Kornimate/medical-research-clean huggingface dataset:
beneficial effects of long term menaquinone-7

Conditions: Bone Loss; Arteriosclerosis

Summary: from all k-vitamins, menaquinone-7 (mk-7) has been identified now as the most effective cofactor for the carboxylation reaction of gla-proteins such as osteocalcin (in bone) and matrix-gla protein (in the arterial vessel wall). the question remains whether supplementation with mk-7 also leads to measurable improvements of bone and vascular health. the purpose of the study is to demonstrate that mk-7 has a health benefit in apparently healthy postmenopausal women. in a placebo-controlled randomized clinical trial the effect of an mk-7- supplement will be monitored during three years on bone quantity and quality and on vascular characteristics and function.


Eligibility criteria:
inclusion criteria: * healthy postmenopausal women between 55 and 65 years old * subjects of normal body weight and height according to bmi \< 30 * subjects of caucasian race * subject has given written consent to take part in the study exclusion criteria: * subjects with (a history of) metabolic or gastrointestinal disease * subjects presenting chronic degenerative and/or inflammatory disease * subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters * subjects receiving corticoϊd treatment * subjects using oral anticoagulants * subject using bisphosphonates * subjects using hormone replacement therapy * subjects undergoing ovariectomy and/or hysterectomy * subject with (a history of) soy allergy * subjects using vitamin k containing multivitamins or vitamin k supplements * subjects who have participated in a clinical study more recently than one month before the current study * subjects who are found to be osteoporotic at baseline (t-score \< -2.5)

Keywords: vitamin k2 menaquinone-7 bone health vascular health
protein a immunoadsorption in dilated cardiomyopathy (rpia-dcm)

Conditions: Dilated Cardiomyopathy (DCM)

Summary: this study is a multicenter, dual-arm and randomized controlled clinical trial. sixty patients with dilated cardiomyopathy and positive β1-adrenergic receptor autoantibodies were selected and randomly divided into an immunoadsorption group (receiving immunoadsorption therapy) and a control group in a 1:1 ratio. changes in cardiac function, morphology and clinical outcomes were followed up and compared.


Eligibility criteria:
inclusion criteria: * dilated cardiomyopathy * presence of anti-β1-adrenergic receptor * age 18-75 years * lvef ≤ 40% determined by echocardiography (according to assessment of the local investigators) * nyha class ii-iv * symptoms of heart failure ≥ 6 months * treatment with guideline-directed medical therapy (gdmt) for ≥6 months and stable dose of acei/arb/arni/β-blocker/sglt2i/mra/sgca for ≥1 month (excluding diuretics) * hemodynamically stable * informed consent exclusion criteria: * icd implantation \< 1 month or crt/d implantation \< 6 months * heart failure caused by other heart diseases * end-stage heart failure, inability to discontinue intravenously positive inotropic or vasoactive drugs * expected survival \< 1 year * hemoglobin \< 90g/l * any disease requiring immunosuppressive drugs * commodities with other acute or severe illnesses, such as infections, severe hepatic or renal dysfunction, hematological diseases, malignant tumors, cachexia, autoimmune diseases, etc. * previous treatment with immunoadsorption therapy or intravenous immunoglobulin therapy * contraindications to extracorporeal circulation therapy, such as mental illness or consciousness disorders, shock, severe bleeding or bleeding tendency, coagulation dysfunction, multiple organ failure, etc. * pregnancy/lactation * any other conditions that the researcher deems may increase the risk to the subject or interfere with the clinical trial and outcome assessment (such as excessive anxiety, alcohol or drug abuse, or cognitive impairment, etc.)
acute responses of postural alignment, kinematic synergy, and intermuscular coherence to postural muscle facilitation (retrospective)

Conditions: Posture; Musculoskeletal Equilibrium

Summary: postural alignment is often intervened upon in health, fitness, and physical medicine settings. despite a long tradition in this area, current notions of optimal or normal posture are superficial and often logically inconsistent. a recent attempt to reconcile diverging opinions about good posture proposes that alignment be considered in relation to individual joints' natural tendencies to collapse under gravity. this theory allows different maladaptive postures to be described in terms of functional deficits and compensatory adaptations at the muscular level. working within this type of theory, postural interventions may be able to account for comparative advantages in maintaining alignment between different muscle systems. this would represent a step forward from current practices, which usually attempt to force arbitrary alignment patterns indiscriminately. the current study presents motion capture and electromyography (emg) data evaluating the effects of two interventions on individual participants' bipedal standing alignment patterns with respect to the gravitational collapsing tendencies referenced above. additional outcomes included functional grouping of muscle activation signals (via intermuscular coherence) and kinetic chain continuity. the interventions include 1) an experimental intervention purported to engage muscles that naturally resist the collapsing effects of gravity, and 2) a control intervention designed to inhibit other muscle groups that are sometimes involved in maintaining bipedal alignment in a compensatory role. study outcomes are measured before and after both interventions to quantify the acute effects of each. all participants complete both interventions in random order, crossing over after a one-week washout period. this research will provide insight into the acute effects of studied interventions, specifically those relating to maintenance of bipedal alignment with respect to gravitational collapsing tendencies.


