Kornimate/medical-research-clean huggingface dataset:
a safety and effectiveness study of the md-12-001 stent in the treatment of superficial femoral artery or popliteal artery blockages in japanese patients

Conditions: Arterial Occlusive Disease

Summary: the purpose of this study is to assess the safety and effectiveness of the md-12-001 stent in the treatment of superficial femoral artery and proximal popliteal artery blockages in japanese patients.


Eligibility criteria:
key inclusion criteria: * rutherford category 2-4 (mild intermittent claudication (pain while walking)to ischemic pain (pain due to decreased blood flow) at rest). * the target lesion(s) has evidence of narrowing or blockage and can be stented. * the total length of the lesion or series of lesions is estimated to be less than or equal to 150 mm. * the target vessel reference diameter is greater than or equal to 4.0 mm and less than or equal to 6.5 mm key exclusion criteria: * the subject has a known reaction (including allergic reaction) or sensitivity to blood thinning medications, or study device materials (nickel, titanium or tantalum) * the subject has a known sensitivity to medical imaging substances (contract media) that cannot be pretreated with medications (steroids or/and antihistamines) * the subject has a history of bleeding disorders (diatheses or coagulopathy). * the subject has kidney failure or is having dialysis treatment. * the subject has insufficient liver function, swelling of vein(s) caused by blood clot (thrombophlebitis), uremia, systemic lupus, or deep vein blood clots. * subject has acute limb ischemia (a sudden loss of blood flow to the limb). * subject has a history of bypass surgery on the study vessel. * subject has a history of heart attack or stroke within 6 months of study procedure. * the subject is receiving immunosuppressive therapy (medications that lower the body's normal immune response). * the subject is diagnosed with a severe infection (septicemia). * principal investigator determines the subject's condition would prevent the subject from undergoing the study procedure or cannot support a vascular bypass graft. * the subject with a stent previously implanted into the target vessel. * subject has disease in both legs where both limbs meet the inclusion criteria and it is planned to treat both limbs within 30 days. * pregnant, possibly pregnant and/or nursing female subjects are excluded, as are female subjects who are willing to have a baby during the trial. * the subject is participating in an investigational drug or another investigational device study. * subject has a large amount of blood clot next to the study lesion.
comparison between rifampicin and gemifloxacin and ciprofloxacin in treatment of rhinoscleroma

Conditions: Rhinoscleroma

Summary: gemifloxacin versus ciprofloxacin and rifampicin in treatment of rhinoscleroma

rhinoscleroma is a chronic specific granulomatous inflammation affecting nose in 95-100% but can affect any part of respiratory tract.(1) it is an endemic disease in egypt. it is endemic as well in sporadic areas worldwide including central america, chili, central africa, india, indonesia and middle east countries.(2) it is completely eradicated from the developed communities. if not treated early, the disease progresses to the final sclerotic phase where permanent complications including nasal deformities, anosmia, dysphonia, dysphagia and stridor could happen.(3-5) of the wide treatments range (antibiotic combinations, cytostatic drugs, radiation, and laser), none is ideal. the causative organism is resistant to most antibiotics and, being intracellular, is not always exposed to sufficient concentrations of drug. a clinical cure is hard to identify because the end-stage is mucosal fibrosis which, even without active infection, interferes with normal function of the upper respiratory tract. the fibrosed mucosa, especially in crusts, can become secondarily infected with bacteria, which may include klebsiella.(6) rifampin (7), streptomycin (8), ciprofloxacin (5) and levofloxacin (9) have been used in treatment of rhinoscleroma. most patients are from a low socioeconomic group and cannot afford the price of antibiotics to which klebsiella is susceptible. (6) the usual regimen given for free by the ministry of health in egypt in histologically positive cases is rifampicin 300 mg twice daily for six months (based on a nasal biopsy and documented as a tuberculosis, not rhinoscleroma, to allow free delivery of the medication) then another biopsy is taken to identify if cure or not. if not, rifampicin is given for another six months and so on. unfortunately, due to the high level of antimicrobial resistance, poor patients' compliance, and drugs side effects, the treatment failure rate is increasing. so there is a real need for an alternative drug that is effective, safe and has a short treatment course. gemifloxacin is a new fluoroquinolone that has bactericidal activity. it has good intracellular penetration and low toxicity.(10) it is more potent than ciprofloxacin, ofloxacin and levofloxacin.(11)

