Kornimate/medical-research-clean huggingface dataset:
fibular fixation in ankle fractures:plate verses nail.

Conditions: Distal Fibula Fracture

Summary: the primary objective of this study will be to evaluate the functional outcome of patients who present with a distal fibula fracture who were treated with either intermedullary nail (imn) fixation or plate fixation.

the primary objective of this study will be to evaluate the functional outcome of patients who present with a distal fibula fracture who were treated with either intermedullary nail (imn) fixation or plate fixation. this objective will be accomplished using the olerud-molander score, a commonly accepted functional outcome score used to evaluate patients post-operatively who have undergone foot and ankle procedures. it is a survey that evaluates patient reported outcomes including pain, stiffness, swelling, stair climbing, running, jumping, squatting, use of supports, and work/activities of daily living (adl) level. it does not involve physician-measured outcomes. the best possible score is a total of 100. patients will be given a form to complete throughout follow-up and be utilized for data analysis. functional outcome will be analyzed with regards to type of fracture, gender, cause of fracture, and affected side to determine if these factors are responsible for any difference.

Eligibility criteria:
inclusion criteria: * distal fibula fracture * pilon fractures * open fractures * ipsilateral foot exclusion criteria: * weber a distal fibula fractures * pathologic fractures
imt in hypercapnic patients with copd

Conditions: COPD

Summary: the overall objective of the study is to investigate the feasibility of home based inspiratory muscle training (imt) on chronic hypercapnia in patients with severe copd, and to examine the relationship between inspiratory muscle strength and carbon dioxide level.

the development of chronic hypercapnia in patients with copd indicates an imbalance of increased ventilatory work caused by hyperinflation and airway resistance and a decreased inspiratory muscle reserve, probably caused by diaphragm- dysfunction. the inspiratory muscle strength can be trained by a devise, which provides a resistance to inspiration. this study will be conducted as an a feasibility study and will examine whether inspiratory muscle training with a power breathe device (k3) is possible over a 6 week period in patients with copd and chronic hypercapnia (pco2 \> 6 kilo pascal). imt will be considered as feasible if 80% of the planned training sessions have been completed, and if the maximum inspiratory strength improves by an average of 10% from mip and if patients do not experience any discomfort or increased dyspnea during training. the training of the respiratory strength is carried out daily with an electronic handheld device (power breathe k3) and will consist of 2x30 inspirations per day with the resistance adjusted individually and progressively with a pressure of 30 - 50% of maximal inspiratory pressure. training will take place in the home.

Eligibility criteria:
inclusion criteria: * have the diagnosis copd with fev1 / fvc \<0.70 and fev1 \<50% * have elevated pco2 in stable phase assessed by arterial blood gas with pco2\> 6 kpa * have given informed consent * can understand written and oral instructions exclusion criteria: * patients are included in other projects with impact on the carbon dioxide level, e.g. home noninvasive ventilation treatment * patients using variable oxygenation rate that may affect the carbon dioxide level. * unstable patients and at high risk of exacerbation during the investigation period * hospitalized patient with copd exacerbation during the intervention period * patients with an expected need for change of copd medication or oxygen supply equipment in the study period. the participation in the study will be postponed if the patient is in a rehabilitation program

Keywords: hypercapnia physiotherapy inspiratory muscle training
uhr-oct and hd-oct for preretinal membranes: icg versus membrane blue

Conditions: Retinal Diseases

Summary: using the uhr-oct and hd-oct to evaluate early postoperative changes in patients with diagnosis preretinal membrane after successfully performed pars-plana vitrectomy and membrane peeling with two different types of dyes.

surgical procedures performed are pars-plana vitrectomy and membrane peeling with or without cataract extraction and iol implantation. the type of the dyes is randomized. the study is designed to include a total of tweny cases (10 cases with icg and 10 cases with membrane blue) main outcome measures are: uhr-oct, hd-oct distance and near visual acuity and contrast sensitivity amsler grid secondary outcome measures are: oct stratus 3000 and visual field. clinical examinations: preoperative, and follow-up examinations after 1 week, 1 months, 3 months, 6 months and 12 months.

