Kornimate/medical-research-clean huggingface dataset:
constraint induced movement therapy for walking in individuals post stroke

Conditions: Stroke

Summary: to compare the effect of constraint induced movement therapy (cimt) vs. treadmill training only on walking function in individuals post-stroke, a 6 week, single-blind, randomized training study will be conducted with three assessments of gait to determine the training effect. subjects will be randomized to either the cimt or treadmill training only groups at the initial test. following the initial test, individuals from the 2 groups will undergo intensive locomotor training. training will be performed 3 times per week for 6 weeks with the training time for each visit set to 45 minutes as tolerated. data collection will proceed until 36 subjects from 2 groups have been trained.

to determine the effect of constraint induced movement therapy (cimt) on locomotor function in individuals post stroke. in order to compare the effect of cimt vs. treadmill training only on walking function in individuals post-stroke, a 6 week, single-blind, randomized training study will be conducted with three assessments of gait to determine the training effect. subjects will be blocked by gait speed into slow (\< 0.4 m/s) or fast (≥ 0.4 m/s) subgroups and randomized to either the cimt or treadmill training only groups at the initial test. following the initial test, individuals from the 2 groups will undergo intensive locomotor training. training will be performed 3 times per week for 6 weeks with the training time for each visit set to 45 minutes as tolerated, excluding set up time. data collection will proceed until 36 subjects from 2 groups have been trained.

Eligibility criteria:
inclusion criteria: 1. age between 21 and 75 years; 2. history of unilateral, supratentorial, ischemic or hemorrhagic stroke; 3. no prior stroke; 4. demonstration of impaired walking function (self-selected walking speed ≤ 0.80 m/s); 5. able to stand and walk (\>10 meters) without physical assistance. exclusion criteria: 1. significant cardiorespiratory/metabolic disease; 2. other neurological or orthopedic injury that impairs locomotion; 3. scores on the mini mental status examination \< 24; 4. stroke of the brainstem or cerebellar lesions; 5. uncontrolled hypertension (systolic \> 200 mm hg, diastolic \> 110 mm hg); 6. botox injection within 6 months of starting the study.

Keywords: stroke, locomotion
skippain - speed of onset of secukinumab-induced relief from pain in patients with axial spondyloarthritis

Conditions: Spondyloarthritis

Summary: the purpose of the study was to evaluate the efficacy and safety of secukinumab 150 mg compared to placebo in the early management (baseline to week 8) of spinal pain, disease activity, fatigue, and predictability of disease flares in patients with axial spondyloarthritis (axspa) who had an inadequate response to prior non-steroidal anti-inflammatory drugs (nsaids). this study also explored the efficacy and safety of secukinumab 300 mg compared to secukinumab 150 mg from week 8 to week 24 in order to assess the potential additional benefits of dose escalation in patients with axspa.

the study consisted of 2 treatment periods: a double-blind, placebo-controlled period from baseline to week 8 (treatment period 1) and a double-blind secukinumab treatment period from week 8 to week 24 (treatment period 2). at baseline (treatment period 1), patients were randomized in a 3:1 ratio to either secukinumab 150 mg (group a) or placebo (group b). at week 8 (treatment period 2), patients were re-randomized and re-assigned respectively to 1 of 5 treatment arms to receive either secukinumab 150 mg or secukinumab 300 mg. patients assigned to secukinumab 150 mg (group a) at baseline who were responders (i.e. spinal pain score \< 4) at week 8 continued on the same dose until week 24 under 1 treatment arm (arm a1). patients assigned to secukinumab 150 mg at baseline who were non-responders at week 8 were re-randomized to 1 of 2 treatment arms: secukinumab 150 mg (arm a2) or secukinumab 300 mg (arm a3) from week 8 to week 24. similarly, patients assigned to placebo (group b) at baseline were re-randomized to 1 of 2 treatment arms: secukinumab 150 mg (arm b1) or secukinumab 300 mg (arm b2) from week 8 until week 24.

