Kornimate/medical-research-clean huggingface dataset:
performance evaluation of von willebrand:collagen-binding assays to diagnose von willebrand factor deficiency in patients with increased risk of bleeding

Conditions: Von Willebrand Disease

Summary: von willebrand disease (vwd) is defined as an inherited bleeding disorder that is caused by deficiency or dysfunction of von willebrand factor (vwf), a plasma protein that mediates the initial adhesion of platelets at sites of vascular injury and also binds and stabilizes blood clotting factor viii (fviii) in the circulation. the most severe forms of vwd are usually easy to diagnose (obvious hemorrhagic symptoms and major vwf deficiency), whereas the mild forms of the disease are still difficult to confirm. it is indeed reported that about 1% of the population carry mild biological vwf deficiency without any bleeding tendency and any "actual disease". on the contrary, some patients with severe bleeding history can carry a true vwf abnormality, well-confirmed by genetic studies, without any vwf deficiency when evaluated with standard biological methods, such as ristocetin cofactor activity (vwf:rco). however, in these patients, the use of alternative methods, such as pfa-100 (platelet fonction analyzer-100), the study of factor viii (fviii:c) to vwf (fviii:c/vwf) ratio or the evaluation of vwf activity using more specialized methods such as vwf:cb (vwf-collagen binding) assay can detect the vwf deficiency and possible hemorrhagic predisposition. in this project, the investigators plan to assess the performance of vwf:cb in the diagnosis of vwf deficiency in patients with unexplained bleeding history.


Eligibility criteria:
inclusion criteria: * patient with bleeding history sent to the hemophilia treatment center in dijon or nantes university hospital with abnormal bleeding score (\>3 in men and \>5 in women * patient who has provided a signed consent to participate at this study and for blood sampling * affiliation with french social security system non-inclusion criteria: * minors will not be included in the study. * on-going pregnancy and postpartum period (3 months after delivery) * substitutive treatment with coagulation factor concentrates or desmopressin administration within 10 days before sampling. * ongoing infectious or inflammatory disease that can modify vwf levels. * diagnosis of obvious hemostasis disorder

Keywords: willebrand factor deficiency hematology willebrand:collagen-binding
get-up trial: impact of an early out-of-bed paradigm in postoperative outcomes of chronic subdural hematomas

Conditions: Chronic Subdural Hematoma

Summary: compare rates of medical complications, recurrence and outcome in 2 randomized groups of patients with surgical chronic subdural hematomas. the intervention group will be assigned to early mobilization (within 12 hours of the surgical procedure). the control group will be assigned to bed rest for 48 hours.

at centro hospitalar do porto it is routinely used burr hole craniostomy with subdural drains and 48 hours of bed rest for the surgical treatment of chronic subdural hematomas. after 48 hours the subdural drains are removed and the patient is allowed to mobilize for the first time. the aim of the present study is to conduct a prospective, randomized, controlled trial with an early mobilization protocol vs 48 hours bed rest to determine the best strategy to reduce postoperative complications and improve functional outcomes. there will be 2 groups: * control group: bed rest 48 hours post-surgery with removal of subdural drains after this period. * intervention group: early mobilization protocol: as early mobilization as possible, within a maximum of 12 hours following surgery, with progressive autonomization in the ward as tolerated by the patient. mobilization time will be recorded. at the time of assuming an upright position the drains will be closed and will only be open again when the patient is in supine position (8 hours per day of supine position). subdural drains will be removed after 48 hours, similar to the practice in the control group. primary end-point: • number of medical complications. medical complication is defined as any occurrence which merits additional tests or, preferentially, requires any form of medical treatment. this includes respiratory infections, urinary infections, wound infections, meningitis, deep vein thrombosis, pulmonary embolism, cerebral infarction or hemorrhage, syncope, among others. secondary end-points: * recurrence rates. a recurrence is defined as any chronic subdural hematoma ipsilateral to that of the original hematoma if a surgical strategy needs to be pursued. * functional status (using both gos-e and mrs). timeframes considered will be pre-operative functional status, functional status at discharge, functional status at 3 months post-operative. * mortality rates. * recurrence free survival. * time to discharge.

