Kornimate/medical-research-clean huggingface dataset:
feasibility of spinal manual therapy interventions for a future clinical study of back pain

Conditions: Back Pain; Back Pain With Radiation; Back Pain, Low

Summary: this study aims to compare two different spinal manual therapy interventions of the back to determine if they are viable and acceptable for a future study investigating the treatment of patients with back pain. the two proposed spinal manual therapy interventions are widely used in the fields of chiropractic, physical therapy, osteopathy, and manual medicine to treat back pain and improve function. this is a randomized study, meaning that participants are randomly assigned (like tossing a coin) to one of two manual spinal therapy interventions.

clinical trials of spinal manual therapy interventions for back pain and back-related leg pain face methodological challenges regarding the design of effective sham control ('control' hereafter) and blinding of the assigned interventions. although the assessment of blinding is often neglected in the field of manual medicine, the implementation of high-quality trials of spinal manual therapy interventions warrants formal evaluation of blinding feasibility among participants and outcome assessors to advance randomized clinical trial methods and design. the objectives of this blinding feasibility trial are: 1. to assess the feasibility of blinding participants, with or without experience of spinal manual therapy or current low back pain, randomly allocated to an active or control spinal manual therapy intervention protocol. 2. to assess the feasibility of blinding managing clinicians (non-treating clinicians or outcome assessors) within the randomised trial context. 3. to examine the impact of spinal manual therapy experience in the past 3 months (yes vs no) and presence of low back pain during the past four weeks (average intensity ≤2 versus ≥3 out of 10) on the feasibility of participant and managing clinician blinding. 4. to explore factors contributing to participant and managing clinician perceptions about the assigned intervention (active versus control) using a qualitative thematic analysis.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * with or without experience of spinal manual therapy * with or without experience of current low back pain exclusion criteria: * serious spinal pathology (e.g. spinal fracture, cancer or infection) * history of lumbar spine surgery * currently under care or in consultation with a specialist, chiropractor, physiotherapist, or osteopath for current back pain * manual medicine health care provider (i.e., chiropractor, physiotherapist, osteopath, massage therapist, manual medicine trained physician) * have a serious comorbidity preventing them from attending the research clinic and receiving the interventions * pregnant or breastfeeding status * involved in pending litigation related to back pain * already participating in another research study related to back pain

Keywords: methods manual therapy randomized trial back pain blinding assessment
european registry on rare neurological diseases

Conditions: Rare Diseases

Summary: the recent implementation of european reference networks for rare diseases (erns) is an unprecedented move to improve the care of patients suffering from rare health disorders by transnational collaboration. ern-rnd, the ern for rare neurological diseases, oversees more than 35,000 patients in 31 specialist centers in 13 countries. the ern-rnd registry aims to gather information on patient cohorts in the multiple specialist centers and to provide an overview on patient numbers principally accessible for translational studies.

the ern-rnd (european reference network on rare neurological diseases) registry aims to establish a demographic platform for collection of relevant core patient information. this will be accomplished by the construction and implementation of a single data base encompassing all rare neurological diseases in pediatric and adult patients (the ern-rnd registry), which will collect information according to the "set of common data elements for rare diseases registration" as it has been defined by the european commission. the ern-rnd network covers the following six disease groups in patients of all age groups: (i) ataxia and hereditary spastic spinal paralysis (hsp), (ii) leukodystrophies, (iii) frontotemporal dementia, (iv) dystonia, paroxysmal disorders and neurodegeneration with brain iron accumulation (nbia), (v) atypical parkinsonism and (vi) huntington's disease \& choreas.

Eligibility criteria:
inclusion criteria: patients suffering of one of the rare neurological diseases indicated below or probands who are at risk to develop such a disease since they are first degree relatives of patients affected by a rnd including: * ataxia and hsp * leukodystrophies * frontotemporal dementia * dystonia, paroxysmal disorders and neurodegeneration with brain iron accumulation (nbia) * atypical parkinsonism * huntington's disease \& choreas exclusion criteria: • missing informed consent of the patient and/ or their parents

Keywords: rare diseases ataxia hereditary spastic spinal paralysis neurodegeneration with brain iron accumulation leukodystrophy dystonia atypical parkinsonism huntington's disease chorea huntington european reference network on rare neurological diseases frontotemporal dementia
identification of carnitine-responsive cardiomyopathy

