Kornimate/medical-research-clean huggingface dataset:
clinical study to evaluate the efficacy of the dietary supplement uromannosa® in women with recurrent lower urinary tract infections

Conditions: Lower Urinary Tract Infection

Summary: to analyze the clinical impact of a food supplement composed of d mannose, cranberry extract (cran-max) and vitamin d3 in the prevention of recurrent lower urinary tract infections (uti)

once patients have been informed about the study, the potential risks and treatment alternatives, those who meet the selection criteria, agree to participate and sign the informed consent, will be randomly and openly assigned, in a 1:1:1 ratio, to one of the following groups: group a: patients with repeat utis who will receive prophylactic treatment for 6 months. group b: patients with repeat utis who will receive prophylactic treatment for 3 months. control group: patients with recurrent utis who will not receive as prophylactic treatment the supplement under study. the three groups will be treated following standard clinical practice with follow-up at 3, 6, 9 and 12 months after inclusion.

Eligibility criteria:
inclusion criteria: * history of recurrent lower urinary tract infection (at least two episodes in the last 6 months or three episodes in the last 12 months). * multiple infections must be spaced a minimum of 2 weeks apart or if less, with a negative urine culture in between. * women who agree to participate and give their informed consent in writing exclusion criteria: * use of antibiotics or cranberry or other preventive treatment, pharmacological or not, for recurrence of urinary tract infections in the last two weeks. * patient with indwelling catheter or intermittent catheterization. * patients who present: interstitial cystitis, neurogenic bladder, diabetes mellitus, nephrolithiasis, cervical-uterine cancer diagnosed and treated less than 5 years ago. * use of anticoagulants or contraceptive methods using spermicides or diaphragms. * women consuming probiotics or foods, beverages or supplements containing extracts or parts of the genus vaccinum sp, including other forms of v. macrocarpon (blueberry), v. myrtillus (european blueberry), v.angustifolium (wild or lowbush blueberry), v. corymbosum ( highbush blueberry) or v. vitis-ideae (mountain blueberry), during the two weeks prior to recruitment. * high consumption of fruits rich in phenolic compounds, with special reference to berries. women allergic to berries * pregnant or breastfeeding women.
antibiotic use in a neonatal intensive care unit practicing integrative medicine

Conditions: Neonatal Infection

Summary: the goal of this study is to describe the antibiotic use in a neonatal intensive care unit (nicu) in germany that is practising integrative medicine. the investigators will review hospital records to find out how often and how long antibiotics were given to newborns; compare antibiotic use to other nicu in the same area; describe how sick infected newborns were (comparing those treated with or without antibiotics); and describe which anthroposophic medicines were used, how often and if there were safety problems.

a retrospective study, analysing antibiotic use in a level 2 neonatology intensive care unit (nicu) in germany over a 4-year period from 2014 to 2017. the study will analyse frequency of antibiotic prescribing; compare antibiotic use to other level 2 nicu; compare clinical and laboratory parameters among neonates with infectious disease diagnosis managed with or without antibiotics; use and tolerability of anthroposophic medicinal products.

Eligibility criteria:
inclusion criteria: * admission to neonatal intensive care unit exclusion criteria: * none

Keywords: neonatal infection neonatal sepsis antibiotic prescribing antibiotic stewardship
evaluation of art-therapy on alexithymia in patients suffering from anorexia nervosa and from bulimia

Conditions: Anorexia Nervosa/Bulimia

Summary: alexithymia is often found in patients suffering from anorexia nervosa or from bulimia. art-therapy is widely used in this indication without there is a study in the literature assessing it. alexart is an observational prospective multicenter cohort pilot study, assessing the effect at 3 months of art therapy on alexithymia, in patients presenting anorexia nervosa or bulimia.

alexithymia, defined by difficulties to identify and describe feelings as well as a poverty of imaginary life, is found in patients with anorexia nervosa (an) or bulimia (bn) in numerous studies. some publications show that it is a factor of resistance in several forms of psychotherapies and of poor prognosis for these patients who already present a high rate of chronification and mortality because of the complications of the undernutrition and the suicide risk. art therapy is very wide-spread in the care of an and of bn, but little studied. about alexithymia, if there is no psychotherapy having made the proof of its efficiency currently, some studies suggest the interest of art-therapy on alexithymic features, but none, to our knowledge, estimated the effect. the investigator suggest to describe the evolution at 3 months of art therapy on alexithymia, using the toronto alexithymia scale in 20 items (tas-20), in patients with an or bn. the investigators shall also describe the evolution at 3 months with the tas-20 as well as the relationship between variations of alexithymia and bmi in patients presenting an at 1 and 3 months globally and in each of the centers. the investigators will also evaluate the effect of depression and anxiety at 1 and 3 months of art therapy on alexithymia.the investigators shall realize an observational prospective multicenter cohort study design. each patient will receive standard care: multidisciplinary and corresponding to the has recommendations and semimonthly or weeklies sessions of art therapy, using all types of art. thus, each patient will be her own control before art therapy.