Eligibility criteria:
key inclusion criteria: * diagnosis of axial spondylarthritis (axspa, either ankylosing spondylitis or non radiographic axial spondylarthritis) according to asas axspa classification criteria * patients with back pain for at least 3 months and age of onset less than 45 years * active axspa as assessed by total basdai score of at least 4 at baseline. * spinal pain numeric rating scale score of more than 4 at baseline. * inadequate response to or failure to respond to at least 2 different nsaids at the highest recommended dose for at least 4 weeks in total prior to randomization key exclusion criteria: * chest x-ray or mri with evidence of ongoing infectious or malignant process * patients previously treated with any biological immunomodulating agents, except those targeting tumor necrosis factor alpha. * patients who have been exposed to more than one anti-tumor necrosis factor alpha agent. * active ongoing inflammatory diseases other than axial spondyloarthritis * other ongoing mechanical diseases affecting the spine.

Keywords: axial spondyloarthritis ankylosing spondylitis non-radiographic axial spondyloarthritis inflammatory back pain spinal pain secukinumab ain457
the effect of an asc-seeded collagen hydrogel on cerebrospinal fluid leak rates following skull base surgery

Conditions: CSF Leak

Summary: this project seeks to test whether a cell-seeded collagen hydrogel dressing can reduce csf leak after skull base surgery. normally, patients at risk for csf leak are treated with a commercial collagen matrix called duragen. in this study, our sterile, cgmp manufactured collagen hydrogel dressing will be seeded with the stromal vascular fraction (svf) mechanically isolated from lipoaspirate taken intra-operatively. this svf contains pro-regenerative adipose stem cells (ascs). the asc-seeded hydrogel will be used as a supplement to duragen to reinforce the skull base closure. the goal is to establish safety as well as to secondarily evaluate for effectiveness in reducing csf leak postoperatively.


Eligibility criteria:
inclusion criteria: * age \>/= 18 * planned for skull base surgery * able to understand and willing to sign a written informed consent form exclusion criteria: * active skull base infection * no plan for duragen repair by operating surgeon
effect of hypocalcemia on the outcome of elderly major trauma patients with trauma-induced coagulopathy

Conditions: Coagulopathy; Trauma

Summary: hypocalcaemia is an independent risk factor of tic in elderly trauma patients. tic combined with hypocalcemia had worse coagulation function and more serious acidosis.

this 5-year retrospective, observational, single-center study was conducted at the second affiliated hospital of zhejiang university medical school (sahzu, china). elderly patients with trauma were registered when they were admitted into intensive care unit affiliated to department of emergency medicine (eicu) since january 2015 and september 2020.the purpose of this study is to elucidate the effect of hypocalcemia on tic in elderly trauma patients through a single-center retrospective study, so as to further optimize the diagnosis and treatment strategies for tic in elderly trauma patients.

Eligibility criteria:
inclusion criteria: * age≥65 years old * history of trauma exclusion criteria: * previous anticoagulants or antiplatelet medication; * coagulopathy caused by previous underlying diseases; * blood products transfused before admission; * cardiac arrest on admission; * malignant tumor; * data incomplete

Keywords: trauma
trial to assess the efficacy of midostaurin (pkc412) in patients with c-kit or flt3-itd mutated t(8;21) aml

Conditions: Acute Myeloid Leukemia

Summary: to assess the efficacy of tyrosine-kinase inhibitor midostaurin in c-kit or flt3-itd mutated t(8;21) aml. to assess the efficacy of midostaurin depending on the type of c-kit mutation

aml patients displaying t(8;21) have a relatively favourable outcome. nevertheless, only approximately 50% of patients carrying this cytogenetic aberration are alive at 5 years. this suggests that some patients have more aggressive leukemic phenotypes and indicates the need for treatment optimization with novel therapies. the mutated kit gene as well as the flt3-itd mutation have recently been identified as factors most likely to explain the heterogeneous clinical outcomes within the group of t(8;21) aml. the flt3 and c-kit genes encode type iii receptor tyrosine kinases (rtk) with important and partly redundant functions in early hematopoietic stem cells. various activating mutations have been described for both genes. for c-kit, the incidence ranges from 17 to 48% depending on the source population and type of mutations determined. it has been consistently shown that in amls with t(8;21), mutated c-kit is associated with a dramatically increased risk of relapse and reduced overall survival compared to their unmutated counterparts. the flt3-itd mutation has a similar negative effect on prognosis in the patient group of t(8;21) mutated amls as c-kit. pkc412 (midostaurin) is known to inhibit the c-kit rtk activity as well as the flt3 kinase, both in patients with itd and tkd mutations. it should therefore be possible to abrogate the negative impact of pathologically increased c-kit or flt3-itd activity on relapse and overall survival by using midostaurin in this patient population. aim of the proposed clinical trial is to prove the efficacy of midostaurin in c-kit or flt3-itd mutated t(8;21)- amls in an open-label one-arm design.

