Kornimate/medical-research-clean huggingface dataset:
anatomical shoulder™ fracture pmcf study

Conditions: Fracture

Summary: the purpose of this study is to obtain outcomes data on the anatomical shoulder fracture system by analysis of standard scoring systems and radiographs. outcome data will be collected using the following standard scoring systems: - constant and murley score

this is a multi-centre, non-comparative, prospective post-market surveillance study involving surgeons skilled in shoulder replacement surgery. each case enrolled will receive an anatomical shoulder fracture implant. all system components are ce (conformité européenne)-marked and commercially available. patients will be selected according to the subject selection criteria. all patients will undergo pe-operative, intra-operative and post-operative physical examination, radiographic evaluation according to the hospital's routine procedure and collection of quality of life metrics. follow-up evaluations are to be conducted at 6-12 weeks (x-rays only), at 6 months and annually thereafter for a minimum period of 5 years post hospital discharge. follow-up evaluation at 10 years post hospital discharge is optional.

Eligibility criteria:
inclusion criteria: * age - 18 years minimum. * sex - male and female. * general health - the patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history. * informed consent - patient or patient's legal representative has signed a 'patient informed consent form'. * indications - diagnosis of trauma in the affected joint with the indication for shoulder hemiarthroplasty. exclusion criteria: * patient is skeletally immature. * patient is pregnant. * patient is unwilling or unable to cooperate in a follow-up program. * patient is planned for a bilateral shoulder replacement. * patient shows one or more of the following medical conditions: * pathological fracture * active infection * patient requires one or more of the following medical interventions: * revision surgery (non-union) * inverse fracture prosthesis

Keywords: fracture shoulder arthroplasty three or four part fracture hemiarthroplasty multi-center europe non-controlled anatomical reconstruction proximal
pulmonary hypertension in interstitial lung disease

Conditions: Pulmonary Arterial Hypertension; Diffuse Interstitial Lung Disease

Summary: hypid study is an observational and prospective study of patients with interstitial lung disease and pre capillary hypertension diagnosed by right heart sided catheterization. the primary aim of the study is to identify prognostic factors.

pre capillary pulmonary hypertension (ph) may be present in patients with diffuse interstitial lung disease. in this context, ph represents an important factor of morbidity and mortality for these patients. one of the purposes of hypid is to determine predictive factors of mortality within this cohort of patients. in order to reach that aim,the study includes an evaluation based on exams conducted for the routine follow-up of patients. each patient will be followed during 2 years at least.

Eligibility criteria:
inclusion criteria: * pre capillary pulmonary hypertension at right heart sided catheterization with: mpap \> or = 25 mmhg,pcwp \< or = 15 mmhg * interstitial lung disease with diffuse infiltrative opacities on chest ct scan exclusion criteria: * pulmonary hypertension related to a thromboembolic disease * respiratory disease other than diffuse interstitial lung disease * any etiological factor of pulmonary arterial hypertension based on dana point classification other than diffuse interstitial lung disease * any progressive disease associated to a life expectancy less than 6 months other than pulmonary hypertension, diffuse interstitial lung disease and respiratory insufficiency

Keywords: pulmonary arterial hypertension, interstitial lung disease at hrct
correction of ear deformities in newborns by modeling, comparison of two protocols

Conditions: Ear Malformation

Summary: evaluation of the non-inferiority of the custom-made device developed in the maxillofacial surgery department of caen university hospital compared to the device from the earwell™ group


Eligibility criteria:
inclusion criteria: * newborn, age between 8 days and 1 month * newborn with ear malformation exclusion criteria: * total chondrocutaneous agenesis of the ear * polymalformative syndrome * age greater than 4 weeks * parental refusal
weight management for the remission of type 2 diabetes using a proprietary meal replacement system- diabetes remission study (drs)

Conditions: Obesity; Diabetes Mellitus, Type 2

Summary: a three month meal replacement dietary system which combines meal replacements and self-prepared meals which hypothetically will result in diabetes remission in \>30% of intervention subjects to assess the efficacy of which patients with type 2 diabetes (non insulin dependent) can be brought into a optimal a1c remission state without the use of medications by achieving clinically significant weight loss (\>20-30 pounds) using a proprietary meal replacement system associated with a 3-month intensive lifestyle program.


