Kornimate/medical-research-clean huggingface dataset:
knee biofeedback rehabilitation through game therapy

Conditions: Knee Osteoarthritis

Summary: the goal of this study is to learn about the effect of video-game based rehabilitation exercise for patients with knee osteoarthritis. the main question the study aims to answer is: do patients who exercise with the game have better functional outcomes and engagement compared to patients who do conventional exercise? participants will complete 10 weeks of physical therapy exercise sessions that focus on quadriceps strengthening. two sessions per week will be conducted in the clinic, and one session will be conducted at home each week. the interventional group will conduct all exercises using the kneebright emg sensors and game software. the control group will conduct all exercises following a standard physical therapy regimen. researchers will compare knee function and engagement between the group who uses the game, and the group who does conventional exercise.

the kneebright game system will be evaluated in a 10-week single-blinded randomized controlled trial. the goals of this study are to: (1) assess improvements in functional outcomes following an exercise regimen conducted by kneebright compared to conventional exercise; and (2) evaluate patient engagement during unsupervised, home-based exercises with and without the kneebright software. over the course of the study period, the knee oa participants will conduct physical therapy sessions with the physical therapist (pt) who enrolled them. the exercise regimen will implement each pt's standard of care, consisting of two weekly clinic sessions and one weekly home exercise session, for 10 weeks. knee oa participants will be randomly assigned (via block randomization for each pt) to use either the kneebright system for both clinic and home exercise, or to receive standard care with conventional exercise routines. participants will conduct functional exercise assessments on study intake and again on study completion. participants will also complete questionnaires focused on exercise engagement on study completion.

Eligibility criteria:
inclusion criteria: * diagnosis via x-ray, with a score of at least 2 (out of 4) on the kellgren-lawrence oa scoring system; independent ambulation without assistive device exclusion criteria: * individuals who have psychiatric or cognitive impairment (e.g., dementia) that interferes with their ability to follow instructions or provide voluntary consent; symptomatic spine, hip, ankle, or foot disease other than oa that would interfere with assessment of the knee.

Keywords: knee osteoarthritis, physical therapy, rehabilitation
extended prone position duration covid-19-related ards: a retrospective study

Conditions: Pressure Ulcer; Respiratory Distress Syndrome, Acute; Hypoxemic Respiratory Failure; COVID-19 Acute Respiratory Distress Syndrome

Summary: prone position (pp) is standard of care for mechanically ventilated patients with severe acute respiratory distress syndrome in the intensive care unit (icu). recommendations suggest pp durations of at least 16 hours. in 2020, covid-19 pandemic led to a great number of patients requiring mechanical ventilation and pp in the icu. risk of icu staff viral contamination and work overload led to prolongation of pp duration up to 48 hours. here investigators report outcomes of prolonged pp sessions in terms of skin complications (pression injuries) and ventilatory improvement.

acute respiratory distress syndrome (ards) is a severe condition in which diffuse ventilation/perfusion mismatching and intra-pulmonary shunt are responsible for profound hypoxemia. in patients with severe ards, prone position (pp) improves oxygenation and reduces mortality. recommendations suggest that pp sessions should last at least 16 consecutive hours. safety concern is mainly related to the risk of pressure injuries. in 2020, covid-19 pandemic led to a great number of patients requiring mechanical ventilation (mv) and pp in the intensive care units (icus) worldwide. in the icu of louis mourier hospital (colombes, france) investigators decided upon a strategy whereby pp sessions duration was extended up to 48 hours in patients with covid-19-related ards, so as to minimize the number and workload of turning procedures, limit staff exposure to viral contamination, and avoid turning patients during night shifts. here, investigators aim to report incidence of skin complications (pression injuries) in patients who underwent at least one prolonged pp session. secondary objective was to evaluate evolution of ventilatory parameters with prolonged pp sessions.