Eligibility criteria:
inclusion criteria: * preretinal membrane * age between 18 and 85 years * combined surgery possible(phacoemulsification and vitreoretinal procedure) exclusion criteria: * age-related macular degeneration * previous retinal detachment surgery * previous laser treatment

Keywords: preretinal membrane vitrectomy uhr-oct hd-oct
acupuncture vs sham acupuncture for hand osteoarthritis

Conditions: Hand Osteoarthritis

Summary: the investigators plan to conduct this multicentered, sham-controlled randomized clinical trial to evaluate the efficacy and safety of acupuncture for clinical symptomatic improvement of hand oa.

symptomatic hand osteoarthritis (hoa) is estimated to affect 15.9% of women and 8.2% of men in the general population. since no therapy can completely cure hoa at present, alternative effective therapies are needed. acupuncture has been an effective treatment to alleviate pain and improve joint motion for patients with knee osteoarthritis according to a considerable amount of research. it is not surprised that acupuncture is effective in treating hoa in clinical practice considering the similar pathogenesis hoa shared with knee osteoarthritis. however, the research on the effects of acupuncture in patients with hoa is very limited. the present study aims to evaluate the efficacy and safety of acupuncture for hoa.

Eligibility criteria:
inclusion criteria: * diagnosed as hand oa according to the american college of rheumatology (acr) clinical classification criteria * history of hand oa for at least 3 months before enrollment and history of taking nonsteroidal anti-inflammatory drugs (nsaids) to treat hand oa * aged 18-80 years * at least 40 mm in visual analog scale (vas) on the average pain intensity of the dominant hand over the last 48 hours (patients applying nsaids at the screening have to have an increase in pain in the dominant hand of ≥ 20 mm after 1-week washout) * posterior-anterior radiographs of the dominant hand shows kellgren-lawrence grade 1, 2, or 3 changes in symptomatic joints * negative results in both rheumatoid factor and anticyclonic citrullinated peptide * able to comply with the study protocol and understand the medical information forms * voluntarily sign the informed consent exclusion criteria: * history or current evidence of secondary oa (due to causes other than a solely degenerative joint disease) or symptomatic oa at additional locations besides the hand(s) requiring treatment, or any painful syndrome of the upper limb which may interfere with evaluation of hand pain; * history of inflammatory arthritis (such as rheumatoid arthritis (ra) or psoriatic arthritis), hemochromatosis, metabolic, or neuropathic arthropathies; * history of trauma, dislocation or operation to the hand or arm in the previous 3 months; * hand pain and stiffness due to tissue scarring or tendinitis; * skin damage or serious skin disorders in the hands; * intake of antidepressants, anticonvulsants, vascular or narcotics during the 10 days prior to beginning the study; * oral, intramuscular, intra-articular or intravenous corticosteroids, or hyaluronic acid injection within 3 months preceding enrollment; * serious uncontrolled medical conditions such as cancer, uncontrolled cardiovascular disorder, severe hepatic/renal insufficiency or coagulation disorder; * known phobic to acupuncture or received acupuncture treatment within 4 weeks prior to enrollment.
effects of the bilateral mandibular nerve block (v3) in mandibular osteotomy

Conditions: Mandibular Fracture Trauma; Orthognathic Surgery; Maxillofacial Osteotomy

Summary: the sensory innervation of the face depends on the trigeminal (fifth cranial) which is divided into three branches, the mandibular nerve (v3) having motor fibers to the temporal and masseter muscle. the regional anesthesia of the face has grown in recent years for performing certain actions under light general anesthesia or sedation. the mandibular block is a simple and reliable technique but little used. yet it reduces postoperative pain sagittal osteotomy of the mandibular branch by reducing consumption of opioids and in the oropharynx cancer surgery. made with ropivacaine, known for its vasoconstrictive action, it also improves the visibility of the operative field during mandibular osteotomies reducing bleeding. despite a real clinical benefit (ease of implementation, latency and duration of action of the local anesthetic), the v3 block ropivacaine is not evaluated in the maxillofacial surgery.


