Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of lumiracoxib in patients with primary knee osteoarthritis (oa)

Conditions: Knee Osteoarthritis

Summary: this study will evaluate the efficacy and safety of using lumiracoxib in the treatment of patients with knee osteoarthritis (oa)


Eligibility criteria:
inclusion criteria: * primary osteoarthritis of knee (confirmed by american college of rheumatology \[acr\] criteria). * requirement of regular non-steroidal anti-inflammatory drug (nsaid) therapy. exclusion criteria: * evidence of active peptic ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years. * known hypersensitivity to analgesics, antipyretics, or nsaids (including celecoxib). other protocol-defined inclusion/exclusion criteria may apply

Keywords: osteoarthritis, lumiracoxib, celecoxib, cyclooxygenase-2 inhibitors
the use of bisphosphonates in the treatment of avascular necrosis of the femoral head

Conditions: Femoral Head Avascular Necrosis

Summary: to determine the safety and effectiveness of pamidronate in patients with radiographically proven avascular necrosis which are the result of unstable (acute) slipped capital femoral epiphysis, traumatic proximal femur fractures, traumatic hip dislocations, or idiopathic in nature.

avascular necrosis of the femoral head and collapse is a devastating condition in the pediatric patient population leading to degenerative arthritis and significant disability. bisphosphonate therapy has been shown to be effective in the treatment of adults with avascular necrosis of the femoral head. for children and adolescents however, there is currently no effective treatment that prevents collapse of the femoral head. some patients with proven avascular necrosis of the femoral epiphysis are treated with bisphosphonates (intravenous pamidronate) at the the hospital for sick children. the main aim of this study is to prospectively collect data on hsc patients receiving bisphosphonate treatment and thereby report the effectiveness of this treatment in the prevention of femoral head collapse.

Eligibility criteria:
inclusion criteria: patients between the ages of 10 and 18 with: * unstable slipped capital femoral epiphysis (defined as inability to bear weight) or acute slipped capital femoral epiphysis (defined as a separation of the epiphysis from the metaphysis of the proximal femur) who have been pinned either in situ or following reduction, * traumatic hip dislocations or traumatic proximal femur fractures, or * "idiopathic" avascular necrosis of the femoral head which includes unknown causes as well as sickle cell disease, post radiation use, post chemotherapy treatment, and post steroid treatment. exclusion criteria: * decline to participate in study. (patients will be still offered this therapy whether or not they wish to be included in the official study protocol. clinical evaluations, laboratory and imaging tests would be unchanged if they choose to be treated with intravenous pamidronate) * significant femoral head collapse - judged radiographically by treating surgeon * idiopathic causes under the age of 10.

Keywords: adolescent avascular necrosis bisphosphonates pamidronate
the effects of semaglutide on taste, tongue tissue transcriptome, gastric emptying and central neural response in women with pcos and obesity

Conditions: PCOS; Semaglutide; Taste, Altered; Tongue Tissue Transcriptome; Gastric Emptying; Central Neural Response

Summary: the purpose of the study is to explore the effects of glp-1 receptor agonist (glp-1 ra) semaglutide on modulation of taste sensitivity, tongue tissue transcriptome, modulation of neural response in central reward processing regions and gastric emptying rate. in addition, we aim to investigate the associations between semaglutide induced modulation of taste sensitivity, neural responses and gastric emptying with changes in body mass, eating- behavioural pattern, food perception and food intake.


Eligibility criteria:
inclusion criteria: * informed written consent * diagnosed with pcos by rotterdam criteria * bmi \> 30 kg/m2 * age 18 years-menopause exclusion criteria: * severe psychiatric disease including schizophrenia, paranoid psychosis, bipolar disorder or mental retardation * current history of neurological disease including traumatic brain surgery * current history of diagnosis of type i or type ii diabetes or plasma haemoglobin a1c 6.5% at inclusion * impaired hepatic function (liver transaminases\>3 times upper normal limit) * impaired renal function (estimated glomerular filtration rate (egfr)\< 50 ml/min * impaired pancreatic function (any history of acute or chronic pancreatitis and/or amylase \>2 times upper limit) * bleeding disorders * women who are pregnant, breast feeding or have intention of becoming pregnant within the next 9 months * women who are planning any operation within the next 6 months * history of medullary thyroid carcinoma (mtc) and/or family history with mtc and/or multiple endocrine neoplasia syndrome type 2 * cardiac problems defined as decompensated heart failure (new york herat association functional class iii or iv), unstable angina pectoris, and/or myocardial infarction within the last 12 months * uncontrolled hypertension (systolic blood pressure \> 180 mmhg, diastolic blood pressure \> 110 mmhg * receiving glp-1 agonist within the last 12 months * use of any weight-lowering pharmacotherapy within the preceding 3 months * contraindication for mr scanning (magnetic implants, pacemaker, claustrophobia etc) * any condition that the investigator feels would interfere with trial participation
covid-19 survivorship registry

