Kornimate/medical-research-clean huggingface dataset:
urinary tract infection study with the antibiotic levofloxacin given at a higher dose over a shorter period of time

Conditions: Complicated Urinary Infection

Summary: the purpose of the study is to compare the safety and effectiveness of the antibiotic levofloxacin by administering a higher dose of levofloxacin and using a shorter course of therapy.

this study will be a pilot study of the efficacy of 750 mg of levofloxacin once daily for 5 days in the treatment of complicated urinary tract infection. the specific objectives include: 1. to describe clinical and microbiological outcome at short and long term follow-up with 5 days levofloxacin in subjects with acute symptomatic complicated urinary infection, both with and without indwelling catheters. 2. to determine the tolerability of levofloxacin 750-mg once daily in patients with complicated urinary infection. 3. to describe some characteristics of the resolution of the inflammatory response with treatment of complicated urinary infection as demonstrated by changes in urine proteins. 4. to identify any emergence of resistant organisms in recurrent urinary infection following therapy.

Eligibility criteria:
inclusion criteria: 1. acute symptoms of urinary infection of less than 7 days duration and an underlying structural or functional abnormality of the genitourinary tract. 2. pre-therapy urine culture \> 105 cfu/ml (\> 108 cfu/l) of at least one urinary pathogen. 3. age 18-80 years, male or female. exclusion criteria: 1. prior allergic reaction to any fluoroquinolone antimicrobial. 2. known infection with a fluoroquinolone - resistant organism. 3. requiring parenteral therapy because of severity of illness or unable to take oral medications. 4. women who are pregnant or breastfeeding. 5. requiring additional antimicrobial therapy for infections elsewhere.

Keywords: complicated urinary infection
evaluation of the pathobiology of calr-mutated mpn cells

Conditions: Myeloproliferative Neoplasm

Summary: the purpose of this study is to understand why there is a greater risk of thrombosis in patients who have the jak2 mutation as compared to those with calr mutations.

this biospecimen study is designed to evaluate the expression levels of tlr 2 and tlr 4 on mononuclear cells in calr mutation positive mpn participants and compare to jak2 v617f mutation positive mpn patients and healthy controls. patients who have mpn with the calr mutation positive will be approached for interest in participating in this study. a research blood collection will occur at any time during the participant's cancer trajectory after enrollment, during a standard of care blood draw. the participant's demographics, mpn subtype, calr mutation status, history of thrombosis/other medical history, and current, concomitant medications will be collected once. clinical data will be collected, including results from the cbc with differential, complete metabolic panel (if available), and pt/ptt/inr (if available) drawn closest to the research blood collection. this study will initially open as a single center study at ahwfbccc.

Eligibility criteria:
inclusion criteria: * written (or electronic) informed consent and hipaa authorization for release of personal health information by participant or his/her legally authorized representative (lar). * age ≥ 18 years at the time of enrollment * diagnosis of myeloproliferative neoplasm (mpn) according to 2022 world health organization classification of mds/mpns * calr-positive genetic mutation exclusion criteria: - diagnosis of mpn with jak2 v617f mutation
a prospective multicenter post approval study to evaluate the long-term safety and efficacy of the resolute integrity in the japanese all-comers patients with coronary artery disease (propel)

Conditions: Coronary Artery Disease; Drug-eluting Stent

Summary: this is a prospective, multicenter, historical controlled study. the present clinical study will measure non-inferiority of 12 month tlf rate compared to historical control.the selected historical control is the xience v arm from resolute all-comer clinical study, that study is a prospective, multicenter, randomized, two-arm, international, open-label study.the historical control did not have angiographic follow up before 12 months, in the present clinical study, only subjects with clinical follow-up conducted at 12 months without any pre-specified angiographic assessment prior to 12 month clinical follow-up will be part of this analysis cohort. out of the total 1200 patients, 900 patients (clinical follow-up cohort) will be included in this analysis cohort.


