Kornimate/medical-research-clean huggingface dataset:
evaluation of flexofytol® versus placebo

Conditions: Osteoarthritis

Summary: this study is a prospective, randomized, double-blind, placebo-controlled with 3 parallel-groups and multicenter trial in patients suffering from knee oa (osteoarthrosis). a first exploratory non comparative study (tilflexy002, nct01909037, henrotin et al., 2014 bmc complementary and alternative medicine) evaluated the efficacy of flexofytol® at the dose of 2x3 caps/day, during a 3-month period, in 22 patients suffering from knee oa, on the serum levels of cartilage-specific and inflammatory biomarkers, on the evaluation of pain and on the global patient assessment of disease activity. this study demonstrated a statistically significant decrease of scoll2-1 cartilage specific biomarker, an early decrease of the ultrasensitive c-reactive protein (crp), an improvement of the global assessment of the disease by the patient as well as a good tolerance and compliance for the treatment. results of this exploratory study are encouraging and justify the setup of a randomized, placebo-controlled double blind and dose-ranging trial.

150 patients suffering from symptomatic knee oa will be randomized in 3 parallel groups (50 patients per group). each patient will be enrolled in the study for 6 months including 4 visits: inclusion visit (t0), follow-up visits after 1 month (t1), 3 months (t3) and 6 months (t6). a. primary objective - evaluate the efficacy of two different dosages of flexofytol® versus placebo on arthritis related biomarker coll2-1 and on patient assessment of disease activity in patients suffering from knee oa after a 3 months treatment b. secondary objectives * evaluate the efficacy of two different dosages of flexofytol® versus placebo on arthritis-related and inflammatory biomarkers. * evaluate the efficacy of two different dosages of fl exofytol® versus placebo on pain and function. * evaluate the tolerance, the compliance and the patients' satisfaction. * evaluate the use of rescue treatments i.e. paracetamol and oral non-steroidal antiinflammatory drugs (nsaids) during the study.

Eligibility criteria:
inclusion criteria: * male or female between the age of 45 and 80 exclusion criteria: * artialis (study coordinator) or tilman (sponsor) 's employees * participation to a therapeutic clinical trial in the last 3 months * under guardianship or judicial protection

Keywords: osteoarthritis; flexofytol®; curcuma; biomarkers
a multi-strain synbiotic versus a multi-strain probiotic in premature infants

Conditions: Feeding; Difficult, Newborn; Necrotizing Enterocolitis

Summary: the aims are to 1) compare two probiotic treatments (multi-strain synbiotic vs. multi-strain probiotic) on bifidobacteria fecal colonization counts at 1, 2, 3, and 4 weeks of life, 34 weeks corrected gestation age (cga) ; 2) compare infants successfully colonized with probiotic organisms to infants not successfully colonized at 1, 2, 3, and 4 weeks of life, 34 weeks cga on infant outcomes and on stress biomarker patterns at birth, day of life (dol) 1, dol 7; 3) determine long-term safety and outcomes of probiotic treatments at 6, 16, and 24 months cga.

feeding intolerance and other gi issues are a major concern in a nicu hospitalized population. successful colonization with probiotic bacteria is thought to impact the incidence of gi related issues. this study will study the impact of prebiotics on the colonization of a population of vlbw infants in the nicu setting.

Eligibility criteria:
inclusion criteria: * infants with a birth weight \< 1500g * admission to nicu at the nebraska medical center exclusion criteria: * infants who have congenital anomalies * have a diagnosis of a congenital metabolic disease * are made a ward of the state or * are born to a mother \< 19 years of age
cesarean scar defects after uterine closure by double-layer barbed or smooth suture

Conditions: Isthmocele; Uterine Scar Defects; Cesarean Section Complications; Uterine Niche

Summary: late sequelae of a cesarean section related to a uterine scar defects include gynecological symptoms and obstetric complications. the aim of this study was to evaluate the incidence and characteristics of cesarean scar defects after uterine closure by double-layer barbed suture.


