate (dfr), overall survival rate (os), incidence and severity of adverse event.

Eligibility criteria:
inclusion criteria: ・ eligibility criteria 1. histological diagnosis of gastric adenocarcinoma. 2. measurable or assessable lesions. 3. age: 18 \~ 75 years. 4. performance status (ecog): 0 \~ 2. 5. no prior chemotherapy or only one regimen of previous chemotherapy (with a washout period \>4 weeks after the final day of the previous therapy). adjuvant chemotherapy is not defined as previous therapy. 6. no history of treatment with cpt-11 or s-1. 7. no history of radiotherapy to the abdomen. 8. oral intake of s-1 is possible. 9. adequate function of major organs (bone marrow, heart, lungs, liver etc.). wbc 3,500/mm3 and 12,000/mm3. hb 10.0 g/dl. platelet count 100,000/mm3. got and gpt 2.5times the upper limit of normal (excluding liver metastasis). t-bil 2.0mg/dl. creatinine \<1.5 mg/dl (but if it is 1.0 \~ 1.5 mg/dl, the dose of s-1 can be decreased according to the dose reduction criteria to allow registration in the trial). normal ecg (not considering clinically unimportant arrhythmias and ischemic changes). 10. predicted survival for \>3 months. 11. able to give written informed consent exclusion criteria: 1. severe pleural effusion or ascites. 2. metastasis to the central nervous system (cns). 3. active gastrointestinal bleeding. 4. active infection. 5. diarrhea (watery stools). 6. uncontrolled ischemic heart disease. 7. serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure). 8. active multiple cancer. 9. severe mental disorder. 10. pregnancy, possible pregnancy, or breast-feeding. 11. flucytosine treatment 12. gilbert's syndrome. 13. judged to be ineligible for this protocol by the attending physician.

Keywords: irinotecan, s-1, phase i/ii, gastric cancer
vacuum assisted wound closure and permanent on-lay mesh-mediated fascial traction in patients with open abdomen

Conditions: Open Abdomen; Temporary Abdominal Closure; Incisional Hernia

Summary: open abdomen therapy is used in trauma and non-trauma patients where the abdomen is not possible to close, or the intraabdominal conditions is not suitable for closure. in 2007, a new technique that made use of negative pressure wound therapy and mesh-mediated fascial traction for closure of the open abdomen was described from the department of surgery in malmö, sweden. with this new technique, fascial closure rates were high but long-term incisional hernia formation was seen in approximately half of the patients alive after five years. to overcome the high incisional hernia incidence, a new technique utilizing a permanent on-lay mesh for traction and reinforcement of the incision at fascial closure was developed. hypothesis lower incisional hernia rates in comparison with literature reported results of other techniques for open abdomen treatment, with similar complication rates. aims to evaluate early and late clinical outcome of the novel vacuum-assisted wound closure and permanent on-lay mesh-mediated fascial traction technique. design a prospective six-center cohort study in sweden and denmark. study inclusion during a two-year period or longer to include at least 100 patients. statistical analysis will be done by intention-to-treat and as sub-group per-protocol analysis.


Eligibility criteria:
inclusion criteria: • all patients ≥18 years old treated with an open abdomen with a midline incision, regardless of indication. exclusion criteria: * patient declining participation * existing incisional hernia or primary ventral hernia ≥3 cm * existing mesh in the abdominal wall, located in the midline and irrespective of mesh size * existing ostomy/parastomal hernia located in a position that prevents the vawcpom technique to be utilized * closure of the abdomen at first dressing change, e. g. without mesh traction