Kornimate/medical-research-clean huggingface dataset:
assessment of the effects of early proprioceptive stimulations in patients with spinal cord injury

Conditions: Spinal Cord Injuries

Summary: "spinal cord injury (sci) is a dramatic event resulting in a long-term handicap. appropriate care from admission to the intensive care unit (icu) is a key element not only for the survival of these patients but also to promote their recovery. moreover, the studies on natural history of sci have shown that most of the recovery occurs within the first 3 to 6 months post-injury. this period is therefore crucial for these patients. however, the environment of the icu and the acute condition of the patients limit the rehabilitation possibilities. in such a context, functional proprioceptive stimulations (vibramoov™ system, techno concept, france) could be a tool of interest. by using tendon vibrations, the vibramoov™ system allows to reproduce the proprioceptive signatures of cyclic movements such as walking. some studies have already demonstrated the benefits of proprioceptive vibrations. however, so far, these benefits have only been studied at the chronic stage of neurological diseases. the investigators hypothesized that early functional proprioceptive stimulations (fps) may reduce spasticity and promote sensorimotor recovery in tetraplegic and high paraplegic patients. to test their hypothesis, the investigators conduct a randomized controlled trial on 40 patients with traumatic sci. these patients will be stratified into two groups according to the completeness of their lesion. every patient will be included within ten days post-injury and receive either fps, either sham stimulations to the joints of the lower limbs, 4 times a week during 8 weeks. the primary outcome measures will assess spasticity. the investigators also assess sensorimotor recovery, pain, muscle wasting, cognitive impairment and functional status. "


Eligibility criteria:
inclusion criteria: * • traumatic spinal cord injury at or above level t6 * age ≥ 18 years old * no pregnancy * not being under guardianship * be affiliated to the french social security system exclusion criteria: * orthopedic lesions or any medical condition that prevent the implementation of the protocol within ten days post-injury * severe brain injury

Keywords: spinal cord injuries quadriplegia proprioceptive stimulation vibration spasticity intensive care units
improving the health and social participation of people with disabilities from underrepresented groups post covid

Conditions: Disabilities Multiple

Summary: this is a single-arm community-based feasibility study examining recruitment, retention, adherence, and satisfaction with engage, a community-based intervention designed to address pandemic-related social isolation among people with disabilities. we will also examine preliminary, within-group effects on social participation. the findings of this study will inform a larger trial to examine intervention efficacy.

social isolation has been shown to negatively affect physical and mental health, particularly among people with disabilities. social isolation among people with disabilities has been exacerbated by the covid-19 pandemic. even now, people with disabilities remain hesitant to return to social and community activities due to ongoing risk of severe cases and death. yet, we do not have strong models of intervention designed to address this problem. engage is an intervention that may address this gap. engage was designed to address social and community participation among people with stroke. we have since conducted qualitative research to inform adaptation of engage to meet the needs of a broader range of people with disabilities related to participation in the context of the ongoing covid-19 pandemic. this study is the next step in testing and refining the adapted intervention protocol. at the end of this study, we will have a finalized adapted intervention protocol ready for large-scale efficacy testing.

Eligibility criteria:
inclusion criteria: * self-identify as disabled * report problems with social participation * speak english * live in a community setting exclusion criteria: * severe communication impairment limiting ability to verbally indicate interest in participation
therapy of chronic cold agglutinin disease with eculizumab

Conditions: Cold Agglutinin Disease

Summary: evaluation of the efficacy and safety of eculizumab in symptomatic or transfusion-dependent patients with untreated or refractory hemolytic cold agglutinin disease(cad)


Eligibility criteria:
inclusion criteria: * individuals at least 18 years of age * diagnosis of cad defined by the combination of chronic hemolysis, cold agglutinin titer (igm or iga) \>64 at 4°c, positive direct antiglobulin test (dat) when performed with polyspecific antiserum, negative (or only weakly positive) anti-igg, and strongly positive with anti-c3d * ldh level \> 2 x upper limit of normal (uln) * clinical symptoms requiring treatment, such as anemia, anemia-related symptoms or hemolysis-related symptoms * sufficient supplementation of iron, folic acid and vitamin b12 prior to treatment phase * patient must be willing and able to give written informed consent; * patients must be vaccinated against n. meningitidis at least 14 days prior treatment * patient must avoid conception during the trial using a method that is most appropriate for their physical state and culture exclusion criteria: * active aggressive lymphoma requiring therapy or an active non-lymphatic malignant disease other than basal cell carcinoma or cis of the cervix * liver disease with elevated ldh * absolute neutrophil count \< 500/µl * presence or suspicion of active bacterial or viral infection, in the opinion of the investigator, at treatment start or severe recurrent bacterial infections * participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days prior to screening period * pregnant, breast-feeding, or intending to conceive during the course of the study, including the post-treatment phase * history of bone marrow/stem cell transplantation * inability to cooperate or any condition that, in the opinion of the investigator, could increase the patient's risk by participating in the study or confound the outcome of the study * hypersensitivity to eculizumab, to murine proteins or to one of the excipients

