Kornimate/medical-research-clean huggingface dataset:
pilot study comparing natroxtm topical oxygen therapy to a placebo in the management of non-healing leg ulcers

Conditions: Skin Ulcer Venous Stasis Chronic; Mixed Arteriovenous Leg Ulcer

Summary: the purpose of this study is to determine the effectiveness of the natroxtm topical oxygen device versus a placebo in patients with non-healing leg ulceration in conjunction with standard best practice.

patients will be screened for two weeks before enrollment to assess whether their ulcers are "non-healing", defined as a reduction in wound surface of \< 25% after two weeks of standard best practice wound care . on enrolment and randomisation to active or placebo treatment the patient will be treated for six weeks or until 100% epithelialisation, whichever is the sooner, and then treatment will revert to standard best practice, defined as moist wound healing plus compression where appropriate. the reference ulcer will be followed up at two weeks and then at six weeks after the end of the active treatment period.

Eligibility criteria:
inclusion criteria: * patients with superficial venous and mixed aetiology leg ulcers on a flat plane in surface area between 4-50cm2 * patients with diabetes may be included providing they have good metabolic control * patients who understand the trial, agree to adhere to the treatment and are able to give consent * patients who can be followed by the same investigating team for the whole period of their participation in the study exclusion criteria: * patients who present with wounds which are clinically infected and require antimicrobial therapy. patients who have been treated for a wound infection with antimicrobial therapy (systematically or topically) may be included providing the wound is no longer assessed as infected and there is a two week wash-out period after the last treatment before the patient is reassessed against the inclusion and exclusion criteria * patients with a known sensitivity to any of the components of the evaluation device * patients with known or suspected malignancy in the wound or surrounding tissue * patients whose wounds show a percentage decrease in surface area of \>25% during the two week screening period * patients who do not have the physical or mental capacity, or a significant other with the ability to change the natroxtm battery pack on a daily basis * patients who present with more than 10% of the wound surface area covered in hard eschar * patients who are actively treated with immunosuppressive or cortico-steroidal medication * patients who are participating in another clinical trial * patients with a known history or poor compliance with medical treatment * patients who have been in this trial previously and have withdrawn * patients who are unable to understand the aims of the trial and do not give informed consent

Keywords: venous leg ulcer mixed aetiology leg ulcers
expanded access to mgawn1 in subjects with suspected west nile neuroinvasive disease; suspected west nile virus infection; or substantial accidental exposure

Conditions: West Nile Virus Infection

Summary: this study will test an experimental drug called mgawn1 for the treatment of west nile infections.

the objective of this study is to provide expanded access to mgawn1; the study is not intended for subjects who are eligible for and have access to non-expanded access protocols.

Eligibility criteria:
inclusion criteria: 1. for west nile neuroinvasive disease subjects: have neurological signs and/or symptoms of west nile meningitis, encephalitis, and/or acute flaccid paralysis 2. for immunocompromised subjects with suspected west nile virus infection: * receiving immunosuppressive treatment for any disease, such as autoimmune diseases, or transplant recipients; or * have received organs or tissues or cells from donors likely infected with west nile virus (as shown by serology or pcr/nat from the donor, organs, or tissues) or * have acquired immunodeficiency (other than from immunosuppressive treatment or from receiving infected transplants) or congenital immunodeficiency 3. for subjects with substantial exposure to west nile virus: exposure by any route, including percutaneous, inhalation, or mucosal exposure (such as might occur in a laboratory accident) 4. develop signs and/or symptoms within 14 days before study enrollment

Keywords: west nile virus wnv encephalitis meningitis acute flaccid paralysis monoclonal antibody wnnd west nile neuroinvasive disease accidental exposure to west nile virus
intervention and outcomes in duarte galactosemia

Conditions: Duarte Galactosemia

Summary: the purpose of this study is to learn about duarte galactosemia (dg). this study will examine the possible effects of duarte galactosemia (dg) in children, and determine whether dietary exposure to milk in infancy or early childhood is associated with developmental outcomes of school-age children with duarte galactosemia (dg).

duarte galactosemia (dg) is an autosomal recessive genetic condition characterized by partial loss of galactose-1-phosphate uridylyltransferase (galt), which results in partially impaired metabolism of the sugar, galactose, which is abundant in milk and also found at lower levels in many other foods. there is currently no consensus on long-term outcome prognosis for infants with duarte galactosemia (dg) and some studies suggest these children might be at increased risk for developmental difficulties later in childhood. there is also no conclusive data on whether children with duarte galactosemia (dg) might benefit from dietary restriction of galactose. the investigator will be assessing whether 6-12 year old children with duarte galactosemia experience developmental disorders relative to controls, and if so, whether dietary exposure to milk in infancy or early childhood is associated with developmental outcomes in this patient population.

