Kornimate/medical-research-clean huggingface dataset:
efficacy, safety and tolerability study of nd0612 vs. oral immediate release levodopa/carbidopa (ir-ld/cd) in subjects with parkinson's disease experiencing motor fluctuations

Conditions: Parkinson's Disease

Summary: this is a multi-center, randomized, double-blind, double-dummy, active controlled clinical study. following a screening period, eligible subjects will be enrolled to an open-label oral ir-ld/cd adjustment period; then an open-label nd0612 conversion period; then after optimization periods subjects will be randomized to receive either nd0612 or its matching placebo with ir-ld/cd. subjects can continue to an optional open-label extension period.

this is a phase iii multi-center, randomized, active-controlled, double-blind, double-dummy (dbdd), parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous (sc) nd0612 infusion in comparison to oral ir-ld/cd in subjects with parkinson's disease (pd) experiencing motor fluctuations. this study is comprised of 6 periods: 1. a screening period; 2. an open-label oral ir-ld/cd adjustment period; 3. an open-label nd0612 conversion period; 4. a randomized dbdd active-controlled maintenance period; 5. an optional open-label treatment extension; and 6. a safety follow-up period.

Eligibility criteria:
inclusion criteria: 1. male and female patients, aged ≥30 years. 2. pd diagnosis consistent with the united kingdom brain bank criteria. 3. modiﬁed hoehn \& yahr score ≤3 during "on" state. 4. average of ≥2.5 hours of off time (≥2 hours "off" time every day) during waking hours as conﬁrmed by patient diary over 3 days. 5. taking ≥4 levodopa doses/day (≥3 doses/day of extended release ld/dopa-decarboxylase inhibitor, e.g., rytary®) at a total daily dose of ≥400mg. exclusion criteria: 1. atypical or secondary parkinsonism. 2. severe disabling dyskinesias, based on investigator's discretion. 3. previous neurosurgery for pd. 4. use of duodenal levodopa infusion (lcig) or apomorphine infusion. 5. use of the following medications: subcutaneous apomorphine injections, sublingual apomorphine, or inhaled levodopa within 4 weeks. 6. previous participation in nd0612 studies. 7. history of signiﬁcant skin conditions or disorders.
phase ii trial of first-line doxycycline for ocular adnexal marginal zone lymphoma treatment

Conditions: Marginal Zone Lymphoma of Ocular Adnexal

Summary: objective of this trial is to establish the efficacy of an upfront targeted therapy consisting of chlamydophila psittaci (cp)-eradicating therapy with prolonged administration of doxycycline followed by eradication monitoring and antibiotic re-treatment at infection re-occurrence in patients with newly diagnosed ocular adnexae marginal zone lymphoma the primary endpoint is the 2-year progression-free survival (pfs) of patients with newly diagnosed stage-ie lymphoma treated with the experimental strategy.


Eligibility criteria:
inclusion criteria: 1. histological diagnosis of marginal zone lymphoma of the ocular adnexae (oamzl) 2. single or bilateral lesion (stage ie) localised to the ocular adnexae (conjunctiva, lachrymal gland or sac, orbit soft tissue, eyelid) 3. absence of b symptoms 4. previously untreated patients 5. no systemic antibiotic therapy in the last three months before enrolment 6. age \>18 years 7. ecog ps 0-2 8. negative hiv, hbv and hcv serology 9. adequate bone marrow, renal, and hepatic function 10. no previous or concurrent malignancies with the exception of surgically cured carcinoma in situ of the cervix, carcinoma of the skin or other cancers without evidence of disease at least from 5 years 11. absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 12. sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation 13. no concurrent treatment with other experimental drugs 14. patient-signed informed consent obtained before registration exclusion criteria: 1. pregnant or lactating women 2. known allergy to tetracycline 3. patients unwilling to comply with the requirements of follow-up 4. myasthenia gravis (tetracycline can exacerbate muscle weakness) 5. systemic lupus erythematous (tetracycline can exacerbate this condition) 6. patients with large or rapidly enlarging tumors requiring immediate radiotherapy
heart rate variability, vagus nerve and cancer

