Kornimate/medical-research-clean huggingface dataset:
treatment for giant cell arteritis with tocilizumab and 8 as compared to 26 weeks of prednisone

Conditions: Giant Cell Arteritis (GCA)

Summary: the gisco study plans to determine whether 8-week therapy is just as effective as 26-week cortisone therapy for treating giant cell arteritis * with tocilizumab, * while using less cortisone.

the aim of this randomized clinical trial investigates whether 1) a shortened gc 8-week regimen is as effective as the current 26-week regimen and 2) associated with less gc exposure when introducing a gc-sparing agent in the treatment of gca.

Eligibility criteria:
inclusion criteria: * patients diagnosed with giant cell arteritis * start of tocilizumab treatment at baseline as part of routine clinical practice * receive ≥ 20 mg/day prednisone (or equivalent) at baseline * written informed consent exclusion criteria: * treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of tocilizumab.

Keywords: tocilizumab glucocorticoid prednisone giant cell arteritis
t-spot.cmv and t-spot.prt diagnostic assays

Conditions: Infection in Solid Organ Transplant Recipients

Summary: the t-spot assay quantifies the number of peripheral blood interferon-γ producing effector t cells \[spot forming cells/million peripheral blood mononuclear cells - pbmc)\]. the t-spot platform technology can be applied to diagnose and monitor any major disease process driven by a t cell response, including a viral disease such as cytomegalovirus (cmv) infection (the t-spot.cmv assay) or an allograft rejection (the t-spot.prt assay).

approximately 600 subjects who meet inclusion/exclusion criteria will be enrolled in the prospective, non-randomized, observational study. sample size is based on having an adequate overall number of subjects to assess the t-spot.prt endpoint (350) and the t-spot.cmv endpoint (250) in the defined populations. subjects may be enrolled from pre-transplantation to post-transplantation up to completion of antiviral prophylaxis. study duration: 37 months; 25 months to enroll all subjects with 12 months (365 days) of patient participation. study population: all subjects enrolled in this study will be men or women, aged 18 years or older and recipients of a first or subsequent renal transplant.

Eligibility criteria:
inclusion criteria: 1. active candidate or recipient of a kidney transplant. patients enrolled post-transplant must be within 6 months of transplantation and on active cmv anti-viral prophylaxis. 2. age ≥ 18 years. 3. cmv serology of donor and recipient confirmed prior to enrollment. for seronegative subjects (r-), cmv serostatus should be confirmed within eight weeks prior to transplant by the site local laboratory. 4. able to provide t-spot pre-transplant samples up to a maximum of one month prior to transplant (in the interval between day -30 and day 0), or at the time of enrollment if this occurs following transplantation. 5. irb approved written informed consent and privacy language per national regulation (e.g., health insurance portability and accountability act for us sites) must be obtained from the subject or legally authorized representative prior to any study related procedures, including screening evaluations and tests. exclusion criteria: 1. anemia prior to transplant that indicates not a candidate for blood draw. 2. on active immunosuppression within two months prior to transplant. 3. multi-organ transplant (dual-kidney allocation is allowed). 4. subject has received prior exposure to a cmv vaccine. 5. subject has undergone or is planning to undergo plasmapheresis. 6. subject requires desensitization for abo blood type incompatibility or a positive t or b-cell crossmatch. 7. subject is known to be hiv positive. 8. subject is known to have a clinically significant medical or psychiatric condition considered a high risk for participation in an investigational study.

Keywords: cmv
nuvasive® acp system study

Conditions: Cervical Spondylosis; Cervical Radiculopathy; Cervical Myelopathy; Cervical Disc Disease; Cervical Stenosis; Cervical Disc Herniation; Cervical Spine Disease

Summary: the primary objective of this study is to evaluate the safety and performance of anterior cervical spine surgery using the nuvasive anterior cervical plate (acp) system as measured by reported complications, radiographic outcomes, and patient-reported outcomes (pros).

this study is a prospective, uncontrolled, multicenter study to evaluate the safety and performance of the nuvasive acp system in patients who undergo anterior cervical spine surgery. consecutive patients at a given site who meet eligibility requirements will be asked to consent to participate in the study. these patients will present with pathologic conditions in the cervical spine that are amenable to surgical treatment and will be screened prior to study enrollment. once enrolled in the study, subjects will undergo anterior cervical spine surgery using the nuvasive acp system based on the surgeon's standard of care. at least 75 subjects will be enrolled and will be followed for 24 months after the surgery.

