Kornimate/medical-research-clean huggingface dataset:
the study is being conducted to evaluate the efficacy and safety of shr-1316 in combination with chemo-radiotherapy in patients with ls-sclc.

Conditions: Small-cell Lung Cancer

Summary: the study is being conducted to evaluate the efficacy and safety of shr-1316 in combination with chemo-radiotherapy in patients with ls-sclc.


Eligibility criteria:
inclusion criteria: 1. male or female, 18-75 years of age. 2. subjects with histologically confirmed limited-stage sclc without previous systematic treatment. 3. ecog ps 0\~1. 4. at least 1 measurable lesion as defined by recist v1.1. 5. adequate organ function. 6. female subjects of childbearing potential or male subjects must be willing to use a recognized effective contraceptive measure during the study and within 3 months after the last dose of the study drug. and female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose. 7. signed the informed consent form. exclusion criteria: 1. mixed sclc or nsclc. 2. subjects who previously received systemic antitumor or immune checkpoint inhibitor therapy. 3. extensive-stage sclc. 4. subjects who is surgically resectable. 5. subjects with malignant pleural effusion. 6. subjects highly suspected of interstitial lung disease, or with conditions that may interfere with the testing or management of suspected treatment-related pulmonary toxicities, or other moderate to severe diseases that seriously affect pulmonary function. 7. active, known, or suspected autoimmune diseases. 8. history of malignant tumors. 9. subjects with severe cardiovascular disease. 10. events of arterial/venous thrombosis within 6 months prior to the first dose. 11. subjects with serious infection. 12. subjects with active pulmonary tuberculosis (tb). 13. subjects with immunodeficiency diseases. 14. subjects with active hepatitis b virus or hepatitis c virus infection. 15. systemic immunosuppressants administation within 14 days prior to the first dose. 16. subjects who received major surgery within 28 days prior to the first dose. 17. subjects who plan to receive or have received live vaccines within 28 days prior to the first dose. 18. subjects who have previously received tissue/organ transplants. 19. subjects with history of severe allergic reactions to monoclonal antibodies/fusion protein drugs. 20. subjects with mental illness, alcohol abuse, inability to quit smoking, and drug or substance abuse.
interaction, monitoring of stroke patients in hospital and home environment

Conditions: Stroke

Summary: clinical assessment and monitoring of balance and arm function in stroke patients with sensor based measurement, in clinical and home environment.


Eligibility criteria:
inclusion criteria: * age: 18 or above * previous stroke in the personal history * able to walk 10 meters. a walking aid (unilateral or bilateral) is permitted * able to walk without special shoes * able to raise the arm against gravity * able to read and understand questionnaires and able to execute commands * able and willing to participate in the study * singed informed consent exclusion criteria: * contraindications on ethical grounds (vulnerable persons) * known or suspected non-compliance, drug or alcohol abuse, * severe aphasia * severe dementia * severe depression * relevant medical disease or increased risk of rehospitalization * severe sensory deficits * severe neglect

Keywords: upper limb lower limb monitoring assessment sensor
regenerex tibial tray multi-center data collection

Conditions: Pain; Arthritis

Summary: the purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the regenerex™ tibial tray.

see protocol

Eligibility criteria:
inclusion criteria: the inclusion criteria will be identical to the indications stated in the fda approved labeling for the device (cleared in 510(k) k080361. these indications are stated below: 1. painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. correction of varus, valgus, or posttraumatic deformity. 3. correction or revision of unsuccessful osteotomy, or arthrodesis. patient selection factors to be considered include: 1. ability and willingness of the patient to follow instructions, including control of weight and activity level 2. a good nutritional state of the patient, and 3. the patient must have reached full skeletal maturity exclusion criteria: the exclusion criteria will be identical to the contraindications stated in the fda approved labeling for the device (cleared in 510(k) k080361. these contraindications are stated below: * absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement. * relative contraindications include: 1. uncooperative patient or patient with neurologic disorders who are incapable of following directions, 2. osteoporosis, 3. metabolic disorders which may impair bone formation, 4. osteomalacia, 5. distant foci of infections which may spread to the implant site, 6. rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, 7. vascular insufficiency, muscular atrophy, neuromuscular disease, 8. incomplete or deficient soft tissue surrounding the knee.

Keywords: press fit tibial tray
evaluation of the feasibility of camera measurement of colorimetric parameters of the brain during neurosurgery operations: tissue oximetry and endogenous or induced fluorescence

Conditions: Brain Diseases

Summary: the management of many brain pathologies involves obtaining a functional and histological diagnosis and performing neurosurgery when possible. histological diagnosis makes it possible to differentiate healthy areas from pathological areas. functional diagnosis allows the identification of brain areas to be spared during neurosurgery in order to avoid any permanent post-operative disability. the visual analysis of the color and texture of the brain by the trained eye of the neurosurgeon is largely part of his operating practice. it allows it to differentiate between healthy and pathological areas. likewise, color variations linked to the functional activation of brain areas are sometimes visible to the naked eye. however, this approach is not optimal due to the limits of human vision. it is also very strongly dependent on the experience and expertise acquired by the neurosurgeon. this approach is therefore largely limited in many operating contexts: low visual contrasts, less experienced neurosurgeon.


