Kornimate/medical-research-clean huggingface dataset:
an observational study of subcutaneous infusion of abbv-951 to assess change in disease activity and adverse events in adult japanese participants with advanced parkinson's disease

Conditions: Parkinson's Disease (PD)

Summary: parkinson's disease (pd) is a neurological condition, which affects the brain. some symptoms of pd are tremors, stiffness, and slowness of movement. the purpose of this study is to assess how safe and effective abbv-951 is in treating participants with parkinson's disease in real world setting. abbv-951 is an approved drug being developed for the treatment of pd in japan. approximately 250 adult participants over 15 years with a diagnosis of pd who are prescribed abbv-951 by their physicians will be enrolled in this study across japan. participants will receive abbv-951 as prescribed their physician and followed for 52 weeks. there is expected to be no additional burden for participants in this trial. study visits may be conducted on-site or virtually as per standard of care.


Eligibility criteria:
inclusion criteria: * diagnosed with advanced parkinson's disease (apd). * prescribed abbv-951 as physicians' decision according to the approved label for treatment of apd. * given informed consent (or by her/his legal representative, if it's a requirement from the participating hospital/clinic) for participating this study. exclusion criteria: * prior treatment with abbv-951 for pd. * currently participating in interventional clinical trials.

Keywords: parkinson's disease (pd) advanced parkinson's disease (apd) abbv-951
sarcopenia and related factors in coronavirus disease 2019 (covid-19) following intensive care

Conditions: Sarcopenia; Covid19; Intensive Care Unit Acquired Weakness

Summary: the primary aim of this study is to evaluate the patients who had pneumonia or severe acute respiratory distress syndrome (ards) due to covid-19 in terms of sarcopenia and related factors following intensive care unit (icu). the patients who had covid-19 infection in the icu and the patients who admitted to the 'physical medicine and rehabilitation' clinic for other reasons during the pandemic period will be compared in terms of sarcopenia.

patients with acute respiratory distress syndrome (ards) could develop muscle weakness associated with impairment of physical function defined as intensive care unit acquired weakness. significant muscle loss occurs in the first week of the intensive care unit (icu) hospitalizations due to acute respiratory failure. patients lose 18 percent of their body weight when discharged from the icu. the presence of sepsis is known as the hypercatabolic process for the muscles. hypophosphatemia and hypomagnesemia can cause respiratory muscle weakness. fever and inflammation, use of muscle relaxant or sedatives may also cause muscle loss in intensive care during this period. covid-19 is an acute infection with a high risk of enormous cytokine storm exacerbating the clinical condition in acute respiratory distress syndrome and is thought to further increase the risk of muscle weakness. the patients will be evaluated for hand grip strength, calf circumference measurement, 'strength, assistance with walking, rise from a chair, climb stairs and falls' (sarcf), sarqol, timed up and go test, sit to stand test, and short form-36.

Eligibility criteria:
inclusion criteria: * patients with ards or severe pneumonia due to covid-19 hospitalized in intensive care unit * \> 18 years old * age and gender matched patients admitted to the 'physical medicine and rehabilitation' clinic for control group exclusion criteria: * other diseases that may cause sarcopenia (cancer, non-respiratory organ failure and heart, liver or kidney failure) * neurological diseases that may cause sarcopenia (stroke, spinal cord injury, muscle diseases)

Keywords: sarcopenia covid19 acute respiratory distress syndrome intensive care unit
oral sulopenem versus amoxicillin/clavulanate for uncomplicated urinary tract infection in adult women

Conditions: Urinary Tract Infections; Cystitis

Summary: study 310 is a clinical study which compares the effectiveness of oral sulopenem versus oral amoxicillin/clavulanate for the treatment of adult women with uncomplicated urinary tract infection.

it001-310 is a phase 3, randomized, multicenter, double-blind, double dummy, controlled study to compare oral sulopenem etzadroxil/probenecid (oral sulopenem) to oral amoxicillin/clavulanate for the treatment of adult female patients with uncomplicated urinary tract infection. approximately 1966 adult women with uncomplicated urinary tract infection will be randomized in a 1:1 fashion to receive either oral sulopenem etzadroxil/probenecid or oral amoxicillin/clavulanate twice daily for 5 days. the primary outcome measure for efficacy evaluation will be the overall success (combined clinical and microbiologic success) on day 12 (± 1 day)/test of cure (toc).