Conditions: Carnitine Deficiency

Summary: there are some adults with skeletal muscle weakness (called "myopathy") and heart muscle weakness (called "cardiomyopathy") who have low blood levels of a compound called carnitine as a cause of their problems. carnitine is very important to energy production in muscles. in fact, there are reports of some people with carnitine deficiency who have developed myopathy and cardiomyopathy that was completely reversed with carnitine treatment. the main objective of our project is to determine the number of patients who have carnitine deficiency as a cause of their myopathy and cardiomyopathy. the investigators will be measuring carnitine levels in 1000 patients with cardiomyopathy and will describe the specific features in all the study patients to see if there are any trends that may help us predict which patients with muscle weakness are at risk of developing low carnitine levels. the investigators will be treating patients with low carnitine levels with carnitine and observing them to see if their cardiomyopathy and their muscle weakness improve. knowing the exact percentage of myopathy and cardiomyopathy patients with carnitine deficiency may allow for screening of patients in a cheap and targeted way to treat the serious complication of this condition, including heart failure and sudden death.

the primary objective of this research is to determine the prevalence of primary and secondary (genetic and acquired) carnitine deficiency in patients with limb girdle weakness and hypertrophic or idiopathic dilated cardiomyopathy where an underlying cause is unknown. identification and treatment with carnitine may potentially reverse or halt heart failure and skeletal muscle weakness in these patients. specific aims: 1. to ascertain the prevalence of primary and secondary carnitine deficiency in a population of adults with myopathy and hypertrophic and dilated cardiomyopathy of unknown etiology 2. to describe the demographic and phenotypic characteristics of patients with myopathy and dilated or hypertrophic cardiomyopathy who have primary and secondary carnitine deficiency 3. to measure the motor and cardiovascular response to carnitine supplementation in patients with myopathy, cardiomyopathy and carnitine deficiency

Eligibility criteria:
inclusion criteria: * an adult patient (\>18 years) with a diagnosis of either hypertrophic or dilated cardiomyopathy, for which the underlying etiology of the cardiomyopathy is unknown. exclusion criteria: * a history of ischemia * a documented or suspected infection including hiv * a history of severe longstanding hypertension * a history of valvular heart disease * a history of chemotherapy exposure * a history of alcohol abuse * carnitine supplementation at the time of recruitment
health economic analysis of islet cell transplantation for the stabilization of the severe forms of type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the main goal is to perform a cost-utility analysis to compare islet cell transplantation versus best medical treatment (defined as sensor augmented pump therapy) for patients with brittle type1 diabetes.

the main goal is to perform a cost-utility analysis to compare islet cell transplantation versus best medical treatment (defined as sensor augmented insulin pump therapy) for patients with brittle type1 diabetes.

Eligibility criteria:
inclusion criteria : * suffering from diabetes since more than 5 years * patient with brittle type 1 diabetes despite an optimized insulin treatment and educational training will be included. a patient will be considered as experiencing a brittle type 1 diabetes if at least two criteria are present among: persistence of severe hypoglycemia, occurrence of ketoacidosis events without obvious etiology, diagnosis of unaware hypoglycemic episodes \ 50%, mage index (mean amplitude of glucose excursions)\>60 mg/dl, lbgi index (low blood glucose index)\>5, clarke score≥4 or hyposcore\>800. * insulin needs \< 0,85 u/kg/day * hba1c \< 12% ; * no residual insulin secretion (plasmatic basal and stimulated c-peptide \< 0.3 ng/ml) * social security membership or benefit from social security * patients who signed the consent form exclusion criteria : exclusion criteria related to islet infusion: * hemostatic disorders, pre-existing liver disease (pal, gamma-gt, asat-alat \>2n) or vesicular lithiasis. exclusion criteria related to diabetic complications: * evolutive proliferative retinopathy, evolutive nephropathy (glomerular filtration rate \ 0.5g/day), evolutive cardiopathy or obliterative arteriopathy with trophic cutaneous lesions. exclusion criteria related to immunosuppressant use: * hemoglobin \ 160/100 mmhg. * corticoid treatment (except for patient that benefited from a kidney graft with maintenance steroid therapy) * presence of anti-hla antibody directed against the donor * positive b or t cells crossmatch

Keywords: islet cell transplantation cost-effectiveness analysis cost-utility analysis type 1 diabetes
creation of arteriovenous ante-brachial fistula under axillary block versus local anesthesia : impact on early complications

Conditions: Kidney Failure, Chronic

Summary: recommended by the kdoqi vascular access guidelines, antebrachial arteriovenous fistula is the best primary vascular access for hemodialysis in patients with end stage renal disease. the primary complications are common, of the order of 10-36 %, including lack of maturation and dominated by stenosis and thrombosis. local anesthesia associated with sedation is a validated method of anesthesia for made arteriovenous fistula but does not cause the motor block and not blocking vasospasm, deleterious to the surgery. multiple injections necessary to cover the operating zone expose patient to pain and to intravascular injection of local anesthetics. regional anesthesia provides better conditions for realize more distal fistula. sympathetic block provides arterial, venous vasodilation and decreases the incidence of vasospasm . it enables an increased flow rate at an early time fistula and faster maturation. however, studies included low numbers of patient or are non-randomized. they cannot concluded a significant difference in the complication rate of arteriovenous fistula at an early time depending on the type of anesthesia . this study aims to demonstrate that axillary block for surgical creation of arteriovenous fistula allows a reduction of complications at 6 weeks compared to local anesthesia