Eligibility criteria:
inclusion criteria: * adult from both sex * neurosurgery requiring a functional diagnosis by cortical electrical stimulation or a histological diagnosis with or without fluorescent agent (5-ala) for a tumor pathology or epilepsy or an arteriovenous malformation. * patient able to sign a non-opposition exclusion criteria: * impaired renal function defined by the presence of creatinine clearance less than 30ml/min * patient under treatment with beta-blocker * contraindication to performing an mri (pacemaker) * contraindication to the use of electrical cortical stimulation * history of life-threatening allergic reactions or known hypersensitivity to 5-ala * pregnant, breastfeeding woman * subject participating in another interventional research including an exclusion period still ongoing at pre-inclusion,... * persons deprived of liberty by a judicial or administrative decision * people receiving psychiatric care * persons admitted to a health or social establishment for purposes other than research * adults subject to a legal protection measure (guardianship, curatorship) * persons not affiliated to a social security scheme or beneficiaries of a similar scheme

Keywords: feasibility tissue identification neurosurgery video
the development of novel clinical tests to diagnose and monitor asthma in preschool children

Conditions: Asthma; Wheeze; Obstructive Sleep Apnea; Food Allergy; Virus

Summary: the study will ascertain the ability of preschool lung function tests to distinguish healthy children from those with wheeze, and to differentiate phenotypes of wheezy children (high and low risk for asthma as defined by api) in order to predict response to therapy, and to explore the correlation between preschool lung function test results and symptoms, in order to develop objective methods for monitoring asthma.

in canada, the most common chronic disease of childhood is asthma. childhood asthma places a significant burden on the health care system (refn). no objective preschool asthma diagnostic tools exist, and the current gold-standard, the asthma predictive index, does not provide information about lung function and symptom management. in this study, it is hypothesized that the lung clearance index (lci), a value derived from the multiple breath washout test, will be the most sensitive, responsive discriminative test for preschool asthma. if it proves useful in the monitoring and diagnosis of preschool asthma, lci has the potential to improve the clinical management and thus potentially significantly reduce hospitalization rates for preschool children suffering with asthma. in this unique data set, the investigators will also compare the relative utility of the forced oscillation technique (fot) and preschool spirometry with the lci in order to detect abnormalities amongst those children at high risk for preschool asthma. in addition, the impact of sleep apnea as a risk factor for and modifier of asthma will be investigated in this study. furthermore, changes to the composition of the nasal microbiome during and after a wheezing episodes and the role of viral infections in wheezing exacerbations will be explored. finally, the utility of new methods of diagnosing food allergy, such as the basophil activation test, will be examined in this canadian cohort.

Eligibility criteria:
inclusion criteria (wheezing subjects): * 3 to 5 years of age (36 to 71 months) * diagnosis of asthma made by a physician in the emergency department * history of at least two other wheezing episode within the previous 12 months * received salbutamol within 4hrs before emergency department visit, during current emergency department visit, or was prescribed salbutamol at discharge from emergency department. inclusion criteria (healthy controls): * 3 to 5 years of age (36 to 71 months) * free of a respiratory infection for a minimum of 4 weeks prior to the testing visit exclusion criteria (both subjects and controls): * history or coexistence of renal, chronic pulmonary, cardiac, neurological or systemic disease * born pre-term (\< 35 weeks ga) * insufficient command of the english language

Keywords: pediatric lung ventilation inhomogeneity preschool asthma wheeze
efficacy and safety of en3324 (axomadol) in subjects with chronic low back pain

Conditions: Chronic Low Back Pain

Summary: the purpose of this study is to determine the efficacy and safety of en3324 (axomadol) in subjects with moderate to severe chronic low back pain

a phase iib, randomized, double-blind, two-arm, multi-center, placebo-controlled, study to assess the efficacy and safety of en3324 (axomadol) in subjects with moderate to severe chronic low back pain

Eligibility criteria:
inclusion criteria: * 18 years of age or older * are females who are participating abstinence or using a medically acceptable form of contraception or have been post-menopausal, biologically sterile, or surgically sterile for more than 1 year. * have been on an unchanged regimen of analgesic medication for chronic low back pain on a daily basis for at least 3 months prior to screening; subjects taking opioids must not exceed total daily doses of 90mg oral morphine equivalent * have a history of moderate to severe clbp exclusion criteria: * have evidence of or a history of alcohol and/or drug abuse * have pain secondary to a confirmed or suspected neoplasm * intend to alter their physical therapy regimen during the study. subjects who begin or end physical therapy (either home exercises or formal therapy sessions) 2 weeks prior to screening or during the study period will be excluded from the study * have a history or physical examination finding, which may confound pain-related data (e.g., fibromyalgia, radiculopathy)
a non-interventional pilot study to explore the role of gut flora in autism