Eligibility criteria:
inclusion criteria: 1. patients who are ≥18 years of age at the time of consent 2. have planned anterior cervical (c2 to c7) spine surgery using the nuvasive acp system in conjunction with a nuvasive interbody implant or vertebral body replacement device (vbr), or a structural bone allograft spacer, for treatment of any of the following conditions: 1. degenerative disc disease, as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies 2. trauma (including fractures) 3. tumors involving the cervical spine 4. cervical spinal deformity (kyphosis, lordosis, or scoliosis) 5. failed previous cervical fusion(s) (e.g., pseudoarthrosis) 6. cervical spondylolisthesis 7. cervical spinal stenosis 3. able to undergo surgery based on physical exam, medical history, and surgeon judgment 4. understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study exclusion criteria: 1. procedures performed with interbody implants with integrated vertebral body screw(s) 2. patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested) 3. use of bone growth stimulators postoperatively 4. active smoking within 6 weeks of surgery 5. patient has known sensitivity to materials implanted 6. systemic or local infection (latent or active) or signs of local inflammation 7. patient has inadequate bone stock or quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment 8. pregnant, or plans to become pregnant 9. patient is a prisoner 10. patient is participating in another clinical study that would confound study data

Keywords: spine surgery
long-term safety study of gs-6624 in adults with idiopathic pulmonary fibrosis (ipf)

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the primary objective of this study is to evaluate the long term safety and tolerability of simtuzumab (gs-6624) in participants with idiopathic pulmonary fibrosis (ipf) who had previously participated in gilead clinical trial ab0024-201.


Eligibility criteria:
key inclusion criteria: * previous participation in phase 1 gilead clinical trial * diagnosis of idiopathic pulmonary fibrosis * females of childbearing potential and non-vasectomized males must agree to use highly effective methods of contraception * females must discontinue nursing * comply with study requirements * have adequate organ function key exclusion criteria: * history or evidence of clinically significant disorder, condition or disease that would pose a risk or interfere with the study * pregnant or lactating * clinically significant heart, hepatic or renal disease * history of cancer within 5 years of screening * infection that is not controlled despite antibiotics or other treatment * history of bleeding diathesis within the last 6 months of day 1 * known history of human immunodeficiency virus, hepatitis b or c * concern's for subjects compliance * other conditions that might put the subject at high risk for treatment complications or reduce the chance to obtain data required * placed on a lung transplant list * previous participation in an idiopathic pulmonary fibrosis clinical trial other than for simtuzumab note: other protocol defined inclusion/exclusion criteria may apply

Keywords: idiopathic pulmonary fibrosis ipf
the findings of ultrasound elastography and arfi in strokes patients with spastic elbow flexor

Conditions: Cerebrovascular Accident

Summary: the aim of this study: 1. to evaluate the correlation between the clinic tools and ultrasound elastography/ arfi imaging in stroke patients. 2. to assess the reliability of elastography/ arfi imaging in spasticity evaluation of stroke patients.

modified ashworth scale (mas) and modified tardieu scale (mts) are the most commonly used tools for spasticity assessment. but these clinic methods cannot reveal the architecture and stiffness of muscles. in recent years, ultrasound elastography and acoustic radiation force impulse (arfi) are used in musculoskeletal disorders, including spasticity. there are no studies about the correlation between spasticity and ultrasound elastography /arfi imaging in stroke patients. the investigators will enroll 50 stroke patients with hemiplegia and biceps brachii muscle spasticity. one physical therapist will measure mas and mts for spasticity of biceps brachii muscle. two physiatrists will perform ultrasound elastography and arfi for intra-rater and inter-rater reliability evaluation. the evaluations of b-mode ultrasound, elastography and arfi included heckmatt scale, biceps brachii ratio, strain ratio, dynamic sonoelastography score, color intensity, and shear wave velocity. after performing all assessments, the investigators will analyze the correlation between the clinic tools and elastography/ arfi imaging and evaluate the reliability of elastography/ arfi imaging in spasticity evaluation.

Eligibility criteria:
inclusion criteria: * stroke patients with hemiplegia and biceps brachii muscle spasticity. exclusion criteria: * elbow joint contracture deformity * combined other neuromuscular system disease * affected upper extremity has local infection * patient who can't follow instruction, who is restlessness and whose elbow can't meet the positioning criteria

Keywords: spasticity stroke ultrasound elastography acoustic radiation force impulse
the lung microbiome and endobronchial valve treatment

