Kornimate/medical-research-clean huggingface dataset:
an open-label study of aficamten for chinese patients with symptomatic ohcm

Conditions: Obstructive Hypertrophic Cardiomyopathy

Summary: this is an open-label extension study of china cohort in the phase 3 study (cy 6031) of aficamten for the treatment of obstructive hcm (ohcm) to collect long-term safety and tolerability data, including assessments of cardiac function and steady-state pharmacokinetics (pk) during chronic dosing with aficamten.


Eligibility criteria:
inclusion criteria: 1. completion of a cytokinetics trial investigating ck-3773274 2. lvef ≥55% at the screening visit exclusion criteria: 1. has participated in another investigational device or drug study or received an investigational device or drug \<1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. other investigational procedures while participating in this study are not permitted. 2. since completion of a previous study of aficamten has:developed new-onset paroxysmal or permanent atrial fibrillation (af) requiring rhythm restoring treatment (e.g., direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) \ 30 days. 3. undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation). 4. had a confirmed lvef \<40% with an associated dose interruption during participation in a prior study with aficamten. 5. history of appropriate implantable cardioverter defibrillator (icd) shock within 30 days prior to screening. 6. has received treatment with mavacamten.
treatment of chronic stroke with ipsihand

Conditions: Stroke

Summary: the ultimate goal of this project is to develop a functioning and clinically feasible method for restoring function to motor-impaired stroke survivors. this ultimate goal will be approached through two different means. the first method is to develop a functioning brain-computer interface that operates based on cortical activity ipsilateral to an intended movement on the motor-impaired side of the body. and secondly, to develop new methods of rehabilitation that involve stimulating peripheral muscles based upon cortical activity ipsilateral to intended movements. finally, the study seeks to assess changes in functional connectivity as a result of using a bci device.

this study will be carried out in two phases designed to achieve the objectives described above. the first phase will determine the feasibility of recording ipsilateral (contralesional) motor commands and use the signals to control a computer. this phase will involve recording eeg signals during the performance of real and imagined motor movements of both the impaired and non-impaired hand in stroke survivors. after recording the signals and analyzing the data, the signals will be used to try to control a cursor on a computer screen or a robotic hand. the second phase of the study will determine if the bci system can be used to impact rehabilitation. motor commands would be performed as in phase 1 to determine the accompanying eeg signals. the eeg signals would then be used to control stimulation of the impaired limb. rehabilitation would be assessed by examining changes in commonly used functional motor scores. the ultimate goal of this project is to develop a functioning and clinically feasible method for restoring function to motor-impaired stroke survivors. this ultimate goal will be approached through two different means. the first method is to develop a functioning brain-computer interface that operates based on cortical activity ipsilateral to an intended movement on the motor-impaired side of the body. and secondly, to develop new methods of rehabilitation that involve stimulating peripheral muscles based upon cortical activity ipsilateral to intended movements. finally, the study seeks to assess changes in functional connectivity as a result of using a bci device.

Eligibility criteria:
inclusion criteria: * 6 months post stroke * modified ashworth scale of 1+ or less of elbow flexion in the affected upper extremity * short blessed test score of 8 or less * unstructured mesulam with 2 or less omissions exclusion criteria: * dementia * severe spasticity in affected upper extremity * unilateral visual inattention (neglect) * contracture(s) in the affected upper extremity * botox injections administered within 9 months * aphasia which limits effective communication

Keywords: stroke rehabilitation bci stroke upper extremity rehabilitation paresis hemiparesis
study of nerve repair and reconstruction associated with major extremity trauma

Conditions: Peripheral Nerve Injury(Ies)

Summary: this is a multi-center prospective observational study that will capture detailed information about the treatment and long term outcomes of 250 patients with pni resulting from upper extremity trauma. the study will focus on a young adult population to include individuals ages 18-65. patients with pni will be recruited during the hospitalization for initial treatment of the upper extremity injury. additional patients may be identified during clinic visits for on-going treatment of upper extremity injuries as nerve injuries evolve or upon referral from outside physicians. however, all eligible nerve injuries must be treated within 6 months of the initial upper extremity trauma. outcomes will be assessed at 3, 6, 12, 18 and 24 months following diagnosis of the nerve injury. all assessments will take place in the clinic and will include a patient interview and a brief exam to evaluate sensory and motor function.


