Kornimate/medical-research-clean huggingface dataset:
long-term outcomes and durability of effect following treatment with cladribine tablets for ms (classic-ms)

Conditions: Multiple Sclerosis (MS)

Summary: the objective of this study was to collect data both retrospectively and prospectively in order to evaluate the long-term outcomes, durability of effect, and real-world treatment patterns following treatment with cladribine tablets or placebo in participants with multiple sclerosis (ms) who were previously participated in the parent studies (oracle ms and clarity/clarity-ext).


Eligibility criteria:
inclusion criteria: * participants with relapsing remitting multiple sclerosis (rrms) randomised in clarity/clarity-ext clinical trial(s) who have received greater than or equal to (\>=) 1 course of in investigational medicinal product (imp) cladribine tablets or placebo * participants with their first clinical demyelinating event randomised in oracle ms clinical trial who have received \>= 1 course of imp cladribine tablets or placebo * participants who has sign informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and this protocol exclusion criteria: * participants who has any uncontrolled disease state other than ms, that in the investigator's opinion, constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation * for study participants at selected sites where mri assessment will be conducted following exclusion criteria will apply to mri assessments only: * female study participants who are pregnant * participants who are taking cladribine tablets as part of another study at the time of the start of this study

Keywords: multiple sclerosis cladribine high disease activity
deep brain stimulation recovery in treatment-resistant schizophrenia

Conditions: Treatment-resistant Schizophrenia; Deep Brain Stimulation

Summary: the purpose of this project is to improve the clinical response and personal recovery of patients with treatment-resistant schizophrenia (trs).

the project aims to improve the efficacy of the first worldwide study of deep brain stimulation (dbs) carried out in our hospital -pi12 / 00042: deep brain stimulation in the treatment of refractory schizophrenia- through the implementation of a white matter tractography approach, which have demonstrated to improve efficacy in other dbs studies . moreover, and in line with the national strategy of mental health of the national health system, this project aims to promote integrated and comprehensive care for patients with mental illness by multidisciplinary teams which includes family care, as we consider it is important to add to the dbs treatment program, a psychological intervention module based on the recovery model. therefore, the main objectives of the present project are: i) to optimizethe efficacy and tolerability of dbs in trs; ii) investigate whether the refocus intervention improves the recovery of patients who are being treated with dbs. to this end, a double-blind, randomized, crossover clinical trial of dbs will be performed for 6 patients with trs. patients will be randomized to receive tractography-based target guidance dbs in the anterior cingulate cortex (acc) or the nucleus accumbens (nac). the 21 patient previously intervened with dbs (affective disorders and trs) and the ones included in this project, will enter into a psychological intervention phase, based on the refocus model

Eligibility criteria:
inclusion criteria: * individuals aged 18-50 years * meet dsm-5 criteria for schizophrenia, with a duration of illness \< than 15 years. * meet updated trs criteria. * non-sustained response to electroconvulsive therapy. exclusion criteria: * contraindications to neurosurgery or dbs * epilepsy or seizures clozapine-induced * suicidal or self-harming behaviour in the last 6 months * other psychiatric disorders (including personality disorders) * significant cognitive impairment (vocabulary test wais iv-tr, iq \<70, and scip\<55) * severe medical non-controlled diseases * pregnancy or breastfeeding * substance use disorders (except nicotine)

Keywords: recovery deep brain stimulation schizophrenia
standing computed tomography (sct) imaging of the knee joint

Conditions: Osteoarthritis, Knee

Summary: this study will help us decide the best way to image the knee for diagnostic purposes: knee computed tomography vs knee x-ray. the computed tomography will provide a weight bearing 3d view.

this will be an ancillary study to the multicenter osteoarthritis study (most) second renewal #201511711). using a prototype curve beam standing computed tomography (sct) scanner to get a 3 dimensional picture of the knee joint, bilaterally. this scanner by curve beam 175 titus ave, suite 300, warrington, pennsylvania 18976, has been approved by the food and drug administration (fda) for ankles and feet. this has been modified to do the scan of the knee but is not yet approved by the fda for the knees. the proposed ancillary study would add the key benefit of providing more sensitive and accurate identification of prevalent knee osteoarthritis (oa) at baseline and incident knee oa at follow-up than is available with plain radiographs. in addition, it would enable biomechanical modeling of the knee joint on a larger scale than achieved in any prior study, allowing testing of biomechanical hypotheses regarding mechanisms of disease development and progression that have not been possible on this scale previously.

