Kornimate/medical-research-clean huggingface dataset:
exploratory study of intermittent hypoxia treatment in chronic cerebral hypoperfusion

Conditions: Chronic Cerebral Hypoperfusion

Summary: this study aims to investigate the safety and efficacy of intermittent hypoxia treatment in patients with chronic cerebral hypoperfusion.

chronic cerebral hypoperfusion is a common and frequently occurring disease in middle-aged and senior people, and an important cause of multiple diseases such as acute ischemic stroke and vascular dementia. however, current treatments for chronic cerebral hypoperfusion are limited and nonspecific. intermittent hypoxia refers to periodic intervention with alternating normoxia and hypoxia. studies have shown that short-term (5-10min), low frequency (3-15 times), and mild to moderate hypoxia (9-16%) usually have protective effects and can improve cerebral blood perfusion. therefore, this study is an exploratory study combining intermittent hypoxia treatment with chronic cerebral hypoperfusion, aiming to preliminarily explore the safety and potential effectiveness of intermittent hypoxia treatment in the using of chronic cerebral hypoperfusion.

Eligibility criteria:
inclusion criteria: * subjects aged 45-70 years, bmi 18.5-24kg/m2, both sexes. * subjects with risk factors of cerebrovascular disease, such as hypertension, diabetes, dyslipidemia, and so on, and the risk factors are well controlled. * cerebral/carotid ultrasound showed mild stenosis of unilateral internal carotid artery (ica) or middle cerebral artery (mca) (\<50%) without stenosis of other major feeding arteries. * subjects with the manifestations of chronic cerebral hypoperfusion, such as dizziness, head pain, memory loss, slow reaction, inattention, emotional instability, decreased ability to work, sleep disorders and mood disorders, the course of more than 3 months. * subjects or their legally authorized representative can provide informed consent. exclusion criteria: * stroke onset in the past 3 months, other severe neurological diseases, such as epilepsy, intracranial infectious diseases or demyelination. * uncontrolled hypertension (systolic blood pressure ≥200mmhg) with antihypertensive drugs before enrollment, other cardiovascular diseases. * history of pulmonary, hepatic, dermatologic, or hematologic diseases. * history of substance abuse. * pregnancy, hypertension, diabetes mellitus, obesity, sleep apnea and neurological disorders.
effectiveness of a multimodal physiotherapy program with virtual reality glasses in duchenne and becker.

Conditions: Muscular Dystrophy, Duchenne and Becker Types

Summary: duchenne's muscular dystrophy and becker dystrophy, hereafter dmd and bmd, is a serious and progressive disease that affects 1 in 3,500-6,000 males born alive. scale 6-minute walking test, is used for determine the inclusion of children with dmd in pharmacological studies. furthemore, is used to verify a training effectiveness assessing muscular endurance and cardio-respiratory functions. this research evaluates the feasibility and effectiveness of a multimodal physiotherapist program with virtual reality glasses.

in addition a physiotherapy program, virtual reality have a lot of importance advantages for train while motivated the kids. a cross over study will be applied. in the control time, patient will received a initial evaluation and a final without making the physiotherapy program and without virtual reality glasses. the data will be collected by principal examiner. in the intervention time the group will received 10 multimodal physiotherapy sessions, two or one per week, along six weeks. also they are going to training walking with with virtual games. multimodal physiotherapist program describes the exercises to be performed, how long it will take, the number of repetitions and the way to do it with the physiotherapist in zoom session. at the end of the multimodal physiotherapy program, variables will be evaluated by the principal examiner.

Eligibility criteria:
inclusion criteria: * children between 4 and 15 years * duchenne and becker diagnosis icd-10 issued by specialist in neurology. * children who can walk 10 m at last 120 seconds. * first punctuation of north start ambulatory assessment bigger than 20 points. exclusion criteria: * an other dystrophies. * older than 10 years. * not physiotherapy. not walk. * asociated heart disease sprains, fractures. fc \>120, sat o2 \<89%.