Eligibility criteria:
inclusion criteria: * men and women * ages 25-65 * have been diagnosed with non-insulin dependent diabetes for less than five years * are taking at least one oral agents for diabetes * english speaking exclusion criteria: * individuals currently being treated for cancer * had a myocardial infarction in the previous 3 months * have uncontrolled persistent hypertension - diastolic \>90 systolic \>160 * individuals with established eating disorder diagnoses * individuals who have recent weight loss attempt in the last 3 months with \> 5-pound loss * use of anti-obesity medications in the last three months * individuals who have had bariatric surgery * individuals taking medications that are known to cause weight gain including but not limited to insulin, steroids, haloperidol clozapine, risperidone, olanzapine, amitriptyline imipramine, paroxetine, and lithium * individuals who are pregnant or planning to become pregnant in the next 6 months

Keywords: obesity diabetes, type 2 meal replacement diabetes remission
use of muscle ultrasound to predict function

Conditions: Spinal Cord Injury

Summary: establish if change from the baseline in ultrasound muscle parameters over 2 months of rehabilitation correlates with functional status of sci patients at the end of rehabilitation

rehabilitation is the key to ambulatory recovery in patients with spinal cord injury, although only 25% of patients regain this ability despite current rehabilitation protocols. there is emerging evidence that intensive and prolonged rehabilitation, though costly and manpower intensive, may result in ambulatory recovery in patients previously thought to be non-ambulant. however, there are no suitable clinical biomarkers which can identify these group of patients who will benefit from this intervention. hence the aim is to establish if change from the baseline in ultrasound muscle parameters over rehabilitation correlates with functional status of sci patients.

Eligibility criteria:
inclusion criteria: 1. first ever acute sci 2. age 21-65 years 3. presence of weakness in the lower limbs (defined as either asia a, b, c or d) 4. independent in ambulation prior to onset of sci 5. able to understand study procedures and sign informed consent 6. clinical suitability for rehabilitation exclusion criteria: 1. presence of premorbid lower musculoskeletal conditions eg contractures, fractures, previous operations, that prevents proper ultrasound assessment of the affected limb 2. cardiorespiratory conditions eg congestive cardiac failure (ef\<40%), chronic arrhythmias, copd stage 3-4 3. end stage illness, end stage renal failure, life expectancy \<6 months 4. other active neurological conditions 5. botulinum toxin injection over the past 3 months
cd8 minibody repeatability study

Conditions: Melanoma; Renal Cell Carcinoma

Summary: zr-89 crefmirlimab berdoxam is a zirconium-89 labelled minibody developed by imaginab for full body pet imaging of cd8+ cell distribution (cd8 immunopet). the primary objective of this study is to assess the test-retest repeatability of cd8 immunopet imaging in oncology patients with stable disease.


Eligibility criteria:
inclusion criteria: * aged 18 years and above * patients with at least one imageable primary or metastatic lesion \> 1 cm in the lymph nodes or soft tissue excluding bone on the most recent standard of care imaging done within the last 3 months * cohort 1: patients with melanoma on single or multiple agent immune checkpoint blockade (icb) therapy with stable response status following initiation of therapy. stable disease would be observed over at least 2 consecutive standard of care ct scans (usually done 8-12 weeks apart) after initiation of therapy. * cohort 2: patients with untreated renal cell carcinoma on active surveillance * women of child bearing potential must not be pregnant on study entry * participants must agree to follow contraceptive advice while on study and for 30 days after ending participation. exclusion criteria: * patients with uncontrolled infection or other concurrent malignancies or conditions that may confound interpretation of the scans in the opinion of the investigator * patients with urinary catheters or stoma bags * patients who have received a vaccine recently can be included to the study but can only be scanned after a washout period of 2 weeks after the vaccine. if participants have a vaccine after the first pet-ct scan, the second pet-ct scan will be delayed for at least 2 weeks after the vaccine * patients on steroids except those on replacement dose of steroids for adrenal or pituitary insufficiency. patients requiring steroids as therapy for an unresolved immune therapy related adverse event will be excluded * participants on immunosuppressive medication e.g. cyclosporine, azathioprine, janus kinase inhibitors * participant enrolled into another therapeutic intervention study * any other contraindication that makes the patient unsuitable to take part in the study in the opinion of the investigator * women who are pregnant or breast feeding * unable to provide informed consent
altropane® spect imaging in patients with parkinson disease

Conditions: Parkinson Disease

Summary: after a screening evaluation including baseline clinical laboratory testing, a physical and neurological evaluation, subjects will be asked to undergo an injection of altropane® followed by up to 60 minutes of serial dynamic imaging. subjects will undergo a second injection of altropane® followed by up to 60 minutes of serial dynamic imaging within 2-6 weeks of the injection 1.