Eligibility criteria:
inclusion criteria: * female patients ≥18 years of age with ≥24 hours and ≤96 hours of urinary symptoms attributable to a uti * two of the following signs and symptoms of uuti: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain. * a mid-stream urine specimen with evidence of pyuria as defined by either a machine-read dipstick positive for leukocyte esterase or at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine or white blood cell count ≥10 cells/high-powered field (hpf) in the sediment of a spun urine exclusion criteria: * presence of signs and symptoms suggestive of acute pyelonephritis defined as: fever (temperature \> 38° celsius), chills, costovertebral angle tenderness, flank pain, nausea, and/or vomiting * receipt of antibacterial drug therapy potentially effective as treatment of uuti within the prior 7 days * concurrent use of non-study treatments that would have a potential effect on outcome evaluations in patients with uuti, including analgesics (e.g., non-steroidal anti-inflammatory drugs, aspirin, paracetamol etc.), phenazopyridine, and cranberry products. * any anatomical abnormality of the urinary tract, including surgically modified urinary tract anatomy, and obstructive uropathy due to nephrolithiasis, stricture, tumor, or fibrosis * ongoing urinary retention * neurogenic bladder * current resident of a long-term care facility * instrumentation of urinary tract in the previous 30 days * an indwelling urinary catheter, ureteral stent or other foreign material in the urinary tract * any history of trauma to the pelvis or urinary tract * receiving hemodialysis, hemofiltration, peritoneal dialysis, or had a renal transplant * history of allergy or hypersensitivity to carbapenems, β-lactams or probenecid, as formulated with their excipients
using fapi pet/mri to evaluate prostate cancer

Conditions: Prostate Cancer Metastatic Disease; Prostate Cancers

Summary: the goal of this clinical trial is to gain more information about how fapi (fibroblast activation protein inhibitor) binds to certain type of cells in the tumor tissue. the main question it aims to answer is how this information can be used to better diagnose and track prostate cancer. participants will undergo two pet/mri scans during two research visits, each of which may last up to 2.5 hours.


Eligibility criteria:
inclusion criteria: * age 18 years or older * able and willing to provide informed consent * known diagnosis of prostate cancer with established or suspected non-osseous, non-nodal metastases * scheduled for or recently performed (within 4 weeks) standard-of-care psma pet * optional: scheduled for soc biopsy of an established or suspected non-osseous, non-nodal metastases. * willing and able to undergo pet/mri as part of this research exclusion criteria: * unable or unwilling to provide informed consent * contraindication(s) to or inability to undergo pet/mri * participants for whom pet/mri will delay timely delivery of treatment * participants requiring intravenous (iv) conscious sedation for imaging care; those requiring mild, oral anxiolytics for the clinical mri will be allowed to participate as long as the following criteria are met: * have their own prescription for the medication * the informed consent process is conducted prior to the self-administration of this medication * come to the research visit with a driver
goutmetalsain: comparison of the perception of metallic taste according to lingual locations in healthy volunteers

Conditions: Taste Disorders; Sensation Disorders; Taste, Metallic; Taste Disorder, Glossopharyngeal Nerve

Summary: this is a mono center , observational study carried out within otorhinolaryngology department in ch valence. this is a descriptive and exploratory study in healthy volunteers. based on the hypothesis that metallic taste is imperfectly assessed, this study will provide a better understanding of the metallic taste.

the study consists of the application of a swab soaked in iron sulfate at a concentration of 10g/l. each patient will rate the intensity he/she perceives (on a numerical scale from 1 to 5) at each of the 4 predefined lingual locations

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * healthy volunteers * read, write and understand the french language * patient affiliated to a social security system * written and signed informed consent exclusion criteria: * head and neck cancer history * olfactory and gustatory disorder * refusal to participate in research * patient under guardianship, deprived of liberty, safeguard of justice