Eligibility criteria:
inclusion criteria: * adult patients and patients from 15 to 18 years old * with mandibular trauma or orthognathic surgery * affiliated to a national insurance scheme * to have signed the informed consent of this study * physical status score 1-3 exclusion criteria: * allergy to local anesthetics * severe coagulopathy * hypovolemic patient * protected minor or major patients or in the incapacity to give his consent according to the article l1121-8 of the code of the health public. * pregnant or breast-feeding women according to the article l1121-5 of the code of the health public. * vulnerable people.

Keywords: mandibular nerve block mandibular osteotomy
the tearad study: tear biomarkers for alzheimer's disease (ad) screening and diagnosis

Conditions: Alzheimer Disease

Summary: the goal of this observational longitudinal study is to investigates whether tear fluid is a non-invasive source of biomarkers for alzheimer's disease. the main aim of the study is to evaluate diagnostic accuracy measures (sensitivity and specificity) of tear and retinal biomarkers to discriminate individuals with and without neurodegeneration. tear fluid from participants will be collected non-invasively with schirmer's strips, which is a small paper strip placed in the lower eye lid for a maximum of 5 minutes. additionally, standard, ultra-wide field and cross-sectional retinal images will be obtained.


Eligibility criteria:
inclusion criteria (healthy controls): * available csf, pet, ct or mri data to evaluate the presence/absence of neurodegeneration (preferably within 1 year of inclusion in this study) * absence of cognitive complaints or treatment and did not seek help for cognitive complaints in the past * mmse score 26-30 at baseline * age \> 50 years * available for follow-up (up to 24 months) * written informed consent obtained and documented inclusion criteria (patients): * available csf, pet, ct or mri data to evaluate the presence/absence of neurodegeneration (preferably within 1 year of inclusion in this study) * available for follow-up (up to 24 months) * written informed consent obtained and documented * capable of giving informed consent themselves (mmse score \> 17/30) exclusion criteria (all subjects): * ocular conditions that could influence tear biochemical parameters (including eye infection, eye inflammation, eye surgery within the last 28 days or other acute eye conditions) * neurological or systemic chronic conditions known to interfere with retinal thickness (e.g., glaucoma, diabetes mellitus) * ocular conditions interfering with optical coherence tomography (oct) quality/retinal thickness: e.g. severe cataract, age-related macular degeneration, and glaucoma

Keywords: tear fluid retinal imaging biomarkers
prevalence of abnormalities in ultrasonography of joint and tendons in patients with gout

Conditions: Gout

Summary: gout is the most frequent inflammatory arthritis in men after 40 years, with a prevalence of 0.9% in france. this disease is characterized by deposits of sodium urate crystals in joints, tendons and soft tissues, which can be detected by ultrasound examination. to date, there was no study assessing inflammatory, structural and deposit lesions due to gout in joints and tendons, since the standardization of ultrasound definitions of gout by the omeract (outcome measures in rheumatology) in 2015. the objective of this study is t estimate the prevalence and severity of ultrasound inflammatory lesions (synovitis, tenosynovitis, soft tissues abnormalities), structural lesions (osteophytes, erosions) and abnormalities due to sodium urate deposits (double contour, aggregates, tophi) in patients with gout.

gout is the most frequent inflammatory arthritis in men after 40 years, with a prevalence of 0.9% in france. this disease is characterized by deposits of sodium urate crystals in joints, tendons and soft tissues, which can be detected by ultrasound examination. to date, there was no study assessing inflammatory, structural and deposit lesions due to gout in joints and tendons, since the standardization of ultrasound definitions of gout by the omeract (outcome measures in rheumatology) in 2015. the objective of this study is t estimate the prevalence and severity of ultrasound inflammatory lesions (synovitis, tenosynovitis, soft tissues abnormalities), structural lesions (osteophytes, erosions) and abnormalities due to sodium urate deposits (double contour, aggregates, tophi) in patients with gout. this is a transversal bicentric study, including patients who consulted for gout in the rheumatology and internal medicine department of ambroise paré hospital. inclusion criteria were adult patients with a diagnosis of gout according to acr/eular 2015 criteria and able to give informed consent. exclusion criteria were the presence of other chronic inflammatory rheumatic diseases and patients without french social insurance. patients had clinical and ultrasound examination, realized by two physicians blinded from each other.