Eligibility criteria:
inclusion criteria: only participants in the multicenter osteoarthritis study (most) who attend a 0/144-month visit at the iowa site are eligible for inclusion. additional inclusion criteria include: * completed knee radiograph (posteroanterior view) at 0/144-month visit of primary most-second renewal study at the iowa site exclusion criteria: * bilateral total knee arthroplasty
health related quality of life of youth and young adults with hemophilia a

Conditions: Hemophilia A

Summary: the relevance of the study will be in establishing whether health related quality of life (hrqol) measures obtained repeatedly during hemophilia care are sensitive to significant changes in health or personal circumstances related to the transition from youth to adulthood. this may support the future use of hrqol measures as part of routine care in order to identify important changes that are not detectible by other clinical means.


Eligibility criteria:
inclusion criteria: * moderate or severe hemophilia a (factor level ≤5%) * receiving helixate fs as on-demand treatment or prophylaxis therapy at time of informed consent * patient age 14 to 29 years at the time of recruitment * complete informed consent process and documentation; (patients under age 18 must assent in addition to consent of legal guardian) * willing/able to follow study protocol, including keeping a bleeding and treatment diary * able to communicate clearly in either english or french - both written and verbal communication is essential. exclusion criteria: * known inhibitor at time of recruitment (\> 0,5 bethesda units) or immune tolerance therapy at time of recruitment * hiv positive * symptomatic hepatitis b or c infection or active treatment for hepatitis b or c * inability to comply with study protocol * hypersensitivity to helixate fs or to any ingredients in the formulation or component of the container * hypersensitivity to mouse or hamster protein * unsuitable to participate in study for any other reason as assessed by investigator

Keywords: quality of life hrqol hemophilia a helixate fs
improving the experience of exercise among individuals with internalized weight bias using acceptance-based strategies

Conditions: Overweight and Obesity

Summary: the goal of this study is to test whether an acceptance based intervention can modify the relationship between heart rate and perceived exertion/negative during physical activity among individuals who have a high degree of internalized weight bias.

in this two-phase pilot, we will first test in a controlled setting whether an acceptance-based intervention can modify the relationship between heart rate and perceived exertion/negative affect during moderate intensity physical activity among individuals high in internalized weight bias (phase 1) and then evaluate these mechanisms in real-time during uptake of a two-week physical activity prescription (phase 2). using a 2x2 factorial design, we will randomize individuals with body mass index (bmi) ≥25, high and low internalized weight bias, and insufficient activity (\<60 min of moderate physical activity/week) to receive a 90-minute acceptance-based intervention workshop versus a multi-health behavior education condition prior to completing a 30-minute session of supervised, moderate intensity treadmill walking. heart rate, self-reported perceived exertion and affect will be assessed throughout physical activity. for phase 2, all participants from phase 1 will receive a two-week physical activity prescription consistent with national guidelines (150 minutes moderate intensity aerobic physical activity, recommended in 30-minute bouts) to determine the effect of treatment condition on subsequent adherence to physical activity. physical activity adherence will be monitored with actigraphy and ecological momentary assessment (repeated daily surveys via smartphone) will be used to evaluate participant self-efficacy, intention, motivation for physical activity in near real-time.

Eligibility criteria:
inclusion criteria: * 18-60 years old, * bmi 25-40 kg/m2 * insufficiently active (\<60 minutes of moderate intensity activity per week). * high/low internalized weight bias * access to personal smartphone device and willing to download free smartphone app for data collection exclusion criteria: * comorbid issues that might interfere with ability to engage in physical activity * factors that would influence ability to complete study protocol (e.g., cognitive, psychological) * medication that would affect heart rate (e.g., beta blocker), * women who are nursing or pregnant
recurrent low back pain:linking mechanisms to outcomes

Conditions: Low Back Pain

Summary: the purpose of this study is to determine if trunk neuromuscular control strategies are changed by therapeutic exercises emphasizing core stabilization. hypothesis: subjects with low back pain who demonstrate clinically meaningful improvements in function and pain will have significantly improved trunk motor control strategies. hypothesis: measures of trunk control will demonstrate 'construct-validity'. this will be tested using a known group method demonstrating: * no significant change in motor control measures within the untreated, healthy control group. * significant changes within the low back subjects who demonstrate clinically meaningful improvements.

a growing body of evidence suggests that poor neuromuscular control of the lumbopelvic region is an important finding in a large number of patients with recurrent and chronic low back pain and may play a role in recurrence of symptoms. despite findings of altered trunk motor control in individuals with low back pain, the neuromuscular strategies underlying these alterations have not been satisfactorily characterized. the aims of this study are to(1) identify which neural control strategies are altered following a rehabilitation program that emphasizes trunk control and stability using a motor learning approach and (2) provide preliminary evidence of a link between hypothesized mechanism and effectiveness for programs designed to improve trunk control.