Eligibility criteria:
inclusion criteria: * to be a woman, aged 16 or more, having dsm-5 diagnosis of anorexia nervosa or bulimia nervosa, inpatient in "psychiatry, psychotherapy and art therapy" ward at chu de toulouse or at " clinique castelviel " in toulouse. exclusion criteria: * acute psychotic symptoms * pregnant women * breast-feeding women * people under justice protection.

Keywords: affective symptom art therapy alexithymia emotional disturbance hyperphagia psychotherapy rehabilitation factor of resistance
safety and effectiveness of abatacept in psoriatic arthritis participants

Conditions: Psoriatic Arthritis (PsA)

Summary: the purpose of this study is a long-term, observational study of abatacept in patients with psoriatic arthritis, a chronic inflammatory disorder.


Eligibility criteria:
inclusion criteria: * participants 18 years or older * participants who signed an informed consent * participants diagnosed with psa as per the criteria of the classification of psoriatic arthritis (caspar) study group18 * participants naïve of abatacept and who at their physician's discretion initiate abatacept * participants meeting criteria for abatacept treatment for psa as specified in the german label exclusion criteria: * participants who are currently included in any interventional clinical trial in psa/rheumatoid arthritis (ra)
conventional vs mindfulness intervention in parents of children with disabilities

Conditions: Psychological Stress; Depression; Anxiety

Summary: this application compares the effectiveness of a conventional parent group intervention to mindfulness- based stress reduction (mbsr) in parents of children with autism spectrum disorders (asd) and other disabilities. parent groups are widely-used to provide information, emotional support, education and advocacy. mbsr is efficacious for people with medical, psychiatric or other concerns, and teaches stress reduction through mindfulness training and practice. in contrast to conventional parent groups, the investigators' studies suggest that mindfulness-based interventions may be particularly effective in reducing stress and improving the health and mental health of parents of children with disabilities. the investigators will assess parent factors that may correlate with intervention efficacy in the 2 treatment arms.

specific aim 1. to compare the effectiveness of parent groups versus mbsr interventions in parents of children with asd or other developmental disabilities. hypothesis 1: mothers and fathers in both treatment groups will show reduced stress, depression, and anxiety, and increased life satisfaction, health, and well-being. treatment effects will be more pronounced in mbsr, including more normalized diurnal cortisol patterns. hypothesis 2: improved parental outcomes will persist after treatment, and relate to booster session attendance, and/or the frequency that parents practice techniques learned in each treatment. improvements will be sustained longer in the mbsr treatment. parental benefits will impact families, and may be associated with improved child behaviors or less family conflict. hypothesis 3. the composition of intervention groups in year 2 will be adjusted based on year 1 data, and may reflect continued separation or integration of asd vs other disability groups, or new combinations of participants. specific aim 2: to identify aspects of maternal, family or child functioning that help explain variability in responses to parent group or mbsr interventions. hypothesis 4: mothers or fathers with relatively more stress, health or mental health problems, will show more robust treatment responses. variability in treatment responses may be associated with child age, maternal age, family ethnicity, and child behavior problems. hypothesis 5. outcomes may relate to factors in the interventionists, greater treatment responses will be found when parents are matched with peer-mentors of the same gender, ethnicity, and child diagnosis.

Eligibility criteria:
inclusion criteria: * parent of a child with a known developmental disorder * parent of a child with a chronic medical condition with known lifelong physical and mental effects, e.g., childhood cancer, cystic fibrosis, and muscular dystrophy exclusion criteria: * those who are not parent of a child with a known developmental disorder or medical condition

Keywords: parent stress parent coping parent anxiety parent health parent depression
computer-aided learning for managing stress

Conditions: Psychosis

Summary: the purpose of this study is to learn whether a new family therapy using computer games with biofeedback might help people at clinical high risk for psychosis and their family members learn to experience less stress and have fewer mental health challenges.

calms revolves around the use of emotional manipulatives (em) developed at boston children's hospital (bch). em are single and multi-user biofeedback games designed to enhance executive control of emotion. the intervention and em in calms were adapted from those used in anger control training (act) with regulate and gain emotional control (rage-control). in a randomized controlled trial at bch, act and rage-control relative to "sham" video-game play without biofeedback led to significantly greater reductions of aggression in adolescents and greater improvement in family functioning. in this feasibility study, family dyads will participate in 12 sessions aimed at 1. enhancing engagement through the use of video and other games, 2. enhancing stress resilience through biofeedback, education, and individualized stress-reduction practice, and 3. harnessing the power of the family to enhance contextual learning and the generality and duration of effects. clinical, self-report, and heart rate measures will be assessed at baseline, 4, 8, and 12 week assessments.