Eligibility criteria:
inclusion criteria: inclusion criteria were adult patients with a diagnosis of gout according to acr/eular 2015 criteria and able to give informed consent. exclusion criteria were the presence of other chronic inflammatory rheumatic diseases and patients without french social insurance. exclusion criteria: -

Keywords: gout ultrasound microcrystal disease
mirs03: paravertebral block with ropivacaine before breast cancer surgery

Conditions: Malignant Neoplasm of Breast

Summary: compare the effect of paravertebral block (pvb) with ropivacaine or placebo on the incidence of chronic pain 3 months after breast cancer surgery.

before anesthesia, the second or third intercostal space is located. after an aspiration, 0.35 ml/kg of solution (ropivacaine 7.5 mg/ml or saline, maximum 30 ml) are injected into the paravertebral space. after 30 minutes, spread of pvb is evaluated by cold test on skin. then, general anesthesia is induced. evaluation of the frequency of chronic pain at 3, 6 and 12 months by the brief pain inventory (bpi) questionnaire and neuropathic pain diagnostic (dn4) and anxiety and depression evaluation by the hospital anxiety and depression questionnaire (had) will be done.

Eligibility criteria:
inclusion criteria: 1. women with non-metastatic invasive breast carcinoma or breast carcinoma in situ treated by: * either breast-conserving surgery with axillary lymph node dissection * either radical surgery with or without axillary lymph node dissection. 2. 18 years ≤ age ≥ 85 years. 3. asa class 1, 2 or 3. 4. no analgesic treatment for 2 days (no pre-existing chronic pain) 5. if a biological control has been requested recently or deemed necessary by the investigator, then it should be satisfactory : adequate hematologic and hemostasis: neutrophil count (anc) \> 1500/mm3, haemoglobin \> 9 g/dl and platelets \> 75 000/mm3, prothrombin time \> 70%, activated partial thromboplastin time \< 1.5 x upper limit of normal (uln) 6. life expectancy ≥ 2 years. 7. signed informed consent form. 8. patient able to meet the self-assessments questionnaires (sufficient understanding assessments, proficiency in french) 9. patient affiliated with a health insurance scheme (beneficiary or legal) there is no prohibition for people to take part simultaneously in another search and there is no exclusion cause at the end of the research period. exclusion criteria: 1. ongoing neoplasm or history of malignancy other than breast cancer with the exception of: basal cell carcinoma, cervical carcinoma in situ, other treated cancer that has not relapsed during the 5 years preceding inclusion in the trial. 2. bilateral breast carcinoma at the inclusion 3. male subjects. 4. metastatic breast carcinoma at diagnosis (m1). 5. severe heart, liver and respiratory failure (asa 4) 6. allergy to local anesthetics and morphine. 7. use of analgesics during the 48 hours preceding the surgical procedure. 8. history of breast surgery with painful sequelae 9. major deformation of the spine 10. puncture site infection 11. history of substance abuse. 12. pregnant or lactating women, or women of childbearing potential without effective contraception 13. subjects deprived of their liberty or under guardianship (including temporary guardianship). 14. subjects unable to comply with medical follow-up of the trial for geographical, social or psychological reasons.

Keywords: surgery paravertebral block chronic pain
a bhi to increase hope level and stress level of parents with a cmc

Conditions: Child With Cancer; Muscular Atrophy, Spinal; Child With Cerebral Palsy; Endocrine System Diseases