Keywords: virtual reality [l01.224.160.875], [l01.296.555] physical therapy modalities [e02.779], [e02.831.535] respiratory therapy [e02.880] dystrophin [d12.776.210.500.250] becker muscular dystrophy [c10.668.491.175.500.300] resistance training [e02.831.535.483.875] muscular stretching therapy [e02.831.535.483.750]
r retreatment in 1st relapsed dlbcl

Conditions: Lymphomas

Summary: it is a phase ii , multicenter, open label clinical trial. only the relapsed dlbcl patients after 1st line induction treatment of 6\~8 cycles of rchop-like chemo will be enrolled to receive 3 cycles of rice as salvage therapy. after treatment each patient should be followed up for 2 years.


Eligibility criteria:
inclusion criteria: 1. relapsed dlbcl patients having received 6 - 8 cycles of rchop-like chemotherapy as 1st line induction treatment. 2. disease relapsed no earlier than 6 months after prior induction treatment. 3. confirmed cd20 positivity of the lymphoma at time of diagnosis (prior to induction therapy) 4. ecog performance status of 0, 1 or 2 at time of inclusion (see appendix iv ) 5. known ipi at time of diagnosis (prior to induction therapy) 6. age ≥18 years and \<65 y 7. life expectancy of \> 3 months 8. be willing and able to comply with the protocol for the duration of the study 9. agree to use effective contraception for the entire treatment period and during the 12 months thereafter 10. patient's written informed consent exclusion criteria: 1. more than one prior chemoimmunotherapy regimen. 2. histologies other than dlbcl according to the who/real classification 3. history of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin, surgically treated malignant melanoma or carcinoma in situ of the cervix within the last 5 years. 4. major surgery, other than diagnostic surgery, within the last 4 weeks. 5. evidence of cns involvement patients 6. unacceptable hematologic status at baseline prior to study start below any of the values listed: wbc: \<3 x 109/l; absolute neutrophil count (segmented + bands) \<1.5 x 109/l; platelets: \<100 x109/l 7. abnormal liver function tests prior to study start above any of the values listed: serum bilirubin \>2 mg/dl (30 mmol/l); alat or asat \>2.5 x upper limit of normal range; or abnormal renal function (serum creatinine \> 150 μmol/l ). 8. hiv-positive patients. 9. contraindication to the investigational medication 10. active viral hepatitis, specifically hbv or hcv infection 11. serious underlying medical conditions, (e.g. ongoing infection, uncontrolled diabetes mellitus, severe cardiac dysfunction or angina, gastric ulcers, active autoimmune disease) 12. life expectancy \< 3 months 13. treatment within a clinical trial within 30 days prior to trial entry 14. women who are breast feeding, are not using effective contraception, are pregnant 15. patients under tutelage

Keywords: diffuse large b cell lymphomas
the neurofibromatosis-associated tumor biobank

Conditions: Neurofibromatoses

Summary: neurofibromatosis-associated tumor is very rare bone tumor. the investigator set up the biobank to ensure every patient has the chance to participate in future research

samples of blood and other stored material such as slides,frozen tissues or leftover diagnostic material. questionnaire information, including health history, growth and development, physical activity and family medical history information. if patients have been diagnosed with a neurofibromatosis-associated tumor or another condition the investigator is interested in， the investigator will ask the patient to release medical record information relating to diagnosis and treatment of neurofibromatosis-associated tumor, other cancers, blood disorders, and similar conditions.