Conditions: Autism; Autism Spectrum Disorder; Autistic Disorder; Autism, Akinetic; Autism; Atypical; Autism; Psychopathy; Autism Fragile Syndrome X; Autism With High Cognitive Abilities; Autism-Related Speech Delay; Autism, Susceptibility to, 6; Autism Spectrum Disorder High-Functioning; Autistic Thinking; Autism, Susceptibility to, X-Linked 6; Autistic Behavior

Summary: this study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding autism.

the goal of this research study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding autism.

Eligibility criteria:
inclusion criteria: 1. signed informed consent by parent or legally authorized representative 2. male or female patients age 6 and older. 3. diagnosis of autism per dsm-v criteria (see appendix) exclusion criteria: 1. refusal by parent or legally authorized representative to sign informed consent form 2. treatment with antibiotics within 2 weeks prior to screening 3. treatment with probiotics within 6 weeks prior to screening 4. history of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 5. postoperative stoma, ostomy, or ileoanal pouch 6. participation in any experimental drug protocol within the past 12 weeks 7. treatment with total parenteral nutrition 8. any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial 9. inability of parent or legally authorized representative to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
liposomal vincristine plus dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: the purpose of this study is to find the highest safe dose and to assess the anti-tumor effect of liposomal vincristine with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (all).

objectives: * determine the maximum tolerated dose (mtd) of liposomal vincristine given with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (all). * determine the efficacy of liposomal vincristine given with dexamethasone in these patients.

Eligibility criteria:
inclusion criteria: * previously treated, relapsed or refractory all (including lymphoblastic lymphoma and burkitt's subtypes) with measurable disease. * performance status ≤3 (ecog). * all ages are eligible. those aged 12 years or older may be counted towards the mtd in the phase i portion of the trial. pediatric patients are eligible, but must be treated at a dose level previously tested in an adult (one full course). * adequate liver function (bilirubin ≤2 x upper limit normal), and renal function (creatinine ≤2 x upper limit normal). * negative pregnancy test in females of childbearing potential. * patients with prior history of stem cell transplant are eligible if they meet all other eligibility requirements. exclusion criteria: * active serious infection not controlled by oral or intravenous antibiotics. * treatment with any investigational agents or chemotherapy agents in the last 21 days before study entry, unless full recovery from side effects has occurred or the patient has rapidly progressive disease judged to be life threatening by the investigator. * concurrent treatment with other anti-cancer agents other than dexamethasone. * known cns leukemia or lymphoma requiring intrathecal or craniospinal radiation therapy or with cns neuropathy limiting evaluation of study drug. patients with controlled cns disease (no progression signs or symptoms at the time of study entry) may be eligible after approval by the principal investigator. lumbar puncture not required in asymptomatic patients. * prior history of grade 3 or 4 sensory or motor neuropathy related to chemotherapeutic treatment, or persistent grade 2 or greater active neuropathy. * history of active neurologic disorders unrelated to chemotherapy (including familial neurologic diseases and acquired demyelinating disorders). * prior history of hypersensitivity reactions to vincristine or any of the other components of vsli. * pregnant and/or lactating women; or fertile men or women not willing to use contraception.
the underlying mechanisms regarding the effect of glucagon on the kidneys will be investigated in healthy males.

Conditions: Kidney Diseases

Summary: the goal of this crossover study is to investigate to what extend glucagon affects the kidneys. the main questions it aims to answer are: does glucagon regulate kidney function through extraction in the kidney in addition to glomerular filtration? does glucagon regulate kidney function by increasing renal plasma flow and glomerular filtration rate? does glucagon regulate kidney function by increasing renal salt excretion?

in patients with type 2 diabetes mellitus, plasma concentrations of glucagon are inappropriately high (hyperglucagonemia). hyperglucagonemia has been speculated to contribute to the pathophysiology of diabetic kidney disease. previously, glucagon has been assumed to cause glomerular hyperfiltration associated with urinary excretion of small proteins, a characteristic of early type 2 diabetic kidney injury. further, glucagon has been shown to acutely increase urinary excretion of urea, sodium, and potassium, and patients with end-stage renal disease have elevated plasma levels of glucagon. the purpose of this study is to clarify the underlying mechanisms behind the physiological effects of glucagon on kidney function and the kidney's ability to clear glucagon from the blood in healthy males. specifically, the investigators aim to answer the following questions: does glucagon regulate kidney function through extraction in the kidney in addition to glomerular filtration? does glucagon regulate kidney function by increasing renal plasma flow and glomerular filtration rate? does glucagon regulate kidney function by increasing renal salt excretion? the renal extraction of glucagon and the renal effects of glucagon will be investigated during a constant glucagon infusion in 10 healthy men aged 20-60 years. the study will be placebo-controlled. each subject will participate in three independent and randomized trial days with a washout period of at least four weeks.