Eligibility criteria:
inclusion criteria: * patients aged 20 years or older. * patients with symptomatic coronary disease. * patients with a clinical indication for pci and stenting of at least one coronary lesion, visually confirmed on coronary angiography. * patients who give informed consent to participate in this clinical study and sign the informed consent form approved by the institutional review board of each study site before the index pci. * patients who agree to undergo all clinical follow-up procedures specified in the protocol for this clinical study. * patients in whom more than 50% occlusion or stenosis is visually confirmed in a native coronary artery with a diameter of 2.5 mm - 3.5 mm on coronary angiography and that has an anatomical structure suitable for pci using resolute integrity zotarolimus-eluting stent. exclusion criteria: * patients aged 85 years or older. * patients with cardiogenic shock. * patients who are pregnant or possibly pregnant. * patients who cannot comply with the antiplatelet therapy specified for this clinical study. * patients scheduled to undergo elective surgery within 6 months post-index pci. * patients with a history of allergic reaction or hypersensitivity to zotarolimus, sirolimus, tacrolimus, everolimus, or other analogues or derivatives. * patients with an allergic reaction to antiplatelet or anticoagulant drugs, such as heparin, aspirin, ticlopidine, or clopidogrel, or contrast agents, or those who cannot tolerate these substances and to whom appropriate treatments cannot be given. * patients with hypersensitivity to cobalt, nickel, chrome, molybdenum, coated polymer (e.g., biolinx) contained in the materials of the study device or in whom these substances are specifically contraindicated. * patients who are currently participating in a clinical study of another drug or medical device and in whom assessment of the primary endpoint of that study has not been completed or clinically interferes with the endpoints of this clinical study.

Keywords: coronary artery disease heart disease myocardial ischemia cardiovascular disease arteriosclerosis vascular disease
effect of chidamide combined with cat-t or tcr-t cell therapy on hiv-1 latent reservoir

Conditions: HIV/AIDS

Summary: to study the safety and effectiveness of the combination of chidamide with chimeric antigen receptor(car)-t or t cell receptor(tcr)-t cell therapy on hiv patients based on cart.

despite the advent of combined antiretroviral therapy (cart), the persistence of viral reservoirs remains a major barrier to cure human immunodeficiency virus type 1 (hiv-1) infection. recently, the shock and kill strategy, by which such reservoirs are eradicated following reactivation of latent hiv-1 by latency-reversing agents (lras), has been extensively practiced. it is important to reestablish virus-specific and reliable immune surveillance to eradicate the reactivated virus-harboring cells. some studies have shown that chidamide can highly activate the hiv reservoirs. the vc-car-t cells effectively induced the cytolysis of lra-reactivated hiv-1-infected cd4 t lymphocytes isolated from infected individuals receiving suppressive cart. our previous study demonstrated that the special features of genetically engineered car-t cells make them a particularly suitable candidate for therapeutic application in efforts to reach a functional hiv cure. the purpose of this study is to evaluate the safety and efficacy of chidamide together with chimeric antigen receptor(car)-t or t cell receptor(tcr)-t cell therapy based on cart in hiv-infected adults whose plasma hiv has been successfully suppressed after cart.

Eligibility criteria:
inclusion criteria: 1. hiv infection confirmed 2. receiving cart more than 12 months. 3. hiv viral-load \< 50 copies/ml and cd4 cell count more than 350 cells/ul. 4. without serious liver , heart, liver and kidney diseases. 5. the subjects know about the study and volunteer to attend the research and sign the informed consent. exclusion criteria: 1. with active hbv or hcv infection, or serious opportunistic infections. 2. with serious chronic disease such like diabetes, the mental illness,et al 3. history of suffering from pancreatitis during cart . 4. pregnant or breast-fed. 5. with poor adherence. 6. unable to complete follow up.

