Kornimate/medical-research-clean huggingface dataset:
the effect of a multispecies probiotic on reducing the incidence of antibiotic-associated diarrhoea in children.

Conditions: Antibiotic-associated Diarrhea

Summary: in this trial, the investigators aim to assess the effectiveness of a multispecies probiotic consisting of 2 strains of bifidobacterium (b. bifidum w23, b. lactis w51) and 6 strains of lactobacillus (l. acidophilus w37, l. acidophilus w55, l. paracasei w20, l. plantarum w62, l. rhamnosus w71, and l. salivarius w24) in reducing the risk of antibiotic-associated diarrhoea in a group of children undergoing antibiotic therapy for common infections.

certain individual probiotic strains have been proven to be effective in reducing the risk of antibiotic-associated diarrhoea (aad). however, the effects of using multispecies probiotics remain unclear. the investigators aim to assess the effectiveness of a specific multispecies probiotic preparation (ecologic aad kids) in reducing the incidence of aad in children. in this trial, a total of 350 children aged 3 months to 18 years, undergoing antibiotic treatment, will be randomly allocated to receive either a multispecies probiotic consisting of 2 strains of bifidobacterium (b. bifidum w23, b. lactis w51) and 6 strains of lactobacillus (l. acidophilus w37, l. acidophilus w55, l. paracasei w20, l. plantarum w62, l. rhamnosus w71, and l. salivarius w24) at a total dose of 10\^10 colony-forming units daily, or a placebo, from the first day of antibiotic treatment until 7 days after antibiotic cessation. the primary outcome measure will be the incidence of aad, defined as ≥3 loose or watery stools (a score of a on the amsterdam infant stool scale for children younger than 1 year and a score of 5-7 on the bristol stool form scale for children older than 1 year) in 24 hours, caused either by clostridium difficile or of otherwise unexplained aetiology (after testing for common diarrhoeal pathogens), occurring during and/or up to 7 days after the end of the antibiotic therapy.

Eligibility criteria:
inclusion criteria: * children receiving oral or intravenous antibiotics for common infections, willing and able to start the probiotic intervention within 24 hours after the start of antibiotic intake, receiving broad-spectrum antibiotics (broad-spectrum penicillins, cephalosporins, fluoroquinolones, clindamycin). exclusion criteria: * prior use of antibiotics within the previous 4 weeks, presence of a severe or generalised infection, history of severe chronic disease (e.g., cancer, inflammatory bowel disease, tuberculosis), critical/life-threatening illness, immunodeficiency, history of pre-existing diarrhoea within the previous 4 weeks, exclusive breastfeeding, allergy or hypersensitivity to any component of the study product, tube-feeding, use of proton-pump inhibitors, laxatives or anti-diarrhoeal drugs, as well as use of a probiotic product containing l rhamnosus gg or s boulardii 14 days before and during the study.

Keywords: antibiotic-associated diarrhea probiotics
safety and efficacy study of egt0001442 in subjects with type 2 diabetes mellitus

Conditions: Diabetes Mellitus Type 2

Summary: the purpose of this study was to assess the effect of egt0001442 on fasting plasma glucose after 28 days of treatment in subjects with type 2 diabetes. the study also assessed the pharmacokinetics, safety and tolerability of egt0001442, the effect on weight and hba1c as well as the effect egt0001442 has on the amount of glucose produced in the body by the urine.

this was a phase 2 study to evaluate the efficacy of egt0001442. the study included two segments: segment 1 was a single center, open labeled, ascending dose study in 4 groups of 5 diabetic subjects per group who received 5, 10, 20, or 50 mg of egt0001442 capsules orally once daily for 28 days. the subjects were in clinic for the first 3 days for safety and pk evaluation. segment 2 was a multi-center, double-blind, placebo-controlled parallel group study. one hundred and thirty one subjects in 5 parallel groups of approximately 25 diabetic subjects per group were randomly assigned to receive oral egt0001442 at 5, 10, 20, or 50 mg/day or placebo once daily for 28 days in an outpatient setting.