Eligibility criteria:
inclusion criteria: * covid-19 proven by pcr-testing of respiratory specimen * acute respiratory distress syndrome (berlin definition) requiring invasive mechanical ventilation and prone position * at least one session of prolonged prone position (that includes two consecutive nights in prone position) exclusion criteria: * transfer to another icu facility after initial admission (inter-regional regulation of icu beds' availability) * incomplete or missing medical file * refusal to consent

Keywords: prone position mechanical ventilation
breast cancer screening with diffusion-weighted mri in women at high risk for breast cancer

Conditions: Breast Cancer

Summary: a prospective observational multicenter study to compare the outcome of breast cancer surveillance using mammography, breast us, contrast-enhanced mri, and diffusion-weighted mr imaging (dwi) as a screening tool, in the high-risk women for breast cancer. * primary objective: to compare the sensitivity of mammography, breast us, contrast-enhanced mri, and dwi for the detection of breast cancer * secondary objective: 1. to compare the specificity of mammography, breast us, contrast-enhanced mri, and dwi for the detection of breast cancer 2. to compare the cancer detection rate of mammography, breast us, contrast-enhanced mri, and dwi 3. to compare the characteristics of detected cancers

* mammography, breast us, contrast-enhanced mri, and dwi will be performed on the same day or within 1 month at baseline and then after 1 year, and images will be interpreted independently according to the breast imaging reporting and data system (bi-rads) by experienced radiologists. * each eligible woman, who provides informed consent for this study, will undergo mammography, breast us, contrast-enhanced mri, and dwi at a 3t mr scanner. * contrast-enhanced breast mri will be performed before and after a gadolinium-based contrast agent injection. * before contrast injection, dwi with b-value of 0, 800 and 1200 s/mm2 will be performed and will transfer into the server. * a total of 890 high-risk women for breast cancer will be enrolled in this study. * the bi-rads 3 or higher is defined as test-positive. the reference standard will be a biopsy or at least 1 year of follow-up.

Eligibility criteria:
inclusion criteria: 1. women aged between 30 years and 75 years at the time of enrollment 2. breast cancer high-risk women who meet one or more of the following criteria: 1) brca mutation carrier or untested first-degree relative of brca mutation carrier 2) family history of breast cancer in first- or second-degree relatives and lifetime risk \>20% calculated by the tyrer-cuzick model 3) family history of breast cancer in first- or second-degree relatives and personal history of breast cancer 4) lobular carcinoma in situ, atypical ductal hyperplasia, or atypical lobular hyperplasia on previous biopsy or surgery and lifetime risk \>20% calculated by the tyrer-cuzick model 5) thoracic radiation therapy between the ages of 10 and 30 exclusion criteria: 1. women with symptoms or signs of breast cancer or recurrence 2. women with bilateral mastectomy 3. pregnant or lactating women 4. women who undergo chemotherapy due to malignancy in other organs 5. in cases of contraindications to mri using contrast media (claustrophobia, renal insufficiency gfr\<30ml/min/1.73m2, metallic foreign body such as pacemaker or clips, history of severe side effects due to mr contrast agent, etc.).
clinical trial to evaluate the efficacy and safety of jpi-289 in patients with acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: clinical trial to evaluate the efficacy and safety of jpi-289 in patients with acute ischemic stroke


Eligibility criteria:
inclusion criteria: * subjects with acute ischemic stroke, aging ≥ 19 * confirmed to have acute anterior circulation cerebral artery occlusion in intracranial internal carotid artery (iica) or middle cerebral artery (mca) m1 segment by ct or mr angiography. * national institutes of health stroke scale(nihss) is 6\~30 before endovascular recanalization therapy (ert) * subject who is reperfused with 2b or 3 stages of thrombolysis in cerebral infarction (tici) (however, if angiography is conducted for thrombectomy after iv tpa treatment and the effect of tpa results in tici 2b-3 reperfusion, the subject can participate) * subject who can administer ip within 6.5 hrs of symptom development * subject who can administer ip within 30 min of vascular reperfusion * subject who can evaluate mri within 90 min of vascular reperfusion exclusion criteria: * subject who is contraindicated for endovascular recanalization * subject who has hypersensitivity to contrast agent or component of investigational product * prohibited or unable to perform mri test * medical history that is related to bleeding * history of hemorrhagic stroke within 6 months of study participation * subjects with chronic liver disorder * kidney disorder (serum creatinine \> 3 mg/dl) * life expectancy is less than 3 months due to concomitant disease other than stroke * pregnant or lactating women * those who have taken tirofiban (anticoagulant agent) during endovascular recanalization therapy * those who have taken other investigational drugs and/or medical instruments 12 weeks prior to screening * subject is unable to be followed up * subject is deemed unable to participate the study in the opinion of the investigator.
study to investigate the safety, tolerability and pharmacokinetics of ad 452 [(+)-mefloquine] compared with racemic mefloquine

