Kornimate/medical-research-clean huggingface dataset:
evaluation of the photobiomodulation using led lamp for curative treatment of radio-induced mucositis.

Conditions: Oral Cancer; Oropharyngeal Cancer

Summary: this is a monocentric, prospective, non-comparative phase ii study with minimal risks and constraints. the study will aim to assess the curative treatment of radio-induced mucositis by photobiomodulation using led lamp.

the aim of this study is to assess the effectiveness of the treatment of radio- or radio-chemotherapy-induced early stage mucositis (stage 1 and 2) by photobiomodulation using led lamp (pled) in terms of controlling the mucositis assessed at the end of radiotherapy or radio-chemotherapy treatment. other objectives of the study include: * to assess the pain evolution over-time, both overall over the evaluation period until the end of radiotherapy and at each session * to assess the needs of level 3 analgesics (morphine, oxycodone, fentanyl, hydromorphone) during the pled protocol. * to assess the quality of life variation between inclusion and the end of treatment by radiotherapy or radio-chemotherapy. * to estimate the frequency of radiotherapy or radio-chemotherapy treatment (temporary or permanent interruption, dose modification), and eventually, the reason of this modification. * to assess the feasibility of photobiomodumation by led (pled) in this context. * to assess the tolerability of photobiomodumation by led (pled) in a short term. * to assess the frequency of the needs of nutritional support by nasogastric tube or gastrostomy tube during the pled protocol. * to assess the weight and general condition variation during the treatment.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * with squamous cell carcinoma of the head and/or neck * stage 1 or 2 mucositis (nci-ctcae v5), wich means a mucositis not requiring an enteral nutrition management (solid or liquid alimentation possible, including with feed supplements) in week 2 to 4 in relation to the beginning of radiotherapy. * during treatment by radiotherapy, with or without concomitant chemotherapy * patient affiliated to a social security system * patient who signed the informed consent for this study exclusion criteria: * radiotherapy treatment completed * stage 3 or higher mucositis already installed * history of skin porphyria or lupus erythematosus * concomitant or within 7 days prior to inclusion, at least one of following drugs : fluoroquinolones, cycline, methotrexate, auranofine * enteral nutrition support in progress * pregnant or breast-feeding woman * patient under guardianship or curatorship

Keywords: oral cancer radiotherapy radio-chemotherapy mucositis led photobiomodulation (pled) oropharyngeal cancer
efficacy of riluzole in hereditary cerebellar ataxia

Conditions: Cerebellar Ataxia

Summary: the hereditary cerebellar ataxias include diverse neurodegenerative disorders. hereditary ataxias can be divided into autosomal dominant ataxias (adcas), autosomal recessive ataxias (arcas), x-linked, and mitochondrial ataxias on the basis of mode of inheritance. the key feature in all these disorders is ataxia typically characterised by poor balance, hand incoordination, postural or kinetic tremor, dysarthria and dysphagia. to date no treatment has been shown to slow progression of the disease and symptomatic therapies are limited to few options that are partially effective. purkinje cells project inhibitory signals to the deep cerebellar nuclei(dcn) which have a critical role in cerebellar function and motor performance. dcn neurons fire spontaneously in the absence of synaptic input from purkinje neurons and modulation of the dcn response by purkinje input is believed to be responsible for coordination of movement, while uncontrolled spontaneous firing of dcn neurons may underlay cerebellar ataxia. recent studies have demonstrated that small-conductance calcium-activated potassium (sk) channels inhibitor are able to increase dcn firing rate. since sk channels are critical regulators of dcn firing rate, sk openers such as the drug riluzole may reduce neuronal hyperexcitability and thereby be useful in the therapy of cerebellar ataxia. on this base the investigators published a pilot study in patients with chronic cerebellar ataxia (ristori et al., neurology 2010) investigating safety and efficacy of riluzole or placebo administration for 8 weeks. the results demonstrated a significative improvement in international cooperative ataxia rating scale (icars) global score after four weeks and after 8 weeks in the riluzole arm. the present protocol is aimed at verifying the safety and efficacy of riluzole administration for a longer period, in a larger sample size of patients, with more stringent diagnostic criteria (hereditary cerebellar ataxia), respect to the above pilot study. sixty patients will be enrolled in a double-blind, placebo-controlled trial. by central randomisation, patients will take 50 mg of riluzole or placebo twice daily for 12 months. treatment effects will be assessed by comparing the scale for the assessment and rating of ataxia (sara) before treatment and during therapy at months 3 and 12.