Eligibility criteria:
inclusion criteria: - patients who underwent elective cesarean section at ≥ 37 weeks of gestation exclusion criteria: * patients who underwent concomitant surgical procedures during the cesarean section (i.e., tubal sterilization); * patients who underwent a previous abdominal surgery (with exception of appendectomy) including a cesarean section or other laparotomic/laparoscopic uterine surgical procedure (i.e., myomectomy); * patients who had a previous diagnosis of mullerian uterine anomalies elective cesarean for the second time or after uterine surgery; * patients who had evidence of pas disorders or placenta previa.

Keywords: uterine scar defects uterine niche isthmocele
technology assisted cognitive behavioural therapy intervention for anxiety in people living with cognitive impairment

Conditions: Dementia; Cognitive Impairment; Anxiety

Summary: this study is a randomized controlled trial (rct) of a remotely-delivered, technology-assisted psychotherapy program, supported by an innovative software platform for people with cognitive impairment experiencing anxiety.

despite harmful health and economic consequences, anxiety is a vexing issue in persons with cognitive impairment with inadequate treatment options. what is needed currently is a digital technology option for treating anxiety in persons with cognitive impairment that can be rigorously evaluated and implemented. the objective of the study is to test the efficacy of a newly modified psychotherapy package (tech-cbt), which incorporates cognitive behaviour therapy (cbt) methods, assisted with technology and telehealth for persons with cognitive impairment experiencing anxiety. this project will also investigate the cost-effectiveness, usability and acceptability of tech-cbt to enhance delivery of anxiety treatment for people with cognitive impairment. a process evaluation will inform its implementation in the community and memory clinics, and will recommend a strategic translational roadmap to enhance delivery of anxiety treatment in health services with a broad reach.

Eligibility criteria:
inclusion criteria: * persons aged 18 years or over * persons with a diagnosis of mild cognitive impairment (mci) or dementia of any aetiology based on a previous diagnosis by a clinician or scoring above threshold (≤32; mci ≤32 and dementia ≤27) for cognitive impairment in the modified telephone interview for cognitive impairment (tics-m). * screening positive for anxiety (scoring ≥9 on geriatric anxiety inventory, gai), and/or subjective complaints of anxiety and/ or clinician diagnosis of a current anxiety disorder and screening positive for anxiety using the rating anxiety in dementia scale (scoring ≥11 on raid) exclusion criteria: * persons with severe dementia * persons unable to communicate or complete questionnaires * persons who have a current risk of suicide within the last month as determined by the study clinical expert team. * persons with major depression as the primary complaint without reported symptoms of anxiety * persons with comorbid psychiatric conditions

Keywords: dementia cognitive impairment anxiety cognitive behavioural therapy technology telehealth randomized control trial
safety and efficacy of cmx-2043 in subjects undergoing coronary reperfusion therapy

Conditions: Stable Coronary Artery Disease; Percutaneous Coronary Intervention

Summary: this study is conducted to assess the safety of cmx-2043 solution for intravenous (iv) injection, and to evaluate efficacy on the basis of the changes seen in the cardiac biomarkers and continuous electrocardiography (ecg) monitoring. additionally, correlation of the levels/changes in the biomarkers and the pharmacokinetic evaluations of the drug will be explored.


Eligibility criteria:
inclusion criteria: * subjects who have stable coronary artery disease undergoing elective pci. * female subjects not of child-bearing potential. * absence of st segment depression \>1.0 mm and absence of st elevation \>1.0 mm in any lead on the baseline 12-lead ecg. * subjects with ck-mb and troponin-t levels lower than the upper limit of normal. * subjects free of acute injuries or illnesses. exclusion criteria: * subjects with unstable angina (angina at rest, worsening frequency, duration of angina) or other signs of unstable coronary artery disease. * subjects who had had an mi within 14 days prior to the pci procedure. * subjects with conditions that contraindicate the pci (e.g. coagulopathy, valvular disease, pvd). * subjects with history of tia/stroke within 90 days or any intracranial bleed. * subjects with creatinine clearance ≥ 1.5 times the upper limit of normal. * subjects with an active history of psychiatric disorders that is likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements. * subjects with a history of alcohol or drug abuse. * subjects with documented history of human immunodeficiency virus (hiv), or hepatitis b (hbsag) or hepatitis c (hcv) virus positive. * subjects with uncorrected clinically significant abnormalities of clinical laboratory tests who in the investigators opinion will interfere with the study conduct. * subject with chronic diseases considered by the anesthetist unfit for surgery and/or who in the opinion of the investigator will increase the risk of the study or obscure the interpretation of results. * subjects who have participated in a clinical study within 1 month or are currently participating in a clinical study of an investigational agent.
innovations in biofeedback and its use in mental health