Conditions: Covid19

Summary: covid-19 is associated with acute pulmonary and cardiac injury. to better understand the degree and severity of cardiopulmonary injury as well as short and long-term sequelae of covid-19 infection, this study will perform longitudinal study in patients who had recent known diagnosis of covid-19.

the objectives for this study include providing structural and function information about lung and heart using chest imaging, mri, echo, spirometry, and blood markers in order to assess severity of cardiopulmonary injury and short- and long-term sequelae of covid-19 infection as well as assess indicators of mental health and quality of life.

Eligibility criteria:
inclusion criteria: * have tested positive for sars-cov-2 and discharged from the icu or, * have tested positive for sars-cov-2 and have been discharged from hospital or, * have tested positive for sars-cov-2 but was not hospitalized * ages 18 and over, and * competent and willing to sign informed consent and comply to all aspects of the protocol control inclusion criteria * no clinical history of covid-19, * no active clinical symptoms indicative of possible covid-19, * ages 18 and over, * competent and willing to sign informed consent and comply to all aspects of the protocol exclusion criteria: • participants cannot sign consent any individual who meets any of the following criteria will be excluded from participation to the mri or x-ray portion of the study: * participants who are pregnant or currently trying to get pregnant * participants unable to comply with any portion of the protocol (i.e. removing metals prior to entering the mri scan room) or who have contraindications to mri scanning (i.e., non-mri-conditional pacemakers/defibrillators, pregnancy, ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants) * persistent symptoms related to covid-19 (in which case the patient may be re-screened later) as is done for all patients undergoing clinical mri in our department, each patient will be screened for contraindications to mri with a routine questionnaire prior to scanning. control exclusion criteria patients with any of the following are excluded from as controls: * pace maker * poorly controlled diabetes * poorly controlled restrictive lung disease * heart failure * parkinson's disease * hypertension * any diagnosis or history of autonomic neuropathy
cardiovascular manifestations of covid-19

Conditions: COVID-19

Summary: electronic medical record review of de-identified patients who tested positive for covid-19 (using a pcr test) at methodist dallas medical center (mdmc) from june 2020 until the date of irb approval. data will be collected on de-identified patients that test positive for covid-19 (using a pcr test) at mdmc from the date of irb approval until december 2022. disclaimer: any cost associated with the procedures stated herein will be billed directly to you or to your insurance (as applicable)

electronic medical record review of de-identified patients who tested positive for covid-19 (using a pcr test) at methodist dallas medical center (mdmc) from june 2020 until the date of irb approval. data will be collected on de-identified patients that test positive for covid-19 (using a pcr test) at mdmc from the date of irb approval until december 2022. variables include patient baseline characteristics, patient presentation, imaging and labs. disclaimer: any cost associated with the procedures stated herein will be billed directly to you or to your insurance (as applicable)

Eligibility criteria:
inclusion criteria: * hospitalized patient * adult over 18 years * positive covid-19 pcr test exclusion criteria: * none
clinical efficacy of different revision times in the reulceration rate in persons with diabetes and remission

Conditions: Diabetic Foot

Summary: the goal of this three arms randomized clinical trial is to compare different revision times in persons with diabetes at high risk of suffering a diabetic foot reulceration (patients in remission). the literature suggests to clinically check the patients in a 4-12 weeks basis, despite this, this recommendation is based in expert opinions. the main question it aims to answer is: - does different revision times could affect the reulceration rate in persons with diabetes in remission. different revision time will be 2 weeks, 4 weeks and 6 weeks.

the planned rct try to elucidate if there exist any difference in ulcer recurrence between different revisions times in persons with a previous healed diabetic foot ulcer and currently under remission. there will exist three different groups for analyses after randomization: * group 1: patients revised every fourweeks. * group 2: patients revised every eightweeks. * group 3: patients revised every twelveweeks. main outcome measure will include: - recurrence: the outcome measure was based on recurrent events in the foot in a binary basis (patient with a recurrent event or patient without a recurrent event), as defined according to the iwgdf guidelines. recurrent events were considered as breaks in the foot skin at the epidermis and part of the dermis level. secondary outcome measure will include: * minor lesions: defined as non ulcerative lesions of the skin on the plantar aspect of the foot and included abundant callus, hemorrhage, or a blister. * minor amputations: evaluated in a monthly basis during the 1-year prospective period follow-up period: all the sample will be followed-up depending on the randomization group up to a 1-year prospective period. in every visit de principal investigator will perform debridement of high-risk points, such as minor lesions or calluses.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older. * type 1 or type 2 diabetes. * presence of diabetic polyneuropathy (diagnosed as an inability to sense the pressure of a 10-g semmes-weinstein monofilament at three plantar foot sites and/or a vibration perception threshold \>25 v, as assessed using a bio-tensiometer. * patients classified as high-risk patients (risk 3 patients according to the iwgdf guidance). previous healed diabetic foot ulcer. exclusion criteria: * active diabetic foot ulcers during inclusion. * active charcot foot process. * conditions other than diabetes also associated with foot ulcers were excluded from the study as well.