Eligibility criteria:
inclusion criteria: * currently meet or have met criteria of prodromal syndromes (cops) according to the sips within the past 2 years * estimated iq \> 70 * speak fluent english * have at least one parent or adult family member who also speaks fluent english and is willing to participate exclusion criteria: * physical limitations precluding effective use of biofeedback videogames * co-morbid psychiatric disorders, including substance disorders, but only if they better explain cops symptoms or make participation counter-indicated. * active suicidal ideation or attempts within the past 2 months unless being actively monitored and treated for this by a clinician

Keywords: prodrome family therapy clinical high risk
compare the effect of dpp-iv inhibitor or tzd on glycemic variability and oxidative stress in patient with 2 diabetes

Conditions: Diabetes Mellitus; Oxidative Stress

Summary: the purpose of this study is to compare the effect of vildagliptin vs. pioglitazone to oxidative stress on daily blood glucose fluctuations, in patients with type 2 diabetes that was inadequately controlled by metformin.

activation of oxidative stress by glucose fluctuations plays a major role in the pathogenesis of diabetic complication. dipeptidyl peptidase iv (dpp-iv), such as vildagliptin, enhances glucose-induced insulin secretion, decreases glucagon secretion, and reduces postprandial hyperglycemia and may also improve acute fluctuations of glucose. we believe that vildagliptin may exert an effect of decreasing oxidative stress by reducing glucose excursion.

Eligibility criteria:
inclusion criteria: * male or female with age 18-80 years * type 2 diabetes mellitus * on stable dose of metformin (more than 1000mg) for at least 1 month * hba1c 7\~10% * subjects on statins, ace inhibitors, arbs and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage is not changed during the course of study * bp under control - no change required to bp medications * agreement to maintain prior diet \& exercise exclusion criteria: * type 1 dm or any kind of secondary dm * pregnant or lactating women. * treatment with sulfonylurea, α-glucosidase inhibitor, glinide, glp-1 analogues, dpp-iv inhibitors or insulin therapy within 1 month prior to informed consent. * treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent. * hba1c \ 10% * uncontrolled hypertension ( bp \> 160/100 mmhg) * congestive heart failure (nyha class i to iv).

Keywords: vildagliptin
a trial investigating the pharmacokinetic properties of formulations of nn1218 in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the purpose of this trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of different formulations of nn1218.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus for more than 12 months * treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (csii) for more than 12 months * body mass index (bmi) between 18.0-28.0 kg/m\^2 (both inclusive) exclusion criteria: * subjects who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to trial start * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
laparoscopic sleeve gastrectomy under general anesthesia in severely obese patients: a retrospective study

Conditions: Obesity

Summary: with the improvement of living standards and changes in living habits in china, obesity has become an important issue. the latest data show that the number of obese people in china has exceeded 100 million. laparoscopic sleeve gastrectomy (lsg), which reduces the volume of the stomach and maintains the original anatomical structure of the gastrointestinal tract, has been widely used in weight loss surgery for obese patients to improve glucose metabolism and other metabolic disease comorbidities.anesthesiologists face specific challenges for obese patients: difficult venous and airway access and the risk of obesity-related comorbidity. since 2015, the investigator's center has performed lsg and gradually formed a multidisciplinary collaboration procedure for the perioperative management of obese patients. this study aims to summarize the clinical characteristics, anesthesia management and outcomes to optimize the perioperative management and accelerate the recovery of these patients.


Eligibility criteria:
inclusion criteria: 1. patients aged\>18 years 2. american society of anesthesiologists (asa) status i-iii 3. receiving selective laparoscopic sleeve gastrectomy (lsg) under general anesthesia exclusion criteria: 1.bmi\<35 kg/m2

Keywords: severely obese
feasibility of a high-intensity interval training program in persons with multiple sclerosis who have walking disability