Eligibility criteria:
inclusion criteria: 1. age above 18 years 2. active rhinoscleroma proved both clinically and histopathologically exclusion criteria: 1. patients younger than 18 years old. 2. inactive rhinoscleroma 3. contraindication to treatment severe renal or hepatic impairment 4. refusal of enrollment in the research by the patient

Keywords: rhinoscleroma gemifloxacin ciprofloxacin
a study evaluating the safety and pharmacokinetics of escalating doses of forimtamig in participants with relapsed or refractory multiple myeloma (r/r mm)

Conditions: Multiple Myeloma

Summary: this is a first-in-human, open-label, uncontrolled, multi-center, monotherapy, dose-escalation and dose expansion study. forimtamig will be administered to participants with r/r mm for whom no standard-of-care treatment exists or who are intolerant to those established therapies. the study consists of two parts: dose-escalation of forimtamig (part 1) and a randomized dose expansion of forimtamig (part 2).


Eligibility criteria:
inclusion criteria: * previously diagnosed with multiple myeloma (mm) based on standard criteria. * dose escalation phase and dose expansion phase: participants with r/r mm who have previously received therapy with an immunomodulatory drug (imid) and proteasome inhibitor (pi) and are intolerant to or have no other option for standard-of-care treatment according to the investigator. * life expectancy of at least 12 weeks. * agreement to provide protocol-specific biopsy material. * aes from prior anti-cancer therapy resolved to grade =\<1. * measurable disease. * for female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating eggs. * for male participants: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm. exclusion criteria: * inability to comply with protocol-mandated hospitalization and activities restrictions. * pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after last dose of study drug. * prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate for mm treatment within 2 weeks before first forimtamig administration. * prior treatment with systemic immunotherapeutic agents within 2 weeks before first forimtamig administration. * treatment-related, immune-mediated aes associated with prior immunotherapeutic agents. * treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 2 weeks, prior to first forimtamig administration. limited field palliative radiotherapy for bone pain or for soft tissue lesions is allowed. * autologous or allogeneic stem cell transplantation (sct) within 100 days prior to first forimtamig infusion and/or signs of chronic graft versus host disease or ongoing immunosuppressive medication. * prior solid organ transplantation. * active auto-immune disease or flare within 6 months prior to start of study treatment * any medical condition or abnormality in clinical laboratory tests that, in the investigator's or medical monitor's judgment, precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results.
a study of zetomipzomib (kzr-616) in patients with active lupus nephritis (palizade)

Conditions: Lupus Nephritis

Summary: the purpose of this study is to assess the efficacy and safety of zetomipzomib (30 mg or 60 mg) compared with placebo in achieving renal response after 52 weeks of treatment in patients with active lupus nephritis (ln).

this study aims to investigate whether zetomipzomib, added to standard of care treatment in patients with active ln, is able to reduce disease activity over a treatment period of 52 weeks. the background standard of care therapy will be mycophenolate mofetil (mmf) and initial optional treatment with iv methylprednisolone, followed by a tapering course of oral corticosteroids. patients are required to have a diagnosis of ln according to established diagnostic criteria and clinical and biopsy features suggestive of active nephritis. patients will be randomized in a 2:1 ratio to receive either zetomipzomib (30 mg or 60 mg) or placebo administered as a subcutaneous injection once weekly for 52 weeks, followed by a 4-week safety follow-up period. efficacy will be assessed by measuring the level of proteinuria (as measured by urine protein to creatinine ratio \[upcr\]) and estimated glomerular filtration rate (egfr) as compared to current standard of care treatment. safety will also be assessed throughout the study to ensure an acceptable safety profile.