Conditions: Lung Cancer; Colorectal Cancer; Multiple Myeloma; Non Hodgkin Lymphoma

Summary: in france, new cancer cases keep on increasing with around 150 000 deaths yearly. cancer therapy research is constantly evolving. indeed, several studies explore new treatments or their combination with conventional cancer treatments. but, at the same time, complementary and alternative medicines, as osteopathy, remain little explored upon their role in the combination with conventional therapy. several studies showed indirect interaction between vagus nerve and cancer. firstly, vagus nerve regulates homeostasis and immunity by reducing systemic inflammation while maintaining local inflammation and antitumor effects. secondly, vagus nerve stimulation increases heart rate variability (hrv). moreover, a higher hrv is associated with an improvement of vital prognosis in cancer patients. vagus nerve could be stimulated by noninvasive osteopathic manipulations. this prospective, monocentric and randomized study is a collaboration between the centre hospitalier d'avignon and the institut de formation en ostéopathie du grand avignon. it focuses on using noninvasive osteopathic mobilizations to stimulate vagus nerve. indeed, this study aims to evaluate effects of vagus nerve osteopathic stimulations on hrv in patients with lung cancer, colorectal cancer, non hodgkin lymphoma or multiple myeloma. more specifically, this study will tell us whether vagus nerve noninvasive osteopathic stimulations induce increase of hrv associated with a decrease of systemic inflammation and an improvement of patient's quality of life.


Eligibility criteria:
inclusion criteria: * patient with lung cancer or colorectal cancer or non hodgkin lymphoma or multiple myeloma (stade i à iv) * no previous treatment * hrv \< 70 ms * no osteopathic contraindication exclusion criteria: * vagotomy * heart arrhythmia * cancer recurrence * consumption of coffee or tabac within 2 hours prior osteopathic treatment * consumption of alcohol within 24 hours prior osteopathic treatment

Keywords: cancer vagus nerve stimulation heart rate variability osteopathy
post-market clinical follow-up study to confirm clinical performance and safety of the codman enterprise® 2 vascular reconstruction device in the endovascular treatment of intracranial aneurysms

Conditions: Intracranial Aneurysm

Summary: the objective of this post-market clinical follow-up (pmcf) is to confirm the performance and safety of the codman enterprise® 2 when used in conjunction with endovascular coil embolization of ruptured or non-ruptured intracranial aneurysms.


Eligibility criteria:
inclusion criteria: 1. subject ≥ 18 years old. 2. subjects with non-ruptured or ruptured intracranial aneurysm that is referred for endovascular treatment. 3. parent vessel with a diameter of ≥ 2.0 mm and ≤ 4 mm. 4. subject understands the nature of the procedure and provides voluntary written informed consent in accordance with the requirements of this study protocol. 5. subject is willing to participate in the telephone follow-ups and to return to the investigational site for the post-procedure follow-up evaluations. exclusion criteria: 1. angiogram demonstrating that the aneurysm is not appropriate for endovascular treatment (i.e.: severe intracranial vessel tortuosity, stenosis, intracranial vasospasm not responsive to medical therapy). 2. mycotic or traumatic aneurysm. 3. arteriovenous malformation (avm) in the territory of the target aneurysm. 4. two or more aneurysms (\>2mm) in associated distribution. 5. hunt and hess scale (hhs) of iv or v at inclusion for subject with ruptured aneurysms. 6. life expectancy of less than 6 months as determined by the treating physician. 7. a planned staged procedure (i.e. a procedure where entire treatment with the devices (e.g. coils/stents) is completed over separate sessions). 8. previous neuro-interventional or neuro-surgical procedure of any kind within 30 days prior to the study procedure. 9. intracranial mass (tumor, abscess, or other infection), or undergoing radiation therapy for carcinoma or sarcoma of the head or neck region. 10. unsuitable for the antithrombotic and/or anticoagulant therapies 11. serum creatinine level \> 2.5 mg/dl within 7 days prior to index procedure 12. known hypersensitivity or allergies to cobalt, nitinol metal, nickel, or sensitivity to contrast media, 13. evidence of an acute myocardial infarction (mi) within 30 days prior to the index procedure. 14. uncontrolled atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms. 15. subject is pregnant
registry for acute pain treatment