Eligibility criteria:
inclusion criteria: proband inclusion criteria: a diagnosis or suspected diagnosis of neurofibromatosis-associated tumor family member inclusion criteria: biological parents and full biological siblings of a case diagnosed with neurofibromatosis-associated tumor exclusion criteria: non-asian

Keywords: bone tumor
moleculight i:x™ in wound healing

Conditions: Ulcer Foot

Summary: diabetic foot disease is a global health problem. diabetes affects over 450million people worldwide, expected to rise to 1 in 10 people by 2040. 60-70% will lose sensation in their feet and up to 25% will develop a diabetic foot ulcer (dfu - a wound on the foot). more than half of dfus become infected requiring hospitalisation and 20% of infections result in amputations contributing to 80% of non-traumatic amputations performed in the developed world. dfus cost the nhs £1billion in financial year 2014-15. a diabetic foot ulcer is a form of chronic wound. chronic wounds are wounds that fail to progress through the normal phases of wound healing in an orderly and timely manner and become hard to heal. almost all chronic wounds are known to have bacteria within and this is termed colonisation. wounds can progress from being colonised to becoming infected. the concentration of bacteria can predict delayed healing or infection. this study aims to use a novel hand held device, moleculight i:x™, in a pilot study to investigate the clinical effectiveness and decision making associated with its use in the assessment of dfus. moleculight i:x™ is a hand held device that emits violet blue light. by controlling distance from the wound and ambient light, moleculight i:x™ identifies bacteria above a pre-determined concentration by identifying natural fluorescence in the bacteria cell wall. patients attending a specialist dfu clinic will be screened and if eligible and consenting will be recruited. patients will be randomised into two groups; those who receive treatments as usual (tau) alone (in line with nice guidelines) and those that receive tau plus moleculight i:x™ imaging. the main objective is to describe the proportion per group with healed dfus at 12week follow up in these two comparable groups of 30 patients each.


Eligibility criteria:
inclusion criteria: 1. aged ≥ 18 years 2. diagnosis of diabetes (according to who criteria) 3. has ulceration of the foot below the malleoli 4. expected to comply with the treatment strategies and follow up schedule 5. consent to foot and wound photography 6. consent to participate (written/witnessed verbal consent) exclusion criteria: 1. has any current clinically infected diabetic foot ulcer (as per idsa guidelines). 2. estimated glomerular filtration rate (egfr) \<20ml/min/1.73m2 (measurements taken within 3 months of randomisation can be used if no change in intervention or vascular events have occurred) 3. has abpi \<0.5 or opening toe pressure \<30mmhg (measured within 3 months of randomisation) 4. planned or previous treatment with corticosteroids to an equivalent dose of prednisolone \>10mg per day or other immunosuppressive therapy within 4 weeks prior to randomisation 5. has evidence of connective tissue disorders (e.g. vasculitis or rheumatoid arthritis) and has planned or is under active treatment. 6. has evidence of dermatological disorders (e.g. pyoderma gangrenosum or epidermolysis bullosa) 7. has previously been randomised to the moleculight i:x™ study 8. lacks mental capacity and is unable to provide informed consent.
nr600 system retinal prosthesis for patients with retinal degenerative diseases

Conditions: Retinitis Pigmentosa; Retinal Degeneration

Summary: the study objective is to demonstrate safety of the nr 600 system, and to evaluate the performance of the device in restoring visual activity of daily living in subjects with retinal degenerative diseases and severe visual impairment

the nr600 is a retinal prosthetic system intended to provide electrical stimulation to the retina to induce visual perception in patients with severe to profound vision loss due to degenerative retinal disease. the system is consisting of an autonomous epiretinal implant with penetrating electrodes, glasses and a clinician station. the implant is infrared (ir) powered and is designed to convert visual input into well-defined electrical stimulation patterns suited to elicit neuronal retina activity. all study subjects will be implanted with the device in one eye and will be followed for 18-months.