Keywords: chidamide,car cell therapy,tcr cell therapy
comparative study of static and dynamic hand grip endurance in pregnancy

Conditions: Hand Grasp; Pregnancy Related

Summary: background: physiology of the mother, changes constantly during pregnancy including reduced hgs that is require for carrying the child after delivery. activities of daily living require manual gripping tasks that require dynamic and static contractions. predictor of upper extremity function is hand grip strength and handgrip endurance. screening of hand grip strength during antenatal care is still uncommon. objectives: to compare static and dynamic hand grip endurance in pregnant females and to find its correlation with deep breathing. material and methods: the study recruited 40 participants of primi-gravida of 1st and 2nd trimester, between ages 20 and 35 years from shalamar gynae opd. the participants assigned to the groups (group 1: with db, group 2: without db) based on their trimester and gravidity. static and dynamic endurance assessed using hand held dynamometer. key words: pregnancy, deep breathing, trimester, endurance, peak grip endurance


Eligibility criteria:
inclusion criteria: * primigravida exclusion criteria: * multigravida * cardiac patients
predictive factors of endoscopic mucosal healing in quiescent ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to determine whether fecal calprotectin, fecal immunochemical test, and rome iii criteria for irritable bowel syndrome (ibs) can predict mucosal healing in patients with quiescent ulcerative colitis (uc).


Eligibility criteria:
inclusion criteria: * patients with ulcerative colitis who have no change of medication for at least 6 months * patients with ulcerative colitis who are in remission (mayo score \<3) * patients with ulcerative colitis who will undergo colonoscopy for surveillance or mucosal healing check-up exclusion criteria: * patients who refuse to participate * patients who have a history of colectomy * patients who have instinal stricture or perforation

Keywords: ulcerative colitis fecal calprotectin mucosal healing
treatment of the medial meniscus with the nusurface(r) meniscus implant

Conditions: Meniscus; Degeneration; Osteoarthritis, Knee

Summary: this is a prospective, multi-center, open label, non-randomized study, evaluating the treating of medial meniscus deficiency with the nusurface meniscus implant.


Eligibility criteria:
inclusion criteria: 1. have a degenerative and/or torn meniscus and/or previous meniscectomy as confirmed by diagnostic mri. 2. have a pain score of 75 or less on the koos pain scale, with 100 being normal. 3. be in neutral alignment +/- 5 degrees of the mechanical axis. 4. be between age 35 and 75 at the time of the planned surgery. 5. be able to be fitted anatomically with a size 30 to 90 nusurface® device. 6. have a normal mental status. 7. be willing and able to attend all follow up visits, complete all study questionnaires, and undergo required x-ray and mri schedule. 8. be able and willing to understand and sign the informed consent form. exclusion criteria: 1. have evidence of a grade iv articular cartilage loss on the medial tibial plateau or femoral condyle that could contact the nusurface implant 2. have lateral compartment pain with lateral articular cartilage damage greater than grade ii (ob), and/or a lateral meniscus tear(s) 3. have a varus or valgus knee deformity \> 5 degrees. 4. have a laxity level of more than ii (icrs), secondary to previous injury of the anterior cruciate ligament (acl) and/or posterior cruciate ligament (pcl) and/or lateral collateral ligament (lcl) and/or medial collateral ligament (mcl). 5. have patella instability or non-anatomically positioned patella 6. have patellar compartment pain and/or patellar articular cartilage damage greater than grade ii (ob). 7. need a tibial osteotomy at the time of surgery. 8. have an acl reconstruction performed less than 9 months before implanting the nusurface® device 9. have any type of previously implanted prosthetic meniscus or ligament or knee implant made of plastic. 10. have a knee flexion contracture \> 10 degrees 11. be unable to flex the knee to 90 degrees 12. have a leg length discrepancy causing a noticeable limp. 13. have had a previous major knee condyle surgery 14. present with insufficiency fractures or avascular necrosis of the medial compartment. 15. have an active infection or tumor. 16. have any type of knee joint inflammatory disease including sjogren's syndrome. 17. have neuropathic knee osteoarthropathy, also known as charcot joint. 18. have any medical condition that does not allow arthroscopy at the point of entry to the knee. 19. be pregnant or is a female intending to become pregnant during the study period. 20. be mentally incapacitated. 21. be a prisoner. 22. be a patient who has economic incentive not to improve (e.g., workman's compensation patient) 23. be morbidly obese (bmi \> 35). 24. is unwilling or unable to have an x-ray, fluro, or mri of the affected knee

