Kornimate/medical-research-clean huggingface dataset:
prospective randomized trial between needle fasciotomy and xiapex for dupuytrens contracture

Conditions: Dupuytrens Contracture

Summary: the purpose of this study is to investigate whether percutaneous needle fasciotomy is as effective for treating dupuytrens contracture as xiapex. immidiate treatment effect is to be investigated, as iskontracture size after 5 years. contracture size after one and three years, and subjective hand function is also to be investigated.

prospective randomized study between percutanous needle fasciotomy and xiapex for dupuytrens contracture. a total of 50 patiens are to be randomized to eighter percutaneous needle fasciotomy or xiapex treatment. the patients randomized to xiapex treatment are treated as described in the product manual. extentin treatment after one day. the patients randomized to percutaneous needle fasciotomy are treated with the cutting teqnique: a littel quaddle local anestesia (xylocaine with adrenaline) is to be injected subcutant over the cord. after thet we use a 19g needle to cut the cord sufficient number sites to extend the finger. the patients will be follwed up at 3 weeks, 3 months, 1 year, 3 years and 5 years. investigators record contracture size, quicq-dash, pain (vas) and hand disability (vas) pretreatment and at all controlls. at 3 weeks investigators register procedure complain. side effects and complications, and advere effects are also to be investigated. our hypothesis is that it is no difference between the two methods in regard of contracture size after five years. inclution criteria: symptomatic primary dupuytrens contracture with palpable cord in one to three fingers, involving mcp, and total contracture size is over 30 degrees. patient age over 18 years. exclution criteria: previously treated dupuytrens contracture in the same hand more than tree affected fingers we will not include thumbs other symptomatic injury or disease influencingf hand function asa\>3 expected lifetime less than five years tetracycline treatment within two weeks pregnancy nursing allergy to clostridium histolyticum concmittent other clinical trial

Eligibility criteria:
inclusion criteria: * symptomatic dupuytrens contracture with palpable cord, involving mcp, total contracture size over 30 degrees exclusion criteria: * previous treated dupuytrens contracture same hand * more than tree fingers involvement * we will not include thumbs * other things affecting hand function * asa\>3 * expected to live under five years * tetracycline treatment within two weeks * pregnancy * nursing * allergy to clostridium histolyticum * participant in other trial

Keywords: percutanepus needle fasciotomy xiapex clostridium histolyticum
clopidogrel response in acute ischemic stroke. the bochumer crisp study

Conditions: Ischemic Stroke

Summary: the aim of this study was to determine the prevalence rate and risk factors for chemical laboratory clopidogrel low-response (clr) in the acute phase after an ischemic stroke.


Eligibility criteria:
inclusion criteria: * acute ischemic stroke * admittance to stroke unit * clopidogrel medication exclusion criteria: * no consent * prior bleeding disorders * severe liver disorders * current gastrointestinal disorders * congestive heart failure * life-threatening malignancies

Keywords: stroke clopidogrel aggregometry antiplatelet therapy platelet function tests
ard-101 for treatment of pws: the hunger elimination or reduction objective trial

Conditions: Hyperphagia; Prader-Willi Syndrome

Summary: the goal of this clinical trial is to learn if ard-101 works to treat hyperphagia-related behavior in patients with prader-willi syndrome (pws). it will also teach us about the safety of ard-101. the main questions it aims to answer are: * does ard-101 improve the total score of the hqct-9 (hyperphagia questionnaire for clinical trials, 9 questions)? * what medical problems do participants have when taking ard-101? researchers will compare ard-101 to a placebo (a look-alike substance that contains no drug) to see if ard-101 works to treat hyperphagia in pws subjects. eligible participants will: * take ard-101 or a placebo every day for 12 weeks. * visit the clinic or have a tele-visit once every 2 to 4 weeks during dosing and then have a tele-visit 4 weeks after stopping the ard-101 or placebo. * patients/caregivers will keep a daily diary.