Keywords: cold agglutinin disease hemolysis eculizumab terminal complement inhibition
efficacy and safety of systemic treatments of bone metastases from kidney cancer in patients treated with targeted therapies

Conditions: Metastatic Renal Cell Carcinoma

Summary: multicenter, randomized, open-label, 2-arm, parallel-group, phase iii study whose goal is to assess the efficacy and safety profile of bone-targeted treatments (arm a: denosumab or zoledronic acid) versus the control arm (arm b: no specific treatment) in patients with bone metastases under targeted therapy for metastatic renal cell carcinoma.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * histologically proven mrcc. * administration of one of the systemic agents in use for the treatment of mrcc (no more than three prior systemic therapy regimens). patients with at least 6 months of 1st line treatment and a bone event may be included. * more than 1 bone metastasis. * eastern cooperative oncology group (ecog) performance status (ps) ≤ 2. * adequate renal function (serum creatinine ≤ 200 mmol/l or creatinine clearance ≥ 30 ml/min according to cockroft formula or mdrd formula for patients older than 65 years). * covered by a medical insurance. * willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. * signed informed consent. * accepting to use effective contraception during study treatment and within 5 months after final dose of study therapy. exclusion criteria: * prior bisphosphonate or denosumab treatment in the year before inclusion. * imminent or ongoing nerve or spinal compression as per the investigator's judgement. * ongoing first-line therapy, started for less than 6 months (patients with bm at time of metastases diagnosis will initially benefit from the angiogenesis targeted agents used and are not at higher risk). * anticancer treatment under investigation. * paraneoplastic hypercalcemia (corrected total calcium \> 2.7 mmol/l). * grade 4 toxicity under previous targeted agents. * liver failure (ast and/or alt ≥ 5.0 x upper limit of normal (uln) or total bilirubin beyond normal limits). * severe hypocalcaemia \> 2.8 mmol/l. * fructose intolerance. * invasive dental procedure (i.e. tooth extraction, dental implants, oral surgery) within the 10 days prior to randomization or required dental procedures at the pre-inclusion dental examination. * psychological, familial, sociological, geographical conditions that would limit compliance with study protocol requirements. * pregnant or breastfeeding woman. females of child-bearing potential must have a negative serum pregnancy test within 7 days prior inclusion. * life expectancy ≤ 3 months. * participation to another clinical trial that might interfere with the evaluation of the main criterion. * known hypersensitivity to the active substance or to any of the excipients of bisphosphonate or denosumab.

Keywords: bone metastases
rehabilitation for total knee replacement: a novel biofeedback system versus conventional home-based rehabilitation

Conditions: Knee Osteoarthritis; Arthropathy of Knee

Summary: the study was designed to test patient acceptance and system usability and to assess clinical outcomes of a home-based rehabilitation program using a novel kinematic biofeedback system in the rehabilitation after total knee replacement versus conventional rehabilitation, this system allows the patients to perform independent rehabilitation sessions at home, under remote monitoring from the clinical team. the investigators hypothesize that the system will be well received by patients and that the clinical outcomes will be at least similar those of conventional rehabilitation. this is a quasi-randomized controlled trial with active comparator. patients will be enrolled pre-operatively and divided into 2 groups: experimental group and conventional rehabilitation group according to geographical criteria. both groups will perform 8 weeks of rehabilitation starting between day 7 and 10 after surgery. the experimental group will perform daily rehabilitation sessions at home using the system, under remote monitoring from a physical therapist. the conventional rehabilitation group will perform 1h rehabilitation sessions 3 times a week, at home, given by a physical therapist. the following feasibility outcomes will be registered: enrollment rate, retention rate (drop-outs), compliance to the program, independence of use, need for therapist contact and patient satisfaction. clinical outcomes will be measured at weeks 4 and 8 and then at 3 and 6 months. the primary outcome will be measured in terms of patient performance in the timed-up-and-go (tug) test in comparison with the pre-operative score. secondary outcomes will be measured in terms of: b) knee osteoarthritis outcome score); c) range of motion of the knee joint.


