Kornimate/medical-research-clean huggingface dataset:
genome-based management of patients in precision medicine (ge-med) towards a genomic health program

Conditions: Rare Diseases; Genetic Predisposition to Disease

Summary: the ge-med approach project will enroll patients (n = appr. 12.000) with unclear molecular cause of the disease, suspected genetic cause of the disease without detailed molecular analysis like whole exome sequencing (wes). the novelty of this study is to integrate genomic health concepts into immediate clinical care. to achieve these goals, a novel structure for the triple p (3p) concept of personalized medicine (personalized, predictive, preventive) integrated into a well-established health care system and associated with novel decentralized disease analysing task forces (datf) will be implemented. the overall goal of this study is to implement, for the first time, whole genome sequencing (wgs) analysis as a first line diagnostic test for all clinical indications such as rare disease (rd )and familial cancer syndromes.


Eligibility criteria:
inclusion criteria: * unclear molecular cause of the disease * suspected genetic cause of the disease exclusion criteria: * missing informed consent of the patient and if applicable the legal representative * previously performed wes or panel analysis

Keywords: rare diseases genetic predisposition whole exome sequencing (wes) whole genome sequencing (wgs) familial cancer syndromes polygenic risk scores (prs)
effects of dynamic flex cast with neurodevelopmental treatment on gross motor functions in cerebral palsy

Conditions: Cerebral Palsy

Summary: the study aims to determine the effects of dynamic flex cast with neurodevelopmental treatment on gross motor functions and gait in children with cerebral palsy.

the study aims to determine the effects of dynamic flex cast with neurodevelopmental treatment on gross motor functions and gait in children with cerebral palsy. combination of dynamic flex cast with neurodevelopmental treatment will be a novel potential treatment to improve gross motor functions in cerebral palsy. we shall try to fill the gaps of previous studies. it will help in facilitating children to perform their activities, restoring normal ranges and treatment of spasticity in cerebral palsy.

Eligibility criteria:
inclusion criteria: * children with cerebral palsy * age 3-8 years * spastic diplegic/ hemiplegic cp * ankle dorsiflexion 5-10 degrees * gmfcs level 1-3 * modified ashworth's scale level 1+ - 3 exclusion criteria: * congenital foot deformities * cognitive impairments * secondary orthopedic, auditory and severe visual impairments * unwilling patients or parents * recent surgical interventions

Keywords: ankle joint cerebral palsy spasticity dynamic cast
does posterior reconstruction of the rhabdosphincter improve early recovery of continence after robotic-assisted radical prostatectomy?

Conditions: Urinary Incontinence

Summary: the present study is a multicenter randomized, controlled trial, whose aim is to verify the effect of the posterior reconstruction of the rhabdosphincter after robot-assisted radical prostatectomy on early recovery of urinary continence.


Eligibility criteria:
inclusion criteria: * age ≥18 and ≤ 80 years; * biopsy proven clinically localized prostate cancer; * informed consent obtained and signed; * understanding of, and willingness to comply with, the study procedures. exclusion criteria: * pre-operative incontinence; * salvage prostatectomy (defined as a prostatectomy prescribed after the failure of a different primary treatment); * surgical posterior plane at the peri - rectal fat, without preserving an edge of the denonvilliers; * history of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements;

Keywords: robotic-assisted radical prostatectomy urinary continence posterior reconstruction of the rhabdosphincter posterior musculofascial plate reconstruction
the relationship between abnormal modified schober index and demographic characteristics and clinical variables

Conditions: Ankylosing Spondylitis

Summary: this study will aim to compare ankylosing spondylitis (as) participants with abnormal modified schober index (amsi) versus as participants with normal modified schober index (nmsi) in pain, morning stiffness, balance, kinesiophobia and the fear of falling. in addition, the investigators will aim to determine which demographic characteristics and variables predispose amsi to occur

ankylosing spondylitis (as), a common type of spondyloarthropathy, is a chronic inflammatory disease that affects spinal joints, and adjacent soft tissues such as sacroiliac joints, tendons, and entheses (1). inflammation of the spinal structures and progressive changes in the surrounding tissue is largely responsible for decreased physical function and mobility in participants with as (2). it is unknown how these parameters of as participants with amsi (smaller than 5 cm) are affected compared to as participants with normal modified schober index (nmsi, bigger than 5 cm). in addition, it is unclear which demographic characteristics and variables predispose amsi to occur. this study will aim to compare as participants with abnormal modified schober index (amsi) versus as participants with normal modified schober index (nmsi) in pain, morning stiffness, balance, kinesiophobia and the fear of falling. in addition, the investigators will aim to determine which demographic characteristics and variables predispose amsi to occur