Eligibility criteria:
inclusion criteria: * diagnosis of c-kit mutated t(8;21) aml i.e. 1. \>20% myeloid blasts in bone marrow and/or peripheral blood at initial diagnosis 2. plus cytogenetic diagnosis of aberration t(8;21)/aml1-eto 3. plus mutation of c-kit gene (mut-kit17 or mut-kit8) or flt3-itd mutation or both c-kit and flt3-itd mutations * chemoresponsive disease as determined by early bone marrow assessment on day 14-16 after first cycle of induction therapy with cytarabine in combination with daunorubicine or idarubicine, or mitoxantrone- fit for further intensive chemotherapy * age 18-65 years * ecog performance status of 0-2 * life expectancy of at least 12 weeks exclusion criteria: * primary refractory or previously relapsed aml * non-eligibility for high-dose cytarabine based consolidation, e.g. intolerance to cytarabine * inability to swallow oral medications * symptomatic congestive heart failure * bilirubin \>2.5 x upper limit of normal

Keywords: aml acute myeloid leukemia c-kit flt3-itd t(8;21) chemotherapy midostaurin
the viblok safety and performance trial

Conditions: HSV-2 Infection; Genital Herpes

Summary: genital herpes has a high prevalence in industrialized as well as developing countries. genital herpes causes genital ulcers, increases risk for acquiring hiv infection, and may be transmitted mother to child during birth with possible serious consequences. medical treatments and condoms only partially reduce the risk for transmission from/ to sexual partners. genital herpes transmission despite use of condoms is thought to be due to transfer via skin-to-skin contact in unprotected areas, and hsv-2 transmission may be enhanced by current shaving habits in the genital area leading to micro lesions (lacerations) of the skin. viblok™ is a cream designed to impede the passage of viruses, such as hsv-2, across the skin. bench and animal experiments indicate that it can block virus transmission such as hsv-2 over 80%. the objective of the safe trial is to assess the safety and performance of viblok in adults with hsv-2 infection by comparing virus detection in the extra-genital area before and after application of the barrier cream.


Eligibility criteria:
inclusion criteria: 1. participant is male or female and at least 18 years of age 2. hsv-2 seropositive by the uw western blot or alegria assay 3. history of recurrent genital herpes with at least 3 recurrences in the last year or, if currently on suppressive/ prophylactic therapy, prior to starting the therapy (antiviral therapy has to be stopped at least 7 days prior to initiation of the trial product). 4. general good health at the discretion of the investigator. 5. willing to not use any topical genital therapy aside from the study device for the duration of the trial. 6. willing to not use any systemic anti hsv therapy during the entire study starting 7 days prior to baseline. 7. willing to obtain 2 swabs from external-genital areas once daily for the duration of the trial. 8. willing to keep a daily trial diary during the treatment period. 9. negative pregnancy test for women at screening. 10. willing to use contraceptives for the duration of the study. 11. subject must be willing and able (in the opinion of the investigator) to understand the patient information and informed consent form and to comply with the clinical trial protocol and procedures. 12. subject must be willing to give written informed consent. exclusion criteria: 1. serious medical conditions, such as diabetes, significant autoimmune disease, cancer or immunosuppression, etc. that at the discretion of the investigator will likely affect study outcomes 2. treatment with systemic steroids or other immune-modulating agents 3. participation in any investigational drug or device trial within 30 days prior to screening. 4. pregnancy or breastfeeding, in case of women. 5. any other conditions that in the judgment of the investigator would preclude successful completion of the clinical trial.

