Kornimate/medical-research-clean huggingface dataset:
study comparing rifaximin with xifaxan 200 mg in traveler's diarrhea

Conditions: Diarrhea

Summary: the primary objective is to demonstrate rifaximin 200 milligrams (mg) tablets (test) and xifaxan® 200 mg tablets (reference) are clinically bioequivalent with respect to the clinical cure rates when administered 3 times a day (tid) for 3 days in participants with travelers' diarrhea.

this is a randomized, placebo-controlled bioequivalent study with a clinical endpoint in the treatment of travelers' diarrhea. after 3 unformed stools are recorded within the 24 hours immediately preceding randomization, participants are to be randomized to receive the generic rifaximin 200 mg oral tablet, xifaxan (the reference listed drug)200 mg oral tablet, or placebo 3 times daily for 3 days (that is; on days 1, 2, and 3).

Eligibility criteria:
inclusion criteria: 1. adult male or nonpregnant female aged ≥18 years non-indigenous travelers (for example; visiting students/faculty or international tourists) affected by naturally acquired acute diarrhea. diarrhea is defined as the passage of at least 3 unformed stools in a 24-hour period. stools are classified as formed (retains shape), soft (assumes shape of container), or watery (can be poured). when using this classification, both soft and watery stools are unformed and abnormal. 2. at least 3 unformed stools recorded within the 24 hours immediately preceding randomization. 3. at least 1 of the following signs and symptoms of enteric infection: * abdominal pain or cramps * nausea * vomiting * fecal urgency * excessive gas/flatulence * tenesmus 4. women of child-bearing potential have a negative pregnancy test prior to beginning therapy and agree to use effective contraceptive methods during the study. exclusion criteria: 1. pregnant, breast feeding, or planning a pregnancy. 2. immediately prior to randomization, acute diarrhea for \>72 hours. 3. presence of: * fever (≥100 degrees fahrenheit \[°f\] or ≥37.8 degrees celsius \[°c\]), or * hematochezia (blood in stool), or * clinical findings suggesting moderate or severe dehydration. 4. active, uncontrolled, or clinically significant diseases or disorders of the heart, lung, kidney, gastrointestinal (gi) tract (other than infectious diarrhea in travelers), or central nervous system. 5. administration of any of the following: * any antimicrobial agents with an expected activity against enteric bacterial pathogens within 7 days preceding randomization * more than 2 doses of a symptomatic antidiarrheal compound such as antimotility agents, absorbent agents, and antisecretory agents within 8 hours preceding randomization 6. use of any drug such as aspirin or ibuprofen (advil), which can cause gi bleeding. acetaminophen (tylenol) or paracetamol is acceptable.
joint preserving surgery for correction of spasmodic flat- foot in skeletally mature foot

Conditions: Flat Foot; Rigid; Flat Foot; Spastic

Summary: the investigators want to obtain a functional and radiological outcome of peroneus brevis, tertius and extensor digitorum longus muscles lengthening together with calcaneal osteotomies in the treatment of the spasmodic flat- foot.

one of the most common foot complaints is the "flatfoot" deformity. clinical evaluation of flatfeet primarily focuses on differentiation between the two main types: flexible and rigid. the rigid flatfoot deformity is an uncommon diagnosis (occurring one-third as often as the flexible type) but often is symptomatic and requires treatment". multiple causes of rigid flatfeet have been identified such as rheumatoid arthritis, tarsal coalitions (being the most common cause) that are excluded from that research. triple arthrodesis is used for treatment of rigid flat foot but the patient satisfaction is not good as there is some stiffness in the foot .but here the investigators want to know what is the effect of extensor digitorum longus, peroneus brevis and tertius lengthening together with osteotomies in alignment of spasmodic flat- foot. in patient with rigid flat- foot or spasmodic flat- foot will often have the hind-foot alignment to the outside. alignment of the heel influences how weight-bearing stress is applied to the foot, ankle, knee and hip. so, these patients may benefit from the calcaneal osteotomies and extensor digitorum longus, peroneus brevis and tertius lengthening to improve that alignment.