Eligibility criteria:
inclusion criteria: healthy children/children with duarte galactosemia: * age between 6-12 years exclusion criteria: * chronic illness * any condition unrelated to duarte galactosemia but known to cause developmental problems * children who did not have the current parent/guardian as the primary caregiver when the child was an infant

Keywords: galactose-1-phosphate uridylyltransferase deficiency cognitive disorders
reverse shoulder prosthesis study

Conditions: Rotator Cuff Arthropathy; Failed Total Shoulder; Failed Hemi-arthroplasty

Summary: the objective of this clinical study is to evaluate the safety and efficacy of the encore reverse shoulder prosthesis (rsp). the clinical results of the rsp will be compared to clinical results published in literature for rotator cuff arthropathy and salvage procedures.


Eligibility criteria:
inclusion criteria: * irreparable rotator cuff or failed hemi or total shoulder arthroplasty with irreparable rotator cuff * evidence of upward displacement of the humeral head with respect to the glenoid * loss of glenohumeral joint space * functional deltoid muscle * patient is likely to be available for evaluation for the duration of the study * visual analog pain scale 5 or greater exclusion criteria: * non functional deltoid muscle * active sepsis * excessive glenoid bone loss * pregnancy * neurological abnormalities, which could hinder patient's ability or willingness to follow study procedures. for example, any that may restrict physical activities such as parkinson's, multiple sclerosis, or previous stroke, which affects upper extremity. * mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere with the patient's cognitive abilities, senile dementia, and alzheimer's disease. * prisoners * conditions that place excessive demand on the implant (i.e. charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity). * known metal allergy (i.e., jewelry). * visual analog pain scale \<5.
teduglutide in short bowel syndrome patients

Conditions: Short Bowel Syndrome

Summary: a retrospective analysis was performed using data of patients suffering from non-malignant sbs-if. they were treated with teduglutide in a multidisciplinary sbs-if program at a single university medical center between june 2016 and june 2020.


Eligibility criteria:
inclusion criteria: * sbs-if exclusion criteria: * \< 18 years * incompliance * \< 6 months of treatment
a study of gemcitabine-carboplatin plus necitumumab (ly3012211) in chemotherapy-naïve participants with locally advanced or metastatic squamous non-small cell lung cancer (nsclc)

Conditions: Locally Advanced Squamous Non-Small Cell Lung Cancer; Metastatic Squamous Non-Small Cell Lung Cancer

Summary: the main purpose of this study is to evaluate the effectiveness and safety of gemcitabine-carboplatin plus necitumumab in chemotherapy-naïve participants with locally advanced or metastatic squamous non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * have confirmed diagnosis of locally advanced or metastatic nsclc in cohort 1 and metastatic nsclc in cohort 2, predominantly squamous histology. squamous nsclc diagnosis must be confirmed by histology or cytology local pathology report. * participants in cohort 1 are required to have epidermal growth factor receptor (egfr) protein expressing tumor (defined by local immunohistochemistry test). this is not required for participants in cohort 2. * measurable disease at the time of study entry as defined by response evaluation criteria in solid tumors version 1.1 (recist 1.1) * the participant has an eastern cooperative oncology group performance status (ecog ps) score of 0-1 * have discontinued all previous treatments for cancer and recovered from the acute effects of therapy: biologic agents (for example, antibodies) and immunotherapy ≥4 weeks; chest radiotherapy ≥4 weeks; major surgery, excluding biopsy ≥4 weeks) * the participant has archived tumor tissue available for biomarker analyses. * participants in cohort 2 are required to have received 1 prior single-agent immune checkpoint inhibitor for squamous nsclc. exclusion criteria: * the participant has nonsquamous nsclc * the participant has received prior anticancer therapy targeting the egfr, vascular endothelial growth factor (vegf), or vegf receptor. * the participant has received previous chemotherapy (including concurrent chemoradiation) for advanced nsclc (participants who have received neo-adjuvant and/or adjuvant chemotherapy are eligible if the last administration occurred at least 1 year prior to start of therapy). * the participant has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants. * the participant has a bleeding tumor. * the participant has a history of arterial or venous thromboembolism within 3 months prior to study enrollment. * the participant has a history or evidence of current clinically-relevant coronary artery disease of current ≥ class iii as defined by canadian cardiovascular society angina grading scale (campeau 1976) or congestive heart failure of current ≥ class iii as defined by the new york heart association. * the participant has experienced myocardial infarction within 6 months prior to study enrollment.