Eligibility criteria:
inclusion criteria: * patients with genetically confirmed diagnosis of hereditary cerebellar ataxia exclusion criteria: * concomitant experimental therapy for ataxia * serious systemic illnesses * pregnancy

Keywords: spinocerebellar ataxia friedreich ataxia
a trial of patients with a charles bonnet syndrome

Conditions: Prevalence, Psychiatrist Intervention

Summary: charles bonnet syndrome (cbs) is defined by the occurence of visual hallucinations (vh) in the absence of any mental disorder. elderly patients with reduced visual acuity due to ophthalmic diseases are most affected. conditions are often associated with the syndrome of age-related macular degeneration, cataract or glaucoma. existing data on the syndrome's prevalence in europe reveal diverse results. aim of this study was to assess the prevalence of cbs in patients with low visual acuity and to evaluate, if an additional therapeutic interview with and treatment by a psychiatrist is beneficial.

patients with a visual acuity of 0.5 logmar or less in the better eye were screened for cbs. instruments used were an interview asking for details of the hallucinations, a mental test and a scale concerning quality of life. patients with cbs were randomized by minimization in two groups: in group 1, a patient-doctor interview by an ophthalmologist was performed and in group 2 an interview and if needed, a therapy by a psychiatrist. at the 3-months follow up, the psychological strain of patients was recorded again.

Eligibility criteria:
inclusion criteria: * written informed consent * visual acuity of 0.5 logmar or less at both eyes * 55 years or older patients with cbs: * have no mental pathologies such as dementia, psychosis or any other neurological diseases * have a normal cognitive state * are not able to control the vh * know that the vh are not real * are usually older * have significantly reduced visual acuity due to an bilateral eye pathology vh associated with cbs: * disappear when the eyes are closed * are repetitive * are complex (eg. objects, geometrical patterns, faces, shapes, figures, scenes, animals or plants) exclusion criteria: * dopamine agonist medication * temporal lobe epilepsy * moderate to severe alzheimer's dementia * present chronic alcohol-/drug abuse * bad cognitive state there are no: * auditory or olfactory hallucinations * other abnormalities like delusions

Keywords: randomized control trial charles bonnet syndrome visual hallucinations age related macular degeneration patient education
evaluation of low dose laser in treatment of tinnitus

Conditions: Subjective Tinnitus

Summary: the purpose of this study is to determine wether low dose laser is effective on idiopathic subjective tinnitus.


Eligibility criteria:
inclusion criteria: * adults older than 18 years old * idiopathic, subjective, unilateral tinnitus with at least 2 month duration exclusion criteria: * patients with chronic otitis media * patients with tympan perforation with any underlying cause * patients with external otitis * patients with tinnitus related to a retrocochlear lesion or other known lesions of the ear

Keywords: tinnitus low power laser
evaluation of post-angioplasty outcomes

Conditions: Critical Limb Ischemia; Peripheral Arterial Disease

Summary: there is no hard and fast rule guiding the clinical decision between angioplasty and amputation. as such, this decision is greatly dependant on each clinician's experience and preference as to whether treatment should be conservative or aggressive. angioplasty can help restore blood flow and long-term patency of the blood vessels can help prevent major surgeries, such as amputation which affects patient's quality of life. however, some of these patients do not benefit from angioplasty and eventually had to undergo amputation. on the other hand, there are patients that undergo amputation, but may stand to benefit from angioplasty. hence, it is essential to identify patients that will likely benefit from angioplasty to increase limb salvage rate. many studies performed have also concluded that before amputations are performed, surgeons should consider angioplasty procedures. through a medical record review of patients that have undergone angioplasty to evaluate post-angioplasty outcomes, we hope to identify factors that potentially affects these outcomes. ultimately with a better understanding of these factors and their impact on angioplasty outcomes, a predictive model or guideline can be developed to identify patients that stands to benefit from angioplasty. such a model can help clinicians to better counsel patients on the risk and benefits, alternatives and prognosis. patients can also make a better informed decision regarding their treatment