Eligibility criteria:
inclusion criteria: * surgically drained chronic subdural hematomas (burr hole craniostomy) * \> or equal to 18 years old exclusion criteria: * previous neurosurgery * surgery for another pathology performed at the same time * \> 6h sedation post-surgery * any previous condition that makes early mobilization impossible

Keywords: chronic subdural hematoma bed rest early mobilization
management of malignant pleural effusions using an indwelling tunneled pleural catheter and non-vacuum collection system

Conditions: Malignant Pleural Effusion

Summary: in this study, the investigators will collect data on patients who are using the aspira system as part of their clinical care for the management of recurrent pleural effusion. data will be collected on patient demographics, placement of the pleural catheter, palliation of dyspnea, complication rates, and rates of spontaneous pleurodesis.


Eligibility criteria:
inclusion criteria: * male or female, at least 18 years of age, inclusive * subject has a symptomatic malignant pleural effusion requiring intervention. for an effusion to be defined as malignant, at least one of the following must be true * there is cytological confirmation of pleural malignancy * the effusion is an exudate (per light's criteria pleural fluid protein/serum protein \>0.5, pleural fluid ldh/serum ldh \>0.6, or pleural fluid ldh \>2/3 the upper limit of normal) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified * subject is able to provide informed consent * subject has sufficient pleural fluid to allow safe insertion of an indwelling tunneled pleural catheter as determined by the pi * subject is able to perform home drainage of the pleural effusion or has sufficient resources (family member, caregiver, home health). exclusion criteria: * subject is pregnant * subject has evidence, in the opinion of the pi, of either ongoing systemic or pleural infection * subjects with uncorrected coagulopathy
multifunctional cataract surgery assistive instruments used in cataract surgery

Conditions: Cataract

Summary: in order to better cope with complex situations of cataract surgery, we designed and improved a new set of multi-functional cataract surgery auxiliary devices, including ophthalmic surgery auxiliary hooks, eye retractor hooks and membranous cataract scissors. their common feature is that they have the function of 2-3 traditional surgical instruments, which can be switched in operations, reducing the replacement of different surgical instruments, lowing the number of surgical instruments in and out of the incision, reducing trauma and improving surgical efficiency. the purpose of this multi-center prospective clinical study is to verify the advantages of this new group of multifunctional devices and further summarize the experience and improvement by comparing the safety and effectiveness of traditional cataract surgical instruments combined with new multifunctional cataract assisted surgical instruments and traditional cataract surgical instruments alone.

cataract is the number one cause of blindness, and the main treatment method is surgery to remove the cloudy lens and install an intraocular lens. the operation relies on ophthalmic micromanipulative instruments, but in complex cases such as abnormal lens capsule, ocular trauma, etc., the difficulty of surgery increases, so that conventional instruments are often unable to complete the operation well. in order to better cope with these complex situations, we designed and improved a new set of multi-functional cataract surgery auxiliary devices, including ophthalmic surgery auxiliary hooks, eye retractor hooks and membranous cataract scissors, which have obtained utility model patents and first-class medical device filings. their common feature is that they have the function of 2-3 traditional surgical instruments, which can be switched intraoperatively, reduce the replacement of different surgical instruments, reduce the number of surgical instruments in and out of the incision, reduce trauma and improve surgical efficiency. the purpose of this multi-center prospective clinical study is to verify the advantages of this new group of multifunctional devices and further summarize the experience and improvement by comparing the safety and effectiveness of traditional cataract surgical instruments combined with new multifunctional cataract assisted surgical instruments and traditional cataract surgical instruments alone.