Conditions: Healthy Subjects

Summary: mefloquine is a quinolinemethanol antimalarial that is effective as therapy and prophylaxis for all species of malaria infecting humans, including multi-drug resistant plasmodium falciparum. the marketed anti-malaria drug consists of two enantiomers of mefloquine. mefloquine's clinical utility has been impaired by its association with neuropsychiatric side effects. the pharmacological basis of mefloquine's side effects is not known but two of the most reported hypotheses relate to its action on (i) the adenosine receptor and (ii) its effect on the cholinesterase enzyme. for both of these mechanisms, there is a significant stereoselective activity of the two enantiomers. in vitro studies show that the (-) isomer is 50-100 fold more potent towards adenosine receptors compared with the (+) isomer. in addition, (-)-mefloquine has considerably more anti-cholinesterase activity. it has therefore been hypothesised that (+)-mefloquine may have a better central nervous system (cns) safety profile compared with either the racemate or (-)-mefloquine. this study is a randomized, ascending dose, double-blind, active and placebo-controlled, parallel group study in healthy male and female volunteers designed to investigate this hypothesis and to describe the comparative pharmacokinetics of the racemate and the single enantiomer.


Eligibility criteria:
inclusion criteria: * a bmi of between 19 and 28 * negative urine drugs of abuse and breath alcohol test * willing to use double barrier contraception for 13 weeks after administration of study drug exclusion criteria: * pregnant or lactating females * existence of any surgical or medical condition which, in the judgement of the principal investigator, might interfere with the absorption and disposition of the drug or with the aim of the study including clinically significant lactose intolerance * receipt of prescription medication within 21 days of the first study day or over the counter medication (with the exception of multi-vitamins or paracetamol) within 1 week before the planned dosing date without prior approval * definite or suspected personal or family history of adverse drug reaction or hypersensitivity to drugs with a chemical structure similar to ad 452 * participation in a clinical study within the previous 12 weeks * a history of sensitivity to antimalarial or related compounds * definite or suspected personal or family history of adverse drug reaction or hypersensitivity to drugs with a chemical structure similar to ad 452 * active depression or a recent history of depression or generalised anxiety disorder * any personal history of psychosis or schizophrenia or other major psychiatric disorders or convulsions * previous exposure to racemic mefloquine

Keywords: mefloquine malaria (+) mefloquine pharmacokinetics
phase iiib subcutaneous missed dose study

Conditions: Rheumatoid Arthritis

Summary: the purpose of the study is to determine whether subcutaneous abatacept administered to patients with rheumatoid arthritis is associated with increased immunogenicity or increased safety events upon withdrawal and reintroduction.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of rheumatoid arthritis * disease activity score (das)28-c-reactive protein (crp) score ≥ 3.2 and ≤5.1 * on background methotrexate at least 3 months (≥10mg weekly) * must be able to self injection or allow a care giver to do it for them * discontinue all biologics and disease-modifying anti-rheumatic drugs (dmards) except for methotrexate exclusion criteria: * participants who had prior exposure to abatacept or ctla-4 ig * received treatment with rituximab. * participants who have received treatment with leflunomide within 1 year of screening * participants who have received treatment with immunoadsorption columns (such as prosorba columns), mycophenolate mofetil (cellcept®), cyclosporine a or other calcineurin inhibitors, or d-penicillamine.