Keywords: thoracic neoplasms lung diseases lung cancer respiratory tract diseases respiratory tract neoplasms antineoplastic agents monoclonal antibodies
the application value of prostate specific membrane antigen pet/ct in biopsy free of psa grey area prostate cancer

Conditions: Prostatic Neoplasms

Summary: the goal of this observational study is to establish an evaluation system for accurate identification of prostate cancer and clinical significant prostate cancer in patients in the psa gray zone. the main questions it aims to answer are: proportion of men who could have avoided biopsy with positive psma-pet and no clinically significant cancer detected on biopsy. participants will: 1. undergo psma pet/ct and multiparametric mri; and 2. undergo prostate biopsy researchers will compare the diagnostic performance of psma pet/ct and multiparametric mri for prostate cancer and clinical significant prostate cancer to see if there are differences.

prostate specific antigen (psa) is a serine protease secreted by prostate epithelial cells, which is a tumor marker of prostate cancer. at present, psa\ 10 ng/ml should be highly suspected of prostate cancer. prostate biopsy is still the gold standard for the diagnosis of prostate cancer. however, as an invasive procedure, it can cause many complications such as pain, bleeding, lower urinary tract symptoms and infection. there is a growing trend to reduce unnecessary prostate biopsies. prostate specific membrane antigen (psma) is a membrane-bound enzyme that is highly expressed in more than 90% of prostate cancer lesions and has become an important target for molecular imaging of prostate cancer. in recent years, radioactive nuclide 18f labeling targeting psma positron emission tomography/computed tomography (pet/ct) has shown important clinical application value in prostate cancer recurrence monitoring. the goal of this observational study is to establish an evaluation system for accurate identification of prostate cancer and clinical significant prostate cancer in patients in the psa gray zone. participants will: 1. undergo psma pet/ct and multiparametric mri; and 2. undergo biopsy researchers will compare the diagnostic performance of psma pet/ct and multiparametric mri for prostate cancer and clinical significant prostate cancer to see if there are differences.

Eligibility criteria:
inclusion criteria: * psa (4-10 ng/ml) * mri and psma pet/ct were not contraindicated * did not receive prostate-related treatment * there are no contraindications to biopsy exclusion criteria: * coexisting with other malignancies

Keywords: pet/ct psma psa grey area
study for patients who have benefited and tolerated prior panitumumab treatment

Conditions: Colorectal Cancer; Non-Small Cell Lung Cancer; Prostate Cancer; Solid Tumors; Advanced Renal Cell Carcinoma

Summary: a multi-center, open-label, extended treatment, clinical trial examining the safety of administering multiple does of panitumumab by intravenous (i.v.) infusion to patients who have previously received panitumumab and benefited from treatment


Eligibility criteria:
inclusion criteria: * able to comprehend and sign an irb approved informed consent form * male or female 18 years of age or older * female patients who are post menopausal (no menstrual period for a minimum of six months), surgically sterilized, or are using an oral or implanted contraceptive, double barrier birth control, or an intrauterine device (iud) and have a negative serum pregnancy test upon entry into this study; or male patients willing to use contraception upon enrollment and during the course of the study * previously received and tolerated panitumumab treatment on studies 20020374 part 2 or 20030138/20040116 * is considered "stable" or "responding" based on the recist (20020374 part 2) or who (20040116) criteria, at the final treatment visit of the previous panitumumab clinical trial and the screening visit for this study * no more than 2 months (60 days) have elapsed since the final treatment visit of the previous panitumumab clinical trial * karnofsky score \> or = 70% exclusion criteria: * brain metastases (20040116 patients are allowed only if controlled and asymptomatic) * uncontrolled hypercalcemia (calcium level outside the upper limit of normal; antihypercalcemic treatment is allowed). exception: patients in the motzer intermediate risk group from 20020374 cohort 2 with uncontrolled high corrected calcium (\>10 mg/dl) may be enrolled * use of any anti-tumor therapy or investigational drug, other than panitumumab, between the last visit of the previous panitumumab study and the initial visit in this 20020375 study * prior treatment with another anti-egfr agent, other than panitumumab * myocardial infarction within 1 year prior to entering the study * has other cancer that has been active and required treatment within the past 5 years (basal cell carcinoma or cervical carcinoma in situ are allowed) * pregnant or breast feeding female; female of childbearing potential (defined as: post menarche and is biologically capable of becoming pregnant) unwilling to use birth control (as defined in the inclusion criteria) during and for 6 months following treatment * male patient unwilling to use birth control (as defined in the inclusion criteria) during and for 1 month following treatment * known to be hiv positive * history of any chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with study drug administration * allergy to the ingredients of the study medication or to staphylococcus protein a * history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis
visualisation of the central analgesic effect of paracetamol in functional mri