Eligibility criteria:
inclusion criteria: - clinical diagnosis of cataract patients need to undergo cataract surgery exclusion criteria: - active intraocular inflammation the intraocular pressure (iop) was higher than 25 mmhg the endothelial cell count (ecc) was less than 1,200 cells/mm2 combined with other eye diseases combined with other serious systemic diseases
a study to evaluate the my hematology oncology patient experience (myhope™) for multiple myeloma (mm) digital care network in patients with mm

Conditions: Multiple Myeloma

Summary: nds-mm-004 is a multi-center, randomized, pilot trial to evaluate the myhope for multiple myeloma (mm) platform in patients with mm. the myhope for mm platform is a validated investigational device manufactured by amalgam rx, inc. and designed to provide patients with a comprehensive set of tools and resources to support the patient throughout their overall experience with mm.


Eligibility criteria:
inclusion criteria: * patient is ≥ 18 years old with a diagnosis of multiple myeloma * patient must reside in the usa. * patients within each of the following subgroups, at one of the following timepoints, will be eligible for entry: 1. newly-diagnosed multiple myeloma transplant-eligible 2. patients undergoing their first asct 3. newly-diagnosed multiple myeloma transplant-ineligible 4. relapsed and/or refractory. exclusion criteria: * patient has a condition(s) that, in the opinion of the investigator, would make participation infeasible such as inability to provide informed consent, illiteracy, or inability to speak, read, and write in english. * patient is on hospice. * patient is receiving or has received an investigational agent \< 28 days prior to randomization or during this pilot study.

Keywords: digital health multiple myeloma myhope hematology oncology
safety and efficacy of actigraft treatment in wound care in medical centers

Conditions: Cutaneous Wounds

Summary: multicenter observational study to explore the efficacy of actigraft in the treatment of exuding cutaneous wounds in real-life usage.


Eligibility criteria:
inclusion criteria: * subject is ≥18 years of age * subject has an exuding cutaneous wound * subject agrees to the use of his health data, including photos of his wound in analysis and publications * subject/lar must be able to read and understand english and/or spanish exclusion criteria: * subject/lar is unable to read and understand english or spanish.

Keywords: dfu, pu, surgical, vascular, trauma
accuracy of endometrial volume measured by vocal versus office hysteroscopy for diagnosis of endometrial polyps

Conditions: Premenopausal; Metrorrhagia

Summary: endometrial volume will be assessed by 3dus and vocal and compared to the results of office hysterscopy to measure the abilty of this technique to diagnose endometrial polyps in women complaining of abnormal uterine bleeding. the safety of both procedures will be compared .


Eligibility criteria:
inclusion criteria: * age more than 20 years * patients with irregular vaginal bleeding exclusion criteria: * age less than 20 years * postmenopausal women * presence of uterine fibroids * causes of vaginal bleeding due to systemic pathology , anticoagulant use , patients on hormonal contraception or using intra uterine contraceptive device ( iucd ) .

Keywords: endometrial volume , vocal , endometrial , metrorrhagia
reboxetine for sleep apnoea after ent surgery

Conditions: Sleep Apnea, Obstructive

Summary: this pilot study will establish the feasibility of a larger trial to investigate whether reboxetine, a medication used to treat depression, can reduce the severity of obstructive sleep apnea (osa) including increased blood oxygenation in post-surgical osa patients where positive airway pressure (cpap) therapy is either frequently poorly tolerated or not an option immediately post surgery. in this randomized, placebo-controlled, double-blind study, participants will use at-home sleep monitoring equipment before and after surgery plus measures of oxygenation. they will be prescribed either reboxetine or a placebo for seven days after surgery and complete questionnaires at the beginning and end of the study.