Conditions: Multiple Sclerosis

Summary: there is considerable evidence to support the efficacy of moderate intensity continuous (mic) exercise benefitting clinically-relevant outcomes in persons with multiple sclerosis (ms). however, persons with ms who have walking impairments (pwms-wd) are severely deconditioned and may achieve superior benefits by engaging in high-intensity interval training (hiit), especially while utilizing adaptive equipment, such as with recumbent arm/leg stepping (rstep). of the published studies on hiit in ms, hiit yielded significant improvements in cardiorespiratory fitness in all but one study. in those studies that directly compared hiit to mic exercise, the data indicated a potential superiority of hiit as compared to mic in improving physiological conditioning in a time efficient manner. however, this evidence is specific to those with ms with mild to moderate disability engaging in cycle/arm ergometry and an investigation of hiit in pwms-wd is needed as the feasibility and potential benefits of engaging in hiit in pwms-wd is relatively unknown. the primary aim of the proposed study is to assess the feasibility of a 12-week, rstep hiit program in pwms-wd. the secondary aim is to examine changes in aerobic fitness, physical activity, ambulation, upper arm function, cognition, fatigue, and depressive symptoms as clinically-relevant efficacy outcomes following the 12-week, rstep hiit intervention. it is hypothesized that the intervention will be feasible and lead to positive changes in aerobic fitness, physical activity, ambulation, upper arm function, cognition, fatigue, and depressive symptoms. this work is informed by recently published data, which indicate that a single bout of rstep hiit taxes the cardiorespiratory system significantly more than mic exercise, yet without untoward effects on walking, gait, cognition, mood, or enjoyment. these data suggest that rstep hiit may be an acceptable, safe, and tolerable stimulus for chronic exercise training.


Eligibility criteria:
inclusion criteria: * age 18 or over * a self-reported diagnosis of multiple sclerosis * self-reported expanded disability status scale (edss) score \< 8.0 or patient determined disability steps (pdds) scale score ≤ 7.0 * relapse free in past 30 days * willing and able to visit berry college or university of north texas on three testing occasions and twenty four training occasions * asymptomatic status for maximal exercise testing; (g) physician approval for undertaking exercise testing * a self-reported ability to speak, read, and understand english exclusion criteria: * any persons who do not meet the inclusion criteria

Keywords: multiple sclerosis adaptive equipment rehabilitation recumbent stepping high-intensity interval training
effect of tamoxifen or an aromatase inhibitor on estrogen metabolism in women treated for newly diagnosed breast cancer

Conditions: Breast Cancer

Summary: rationale: studying samples of urine in the laboratory from women with breast cancer may help doctors learn whether tamoxifen and aromatase inhibitors alter the metabolism of estrogens. purpose: this clinical trial is studying the effect of tamoxifen or an aromatase inhibitor on estrogen metabolism in women undergoing treatment for newly diagnosed breast cancer.

objectives: * learn the effects of selected chemotherapy agents on the profile of estrogen metabolites, glutathione conjugates, and depurinating dna adducts in urine from women with breast cancer. * determine whether tamoxifen citrate or aromatase inhibitor alters the metabolism of estrogens. outline: patients are stratified according to planned therapy (tamoxifen citrate vs aromatase inhibitor). patients receive tamoxifen citrate or an aromatase inhibitor as planned. urine samples (and nipple aspirate fluid, if possible) are collected before beginning treatment and after 2-6 months of treatment. samples are analyzed for 40 estrogen metabolites, conjugates, and depurinating dna adducts by ultraperformance liquid chromatography with tandem mass spectrometric detection. patients' information, including race, body mass index, age at menarche, menopausal status, age at menopause if applicable, smoking history, alcohol consumption, pregnancy history including age at each pregnancy, lactation, history of benign breast disease, hysterectomy, and disease type, is collected through medical record review.

Eligibility criteria:
inclusion criteria: * newly diagnosed ductal carcinoma in situ or invasive breast cancer * scheduled to receive tamoxifen citrate or an aromatase inhibitor * estrogen receptor or progesterone receptor positive * ecog performance status 0, 1, or 2 exclusion criteria: * not pregnant or nursing * no prior antiestrogen drug such as tamoxifen citrate or raloxifene * no concurrent estrogens

Keywords: breast cancer in situ ductal breast carcinoma in situ stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer
a prospective research investigation of ischemia using mcg

Conditions: Acute Coronary Syndrome

Summary: prism is a prospective, pilot research study that aims to systematically characterize the usefulness of cardiaq mcg, a bedside magnetocardiography device, in the evaluation of myocardial ischemia and infarction status.


Eligibility criteria:
inclusion criteria: * scheduled to undergo a diagnostic angiography or revascularization procedure for the diagnosis or treatment of ischemia or acute myocardial infarction * ability for participant to comply with study requirements * patient consented before the planned, clinically indicated cath-lab procedure begins to allow sufficient time for study related activities * written informed consent exclusion criteria: * present stemi * pregnant or breastfeeding * having an active atrial fibrillation episode as seen on most current 12-lead ecg * active thoracic metal implant * poor access to follow-up

Keywords: magnetocardiography mcg