Eligibility criteria:
key inclusion criteria: * body mass index of ≥18 kg/m\^2 * egfr ≥30 ml/min/1.73 m\^2 * unequivocally positive ana test result and/or a positive anti-dsdna serum antibody test * diagnosis of ln according to 2003 or 2018 isn/rps criteria and confirmed by renal biopsy performed within 12 months prior to screening. * upcr ≥1.0 (class iii/iv +/-v) or upcr ≥2.0 (class v) * adequate hematologic, hepatic, and renal function key exclusion criteria: * current or medical history of: * central nervous system manifestations of sle * overlapping autoimmune condition that may affect study assessments/outcomes * antiphospholipid syndrome with history of thromboembolic event of within the 52 weeks prior to screening * thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies (i.e., plasmapheresis or acute blood or platelet transfusions * solid organ transplant or planned transplant during study * malignancy of any type, with exceptions for non-melanoma skin cancers and certain cancers \>5 years ago * has received dialysis within the 52 weeks prior to screening * positive test at screening for hiv, hepatitis b/c * known intolerance to mmf or equivalent and corticosteroids

Keywords: immunoproteasome inhibition selective immunoproteasome inhibition complete renal response partial renal response glucocorticoids steroids sle (systemic lupus erythematosus upcr (urine protein to creatinine ratio) egfr (estimated glomerular filtration rate)
prospective registry of corona virus disease 2019 (covid-19) patients with neuromuscular involvement

Conditions: COVID; Sars-CoV2; Corona Virus Infection; Myositis; Myocarditis

Summary: prospective registry for multimodal assessment of neuromuscular pathology associated with severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection, enrolling consecutive patients with corona virus disease 2019 (covid-19), who are admitted to the intensive care unit of the department of anesthesiology and intensive care medicine, or the department of neurology at tübingen university hospital.

the prospective registry shall provide new insights into muscular involvement associated with severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection. for that reason consecutive patients with proven corona virus disease 2019 (covid-19), who are admitted to the intensive care unit of the department of anesthesiology and intensive care medicine, or the department of neurology at tübingen university hospital, are enrolled. multimodal assessment of neuromuscular pathology is based on medical history, laboratory biomarkers including inflammation parameters and autoimmune antibodies, vital parameters monitoring, muscle ultrasound, transthoracic echocardiography, electroneurography, as well as electromyography. inclusion of follow-up visits permit longitudinal and prognostic evaluation of diagnostic and therapeutic interventions (e.g. immunomodulation with immunoglobulins, corticosteroids, or interleukin 6 receptor antagonists).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * proven severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection exclusion criteria: * active or known history of myopathy or advanced stage neuropathy * refusal to participate in clinical research
the relationship between adipokines, obesity and insulin resistance in women with polycystic ovarian syndrome

Conditions: Polycystic Ovarian Syndrome

Summary: to evaluate possible clinical effects of adipokines , ( ghrelin, resistin and adiponectin), in obese and non-obese patients with polycystic ovary syndrome (pcos).

seventy selected pcos patients will be recruited for this study, and will be divided into two groups based on their body mass index (bmi): 35 obese (bmi≥ 25 kg/m2, group a), 35 non-obese (bmi\<25 kg/m2, group b). in addition, 35 healthy non-obese women (bmi\<25 kg/m2) will bw enrolled as the control (group c). serum levels of fsh (follicle stimulating hormone), lh (luteinizing hormone), t(testosterone), glucose, insulin, adiponectin, resistin and resistin will bw detected, and compared the differences of them among three groups