Keywords: barrier cream
efficacy of sulphadoxine-pyrimethamine and artemisinin-containing combination therapy for malaria

Conditions: Malaria (Uncomplicated)

Summary: this is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (sp), which is the current national treatment of choice for uncomplicated malaria in tanzania, and a combination of sp and artesunate among children \< 5 years in 3 sites in rural tanzania. protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection

this is an ongoing monitoring activity of efficacy of sulfadoxine-pyrimethamine (sp), which is the current national treatment of choice for uncomplicated malaria in tanzania, and a combination of sp and artesunate among children \< 5 years in 3 sites in rural tanzania. protocol was amended in 2004 to (1) include lumefantrine+artemether, the newly identified first-line treatment for malaria to be introduced into tanzania in 2006; (2) on a limited basis, include adult patients; (3) extend follow-up to 28 days; (4) investigate whether treated bednets would reduce confounding by reinfection

Eligibility criteria:
inclusion criteria: children \< 5 years of age (in one site, patients of all ages are eligible). documented fever (axillary temperature \>= 37.5oc) in the absence of another obvious cause of fever or other serious or chronic medical condition unmixed infection with p. falciparum of between 2,000 and 250,000 asexual parasites/mm3 patients' or the patients' parent's or guardian's informed consent and willingness to participate in the study exclusion criteria: any evidence of severe malaria that would require hospitalization for treatment. reported allergy to any antimalarial drugs, including sulfa and artemisinin drugs. history of pregnancy or delayed menstrual period breastfeeding a child less than 8 weeks of age

Keywords: malaria sulfadoxine-pyrimethamine sulfadoxine-pyrimethamine plus artsunate lumefantrine plus artemether combination therapy
right-sided 1-hz repetitive transcranial magnetic stimulation (rtms) versus left-sided intermittent theta burst stimulation (itbs) in patients with depression

Conditions: Depression - Major Depressive Disorder; Depression Bipolar

Summary: aim: the purpose of the study is to establish the non-inferiority of right-sided inhibitory 1 hz stimulation compared to left-sided intermittent theta burst stimulation (itbs) in unipolar and bipolar depression. design: a national, non-inferiority, register-based, randomized trial, unmasked, with two treatment arms. primary objective: the primary objective is to determine if right-sided inhibitory 1-hz stimulation to dorsolateral prefrontal cortex (dlpfc) is non inferior to itbs in treating unipolar and bipolar depression by measuring reduction in montgomery-åsberg depression rating scale, self-assessed version (madrs-s) from baseline to end of treatment. secondary objectives: include testing for differences in: * observer rated response according to clinical global impression scale-improvement (≥2 point reduction cgi). * response to treatment (a decrease of 50% on madrs-s) * self-rated global health measured with the euroqual-group 5 dimensions scale visual analogue scale (eq-5d-vas). * drop-out from treatment. * stimulation site pain measured with the numerical rating scales (nrs). * adverse events. * admission and suicides within 6 months. * new treatment course of rtms or ect within 6 months * remission (score \< 11 on the madrs-s) * memory impairment measured with the comprehensive psychopathological rating scale (cprs). study population: patients with unipolar or bipolar depression. sample size: 350 patients. inclusion criteria: * at least 18 years of age at the time of inclusion. * a clinical diagnosis of unipolar or bipolar depression according to icd-10. * acceptance of rtms. * a swedish personal identity number. * capable of giving informed consent. exclusion criteria: • if the investigator judges one of the two treatment protocols inappropriate for the patient. inclusion time: 2025-07-01 to 2029-01-01


Eligibility criteria:
inclusion criteria: * at least 18 years of age at the time of inclusion. * a clinical diagnosis of unipolar or bipolar depression according to icd-10. * acceptance of rtms. * a swedish personal identity number. * capable of giving informed consent. exclusion criteria: • if the investigator judges one of the two treatment protocols inappropriate for the patient.

Keywords: rtms itbs repetitive transcranial magnetic stimulation randomized controlled trial intermittent theta-burst stimulation
esketamine on postpartum depression in cesarean section women

Conditions: Esketamine; Postpartum Depression

Summary: this study was to explore the preventive effect of esketamine on postpartum depression (ppd) in cesarean section, and to evaluate the safety of the drug

studies have shown that esketamine can treat clinical refractory depression, the drug takes effect quickly, can quickly eliminate the patient's suicide intention, low-dose maintenance treatment is conducive to the stability of the patient's condition, and less adverse reactions, is the current hot spot of antidepressant drug research. esketamine has been approved by fda for the treatment of refractory and suicidal depression, but can it effectively prevent and treat postpartum depression? it is not clear. based on this, this study aims to explore the preventive effect of prophylactic administration of esketamine on postpartum depression in cesarean section, and evaluate the safety of the drug.