Keywords: diabetic foot reulceration prevention
efficacy of dextenza insert in upper vs lower punctum following cataract surgery with pciol.

Conditions: Cataract

Summary: to assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (iol) with or without istent/hydrus/goniotomy when placed in the lower punctum compared to the upper punctum.

this is a randomized, controlled study to evaluate the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (iol) with or without istent/hydrus/goniotomy when placed in the lower punctum compared to the upper punctum.

Eligibility criteria:
inclusion criteria: subjects will be eligible for study participation if they: 1. are planning to undergo non-complicated cci ce/pciol in one or both eyes with or without istent/hydrus/goniotomy. 2. are willing and able to comply with clinic visits and study related procedures. 3. are willing and able to sign the informed consent form. 4. not pregnant. exclusion criteria: subjects are not eligible for study participation if they: 1. are currently being treated with corticosteroid implant (i.e. ozurdex). 2. have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye. 3. have a history of complete punctal occlusion in one or both punctum. 4. currently use topical ophthalmic steroid medications. 5. are unwilling or unable to comply with the study protocol. 6. are determined by the investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) or if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment. 7. have active infectious systemic disease. 8. have active infectious ocular or extraocular disease. 9. have unobstructed nasolacrimal duct in the study eye(s) (dacrocystitis). 10. have known hypersensitivity to dexamethasone or are a known steroid responder. 11. have a history of ocular inflammation or macular edema. 12. are currently being treated with immunomodulating agents in the study eye(s). 13. are currently being treated with immunosuppressants an/or oral steroids. 14. are pregnant or breast-feeding or wish to become pregnant during the length of study participation.

Keywords: pciol cci ce
marker technique comparison in targeted axillary dissection

Conditions: Breast Cancer

Summary: comparison of two methods (magnetic marker and standard metal clip) used for localisation and extraction of lymph nodes in targeted axillary dissection (tad) in patients with breast cancer.this project will investigate and compare the duration of intervention, detection rate and safety. the participants will be randomized into two groups of equal size.

this project will investigate and compare the duration of intervention, detection rate and safety of two methods (magnetic sirius pintuition marker and standard metal clip) used for the localisation and extraction of lymph nodes in targeted axillary dissection (tad). the participants will be randomized into two groups of equal size. the groups differ in terms of the method used to mark the lymph nodes prior to tad. one group will receive a metal clip (hydromark© clip), which will be localized and extracted during the tailoring surgery. intraoperative ultrasound is used to localize the clip. this method is considered as standard practice today. the second group will receive metal clip (sirius pintuition) to localize axillary lymph nodes during tad. intraoperative localization of the lymph node will be conducted using a hand-held probe. successful localization of the lymph node, duration of the intervention (beginning of the localization until successful extraction) and adverse effects will be documented.

Eligibility criteria:
inclusion criteria: * indication: patients undergoing lymph node marking before targeted axillary dissection due to suspicious lymph nodes or confirmed lymph node metastasis in breast cancer patients * female participants ≥ 18 years of age * the subject was informed about the project and gave her written informed consent to use her data and samples for this project. * bmi \< 30 * indication for neoadjuvant chemotherapy exclusion criteria: * not fulfilling inclusion criteria
assessing brain metabolism using mrs with deuterated glucose

Conditions: Glioma

Summary: this study will investigate the use of hydrogen 1 (1h) magnetic resonance spectroscopy (mrs) with deuterated glucose (2h-glucose) to detect dynamic glucose uptake in the brain.

primary objective: 1. to define the most appropriate imaging parameters of 1h mrs for obtaining deuterium-labeled glucose metabolism (cohorts 1 and 2). 2. to evaluate treatment induced metabolic changes after the administration of 2h-glucose in participants with glioma (cohort 3). outline: participants with and without glioma will be evaluated to develop a robust strategy for obtaining 2h-glucose metabolism in twenty healthy participants (cohort 1) and thirty participants with glioma (cohort 2), while the remaining thirty glioma participants will be studied at baseline and after completion of non-investigational therapy (cohort 3).