Eligibility criteria:
inclusion criteria: * documented confirmation of prader-willi syndrome (pws) * stable care setting with same, single designated caregiver for at least 6 months prior to visit 1 exclusion criteria: * diagnosis of schizophrenia, bipolar disorder, personality disorder or other severe mood, anxiety or eating disorder (other than hyperphagia). * presence of any malignancy within 5 years with the exception of basal or squamous cell carcinoma of the skin, in situ carcinoma of the service, or in situations prostate cancer. * presence of clinically relevant renal, hepatic, pancreatic, cardiovascular, neurological, psychiatric, hematological, pulmonary, or gi abnormality that, in the opinion of the investigator, may preclude the patient from safe completion of the study * adults: systolic blood pressure \>=160 mmhg and/or diastolic blood pressure \>=100 mmhg * children and adolescents: systolic blood pressure \>=140 mmhg and/or diastolic blood pressure \>=90 mmhg. * type 1 diabetes mellitus; hba1c \>8.5% * use of agents to promote weight gain or loss, alter hunger or appetite within 30 days of visit 1 and throughout the study. * use of glucocorticoids: oral, intra-articular, or intravenous

Keywords: prader-willi syndrome ard-101 pws prader-willi prader willi prader willi syndrome
geriatric intervention contribution on quality of life of elderly patients with metastatic neoplasia

Conditions: Systemic Treatment; Metastatic Neoplasia; Elderly Patients

Summary: the aim of this study is to describe the impact of : geriatric intervention contribution on quality of life of elderly patients receiving systemic treatments for metastatic neoplasia

elderly cancer incidence increases exponentially with advancing age. however, elderly patients are largely underrepresented in cancer treatment trials. the geriatric population presents particular physical, mental, psychological or social specificities that may condition the prognosis especially for patients with metastatic neoplasia. recently, the measurement of quality of life (qol) in aging population is being recognized as an important part of clinical decision. it is therefore essential to set up prospective studies to evaluate the impact of oncogeriatric practices on the quality of life of elderly patients with metastatic neoplasia. the main objective of this prospective study is to describe the contribution of geriatric intervention on quality of life for for elderly (\> 75 years) with metastatic solid cancer receiving systemic treatment during the first 6 months of their therapeutic management.

Eligibility criteria:
inclusion criteria: * patient with solid metastatic neoplasia * 75 years old or more * men or women * ecog between 0 and 3 * patient receiving systemic antineoplasic treatment (chemotherapy, hormonotherapy, immunotherapy, targeted therapy) exclusion criteria: * ecog 4 * localized cancer * patients already included in a study witch could modify quality of life * patient unable to give their consent

Keywords: quality of life elderly metastatic neoplasia systemic therapies
effectiveness of non-invasive phrenic nerve neuromodulation in subjects with inflammatory bowel disease and neck pain.

Conditions: Inflammatory Bowel Diseases; Neck Pain

Summary: inflammatory bowel diseases (ibd) are chronic relapsing diseases that generate an autoimmune response against the bowel and its microbiota. its prevalence is increasing worldwide. these include ulcerative colitis (uc) and crohn's disease(cd). the phrenic nerve originates at the roots c3-c4-c5 carrying motor and sensory information. directly or through connections it innervates the diaphragm, pleura, right atrium, pericardium, oesophagus, peritoneum, stomach, falciform and coronary ligaments of the liver, glisson's capsule, hepatic and inferior vena cava, liver (parenchyma), gallbladder and the rest of the biliary tract, pancreas, small intestine and adrenal glands. it also has fibres of the autonomic nervous system. studies show that there is a link between people suffering from ibd and hepatopancreato-biliary diseases. it can therefore generate referred pain to the c3-c4-c5 dermatomes. based on the above, the main objective would be to analyse whether non-invasive neuromodulation of the phrenic nerve reduces neck pain in people with ibd. secondary objectives were to assess the impact of treatment on quality of life and to study the relationship between ibd and cervical pain. hypothesis: non-invasive phrenic nerve neuromodulation in subjects suffering from inflammatory bowel disease and neck pain will improve their quality of live, disability and sensitisation, as well as neck pain and mobility.