Conditions: Anxiety; Biofeedback, Psychology

Summary: this study investigates the use of new technologies in "biofeedback gaming" and their potential for use as a treatment for stress and anxiety. biofeedback training is typically accomplished through devices that measure heartrate variability (hrv), galvanic skin response (gsr), or electroencephalogram (eeg). typically, the use of this equipment requires a practitioner with specialized training in reading and interpreting hrv, gsr, and/or eeg. however, recent advances in technology have made biofeedback devices more readily available to the general public, and some commercial devices are now being sold. this study investigates the utility of these commercial devices with a mild clinical population. in this study, participants use two tools for biofeedback training, one is called "the pip," described in group c, below, and another is a computer game called nevermind, described in groups a and b, below. these are compared against a control group (group d), which is standard relaxation training without biofeedback.


Eligibility criteria:
inclusion criteria: 1. participant scores at least 1.5 standard deviations above the mean on any anxiety or stress-based scale (bai or pss), or 2. patient is assigned a csr of 4 or higher on any anxiety disorder using the adis-5, or 3. patient exhibits maladaptive coping strategies, as demonstrated by cope profile, and 4. patient shows some level of functional impairment as a result of stress, anxiety, and/or restlessness (i.e. the symptoms are judged by clinician to be clinically meaningful). exclusion criteria: 1. participant is not english-speaking. 2. participant appears to meet criteria for a comorbid psychiatric diagnosis that warrants alternative psychological treatment (e.g. ptsd, ocd, major mood disorder, substance use disorder, psychotic disorder, etc.). 3. any medical condition that would contraindicate participation in deep breathing practices associated with relaxation training. some examples may include, but are not limited to, increased intracranial pressure, unstable head or neck injury, active hemorrhage, recent spinal injury, empyema, bronchopleural fistula, flail chest, uncontrolled hypertension, anticoagulation, rib or vertebral fractures or osteoporosis, acute asthma or tuberculosis, recent heart attack, recent skin grafts in chest area, spinal fusions, bony metastases, brittle bones, bronchial hemorrhage, emphysema, untreated pneumothorax, and chest tubes. 4. any history of epileptic seizure activity which may be worsened by prolonged exposure to a computer screen. 5. participant is unable to hold small object between thumb and forefinger. 6. participant is unable to manipulate computer keyboard or computer mouse. 7. participant has substantial visual deficit in both eyes, which cannot be corrected, that would interfere with ability view a small screen on a mobile device or a laptop screen. 8. participant is unable to wear a cheststrap heart monitor.

Keywords: videogames commercial biofeedback device
feasibility and acceptability of the cannabis awareness and prevention toolkit

Conditions: Cannabis Use

Summary: the stanford tobacco prevention toolkit is a free, online toolkit that consists of a curriculum, educational resources, and a resource directory to be used by educators, parents, juvenile justice workers, and healthcare providers to increase knowledge and awareness of cannabis and reduce use among youth. the aim of this study is to investigate the extent to which the curriculum changes students' intentions to use and actual use of cannabis.


Eligibility criteria:
inclusion criteria: * middle school and high school students receiving health education at schools participating in the study exclusion criteria: -

Keywords: youth cannabis education health prevention marijuana
intravitreal bevacizumab for inflammatory neovascular membranes

Conditions: Vogt Koyanagi Harada Disease; Serpiginous Choroiditis; Multifocal Choroiditis

Summary: intravitreal injection of bevacizumab in patients with neovascular membranes secondary to intraocular inflammation. we injected a single injection of bevacizumab (2.5 mg/0.1 ml) and evaluate visual acuity , fluorescein angiogram and retinal thickness by optical coherence tomography (oct) in 4 patients with vogt koyanagi harada disease, 1 patient with serpiginous choroidopathy and 1 patient with multifocal choroiditis.


