Kornimate/medical-research-clean huggingface dataset:
study to evaluate a procedure for intra-articular injection of fx006 in patients with osteoarthritis of the hip

Conditions: Osteoarthritis, Hip

Summary: this is a multi-center, single-arm, open-label study of fx006 in patients with hip oa. a maximum number of approximately 30 patients may be enrolled in this protocol. all enrolled patients will receive a single intra-articular (ia) injection of fx006.

this is a multi-center, single-arm, open-label study in patients with hip oa to evaluate a procedure for intra-articular injection of fx006 in patients with hip oa. a maximum number of approximately 30 patients may be enrolled in this protocol. all enrolled patients will receive a single intra-articular (ia) injection on day 1 and be followed for 8 weeks.

Eligibility criteria:
inclusion criteria: * willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions * patients 40 to 80 years of age, inclusive, on the day of consent * body mass index (bmi) ≤ 40 kg/m\^2 * has a documented clinical diagnosis of unilateral or bilateral hip oa for at least six months * kellgren-lawrence (kl) grade 2 or 3 in the index hip as confirmed by local read of x-ray obtained during screening or ≤ 6 months of screening visit * has clinically significant pain in the index hip exclusion criteria: * has a history of hypersensitivity to triamcinolone acetonide, plga or lidocaine * is receiving anticoagulants (including warfarin, dabigatran, rivaroxaban, apixaban or low molecular weight heparin, ritonavir or cobicistat) * has had any previous surgery on the index hip * presence of surgical hardware or other foreign body in the index hip * has a history of infection of the index hip * has a diagnosis of other disorders in the index hip that can cause pain * has received any intra-articular injection in the index hip of corticosteroids, investigational (including fx006) or marketed (including zilretta®) within the 3 months prior to screening * has had trauma to the index hip in the past 3 months requiring immobilization * has a history or evidence of active or latent systemic fungal or mycobacterial infection (including tuberculosis), or of ocular herpes simplex * has within the past 3 months received corticosteroids by mouth, or by parenteral injection. multiple courses or chronic intermittent use of inhaled, intranasal, or topical steroids is also exclusionary. single courses of 14 days or less by those routes are permitted * has, at screening, or any time prior to day of scheduled injection (day 1), clinical suspicion of local or systemic infection, including any infection in the index leg. * has a history of or active significant concomitant illness (known or suspected) * any bacterial or viral infection requiring parental antibiotics within 4 weeks of day 1 or oral antibiotics within 2 weeks of day 1 * is a woman who is pregnant, nursing, lactating, or plans to become pregnant during the study * is a man who plans to conceive during the study

Keywords: osteoarthritis hip intra-articular injection
levetiracetam as add-on treatment of myoclonic jerks in adolescents + adults

Conditions: Generalized Convulsive Epilepsy

Summary: a double-blind, placebo-controlled study to assess the efficacy of adjunctive treatment with lev 3000mg/day in reducing myoclonic seizures in adolescents and adults suffering from idiopathic generalised epilepsy and to evaluate the safety of lev in the same population.


Eligibility criteria:
inclusion criteria: * subjects with a confirmed diagnosis consistent with idiopathic generalized epilepsy experiencing myoclonic seizures (iib) that are classifiable according to the international classification of epileptic seizures. to ensure an idiopathic generalized epilepsy population, only these subjects with the diagnosis of juvenile myoclonic epilepsy (jme), juvenile absence epilepsy (jae) or epilepsy with generalized tonic- clonic seizures on awakening must be included. * presence of at least eight days with at least one myoclonic seizure (iib) per day during the eight weeks of the baseline period. * absence of brain lesion documented on a ct scan or mri; if a ct scan or mri has not been performed within the past five years before visit 1, a ct scan (or mri where legally required) should be performed during the baseline period. * presence of eeg features consistent with idiopathic generalized epilepsy on an eeg recorded during the baseline period or no more than one year before visit 1. * male/female children ≥ 12 years of age or adult ≤ 65 years of age at visit 1. * subject on a stable dose of one standard anti-epileptic treatment for at least four weeks before visit 1. exclusion criteria: * previous exposure to levetiracetam. * history of partial seizures. * history of convulsive or non-convulsive status epilepticus within 3 months prior to visit 1. * subject taking vigabatrin or tiagabine, subject on felbamate with less than 18 months exposure, and subject under vagal nerve stimulation or ketogenic diet. * subject taking any drug (except the concomitant aeds) with possible cns effects.

Keywords: idiopathic generalized epilepsy, myoclonic seizures keppra - levetiracetam
excretion of rivaroxaban in human breast milk

Conditions: Postpartum; VTE Prophylaxis; VTE (Venous Thromboembolism); Rivaroxaban; Breastfeeding; Breast Milk Collection

Summary: the purpose of this study is to investigate the distribution of rivaroxaban into human milk at both therapeutic and prophylactic doses, and over time with repeated dosing.

the aim of our study is to perform a phase 1, single arm clinical trial to investigate the distribution of rivaroxaban into human milk at both therapeutic and prophylactic maternal doses. our goal is to enhance the limited, although positive, data regarding the safety of rivaroxaban in breastfeeding. our novel contributions to the existing body of literature will be in our investigation of rivaroxaban at both prophylactic and therapeutic doses, in repeated doses over time, and in a larger sample of participants. these results will provide physicians and national societies with safety data needed to properly counsel patients and advance clinical guidelines for postpartum care.