Eligibility criteria:
inclusion criteria: 1. participants must be \>= 18 years old * cohort 1: healthy controls * cohort 2: participants with histological proven glioma who have evidence of evaluable disease (with contrast enhancing lesion or non-enhancing lesion \> 4 cc) based on a prior mr scan, karnofsky performance status of \>=70 and life expectancy \> 4 weeks. * cohort 3: participants with histologically proven glioma who will be undergoing any treatment, karnofsky performance status of \>=70 and life expectancy \> 12 weeks. 2. participants must not have any significant medical illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the subject's ability to participate in this study or any disease that will obscure toxicity or dangerously impact response to the imaging agent. 3. participants must not have a history of any other cancer unless they are in complete remission and have been off all therapy for that disease for a minimum of 3 years. 4. participants must not be pregnant or breast-feeding. persons of childbearing potential are required to obtain a negative serum or urine pregnancy test within 14 days of the scan. effective contraception (men and women) must be used in subjects of childbearing potentials. 5. participants must sign an informed consent indicating that they are aware of the investigational nature of the study exclusion criteria: participants must be excluded from participating in this study if they are not able to comply with the study and/or follow-up procedures. 1. participants exceeding the weight limitations of the scanner (300 pounds) 2. inability to lie still for the entire imaging time (e.g., cough, severe arthritis, etc.) 3. inability to complete the study due to other reasons (severe claustrophobia, mr incompatible medical implants or devices, inability to comply with pre-procedure fasting, etc.) 4. pre-examination blood glucose level of \> 120 mg/dl as measured by point of care finger stick blood glucose test prior to mr examination. 5. participants, either healthy volunteers (recruited for cohort 1) or participants with glioma (for cohorts 2 \&3), have history of diabetes mellitus.

Keywords: glucose metabolism
neurofeedback for stroke rehabilitation

Conditions: Stroke

Summary: real-time neurofeedback aims to alter brain activation patterns through online feedback of ongoing brain activity using magnetic resonance imagining (mri). stroke survivors will be randomised to receive 3 sessions of real or sham neurofeedback. this study aims to investigate whether: 1) stroke survivors can maintain alterations in brain activity after the feedback is removed, 2) neurofeedback training leads to improvements in movement of the hand and arm, 3) neurofeedback training leads to changes in brain structure and function, 4) variability in response across people can be understood.

many stroke survivors experience impairment in upper limb function, reducing independence in activities of daily living. these impairments are associated with atypical brain activity patterns. real-time neurofeedback aims to alter brain activation patterns through online feedback of ongoing brain activity using magnetic resonance imagining (mri). patterns of brain activity are displayed to a participant while a task is being performed. the participant is instructed to try to alter the patterns in a particular way, promoting specific brain activity patterns. previous studies have found that people with and without stroke are capable of utilising the feedback to alter their brain activity. this study aims to investigate whether: 1. stroke survivors can maintain alterations in brain activity after the feedback is removed 2. neurofeedback training leads to improvements in movement of the hand and arm 3. neurofeedback training leads to changes in brain structure and function 4. variability in response across people can be understood. 30 stroke survivors (\> 6 months after stroke), with residual upper limb impairment, will be recruited between february 2018 and december 2020. participants will be randomised to receive 3 sessions of real or sham neurofeedback over one week, taking place at the wellcome centre for integrative neuroimaging, university of oxford. changes in brain activity during affected hand movements will be assessed with and without feedback using functional mri and after feedback sessions using electroencephalography (eeg). brain connectivity and structure will also be assessed using mri at baseline and at a follow-up one week later. clinical measures of upper limb function and impairment will be performed at baseline and at follow up sessions one week and one month later (action research arm test, fugl-meyer upper limb assessment, jebsen taylor hand function test), and in each session following neurofeedback (jebsen taylor test).

Eligibility criteria:
inclusion criteria: * stroke \> 6 months previously * unilateral upper limb impairment, but physically able to complete the tasks required exclusion criteria: * contraindications to mri, such as a pacemaker, metallic implants or aneurysm clips * inability to provide informed consent * inability to actively participate in the research procedures

Keywords: motor function brain activity
electrogastrography in small for gestational age preterm infants

Conditions: Premature Birth

Summary: the purpose of this study is to determine whether small for gestational preterm infants, have delayed or decrease gastric motility compared to appropriate for gestational age preterm infants.


Eligibility criteria:
inclusion criteria: 1. preterm infants 32-37 weeks' gestation 2. no sepsis or ventilation 3. feeding orally or with ng tube. 4. age \<48 h to be included exclusion criteria: 1. ge reflux 2. medication that affect gastric motility

Keywords: preterm infants small for gestational age electrogastrography