Eligibility criteria:
inclusion criteria: * all patients admitted into sgh department of vascular surgery, and have successfully undergone angioplasty exclusion criteria: * minors under age of 21
randomized evaluation of maxillary antrostomy versus ostial dilation efficacy through long-term follow-up

Conditions: Chronic Sinusitis

Summary: the objective of this study is to show that long-term symptom improvement after sinus balloon dilation is not worse than symptom improvement after functional endoscopic sinus surgery (fess) and that fewer postoperative debridements are required after balloon dilation than after fess.

this is a postmarket, multicenter, prospective, randomized clinical trial conducted at up to 15 us clinical sites comparing the efficacy of balloon sinus dilation with traditional endoscopic sinus surgery. the primary hypotheses were to demonstrate that: 1) long-term change in sinus symptoms after balloon dilation is not worse (non-inferior) than after fess, and 2) balloon dilation is superior to fess for a reduction in the number of postoperative debridements per patient. a minimum of 36 participants per arm is required to test the primary hypotheses. all participants will be followed through a minimum of 12 months post treatment.

Eligibility criteria:
inclusion criteria: * 18 years or older * maxillary sinus disease * chronic sinusitis exclusion criteria: * fungal disease * samter's triad * hemophilia * prior sinus surgery
assessing the repeatability of nt-probnp testing using laboratory and point of care testing in pah

Conditions: Pulmonary Artery Hypertension

Summary: the purpose of this study is to examine n-terminal pro brain natriuretic peptide (nt-probnp) and brain natriuretic peptide (bnp) biomarkers in a number of different settings including assessing the repeatability of laboratory and point of care testing (poct), the effect of a time delay and exercise have on laboratory measurements. also to compare the clinical and analytical performances of nt-probnp and bnp poct samples across the spectrum of disease severity and finally assess whether poct in pah can detect change in patients commencing or escalating pah treatment.

* patients that are attending clinical appointments will be approached to ask if they will take part in the study. * patients will be assessed at two separate visits. * patients will be randomised to either exercise or rest group on their 1st visit. on the 2nd visit patients will be asked to participate in the alternate group to what they completed on their previous visit. * at each visit they will have 2 blood samples taken, at time point 1 and at time point 2 (t1 and t2). these will be taken at least one hour apart, each with a period of at least 15 mins rest in the sitting position prior to sampling. * on one of these two visits the patient will undergo exercise testing between t1 and t2. * in addition, a further laboratory testing tube will be taken for a delayed nt-probnp. this will be subjected to gentle agitation (laboratory rotator) for 48 hours prior to processing to simulate, in a controlled environment, the effect of transport and delay on sample measurement. * retrospectively information will be collected regarding the patient's disease severity and any change to treatment that occurred between the two visits. * a total of 40 patients with be sampled with an interim analysis after 20 patients.

Eligibility criteria:
inclusion criteria: * patients who have met the criteria for the sheffield teaching hospitals observational study of patients with pulmonary hypertension, cardiovascular and other respiratory diseases (sth-obs) * patient diagnosed with group 1 pah, including ipah, hpah, pah-ctd but excluding pah-chd. mean pulmonary artery pressure \>20mmhg, pawp ≤15mmhg and pvr \>240 dynes. * willing to participate in the study and able to provide informed consent exclusion criteria: * diagnosed with pah-chd or any non-group 1 ph * creatinine clearance \< 15 ml/min/m2
prospective 2-year data collection of the first 10 patients after ankle spacer implantation