Eligibility criteria:
inclusion criteria for healthy controls: no history of low back is defined as: 1. no pain limiting performance of daily activities for greater than 3 days, 2. no pain for which they sought medical or allied health intervention. inclusion criteria for individuals with a history of low back pain: 1. duration of the current episode of low back pain less than 3 months, 2. average pain intensity over past 2 weeks at least 3 on an 11 point (0 = no pain, 10 = worst pain ever) numeric pain rating scale, 3. no medical intervention for low back pain in last 6 months, 4. oswestry disability score greater than 20% 5. a physical therapy diagnosis of clinical lumbar instability based upon specific examination findings. exclusion criteria for both groups: 1. permanent structural spinal deformity (e.g., scoliosis) 2. history of spinal fracture or diagnosis of osteoporosis 3. diagnosis of inflammatory joint disease 4. signs of systemic illness or suspected non-mechanical lbp (i.e. spinal tumor or infection) 5. previous spinal surgery 6. frank neurological loss, i.e., weakness and sensory loss 7. history of neurologic disease that required hospitalization, 8. active treatment of another medical illness that would preclude participation in any aspect of the study or any lower extremity injury that would potentially alter trunk movement in standing 9. leg length discrepancy of greater than 2.5 cm. 10. pregnancy 11. vestibular dysfunction

Keywords: low back pain clinical instability neuromuscular control core stabilization physical therapy
effects of tdcs on high level and recreational athletes

Conditions: Healthy; Athlete

Summary: healthy recreational and high level athletes will undergo 2 randomized, cross-over counterbalanced sessions of anodal tdcs or sham tdcs. the primary outcome is an isokinetic evaluation of their hamstrings' and quadriceps' endurance after each session

recruitment : healthy recreational and high level athletes will be recruited through social media and advertisements. each subject came twice to the liege university hospitals' isokinetic lab. each session began with strapping the subjet into the isokinetic machine, making sure that all the settings were adapted to the subject. then, each subject received either anodal tdcs, of sham tdcs. neither the evaluator or the subject knew which they were receiving. immediately following tdcs, there was a warmup consisting of stationary bike, and an isokinetic warmup. then, subjects' endurance was using a maximal isokinetic tests, at 30 maximal concentric and eccentric contractions at a speed of 180°/s.

Eligibility criteria:
inclusion criteria: * for the "recreational" group at most 3 hours of sport a week * for the "athletic" group, at least 10 hours of sport a week * right handed and footed exclusion criteria: * one on the tsst (in high and relatively high risk sections) * previous neurological or orthopedic pathologies affecting limbs

Keywords: tdcs athlete isokinetic endurance fatigue
response or resistance to chemotherapy in young patients with acute lymphoblastic leukemia treated with methotrexate

Conditions: B-cell Childhood Acute Lymphoblastic Leukemia; Childhood Acute Lymphoblastic Leukemia in Remission; Recurrent Childhood Acute Lymphoblastic Leukemia; T-cell Childhood Acute Lymphoblastic Leukemia

Summary: this laboratory study is looking at response or resistance to chemotherapy in young patients with acute lymphoblastic leukemia treated with methotrexate. studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in dna and drug resistance in patients.

objectives: i. determine the molecular basis for human reduced folate carrier (hrfc) transcripts in b-precursor and t-cell acute lymphoblastic leukemia (all) blasts obtained from children with newly diagnosed all subsequently treated with methotrexate. ii. correlate hrfc expression in these specimens with methotrexate transport and sensitivities. iii. determine the roles of high frequency gene/transcript variants for hrfc as determinants of response and resistance to methotrexate in these patients. iv. determine the roles of multidrug resistance-associated proteins as determinants of response and resistance to methotrexate and mercaptopurine in these patients. outline: this is a multicenter study. tumor diagnostic specimens from patients who subsequently failed therapy within 4 years of diagnosis or who did not fail therapy within 4 years of diagnosis (control patients) are obtained from the children's oncology group cellbank. specimens are studied for molecular determinants of human reduced folate carrier (hrfc) gene expression and gene sequence alterations using reverse transcriptase-polymerase chain reaction (rt-pcr), thymidylate synthase inhibition assay, rnase protection assay, or 5'race. multidrug resistance proteins are also studied by rt-pcr. a certificate of confidentiality protecting the identity of research participants in this project has been issued by the national cancer institute.