Eligibility criteria:
inclusion criteria: * age \>18 years * undergoing elective upper airway surgery * history of obstructive sleep apnoea (osa) exclusion criteria: * clinically significant cardiac disease (e.g., arrhythmia, coronary artery disease, or cardiac failure) * history of clinically significant urinary retention, bladder outlet obstruction, or benign prostatic hyperplasia * poorly controlled hypertension * epilepsy * history of schizophrenia, schizoaffective disorder or bipolar disorder according to diagnostic and statistical manual of mental disorders-v or international classification of disease 10th edition criteria * history of attempted suicide or suicidal ideation within 1 year prior to screening, or current suicidal ideation * narrow angle glaucoma

Keywords: sleep apnea, obstructive upper airway surgery ent surgery reboxetine noradrenaline reuptake inhibitor randomised feasibility placebo double-blind
feasibility of assessing lymphoma response to precise local injection of candidate chemotherapy agents

Conditions: Lymphoma

Summary: many cancer patients are prescribed drugs to which their cancer is already resistant - and thus suffer toxicity with no potential for benefit. previous attempts to assess chemoresistance or sensitivity in vitro have failed. this is a feasibility study in human patients with newly diagnosed or recurrent lymphoma to determine how human cancerous lymph nodes in situ respond to standard of care therapeutics precisely microinjected with the civo(tm) microdosing system.


Eligibility criteria:
inclusion criteria: * 18 years of age or over * has enlarged lymph node(s) highly suspicious of lymphoma; or has been diagnosed with lymphoma but is untreated; or has persistent recurrent, or progressive lymphoma * at least one enlarged lymph node that is considered accessible for percutaneous injection by the investigator and that is at least 2 cm in longest dimension. * ecog performance status of 0-2 (or a karnofsky performance status of \>50%). * labs required for enrollment: absolute neutrophil count \> 1000/mm3, platelet count \> 50,000/mm3, hematocrit \> 25%, creatinine \<3.0 mg/dl, total bilirubin \<4.0 mg/dl, sgot and sgpt less than five times the institutional upper limits of normal. exclusion criteria: * lymphoma patients in which the delay of surgery until the lymph node resection date or other factors associated with the study are not feasible. * patients with central nervous system disease. * any therapy that is potentially immunosuppressive or has anticancer activity in the 4 weeks prior to device microinjection. * patients with active fungal, viral, or bacterial infections * pregnant women. * inability to give informed consent.

Keywords: personalized medicine in vivo drug sensitivity chemotherapy lymphoma microinjection
role of vitamin c at 6 months on incidence of complex regional pain syndrome type i in upper limb surgery

Conditions: Complex Regional Pain Syndrome (CRPS) TYPE I

Summary: vitamin c with its antioxidant role has many indications. the objective of this study is to demonstrate that taking vitamin c as a preventive significantly reduces the occurrence of complex regional pain syndrome (crps) type 1 in the aftermath of a scheduled surgery of the upper limb.

the preventive role of vitamin c on the development of crps type 1 was already demonstrated in traumatology and foot surgery. the management of crps type 1 is long and expensive. a preventive care seems beneficial. some studies already performed suggest a similar role in scheduled surgery of the upper limb, major provider of crps type 1.the aim of the study is to demonstrate a significant reduction of crps 1 when taking vitamin c during the perioperative period in upper limb surgery. it is a prospective, randomized, double-blind, with placebo use, in two parallel group, multicenter and national. patients are followed by their surgeon, under the terms of monitoring their disease. two visits are required: one at 6 months and at 12 months. the patients will be reviewed at least in the two consultations looking for crps type 1 according to the criteria of the international association for the study of pain (iasp)

Eligibility criteria:
inclusion criteria: * patients over 18 yo * patients undergoing major surgery of the upper limb * patients able to give their consent to follow the protocol of treatment and monitoring. exclusion criteria: * children, * patients under guardianship, * pregnant or lactating women, * patients with hemochromatosis, * allergy or known hypersensitivity to one of the molecules of treatment, * patients suffering or having already suffered from complex regional pain syndrome type 1 or type 2, * patients unable due to personal or professional mobility, to conduct post-operative follow up, * patients undergoing surgery with nerve suture with nerve graft, emergency surgery, * patients with glucose-6-phosphate dehydrogenase (g6pd) deficiency, * patients with chronic kidney disease

Keywords: vitamin c crps upper limb surgery
open-label of spn-820 in adults with major depressive disorder

Conditions: Major Depressive Disorder

Summary: this study will evaluate the efficacy and safety of spn-820 in adults with major depressive disorder (mdd)

this is an open-label, single-group study of adjunctive spn-820 in adults with mdd