Summary: being a parent of a child with medical complexity (cmc) poses an enormous stress because these cmc have a multisystem disease, a severe neurologic condition or cancer which may result in premature death. parents may feel challenged, lacking in confidence and high level of stress when managing their daily caregiving activities and child's new symptom. literature suggested that hope is believed to be the central agent in facilitating positive psychological change when parents are facing difficulties and feeling stress. brief hope intervention (bhi) is an alternative method considered to be feasible in improving parental hope level meanwhile, decreasing their stress level associated with daily caregiving activities. the purpose of bhi is to help these parents to develop workable goals, and concentrate on problem solving skill along with achievable planned actions in order to terminate the stressors associated from the caregiving activities. this proposed pilot randomized controlled trial will test the feasibility and preliminary effect of the bhi in term of increasing the level of hope meanwhile decreasing the stress level of parents with a cmc. eligibility, recruitment rates, and attrition rates will be collected in percentage to evaluate the feasibility of the study. content analysis will be adopted to analysis the qualitative feedback on the acceptability of bhi from the parents. a repeated-measures, two-group design will be used to evaluate the preliminary effects between intervention and wait-listed control groups by comparing brief hope intervention and wait-listed control groups receiving usual community care for 64 randomly selected parents over a 1-month follow-up. the outcome measures include parental hope and stress level. they will be measured before intervention, immediately after intervention and one-month after intervention. with positive outcomes found in this study, this intervention will be implemented in a larger scale to improve local psychological health service for parents with a cmc.


Eligibility criteria:
inclusion criteria: parents of a cmc will be recruited via the special schools for the children with physical disabilities. the eligible criteria for parents are 1. one of the parent of a child with medical complexity aged 5-18, 2. able to communicate in chinese and read chinese, 3. willing to participate in face-to-face activities and a telephone follow-up, 4. alert and oriented, able to sustain approximately 1 hour of attention and interaction, and 5. able to be reached by phone. exclusion criteria: parents are 1. a reported mental health disorder, 2. inability to communicate in cantonese, 3. engaging in other hope therapy related to stress relief and hope enhancement, and 4. severe hearing deficit that prevented them from engaging in phone communication.

Keywords: brief hope therapy parent children with medical complexity stress
efficacy and safety study of ibi-10090 in patients undergoing cataract surgery

Conditions: Inflammatory Reaction Due to Ocular Lens Prosthesis

Summary: this study will test the efficacy and safety of ibi-10090 for the reduction of ocular inflammation after cataract surgery.

all patients received active treatment in this study. dose group 1 received 114ug of dexamethasone, dose group 2 received 513ug and dose group 3 received 684ug.

Eligibility criteria:
inclusion criteria: * male or female patients 40 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation. exclusion criteria: * patients who have used any ocular, topical or oral corticosteroids within 7 days prior to day 0. * patients who have used topical ocular nsaids in the study eye within 15 days prior to screening. * patients with any signs of intraocular inflammation in either eye at screening. * patients who have received any prior intravitreal injections in the study eye.

Keywords: ocular inflammation cataract surgery post cataract surgery inflammation
diabase; diabetes mellitus registry in second care

Conditions: Diabetes Mellitus

Summary: this study aims to examine real world data from medical devices and clinical outcome from diabetes mellitus patients to gain the necessary insights to be able to improve individual patient care by building a registry.


Eligibility criteria:
inclusion criteria: * patients with type 1 or type 2 diabetes * patients aged 18 years or older * patients visiting the outpatient clinic internal medicine in the zgt hospital * written informed consent exclusion criteria: * severe general diseases or mental disorders making the participation in the study impossible
a study to see why patients agree to or decline to have treatment after surgery

Conditions: Cutaneous Melanoma

Summary: the purpose of this study is to find out what patients consider when deciding whether or not to receive adjuvant treatment, and how patients feel about their decision after one year.


Eligibility criteria:
inclusion criteria: * patients with stage iiib, iiic, iiid, or iv (ajcc, 8th edition) cutaneous melanoma rendered free of disease by surgical resection. * patients are being offered adjuvant nivolumab or pembrolizumab therapy * patient has not yet formally discussed their treatment options with their medical oncologist. * age 18 or older. * ability to speak and read english because we do not have the resources to translate materials into other languages. exclusion criteria: * patient not currently free of disease. * candidate for adjuvant dabrafenib/trametinib therapy. * patients who have received prior checkpoint inhibitor therapy.

Keywords: decline adjuvant immunotherapy agree to adjuvant immunotherapy nivolumab pembrolizumab 19-012