Eligibility criteria:
inclusion criteria: * crohn's disease or ulcerative colitis. * be over 18 years old. * disorder of the peridiaphragmatic abdominal viscera. * chronic mechanical neck pain. exclusion criteria: * previous trauma or surgery to the cervical spine. * infection. * congenital vertebral anomaly. * neurological diseases. * signs of neural compression or spinal stenosis. * impossibility of applying neuromodulation (fever, pregnancy, pacemaker, epilepsy, neoplastic processes close to the cervical area and skin alterations). * severe cognitive impairment and communication deficits. * application of physiotherapeutic treatment three months prior to the study. * use of analgesics, anti-inflammatory drugs or relaxants in the 24 hours prior to the intervention.
efgartigimod in ivig dependent myasthenia gravis patients

Conditions: Myasthaenia Gravis

Summary: this study is an open label, single center, prospective, 26 weeks study with descriptive analysis where ivig is replaced by efgartigimod therapy. mg-adl and mgqol evaluations will occur weekly throughout the study to week 26.

objectives: to determine if efgartigimod is equivalent or non-inferior in efficacy to ivig in the treatment of stable, acetylcholine receptor antibody positive, ivig dependent myasthenia gravis patients. to determine patient treatment preference between ivig and efgartigimod in stable, ivig dependent acetylcholine receptor antibody positive myasthenia gravis patients. to determine the safety and tolerability of efgartigimod administered in a fixed regular dosing regimen over 6 months in stable ivig dependent acetylcholine receptor antibody positive myasthenia gravis patients. ivig will be discontinued one week prior to the baseline visit (week 0) while other concurrent medications (non-steroidal immunosuppressive therapies (nsists), acetylcholinesterase (ache) inhibitors or corticosteroids) for myasthenia will be kept unchanged for the duration of the study. the dose and frequency of efgartigimod treatment will be 10mg/kg (max of 1200mg) administered as a one-hour intravenous infusion every week x 4 infusions followed by a four-week break and repeated for a total four treatment cycles till week 24 and then followed by a two-week observation with an end of study visit at week 26.

Eligibility criteria:
inclusion criteria: * 1. signed informed consent. 2. age 18-80 years 3. acetylcholine receptor antibody positive, myasthenia gravis patients, with stable disease for the past four or more months. stable disease is defined as no change in dosage or interval in ivig treatments and without any significant change in clinical status. 4. no modification or addition of nsists in the past six months 5. no modification or addition in corticosteroid therapy for the past three months 6. myasthenia gravis diagnosis was supported by abnormal neurotransmission test or history of improvement with ache inhibitors. 7. receiving chronic regular ivig treatments for myasthenia gravis for the past year or more. exclusion criteria: * 1. patients with previous rituxan or eculizumab treatment or plasma exchange within the past six months 2. patients with previous thymectomy within the past 3months 3. patients that have active hepatitis b, are seropositive for hepatitis c or hiv or have latent, untreated or active tb or any other significant active infection 4. patients that have at screening a serum igg less than 6.0gm/l or a history of chronic hypogammaglobulinemia from any cause. 5. patients that are pregnant or considering becoming pregnant in the next 6 months. 6. patients with severe renal impairment (egfr less than 30ml/min) 7. patients who in the opinion of the investigator should not participate in the study.

Keywords: myasthenia gravis vyvgart ivig
paired vagus nerve stimulation (vns) with rehabilitation for upper limb function improvement after stroke

Conditions: Stroke

Summary: patients (uk only) at least 6 months post stroke, with upper limb deficits, may enroll. patients will be randomized to one of two groups - a group implanted with a device that allows pairing vns with rehabilitation and a group that only receives rehabilitation (no implant). patients have two baseline evaluations, one evaluation after implant but before initiation of treatment, and then six weeks of rehabilitation or rehabilitation + vns, followed by post acute therapy evaluations at 1, 7, and 30 days after the 6-weeks of treatment. the intent is to assess safety and provide preliminary effectiveness information for vns for upper limb functional improvement after stroke. implanted patients may receive longer-term treatment and follow-up after the acute study.