Eligibility criteria:
inclusion criteria: * male or female between the ages of 18 and 70 years diagnosed with type 2 diabetes. * body mass index (bmi) between 18 kg/m2 and 37 kg/m2 (inclusive). * hba1c levels between 6.5 and 9.5 (inclusive) where the upper limit of normal for the hba1c assay is 6.4% or hba1c levels between 6.2 and 9.5% (inclusive) where the upper limit of normal for the hba1c assay is 6.1%. * fasting plasma glucose levels between 126 and 270 mg/dl (7 - 15 mmol/l, inclusive) while on diabetic medications. * treatment naïve subjects with hba1c between 6.5 and 9.5 and fasting plasma glucose between 126 and 270 mg/dl (7 - 15 mmol/l). * if taking drugs for diabetes, must be medically able and willing to discontinue diabetic medications for the duration of the study. * female subjects must be surgically sterilized or postmenopausal. exclusion criteria: * type 1 diabetes or diabetes treated with insulin injection. * insulin therapy or oral antidiabetic medication other than metformin, sitagliptin, saxagliptin, a sulfonylurea or combination of these. * sitting blood pressure above 150/95 mmhg on two evaluations at least 10 minutes apart at screening. * positive results on screen for drugs of abuse. * previous treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer. * previous treatment with egt0001474 or egt0001442.

Keywords: diabetes mellitus type 2
myelofibrosis and essential thrombocythemia observational study (most)

Conditions: MPN (Myeloproliferative Neoplasms)

Summary: the purpose of this prospective, longitudinal, noninterventional study is to describe clinical characteristics, evolution of disease burden, and treatment patterns in patients with select subcategories of essential thrombocythemia (et) or myelofibrosis (mf).


Eligibility criteria:
inclusion criteria: * mf cohort: diagnosis of mf and low-risk using dipss risk categorization or intermediate-1 risk by dipss by reason of age alone. * et cohort: diagnosis of et and age ≥ 60 years or history of thromboembolic events or currently receiving et-directed therapy (eg, hydroxyurea, anagrelide, interferon, busulfan, ruxolitinib, etc). * willing and able to provide written informed consent. * willing and able to complete patient assessment questionnaires either alone or with minimal assistance from a caregiver and/or trained site personnel. * under the supervision of a physician for the current care of mf or et. exclusion criteria: * individuals who are participating in blinded investigational drug studies. * individuals who are participating in incyte investigational/interventional drug trials (company- or investigator-sponsored studies) until they have completed the 30-day end of study visit. * life expectancy ≤ 6 months. * diagnosis of secondary acute myeloid leukemia, myelodysplastic syndrome, chronic myelogenous leukemia, or secondary thrombocytosis.

Keywords: myelofibrosis essential thrombocythemia clinical characteristics disease burden patient-reported outcomes
exercise training in women with heart disease

Conditions: Cardiovascular Diseases; Coronary Heart Disease

Summary: coronary heart disease (chd) is a leading cause of premature death in canadian women. women who suffer an acute coronary event are more likely than men to be physically inactive, have lower exercise capacity, and die in the next year. the standard cardiac rehabilitation (cr) programs do not meet women's needs. there is a need to address these issues to increase participation in cr. the main purpose of this project is to evaluate the effects of high-intensity interval training (hiit) compared to moderate-intensity continuous exercise training (mice) on exercise capacity and quality of life in women with chd. positive results of this study will fill the gap in knowledge in exercise training, levels of motivation, self-efficacy and enjoyment following hiit vs. mice in women with chd.


Eligibility criteria:
inclusion criteria: * women with chd (e.g. cabg or pci at least 4 weeks but less than 12 weeks post event or procedure; acute myocardial infarction; or, stable angina with corroborating evidence of chd); * patient is able to perform a symptom-limited cpet (this is needed to determine peak hr for the exercise training prescription); and, * patient is able to read and understand english or french. exclusion criteria: * patient is currently participating in routine exercise training (\>2x/week) (this may reduce the impact of the program on outcomes); * patient has: a ventricular ejection fraction \<45%; unstable angina; or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy (this may interfere with the ability to engage in mice or hiit); * patient has unmanaged psychiatric illness (e.g. active psychosis, suicidal ideation) or cognitive impairment (this may confound improvements in physical and health outcomes); * patient does not have internet connection; * patient is unable to provide written informed consent; or * patient is unwilling or unable to return for follow-up visits at 12 and 26 weeks. * patient is unwilling to be randomized to hiit or mice
a retrospective biomarker study of stored samples obtained from patients with chronic hepatitis b

Conditions: Hepatitis B, Chronic

Summary: this retrospective study will evaluate the association of biomarkers and the treatment response of patients with chronic hepatitis b, who have completed therapy with pegasys (peginterferon alfa-2a) ± lamivudine. for the analysis stored serum samples obtained from patients will be used; no actual patients are involved.