Eligibility criteria:
inclusion criteria: * healthy adult * 18 - 40 years of age exclusion criteria: * recent (\< 6 months) history of lower extremity injury * recent (\< 6 months) history of other musculoskeletal or neurological disorder affecting balance * contraindications to participation in physical activity
occupational therapy trauma informed workshops and consultations for teachers at head start

Conditions: Trauma

Summary: this study will utilize a pre/post mix method design quantitative data will be gathered through surveys (including satisfaction questionnaires) administered pre/post workshops. qualitative data will be obtained through interviews post- workshop and consultations.


Eligibility criteria:
inclusion criteria: * home visitors or teaching staff at head start within san bernardino county * between 18-65 years of age * all genders * english speaking exclusion criteria: * na

Keywords: occupational therapy trauma informed care
memory rehabilitation by means of working memory training in combination with a recollection training

Conditions: Memory Deficits

Summary: memory deficits after brain damage are common and there is still a need for evaluated therapy methods. in this study we compare two therapeutic interventions and investigate whether therapy effects can be found on neuropsychological tests and on a test measuring memory in everyday life.

in the interventiongroup a computerbased working memory training is combined with a recollection training (repitition-lag procedure). the patients in the active control group undergo the standard memory therapy that is normally provided in the rehabilitation centre (with a focus on the acquisition and execution of different memory strategies, e.g. the spaced retrieval method). the patients in both groups are tested on different neuropsychological tests before and after nine hours of therapy. additionally, a test is conducted that assesses memory in everyday life.

Eligibility criteria:
inclusion criteria: * brain injury * memory deficits (performance below average in the california verbal learning test in learning trial 1 or 5, sfr or lfr) exclusion criteria: * severe amnesia (less than 2 words in sfr of the cvlt), dementia, sensory or motor aphasia, impaired vision, insufficient german language skills, lack of patient's consent

Keywords: working memory, recollection training, transfer
effect of smoking on postprandial gastric emptying, glucose tolerance and secretion of gut and pancreatic hormones

Conditions: Diabetes Mellitus

Summary: the study aims to evaluate the effect of smoking on postprandial responses such as plasma glucose, secretion of gut - and pancreatic hormones and gastric emptying in healthy, heavy smoking men.

epidemiological studies show that active smoking increases the risk of type 2 diabetes in a dose-dependent fashion. smokers seem to be characterized by central obesity, increased inflammatory markers and oxidative stress, which may lead to insulin resistance and irregularities in glucose metabolism. the current study is a meal test study, in which the aim is to examine a number of variables during a liquid mixed meal test (including gastric emptying, glucose tolerance, gut and pancreatic hormone responses, gall bladder emptying, appetite and food intake) performed in healthy non-smoking subjects and in healthy smokers with or without concomitant cigarette smoking. the investigators hypothesize that smoking-induced increases in circulating nicotine levels and simultaneous activation of nicotinic receptors in the gastrointestinal tract and in the autonomic nervous system would have detrimental effect on postprandial glucose metabolism and, thus, constitute an important link between smoking and the risk of type 2 diabetes. the current study will help to clarify this hypothesis and improve our general understanding of the association between smoking and gut hormone secretion, gastric emptying and glucose metabolism.

Eligibility criteria:
inclusion criteria: * both groups * caucasian ethnicity * healthy males * normal haemoglobin * age above 18 years * informed and written consent * bmi \>20 kg/m2 smokers • minimum 20 cigarettes pr. day for at least 1 year non-smokers • no smoking on a regular basis exclusion criteria: * both groups * diabetes or prediabetes (fasting plasma glucose levels \>6.5 mm or hba1c \>6.0%) * first- or second-degree relatives with diabetes * liver disease (alanine aminotransferase (alat) and/or serum aspartate aminotransferase (asat) \>2 times normal values) or history of hepatobiliary disorder * gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery * hypo- or hyperphosphataemia * nephropathy (serum creatinine \>150 µm and/or albuminuria * treatment with medicine that cannot be paused for 12 hours * hypo- or hypercalcaemia * hypo- and hyperthyroidism * treatment with oral anticoagulants * active or recent malignant disease * any treatment or condition requiring acute or sub-acute medical or surgical intervention * any condition considered incompatible with participation by the investigators