the underlying goal of this open label imaging study is to optimize the imaging outcome for altropane® in mild to moderate pd subjects. all study procedures will be conducted at the institute for neurodegenerative disorders (ind) and molecular neuroimaging (mni) in new haven, ct. subjects with pd (n=15) will be recruited to undergo altropane® spect. all subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a physical and neurological evaluation. subjects will be asked to undergo an injection of altropane® followed by up to 60 minutes of serial dynamic imaging. subjects will be asked to undergo a second imaging visit two-six weeks following the initial imaging visit to assess the reproducibility of the imaging outcome. the imaging analyses will be performed by an image-processing specialist who will remain masked to clinical severity. the primary imaging outcome measure will be the brain regional distribution volumes expressed as a target region to occipital ratio. striatal regions of interests for caudate and putamen will be defined and placement standardized based on previously optimized region placement protocols. imaging data will also be analyzed using an automated objective striatal analysis software package.

Eligibility criteria:
inclusion criteria: * the participant is 30 years or older at time of pd diagnosis. * written informed consent is obtained. * participants have a clinical diagnosis of idiopathic parkinson's disease of \< 7 years. * hoehn and yahr stages i-iii. * negative drug screen exclusion criteria: * the participant has atypical or drug-induced parkinson's disease. * the participant has dementia. * the participant has a clinically significant clinical laboratory value and/or clinically significant unstable medical or psychiatric illness. * treatment within the six months prior to screening with bupropion, methylphenidate, reserpine, alpha methyldopa, or amphetamine. * the participant has a history of alcohol, narcotic, or any other drug abuse within the past 2 years. * the participant has received an investigational drug within 60 days of screening visit. * pregnancy

Keywords: parkinson imaging dopamine transporter
gait analysis in mps iva

Conditions: MPS IVA; Morquio Syndrome

Summary: the purpose of this study is to learn about gait (walking) characteristics in mps iva and possible changes in gait with enzyme replacement therapy.

the purpose of this 3-year study is to conduct a longitudinal investigation using motion analysis of gait to objectively and quantitatively assess gait characteristics of mps iva patients. data documenting gait characteristics and abnormalities will be gathered in patients initiating enzyme replacement therapy. inclusion criteria individuals with mps iva diagnosed by enzyme or molecular studies exclusion criteria individual with mps iva previously enrolled in bmn-110 individual is non-ambulatory the individual is unable to complete longitudinal study visits at least yearly

Eligibility criteria:
inclusion criteria: -diagnosis of mps iva exclusion criteria: non-ambulatory * previous enrolled in clinical trial bmn-110
assessing covert consciousness in unresponsive patients

Conditions: Consciousness Disorders

Summary: in this study, the investigators explore anesthesia as a tool for providing further insight into the level of consciousness of individuals with a clinical diagnosis of unresponsive wakefulness syndrome (uws), but who possess some neurophysiological signatures of conscious awareness. this group, who could potentially be conscious, will herein be referred to as the target population. our goal is to assess whether or not neurological patterns of consciousness in the target population respond to anesthesia in a similar manner to neurologically compromised individuals with known consciousness (e.g. those in minimally conscious state (mcs). in healthy controls, propofol-induced unconsciousness results in an elimination of the mismatch negativity event-related brain potential (erp) and a diminished directed connectivity. the investigators hypothesize that at doses well below those required for surgery, anesthesia will have similar effects on these neural patterns in neurologically compromised patients with the potential for conscious awareness, but will not affect these patterns in those who lack consciousness.


Eligibility criteria:
inclusion criteria: * patients admitted to the intensive care unit at hamilton general hospital who: * clinical status consistent with uws (no responsiveness to commands) * clinical status consistent with mcs (minimal response to at least one command) * presence of an endotracheal tube (ett) or a tracheostomy tube * between 18 and 50 years of age exclusion criteria: * • elevated intracranial pressure (icp) * hepatic or renal failure * hemodynamic instability * active vasopressor therapy * previous open-head injury * previous intracranial pathology requiring neurosurgical interventions in the past 72 hours * anticipated icu stay \< 24 hours * documented allergy to propofol * pregnancy * bmi \> 35 kg/m2 * anyone who is deemed medically unsuitable for this study by the attending intensivist * patients who are already in a medically-induced coma for intracranial hypertension or status epilepticus
study evaluating the efficacy of hydroxychloroquine and azithromycine in patients with covid-19 and hematological malignancies (hyacinthe)

Conditions: COVID19; Hematologic Malignancy

Summary: the primary objective of this phase 2, multicentric, placebo-controlled double-blind, randomized study is to evaluate the efficacy of the combination of hydroxychloroquine and azithromycine on the viral load drop at day 5 among patients with covid-19 and hematological malignancies.