Eligibility criteria:
inclusion criteria: * patients with hbe-antigen positive or negative chronic hepatitis b, and no other chronic viral infections who completed therapy for hepatitis b with pegasys ± lamivudine * inclusion criteria relevant to the clinical studies wv16240, wv16241, and neptune/wv19432 * samples from patients treated with either pegasys or pegays + lamivudine are included in this analytical study * samples will only be analyzed for patients where investigational review board approval has been granted exclusion criteria: * exclusion criteria relevant to the clinical studies wv16240, wv16241, and neptune/wv19432
effects of cognitive strategy training on daily function in people with subjective cognitive decline

Conditions: Subjective Cognitive Decline

Summary: subjective cognitive decline (scd) is the transitional state between normal aging and mild cognitive impairment. scd is defined as having self-perceived declines in any cognitive domain over time; having normal performance on cognitive testing; no dementia or depression. cognitive difficulties can lead to a decline on daily function and quality of life. early intervention can prevent scd from developing into dementia. cognitive strategy training (cst) aims to generate individualized strategies to solve cognitive problems, which can be effective to improve daily functions and performances. however, there is limited clinical research aimed at improving daily functions for scd. most non-pharmacological studies have conducted objective cognitive training, which may not enhance daily performance. previous studies also seldom examine the effectiveness of the intervention to improve daily function, quality of life, self-efficacy and motivation. this study adopts a quasi-experimental design. the investigators will recruit 80 community-dwelling people with scd who are aged 55 and older. there will be 40 participants in each group. the experimental group will receive the cst. the active control group will receive group interactive game. both groups will have 8 sessions for one hour per week for a total of 8 weeks. outcome measures include daily function, self-efficacy, motivation for change, and quality of life. assessments will be performed at baseline, post-intervention, and 3-month follow-up. the demographic data of the two groups will be compared using the independent sample t-test and chi-square test. changes on outcomes between the two groups will be analyzed by two-way anova. this study was approved by the human research ethics committee at national cheng kung university. all participants provided written informed consent before testing. this study aims to (1) examine the feasibility of the cst in community-dwelling people with scd; (2) explore the efficacy of the cst on daily function, self-efficacy, motivation for change, and quality of life.


Eligibility criteria:
inclusion criteria: * aged 55 and above * live in community * self-perceived decline in cognition compared to five years ago * subjective cognitive decline, cognitive failure questionnaire (cfq) score above zero. exclusion criteria: * objective cognitive impairment, taiwanese version of the montreal cognitive assessment (moca-t) scores below 24 * any medical, neurological or psychiatric disorders, brief symptom rating scale (bsrs-5) scores 10 or more * severe visual, auditory, verbal or physical impairments interfere with communication, command compliance, and strategy execution * participate in other research related to cognitive strategy at the same time.
self directed positive parenting program (triple p) for psychosis: a clinical case series

Conditions: Schizophrenia; Spectrum; Disorders

Summary: the aim of the case series study is to explore if a self directed version of the positive parenting program (triple p) is a feasible and acceptable intervention for individuals with psychosis who are parents.

as above.

Eligibility criteria:
inclusion criteria: * 1. parents/caregivers (mothers or fathers) with a schizophrenia-spectrum diagnosis who are: 2. aged 18 years or more 3. have at least one child aged 3-10 years old 4. have a least 10 hours contact time per week with the child. 5. identify difficulties in parenting during assessment exclusion criteria: * 1. parents/caregivers and family members who do not have good working knowledge of english. they should have enough practical experience to be able to adequately use the english language to understand and respond to questions, to read and complete questionnaires 2. families who do not have at least one adult who has basic literacy skills 3. families where there is known intention for their children to be taken into care or where the parent(s) have no regular contact with the index child 4. parents with a clinical schizophrenia-spectrum diagnosis who have recently been discharged from acute in-patient care for their condition and have less than four weeks of stabilisation of psychotic experiences (operationally defined as no significant change to management or severity of symptoms in a four-week period since discharge as assessed from case notes). this is because if a potential parent with schizophrenia had recently required an inpatient stay, it is important to give them sufficient time to readjust to living in the community and ensure sufficient time is provided for symptom stabilisation before taking part 5. families seeking support from services regarding child management issues 6. families actively involved in another current cognitive behavioural therapy based intervention

Keywords: parenting psychosis schizophrenia delusions hallucinations
efficacy and safety of ketoprofen topical patch 20% in the treatment of pain associated with ankle sprain or strain

Conditions: Sprain; Strain

Summary: the purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with ankle sprain or strain.

this randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with grade 1 or grade 2 ankle sprains or strains. eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with either the ktp or a matching placebo patch to be applied once daily for 14 days. patients will return to the clinic for assessments on day 3, day 7 and day 14; a follow-up assessment will be conducted by telephone on day 28. at each visit through day 14, patients will rate their average pain intensity during daily activities and while at rest using an 11-point scale, and will rate their functional disability. patients will also complete an electronic diary in which pain intensity and pain relief ratings will be recorded three times daily. ratings of the quality of sleep will be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day. ibuprofen will be provided as rescue medication