Conditions: Pain

Summary: paracetamol is one of the most widely used analgesic in the world, indicated for the symptomatic treatment of fever and pain. the objective of this study is to evaluate the mechanism of action of paracetamol (versus placebo) in the brain with new assessment tools (functional mri and test inducing pain by thermal stimulation.

visit 1 / visit 2 inclusion of the subject, clinical examination trainings tests study period 1 clinical examination measurement of the basal pain thresholds administration of product (t0) t0+100min : thermal stimulation according to the established paradigm and fmri data acquisition t0+180min : thermal stimulation according to the established paradigm and fmri data acquisition study period 2: same of period 1.

Eligibility criteria:
inclusion criteria: * - healthy volunteers * aged at last 18 years and over 60 years * male * non-smoking subject * fasting coffe, tea, coca-cola or other stimulant products since the last evening * subject free of any treatment within 7 days prior to inclusion including no use of analgesics or anti-inflammatory treatments exclusion criteria: * contraindications to the administration of paracetamol * contraindications to the completion of mri * medical history and/or surgical judged by the investigator as being incompatible with the test * progressive disease at the inclusion

Keywords: mechanism of action of paracetamol in the brain structures
establishment of a prognosis prediction model and scoring criteria of pulmonary contusion caused by severe thoracic trauma

Conditions: Pulmonary Contusion , Chest Trauma , Prediction Model

Summary: pulmonary contusion caused by severe thoracic trauma is a complex disease. some patients may be secondary to severe complications such as pulmonary infection or even acute respiratory distress syndrome. at present, there have been no reports on related studies based on chinese population. in this study, 800 patients with pulmonary contusion will be retrospectively investigated to determine the risk factors and independent risk factors of their poor prognosis, and to construct a prognosis prediction model and scoring criteria.


Eligibility criteria:
inclusion criteria: chinese patients aged 18 to 80 years,severe chest trauma (flail chest, more than 4 rib fractures without flail chest, multiple anterior rib fractures with sternal fractures, bilateral fractures, severely displaced sternal fractures),pulmonary contusion. exclusion criteria: patients were excluded if they had a history of tuberculosis, heart failure,respiratory failure,severe brain injury(gsc score \< 15),loss of consciousness, spinal fracture complicated with paraplegia,abdominal trauma requiring surgical intervention,shock.

Keywords: pulmonary contusion severe chest trauma prediction model
real world evidence of fedratinib effectiveness in mf

Conditions: Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis

Summary: this is a multicenter prospective and retrospective observational clinical study in patients with primary or post polycythemia vera or post essential thrombocythemia myelofibrosis to test the efficacy of fedratinib in the rea world. participants will be managed according to the clinical practice of the participating center. all centers will be italian hematology units belonging to the gimema organization in italy.

this is a multicenter prospective and retrospective observational clinical study with the aim of assessing the efficacy of fedratinib upon aifa approval in patients with primary myelofibrosis or post polycythemia vera or post essential thrombocythemia myelofibrosis. patients must meet current diagnostic criteria of mf, according to the who (world health organization) classification version 5th or the icc (international consensus conference) either published in 2022 or post- polycythemia vera and post-essential thrombocythemia myelofibrosis (according to the icc classification 2022). patients enter the study at diagnosis or already in follow-up, at any stage of disease, except if transformed to blast phase. patients who received fedratinib after june 2022 (time of aifa reimbursement in italy) will be enrolled and will be included both those ruxolitinib-naïve and ruxolitinib-exposed.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older. * patients diagnosed with primary myelofibrosis \[according to the who (world health organization) classification version 5th or the icc (international consensus conference) either published in 2022 or post-polycythemia vera and post-essential thrombocythemia myelofibrosis (according to the icc classification 2022)\]. * patients who met the reimbursement criteria for fedratinib, in accordance with the aifa (agenzia italiana del farmaco) after june 2022. * patients eligible or not for stem cell transplant (sct) or patients already undergoing sct. * patients on non-jaki cytoreductive treatment. * patients with palpable splenomegaly at baseline of fedratinib treatment. * informed consent signed, if applicable. exclusion criteria: * diagnosis of mpn, unclassifiable, myelodysplastic/myeloproliferative neoplasms, myelodysplastic syndromes, essential thrombocythemia, polycythemia vera. * blast phase of mf. * patients with platelets \<50 x10\^9/l at baseline of fedratinib treatment. * patients ruxolitinib-exposed for other diseases.