Eligibility criteria:
inclusion criteria: * have confirmed diagnosis of end-stage hereditary outer retinal degeneration such as rp or cone-rod dystrophy * visual acuity in both eyes from light perception to no light perception * confirmed functional ganglion cells and optic nerve in the implanted eye * history of useful vision * mentally competent exclusion criteria: * diseases or condition that affect retinal and or optic nerve function * optic nerve diseases * diseases or conditions that, in the judgement of the surgeon, impede the ability to implant the device or would prevent the system from functioning * dry eye * pre-disposition to eye rubbing * posterior pole severe staphyloma * strabismus superior to 10 prismatic diopter * severe nystagmus * corneal endothelium density \< 1500 cells/mm2 * refractive error ≥±8 diopters spheric and 3.5 diopter cylindric * currently pregnant (female subject) or inadequate contraceptive treatment in female subjects \<50 years of age. * hyperthyroidism or hypersensitivity to iodine * neurological and/or psychiatric diseases (e.g. m. parkinson, epilepsy, depression) * participation in another study with any investigational drug or device that may conflict with the objectives, follow-up or testing of this study * conditions likely to limit life to less than 1 year from time of recruitment to the study
phase ii study to evaluate efficacy and safety of rp101 in combination with gemcitabine

Conditions: Pancreatic Cancer

Summary: this will be a phase ii, multicenter, randomized, double blind, placebo controlled, study of six 28-day treatment cycles for patients with locally advanced, unresectable, or metastatic pancreatic cancer. the study will be conducted at approximately 55 sites in the north american, europe, and south america. approximately 153 subjects will be enrolled in a randomization (ratio 2:1).


Eligibility criteria:
inclusion criteria: * subjects must be 18 years of age or older * not previously treated with chemotherapy for pancreatic cancer * ecog performance status of 0 or 1 * life expectancy \> 3 months * documentation of all sites of pancreatic disease within 28 days prior to randomization * adequate hematological, renal, and hepatic function * not pregnant or nursing * fertile subjects must practice a medically approved method of contraception exclusion criteria: * prior history of other malignant tumors * participation in another investigational study within 4 weeks prior to treatment start * major surgery within 14 days prior to treatment start * radiation treatment within 28 days prior to treatment start * uncontrolled cardiac atrial or ventricular arrhythmias * gastrointestinal tract disease such resulting in an inability to take oral medication * known to be seropositive for hiv, hbv, or hcv * uncontrolled cancer pain

Keywords: unresectable locally advanced metastatic pancreatic adenocarcinoma stage iii stage iv
alleviate trial - a phase 3 trial in subjects with allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: a multi-center, double-masked, randomized, parallel-group, vehicle-controlled, clinical trial to assess the safety and efficacy of reproxalap ophthalmic solutions in subjects with acute allergic conjunctivitis


Eligibility criteria:
inclusion criteria: * be at least 18 years of age of either gender and any race * have a positive history of ocular allergies and a positive skin test reaction to a seasonal allergen (grasses, ragweed, and/or trees) as confirmed by an allergic skin test at the screening visit or within the past 24 months; * have a calculated visual acuity of 0.7 logmar or better in each eye as measured using an etdrs chart exclusion criteria: * have known contraindications or sensitivities to the use of the investigational product or any of its components * have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or a diagnosis of dry eye) * have had ocular surgical intervention within three (3) months prior to visit 1 or during the trial and/or a history of refractive surgery six (6) months prior to visit 1 or have ocular or systemic surgery planned during the study or within 30 days after * have a known history of retinal detachment, diabetic retinopathy, or active retinal disease * have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit * be a female who is currently pregnant, planning a pregnancy, lactating, not using a medically acceptable form of birth control throughout the trial duration, or has a positive urine pregnancy test at visit 1

Keywords: reproxalap
clinical effectiveness of combining mindfulness-based stress reduction with exercise interventione

Conditions: Non-Small Cell Lung Cancer

Summary: this study is to assess the clinical effectiveness of combining mindfulness-based stress reduction (mbsr) with exercise intervention in improving anxiety, depression, sleep quality, and mood regulation in chinese patients with non-small cell lung cancer (nsclc).the control group received conventional psychological nursing care, while the intervention group received a combination of mbsr and exercise therapy. pre- and post-treatment scores of anxiety, depression, sleep quality, and the bsrs-5 were compared.