Conditions: Chronic Obstructive Pulmonary Disease; Emphysema

Summary: lung emphysema is often associated with chronic obstructive pulmonary disease (copd) and without any cure. dyspnea is the main, debilitating symptom and is relieved by inhaled bronchodilators and rehabilitation. however, a substantial number of patients continue to suffer from dyspnea and among these, many patients have severely hyperinflated lungs due to predominant emphysema. for selected patients, lung transplantation or lung volume reduction by surgical removal (lvrs) of the most emphysematous parts of the lung can improve symptoms and survival. however, lvrs is related to complications and not all patients are suitable for surgery. an alternative to lvrs is bronchial lung volume reduction with endobronchial valves (ebv). one-way valves are inserted in the bronchial system using a bronchoscope and it has emerged as a valid treatment option with similar effects as lvrs with reduction of hyperinflation and increasing pulmonary function, quality of life, and exercise capacity. the normal lung is colonized with several types of bacteria, and together this is called the microbiome. some bacteria are potentially beneficial, while others are potentially harmful. after the insertion ebv, some patients develop chronic infections. the hypothesis is that the microbiome can affect the risk of this chronic infection, and therefore the objective of this study is to access the microbiome during the insertion of the ebv, and afterwards observe which patients develop chronic infection and if these patients are harbouring specific types of bacteria.

the objective of this study is primarily to investigate the significance of the lung microbiome on the outcome and morbidity after ebv treatment. second, to investigate the evolution of the lung microbiome in patients later requiring valve removal or clean-up. before the insertion of the ebv, but during the procedure, the patient will undergo a bronchoalveolar lavage (bal). bal fluid will undergo bacterial profiling through s16-ribosomal analysis and ordinary bacterial culturing. number of infections and need for clean-up or valve removal will be registered during the following 24 months, where the patient follows the ordinary follow-up programme. as a secondary part of the study, during the potential clean-up or valve removal, the removed material will again undergo s16-ribosomal analysis and bacterial culturing to investigate shift in microbiome.

Eligibility criteria:
inclusion criteria: * copd patients with emphysema selected for ebv treatment by multidiciplinary team, independent of this study. * written informed consent exclusion criteria: - intake of oral antibiotics within 1 month before the procedure. patients receiving preventive long-term treatment with antibiotics can be included.
evaluation of metzenbaum technique in correction of caudal end nasal septal deviation

Conditions: Nasal Septal Caudal Dislocation

Summary: • to evaluate the results of metzenbaum 's technique in correction of the caudal end septal deviation on nasal airway obstruction

deviation of nasal septum in different parts may have various functional or aesthetic effects . the etiology of a deviated septum is generally congenital, but may also be as a result of trauma or iatrogenic causes. most important is the caudal septal deviation which narrows the airway and impairs major mechanisms supporting the tip, leading to tip-ptosis and airway collapse. .the correction of caudal septal deviations can be a challenging problem so many techniques have been described and tested to correct caudal septal deflections . attempts to correct nasal septal deformities were described in the medical literature as early as the late 19th century , and till now there is not one specific technique that is agreed upon by surgeons worldwide.

Eligibility criteria:
inclusion criteria: * patients presenting to assiut university clinic of otolaryngology department. * aging from 16 to 45 years old * patients complaining of nasal airway obstruction causes by caudal septal deviation. exclusion criteria: * other causes of airway obstruction e.g. nasal polyps, hypertrophied inferior turbinates' * external nasal deformities * contraindications for general anesthesia

Keywords: caudal end nasal septal deviation
safety of inhaled hydrogen gas mixtures in healthy volunteers

Conditions: Healthy

Summary: hydrogen gas may decrease the degree or incidence of brain injury following ischemia. the purpose of this study is to determine the safety and tolerability of inhaled hydrogen gas at the dose exposures required for a clinical efficacy study in healthy adult participants. participants will breathe a gas mixture that contains a low concentration of hydrogen gas in air through a high flow nasal cannula. investigators will test for any changes in breathing and neurologic status, as well as lab tests during and following the exposure period.

inhaled hydrogen gas (h2) has been shown to have significant protective effects on ischemic organs. clinical trials abroad have shown promise that treatment of patients suffering from stroke, cardiac arrest, or heart attacks may benefit from inhaling hydrogen gas during the early recovery period. the purpose of this study is to determine the safety and tolerability of inhaled hydrogen gas at the dose exposures required for a clinical efficacy study in healthy adult volunteers. study design. eight (8) healthy adult participants will be recruited from the greater boston area for this study. consenting participants will be admitted to the hospital and will undergo a series of screens (questionnaires, examination, tests) to ensure suitability to participate. eligible and consenting participants will then undergo exposure to 2.4% h2 in medical air via high flow nasal cannula for either 24 (n=2), 48 (n=2) or 72 (n=4) hours. participants will be screened for adverse effects as follows: vital signs every 8 hours, nursing assessment of symptoms (codified based on the national cancer institute's common terminology criteria for adverse events, ctcae) every 8 hours, bedside spirometry daily, mini-mental state exam daily, physician physical exam daily, and serum testing (blood count, chemistry, liver and coagulation profile, venous blood gas) following exposure period.