Eligibility criteria:
inclusion criteria: * participants who meet the modified new york criteria for as * participants over 18 years exclusion criteria: * participants with other concomitant rheumatic diseases (such as fibromyalgia, rheumatoid arthritis, etc.), * participants with cognitive or psychiatric disorders, * participants with neuromuscular or orthopedic diseases

Keywords: ankylosing spondylitis spinal mobility kinesiophobia balance
multicentre, double-blind study versus placebo on impact and safety of extramel® 140 iu on perceived stress, physical and intellectual fatigue, pain perception if present, and the impact on the quality of life

Conditions: Life Stress; Fatigue; Pain; Quality of Life

Summary: objectives of this multicentre, double-blind study versus placebo were to evaluate impact and safety of the daily administration of extramel® 140 iu sod for 12 weeks on perceived stress, physical and intellectual fatigue, pain perception, if present, and the impact on the quality of life of 70 subjects included with 60 that can be evaluated.


Eligibility criteria:
inclusion criteria: * male or female person using an effective contraceptive method, with a negative urine pregnancy test on the inclusion visit for the women of reproductive age. * older than 30 years and younger than 65 years * bmi ≤ 30 * score greater than 30 on the cohen perceived stress scale pss 14. * score between 5 and 20 in the hamilton anxiety scale (excluding the limits). * presenting an impact of stress on at least one of the following domains. * pain domain with a score greater than 20 millimeters measured on the visual pain evaluation scale, * physical condition domain with a score greater than 50 on the prevost subjective fatigue scale, * the psychical condition domain with a global score below 160 in the stroop test and the reverse stroop test. * stable professional activity since at least 1 year. * completely healthy on the day of inclusion, and not taking any medicinal product or dietary supplement with an anti-stress or anti-pain objective. * not taking any herbal tea or drink with an anti-stress or anti-pain objective. * accepting not to modify his/her dietary habits. * having given his/her free, informed and express consent. * capable of understanding the nature of the objectives, the consequences of the study and accepting to comply with the protocol requirements. * affiliated with a social security insurance or beneficiary of such an insurance system. exclusion criteria: * subject presenting an acute pain or pain considered to be incapacitating by the patient him/herself or the observer physician. * subject currently under a chronic or acute treatment indicated for stress or anxiety, irrespective of the treatment. * subject currently under a chronic or acute treatment indicated for pain problems, irrespective of the treatment. * pregnant and/or breast-feeding women. * any person who does not satisfy by definition the inclusion criteria. * adult protected by the law. * any history of psychiatric disease. * any pathology in progress or active in the previous month. * any administration of a dietary supplement in progress or in the previous month. * any subject who within the 3 months following inclusion is likely to experience a major modification of his/her life rhythm (for example marriage, birth of a child, scheduled hospitalization, important exam, etc.) this is left to the discretion of the investigator.

Keywords: super-oxyd-dismutase sod melon juce perceived stress
amyotrophic lateral sclerosis registry

Conditions: Amyotrophic Lateral Sclerosis

Summary: this study takes amyotrophic lateral sclerosis (als) patients as the main research object. through collecting genetics, imaging and clinical symptoms for exploratory research, we will construct the gene spectrum of als in china, explore unknown pathogenic genes, explore the characteristic image characteristics of als, and establish the ipscs library of als, providing resources and basis for the research of pathogenesis and treatment targets of als.

this study is a multicenter, prospective registration study that will follow up patients with clinically confirmed and suspected amyotrophic lateral sclerosis for a period of 2 years. a total of 1000 patients will be included to dynamically observe the changes in clinical symptoms and signs, imaging, electrophysiology, biomarkers, biological samples and so on, which will construct a genetic profile of als in china, explore the etiology and pathogenesis, and establish an ipscs library, provide a basis for finding treatment targets.