Keywords: taste, metallic
dalteparin in preventing dvt in participants with cancer

Conditions: Bone Sarcoma; Femur Fracture; Lymphoma; Metastatic Neoplasm; Pathologic Fracture; Plasma Cell Myeloma; Soft Tissue Sarcoma

Summary: this trial studies how well dalteparin works in preventing deep vein thrombosis (dvt) (blood clots) in participants with cancer. dalteparin is a blood thinner that can treat blood clots and may prevent them from forming.

primary objectives: i. to determine the safety of dalteparin as prophylaxis against deep venous thrombosis (dvt) in orthopedic oncology patients. ii. to determine whether there are significantly increased bleeding complications at the surgical site after major oncologic operations in the lower extremity. outline: participants receive dalteparin subcutaneously (sc) once daily (qd) starting 12-24 hours after surgery on post-operative day 1 until hospital discharge, about 7-10 days.

Eligibility criteria:
inclusion criteria: * group a * metastatic disease, myeloma, lymphoma. * pathologic fracture or impending pathologic fracture of the femur. * intramedullary rod, plating, cementation, hip arthroplasty, or knee arthroplasty. * group b * primary sarcoma of bone or soft tissue of the lower extremity. * t2 tumor (\> 5 cm by \< 20 cm). * radical resection of tumor, which may necessitate major bone or soft tissue reconstruction. exclusion criteria: * presence of dvt on pre-operative screening ultrasound study. * massive tumor (\> 20 cm in greatest dimension). * amputation of the affected leg as treatment of tumor. * estimated blood loss \> 2 liters during surgery. * surgical drain output \> 500 cc of bloody fluid during first 8 hours. * international normalized ratio (i.n.r.) \> 1.3 pre-operatively or \> 1.5 post-operatively. * platelet count \< 100,000 either pre-operatively or post-operatively. * indwelling post-operative epidural catheter for pain control. * history of underlying bleeding disorder, such as hemophilia. * history of adverse reaction to heparin such as heparin-induced thrombocytopenia. * severe liver or renal insufficiency. * history of hypertensive or diabetic retinopathy. * history of gastro-intestinal bleeding within 12 months. * treatment with warfarin, clopidogrel, aspirin, nonsteroidal antiinflammatory drugs (nsaids), low molecular weight heparin (lmwh) or other anti-coagulants for conditions. * history of stroke. * women of child bearing potential having a positive urine or serum pregnancy test (human chorionic gonadotropin \[hcg\]) at the time of pre-operative evaluation (within 7 days of surgery). * women who are breastfeeding. * hemoglobin \< 8.0 g/dl. * platelet count \< 100,000/l. * alanine aminotransferase \> 100 iu/l. * aspartate aminotransferase \> 100 iu/l. * direct bilirubin \> 0.5mg/dl. * serum creatinine \> 2.0 mg/dl. * patients taking cox-2 inhibitors. * patients who have fragmented mechanical heart valves.
investigations of the optimum serum bicarbonate level in renal disease.

Conditions: Chronic Renal Insufficiency; Diabetes Mellitus

Summary: the purpose of this study is to see if treatment with sodium bicarbonate will lower urine levels of proteins that are indicators of kidney damage in people with diabetes who also have chronic kidney disease.

diabetic chronic kidney disease (ckd) is a common problem in veterans and progresses to end-stage renal disease in many people. it is important to identify treatment strategies that will help prevent the progression of ckd to overt kidney failure. the purpose of this study is to see if sodium bicarbonate reduces urinary markers of kidney damage in veterans with diabetic ckd and normal serum bicarbonate levels.