Keywords: nusurface meniscus knee koos
a feasibility study of gallium-68 citrate pet to detect aberrant myc proto-oncogene, bhlh transcription factor (myc) protein expression in diffuse large b-cell lymphoma

Conditions: Lymphoma, Large B-Cell, Diffuse; Burkitt Lymphoma

Summary: this is a single center imaging study investigating the use of pet with 68ga-citrate in patients with dlbcl or bclu.

this is a single center feasibility imaging study in patients with diffuse large b-cell lymphoma (dlbcl) or b-cell lymphoma, unclassifiable with features between dlbcl and burkitt's (bclu). study participants will undergo pet/mri of the whole body with 68ga citrate. the study will include at least 5 patients with double hit lymphoma and 5 patients with dlbcl with an additional 5 more patients as expansion once the dose level has been established. patients with dlbcl will be included once an optimal dose level for the resolution of cancer lesions has been established.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed dlbcl or bclu. * double hit lymphoma, defined by positive cytogenetic/ fluorescence in situ hybridization (fish) analysis for translocations involving myc and bcl2 or a double hit score of 2 by immunohistochemistry as described by johnson et al. * dlbcl without myc translocation or overexpression by the above methods 2. presence of palpable or radiographically measurable disease of at least 1.5 cm in longest dimension. 3. available prior ct or pet/ct scan done in the last 8 weeks for comparison 4. prior chemotherapy or radiation to the measurable lesion must be completed at least 14 days prior. 5. adequate renal function with estimated creatinine clearance ≥50 ml/min (by the cockcroft gault equation) 6. no contraindications to mri (e.g. pacemaker, aneurysm clips, severe claustrophobia) 7. ability to sign a study-specific internal review board (irb) approved consent prior to study entry. patients must be able and willing to consent and undergo study procedures. 8. age ≥18 years old exclusion criteria: 1. any serious and/or unstable pre-existing medical, psychiatric, or other medical condition that could interfere with subject's safety, provision of informed consent, or compliance with study procedures 2. body weight over 300 pounds 3. female patients who are pregnant or breast-feeding 4. prior mri with gadolinium performed \<24 hours before the study scan 5. no red blood cell transfusion or iron administration by any route in the last 7 days 6. prior hypersensitivity or intolerance to gadolinium or gallium citrate.

Keywords: lymphoma gallium citrate pet
a prospective, observational cohort study on the clinical impact of novel monoclonal antibodies in b-cell non-hodgkin lymphoma in italian clinical practice

Conditions: Non-Hodgkin Lymphoma, B-cell

Summary: this is a prospective, observational cohort study to evaluate the clinical impact of novel monoclonal antibodies (mab) in b-cell non-hodgkin lymphoma (nhl) in italian clinical practice.

this is a large prospective, observational cohort study aimed at collecting clinical information on use, feasibility, short- and long-term efficacy and short- and long-term toxicity of novel mab that have received approval from ema since 2020 and are prescribed according to the indications for use authorized for marketing in italy. patients entering the study will be subdivided into different cohorts based on approved treatment indications, type of antibody employed and histological subtype. additional sub-cohorts will be defined if needed. final outputs will be based according to: * per indication analysis; * pooled analyses by type of antibody and subtype and other parameters; * a general analysis of the whole cohort.