Eligibility criteria:
inclusion criteria: * 18 years old ≤ age ≤ 80 years old; * patients are diagnosed definite or probable als according to the awaji diagnostic criteria; * sign an informed consent form. exclusion criteria: * unable to cooperate with research or complete follow-up due to geographical or other reasons.

Keywords: amyotrophic lateral sclerosis
augmenting single-session behavioral activation (ba) with delta-beta transcranial alternating current stimulation (tacs) for the treatment of depression

Conditions: Major Depressive Disorder

Summary: investigating whether delta-beta cross-frequency transcranial alternating current stimulation can augment the effects of a single session of behavioral activation in participants with major depressive disorder.

the purpose of this study is to examine whether concurrent transcranial alternating current stimulation (tacs) augments the effects of a single session behavioral activation (ba) treatment of depression. following a series of clinical assessments, participants will perform a reward-based decision-making task while electroencephalography (eeg) is collected. then, all participants will take part in a single-session 90-minute ba intervention; half of the participants will receive delta-beta tacs during the final 30 minutes of the session and half will receive an active sham stimulation. participants will return two weeks later for another task-based eeg. four weeks after the intervention session, they will receive self-report questionnaires via email to complete online.

Eligibility criteria:
inclusion criteria: * 18 years old or order * able to provide informed consent * willing to comply with all study procedures and be available for the duration of the study * speak and understand english * dsm-5 diagnosis of major depressive disorder (mdd) as assessed by the mini exclusion criteria: * participants must not have active suicide intent as determined by the columbia suicide severity rating scale (c-ssrs). active suicide intent will be captured in responses to items 4 and/or 5 on the c-ssrs. * participants must not meet criteria for current severe substance use disorder, anorexia nervosa, or active psychosis as captured by the mini. * participants may not currently be in psychotherapy and have not received any other psychotherapy and/or stimulation (ect, tms) within the last 4 weeks. * any participants taking psychotropic medication must be on a stable dose for at least 4 weeks with no planned dose changes within the next 4 weeks. * (for female participants) participants must not be pregnant or breastfeeding. * participants may not have any medical or neurological illness for which symptom presentation or treatment could interfere with study participation * participants may not have undergone prior brain surgery * participants may not have any brain devices/implants, including cochlear implants and aneurysm clips * participants may not have had brain injury or concussion within the last three months * participants may not have a history of brain injury requiring current treatment

Keywords: transcranial alternating current stimulation cross-frequency coupling behavioral activation
assessing the induction of long-term immune regulation following treatment with lemtrada® (alemtuzumab).

Conditions: Multiple Sclerosis

Summary: in this study the investigators wish to test the hypothesis that treatment with lemtrada is associated with alterations in immune homeostasis in favor of multiple regulatory leukocyte populations which persist long after completion of the treatment phase. specifically, the investigators propose that regulatory b-cells are induced rapidly following the first course of treatment with lemtrada, that this occurs prior to induction of other regulatory populations, and that these cells are functionally capable of regulating immune responses. the investigators also propose that there is a concomitant induction of functional regulatory t-cells and alternatively-activated monocytes during the first year after treatment giving a "blanket" enhanced regulatory immune profile. this study is designed primarily to identify possible mechanisms by which lemtrada acts to modify the immune environment in recipient patients, as such the "outcome" measures are all immunological.


Eligibility criteria:
inclusion criteria: * patient must qualify to receive treatment with lemtrada according to the usc, department of neurology, ms group clinical lemtrada protocol. * patient must have been diagnosed with clinically definite multiple sclerosis defined by the revised mcdonald criteria (polman et al., 2005, polman et al., 2010) of the relapsing-remitting form with an expanded disability status scale (edss) score of 0 to 5.5. * patient must have the ability to understand and sign this study-specific irb-approved informed consent form. * patients must be willing to donate 80mls of blood for immunological testing either prior to receiving lemtrada or 6, 12, 18 or 24 months after first round of treatment. exclusion criteria: * patient does not qualify to receive treatment with lemtrada according to the usc, department of neurology, ms group clinical lemtrada protocol. * inability to understand nature of the study. * patient has any form of progressive ms. * patient has been diagnosed with any other autoimmune disease. * patient is of child bearing age with a positive pregnancy test or is unwilling to agree to use a reliable contraceptive method. * treatment with any of the following within 30 days of commencing treatment with lemtrada or collection of baseline blood sample: gilenya, aubagio, tecfidera. * treatment with natalizumab within 60 days of commencing treatment with lemtrada or collection of baseline blood sample. * treatment with any of the following within 6 months of commencing treatment with lemtrada or collection of baseline blood sample: rituximab, ocrevus. * treatment at any time with any of the following: mitoxantrone, cyclophosphamide, cladribine, cyclosporine, azathioprine, methotrexate or any other immunomodulatory, immunosuppressant or immune homeostasis altering drug.
financially sustainable remote treatment for alcohol abuse: feasibility