Eligibility criteria:
major inclusion criteria: 1. history of unilateral supratentorial ischemic stroke that occurred at least 6 months prior 2. age \> 18 years and \< 80 years 3. right or left sided weakness of upper extremity major exclusion criteria: 1. hemorrhagic stroke 2. any deficits in language or attention that interferes with reasonable study participation 3. presence of significant apraxia 4. profound sensory loss 5. active major neurological or psychiatric diagnosis that would likely interfere with study protocol including alcohol or drug abuse

Keywords: upper limb deficits rehabilitation vns
exercise and plasticity in parkinson disease

Conditions: Parkinson Disease

Summary: we will study the effects of intensive rehabilitation in pd on plasticity with a multimodal approach. we will define first, whether exercise in pd restores the potentiation of the motor cortex to normal levels with both 5 hz-rtms pas and beta modulation and whether such improvements are accompanied by structural changes studied with diffusion mri tractography and network analysis (aim 1). with the study of muscle synergies and spatiotemporal organization of the spinal motoneuronal output during gait and reaching movements we will define the presence of functional changes in spinal cord mechanisms and connectivity and whether such changes are global or involve selective districts (aim 2). finally, we will study post-exercise changes in sleep pattern, as sleep is impaired in pd and plays a crucial role in the definition of plasticity-related phenomena (aim 3). this project will generate breakthrough data on the mechanisms of exercise, novel biomarkers to monitor efficacy of treatments and thus, possibly leading to better restorative, disease-modifying and symptomatic therapies for pd.

we will study the effects of intensive rehabilitation in pd on plasticity with a multimodal approach. we will define first, whether exercise in pd restores the potentiation of the motor cortex to normal levels with both 5 hz-rtms pas and beta modulation and whether such improvements are accompanied by structural changes studied with diffusion mri tractography and network analysis (aim 1). with the study of muscle synergies and spatiotemporal organization of the spinal motoneuronal output during gait and reaching movements we will define the presence of functional changes in spinal cord mechanisms and connectivity and whether such changes are global or involve selective districts (aim 2). finally, we will study post-exercise changes in sleep pattern, as sleep is impaired in pd and plays a crucial role in the definition of plasticity-related phenomena (aim 3)

Eligibility criteria:
inclusion criteria: idiophatic parkinson disease * h\&y stage i-ii stable medication exclusion criteria: * severe comorbid medical illness (diabetes, heart disease, hypertension); history of known causative factors (encephalitis or neuroleptic treatment); other neurologic disability; chronic treatment for sleep complaints; history of seizure, including febrile seizures, family history of epilepsy; pacemakers, neurostimulators, tattoos, metal foreign bodies in the head area; recurrent visual hallucinations; fluctuating cognition, attention or alertness; depression (hamd\> 12) or dementia (mmse \<24). controls will be age- and education- matched subjects.
implementation of nutritional efforts on discharged older patients

Conditions: Malnutrition

Summary: the aim of the study is to implement a nutritional treatment when discharging older patients at risk of malnutrition. data collected in the study will include an assessment of whether a combination of nutritional treatment and a liaison team reduces the risk of readmissions and mortality, improves nutritional status, physical function and quality of life

during hospitalization, many older patients are at risk of malnutrition. malnutrition in older adults is related to reduced physical function, more complications, re-admissions, days in hospital and reduced quality of life. as hospitalizations are often short (approximately 5 days), it is important to focus on nutritional intake during the convalescence period. upon discharge, a "nutrition gap" often occurs in practice, where the patient does not consume sufficient nutrition to ensure an optimal convalescence period. the lack of nutritional follow-up in connection with the discharge of older patients has been shown to have a markedly negative effect on, among other things, functional ability and readmissions. a study from herlev hospital, where the effect of a nutritional treatment upon discharge of older patients was investigated, showed a significant effect on muscle strength, quality of life and nutritional status. another study from herlev hospital has shown that by associating a clinical dietitian with a liaison team and thus focusing on nutrition, the readmission rate was halved. the problem is that it has not been investigated whether such a cross-sectoral effort can be implemented in practice and the results confirmed. hypothesis 1 is that it is possible to include and retain the older patients who are discharged with the liaison team for an effort that includes treatment of the risk of malnutrition and that the older participants find the effort relevant hypothesis 2 is that nutritional treatment will be able to reduce the number of unintended readmissions and thereby be cost-effective. furthermore, it is expected that the nutritional treatment will increase the participants' nutritional status, muscle strength, muscle mass, quality of life and possibly have a positive effect on mortality.