Conditions: Osteochondritis Dissecans

Summary: osteochondral defects (ocd) of the talus are pathologic lesions of the talar cartilage and its subchondral bone and might severely deteriorate the quality of life. for the treatment of multiple and/or large talar ocds and in patients with failed previous surgical treatment the ankle spacer was developed. six patients are included in a prospective clinical and radiological study with a follow-up of two years.

one surgeon in the investigator's center implanted 10 ankle spacers between april 2018 and october 2020. the average age was 41.7 years (20 - 70 years). all patients get a standard followed-up at 6 weeks, 12 weeks. after the first four patients, all following patients are enrolled in a prospective study and where followed up after 1 and 2 years additionally. the american orthopaedic foot and ankle society (aofas) score, the foot and ankle outcome score (faos), the european foot and ankle score (efas), the visual analogue scale (vas) for pain are collected. radiographic parameters such as implant loosening, cystic changes, lateral/medial prominence of the implant, congruency to the talar rounding, progression of osteoarthritis or bone ware of the tibia plafond are recorded. the ankle spacer is a one-piece implant system that replaces the articulating upper talus surface of the tibio-talar joint, and offers several implant sizes in order to fit to the different talus sizes. it is anatomically designed to the native upper talus surface to provide an optimal fit to the distal articular surface. it has a rough titanium plasma spray (tps) coated under surface with two posts and spikes for implant fixation. the rough surface enables secondary fixation by means of bone ingrowth and the spikes at the posterior part of the prosthesis allowing for optimal adherence of the implant and for minimal iatrogenic damage upon fixation. by these means, the anatomical situation and the natural congruency of the ankle joint are mirrored to an optimal extent.

Eligibility criteria:
inclusion criteria: * women and men aged 18-80 years * indication for implantation of the ankle spacer exclusion criteria: * florid infections * relevant circulatory disorders on the affected leg * malposition of the osg (upper ankle joint) greater than 5 ° varus or valgus * fractures of the osg or near the ankle that were less than 6 months ago * obesity with a bmi greater than 30 kg / m2 * known insulin-dependent diabetes mellitus * known rheumatoid arthritis * osteoarthritis of the osg ii ° or higher according to kellgren / lawrence * deformation of the osg, which does not allow implantation of the ankle spacer

Keywords: osteochondral defects (ocd) of the talus ankle spacer osteoarthritis of the ankle joint
the ability of peripheral perfusion index to detect changes of hemodynamics in patients with pacemaker

Conditions: Pacemaker Dependence

Summary: pacemakers are widely used in postcardiotomy patients to avoid severe arrhythmia. the peripheral perfusion index (pi) has been considered as an effective parameter evaluating the circulation. in this study, investigators aim to avaluate the ability of peripheral perfusion index to detect changes of hemodynamics in postcardiotomy patients with pacemakers.

pacemakers are widely used in postcardiotomy patients to avoid severe arrhythmia. the peripheral perfusion index (pi) has been considered as an effective parameter evaluating the circulation. in this study, investigators aim to evaluate the ability of peripheral perfusion index to detect changes of hemodynamics (cardiac output or storke volume,et al) in postcardiotomy patients with pacemakers.

Eligibility criteria:
inclusion criteria: * age \>=18 years old; * postcardiotomy * placement of temportary pacemaker during the surgery * dependence of pacemaker (abscence of autonomic cardiac rhythm） exclusion criteria: * hemodynamic unstable （high dose of vasoactive drugs） * fingers ischemia, cannot monitor the peripheral perfusion index

Keywords: peripheral perfusion index cardiac output stroke volume
decompressive craniectomy following trauma