Conditions: Alcohol Use Disorder

Summary: directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. the goal of this feasibility study is to use a breathalyzer and cost-controlling deposit contracts to facilitate a contingency-management intervention to reduce alcohol use that requires no in-person contact between the participants and the study staff during the intervention phase.


Eligibility criteria:
inclusion criteria: * at least 18 years old * provide written informed consent * meet diagnostic and statistical manual criteria for alcohol use disorder * express a desire to cut down or quit drinking * be willing to pay a $75 deposit toward their incentive fund exclusion criteria: * pregnant or lactating * meet diagnostic and statistical manual criteria for other substance use disorder (except caffeine or nicotine) * score 23 or greater on the alcohol withdrawal symptom checklist * have immediate plans to move out of the area
a study to examine the pharmacokinetics, tolerability, safety and efficacy of exenatide once weekly suspension

Conditions: Type 2 Diabetes Mellitus

Summary: this study is designed to evaluate the pharmacokinetics, tolerability, and safety of exenatide once weekly suspension in both healthy subjects and in subjects with type 2 diabetes. the study will also evaluate efficacy in the type 2 diabetes patients. development of this exenatide once weekly presentation would eliminate the need to reconstitute the product prior to use.


Eligibility criteria:
inclusion criteria: cohort 1: * is 19 to 65 years old * has a body mass index (bmi) of 23 kg/m2 to 35 kg/m2, inclusive, at study start cohort 2: * is 19 to 75 years old * has been diagnosed with type 2 diabetes mellitus * has hba1c of 7.1% to 10.0%, inclusive, at study start * has a body mass index (bmi) of 25 kg/m2 to 45 kg/m2, inclusive, at study start * has been treated with diet and exercise alone or with a stable regimen of metformin, a tzd, or a combination of metformin and a tzd, for a minimum of 2 months prior to study start * either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start: * hormone replacement therapy (female subjects) * oral contraceptives (female subjects) * antihypertensive agents * lipid-lowering agents * thyroid replacement therapy * antidepressant agents exclusion criteria: cohort 1: * has a personal history of diabetes mellitus (including impaired glucose tolerance, impaired fasting glucose, or gestational diabetes) * has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to study start * has ever been exposed to exenatide (byetta, exenatide once weekly, or any other formulation of exenatide) or any glp 1 analog cohort 2: * has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to study start * has ever been exposed to exenatide (byetta, exenatide once weekly, or any other formulation of exenatide) or any glp 1 analog * has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications: * any dpp-4 inhibitor or sulfonylurea (su) within 3 months prior to study start * alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (symlin®) within 30 days prior to study start * insulin within 2 weeks prior to study start or for more than 1 week within 3 months prior to study start * systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including advair®) steroids known to have a high rate of systemic absorption * prescription or over-the-counter weight loss medications within 3 months prior to study start

Keywords: diabetes exenatide once weekly byetta amylin lilly
prednisolone in the treatment of withdrawal headache in probable medication overuse headache

Conditions: Headache

Summary: the purpose of this study is to determine whether prednisolone is more effective than placebo in the first six days after initiation of medication withdrawal therapy for a medication overuse headache. another purpose is to study whether patients followed by a neurologist 1 year after withdrawal do better than patients followed by a general practitioner.

data published boemg,mygland a,salvesen r; neurology 2007 jul 3;69(1):26-31

Eligibility criteria:
inclusion criteria: * chronic daily headache and medication overuse fulfilling international headache society (ihs)-ii criteria exclusion criteria: * pregnancy * age under 18 and over 70 years * major mental disorders

Keywords: migraine analgesics tension type headache