Eligibility criteria:
inclusion criteria: * patients with diagnosis of b-cell nhl and need of treatment (as per guideline indications), both first-line and relapsed or refractory. * patients aimed to be treated in indication with a "novel" mab (alone or in combination) based on presence of an ema clinical indication since 2020 and prescribed according to the indications for use authorized for marketing in italy. * signed written informed consent. exclusion criteria: * being involved in a prospective interventional trial outside indication. * patients treated outside approved indications: * 648-approved indication. * 5% aifa support. * compassionate use. * age less than 18 years. * inability to provide an informed consent.

Keywords: non-hodgkin lymphoma b-cell monoclonal antibodies novel antibodies
intramedullary headless screw fixation for metacarpal and phalangeal fractures

Conditions: Metacarpal Fracture; Phalanx Fracture

Summary: intramedullary headless screw fixation for metacarpal and phalangeal fractures

the most frequent fractures in the upper extremities are phalangeal and metacarpal fractures accounts about 40%, which follow distal radius fractures in order of frequency. there are many methods of fixation of these fractures as plates and k-wires. plate fixation is able to provide open reduction and stability for early range of motion with mixed clinical results. reported complications include stiffness, fixed flexion contracture of the adjacent joints, soft tissue dissection, and extensor lag. there are minimally invasive techniques, including the use of k-wires, lag screws, cerclage wiring, and external fixation that limit soft tissue dissection. these options have drawbacks of malunion, nonunion, infection, need for hardware removal, and stiffness. intramedullary headless screw fixation is an emerging alternative to k-wire or plate fixation of displaced and unstable fractures of the phalanges and metacarpals. the intramedullary headless screw fixation is a new option that offers rigid stability, early active range of motion, and easy insertion. due to the minimally invasive nature of this technique, patients will experience better results in terms of range of motion, return to work faster, and minimize complications. beck et al. reported 100% of patients achieved full radiological union with minor complication rate and full range of motion and early return to work with average 96% of grip strength.

Eligibility criteria:
inclusion criteria: 1. skeletally mature patients with closed fractures of phalanges and metacarpals. 2. patients with open type i fractures of phalanges and metacarpals. exclusion criteria: 1. skeletally immature patients with open physis. 2. patients with open type ii or iii fractures of phalanges or metacarpals. 3. patients with fractures of phalanges or metacarpals with neurovascular injury. 4 patients with associated tendon injuries.

Keywords: intramedullary headless screw fixation
a retrospective study in patients with liver injury after the use of novel antineoplastic agents

Conditions: Liver Injury; Liver Injury, Drug-Induced

Summary: this is an open-enrollment, retrospective, observational study without interventions. its primary objective is to understand 1) incidence of liver injury among all the hospitalized patient from participating centers after the administration of immune checkpoint inhibitors or molecularly targeted agents; 2) epidemiologic and clinical characteristics of liver injury, including suspected medications, clinical types, histological characteristics, severity, treatment and outcomes.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * abnormality of liver biochemistry after the administration of any molecularly targeted agent or immune checkpoint inhibitor exclusion criteria: * missing major baseline or clinical data * prior liver loco-regional therapy or surgery
reinforced feedback in virtual environment

Conditions: Stroke

Summary: the aims of the study is to explore whether the rehabilitation of the upper extremity performed in interaction with a virtual environment could improve motor function in post-ischemic and post-haemorrhagic stroke subjects with hemiparesis, in comparison to the traditional neuromotor rehabilitation treatment.


Eligibility criteria:
inclusion criteria: * patients affected by a stroke occurring in the period no longer than 1 year before the enrolment * both first ischemic and hemorrhagic stroke * subjects who did not had rfve treatment previously * scoring higher than 24 points in the mini-mental state examination test exclusion criteria: * upper extremity complete hemiplegia * upper limbs sensory disorders * clinical evidence of cognitive impairment * neglect * apraxia * comprehension difficulties * post-traumatic injury of the upper limb

Keywords: virtual reality, motor learning, rehabilitation, upper limb