Eligibility criteria:
inclusion criteria: * chronic kidney disease stade 4 or 5 * first creation of arteriovenous fistula on the side of the surgery * written consent * health care system adherent * no decision of juridical protection exclusion criteria: * pregnancy or breast-feeding * participation to an other research study that may interfere with this study * brachial arterio-venous fistula creation (upper elbow crease) * antecedent of homolateral arteriovenous fistula (controlateral fistula non excluded) * other surgery on arteriovenous fistula (superficialisation procedure, refection...) * contraindications to local anesthetics : ropivacaine or lidocaine allergy * contraindication to regional anesthesia : homolateral axillary lymphadenectomy

Keywords: arteriovenous fistula regional anesthesia local anesthesia early complication
evaluating oxidative stress in menopause

Conditions: Menopause; Oxidative Stress

Summary: thiol disulfide levels will be determined using venous blood samples from pre- and postmenopausal women to evaluate oxidative stress in menopause. furthermore, oxidative stress will be assessed according to age, and years since the start of menopause. also, whether the presence of menopause related osteoporosis has any association with oxidative stress will be determined.

a total of 77 subjects are divided into two groups: study group (postmenopausal women) and control group premenopausal women). biometric data such as age, bmi, obstetric anamnesis, history of komorbidities, pap smear results are recorded. mammography results, dexa scores of post menopausal women are also obtained. venous blood samples from all subjects are collected. thiol disulfide levels will be determined from serum samples. thiol disulfide levels will first be compared between the study and the control group in order to determine the oxidative stress in menopause. in secondary evaluation years of menopause, age, and dexa scores will be included.

Eligibility criteria:
inclusion criteria: women who entered menopause as a natural process women within the age limits still menstruating healthy women as control subjects exclusion criteria: women who have entered menopause prematurely women who have entered menopause following a surgery women with medically induced menopause women without any autoimmune or chronic inflammatory diseases women who are taking hormone replacement therapy due to menopausal symptoms women without any malignant diseases
evaluate the efficacy and safety of genexol®-pm compared to genexol® in recurrent or metastatic breast cancer

Conditions: Breast Cancer

Summary: phase iii trial to evaluate the efficacy and safety of genexol®-pm compared to genexol® in subjects with recurrent or metastatic breast cancer.


Eligibility criteria:
inclusion criteria: subjects should meet all of the following criteria to participate in the trial. 1. subjects who aged 18 years or older. 2. subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial. 3. subjects who have histologically or cytologically confirmed breast cancer with evidence of recurrence or metastasis. 4. if subjects have received taxanes as neo-adjuvant or adjuvant therapy, the subjects should have relapsed with breast cancer after 12 months of completing neo-adjuvant or adjuvant therapy with taxanes. 5. subjects who have measurable disease in accordance with the recist criteria
stuttering and anxiety

Conditions: Stuttering, Childhood; Anxiety Disorders

Summary: stuttering was defined as a common neurodevelopmental speech disorder characterized by repetitions, prolongations, and interruptions in the flow of speech. in other words, stuttering is a speech disorder characterized by involuntary disruptions to speech which impede the capacity to communicate effectively. physiological and emotional anxiety has been reported in persons who stutter. it has been reported that as high as 44% of clients seeking treatment for stuttering could be assigned a co-occurring social phobia or social anxiety diagnosis.

according to the diagnostic and statistical manual of mental disorders, social anxiety disorder is characterized by marked or intense fear of social or performance-based situations where scrutiny or evaluation by others may occur. feared situations often include speaking in public, meeting new people, and talking with authority figures. there are several reasons to expect that stuttering may be associated with social anxiety disorder. to begin with, stuttering is accompanied by numerous negative consequences across the lifespan which may increase vulnerability to social and psychological difficulties. these consequences are intensified during the school years when children become more involved in social and speaking situations. as a result, children and adolescents who stutter frequently experience peer victimization, social isolation and rejection, and they may also be less popular than their non-stuttering peers.