Conditions: Pain, Postoperative; Regional Anesthesia

Summary: the german network for acute pain management and regional anesthesia (nra) is a multi-center, non-interventional registry and benchmark project, assessing and analysing clinical and patient-reported procedural and outcome data of systemic analgesia and regional anesthesia hosted by the german society of anesthesia and intensive care medicine (dgai) and professional society german anesthetists (bda)

nra offers the systematic documentation of patient related and procedure related components for acute pain treatments during and after surgery. nra collects preoperative, intraoperative, and postoperative data from treating physicians who complete a standard form. data are collected concurrently with patient care by pain nurses or treating physicians and include detailed information about the medical conditions of patients having acute pain treatment along with the procedure and postoperative course. the registry provides the basis for large scale analyses and benchmarks for several parameters. the registry also aims at performing population-based research. furthermore, its infrastructure allows for the conduct of prospective studies comparing the effectiveness of processes of care.

Eligibility criteria:
inclusion criteria: * the investigators include anonymous data from patients with continuous regional anesthesia, single shot regional anesthesia, or systemic analgesia exclusion criteria: * none.

Keywords: anesthesia continuous regional anesthesia complications epidural analgesia antibiotics
effect of vitamin d3 supplementation on insulin resistance- the dir study

Conditions: Sub-optimal Vitamin D Status; Pre-diabetes; Insulin Resistance

Summary: insulin resistance is a state where the body does not respond as it should to the insulin it produces. individuals who are insulin resistant are at increased risk of both heart disease and type 2 diabetes; importantly, diabetes more than doubles the risk of heart disease, independent of other recognised risk factors. interventions that prevent or reverse insulin resistance may help to attenuate risk of heart disease and diabetes. a number of randomised controlled trials provide proof of concept evidence regarding a beneficial effect of vitamin d on insulin resistance and other cardiovascular risk markers but experts have stated that further studies are required. importantly, these studies should use appropriate endpoints, provide a high enough dose of vitamin d to optimise vitamin d status, and they should be conducted in clearly defined populations, the vitamin d trial we propose addresses these issues and aims to evaluate a potentially straightforward and low cost health care intervention for populations at highrisk of heart disease and diabetes. specifically, this study would provide clinically relevant information on the metabolic effects of optimising vitamin d status in these high risk patients. this has clear economic and social implications given the current, and projected, burden of heart disease and diabetes. this study will investigate the effect of vitamin d3 supplementation on insulin resistance and cardiovascular risk factors in people at high risk of type 2 diabetes and cardiovascular disease using the gold standard euglycaemic hyperinsulinaemic clamp method.


Eligibility criteria:
inclusion criteria: * impaired glucose tolerance (fasting glucose \<7.0 mmol/l (126mg/dl) and 2hr post-glucose load 7.8-11.0 mmol/l (140-199 mg/dl) or impaired fasting glucose 5.6-6.9 mmol/l (100-125mg/dl) defined according to american diabetes association * sub-optimal vitamin d status (\<50nmol/l) exclusion criteria: * diabetes mellitus * established cardiovascular disease * psychiatric problems * pregnant or lactating * medical conditions or dietary restrictions that would substantially limit ability to complete the study requirements * excessive alcohol consumption (\>28 units/week men or \>21 units/week women) * already taking vitamin d supplements \> 10 µg/d * medical conditions or medications that could influence vitamin d metabolism * history of kidney stones * hypercalcaemia * hyperparathyroidism * significant liver and renal disease (liver function tests \>3x upper limit of normal and glomerular filtration rate \<30ml/min)

