Kornimate/medical-research-clean huggingface dataset:
efficacy of group exercise program in older people with nonspecific low back pain

Conditions: Low Back Pain; Back Pain

Summary: the main objective of the study is to assess the feasibility of a randomized clinical trial that investigates the effects of an 8-week group exercise program on pain, disability, fear of falling, overall impression of recovery, frequency of falls and level of physical activity in elderly people with nonspecific low back pain.

the main objective of the study is to assess the feasibility of a randomized clinical trial that investigates the effects of an 8-week group exercise program on pain, disability, fear of falling, overall impression of recovery, frequency of falls and level of physical activity in elderly people with nonspecific low back pain. the evaluation of feasibility will be related to: (1) blinding the evaluator to allocate the groups; (2) eligibility and recruitment rates; (3) acceptability of random allocation to a group; (4) possible contamination between groups; (5) adherence to treatment; (6) satisfaction with the treatment; and (7) difficulty in understanding the information provided by the physiotherapist.

Eligibility criteria:
inclusion criteria: * older people aged 60 years old or over who have nonspecific lbp, defined as pain below the costal margin and above the lower gluteal folds, with or without referred leg pain for at least 3 months. * disability with score 4/24 in roland-morris disability questionnaire or higher and persistent back pain of pain 3/10 or higher. exclusion criteria: * suspected or confirmed serious spinal pathology (fracture, metastatic, inflammatory or infective diseases of the spine, cauda equina syndrome/widespread neurological disorder); * radiculopathy (i.e. presence of 2 of the 3 following criteria: strength, reflex or sensation alterations compatible with lumbosacral nerve root compression); * previous history of spinal surgery; scheduled for major surgery during the study or at the follow up period; * any of the contraindications to exercise listed on page 103 of the american college of sports medicine (acsm) guidelines.
human milk-derived fortification in preterm infants

Conditions: Postnatal Growth Restriction; Necrotizing Enterocolitis

Summary: human milk alone is unable to meet the high nutritional requirements of preterm infants. the american academy of pediatrics recommends fortification of human milk as a standard practice in all very low birth weight (vlbw) infants. multi-nutrient human milk fortifiers (hmfs) are designed to meet the macro and micro-nutrient needs of vlbw infants. hmfs differ by the origin of milk and by nutrient composition. traditionally, bovine milk has been the main source of multi-nutrient hmfs.

recent advances in lacto-engineering techniques allowed the manufacturing of multi-nutrient hmf from human milk as an alternative to bovine milk. since exposure to infant bovine-based formula feeds is frequently shown to increase neonatal morbidities, human milk-derived hmfs (h-hmfs) have been frequently proposed to minimize exposure to bovine products prior to 34 weeks gestation with an intent to decrease the risks of necrotizing enterocolitis and feeding intolerance. the use of multi-nutrient h-hmfs is a promising intervention however currently available h-hmfs are expensive. the main objective of this randomized controlled trial is to compare the weight gain achieved by preterm infants born \<1250 g and fed human milk fortified with h-hmfs (made from mother's own milk (mom) when mom supply exceeds the daily need of her preterm infant or from donor human milk (dhm) compared with counterparts fed human milk fortified with the currently used bovine-derived fortifier (b-hmf).

Eligibility criteria:
inclusion criteria: * birthweight between 400 g-1250 g * less than or 32 weeks gestational age at birth * subject has been classified as appropriate for gestational age * enteral feeding of human milk is initiated by 72 hours * subject is expected to be on human milk for at least 3 weeks. exclusion criteria: * congenital abnormalities or underlying disease that may affect growth * maternal cocaine, alcohol, or opioid abuse during pregnancy * mother or infant is currently receiving treatment for hiv infection * infant with major surgery

Keywords: human milk
comtess® versus cabaseril® as add-on to levodopa in the treatment of parkinsonian patients suffering from wearing- off.