Eligibility criteria:
inclusion criteria: * male or female subject, aged 18 to 65 years (inclusive) at screening. * diagnosis of mdd according to the diagnostic and statistical manual of mental disorders, 5th edition (dsm-5) for either recurrent or single episode mdd without psychotic features that is confirmed by the mini international neuropsychiatric interview (mini) at screening. * madrs total score of ≥22 for the current major depressive episode (mde) at screening and baseline (day 1) before sm administration. * cgi-s score of ≥4 (moderately ill or worse) at screening and baseline (day 1) before sm administration. * stable, therapeutic dose of one of the following protocol-defined adts for the current mde for ≥4 weeks prior to screening: citalopram, escitalopram, paroxetine, fluoxetine, sertraline, duloxetine, venlafaxine (immediate release or extended release), desvenlafaxine, vilazodone, levomilnacipran, vortioxetine, bupropion, or dextromethorphan/bupropion. * stable therapeutic dose of the approved adt throughout the study. exclusion criteria: * madrs total score improvement of ≥25% from the highest to the lowest score from screening to baseline. * clinically significant abnormal laboratory profiles, vital sign measurements, or ecgs prior to baseline. * history of psychotic disorder, including but not limited to schizophrenia, mdd with psychotic features, or bipolar i/ii disorder with and without psychotic features. * diagnosis within the last 12 months before screening or current diagnosis of ptsd, ocd, panic disorder, acute stress disorder, or has a history of intellectual disability, autism, or cluster a or b personality disorder. * suicidal behavior or suicidal ideation of type 4 or type 5 based on the c-ssrs in the 2 years before screening; a history of suicide attempt in the last 6 months; or more than 2 lifetime suicide attempts. * history of substance use disorder within 6 months prior to screening or is currently using or has a positive result (urine drug screen) at screening or baseline for drugs of abuse. * history of alcohol use disorder within 6 months prior to screening. * in the investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any other reason.
a registry study to assess photobiomodulation in dry age-related macular degeneration (eurolight) (eurolight)

Conditions: Dry Age-related Macular Degeneration

Summary: the eurolight study is being conducted to collect real life data for the safety and effectiveness of pbm in dry amd, in routine clinical practice both retrospectively and prospectively.

this is a multi-center, retrospective and prospective registry study on the use of the valeda® pbm system as a treatment for visual improvement in participants with dry amd. the target is at least 25 participants/site in up to 20 participating sites in europe. participants will or will have received nine non-invasive, short treatments over three to four weeks starting at baseline (bl), with up to five additional rounds of treatment every four to six months, or as determined by the investigator. standard visual outcome measurements collected will include visual acuity (either etdrs bcva or logmar) prior to and following treatment. oct and fundus autofluorescence (faf) imaging of the retina should be taken at screening, and after each round of treatment. as this is a registry study, missing

Eligibility criteria:
inclusion criteria: 1. diagnosis or confirmation of diagnosis of dry amd disease by investigator 2. able to communicate well with the investigator and able to understand and comply with the requirements of the study 3. informed of the nature of this study and has provided written, informed consent (participants enrolled retrospectively will need to be contacted and sign an informed consent form prior to their data being used). exclusion criteria: 1. signs of active, inactive or history of exudative macular neovascularization (mnv) 2. history or active accumulation of intra and subretinal fluid of any cause (e.g., diabetic macular oedema, central serous retinopathy, cystoid macular oedema) 3. use of any photosensitizing agent (e.g. topicals, injectables) activated by the valeda light deliver system within 30 days prior to treatment without consulting participant's physician 4. has any known photosensitivity to yellow light, red light, or near infrared radiation (nir), or has a history of light activated cns disorders (e.g. epilepsy, migraine) 5. in the opinion of the investigator, is unlikely to comply with the study protocol or has a history or current evidence of any condition that, in the opinion of the investigator, might interfere with the participant's involvement in the trial, or is not in the best interest of the participant.