Eligibility criteria:
inclusion criteria: * painful, incorrectable pes plano valgus after failure of conservative treatment * age: patients with skeletally mature foot as proved by x-ray exclusion criteria: * coalition bar * ankle subtalar joint arthritis. * previous foot fractures. * severe trophic skin disorders * standard contraindications to any surgery such as poor circulation, concurrent infection, other co-morbidity".
a prospective case series analysis of initial users of the urovac device

Conditions: Incontinence, Urinary

Summary: to document usage of the urovac device among 30 initial users of the device in an acute rehabilitation facility, with analysis of whether and how patients benefitted, challenges encountered, and how benefits and challenges varied by patient type.

the urovac device holds the promise of improving care for many of these patients in a manner that may also significantly decrease costs. the aim of the study is to determine if this device may increase quality of life for patients by reducing urine spills, reducing falls by avoiding urgent situations where patients try to ambulate to the bathroom to avoid wetting sheets, reducing skin breakdown by avoiding urine spills, reducing excoriation of the glans penis, and reducing urinary tract infections. the urovac is simply a regular plastic handheld urinal attached by tubing to a pump that evacuates urine to a reservoir. there is also a removable cloth-covered platform to reduce spills. allowing for the evacuation of urine from the urinal significantly improves its functionality. the urovac can be left in place without risk of overflow or other spillage, such that a patient with ui requires less assistance. improving the handheld urinal in this manner should thus allow for reduced usage of diapers, catheterization, and institutionalization. for patients with ui requiring hospitalization or institutionalization for other reasons, the urovac could potentially reduce the associated labor and complication costs. despite the clear clinical promise of the urovac, it has only been used by a small number of patients to date. this study will document usage of the urovac among 30 of the initial users of the device to better understand the benefits and challenges.

Eligibility criteria:
inclusion criteria: * male patients who identify as having difficulty with functional urinary incontinence, such that it may be difficult to get to the toilet in time to urinate * patients age 18 or older exclusion criteria: * patients with leg wounds or dysfunction which could be worsened by urovac device placement * patients under age 18
trenev trio/healthy trinity for symptoms of diarrhea-predominant irritable bowel syndrome (ibs) and functional dyspepsia

Conditions: IBS-D and Functional Dyspepsia

Summary: primary objective: • to confirm the efficacy of the probiotic product healthy trinity (retail label)/trenev trio (professional label) in the improvement of symptoms in adult patients with diarrhea-predominant irritable bowel syndrome (ibs-d) and functional dyspepsia secondary objective: • to confirm the safety of the probiotic product healthy trinity (retail label)/trenev trio (professional label) in adult patients with ibs-d and functional dyspepsia


Eligibility criteria:
inclusion criteria: 1. age 18 to 75 years 2. diagnosed with ibs-d including: a) weekly average of worst abdominal pain in the last 24 hours of ≥3 on a 0-10 scale, and b) weekly average of bristol stool form of ≥6 on a 1-7 scale 3. diagnosed with functional dyspepsia defined as presence of at least one of the following symptoms: bothersome postprandial fullness, early satiation, epigastric pain, or epigastric burning and no evidence of structural disease that is likely to explain the symptoms 4. history of ibs-d and dyspepsia symptoms for at least 12 weeks 5. agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only) 6. able to understand the nature and purpose of the study including potential risks and side effects 7. willing to consent to study participation and to comply with study requirements 8. successful completion of 2-week placebo-only run-in period, defined as ≥90% product compliance and completion of required questionnaires exclusion criteria: 1. major gastrointestinal complication, e.g. crohn's disease or ulcer 2. prior abdominal surgery with the exception of hernia repair and appendectomy 3. subjects over 60 years who have not had a sigmoidoscopy or colonoscopy in the past 10 years 4. clinically significant systemic disease 5. life expectancy \< 6 months 6. pregnant female or breastfeeding 7. lactose intolerance 8. immunodeficient subjects 9. anti-psychotic medication within the prior 3 months or major psychiatric disorder within the past 2 years 10. systemic steroids within the prior month 11. current treatment with nasogastric tube, ostomy, or parenteral nutrition 12. use of proton pump inhibitors 13. eating disorder 14. recent (\< 2 weeks) antibiotic administration 15. history of alcohol, drug, or medication abuse 16. daily consumption of probiotics, fermented milk, and/or yogurt 17. known allergies to any substance in the study product 18. participation in another study with any investigational product within 3 months of screening