Conditions: Parkinson's Disease

Summary: multi-centre, randomised, parallel-group study, rater-blinded. total duration of the study per subject is 12 weeks plus a one- to two-week screening period. there are 6 pre-planned visits per subject: screening visit followed by 5 visits. approximately 300 patients altogether in up to 25 active german study centres and up to 3 active lithuanian study centres will be randomised.


Eligibility criteria:
inclusion criteria: * patients suffering from idiopathic parkinson's disease (pd) with wearing-off phenomenon * off-time per day \>= 60 min after the first on-period in the morning * 3-5 daily dosages of standard levodopa/ddc inhibitor * stable antiparkinsonian treatment 3 weeks prior to the randomisation exclusion criteria: * symptomatic parkinsonism * concomitant treatment with non-selective mao inhibitors or a selective mao-a inhibitor while treated with a mao-b inhibitor already * concomitant treatment with one of the following catechol-structured drugs: rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine or apomorphine * concomitant treatment with alpha-methyldopa, reserpine, typical or atypical neuroleptics, neuroleptic antiemetics (such as metoclopramide) or other drugs with antidopaminergic action * treatment with comt-inhibitors 4 weeks prior to the randomisation * treatment with dopamine agonists 4 weeks prior to the randomisation * known hypersensitivity to ergot derivatives and entacapone * dementia (mmse \<= 24) * depression (beck scale \>= 17)
detection of perioperative atrial fibrillation after noncardiac surgery

Conditions: Atrial Fibrillation; Atrial Flutter

Summary: this is a multicentre prospective cohort study where patients will receive up to 14 days of continuous ecg monitoring by wearing a portable monitoring device, starting within 72 hours after noncardiac surgery.

poaf commonly occurs after noncardiac surgery and is associated with adverse long-term outcomes. despite this, patients with poaf are routinely being missed during clinical practice. continuous ecg monitoring has the potential to enhance poaf detection and improve clinical care in affected patients. based on this background, the detect-poaf study will determine the incidence of clinically important poaf in those receiving up to 14 days of continuous ecg monitoring within 35 days after noncardiac surgery.

Eligibility criteria:
inclusion criteria: 1. had undergone noncardiac surgery within the past 72 hours and requiring, or expected to require, at least one of the following: * an overnight hospital admission after surgery * day surgery that would result in a large enough physiological insult to be able to cause poaf. procedures excluded include those that are conducted using local anesthesia alone, are less than 30 minutes in duration, and/or are judged to be of low physiologic insult by the local investigator. 2. have one of the following high-risk criteria; * age 55-64 years, and having either established cardiovascular disease, recent major vascular surgery, a cha2ds2-vasc score ≥3, or an elevated postoperative troponin level; * age 65-74 years, and having either established cardiovascular disease, recent major vascular surgery, a cha2ds2-vasc score ≥2, or an elevated postoperative troponin level; or * age ≥75 years; 3. provide written informed consent to participate. exclusion criteria: 1. history of documented chronic (i.e., non-transient) af before noncardiac surgery; 2. need for long-term systemic anticoagulation; 3. ongoing need for long-term dual antiplatelet treatment; 4. contraindication to oral anticoagulation; 5. severe renal insufficiency; 6. severe liver cirrhosis; 7. acute stroke in the past 14 days; 8. underwent cardiac surgery in the past 35 days; 9. history of nontraumatic intracranial, intraocular, or spinal bleeding; 10. hemorrhagic disorder or bleeding diathesis; 11. known life expectancy \<1 year due to concomitant disease; 12. women who are pregnant, breastfeeding, or of childbearing potential not taking effective contraception; 13. expected to be non-compliant with follow-up and/or device use; 14. known contact allergy to monitoring device and/or its peripheral components; 15. previously enrolled in detect-poaf.