Eligibility criteria:
inclusion criteria: * veteran * age older than 18 years * diabetes mellitus * serum bicarbonate 22 - 28 mmol/l on the most recent measurement within the past six months * stage 2, 3, or 4 ckd (defined as estimated glomerular filtration rate (egfr) 15 - 89 ml/min/1.73m2 using the ckd-epidemiology equation) * urinary albumin:creatinine ratio \> 30 mg/gm on the most recent sample within the past 12 months. exclusion criteria: * lean body weight \> 100 kg * use of oral medications typically prescribed to raise low serum bicarbonate levels (i.e. sodium bicarbonate, sodium citrate, potassium citrate). * serum potassium \< 3.5 meq/l at enrollment visit * use of 5 or more antihypertensive agents, regardless of the indications of each agent * systolic blood pressure \> 140 mmhg or diastolic blood pressure \> 90 mmhg at the enrollment or baseline visit * diagnosis of congestive heart failure with current, active class iii or iv new york heart association symptoms. * significant fluid overload such that it is unsafe in the opinion of the pi for the patient to participate in the trial * chronic gastrointestinal disorder or any other factors judged to be likely to limit adherence to interventions (i.e. alcoholism, a history of missing clinic visits) * chronic immunosuppressive therapy for transplanted organs or other indications * individuals who are currently a member of a vulnerable population (i.e. incarcerated, pregnant). 11.currently participating in another interventional research study
optimal duration of early intervention for psychosis

Conditions: Psychotic Disorders

Summary: a total of 160 subjects, who aged 18-35 and had completed the first 2 years of case management in the easy programme will be randomized in 1:1 ratio into either (1) receiving an additional year of case management, or (2) terminating case management for the next 12 months. the current study aims to investigate whether an additional year of case management in year 3 will confer additional benefits in outcome, in terms of functioning, symptoms, quality of life and health economics.

psychotic disorders involve disturbances in perceptual, cognitive and motivational processes central to the human life experience, which resulting in long-term and pervasive functional disability. in order to achieve the best possible long-term community outcome of psychotic disorders, early intervention service is set up, focusing on the first few years (the critical period) of the illness. in hong kong, early intervention for psychotic disorder was provided since 2001. the integrated early assessment service for young people with psychosis (easy) provide specialized care to early psychosis patients up to age 25. evaluation of the easy programme using a matched historical control suggesting that early intervention is a promising approach to promote community care for patients with psychosis. in the current service, case management for patients will terminate after two years, and the patients will make transition to general psychiatric care afterwards. it is not clear whether the provision of additional case management in the community (e.g., for another year) will significantly enhance outcome further. the proposed study aims to investigate the effectiveness of providing community based case management for an additional year for patients with psychotic disorders by using a randomized controlled design. the study recruit patients who had completed the first 2 years of case management in the easy programme and randomized them to receive either an additional year of case management, or to terminate case management for the next 12 months. the hypothesis is that better outcome are found in patients who had 3-year case management compared with those who had only 2 years.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, psychosis not otherwise specified or delusional disorder * received easy service for 2 years following a first-episode psychosis * cantonese-speaking chinese * ability to understand the study and to provide written informed consent exclusion criteria: * organic brain disorder * known history of intellectual disability * drug-induced psychosis

Keywords: psychotic disorders psychosis
rans. study in patients with severe eosinophilic asthma and nasal polyps.

Conditions: Severe Eosinophilic Asthma; Nasal Polyps

Summary: the purpose of this observational study is to describe the population of patients with sea + np who have been prescribed fasenra and assess available clinical outcomes for both np and asthma.

in light of the increasing importance of comorbidities in driving choice for biologics in severe asthma there is a knowledge gap to understand sea patients with comorbid np for whom the decision to start biologics was based on the presence of severe, uncontrolled asthma. this retrospective, observational study will describe the population of patients with sea + np who have been prescribed fasenra and assess available clinical outcomes for both np and asthma.

Eligibility criteria:
inclusion criteria: 1. current or previous treatment with benralizumab for sea 2. physician-confirmed diagnosis and evaluation of np using nps and/or snot-22 before and after first benralizumab injection 3. patients who have follow-up period of at least 5 months from first benralizumab injection or at least 4 consecutive injections of benralizumab 4. able to provide signed informed consent (if required based on local guidelines) exclusion criteria: 1. patient on any other biologic during the 12 months prior to treatment with benralizumab 2. previously or currently receiving any biologics for the treatment of asthma or np in a clinical trial. this exclusion criteria does not apply to patients that received biologic treatment from openlabel one-arm interventional studies that provided biologic treatment as part of standard of care (according to approved labelling in that country).