Keywords: ibs diarrhea dyspepsia
propofol versus dexmedetomidine effect on prevention emergence agitation

Conditions: Emergence Agitation

Summary: the goal of this clinical trial is to compare propofol versus dexmedetomidine in children undergoing squint surgery. the main question it aims to answer is: • which drug is more effective in preventing the appearance of emergence agitation in children after sevoflurane anesthesia in squint surgery, propofol or dexmedetomidine? emergence agitation (ea) is a period of restlessness, agitation, inconsolable crying, disorientation, delusions, and hallucinations with impaired cognition and memory that commonly occurs in children undergoing ophthalmic surgery especially after short acting volatile agents such as sevoflurane.


Eligibility criteria:
inclusion criteria: * pediatric patients from 3 to 7 years. * american society of anesthesiologists (asa) physical status class-i and ii. * patients undergo squint surgery. exclusion criteria: * declining to give written informed consent by patient legal guardian. * age younger than 3 years or older than 7 years. * asa classification ≥ iii. * history of allergy to the medications used in the study or egg products. * psychiatric disorder * other co-morbidities or congenital anomalies or neurological.
low-dose pentavalent antimony treatment of cutaneous leishmaniasis in old age patients

Conditions: Localized Cutaneous Leishmaniasis

Summary: this study was designed to evaluate the effect of low doses of pentavalent antimony (meglumine antimoniate) to treat cutaneous leishmaniasis ulcers in patients older than 65 years. the hypothesis is that older patients may have a positive response with a lower dose of pentavalent antimony, avoiding the frequent adverse events observed with the standard dose. the design is that of an open uncontrolled trial enrolling 20 patients infected with the parasite leishmania braziliensis in an endemic area of the state of bahia, brazil. the endpoint of cure or therapeutic failure will be evaluated at the third month of follow-up after treatment to avoid the impact of spontaneous cure as a confounding factor.


Eligibility criteria:
inclusion criteria: * age \> 65 years * permanent residence in the endemic area * availability of a caregiver for dependent patients exclusion criteria: * mucosal disease caused by leishmaniasis * disseminated cutaneous disease * severe cardiac, renal or hepatic disorders * active cancer * active tuberculosis * leprosy * hiv positive * total bilirubin \> 1.5mg/dl * urea and creatinin \> 1.5 times the upper normal level * alkaline phosphatase and aminotransferases \> 2.5 times the upper normal level * lipase and amylase \> 1.5 the upper normal level * hemoglobin \< 5 g/dl of

Keywords: leishmaniasis cutaneous leishmaniasis leishmania braziliensis pentavalent antimonial glucantime
influence of acid reflux on stromal epithelial interaction in barrett's esophagus

Conditions: Barrett's Esophagus

Summary: the purpose of this study is to determine the association between acid reflux and cell changes in barrett's esophagus. specific aim 1: to test the hypothesis that controlled acid reflux is associated with lesser degree of stromal activation. specific aim 2: to test the hypothesis that stromal fibroblast derived growth factors drive be epithelial proliferation.


Eligibility criteria:
inclusion criteria: 1. prior histological demonstration of barrett's esophagus that is endoscopically visible; length of visible segment \>/= 1 cm 2. absence of dysplasia or lgd on biopsies within the past 5 years 3. ability to provide informed consent 4. age between 18 years and 90 years at study entry. exclusion criteria: 1. eastern cooperative oncology group performance status 3 or 4 2. inability to tolerate endoscopic procedures 3. pregnancy: females of child-bearing age will be screened with pregnancy test. 4. prior esophageal surgery, or cancer

Keywords: barrett's esophagus
improved understanding of ongoing transmission of leprosy in the hyperendemic comoros (comlep)