Eligibility criteria:
inclusion criteria: 1. age 18 to 35 2. able to remain inpatient for duration of admission (24-72 hours) exclusion criteria: 1. history of any chronic illness, including respiratory disorders such as asthma, chronic obstructive pulmonary disease, prior acute lung injury or acute respiratory distress syndrome; 2. inflammatory disorders, such as lupus erythematosus, inflammatory bowel disease; 3. heritable disorders, such as trisomy 21, cystic fibrosis; 4. mitochondrial disorders; 5. currently smoking cigarettes or have a history of smoking cigarettes; 6. the regular use of prescription medications (except for contraceptive medications) within 30 days of enrollment; 7. any lifetime inpatient hospitalization for respiratory illness; 8. pregnancy.
effectiveness and safety of korean medicine for lumbar stenosis patients with sciatica

Conditions: Lumbar Spinal Stenosis

Summary: a prospective study investigating the effectiveness and safety in lumbar stenosis patients receiving integrative korean medicine treatment at 3 locations of jaseng hospital of korean medicine through assessment of pain, functional disability, and quality of life

this is a prospective study to the aim of investigating the effectiveness and safety in patients with neurogenic claudication diagnosed as lumbar stenosis by lumbar mri and receiving integrative korean medicine treatment (herbal medicine, chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, and cupping) at 3 locations of jaseng hospital of korean medicine (bucheon, daejeon, busan (haeundae)) through assessment of pain, functional disability, and quality of life with 1-year follow-up period

Eligibility criteria:
inclusion criteria: * patients with radiating leg pain with or without low back pain (lbp) (walking pain nrs ≥4) * patients with dural sac cross-sectional area (dsca) of \<100 mm2 or morphological grading ≥b as assessed on mri * patients with clear neurogenic claudication symptoms (symptoms aggravated with walking, and alleviated upon resting in lumbar flexion position) * patients who have received surgery recommendation for lumbar spinal stenosis * patients with plans of receiving korean medicine treatment for lumbar spinal stenosis for ≥2 months * patients who have agreed to study participation exclusion criteria: * patients with vascular claudication * patients with other systemic diseases that may interfere with treatment effect or outcome interpretation * patients with soft tissue pathologies or pathologies of non-spinal origin that may cause lbp or radiating leg pain (e.g. spinal tumor, rheumatoid arthritis) * patients for whom acupuncture treatment may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, serious diabetes with risk of infection, severe cardiovascular diseases, or other conditions deemed unsuitable for acupuncture treatment) * pregnant patients or patients planning pregnancy * patients with serious psychological disorders * patients unable to fill out study participation consent form * subjects deemed unsuitable for study participation as assessed by the researchers

Keywords: magnetic resonance imaging patient satisfaction numeric rating scale
bioequivalency study of 5 mg piolocarpine tablets under fed conditions

Conditions: Dry Mouth

Summary: the objective of this study was the bioequivalence of a roxane laboratories' pilocarpine tablets, 5 mg, to salagen® tablets, 5 mg (mgi pharma) under fed conditions using a single-dose, 2-treatment, 2-period, crossover design.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to pilocarpine or any comparable or similar product.
tissue and functional assessment of myocardial injury in hodgkin lymphoma (hl) survivors

Conditions: Hodgkin Lymphoma Survivor

Summary: this study will test whether cardiac mri can improve early detection of hodgkin lymphoma associated heart disease compared to a stress echocardiogram. by doing both stress echocardiography and cardiac mri, we will compare the ability of the two tests to detect heart disease.


Eligibility criteria:
inclusion criteria: * classical or nodular lymphocyte predominant hl treated at memorial sloan-kettering cancer center. * age ≥ 18 years * treatment for hl that included mediastinal rt at initial diagnosis or relapse. * ≥ 5 years from last hl treatment. exclusion criteria: * primary hl diagnosis prior to 1980. * additional mediastinal rt or subsequent cardiotoxic systemic therapy for secondary malignant neoplasm. * known cad/chf (defined as documented myocardial infarction, cardiac revascularization, angiographic obstructive cad, or decreased lv function \[ef \< 55%\] during prior clinical care). * contraindication to mri (i.e. pacemakers, defibrillators, or aneurysm clips, or other implanted ferromagnetic objects), gadolinium (i.e. known hypersensitivity to gadolinium, advanced renal insufficiency as defined by glomerular filtration rate \<30 ml/min/1.73m\^2). * contraindication to exercise stress testing other than the above (i.e. unstable angina or severe valvular stenosis).

Keywords: mri stress echo clinical assessment 14-017