Eligibility criteria:
inclusion criteria: * females with pcos in child bearing age who presented at reproductive and endocrinology clinics at ain shams university maternity hospital exclusion criteria: * known androgen secreting tumor. * pco on ovarian stimulation medications * pco with any other medical illness.
community based music and dance movement therapy group for older adults with dementia

Conditions: Dementia

Summary: this study explores the value of a particular community based music and dance movement therapy group for older adults with dementia? to answer this question, the investigators intend to address the following two sub-questions: 1. how does participants' use of music and movement change over time? 2. did a music and dance movement therapy group improve participants' depressive symptoms?

a systematic review identified a need to explore the value of an arts therapies group for older adults with dementia living in the community with early to moderate stage dementia. this client population commonly experience depression, social withdrawal and cognitive difficulties and literature suggests a music and dance movement therapy group could potentially make a contribution to both reducing symptoms and improving communication and wellbeing. however, there is still lack of clarity on clinically meaningful outcome measures, detail regarding the therapeutic process and questions remain regarding the trustworthiness of qualitative observations. this mixed method feasibility study aims to test whether the interventions translate to a community setting, provide richer insight into the meaningful aspect of the therapeutic process and provide some preliminary quantitative findings.

Eligibility criteria:
inclusion criteria: * over 65 years old * living in the community * diagnosis of dementia * adequate functional hearing/vision * sufficient knowledge of english to understand participant information sheet exclusion criteria: * participants excluded if they suffered from any physical or psychological conditions that make it difficult to access a group setting independently.
success of paravertebral blocks in analgesia for interventional hepatic procedures

Conditions: Liver Neoplasms

Summary: this study is aimed at assessing whether performing a paravertebral block (a type of regional pain relief) can reduce the pain and anxiety patients experience during radiological procedures on the liver.

percutaneous procedures of the liver can be very painful and range from bliliary drain insertions to tumor ablation procedures. the study will randomize patients in two groups, one receiving a paravertebral nerve block prior to the procedure and one receiving a sham procedure in which saline will be injected in the paravertebral space. pain scores and use of iv sedation will be monitored post procedure and both groups will be compared to assess whether paravetebral nerve blocks are effective at reducing pain in patients receiving such procedures.

Eligibility criteria:
inclusion criteria: * male or non-pregnant female subjects, between the ages of 18 and 80 at the time of enrollment. subjects referred for liver/biliary interventions to the angiography department. written informed consent to participate in the study. ability to comply with the requirements of the study procedures exclusion criteria: * subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment. subjects with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study. patients will only be excluded on this basis following discussion with another interventional radiologist. subjects who are uncooperative or cannot follow instructions. mental state that may preclude completion of the study procedure or ability to obtain informed consent. pregnant or nursing female subjects. patient who are to undergo liver biopsy or routine biliary tube exchange. patients with neurological/spinal conditions, or a bmi over 40, that would prevent safe/effective or well-targeted paravertebral blockade. patient unable to tolerate the paravertebral block procedure, for example due to inability to lie prone
clinical validation of the m5l lung cad

Conditions: Lung Cancer Metastatic

Summary: to compare the diagnostic performance and time efficiency of computer-aided detection (cad) assisted reading for the identification of pulmonary nodules in chest computed tomography (ct) from oncological patients with that of unassisted reading.

the main aim of this study is to compare the diagnostic performance of cad assisted interpretation with that of unassisted reading in the detection of lung metastases in consecutive patients staged for extrathoracic malignancies. this study also aims at validating a new web/cloud based workflow for the use of cad systems in clinical practice, not requiring installation of additional software or hardware and potentially representing a cost-effective cad solution for clinical facilities.