Keywords: vitamin d, pre-diabetes, insulin resistance
the impact of music intervention on sleep

Conditions: Dementia

Summary: the primary purpose of this stage 1b nih-funded clinical trial (k23ag073618, pi petrovsky) is to determine the efficacy of a 1-month music intervention (calming music personalized for sleep enhancement in persons living with dementia, composer) on health outcomes in 72 dyads (144 participants) of persons living with dementia (plwd) and their caregivers (stage 1b). the secondary purpose of this research project is to examine the mechanism of stress reduction and sustained effects of the music intervention on plwd and caregiver well-being. we will evaluate the acceptability of the mobile application composer in a pilot rct and determine the impact of the mobile application composer on plwd (sleep latency, sleep efficiency, wake after sleep onset, total sleep time, sleep quality) and caregiver (perceived stress and well-being) outcomes.

aim 1: evaluate the acceptability of the mobile application composer in a pilot rct. aim 2: determine the impact of the mobile application composer on plwd (sleep latency, sleep efficiency, wake after sleep onset, total sleep time, sleep quality) and caregiver (perceived stress and well-being) outcomes. aim 3: examine stress reduction as a mechanism of action measured via salivary cortisol by which 1-month long composer intervention affects insomnia symptoms in plwd. aim 4: to determine the sustained (3 months) efficacy of composer compared to control group on plwd and caregiver health outcomes.

Eligibility criteria:
inclusion criteria for persons living with dementia (plwd): * age 60 and above * existing physician diagnosis of dementia or self-reported memory impairment and clinical dementia rating scale score of greater than 0.5, * score of \>10 on the insomnia severity index * stable dose of psychotropic medications * agreeing to wear an actiwatch for the duration of the study plwd exclusion criteria: * hearing impairment * planned transition to a residential or institutional care facility in 3 months * presence of extrapyramidal symptoms or acute sleep disruption * bed bound * living in an alternative home setting (such as assisted living community) informal caregivers inclusion criteria: * age 18 and above. * providing at least 4 hours of daily care * living with plwd * able to read and communicate in english

Keywords: dementia
endotracheal tube securement study

Conditions: Mechanical Ventilation Complication

Summary: to evaluate the safety and efficacy of endotracheal tube securement techniques, a pragmatic, randomized controlled trial will compare the effect of adhesive tape versus endotracheal tube fastener on complications including lip ulcers, facial skin tears, endotracheal tube dislodgement, and ventilator associated pneumonia among critically ill adults requiring intubation and mechanical ventilation for at least 24 hours.

background: the optimal securement method of endotracheal tubes is unknown, but should provide adequate security while minimizing complications. this study tests the hypothesis that use of an endotracheal tube fastener would reduce complications among critically ill adults undergoing endotracheal intubation. this hypothesis will be tested in a pragmatic, single center, randomized trial comparing the effect of adhesive tape versus endotracheal tube fastener (hollister) among critically ill adults requiring intubation and mechanical ventilation for at least 24 hours.

Eligibility criteria:
inclusion criteria: * patient intubated prior to admission to the micu and the intubation time was less than 12 hours from the time of admission * patients intubated in the micu for greater than 24 hours exclusion criteria: * intubated greater than 12 hours prior to admission to the micu * presence of oral mucosa or facial skin breakdown prior to enrollment * required nasotracheal intubation, * had a documented allergy to tape * pregnant * prisoners

Keywords: endotracheal tube tube fastener facial skin tear lip ulcer endotracheal tube dislodgement
stereotactic radiosurgery (srs) in malignant spasticity and hypertonia

Conditions: Spasticity/Paresis

Summary: this is a pilot, experimental, monocentric study. the main objective of the study is to evaluate whether stereotactic radiotherapy is able to reduce symptomatic spasticity from a clinical point of view, and therefore induce an improvement in posture and quality of life in patients with malignant spasticity. the study foresees the enrollment of about 10 patients, in a period of 24 months. the radiotherapy treatment will be delivered in a single session with an image-guided stereotaxic technique, and a prescription dose between 45 and 60 gy; subsequently the patients will be followed up for one year.