Eligibility criteria:
inclusion criteria: 1. ages 18-65 2. sustained a peripheral nerve injury (including iatrogenic injuries and partial nerve injuries) resulting from upper extremity trauma meeting the following criteria: 1. involves injury or dysfunction to motor, or motor and sensory function of the axillary, radial, median, ulnar, or musculocutaneous nerve with injury localized distal to the brachial plexus cord level and proximal to the distal flexion crease of the wrist 2. involves a "mixed" nerve segment (i.e. involves a location of any of the above specified nerves that can be expected to have both sensory and motor axons present) but does not include sensory only distal terminations of the same nerves. 3. receiving surgical treatment (i.e. exploration, neurolysis, repair or reconstruction, nerve or tendon transfer) within 6 months of the initial injury. exclusion criteria: 1. injuries to the brachial plexus roots, trunks, divisions and cords 2. injuries to the nerves distal to the distal flexion crease of the wrist 3. injuries that involve a distal extension of the parent nerve that is considered sensory only (superficial radial nerve, lateral ante brachial cutaneous nerve, etc) 4. previous motor or sensory deficit prior to injury (e.g. resulting from trauma, stroke, muscular, neurologic, neuromuscular disorder, etc.) 5. documented psychiatric disorder that limits ability to consent and maintain follow-up 6. unable to speak either english or spanish 7. severe problems with maintaining follow up (e.g patients who are prisoners or homeless at time of injury or who are intellectually challenged without adequate family support).
eradicate s. aureus in patients with bacteremia and endocarditis

Conditions: Bacteremia Due to Staphylococcus Aureus; Left Sided Infective Endocarditis (Disorder); Right Sided Infective Endocarditis (Disorder); Endocarditis Infective

Summary: this study evaluates safety and tolerability of endolysin-derived lsvt-1701 (tonabacase) as an add-on to standard of care (soc) antibiotic therapy for the treatment of patients with complicated staphylococcus aureus bacteremia (sab), including left- and right-sided infective endocarditis (ie).


Eligibility criteria:
inclusion criteria: * age of 18 to 90 years * index blood culture collection within 96 hours prior to enrollment positive for s. aureus * experienced at least one sign or symptom related to sab within past 96 hours prior to enrollment * known or suspected left- and/or right-sided endocarditis by modified duke criteria and/or known or suspected complicated sab * required duration of soc antibiotic therapy ≤ 42 days exclusion criteria: * previous receipt of lsvt-1701 or cf-301 (exebacase) * known hypersensitivity to kanamycin or other aminoglycosides * treatment with any potentially effective (anti-s. aureus) systemic antibiotic for \> 96 hours within 7 days before enrollment. exception: persistent s. aureus bacteremia after 96 hours of prior appropriate systemic antistaphylococcal antibiotic, and/or resistance to the prior systemic antibiotic * treatment with dalbavancin or oritavancin within the previous 90 days * known or suspected brain abscess or meningitis * community acquired pneumonia, nosocomial pneumonia because of pathogens other than s. aureus, or known polymicrobial bacteremia * presence of an intravascular infection source or extravascular material that cannot be removed within 96 hours after enrollment

Keywords: staphylococcus aureus bacteremia left-sided endocarditis right-sided endocarditis sab
effects of normobaric hypoxia exercise program on bone turnover markers and metabolism in premenopausal women

Conditions: Hypoxia

Summary: the impact of a proprietary training program in normobaric hypoxia on changes in bone turnover markers as well as carbohydrate and lipid metabolism in premenopausal women falls within the realm of physical culture for an active and healthy society. within this context, the implementation of a project is supported aiming to: 1. monitor, support, and promote physical development, fitness, and physical activity in society, by assessing the effects of a proprietary training program in normobaric hypoxia on changes in bone turnover markers as well as carbohydrate and lipid metabolism in premenopausal women. 2. develop and implement innovative methods, forms, and means of physical activation and training for individuals of various ages, by formulating general assumptions of an endurance-strength training concept under normobaric hypoxia conditions, concerning changes in bone turnover markers as well as carbohydrate and lipid metabolism in premenopausal women. 3. prevent injuries in physical education and sports, by designing a useful training program for osteoporosis prevention as well as for managing carbohydrate and lipid metabolism disorders in premenopausal women.


Eligibility criteria:
inclusion criteria: * no significant cardiovascular, respiratory system diseases and musculoskeletal system, * no contraindications to physical activity. ecg, baseline urinalysis, morphology are required. * t-score within normal limits (+1.0 to -1.0). * informed consent of the patient to participate in the study. exclusion criteria: * use of hormone replacement therapy (hrt). * use of substances (cigarettes, alcohol). * any training (including hypoxia training or exposure) performed in the 6 months prior to the beginning of the intervention * any other factors determined by the study investigators as unsuitable for participation.