Eligibility criteria:
inclusion criteria: * diagnosed extra-thoracic neoplasm exclusion criteria: * more than 10 nodules * severe pulmonary fibrosis * diffuse bronchiectasis * extensive inflammatory consolidation * massive pleural effusion * pregnancy

Keywords: computer-aided diagnosis web cloud computing lung cancer
safety and efficacy of the sl plus and the sl plus mia hip stem

Conditions: Coxarthrosis

Summary: randomized controlled trial using two types of hip stems, sl plus mia (control group) and sl plus (study group). we compare primary and secondary stability of both hip stems for radiographic outcome using ebra (ein-bild-roentgen-analyse) after a two year follow-up period. further, we compare all differences in clinical outcome using harris hip score, oxford hip score and radiographic findings.

this study is a monocentric study, randomized and controlled including two types of hip stems: sl plus mia (control group) and sl plus (study group). each group will include 45 patients where a number of 5 patients for each group calculated extra in case of loss. patients will be followed after * 6 weeks * 6 months * 12 months * 24 months. radiographs are taken in a-p and lateral view using a standard protocol. primary and secondary stability of both hip stems will be analyzed using the ebra software (ein-bild-roentgen-analyse, university of innsbruck, austria) after the completion of the two year follow-up. further, we compare all differences in clinical outcome using harris hip score, oxford hip score and radiographic findings such as radiolucent lines.

Eligibility criteria:
inclusion criteria: * patient needs primary total hip arthroplasty with sl-plus (standard or lateralized depending on bone morphology) * age at surgery : 18-80 years old * patient has social security number * patient gives informed consent (ic) by signing the ic form and patient is willing to attend the follow-up control exclusion criteria: * patient's bmi is over 35 * patient has bone tumors that can affect implant stability * patient needs cortical steroid treatment * patient needs hip revision arthroplasty * patient has general inflammation that could affect bone quality * patients classified charnley c

Keywords: hip arthroplasty primary stability secondary stability ebra
iudr/budr cell cycle labelling

Conditions: Hematologic Malignancies

Summary: to determine cell cycle parameters and changes after treatment, the labelling agent is given and a bone marrow aspiration is accomplished before treatment and after treatment for comparison. participants must be undergoing concurrent therapy for hematologic malignancy.

cell cycle parameters include li, ts, tc, t dpot, changes in these parameters, and differences between normal and leukemic cells in patients with hematologic malignancy prior to and following treatment.

Eligibility criteria:
histologic proof of one of: * aml, all, or aul * mds or cmml * cml * or undergoing bone marrow transplantation. participants should be: * off therapy for at least two weeks * at least 18 years old or older * using adequate contraception if of child-bearing capability.

Keywords: cell cycle interphase g0 g1 g2 s phase
icare self-tonometry - a head-to-head comparison to the gold standard goldmann tonometer

Conditions: Glaucoma

Summary: the purpose of this study is to compare glaucoma patients' own i care measurements by the standard goldmann applanation tonometer intraocular pressure (iop) measurements.

not necessary

Eligibility criteria:
inclusion criteria: * ocular hypertension (oht):with/without glaucoma drugs * primary open angle glaucoma (poag)- high pressure: diagnosis based on optic nerve head rim loss and/or visual field defects and intraocular pressure (iop) \>21 mmhg. * primary open angle glaucoma, normal pressure: cfr high pressure but intraocular pressure ≤ 21 mmhg * exfoliative glaucoma (pex): diagnosis based on optic nerve head rim loss and/or visual field defects and intraocular pressure (iop) \>21 mmhg, with exfoliation material in the anterior segment. * pigmentary glaucoma (pdg): diagnosis based on optic nerve head rim loss and/or visual field defects and intraocular pressure (iop) \>21 mmhg, with krukenberg's spindle and/or pigment dispersed on the trabecular meshwork. exclusion criteria: * age \<18 years * other glaucoma types * corneal pathology (edema, dystrophia, corneal transplantation, severe keratoconus, permanent contact lens wear, recurrent corneal erosion) * severe arthritis (unable to handle home i care device) * lack of comprehension * intra ocular surgery and laser treatment during the last 6 months

Keywords: intraocular pressure tonometry, ocular icare