Eligibility criteria:
inclusion criteria: * patients over 18 years old * clinical and imaging evidence of knee osteoarthritis * indication for total knee replacement according to the patient´s orthopedic surgeon * ability to walk unaided, with unilateral or bilateral support * availability of a carer to assist the patient after surgery exclusion criteria: * patients admitted for revision of total knee replacement * contralateral hip or knee osteoarthritis severely limiting patient mobility and ability to comply with a rehabilitation program * aphasia, dementia or psychiatric comorbidity interfering with the communication or compliance to the rehabilitation process * respiratory, cardiac, metabolic or other condition incompatible with at least 30 minutes of light to moderate physical activity * major medical complications occurring after surgery that prevent the discharge of the patient within 10 days after the surgery * other medical and/or surgical complications that prevent the patient from complying with a rehabilitation program * blind and/or illiterate patients
two-site intradermal influenza vaccination in elderly

Conditions: Influenza

Summary: one-site dose sparing intradermal influenza vaccination in elderly had been studied but resulted in unsatisfactory outcomes. the investigators evaluate the safety and immunogenicity of the two-site intradermal injection of influenza vaccine containing all 6 and 12 micrograms of hemagglutinin antigen per strain (with 4/10th and 8/10th of a regular 15 microgram ha/strain intramuscular vaccine respectively) in elderly over 60 years of age. an influenza vaccine administered intramuscularly at the standard dose is used as the reference vaccine.

the subjects would be randomly divided into three groups of 60 subjects each. group1 receives a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microgram of hemagglutinin antigen per strain, group ii receives two-site intradermal dose of 0.1 ml each, containing at least 3 microgram of hemagglutinin antigen per strain per site and group iii receives two-site intradermal dose of 0.2 ml each, containing at least 6 microgram of hemagglutinin antigen per strain per site. check for ha antibody

Eligibility criteria:
inclusion criteria: * healthy male or female volunteer aged at least 60 years old * willing to participate in this study exclusion criteria: * previous influenza vaccination within 6 months * systemic ypersensitivity to egg or chicken proteins or any of the vaccine components * history of a life-threatening reaction to the study vaccine or a vaccine containing the same constituents. * ongoing acute febrile illness (oral temperature, ≥37.5 c ) * congenital or acquired immunodeficiency * treatment with immunosuppressive or other immune- modifying drugs or cancer therapy within previous 6 months * long-term treatment with systemic corticosteroids * receipt of blood or blood-derived products in the previous 3 months * history of thrombocytopenia or a bleeding disorder contraindicating for intramuscular vaccination.

Keywords: influenza aged intradermal injection
al-54478 proof of concept study

Conditions: Open-angle Glaucoma (OAG); Ocular Hypertension (OHT)

Summary: the purpose of this study is to assess the safety and efficacy of al-54478 0.005% compared with latanoprost 0.005% and al-54478 vehicle in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * patients diagnosed with either oag or oht. * patients who are able to comply with the scheduled visits. * patients who have had a physical exam within 6 months of the screening visit. * other protocol-defined inclusion criteria may apply. exclusion criteria: * females of childbearing potential who meet any 1 of the following conditions: a) currently pregnant; b) positive urine pregnancy test; c)intend to become pregnant; d) breast feeding; e) not using highly effective birth control measures. * patients with extreme narrow angle with complete or partial closure. * patients with a cup to disc ratio more than 0.8. * patients with a severe central visual field loss in either eye. * patients with chronic or recurrent inflammatory eye disease or acute ocular infection or inflammation. * patients who have had ocular trauma within the past 6 months or have had intraocular surgery within the past 6 months or have had ocular laser surgery within the past 3 months. * patients with best-correct visual acuity less than 20/80. * patients who have had ocular infection or inflammation within the past 3 months. * patients who have clinically relevant progressive retinal disease. * patients who have severe illness or conditions. * patients who have hypersensitivity to a prostaglandin analogu.e * patients who are unable to safely discontinue all iop-lowering medications during washout. * patients who are currently on therapy with another investigational agent within 30 days prior to the screening visit. * other protocol-defined exclusion criteria may apply.

Keywords: elevated iop
comparison of standard epidural and dural puncture epidural analgesia in open gynecological surgery techniques

Conditions: Analgesia

Summary: the aim of this study is to compare the effectiveness of standard epidural and dural puncture epidural analgesia techniques used under nol guidance. the primary aim of this study was to evaluate the effect of nol-guided antinociception on intraoperative total local anesthetic consumption during anesthesia. the secondary aim is to compare onset time, analgesia duration time, hemodynamic parameters, time to first postoperative analgesic requirement, and postoperative side effects.

this prospective randomized double-blind study was planned in 36 adult female patients aged 18-75 years, with asa i-iii, who underwent elective open gynecological surgery under general anesthesia with lower midline or pfannenstiel incision after ataturk university medical faculty hospital ethics committee approval and written consent of the patients.