Keywords: cardiac monitoring
development and needs assessment and efficiency of smart communication system for patients with als (part 1)

Conditions: Amyotrophic Lateral Sclerosis

Summary: the research is aimed to explore the needs of clinical patients and their caregiver,so as to provide suggestions to the designer of the communication system.

to promote and develop a smart communication system is helpful to patients with amyotrophic lateral sclerosis (als),especially for stage 3 and stage 4 (late stage). through the needs assessment, the research is aimed to explore the needs of clinical patients and their caregiver,so as to provide suggestions to the designer of the communication system.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of als * taiwanese and used traditional chinese(mandarin). * if they were older than age 20 years. exclusion criteria: * frontotemporal dementia, severe depression, or schizophrenia. * if they cannot complete the questionnaire with researchers or family members help.

Keywords: amyotrophic lateral sclerosis, als, communication, needs
flourish hec to prevent recurrence of bv

Conditions: Bacterial Vaginosis

Summary: in a population of women with heightened vulvovaginal sensitivity and recurrent bacterial vaginosis (bv), the use of the flourish hec vaginal care system is being tested for prevention of bv recurrence over six months of use.

bv treated with metronidazole or clindamycin recurs within 3 months in at least 43% of women, requiring additional rounds of antibiotics. preliminary data show that the use of a commercially available 3-component kit can dramatically reduce bv recurrence over 11 weeks of use. this study tests a similar kit with one component altered - the intravaginal gel is composed of hydroxyethylcellulose rather than aloe, making it less likely to trigger reactions in women with sensitive tissues. the study will examine recurrence of bv, vaginal ph, and vulvovaginal symptoms as in the prior study, though extended to 6 months. additionally, this study examines changes in the vaginal microbiome using targeted next-generation sequencing with the use of the flourish hec system.

Eligibility criteria:
inclusion criteria: * pre-menopausal women between the ages of 18 and 52. * diagnosis of recurrent bv: \>= 3 episodes of bv within last year, or \>= 2 episodes of bv within past six months, recorded in medical record * desire to use personal hygiene products to avoid recurrence of bv. exclusion criteria: * known allergy or sensitivity to any other ingredient in the flourish hec vaginal care system * immunosuppressed or immunocompromised individuals * known allergy or intolerability to metronidazole * anyone who may have mental health disorders triggered by answering questions related to vulvar or vaginal health, by pelvic exams, or self-application of vaginal products * known vaginal infection that is not bv or yeast infection * adults unable to consent * individuals who are not yet adults (infants, children, teenagers) * pregnant women * prisoners

Keywords: bv recurrence probiotic intravaginal gel vaginal ph vulvovaginal symptoms questionnaire
molecular characterization of gliomas using a broad next generation sequencing (ngs)panel

Conditions: Malignant Glioma

Summary: gliomas are the most common malignant primary brain tumors with poor prognosis. the genotyping of tumors using ngs platforms enables the identification of genetic alterations that constitute diagnostic, prognostic and predictive biomarkers.here in, we investigated the molecular profile of 32 tumor samples from 32 patients with high grade gliomas by implementing a broad 80-gene targeted ngs panel while reporting their clinicopathological characteristics and outcomes.


Eligibility criteria:
inclusion criteria: diagnosis of high grade glioma based on tissue biopsy exclusion criteria:

Keywords: molecular profile mutational status
evaluation of vx-828 in healthy participants and in participants with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the purpose of the study is to evaluate safety, tolerability, and pharmacokinetics of vx-828 and vx-828 in triple combination (tc) with tezacaftor (tez)/ vx-118 or tez/ deutivacaftor (d-iva) in healthy participants and vx-828 in combination with d-iva with or without tez in participants with cystic fibrosis (cf).