Keywords: severe eosinophilic asthma, nasal polyps, benralizumab, fasenra.
evaluation of the free α-hemoglobin pool in the red blood cells : prognostic marker and severity index in thalassemic syndromes

Conditions: Thalassemic Syndromes

Summary: our project aims to assess and validate an innovative prognostic and diagnostic test in order to i) define a severity index of the β-thalassemia according to the free α-hb pool for a better management of the patient; ii) differentiate the α-thalassemia and β-thalassemia and iii) follow the evolution of this pool in response to treatment of patients. in the future, this prognostic test based on the measurement of free α-hb pool may be suitable for routine laboratory practice. to carry out this project, cohort of 85 thalassemic patients and a group of 50 healthy volunteers have been recruited.


Eligibility criteria:
inclusion criteria patient * age ≥ 18 years * written informed consent * affiliation to social security * known hb phenotypes * biological phenotype corresponding to a classical picture of thalassemia healthy volunteers * age ≥ 18 years * written informed consent * affiliation to social security exclusion criteria patient * transfusion for less than 3 months * chronic active viral disease: hepatitis b, c, hiv * ongoing infections or known inflammatory diseases * hyper or hypothyroidism known or subject treated by levothyrox * active pathology or tumor remission for less than 5 years * oral corticosteroid * hemoglobinopathy other than thalassemia for patients * treatment by hydroxyurea for more than 3 months * treatment by stimulating agent erythropoiesis for longer than 3 months healthy volunteers * transfusion for less than 3 months * chronic active viral disease: hepatitis b, c, hiv * ongoing infections or known inflammatory diseases * hyper or hypothyroidism known or subject treated by levothyrox * active pathology or tumor remission for less than 5 years * oral corticosteroid * genetically related to person with hemoglobinopathy

Keywords: alpha-hemoglobin stabilizing protein alpha-hb pool thalassemias diagnostic method biomarker
defining the decline in endogenous insulin secretion in type 1 diabetes diagnosed after 30 years of age.

Conditions: Diabetes Mellitus, Type 1; Progression

Summary: the study aims is to find out if people with type 1 diabetes diagnosed in later life (after age 30) have the same rapid loss of insulin secretion (measured using c-peptide) that occurs in younger adults with type 1 diabetes. the investigators will recruit 135 participants aged over 30 years with a clinical diagnosis of type 1 diabetes and diabetes duration ≤100 days. the investigators will also recruit a comparison group of 61 participants aged 18-30 with a clinical diagnosis of type 1 diabetes and diabetes duration ≤100 days. c-peptide will be measured during mixed meal tolerance tests (mmtt) performed at baseline, 6 months and a year. this study also aims to test a new more practical way of monitoring insulin secretion at home using a finger prick 'blood spot' rather than time consuming tests in a hospital. finger-prick c-peptide samples will be collected after the mmtt and by the participants at home throughout the year.

the study aims to evaluate progression of type 1 diabetes. primary analysis will be conducted on those with \>=1 diabetes autoantibody positive (gad, ia2 znt8). sensitivity analysis will be performed by repeating all analysis defining t1d as a) double antibody positivity and b) single antibody positivity combined with a high genetic risk score for t1d (t1dgrs\>5th centile of a control population). further aims will be to evaluate the utility of dried blood spot testing to detect change in c-peptide and the utility of home test results as a marker of hypoglycaemia and glucose variability.

Eligibility criteria:
inclusion criteria: * adults with a clinical diagnosis of type 1 diabetes within the previous 100 days. * aged \>30 at the time of type 1 diabetes diagnosis or (additional early onset type 1 diabetes cohort) aged ≥18 and ≤30 at the time of type 1 diabetes diagnosis. * insulin treated at the time of recruitment * able and willing to provide informed consent. exclusion criteria * pregnancy * known monogenic diabetes * known secondary diabetes (diabetes considered likely due to medication, cystic fibrosis, pancreatitis, pancreatic cancer, pancreatic surgery, hemochromatosis or cushing's syndrome).