Keywords: rheumatoid arthritis (ra)
predicting alcoholics' treatment responses to a selective serotonin re-uptake inhibitor (ssri)

Conditions: Alcoholism; Alcohol Abuse

Summary: this study is being done to determine if citalopram is safe and effective in the treatment of alcohol dependence. a second purpose is to evaluate whether alcohol dependent individuals who differ in a specific genetic marker respond differently to citalopram. citalopram is a drug approved by the u.s. food and drug administration (fda) for the treatment of depression. it belongs to a category of medications called selective serotonin re-uptake inhibitors or ssris. the u.s. fda has not approved citalopram for the treatment of alcohol dependence. therefore, it is being used "off-label" in this study.

relapse to alcoholism remains a vexing clinical and national health problem. efforts to match alcohol dependent patients to specific treatments based on their clinical characteristics have produced mixed results. pharmacogenetics (the study of genetic influences on therapeutic response to drugs) offers a powerful new tool to match specific elements of an individual patient's complex genetic blueprint with targeted pharmacotherapies to which that individual may optimally respond. the purpose of this proposed research is to apply pharmacogenetic techniques to predict which alcohol dependent patients will respond favorably to a trial of a selective serotonin re-uptake inhibitor (ssri) for the prevention of alcoholism relapse. our central hypothesis is that genetic differences affecting serotonin transporter function will influence an alcohol dependent individual's treatment response to the ssri, citalopram. to test this hypothesis, we will perform a 14-week, randomized, double blind, parallel group comparison of citalopram and placebo in treatment seeking outpatients who meet dsm-iv criteria for alcohol dependence. all subjects will receive a single motivational interview and 9 brief sessions of a manual-guided compliance enhancement therapy designed to promote treatment adherence and enhance motivation to quit or cut down on drinking. post-treatment follow-up assessments will be conducted at 4, 12 and 24 weeks. subjects' dna will be genotyped to determine allelic variants in the promoter region of the serotonin transporter gene that have been found to markedly affect serotonin reuptake and influence treatment responsiveness to ssris.

Eligibility criteria:
inclusion criteria: * outpatients with a diagnosis of dsm-iv alcohol dependence * not morbidly obese or underweight * express desire to quit or cut down on drinking for duration of trial exclusion criteria: * clinically significant laboratory evidence of diseases * have active psychological disorders other than alcoholism

Keywords: clinical trial alcoholism alcohol pharmacogenetics citalopram genotype therapy compliance serotonin inhibitor alcoholism/alcohol abuse therapy
short course radiation therapy in palliative treatment of abdominal cancer

Conditions: Abdomen Tumors; Radiotherapy; Palliative Care

Summary: aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic abdominal malignant lesions

standard treatment for abdomen lesions (3000 cgy in 10 daily fractions of 300 cgy each) is compared with experimental treatment (1800 cgy in 4 fractions of 450 cgy twice a day) to demonstrate non-inferiority of this scheme

Eligibility criteria:
inclusion criteria: * symptomatic abdomen malignant lesions (primary solid tumor or metastases from solid tumor) * age\>18 years * ecog performance status 0-3 * no changes in supportive care in the week before radiotherapy exclusion criteria: * pregnancy * previous irradiation of the same region

Keywords: short course radiotherapy symptomatic abdomen lesions
biomechanical risk factors of cervical pain in pregnant women

Conditions: Cervical Pain

Summary: the purpose of the study is to assess the biomechanical risk factors for neck pain in pregnant women.

neck pain during pregnancy has significant physical, psychological, and social impacts on women's lives. moreover, the economic burden of neck pain is remarkable and includes treatment costs, reduced productivity, and job-related problems. untreated neck pain during pregnancy can potentially lead to chronic musculoskeletal problems postpartum. the significance of the study is based on the concept of "early prediction for early mitigation of the risk and prevention of the onset or progression". studies have investigated risk factors for neck pain. however, there is a notable gap in research regarding these factors in pregnant women, especially physical (biomechanical) risk factors, despite the significant biomechanical changes they undergo during pregnancy. this study aims to fill this gap by investigating the relationship between biomechanical risk factors and neck pain in pregnant women. to our knowledge, this is the first study in which this relationship will be assessed to provide evidence about the biomechanical risk factors for neck pain in pregnant women.