to assess the clinical effectiveness of combining mindfulness-based stress reduction (mbsr) with exercise intervention in improving anxiety, depression, sleep quality, and mood regulation in chinese patients with non-small cell lung cancer (nsclc). a total of 60 lung cancer patients from a hospital in shanxi province were selected using convenience sampling and divided into an intervention group and a control group, with 30 patients in each group. the control group received conventional psychological nursing care, while the intervention group received a combination of mbsr and exercise therapy. the two group were evaluated by the questionnaire three times. one day before the intervention, the first questionnaire was conducted, and the basic data of the two groups of patients were collected. the second questionnaire evaluation of anxiety, depression, sleep quality, and the brief symptom rating scale (bsrs-5) was conducted 6 weeks after the end of the intervention, and the third questionnaire evaluation was conducted 8 weeks after the end of the intervention to evaluate the intervention effect of the two groups. pre- and post-treatment scores of anxiety, depression, sleep quality, and the bsrs-5 were compared.

Eligibility criteria:
inclusion criteria: * patients diagnosed with non-small cell lung cancer * patients aged between 20 and 74 years, without gender limitation * a score of 4-14 on the short symptom rating scale (bsrs-5) * a clinical prognosis of at least 6 months * clear consciousness, good functional ability, and unrestricted language communication * written informed consent provided by the patient exclusion criteria: * patients with severe physical illnesses or symptoms that impede learning and are considered life-threatening * patients with a bsrs-5 assessment score \> 15 and suicidal ideation \> 2 * patients unable to accurately describe their symptoms * patients with limited cooperation ability * patients who have previously undergone mbsr or other positive-thinking-focused psychotherapy methods

Keywords: lung cancer mindfulness-based stress reduction exercise intervention anxiety depression
evolocumab in acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: vascular and myocardial inflammation are significantly increased in acute coronary syndrome (acs) patients, are closely correlated to ldl-c levels, and are associated with these adverse consequences in the post-acs patient population. serum proprotein convertase subtilisin/kerin type 9 (pcsk9) levels are also increased in acs, may raise ldl-c, and the investigators' pre-clinical studies indicate that pcsk9 is also a potent inducer of vascular inflammation. the addition of the pcsk9 antibody evolocumab, currently approved to lower ldl-c in certain patient populations, to current medical therapies would appear to be of particular benefit in an important subset of acs patients, those with non-st elevation myocardial infarction (nstemi) by markedly reducing ldl-c, stabilizing vulnerable plaque, and limiting inflammation-associated myocardial cell loss and resultant dysfunction.

in a placebo-controlled, randomized double blind trial, the addition of evolocumab to standard care in nstemi patients (1) decreases ldl-c during hospitalization and at 30 days, (2) decreases vascular/plaque and myocardial inflammation as assessed by positron emission tomography (pet) scanning at 30 days, and improves (3) serum markers of endothelial function at hospital discharge and at 30 days, and (4) echocardiographic assessment of left ventricular function at 30 days and six months. this is the first pcsk9 inhibitor trial which examines these outcomes in the acs patient population. it will provide valuable data on the extent and time course of ldl-c reduction as well as the impact of inhibition on inflammatory markers and on imaging assessment of vascular and myocardial inflammation, all of which may significantly impact important clinical outcomes in this high risk patient cohort.

Eligibility criteria:
inclusion criteria: * non st segment elevation myocardial infarction * troponin i \>/ 5.0 ng/dl * permission of attending physician exclusion criteria: * st elevation myocardial infarction * patients requiring invasive hemodynamic support * scheduled for cardiac surgery * current or prior treatment with a pcsk9 antibody * current participation in an intervention clinical trial * female of childbearing potential who has not used acceptable method(s) of birth control for at least one month prior to screening * contraindication to statin therapy * subject likely not able to complete protocol related visits or procedures * latex allergy * history of hypersensitivity to any monoclonal antibody