the study will evaluate the effect of the combination of hydroxychloroquine and azithromycine versus placebo among 114 patients with covid-19 and hematologic malignancy. after randomization in 1:1 ratio, patients will receive either the study treatment or placebo : * patients enrolled in the experimental arm will receive hydroxychloroquine (200mgx3 tablets per day during 10 days) and azithromycine (500 mg at day 1 then 250mg per day during 4 days) * patients enrolled in the control arm will receive a placebo of hydroxychloroquine (3 tablets per day during 10 days) and a placebo of azithromycine (2 capsules at day 1, then 1 capsule per day during 4 days)

Eligibility criteria:
inclusion criteria: * 18 years or older patients * patient with hematologic malignancy who received or not hematopoietic stem cell transplantation * non severe covid-19 disease * pcr-confirmed covid-19 disease by a nasopharyngeal swab * life-expectancy related to the hematologic malignancy of at least 1 month * men or women of child-bearing potential accepting to use effective contraception during and until 8 months after the end of the study treatment exclusion criteria: * patients with severe form of covid-19 infection defined as the presence of crackles observed during clinical exam, associated with less than 94% oxygen saturation or patients with respiratory insufficiency on oxygen therapy or mechanical ventilation * previous treatment with hydroxychloroquine or azithromycine for covid-19 infection * qtc interval greater than 480 ms * hypersensibility to hydroxychloroquine or azithromycine * retinopathy * tgo or tgp geater than 5 x the normal upper limit * creatinine clearance lower than 30 ml/min * concomitant treatment that may lead to prolongation of the qt space * concomitant treatment with dihydroergotamine, ergotamine, cisapride or colchicine * known g6pd deficiency

Keywords: sars-cov-2 hematologic malignancy
safety and efficacy of momelotinib in subjects with polycythemia vera or essential thrombocythemia

Conditions: Polycythemia Vera; Essential Thrombocythemia

Summary: this open-label study is to determine the safety and efficacy of momelotinib in participants with either polycythemia vera (pv) or essential thrombocythemia (et) who have not yet received treatment with a janus kinase (jak) inhibitor.


Eligibility criteria:
inclusion criteria: * diagnosis of either pv or et as defined by the 2008 world health organization (who) diagnostic criteria * requires treatment for pv or et, in the opinion of the study investigator * intolerant of, resistant to, or refuses current or available treatment for pv or et * direct bilirubin ≤ 2.0 x upper limit of the normal range (uln) * aspartate transaminase (ast) and alanine transaminase (alt) ≤ 3 x uln * calculated creatinine clearance (crcl) of ≥ 45 ml/min * life expectancy \> 24 weeks * male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception * females who are nursing must agree to discontinue nursing before the first dose of study drug * able to comprehend and willing to sign informed consent form exclusion criteria: * prior splenectomy * uncontrolled intercurrent illness, per protocol * known positive status for human immunodeficiency virus (hiv) * chronic active or acute viral hepatitis a, b, or c infection, or hepatitis b or c carrier * myeloproliferative neoplasm-directed therapy, other than aspirin, hydroxyurea, anagrelide, and/or phlebotomy, within 21 days prior to the first dose of study drug * anagrelide within 7 days prior to the first dose of study drug * presence of peripheral neuropathy ≥ grade 2 * unwilling or unable to take oral medication * prior use of a jak1 or jak2 inhibitor * use of strong cyp3a4 inducers within 1 week prior to the first dose of study drug * qtc interval \> 450 msec, unless attributed to bundle branch block

Keywords: polycythemia polycythemia vera essential thrombocythemia thrombocytosis myeloproliferative disorders bone marrow diseases hematologic diseases blood coagulation disorders blood platelet disorders hemorrhagic disorders
the relationship between serum levels of angiogenin, bfgf, vegf and ocular involvement in patients with behçet's disease

Conditions: Behçet's Disease

Summary: objectives: behçet's disease (bd) is a systemic vasculitis. since vascular endothelial dysfunction plays a prominent role in the pathogenesis of the disease, we considered angiogenic cytokines as an interesting target for investigation in bd. the aim of this study was to investigate the possible role of angiogenin, vascular endothelial growth factor (vegf) and basic fibroblast growth factor (bfgf) in the pathogenesis of bd. design and methods: sixty five patients with bd and 21 healthy control subjects were included in the study. serum angiogenin, bfgf and vegf concentrations were determined by using in vitro enzyme immunoassay (elisa) kits according to the manufacturer's instructions.


Eligibility criteria:
inclusion criteria: * age between 18-65 * fulfilling the international diagnostic criteria for behçet's disease exclusion criteria: * to have another systemic disease

Keywords: angiogenin, behçet's disease, bfgf, vegf