Eligibility criteria:
inclusion criteria: prescription of the liaison team at nutritional risk according to nrs2002 age 50+ can read, hear and understand danish or english cognitive able to participate in the study, based on whether they are informed in time, place and own data exclusion criteria: receives enteral or parenteral nutrition following a special diet including texture modified food and drinks short life expectancy not deemed eligible by the project staff

Keywords: food dietician malnutrition nutrition risk quality of life muscle strength readmissions mortality multimodal
women's health study: immunological factors and risk of vulvodynia

Conditions: Vulvodynia

Summary: the investigators plan to study the etiology of vulvodynia, a condition characterized by chronic vulvar discomfort, most often described as burning pain, occurring in the absence of relevant visible findings or a specific, clinically identifiable, neurologic disorder. our hypothesis is that vulvodynia is the result of an altered immuno-inflammatory response mechanism that occurs as a consequence of reproductive, gynecologic, environmental, or psychological exposures, with abnormal vaginal microflora and genetic polymorphisms as potential modifiers of the effects of interest. therefore, the investigators propose to collect information about reproductive, gynecological and environmental exposures, psychological trauma and psychiatric morbidity, and biological markers of immuno-inflammation and nerve fiber proliferation.

women aged 18-40 years who were seen for any reason within a 2-year period at one of the twin cities metro-area's fairview health services outpatient clinics will be send a confidential self-administered questionnaire, and given the option to return it by mail, or complete it via phone or via a secure online server. this questionnaire will serve to determine any history of unexplained vulvar pain. those with a history of past or current vulvar pain likely to represent vulvodynia, will be asked to come to one of four study clinic locations to confirm the diagnosis of vulvodynia. if confirmed, they will be asked to provide venous blood and vulvovaginal specimens. in addition, they will be asked to complete a medical history and psychosocial survey, along with an interviewer-administered structured clinical interview for the diagnostic and statistical manual-iv (scid-iv). a random sample of women with no history of vulvar pain will be asked to serve as controls. those confirmed as controls will also be asked to provide the same biological specimens and complete the same questionnaires/interview. the long-term objective of this research is to provide etiological information that may prove critical to the treatment and prevention of vulvodynia, an under-recognized and extremely debilitating condition that we and others have shown may affect up to 10% of the adult female population.

Eligibility criteria:
inclusion criteria: * clinically confirmed vulvodynia * women with no history of vulvar discomfort and clinically confirmed as acceptably control. exclusion criteria: * women with vulvar pain attributed to a known cause. * women with any active gynecological yeast, bacterial, or viral infection.
phase 2a study of cg400549 for the treatment of cabsssi caused by methicillin-resistant staphylococcus aureus

Conditions: Skin Infection

Summary: primary objective: to make a preliminary assessment of the efficacy of cg400549 (960 mg daily) in subjects with cabsssi (major cutaneous abscesses) due to mrsa. secondary objective(s): * to assess the pharmacokinetics of cg400549 (960 mg daily) in subjects with cabsssi due to mrsa * to explore the in vitro susceptibility of cabsssi-related bacteria to cg400549. * to assess the safety of multiple doses of cg400459

this will be an open-label, exploratory study to evaluate the safety, pharmacokinetics, and efficacy of cg400549, daily for 10 to 14 days, in subjects with cabsssi (major cutaneous abscesses) due to mrsa. all subjects will receive active treatment. subjects will begin study treatment upon confirmation of clinical eligibility (ie, confirmation of mrsa infection is not required pretreatment). subjects who begin treatment with cg400549 and are subsequently not found to have s. aureus infection will be discontinued from study treatment, treated as appropriate for the identified pathogen(s), and followed for safety. these subjects will be included in the safety analyses but not in the primary efficacy analysis.

Eligibility criteria:
inclusion criteria: 1. diagnosis of major cutaneous abscess suspected or confirmed to be caused by a mrsa. 2. signs and symptoms should include at least 2 of the following: purulent drainage or discharge, erythema, fluctuance, heat or localized warmth, edema/induration, pain or tenderness to palpation exclusion criteria: 1. prior systemic or topical antibacterial therapy 2. severe sepsis or refractory shock

Keywords: cabsssi mrsa