Eligibility criteria:
inclusion criteria: * age: 20-60 years * normal health ascertained through questioning and medical examination * normal values for blood concentrations of fasting plasma glucose, fasting plasma total cholesterol, fasting triglycerides, hdl, ldl, creatinine, liver function, and electrolytes * informed consent exclusion criteria: * immunosuppressive treatment in the preceding 12 months * alcohol abuse * medical treatment with oral glucocorticoids, dipeptidyl peptidase-4 (dpp-4) inhibitors, or glp-1 receptor agonists, which, in the opinion of the investigator, may interfere with glucose metabolism * use of lithium * medical treatment that affects insulin secretion or cardiovascular performance measures * liver disease (alt \> 2x normal value) * renal impairment (se-creatinine \> 130 μm and/or albuminuria)
venous thrombosis in turner syndrome

Conditions: Thromboembolic Disease

Summary: in the literature, cases of thrombosis in the venous system have been described in girls and women with turner syndrome. by screening a group of women with turner syndrome, the researchers wish to find out if this condition is more frequent in this patient population.

in the literature cases of thrombosis in the venous system has been described in girls and women with turner syndrome. by screening a group of women with turner syndrome we wish to find out if this condition is more frequent in this patient population. participants are examined with screening blood tests evaluating thromboembolic disturbances.

Eligibility criteria:
inclusion criteria: * turner syndrome verified by karyotyping * aged 18 or above exclusion criteria: * malignant disease * treatment with anticoagulants

Keywords: turner syndrome thromboembolic disease
study of 0.1% uracil topical cream (utc) for the prevention of hand-foot syndrome

Conditions: Palmar-Plantar Erythrodysesthesia; Breast Cancer

Summary: the purpose of this research study is to see if combining uracil cream (utc) with capecitabine (xeloda) can prevent hand-foot syndrome. the study will also see what effects utc and capecitabine may have in patients with metastatic breast cancer.

capecitabine is used in the treatment of human breast cancer among other human cancers. following absorption, capecitabine is converted enzymatically to 5-fluorouracil (5-fu). the administration of capecitabine or 5-fu can cause a cutaneous toxicity known as hand-foot syndrome (hfs) or palmar-plantar erythrodysesthesia (ppe). hfs is progressive with dose and duration of exposure to 5-fu or capecitabine. hfs is characterized by progressive redness and cracking of hands and feet. currently, there are no approved therapies for hfs.

Eligibility criteria:
inclusion criteria: * females, at least 18 years old * histologically or cytologically confirmed metastatic breast cancer * you also cannot have any ulcerations or open wounds on palms of hands or soles of feet exclusion criteria: * patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin c)prior to entering the study or if you have not recovered to grade 1 or better (except for alopecia)from adverse events due to agents administered more than 2 weeks earlier. * use vitamin 6, chronic use of cox-2 inhibitors, use full-dose anti- coagulants or use nicotine patches. the above is not a complete list of eligibility criteria. please see your study doctor for more information.

Keywords: hfs, hand-foot syndrome, capecitabine, breast cancer
desvenlafaxine succinate (pristiq): postmarketing surveillance study among filipino patients

Conditions: Major Depressive Disorder; Vasomotor Symptoms

Summary: this is a non-interventional study to review safety data on administration of desvenlafaxine succinate among filipino patients with mdd and vms per usual clinical practice within the first three years post commercial distribution.

post marketing surveillance none

Eligibility criteria:
inclusion criteria: patients diagnosed with major depressive disorder and vasomotor symptoms secondary to menopause prescribed with desvenlafaxine succinate exclusion criteria: hypersensitivity to desvenlafaxine succinate
observational non-interventional study with spiriva in chronic obstructive pulmonary disease patients with exercise-induced dyspnoea

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this observational non-interventional study is designed to demonstrate the improvement of physical function in copd patients with exercise-induced dyspnoea on treatment with spiriva (tiotropium 18 µg capsules) and allows adverse events to be recorded and evaluated.

study design:

Eligibility criteria:
inclusion criteria: men or women with copd and a thoracic gas volume (tgv) of \< 140% at rest, mrc value of 2 or more. exclusion criteria: * patients cannot be recruited if any of the general or specific contraindications listed in the patient information leaflet or the summary of product characteristics applies. * tiotropium bromide inhalation powder is contraindicated in patients with a hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to the excipient lactose monohydrate which contains milk protein.