Eligibility criteria:
inclusion criteria: * diagnosis of b-precursor or t-cell acute lymphoblastic leukemia * newly diagnosed disease subsequently treated with methotrexate * banked diagnostic blast specimens are available from childrens oncology group (cog) cellbank
the effect of lifestyle intervention versus gastric bypass on various comorbidities in morbidly obese subjects

Conditions: Obstructive Sleep Apnea; Diabetes Mellitus; Hypertension

Summary: this follow up study (\>1 year) aims to compare the effects of lifestyle intervention and gastric by pass surgery on various comorbidities associated with morbid obesity.

not addressed

Eligibility criteria:
inclusion criteria: * morbidly obese patients exclusion criteria: -
vascular effects of carvedilol versus metoprolol in hypertensive patients with type 2 diabetes

Conditions: Hypertension; Type 2 Diabetes Mellitus

Summary: the purpose of this study is to compare the vascular effects of two commonly used blood pressure medications, carvedilol and metoprolol in hypertensive patients with type 2 diabetes.

carvedilol and metoprolol are two commonly used blood pressure medications that have both been shown to be effective in controlling hypertension. although in the same drug class, preliminary data have shown that these medications may have different vascular effects. this study will assess which medication is better at improving artery health independent of their blood pressure lowering effects. artery health will be assessed non-invasively by ultrasound. certain markers of atherosclerosis found in the blood will also be measured.

Eligibility criteria:
inclusion criteria: * age 30-80 years old * documented history of type 2 diabetes * stable angiotensin converting enzyme/angiotensin receptor blocker (ace/arb) regimen 30 days before and throughout the study period * stable anti-diabetic regimen throughout the study period * body mass index (bmi) between 22-45 kg/m2 * hba1c between 6-9% for patients on anti-diabetic treatment regimen and hba1c between 6-8% for patients who are being controlled by diet alone * screening blood pressure (bp) \> 130/80 (average of 3 sitting measurements), with current medications exclusion criteria: * uncontrollable or symptomatic arrhythmias * unstable angina * sick sinus syndrome or second or third degree heart block * decompensated heart failure * myocardial infarction (mi) or stroke within 3 months of screening * bradycardia * chronic obstructive pulmonary disease (copd) with required inhaled or oral bronchodilators or corticosteroids * bronchial asthma or related bronchospastic conditions * new onset/diagnosed type 2 diabetes (\<3 months) * clinically significant renal or liver disease (creatinine \>2.5 mg/dl) * endocrine disorders * use of anorectic or other diet drugs inconsistent with recommendations for type 2 diabetics * use of beta-blockers within 3 months of screening * use of corticosteroids * systemic disease, including cancer, with reduced life expectancy (\<12 months) * psychological illness/condition that interferes with comprehension of study requirements * use of an investigational drug within 30 days of entry into study

Keywords: beta-blockers endothelial function
assessment of the prevalence of lysosomal acid lipase deficiency in patients waiting for a liver transplant.

Conditions: Patients Waiting for a Liver Transplant.

Summary: lysosomal acid lipase (lal) deficiency is a rare, autosomal recessive storage disease linked to decrease enzymatic activity of lal, responsible for intracellular accumulation of cholesterol esters and triglycerides. the accumulation of lipid is in hepatocytes, kupffer cells and macrophages leading to a fatty liver, hepatic fibrosis that can evolve up to cirrhosis. lal deficiency is responsible for significant morbidity and early mortality in children, adolescents and adults in connection with a multi visceral disease reaching the liver, gastrointestinal tract and the vascular endothelium. the disease is caused by homozygous or heterozygous mutations in the gene (lipa chromosome 10q23.2-23.3) which is responsible for the synthesis of the lal. the disease can be diagnosed by enzymatic analysis using few drops of blood absorbed onto blotting paper . patients with this deficiency lal, have no or reduced activity of this enzyme. because of its rarity, the deficit in lal is under diagnosed or is diagnosed in patients with liver biological disturbances and / or lipid profile disturbances, steatohepatitis-hepatitis (nash), the steatosis (nafld), the cryptogenic cirrhosis or wilson disease. inclusion period of 12 to 18 months (100 patients).


Eligibility criteria:
inclusion criteria: * patients registered on the liver transplant waiting list. * patients with cryptogenic cirrhosis, nash exclusion criteria: * patients without metabolic syndrome clinical, biological or radiological.

Keywords: liver transplant lysosomal acid lipase