Keywords: smoking diabetes incretin hormones glucose tolerance
myofascial release or trigger point injections for the reduction of post-mastectomy pain syndrome

Conditions: Breast Carcinoma

Summary: this clinical trial studies the effect of myofascial release in decreasing post-mastectomy pain compared to standard of care trigger point injections in patients with post-mastectomy pain syndrome. patients who have mastectomies often experience pain that does not go away after time. this is known as post-mastectomy pain syndrome. myofascial release is a form of physical therapy in which pressure is applied to the affected areas. myofascial release may be an effective way of decreasing pain in patients with post-mastectomy pain syndrome without the use of medication.

primary objective: i. to evaluate the change in pain score using the numerical rating scale for pain on an 11-point scale (0-none to 10-worst) from implementation of myofascial release (mfr) versus trigger point injections (tpi) in the treatment of myofascial trigger points (mtp) as noninvasive therapies for post mastectomy pain syndrome (pmps). secondary objectives: i. to evaluate the change in medications, particularly opiate medications in the treatment of post mastectomy pain. ii. to evaluate a patient's satisfaction with therapy or treatment throughout the course of the study at each consecutive encounter or follow up. iii. to evaluate a patient's range of motion with therapy or treatment beginning at time of screening and until the end of the study. iv. to evaluate a patient's degree of lymphedema both subjectively and objectively in the affected extremity(ies) unilateral to the site(s) of mastectomy in response to the various forms of treatment throughout the study. v. to evaluate quality of life measure changes with treatments used throughout the study. outline: patients are randomized to 1 of 2 arms. arm i: patients receive standard of care trigger point injections at baseline. arm ii: patients perform myofascial release for 10 minutes each day.

Eligibility criteria:
inclusion criteria: * chronic post-mastectomy pain syndrome (\>= 3 months) * able to perform mfr techniques and follow basic instructions * \>= 18 years old exclusion criteria: * current chemotherapy * pending surgery during treatment * active infection * active debilitating disease * pregnant * other chronic pain diagnosis beside pmps * untreated psychiatric diagnosis (not receptive to taking precautions and interventions by treating psychiatrist/psychologist/physician i.e. taking necessary medications) * morbid obesity (body mass index \[bmi\] \> 40) * allergy history of bupivacaine and/or lidocaine
efficacy and safety of rapid titration protocols of lacosamide

Conditions: Focal Epilepsy

Summary: three different dose titration schedules are tested to find a way to reduce the titration period of lacosamide

the investigators intend to find a way to reduce the titration period of lacosamide. dosage of lacosamide is increased from 100-200 mg/d to 400 mg/d by three different titration schedule. safety of lacosamide administration is primary endpoint. 50% responder rate (seizure reduction) and blood level of lacosamide are investigated for secondary endpoints.

Eligibility criteria:
inclusion criteria: * adults aged 18-85 years old * patients diagnosed with focal epilepsy * patients subjected to the addition of lacosamide to treat focal onset seizures according to physician's judgement * subjects provided informed consent exclusion criteria: * subjects who changed other antiepileptic drugs at the beginning of lacosamide treatment * subjects with unstable physical, mental or other disease condition that can impede with accurate evaluation or treatment * subjects with terminal illness or general medical condition that can impede with the participation of the clinical trial * subjects who do not agree with prior consent
efficacy and safety of dwp450 in subjects with benign masseteric hypertrophy

Conditions: Benign Masseteric Hypertrophy

Summary: this study is a double-blind, randomized, placebo-controlled, multi-center, phase iii study to evaluate the efficacy and safety of dwp450 in subjects with benign masseteric hypertrophy