Conditions: Leprosy

Summary: despite decades of a solid leprosy control program, including active case finding and follow-up on therapeutic outcome, the comoros islands of anjouan and moheli continue to be hyperendemic for leprosy, with leprosy case notifications far exceeding those for tuberculosis, while the third island, grande comore, presents few cases. the high proportion (31% in 2015) of disease in children indicates that recent transmission is a major driver of the persistent endemicity, and that present control measures are not sufficient. the low proportion (2.6% average in last 10 years) of grade ii disabilities in newly diagnosed cases indicates that case detection is early. the main objective of the present proposal is to identify which persons would most benefit from prophylactic treatment. the secondary objective is to unravel human, bacterial and environmental risk factors for transmission of and progression to leprosy disease, with the ultimate goal to reduce the leprosy incidence.. the program has remaining expertise to re-establish laboratory confirmation of leprosy patients, allowing to optimize and validate molecular genotyping techniques to complement conventional epidemiological investigations in a 3-year prospective cohort of leprosy patients and their close contacts, aiming to identify transmission links. a third objective is to document diagnostic delays in more detail as the leprosy control programme has initiated a pilot study on rifampicin prophylaxis in four villages on anjouan in 2015, a prospective cohort study will permit measuring the leprosy incidence in close contacts as well as those in neighboring houses, who did or did not receive rifampicin prophylaxis. the expected outcome of this project will be to identify risk factors for leprosy transmission. specifically, we expect to identify those contacts at highest risk of developing leprosy disease, who would most benefit from rifampicin prophylaxis or other preventive measures.


Eligibility criteria:
inclusion criteria: * in the prospective cohort study: all newly diagnosed leprosy patients (any age) on the island of anjouan who provide written informed consent. * in the in-depth interviews: patients who are part of a cluster and provide written informed consent. additional written informed consent will be asked for questions in which the identity of other member(s) of a cluster needs to be revealed. exclusion criteria: * in the prospective cohort study: none. * in the in-depth interviews: patients belonging to clusters not extending beyond the same first or second circle

Keywords: transmission genotyping risk factors
brief behavioral activation treatment for depression with inpatients

Conditions: Depression

Summary: the purpose of the current study was to examine brief behavioral activation treatment for depressions (batd) effectiveness, credibility, and acceptability with moderate to severly depressed inpatients. the study is a systematic replication of a randomized controlled trail from 2003, that provided initial support for batd with inpatients. the current study compared batd to treatment as usual in a randomized controlled trial.


Eligibility criteria:
inclusion criteria: * moderate to severe depression (bdi-ii \> 28 points). * admission length of at least 3 days * evaluated to benefit from depression treatment by unit psychiatrist. exclusion criteria: * current psychotic disorder * previously diagnosis with psychotic disorder (including bipolar disorder)

Keywords: depression inpatient acute brief behavioral activation treatment for depression
reliability of functional outcome measures in plantar fascitis patients

Conditions: Plantar Fasciitis

Summary: plantar fasciitis (pf) is the most common foot condition treated by healthcare providers, striking approximately 2 million americans each year. nevertheless its causes are still not known. the risk factors for pf are known and the diagnosis, which is based on clinical assessment, is relatively simple. still most of the treatments for pf focus on short term symptoms relief instead of prevention or reduction of recurrence. physical therapy treatment that focuses on reducing the symptoms for the long run and prevention, should include outcome measures, which if found to be reliable, will make the diagnosis clearer. diagnosis based on reliable clinical and functional measures will assist the physical therapist to understand the major deficiencies of the patient, and accordingly to help him to make the right decision in choosing treatment. also comprehensive knowledge of the characteristics of pf may enable selection of appropriate preventive measures.

objectives: characterize the unilateral pf syndrome using functional outcome measures, while comparing them to the healthy foot of the same patient. in addition the study will investigate the reliability of these functional outcome measures in pf patients. methodology: individuals referred to physiotherapy for pf will be assessed for eligibility and consent for the study. they will undergo two evaluations on the same week to evaluate the test- retest reliability of the functional measurements.