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: parts a-d: * participants between the ages of 18 and 55 years * body mass index (bmi) of 18.0 to 32.0 kilogram per meter square (kg/m\^2) * a total body weight of more than (\>) 50 kg * nonsmoker or ex-smoker for at least 3 months before screening with current nonsmoking status confirmed by urine or blood cotinine at screening * cohort c2 only: willing to provide a single dna sample part e: * participants 18 years or older * confirmed diagnosis of cf as determined by the investigator * a total body weight of more than or equal to (\>=) 35 kg * participants must be heterozygous for f508del with a second cftr allele carrying a minimal function mutation that is not responsive to elx/tez/iva therapy * participants must have a forced expiratory volume in 1 second (fev1) of greater than or equal to (≥) 40% of predicted normal for age, sex, and height key exclusion criteria: parts a-d: * history of febrile illness or other acute illness within 14 days before the first dose of study drug * any condition possibly affecting drug absorption part e: * an acute illness not related to cf (e.g., gastroenteritis) within 14 days before the first dose of study drug * history of solid organ or hematological transplantation * history of clinically significant cirrhosis with or without portal hypertension * lung infection with organisms associated with a more rapid decline in pulmonary status other protocol defined inclusion/exclusion criteria will apply.
screening of nash in oupatients followed in various hospital specialty clinics at the university hospital of strasbourg

Conditions: Nonalcoholic Fatty Liver Disease

Summary: the aim of the present study is to assess, by using a simple algorithm combining fib-4 and fibroscan, the prevalence of nash with advanced fibrosis in outpatients followed in various hospital specialty clinics other than hepato/gastroenterology and to examine risk factors associated with this condition. the prevalence of nash will be investigated among 6 cohorts of outpatients followed in different hospital specialty clinics at hôpitaux universitaires de strasbourg.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * outpatients followed at specialty clinics in hus and at risk of nafld: with at least one metabolic risk factor (overweight, diabetes mellitus, hypertension, hypertriglyceridemia) and/or elevated transaminases and/or liver steatosis on us. * endocrinology cohort : type 2 diabetes patients * infectious disease cohort : hiv positive patients * rheumatology cohort : patients with psoriasis, gout or rheumatoid arthritis * nephrology cohort : patients with chronic kidney disease such as diabetic nephropathy or hypertensive nephropathy, including those receiving hemodialysis. * cardiology cohorts: patients with history of angina, myocardial infarction, stroke or arteritis of lower limbs. * internal medicine cohort: patients with auto immune systemic diseases such as lupus, sclerosis or rheumatoid arthritis. * subjects who have given their informed consent * subjects affiliated to a social security system exclusion criteria: * alcohol consumption \> 30g/d in male or \> 20g/d in female in the past 6 months * history of chronic viral hepatitis * history of liver auto immune disease, genetic hemochromatosis, wilson disease * biliary disease, bile duct obstruction * drug-induced liver injury * secondary liver cancer or other active cancer * organ graft * use of medications associated with secondary nafld (corticosteroids, tamoxifen, amiodarone, methotrexate). * congestive heart failure * aids * pregnancy, breastfeeding * no information could be given to the patient (subject faces emergency situation, comprehension difficulties, etc.) * patient under guardianship * patients under judicial protection
lenvatinib combined with gefitinib in the treatment of lenvatinib-resistant hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Molecular Targeted Therapy

Summary: this is a prospective clinical study aiming to tests the safety and efficacy of lenvatinib in combination with gefitinib in people with lenvatinib resistant hepatocellular carcinoma. this study will help find out if lenvatinib and gefitinib is a safe and useful combination for treating patients with lenvatinib resistant hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: (1) unlimited gender, aged 18-75 years; (2) meets american association for the study of liver diseases (aasld) or european association for the study of the liver (easl) clinical diagnostic criteria of hepatocellular carcinoma; (3) barcelona clinic liver cancer (bclc) stage b or c, and there is at least one measurable tumor in the liver (long diameter ≥ 1cm);(4) progressing after standard treatment; (5) unresponsive or resistant to lenvatinib; (6) child-pugh a or scored 7 b; (7) eastern cooperative oncology group performance status score \ = 60x10\^9/l, prothrombin time prolonged \<= 6 seconds. exclusion criteria: (1) uncorrectable coagulopathy with obvious bleeding tendency; (2) patients need long-term anticoagulant or anti platelet therapy and cannot stop the drugs; (3) patients with unstable or active ulcer or gastrointestinal bleeding; (4) heart disease requiring treatment or not well controlled high blood pressure; (5) patients with interstitial pneumonia; (6) hepatic encephalopathy or refractory ascites requiring treatment; (7) there is a clear active infection; (8) receiving radiotherapy/chemotherapy/interventional therapy for tumor within 4 weeks before the start of the study; (9) severe insufficiency of important organs, such as severe cardiopulmonary insufficiency; (10) other accompanying anti-tumor treatments; (11) the investigator assessed that the patient was unable or unwilling to comply with the protocol.