Eligibility criteria:
inclusion criteria: 1. male or female subject over 18 years of age and written informed consent is obtained. 2. subject with benign masseter hypertrophy. 3. subject who has bisymmetry of masseter at visual assessment. 4. subjects who meets thickness of masseter muscle by ultrasonography. 5. subjects who can and will comply with the requirements of the protocol. exclusion criteria: 1. diagnosis of myasthenia gravis, eaton-lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function. 2. subject who got any facial aesthetic procedure (e.g. surgery, laser, thread treatment etc.) in lower facial area within 52 weeks prior to the study entry. 3. subject who had previously received botulinum toxin within 12 weeks prior to the study entry. 4. subject with known hypersensitivity to botulinum toxin. 5. subject who are pregnant or lactating or found pregnancy though the urine or sebum test or disagreed to avoid pregnancy during study period. 6. subjects who are not eligible for this study at the discretion of the investigator.
extension study of ataluren (ptc124) in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) is a genetic disorder caused by a mutation in the gene that makes the cystic fibrosis transmembrane conductance regulator (cftr) protein. a specific type of mutation called a nonsense (premature stop codon) mutation is the cause of cf in approximately 10% of patients with the disease. ataluren is an orally delivered investigational drug that has the potential to overcome the effects of the nonsense mutation. this study is a phase 3 extension trial that will evaluate the long-term safety of ataluren in adult and pediatric participants with nonsense mutation cf (nmcf), as determined by adverse events and laboratory abnormalities. the study will also assess changes in pulmonary function, cf pulmonary exacerbations, health-related quality of life, antibiotic use for cf-related infections, cf-related disruptions to daily living, body weight, and cf pathophysiology. funding source for this study is the fda oopd.

this phase 3, open-label, safety and efficacy study will be performed at sites in north america, europe, and israel. the study will enroll up to approximately 208 participants with nmcf who participated in a previous phase 3 study of ataluren (ptc124-gd-009-cf \[study 009\], nct00803205). participants will receive study drug 3 times per day (tid) (at breakfast, lunch, and dinner) for approximately 48 weeks (approximately 1 year). study assessments will be performed at clinic visits every 8 weeks.

Eligibility criteria:
inclusion criteria: * completion of blinded study drug treatment in the previous phase 3 study (ptc124-gd-009-cf). * ability to provide written informed consent (parental/guardian consent if applicable)/assent (if \<18 years of age). * in participants who are sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during ataluren administration and the 4-week follow up period. * willingness and ability to comply with scheduled visits, drug administration plan, study procedures, laboratory tests, and study restrictions. exclusion criteria: * known hypersensitivity to any of the ingredients or excipients of the study drug (list provided at study sites). * current pregnancy or lactating, or pregnancy or lactating during the previous phase 3 study. * ongoing participation in any other therapeutic clinical trial. * prior or ongoing medical condition (for example, concomitant illness, psychiatric condition, behavioral disorder, alcoholism, drug abuse), medical history, physical findings, ecg findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the participant, makes it unlikely that the course of treatment or follow up would be completed, or could impair the assessment of study results.
feasibility pilot of accelerated stimulation with tms for treatment of major depressive disorder (fast-mdd)

Conditions: Major Depressive Disorder

Summary: this is a mixed-methods study that includes three steps. the first is a focus group to collect opinions and feedback about implementation of atms among clinicians, technicians, nurses, and other clinical staff at the st. louis park (slp) clinic who are experienced with delivering tms. the second is the delivery of a set of questionnaires delivered to tms patients at the slp clinic who are awaiting the start of their tms series. the third is the delivery of atms utilizing the magventure tms device to patients on the slp rtms waitlist. the purpose of this feasibility study is to examine the acceptability and efficacy of accelerated transcranial magnetic stimulation (atms) delivered using an accelerated schedule. repetitive transcranial magnetic stimulation (rtms) is traditionally delivered once a day, five days a week, for nearly 7 weeks for a total of 36 treatments. while atms is quick to deliver, a standard session lasting 10-20 minutes, this schedule is time intensive for patients. it often requires time off from work to accommodate daily driving time to and from the clinic as well as treatment time. this can be disruptive to a patients life and ability to attend all treatment sessions while continuing with their own life responsibilities.


Eligibility criteria:
inclusion criteria: * age between 18 and 70 years old * current patient of slp clinic * diagnosis of unipolar depression * have tried at least 1 antidepressant * ability to maintain stable medication regimen for duration of study exclusion criteria: * has received tms in the last 3 months * diagnosis of bipolar depression * any lifetime psychosis or mania * recent suicide attempt within 90 days of study visit * use of benzodiazepines in past 4 weeks * presence of any contraindication to tms assessed by the tms adult safety screen including individual history of uncontrolled seizures * current or history of alcohol abuse
evaluation of treatment and prophylaxis of invasive fungal infections in immuncompromised patients in austria (study p05532)(withdrawn)

Conditions: Mycoses

Summary: the purpose of this program is to determine the frequency of the use of posaconazole in immunocompromised patients refractory to first line therapy receiving therapeutic treatment based on different pathogens in comparison to other antifungal therapy. a further objective is to determine the frequency of the use of posaconazole in immunocompromised patients receiving prophylactic treatment in comparison to other antifungal prophylaxis.


Eligibility criteria:
inclusion criteria: * immunocompromised patients with refractory ifi * patients eligible for prophylactic treatment due to anticipated neutropenia for more than 7 days. exclusion criteria: * none