Conditions: Head Injury Trauma

Summary: a prospective clinical trial on trauma patients with increased intracranial pressure(icp) applied for decompressive craniectomy to lower icp

traumatic brain injury (tbi) remains a major health problem across the globe . intracranial pressure (icp) following tbi can be elevated due to increasing mass effect from hematomas, contusions, and diffuse brain swelling. decompressive craniectomy (dc) is a surgical procedure which involves removing a large part of the skull (bone flap) out to make more room for the swollen brain.mass lesions can be acute subdural hematoma (asdh), intraparenchymal, brain oedema, or a combination thereof. the most frequent indication for a dc is an acute subdural hematoma (asdh). the first modern use of dc following tbi was done by harvey cushing in 1908. cushing treated head-injured patients with a subtemporal dc and he reported a substantial reduction in mortality. the management of tbi progressed significantly in the 21st century due to advances in neuroimaging, prehospital management, neurointensive care, neuroanaesthesia, and rehabilitation. this led to a renaissance of interest in dc for improvement patient conditions. one of the serious concerns regarding dc is that it may reduce mortality, but increase the subset of patients with severe disability and persistent vegetative state. the discrepancy in published outcome may, to some extent, be explained by difference in patient selection, indications, timing , and technique of surgery. in terms of surgical consideration regarding dc, it is now well accepted that the dura mater has to be opened and the minimum diameter of unilateral dc should be around 11-12 cm. skull reconstruction (cranioplasty) after improvement of neurological state is recommended. decompressive craniectomy provides additional space for the swollen brain and can effectively reduce icp, thereby mitigating the risk of herniation. however, despite the positive effect of dc on uncontrollable intracranial hypertension, the effect of surgical decompression in mortality and overall functional outcome following tbi remained controversial.

Eligibility criteria:
inclusion criteria: * all patients with signs of increased intracranial tension (subdural hematoma, brain edema, intracerebral hematoma) after trauma diagnosed clinically, radiologically, and resistant to medical decompression. * age: up to 60 * midline shift more than 5 mm. * gcs \> 8 exclusion criteria: * age: more than 60 * old trauma * unfit for surgery (ex: cardiac patient) * gcs \< 8 * midline shift less than 5 mm. * unwillingness to participate in the study.
sphenopalatine ganglion block versus occiptal nerve block in treatment of post dural puncture headache

Conditions: Headache

Summary: postdural puncture headache (pdph) is a common complication associated with neuraxial anesthesia and diagnostic lumbar puncture (lp). pdph is defined as a bilateral headache that develops within 7 days and disappears within 14 days after the dural puncture with a distinct postural quality. pdph causes significant short-term disability, prevents ambulation and care of the newborn (in obstetrics), and results in a prolonged hospital stay.

the sphenopalatine ganglion (spg) is an extra-cranial neural structure located in the pterygopalatine fossa that has both sympathetic and parasympathetic components as well as somatic sensory roots. the trans-nasal approach is a low risk, noninvasive technique that is easily performed and could potentially be beneficial in the treatment of pdph through blocking the parasympathetic ﬂow to the cerebral vasculature through the sphenopalatine ganglion which will allow the cerebral vessels to return to normal diameter and thus relieve the headache. the greater occipital nerve contains sensory fibers from c2 and c3 segments of medulla spinals. it arises from the dorsal ramus of c2 segment, contains a thin branch from c3 segment, and innerves the medial aspect of posterior scalp up to the anterior aspect of vertex. greater occipital nerve block (gonb) inhibits the pain sensation of this region. there is some evidence to suggest the effectiveness of gonb in the management of pdph. nowadays, guidelines for the management of pdph were modified and included gonb as a part of standard management of pdph. * dexamethasone possess potent antiinflammatory and immunosuppressive actions by inhibiting cytokine-mediated pathways. * many providers believe that the local anesthetic produces the rapid onset of headache relief, like an abortive agent, and that the locally acting steroid produces the preventive like action of up to 6 weeks.

Eligibility criteria:
inclusion criteria: asa i-ii patients undergoing elective cesarean section requiring spinal anesthesia, who developed pdph during hospitalization or within days of the intrathecal block. exclusion criteria: * patient refusal. * any contraindication to regional block (coagulopathy or anticoagulant therapy). * local scalp infection. * nasal polyp, trauma, septal deviation or any nasal pathology. * allergy to local anesthetics. * pregnancy induced hypertension. * history of major psychiatric disorders. * chronic headache. * substance abuse. * current opioid use.