Eligibility criteria:
inclusion criteria: * age ≥ 6 years to 16 years * gender: both sex is included in the study * intelligence quotient ≥ 85 exclusion criteria: * intelligence quotient \< 85 * age below 6 years or above 16 years * presence of other speech, language or physical disorders

Keywords: stuttering anxiety
bloodstream infections in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis; Staphylococcus Aureus Bacteremia

Summary: study of incidence and risk factors of staphylococcus aureus bacteremia in patients with rheumatoid arthritis compared with the general population in a nationwide cohort of all adult members of the population from 1996 until 2017 using national registries


Eligibility criteria:
inclusion criteria: * all members of the adult danish population exclusion criteria: * staphylococcus aureus bacteremia prior to inclusion. * rheumatoid arthritis diagnosed prior to inclusion.
randomized study of fluoxetine in children and adolescents with autism

Conditions: Autism

Summary: objectives: i. evaluate the efficacy of fluoxetine on social and language deficits, global severity and compulsive dimensions of children and adolescents with autism. ii. assess the effectiveness of this treatment regimen on neurocognitive deficits in this patient population. iii. compare the baseline compulsive severity and treatment outcome in these patients.

protocol outline: this is a randomized, double blind, placebo controlled, crossover study. all patients receive oral placebo daily during week 0. patients are randomized to receive either oral fluoxetine or oral placebo daily on weeks 1-8. patients then crossover to receive treatment on the other arm during weeks 12-20. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- meets diagnostic criteria for autism --prior/concurrent therapy-- other: * at least 3 months since prior electroconvulsive therapy * at least 1 month since prior investigational drugs or treatment with any drug known to cause major organ toxicity * at least 2 weeks since prior monoamine oxidase inhibitors * at least 6 weeks since prior long acting phenothiazines * at least 1 week since prior other psychotropic drugs * no prior fluoxetine of 20 mg/day for 6 weeks * at least 6 weeks since prior fluoxetine * no concurrent use of terfenadine (seldane) or astemizole (hismanal) * no concurrent electroconvulsive therapy or other psychotropic drugs (unless otherwise permitted) * prior participation in another serotonin reuptake inhibitor trial allowed --patient characteristics-- hematopoietic: no significant hematopoietic disease hepatic: no prior or concurrent liver disease renal: no prior or concurrent kidney disease cardiovascular: * no significant cardiovascular disease * no abnormal ekg neurological: * no prior seizure disorder or high risk development of seizures * no prior cerebrovascular disease * no prior brain trauma other: * not pregnant or nursing * negative pregnancy test * no unstable major medical illness or systemic disease * no moderate or severe mental retardation and motor deficits (iq less than 50) * no family history of bipolar disorder * no prior or concurrent other mental disorders (e.g., schizophrenia, schizoaffective, organic, or bipolar disorders) * no significant autoaggressive behavior or serious suicidal risk * no prior or concurrent gastrointestinal conditions * no unstable endocrine disease (e.g., hypo or hyperthyroidism) * no prior or concurrent malignancy * must be able to tolerate tapering of psychoactive medication * no history of hypersensitivity or severe side effects to fluoxetine or other serotonin reuptake inhibitors * no history of severe personality disorder or noncompliance

Keywords: autism neurologic and psychiatric disorders rare disease
pharmacokinetics of imeglimin in hepatic impaired subjects

Conditions: Hepatic Impairment

Summary: this is a phase 1, single-centre, open-label, parallel-group study in subjects with moderate hepatic impairment and subjects with normal hepatic function. child-pugh (cp) scoring will be used to determine hepatic impairment.


Eligibility criteria:
inclusion criteria: * caucasian * bmi :18.0 and 40.0 kg/m2 and weight ≥50 kg. * stable hepatic impairment or normal hepatic function for healthy volunteer * no clinically significant findings from medical history, physical examination, 12-lead ecg, vital sign measurements, and clinical laboratory evaluations (subjects with moderate hepatic impairment may have medical findings consistent with their hepatic dysfunction) * females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception * informed consent signature exclusion criteria: * clinically relevant abnormal findings at the screening assessment * severe adverse reaction to any drug or sensitivity to the trial medication or its componentsclinically significant vital signs outside the acceptable range at screening * history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs * drug or alcohol abuse * positive test hiv * smoking more than 10 cig/day * participation in other clinical trials of unlicensed or prescription medicines exclusion criteria for healthy volunteer * positive test for hbv, hbc * egfr less than 90 ml/min/1.73 m2 * liver diseases exclusion criteria for hepatic impaired * egfr less than 80 ml/min/1.73 m2 * hepatic impairment due to non liver disease * history of hepatocellular carcinoma or acute liver disease * clinically significant change in liver disease status within 6 months * ascites * encephalopathy grade iii or iv

Keywords: pharmacokinetics