Keywords: bone turnover carbohydrate metabolism lipid metabolism normobaric hypoxia
clinical study of cdp870/certolizumab pegol in patients with active crohn's disease

Conditions: Crohn's Disease

Summary: this is a multi-centre, randomized, double-blind, dose response clinical study of cdp870 in patients with crohn's disease.


Eligibility criteria:
inclusion criteria: inclusion criteria: * patients who are diagnosed with crohn's disease (according to the crohn's disease diagnostic criteria developed by the research group on intractable inflammatory bowel disorders \[shimoyama group, january 25, 2002\]) at least 24 weeks before the starting date of the observation period * patients with crohn's disease activity index (cdai) score ranging from 220 to 450 inclusive during the observation period * c-reactive protein (crp) of 1 mg/dl or higher in the laboratory test performed at the start of the observation period exclusion criteria: * stoma patient * patients with a history of severe hypersensitivity or anphylactic reaction to anti-tnf alpha antibody * patients who participated in a clinical study with cdp870 * pregnant or lactating patients, patients of childbearing potential, or patients who will attempt pregnancy during the study period * patients who are judged inappropriate for enrollment by the principal investigator or subinvestigators exclusion criteria:

Keywords: crohn's disease cdp870 certolizumab pegol
composix kugel mesh recall leaves unresolved problems of patient management

Conditions: Incisional Hernia

Summary: from its introduction in 2000 until its us recall in december 2005, the composix kugel mesh was implanted in an estimated 350,000 patients worldwide. the purpose of the study is to evaluate retrospectively the complications related to this mesh that occurred in our patients between 2003 and 2005, since new complications continue to be diagnosed, although the investigators discontinued the use of the mesh.

from 2003 to 2005(2006) we implanted komposix kugel meshes in 21 patients with incisional ventral hernias. with the recall of january 2006 (in germany), we stopped the implantation of this mesh and continued to monitor the patients with follow up and phone interviews. late complications still continue to occur, mainly as a consequence of the product defect identified 7 years ago.

Eligibility criteria:
inclusion criteria: * age \> 18 * incisional hernia exclusion criteria: * younger than 18 years * peritonitis * intestinal fistula

Keywords: incisional hernia mesh surgery composix kugel ipom technique
the phenosar trial: use of antibiotics in treatment of sarcoidosis

Conditions: Sarcoidosis, Pulmonary; Sarcoidosis Skin

Summary: in this study it is investigated whether treatment with azithromycin in combination with doxycycline reduces the bacterial load of c. acnes in granulomatous tissue of patients with sarcoidosis and subsequently decreases the inflammatory activation measured by fdg uptake and serum biomarkers.

sarcoidosis is a multisystemic disease with unknown origin mostly affecting intrathoracic lymph nodes, lungs and skin. sarcoidosis is characterized by the formation of non-caseating granulomas causing a variety of symptoms based on the organs involved. although frequently described as a benign disease, mortality rate has been estimated to be around 11.0 per 1000 person-years in patients with sarcoidosis, with respiratory failure as the most common cause of death in the western world. the main treatment indication in sarcoidosis is risk of organ failure. in the literature the need for systemic treatment varies between 20-70%. since there is no curative treatment for sarcoidosis, treatment is focused on suppression of the inflammation. this is usually done with the use of immunosuppressive drugs, such as prednisone and/or methotrexate, and in patients with severe refractory disease infliximab. it is well known that treatment with immunosuppressive drugs is associated with burdensome side effects for patients and impaired quality of life. considerable research has been done on the possible role c. acnes in the pathogenesis of sarcoidosis. in a recent work of our own group it was shown that presence of c. acnes within granulomatous tissue can be detected in 41% of dutch patients with sarcoidosis. azithromycin has an inhibiting effect on several bacterial infections, such as c. acnes. therefore, sarcoidosis patients with c. acnes in the granulomatous tissue might benefit from treatment with azithromycin. given the fact that microbial resistance to azithromycin is relatively easy to develop, it is common practice to treat c. acnes with a combination of azithromycin and doxycycline.