Eligibility criteria:
inclusion criteria: * asa i-iii physical condition * patients aged between 18-75 years * elective surgeries under general anesthesia for gynecological procedures * lower midline or pfannenstiel incision exclusion criteria: * patients with classical contraindications to neuraxial procedures, * morbidly obese (body mass index \> 40 kg / m2), * pregnant and lactating women * hypersensitive or allergic to local anesthetic agents, * abuse of drugs or alcohol in the past 6 months. * chronic opioid use before surgery, * using chronic psychoactive drugs in the 90 days before surgery, * patients with peripheral and central nervous system disease, * preoperative hemodynamic compromise (patients with irregular sinus heart rhythm and pacemaker) * patients using antimuscarinic, α2-adrenergic agonists, β1-adrenergic antagonists, antiarrhythmic agents, * patients with diabetes, severe lung and significant liver disease with increased bilirubin, * operations that will take less than 2 hours * map \>160 mmhg or \ 90 beats/min or \<45 beats/min on the day of surgery * patients who do not want to participate in the study will be excluded from the study
head-down position for ischemic stroke with middle cerebral artery (hopes)

Conditions: Ischemic Stroke

Summary: the study is designed to explore the efficacy and safety of head-down position in patients with acute ischemic stroke。

currently, the guideline recommended re-perfusion such as intravenous thrombolysis and mechanical thrombectomy as the most effective treatment for acute ischemic stroke. however, the two methods are restricted by a strict time window, which greatly limits the number of the patients receiving treatment. the abundant studies have suggested that good collateral circulation can provide compensatory blood supply to save the ischemic penumbra and reduces the infarct volume, which improves the prognosis. how to improve collateral circulation in an efficient and safe way is a clinical challenge. our recent experiment results of the animal and clinical experiments show that head-down position can significantly increase cerebral perfusion and improve neurological function. clinically, head-down position is simple and easy to operate, and theoretically may increases brain perfusion and improve collateral circulation. a pilot randomized clinical trial is designed to investigate the effect of head-down position combined with routine rehabilitation in patients with ischemic stroke.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. acute ischemic stroke within 10 - 30 days of onset 3. neurological deficit: 6≤nihss≤16 4. large artery atherosclerosis stroke based on toast criteria 5. the responsibility vessels were the middle cerebral artery or internal carotid artery, and the degree of stenosis was more than 50%. 6. first stroke onset or past stroke without obvious neurological deficit (mrs≤1) 7. fully understand and cooperate with the doctor's instructions. 8. the availability of informed consent; exclusion criteria: 1. hemorrhagic stroke or mixed stroke 2. combining with severe organ dysfunction 3. past hemorrhagic stroke 4. a history of stroke with severe sequelae 5. planning revascularization in 3 months 6. ischemic stroke due to surgical intervention 7. participating in other clinical trials within 3 months 8. pregnant or lactating women 9. any inappropriate patients assessed by the researcher

Keywords: head-down position ischemic stroke rehabilitation
efficacy of corticosteroids to treat outpatients with acute exacerbations of copd

Conditions: Pulmonary Disease; Chronic Obstructive (MeSH)

Summary: primary objective: the aim of this study is to determine the efficacy and safety of five days of oral corticosteroids (40 mg / day) for the treatment of acute exacerbations of copd (aecopd) in outpatients.

copd is a major and growing public health issue. the vast majority of cases are cared for in primary care, both for follow-up in stable state and for treatment of exacerbations, which represent major events in the natural history of the disease. systemic corticosteroid treatment is often proposed for exacerbations treatment, although guidelines in this area are heterogeneous regarding precise indications of this treatment. the latest data from the literature, seems to show efficacy of oral corticosteroids but involved only patients seen at the hospital. general practitioners need evidence-base informations to choose whether or not they have to give oral corticosteroids to their patients ; therefore it is very important to better define the benefit-risk ratio and precise indications of oral corticosteroids as part of the care for copd exacerbations. the investigators built a randomized double-blind controlled trial to answer this question.

Eligibility criteria:
inclusion criteria: * adults aged 40 years and over * smoking ≥ 10 pack-years * patients with suspected acute exacerbation of copd * patients who gave their written informed consent to participate in the study exclusion criteria: * known or suspected chronic respiratory disease other than copd (asthma, bronchiectasis ...) * suspected pneumonia or pulmonary oedema * decision of hospitalization * patients taking oral corticosteroids running or stopped for less than a week before inclusion * pathology compromising compliance * fever unexplained by the current aecopd * uncontrolled hypertension * uncontrolled diabetes * deep infectious disease * history of ancient untreated tuberculosis * untreated peptic ulcer * unhealed wound * ulcerative colitis * allergy to steroids * any severe or uncontrolled infections who are not specified as therapeutic indication in the spc (summary of product characteristics) * hepatitis, acute genital herpes, varicella, acute zoster * live attenuated vaccine, recent or planned * psychoses not controlled by treatment * hypersensitivity to prednisone or any of the excipients of cortancyl®, including lactose intolerance * patients who have already been included in becomeg * patients who have to move within 8 weeks after inclusion in the study * patients who are not affiliated to the national health insurance

Keywords: double-blind method randomized controlled trials