Eligibility criteria:
inclusion criteria: * unilateral plantar fasciitis * painful first step in the morning * calcaneal soreness in palpation * insured by clalit health care services * signed informed consent exclusion criteria: * ankle or foot surgery * congenital deformation of foot * lower limb spasticity * using assistive devices * bilateral plantar fasciitis * refuse to participate or sign informed consent

Keywords: plantar fasciitis physiotherapy
an optional two year follow up study to study cp005a

Conditions: Cat Allergy; Rhinoconjunctivitis

Summary: cat allergy is an increasingly prevalent condition affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma. the purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to cat dander in the eec among subjects who completed all dosing visits in study cp005 and all visits in study cp005a approximately two years after the start of treatment.

subjects who completed all visits in studies cp005 and cp005a will be invited to attend the screening visit for cp005b. subjects will attend for 4 visits to the eec on successive days. following the last eec visit is a follow-up visit which will be performed 3-10 days later.

Eligibility criteria:
inclusion criteria: - previously randomised into study cp005 and completed all visits in the follow-on study cp005a exclusion criteria: * "partly controlled" and "uncontrolled" asthma * history of anaphylaxis to cat allergen * subjects with an fev1 \< 70% of predicted * subjects who cannot tolerate baseline challenge in the eec * treatment with beta-blockers, alpha-adrenoceptor blockers, tranquilizers, or psychoactive drugs * symptoms of a clinically relevant illness, in the investigator's opinion, within 6 weeks prior to screening visit

Keywords: cat allergy rhinoconjunctivitis
long-term immune persistence of gsk biologicals' combined hepatitis a & b vaccine injected according to a 0,1,6 month schedule

Conditions: Hepatitis B; Hepatitis A

Summary: the aim of this study is to evaluate the long-term persistence of hepatitis a and b antibodies at years 11, 12, 13, 14 and 15 years after subjects received their first dose of a 3 dose vaccination schedule of combined hepatitis a/hepatitis b vaccine. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007. this protocol posting deals with objectives \& outcome measures of the extension phase at year 11 to 15.

this is a long-term follow-up study at years 11, 12, 13, 14 and 15 after primary vaccination with gsk biologicals' hepatitis a/hepatitis b vaccine (three-dose schedule, 3 different lots). to evaluate the long-term antibody persistence, volunteers will be bled at years 11, 12, 13, 14 and 15 after the first vaccine dose of the primary vaccination course to determine their anti-hav and anti-hbs antibody concentrations. no additional subjects will be recruited during the course of this long-term study. if a subject has become seronegative for anti-hav antibodies or lost anti-hbs seroprotection concentrations at the long-term blood sampling time point (i.e. years 11, 12, 13, 14 or 15), he/ she will be offered an additional vaccine dose.

Eligibility criteria:
inclusion criteria: * subjects participating in this study should have received three-dose primary vaccination with combined hepatitis a/hepatitis b vaccine in the primary study. * written informed consent will be obtained from each subject before the blood sampling visit of each year

Keywords: combined hepatitis a and b vaccine hepatitis a hepatitis b
study in ankylosing spondylitis (as) and psoriatic arthritis (psa) patients to evaluate work productivity before and after the start of adalimumab therapy in daily practice in belgium

Conditions: Ankylosing Spondylitis; Psoriatic Arthritis

Summary: this observational study will document to what extent in daily clinical practice the work productivity is affected before and after the start of adalimumab treatment. changes in the employment status and work productivity of participants with as and psa before and after the start of adalimumab will be noted. the relationship between employment status, work productivity, disease activity and clinical evaluations will be evaluated. since as and psa might be diseases with a strong impact on the daily life of the participant, an evaluation will be performed to the effect of the disease on quality of life and work productivity.


Eligibility criteria:
inclusion criteria: * patient \>= 18 years and \<= 50 years * patient diagnosed with as or psa * patient to be initiated on adalimumab (according to the marketing authorization and belgian reimbursement criteria) * patient willing to sign informed consent exclusion criteria: * any contraindication for adalimumab as specified in the corresponding summary of product characteristics (smpc) * patient previously treated with biologics * patient participating in other abbvie-sponsored trials

Keywords: work productivity multicenter study