Eligibility criteria:
inclusion criteria: * clinical diagnose * patient consent * chronic stage of inflammation exclusion criteria: * only eye * age lower than 30 yo. * systemic condition

Keywords: neovascular membrane uveitis bevacizumab
effect of glp1 receptor agonists on physical function, body composition, and markers of aging in older adults

Conditions: Aging; Diabetes Mellitus, Type 2; PreDiabetes; Overweight and Obesity

Summary: semaglutide is a medication approved by the us food and drug administration (fda) as an antihyperglycemic (a drug that reduces glucoses in those with diabetes) and for weight management. this new study will help find out what effects, semaglutide has on people who take the drug and the drug's effect on physical function, body composition, and aging.


Eligibility criteria:
inclusion criteria: * older than 65 * have prediabetes or diabetes * bmi ≥ 27.0 kg/m2 * living independently (not in assisted living or nursing home) exclusion criteria: * have heart disease * have liver disease * smoke
registry for vascular trauma and follow-up examinations

Conditions: Vascular Injury

Summary: within the framework of the project presented here, a registry for traumatic vascular injuries will be established at augsburg university hospital. patients who are treated at our hospital for an isolated vascular trauma or a vascular involvement in (poly-)trauma will be included. this is a rare complication of trauma, so data collection in a registry is useful to pool data on therapeutic procedures and outcome. these patients differ from the usual vascular surgery patient clientele because there is usually no previous vascular disease. healthy vessels show different physiological responses than pre-diseased vessels. the usual therapeutic procedures and materials are also developed for arteriosclerotic or aneurysmatic vessels. therefore, a core objective of this study is to assess long-term outcomes after vascular trauma.


Eligibility criteria:
inclusion criteria: * age over 18 years * vascular involvement in trauma * isolated vascular injury * written informed consent, except for those deceased from trauma sequelae exclusion criteria: * minority * lack of consent

Keywords: trauma vascular trauma bleeding ischemia registry
study to assess adverse events and how oral abbv-990 moves through the body of adult healthy participants

Conditions: Healthy Volunteers

Summary: this study will assess how safe abbv-990 is and how abbv-990 moves through the body of adult healthy participants. adverse events will be assessed. abbv-990 is an investigational drug being developed for the treatment of sars-cov-2 infections. participants are randomly assigned to one of the 5 treatment groups. each group receives different treatment. there is 1 in 4 chance that participants are assigned to placebo. approximately 40 adult healthy volunteers will be enrolled in a single site in the united states. participants will receive oral tablet of abbv-990 or matching placebo on day 1 and followed for approximately 30 days. participants will be confined for 5 days. adverse events and blood tests will be performed.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) is \>= 18.0 to \<= 32.0 kg/m2. * laboratory values meet the protocol-specified criteria. * a condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ecg). * in the opinion of the investigator, participant is a suitable candidate for enrollment in the study. exclusion criteria: * have any clinically significant ecg abnormalities. * history of any clinically significant sensitivity or allergy to any medication or food. * known active sars-cov-2 infection at screening and upon initial confinement. * history of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug. * currently enrolled in another interventional clinical study.

Keywords: healthy volunteers coronavirus disease-2019 (covid-19) abbv-990 sars-cov-2 severe acute respiratory syndrome coronavirus-2
a real world study on clinical efficacy of bicarbonate ringer's solution in biliary atresia children