Keywords: hepatocellular carcinoma lenvatinib gefitinib
contrast-free magnetic resonance angiography (mra) at 3.0 t for intracranial aneurysm detection

Conditions: Intracranial Aneurysms

Summary: the chinese cerebral aneurysms survey is a continuing prospective study to evaluate the effectiveness of unenhanced, three-dimensional time-of-flight magnetic resonance angiography (3d-tof-mra) with volume rendering (vr) at 3-t in the detection of intracranial aneurysms.

recent years,three-dimensional time-of-flight mra (3d-tof-mra) has become a useful, contrast-free method for observing intracranial vessels and is widely utilized as a screening examination for intracranial aneurysms. the studies available in medline show mixed results.some of these studies just included mri/mra in the analysis, which have a high rate of false-positives and are unreliable, and some were lack of control (ruptured aneurysm), precise numbers of false-positive results, standard images process and review, or corroborative iadsa in some patients. furthermore, most previous studies included small sample size with aneurysm detection at 0.5-t or 1.5-t mr. thus, these results have been inconclusive because of certain pitfalls in these studies. since 2007, we have conducted a clinical study to objective detection of intracranial aneurysms in our routine diagnostic work-up of intracranial aneurysms by our neuroradiologists using a standard procedure with 3d-tof-mra with vr at 3t. the investigators want to establish the quality data to prospectively compare 3d-tof-mra with vr at 3t vs 3d-rdsa in the diagnosis of intracranial aneurysms in a largest cohort of patients and test it accuracy in screening for suspected patients

Eligibility criteria:
inclusion criteria: * suspected or known intracranial aneurysms exclusion criteria: * patient's inability to cooperate * chronic renal failure patients * any patients with a contraindication to mra examination, such as pacemaker, orbital metallic foreign body, coronary stent, etc. * any patients with a contraindication to dsa examination, such as allergic to contrast medium, etc.

Keywords: magnetic resonance angiography intracranial aneurysm digital subtraction angiography volume rendering
a clinical trial of ale.f02 in patients with advanced liver fibrosis and/or with mild cirrhosis

Conditions: Advanced Liver Fibrosis; Liver Cirrhosis

Summary: the purpose of this study is to evaluate how a human body processes ale.f02 (pharmacokinetics profile) in patients with impaired liver function.


Eligibility criteria:
principal inclusion criteria: * outpatients between 18 and 80 years * have been diagnosed with advanced liver fibrosis or mild cirrhosis attributable to nash, ald, or following a sustained virological response to treatment for hepatitis c * have an elf score of at least 9.5 but no more than 13 * have stable hepatic impairment, defined as no clinically significant change in disease status, and no previous liver cirrhosis decompensation episodes * body weight within the range of 50.0 kg to 140.0 kg * clinical frailty score \<6 principal exclusion criteria: * child-pugh score ≥7, as determined at screening * meld score ≥12, as determined at screening * estimated glomerular filtration rate \<60 ml/min per the ckd-epi creatinine-cystatin c equation * current or history of hcc * be suffering from or have symptoms of an acute or chronic infection * have active hepatitis c infection * other causes of liver disease including, but not limited to, hepatitis b, autoimmune disorders drug-induced hepatotoxicity, wilson's disease, iron overload, and alpha-1-antitryspin deficiency, based on medical history review. * is a woman of childbearing potential