Eligibility criteria:
inclusion criteria: * males or females 18 years of age or older * diagnosis of grade i or grade ii ankle sprain or strain * meet pain entry criteria * willing to discontinue use of any pain medication not provided as part of the study exclusion criteria: * have a grade 3 sprain or grade 3 strain, bilateral sprain or strain, or concomitant fracture or wound at the site of the sprain or strain. * have received corticosteroids in the 30 days preceding screening * have a history or physical examination finding that is incompatible with safe participation in the study * have a history or physical examination finding that is incompatible with study product use * are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions. * are taking medications that may significantly affect renal function

Keywords: sprain strain pain ankle pain muscle, bone and cartilage disorders
evaluation of sarcopenia-related malnutrition in older adults

Conditions: Sarcopenia; Malnutrition

Summary: sarcopenia and malnutrition are two geriatric syndromes that are frequently seen in the elderly and have multifactorial etiology and severe clinical effects. however, the results vary widely due to the many methods and criteria used in the diagnosis and prevalence rates of both syndromes. in this study, it is aimed to investigate the relationship between the glim (global leadership initiative on malnutrition) criteria and various sarcopenia levels, which are newly defined worldwide and have the widest spectrum so far in describing malnutrition.


Eligibility criteria:
inclusion criteria: * to get a score of 21 and above in the mini-mental state examination * to be able to walk independently or with the help of a device (cane, etc.) exclusion criteria: * individuals with a serious orthopedic (advanced hip or knee arthrosis, etc.) or neurologic conditions that may affect ambulation
longitudinal study of traumatic brain injury (tbi) in (university of florida) uf athletes

Conditions: Traumatic Brain Injury

Summary: to identify the changes in the brain following repeated sports-related concussion in men's football, women's soccer, and women's lacrosse college athletes by reviewing the findings of mri studies that look at the structure of the brain and the appearance of the white matter at baseline, during the acute phase of a concussive injury, and upon completion of collegiate athletic play and correlate these findings with standard clinical measures.

this proposal seeks to study diffusion tensor imaging and functional mri of the brain at 1) baseline, 2) after concussion and 3) at the end of an athlete's college career. findings will be compared to standard clinical measures already performed in the management of concussion at the university of florida athletic association and to serum biomarkers already being obtained as part of a uf/ banyan biomarker study. as in the biomarker study, uf athletes on teams with higher incidences of sports related concussion; men's football, women's soccer, and women's lacrosse will be offered enrollment. longitudinal examinations will allow identification and quantification of concussive dti findings as comparisons can be made to the individual athlete's baseline data. this will provide valuable correlation of imaging findings with severity of clinical symptoms at the time of injury and also with timing of return to play.

Eligibility criteria:
inclusion criteria: * currently enrolled and active uf student athlete in mens football, womens soccer, or womens lacrosse. * age 18-30 exclusion criteria: * contraindications to mri, such as retained metal * pregnancy

Keywords: traumatic brain injury tbi concussion sports related injury
restoresensor study

Conditions: Chronic Pain

Summary: the purpose of the study is to gather clinical information on subjects' experiences with and without the use of the new feature of the restoresensor implantable neurostimulator (ins).

this study is a multi-center, prospective, open-label, randomized, crossover study that is designed to gather clinical information on subjects' experiences with the use of the new feature of the restoresensor implantable neurostimulator. current spinal cord stimulators for chronic intractable pain stimulate targeted nerves along the spine using electrical impulses. the stimulation interferes with the transmission of pain signals to the brain replacing painful sensations with a tingling sensation called paresthesia. variation in the intensity of neurostimulation with body position is a challenge for some patients implanted with conventional spinal cord stimulation systems because positional changes may result in overstimulation or understimulation. patients need to manually adjust their stimulation using the patient programmer to maintain their comfort level during position changes. the adaptivestim feature of the restoresensor neurostimulator was developed to address this challenge by improving pain relief and/or convenience relative to manual programming adjustments.

Eligibility criteria:
inclusion criteria: * meets the indications as an appropriate surgical candidate (after successful scs screening trial) for implant of a neurostimulation system for spinal cord stimulation (scs) treatment of trunk and/or limb pain, per labeled indications * 18 years of age or older * willing and able to attend visits and comply with the study protocol * capable of using the patient programmer and recharging the neurostimulator (ins), able to read and answer questionnaires in english, without assistance of a caregiver * males and non-pregnant females exclusion criteria: * has had a prior implantable scs neurostimulation system * currently enrolled, or plans to enroll in another investigational device or drug trial during the study * has unresolved legal issues related to their pain condition for which they would be receiving neurostimulation * requires cervical placement of leads.