Conditions: Biliary Atresia

Summary: in most babies with biliary atresia (ba) bile ducts on the inside and outside of the liver are affected eventually leading to a complete blockage of bile flow from the liver. this in turn causes scarring (fibrosis) in the liver. the surgery called the kasai procedure and eventually, a liver transplant could treat biliary atresia. however, children with ba have poor liver function, poor renal reserve, and poor ability to regulate water and electrolytes. therefore, a reasonable and effective perioperative fluid management is more significant. considering the high chlorine of saline, the liver burden of lactated ringer's solution and acetated ringer's solution, the bicarbonate ringer's solution which composition is similar to plasma, could be the best choice for perioperative fluid management of ba children. therefore, we hypothesize that compared with other crystalloids, bicarbonate ringer's solution is a better choice to maintain water, electrolyte and acid-base balance in ba children.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with biliary atresia before surgery. 2. age less than 90 days. 3. american society of anesthesiologists score of 1\~2. exclusion criteria: 1. patients with severe allergies. 2. patients with severe deformities or lesions. 3. other situations not suitable for enrollment judged by researchers.

Keywords: biliary atresia bicarbonate ringer's solution perioperative fluid management
studying biomarkers in samples from younger patients with acute myeloid leukemia

Conditions: Childhood Acute Monoblastic Leukemia (M5a); Childhood Acute Monocytic Leukemia (M5b); Childhood Acute Myeloblastic Leukemia Without Maturation (M1); Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies; Childhood Acute Myelomonocytic Leukemia (M4)

Summary: this laboratory study is looking into biomarkers in samples from younger patients with acute myeloid leukemia. studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer

study subtype: observational observational study model: case-control time perspective: retrospective biospecimen retention: samples with dna biospecimen description: cryopreserved bone marrow samples study population description: patient samples with the aml1-eto translocation and cytologically normal aml samples for controls sampling method: non-probability sample objectives: i. to address whether the mutation-specific cell-surface markers observed in murine system will allow the prospective isolation of leukemia stem cells (lsc) from human bone marrow samples that have the same cytogenetic abnormalities. ii. to compare the incidence of leukemia in nsg mice that have received cd34+cd38 marker+ cells to nsg mice that receive what are hypothesized to be normal cells (cd34+cd38 marker-subset) from the same patient. outline: samples and controls are sorted and re-sorted for cd34, cd38, and cd55 subsets by single-cell polymerase chain reaction (pcr) analysis, flow cytometry, and reverse-transcriptase pcr. sorted cell subsets are then transplanted into nsg mice. beginning 6 weeks after transplantation, peripheral blood samples are collected and analyzed for human lymphoid- and myeloid-lineage cells by fluorescence-activated cell sorting (facs).

Eligibility criteria:
inclusion criteria: * frozen bone marrow aspirates obtained from childhood acute myeloid leukemia (aml) patients possessing defined cytogenetic mutations; aml1-eto or inv(16) * samples of cytogenetically normal aml cases obtained from the university of alabama at birmingham (uab) as controls
an observational study of insulin aspart and, if necessary, insulin levemir (flexpen®) in the evening or at bedtime

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of this study is investigate the potential of a supplementary insulin therapy regimen (sit) as intensification for insufficiently controlled patients with type 2 diabetes in a normal diabetes care setting.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * oad monotherapy * oad combination therapy * therapy with oad and basal insulin * conventional insulin therapy with premixed insulin
family meeting study for end stage renal disease

Conditions: End-stage Renal Disease

Summary: a randomized clinical trial for patients with end stage renal disease in which a family consultation condition is compared against a treatment as usual control condition on the hospital readmissions after 1 month as the primary outcome variable.

patients hospitalized at henry for hospital who have end stage renal disease will complete baseline questionnaires and be randomized into the experimental or control condition. patients randomized into the experimental condition will have a single family consultation session before the patient is discharged. a trained, master's level therapist will conduct the family consultation, which will use education, motivational interviewing, and other techniques to help the family engage and support the patient's health needs. patients in both the experimental and control conditions will complete follow up questionnaires 1 month after discharge. investigators will conduct chart reviews of outcome data, including readmissions, at 1, 3, and 6 months post-discharge.

Eligibility criteria:
inclusion criteria: * hospitalized in inpatient nephrology unit at henry ford hospital * has end-stage renal disease * willing and able to contact support person / family member about participating in the study exclusion criteria: * persistent delirium * non-english speaking