Eligibility criteria:
inclusion criteria: * elective cesarean section; * 18-40 years; * primipara; * singleton pregnancy; * sign informed consent. exclusion criteria: * american society of anesthesiologists (asa) grade iii and above; * intracranial hypertension; * hypertension; * severe heart disease; * hyperthyroidism patients without treatment or insufficient treatment; * liver and kidney dysfunction; * preeclampsia or eclampsia; * mental disorder, mental retardation; * drug abuse and alcoholism; * contraindication of intraspinal anesthesia; * the preoperative epds score ≥10; * participated in other clinical studies.
a study of nivolumab in patients with head and neck cancer.

Conditions: Squamous Cell Carcinoma of the Head and Neck; Head and Neck Cancer; Head and Neck Carcinoma; Cancer of the Head and Neck

Summary: a prospective real world evidence study of nivolumab use in france in patient with recurrent or metastatic squamous cell carcinoma of the head and neck progressing on or after a platinum based therapy


Eligibility criteria:
inclusion criteria: * diagnosis of squamous cell carcinoma head and neck (scchn) patients progressing on or after platinum-based therapy. * diagnosis of scchn has been confirmed by histology or cytology (either at initial diagnosis or any time later during the course of the disease) * treatment decision to initiate a treatment with nivolumab for the first time for the treatment of scchn (according to the label approved in france) has already been taken exclusion criteria: * patients previously treated with nivolumab, ipilimumab, or any other antibody or drug specifically targeting t-cell co stimulation or immune checkpoint pathway. * patients currently included in an interventional clinical trial for their scchn. other protocol defined inclusion/exclusion criteria could apply
real world data study assessing the persistency of xalacom and the other fixed dose combination products, duotrav and ganfort, in the united kingdom

Conditions: Glaucoma; Ocular Hypertension

Summary: the hypothesis is that there is no difference in persistency between xalacom and the alternative fixed dose combination products (duotrav and ganfort) over a 12 month period.


Eligibility criteria:
inclusion criteria: * patients who had received a prescription for either xalacom, ganfort and duotrav * greater than 18 years old * diagnosed with glaucoma or ocular hypertension * registered at the primary care practice for \> 12 months exclusion criteria: * none

Keywords: real world observational retrospective database analysis
wibofa - validation of sct02 with ecg-app for detection of af

Conditions: Atrial Fibrillation

Summary: the aim of the study is to evaluate the performance of withings sct02 with embedded withings ecg-app in the automatic detection of atrial fibrillation


Eligibility criteria:
inclusion criteria: * male or female who are 22 years of age or older * subject able to read, understand, and provide written informed consent * subject willing and able to participate in the study procedures as described in the consent form * subject able to communicate effectively with and willing to follow instructions from the study staff exclusion criteria: * subject with an implanted electrical device (i.e. pacemaker, icd ...), whether active or inactive * pathologic disorders that may affect motricity resulting in significant hands tremor that prevents subject from being able to hold still (e.g. parkinson disease) * myocardial infarction (mi) within 90 days prior to the enrollment * pulmonary embolism or pulmonary infarction within 90 days prior to the enrollment * stroke or transient ischemic attack (tia) within 90 days prior to the enrollment * active or history of life-threatening rhythms as determined by investigators (e.g. ventricular tachycardia, ventricular fibrillation, 3rd degree heart block) * any cardiovascular disease that investigators would consider as a risk to subject or renders data uninterpretable (e.g. recent or ongoing unstable angina, decompensated heart failure, active myocarditis or pericarditis) * active or symptomatic skin disease on schiller electrode attachment sites or fingertips which would be in contact with beamo electrodes (e.g. eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis) * known sensitivity to medical adhesives, isopropyl alcohol,, electrocardiogram (ecg) electrodes, including known allergy or sensitivity to stainless steel (used in beamo electrodes).