Eligibility criteria:
inclusion criteria: * biopsy proven sarcoidosis. * no treatment indication for the sarcoidosis * inflammatory activity according to fdg-pet scan at baseline * suvmax above 3 in the lung and/or above 5 in mediastinum/hili exclusion criteria: * increased duration of qt interval (\>440ms for men and \>450ms for women) on ecg * hearing deficits, as this is a possible side effect of azithromycin * being pregnant or breastfeeding at time of inclusion

Keywords: cutibacterium acnes antibiotics azithromycin doxycycline
self-management program in chronic neck pain

Conditions: Neck Pain

Summary: neck pain is a complex biopsychosocial disorder often precipitated or aggravated by neck movements or sustained neck postures. the onset and course of this pain is influenced by environmental and personal factors.many studies report that participants preferred self-care measures for the management of neck pain and they sought professional help only when those measures fail.

neck pain is the fourth leading cause of disability worldwide causing an enormous impact on individuals and their families, communities and healthcare systems.while neck pain can be severely disabling and costly, treatment options have shown moderate evidence of effectiveness. no previous study has used foam roller in patients with neck pain. in addition, it has been suggested that neurodynamic interventions provide a peripheral stimulus, reducing the pressure existing within the nerve, improving blood flow, axonal transport and nerve conduction. it was hypothesized that a self-administered intervention focused on myofascial release of main muscles related to neck pain and upper-limb active neurodynamics could reduce the presence of active trigger points and pain, improving functionality and active mobility.

Eligibility criteria:
inclusion criteria: * chronic neck pain (at least 6 months' duration) not related to trauma . exclusion criteria: * whiplash related neck pain * previous cervical surgical intervention * cognitive impairments which prevent them to follow instructions * visual or acoustic limitations * physical therapy in the previous six months

Keywords: chronic pain
treatment of children and adolescents with growth failure associated with primary igf-1 deficiency

Conditions: Growth Disorders

Summary: this is an extension study to tercica study ms301 (nct00125164) and is intended to collect long term safety and efficacy data on the continued use of recombinant human insulin-like growth factor-1 (rh igf-1) in children and adolescents treated for primary igf-1 deficiency (igfd). the secondary objective is to use the data collected to learn more about the relationship of igf-1 exposure to the promotion of normal growth and pubertal development.

primary igfd is a term that has been used to describe patients with intrinsic cellular defects in gh action. in this protocol, subjects that have completed one year of mecasermin treatment on tercica protocol ms301 (nct00125164) will be allowed to enroll in this extension study. all subjects were planned to receive treatment. this is a phase iiib open-label, multi-center, parallel dose, extension study conducted in approximately 40 centers across the united states.

Eligibility criteria:
inclusion criteria: * parents or legally authorized representatives must give signed informed consent before any trial related activities are conducted * where required, assent of the subject will be appropriately documented prior to any study related activities * completion of assessments at visit 9 (month 120 of study ms301 \[nct00125164\]) exclusion criteria: * incomplete participation in ms301 (nct00125164) * known or suspected allergy to the trial product (mecasermin, recombinant human igf-1 injection) or its formulation * development or presence of a chronic condition except as approved by the medical monitor * pregnancy * any social or medical condition that, in the opinion of the investigator, would be detrimental to either the subject or the study

Keywords: insulin-like growth factor deficiency igf-1 short stature
preventing the spread of infection in nursing homes

Conditions: Staphylococcus Aureus

Summary: this study evaluates the feasibility of targeting more frequent gown and glove use for specific high risk moments of care in specific nursing home residents in order to prevent staphylococcus aureus (sa) acquisition and infection.

nursing homes are settings with a high rate of staphylococcus aureus (sa) acquisition, which leads to infection, particularly for short stay residents. the current standard of care for preventing sa acquisition and sa infection in nursing homes is standard precautions (gowns and gloves for anticipated contact with blood, body fluids, skin breakdown or mucous membranes) for all residents. the investigators propose a feasibility study of a novel strategy, the addition of targeted gown and glove use, to prevent sa acquisition and sa infection in residents of nursing homes. rather than wearing gowns and gloves for all care activities to prevent transmission, gown and glove use can be targeted to specific high risk "moments" of care for specific high risk residents. high risk "moments" for gown and glove use are care activities most likely to transmit sa based on prior research. residents with chronic wounds and medical devices are: 1) most likely to be colonized with sa; 2) most likely to acquire sa; 3) most likely to transmit sa to healthcare worker clothing and hands; and 4) most likely to develop a sa infection based on prior research and thus would be considered high risk residents. the investigators will perform a quasi-experimental (before-after) study of this intervention, targeted gown and glove use, at two community-based nursing homes to demonstrate its feasibility and evaluate its effect on sa acquisition and sa infection rates.

Eligibility criteria:
inclusion criteria: * age ≥18 years * reside in a participating nursing home exclusion criteria: * identified by nursing home staff as combative or with other behavioral problems which could lead to agitation if approached by project staff