Eligibility criteria:
inclusion criteria: * pregnant women in their third trimester suffering from cervical pain. * they have experienced cervical pain starting during pregnancy. * they reported no neck pain or neck-related disorders during the previous year and were screened for the absence of cervical pathology during a physical examination. exclusion criteria: * objective signs of structural pathology on physical examination, including but not limited to shoulder bursitis, impingement, tendonitis, fracture, cervical nerve or disc impairment, radiculopathy, or loss of upper extremity sensory or motor function. * acute injury of the neck or shoulders (\<12 weeks before the study). * history of fibromyalgia or musculoskeletal pain present in more than 4 body regions concurrently. * self-reported systemic illness, including cancer, rheumatic, cardiovascular, or neurological disease * untreated psychiatric condition * previous surgery involving the cervical spine or shoulders * uncontrolled hypertension (resting systolic blood pressure \>150 mm hg, or diastolic blood pressure \>90 mm hg).
dextromethorphan added on for children with chronic irritability

Conditions: Irritable Mood

Summary: dextromethorphan added on for children with chronic irritability

objectives: it is known that the etiology and mechanism of neuropsychiatric diseases may be related to nerve inflammation. it has been found that dextromethorphan (dm) is an active ingredient in cough-remedies, which can protect neurons in glial cell cultures in the rat brain from inflammatory substances. although the mechanism of dm is still unknown, it may be related to the regulation of immune dysfunction. therefore the purpose of this present study was to investigate the adjuvant treatment with dm in the children and adolescents with chronic irritability. methods: this randomized double-blind clinical trial will evaluate 120 outpatients, aged between 7 and 17 years, with chronic irritability. the study subjects will be randomly assigned into one of the two groups: receiving routine medicine plus dm or routine medicine plus placebo for 8 weeks. assessments comprising the parents' reported mood disorder questionnaire (mdq), affective reactivity index (ari), the chinese version of the child behavior checklist (cbcl-c) scale, the swanson, nolan and pelham questionnaire (snap-iv), the sleep disturbance scale for children (sdsc), problematic smartphone use (psu) and checklist for autism spectrum disorder-chinese version (casd-c). comparison will be done between groups at baseline and at 8 weeks before-and-after the treatment.

Eligibility criteria:
inclusion criteria: * patients aged 7 to 17 who have irritability symptoms will be recruited. they will be screened for the irritability symptoms with ari scale. exclusion criteria: * patients who are not willing to participate in the study after detailed explanation. * patients who could not follow the investigator's instructions. * patients who have problems to express questions or emotional problems exactly. * patients who have severe neurological or mental illness like epileptic disorder, history of stroke, schizophrenia, bipolar disorder, mental retardation or uncontrolled suicide risk. * patients who have severe medical illness or surgical conditions like uncontrolled abnormal thyroid function, history of heart attack, uncontrolled hypertension. * patients who are allergic to methylphenidate or dextromethorphan. * patients with autoimmune disorders * patients with asthma or severe infection disorder currently or in the previous two months to avoid the influence of the level of cytokines.
evaluation of the efficacy and tolerance of plasmapheresis by double cascade filtration in a university centre

Conditions: Kidney Failure

Summary: a study is being carried out to evaluate the biological, technical and clinical/biological efficacy of this technique, the practice of which is standardized in the department, in order to evaluate our practices and to improve them if necessary. as part of this study, the investigators will ask all patients scheduled for this procedure to participate in this observational prospective study without changing usual practices.

the objective of the study is to conduct a prospective evaluation of the practice of apheresis by double filtration system cascade system in a university centre in current practice with evaluation of the technical and biological effectiveness as the main objective and clinical and biological tolerance as the secondary objective for all consecutive sessions performed in a university centre over a period of 1 year.

Eligibility criteria:
inclusion criteria: over 18 years of age i indication for plasmapheresis and hospitalized at chu de nimes. exclusion criteria: under guardianship or curatorship refusal to participate

Keywords: chronic hemodialysis