Eligibility criteria:
inclusion criteria: * malignant spasticity measured with the modified ashworth scale (mas≥3) or highly impairing spasticity and hypertonia (numeric rating scale \>8 scored by patient or care-giver) * age ≥ 18 years old * availability of a diagnostic mr scan of the spine segment of interest and electromyography of inferior limbs within 3 months prior to study entry * previous ineffective conventional treatment for spasticity or absence of others therapeutic strategies (i.e. negative baclofen pump test, comorbidity limiting the pump implant as spondylodiscitis or severe obesity) * plegic patients or minimally conscious state patient * signed informed consent (in case of minimally conscious state patients, consent form will be signed by her / his legal representative) exclusion criteria: * age \< 18 years old * previous radiation in the same anatomical site
effect of medical food on reducing asthma symptoms in asthmatic children

Conditions: Asthma

Summary: to determine the effect of medical food on reducing asthma symptoms in asthmatic children.


Eligibility criteria:
inclusion criteria: * male and female children who have had mild to moderate persistent asthma for at least 1 year and are between 6 and 14 years of age, and not currently being treated with steroids are eligible. each subject also has to have: * subject is off of controller therapy 4 wks preceding visit 1. * mild to moderate persistent asthma * methacholine responsiveness with an fev1 pc20 * able to perform reproducible spirometry * verbal assent in addition to consent * history of prior clinical varicella or varicella vaccine. * nonsmoker in past year. exclusion criteria: * asthma symptoms and/or albuterol use consistent with severe persistent asthma during the run-in period. * subject with fev1 \< 80% predicted at visit 1 or fev1 \< 70% predicted at visit 2. * two or more hospitalizations for asthma in the past year. * subject has received oral, nasal, inhaled, or im corticosteroids during the preceding month. * subject has received leukotriene modifiers, theophylline derivatives, or mast cell stabilizers for asthma within 4 weeks before visit 1 * subject is receiving one or more of the following medications: * astemizole prior to 3 months of visit 1 * oral, inhaled or parenteral corticosteroids prior to 4 weeks of visit 1 * cromolyn, antimuscarinics, cimetidine, metoclopramide, phenobarbital, phenytion, terfenadine, loratadine, or anticholingeric agents prior to 2 weeks of visit 1. * theophylline prior to 4 weeks of visit 1 * subject with active upper respiratory tract infection prior to 4 weeks before visit 1 * subject with acute sinus disease requiring antibiotic treatment within 1 week before visit * subject with an emergency department treatment for asthma within 1 month, prior intubation for asthma, or hospitalization for asthma within 3 months * subject has known bleeding disorder and/or is on medication known to have significant anticoagulant effects. * subject has known hypersensitivity to any of the ingredients * subject is taking either pill, powder, or liquid forms of nutritional and/or health food supplements within the past 4 weeks prior to visit * subject unable to tolerate or unwilling to take the full dose of the nutritional study formulas * cystic fibrosis or any other chronic lung disease other than asthma. * subject having gastroesophogeal reflux undergoing medical treatment * significant medical illness other than asthma that could require oral corticosteroids during the study. * subject is receiving allergen hyposensitization therapy other than an established maintenance regimen * subject has received iv globulins or immunosuppressants. * subject is known to be human immunodeficiency virus (hiv) positive. * pregnancy or lactation. * if of child bearing potential, failure to practice abstinence or use of an acceptable birth control method. * subject is morbidly obese