Eligibility criteria:
inclusion criteria: 1. postpartum within 6 weeks of delivery 2. greater than 18 years old at expected date of delivery 3. english speaking 4. hemodynamically stable without concern for ongoing blood loss 5. non-breastfeeding 6. or breastfeeding an infant born at or equal to 37 weeks' gestation, weighing \>2600g at birth and is not requiring intensive care 7. meet inclusion criteria for prophylactic rivaroxaban dose: pre-pregnancy bmi \>/= 40 and/or any personal history of vte. or \>/= 2 of the following: pre-pregnancy bmi 30-39, immobility, pregnancy complications, cesarean delivery, hysterectomy 8. or meet inclusion criteria for therapeutic rivaroxaban dose: have an indication for therapeutic anticoagulation per the american college of obstetricians and gynecologists' (acog) practice bulletin #196, or other indication per their primary team, and recommended for such anticoagulation per their primary practitioner. exclusion criteria: 1. pregnant 2. less than 18 years old at estimated date of delivery 3. hemodynamic instability and/or concern for ongoing blood loss 4. newly diagnosed deep vein thrombosis (dvt) or pulmonary embolism (pe) in the postpartum period 5. abnormal maternal renal or liver function (creatinine clearance \< 30 ml/min and/or liver function tests greater than lab normal) 6. a contraindication to rivaroxaban: hypersensitivity to rivaroxaban; active pathological bleeding 7. breastfeeding an infant admitted to neonatal intensive care unit, infant gestational age at birth \<37w0d or weighing \<2600g. 8. if all of the following are met: age less than 40, ambulating, body mass index (bmi) less than 30, no active history of malignancy. 9. if patient lacks indication for therapeutic anticoagulation in the postpartum period per the american college of obstetricians and gynecologists' (acog) practice bulletin #196

Keywords: rivaroxaban relative infant dose lact rivaroxaban in breast milk
trial to assess the effects of vorapaxar (sch 530348; mk-5348) in preventing heart attack and stroke in patients with atherosclerosis (tra 2°p - timi 50) (p04737)

Conditions: Atherosclerosis; Ischemia; Myocardial Infarction; Cerebrovascular Accident; Peripheral Arterial Disease

Summary: the study is designed to determine whether vorapaxar, when added to the existing standard of care (soc) for preventing heart attack and stroke (eg, aspirin, clopidogrel) in participants with a known history of atherosclerosis, will yield additional benefit over the existing standard of care without vorapaxar in preventing heart attack and stroke. the study is also designed to assess risk of bleeding with vorapaxar added to the standard of care versus the standard of care alone.


Eligibility criteria:
inclusion criteria: men and women at least 18 years old with evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems by one or more of the following: * history of myocardial infarction (heart attack) * history of ischemic stroke (stroke due to a blocked artery) * history of peripheral arterial disease exclusion criteria: * history of intracranial hemorrhage or of central nervous system (cns) surgery, tumor, or aneurysm * any bleeding disorder or abnormality * sustained severe hypertension or valvular heart disease * current or recent platelet count \<100,000 mm\^3 * planned or ongoing treatment with a blood thinning medication * pregnancy * any significant medical or physiological condition or abnormality that could put the subject at increased risk or limit the subject's ability to participate for the duration of the study
european real-world registry for use of the ion endoluminal system

Conditions: Pulmonary Nodule; Lung Cancer

Summary: the objective of this study is to collect collect real-world data for the ion endoluminal system.

this is a prospective, observational, multi-center, single-arm study to collect real-world data evaluating procedural characteristics and short- and long-term clinical outcomes following the use of the ce-marked ion endoluminal system for elective lung nodule biopsies and/or localization procedures. it is a post-market study using the device per the approved indications. all patients will be enrolled per the protocol eligibility criteria. enrollment for this study will conclude when approximately 1,200 patients have had a nodule biopsy and/or localization procedure attempted or performed.

Eligibility criteria:
inclusion criteria: * patient is aged 18 years or older at time of consent. * patient is planned to undergo a lung lesion biopsy(s) and/or localization procedure(s) utilizing the ion endoluminal system. * patient is willing and able to give written informed consent for clinical study participation. exclusion criteria: * patient is participating in an interventional research study or research study with investigational agents with an unknown safety profile that would interfere with participation in this study or study results. * female patient that is pregnant or breast feeding as determined by standard site practices. * patient is legally incapacitated or in a legal/court ordered institution or is part of a known vulnerable population, including but not limited to dependency on the sponsor, hospital or study doctor. * patient is not willing to comply with post-procedure study participation requirements. * investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the clinical study.

Keywords: biopsy bronchoscopy pulmonary biopsy pulmonary nodule localization
safety and efficacy study of xelox vs. oxaliplatin+5-fu ci as first line treatment in metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of this study is to determine time to disease progression of combination therapy with capecitabine and oxaliplatin (xelox) vs. oxaliplatin and 5-fluorouracil in continous infusion (5-fu ci) as first line treatment in advanced or metastatic colorectal cancer

the purpose of this study is to determine time to disease progression of combination therapy with capecitabine and oxaliplatin (xelox) vs. oxaliplatin and 5-fluorouracil in continous infusion (5-fu ci) as first line treatment in advanced or metastatic colorectal cancer

Eligibility criteria:
inclusion criteria: written informed consent. men and women \> or = 18 years karnofsky functional status \>or=70% at the time of enrollment in study histologically confirmed diagnosis of crc patients must not have received chemotherapy (exception: adjuvant treatment \> 12 months following conclusion of treatment) presence of at least one lesion detectable by two-dimensional measurement.. life expectancy greater than 3 months. exclusion criteria: pregnant or nursing woman prior administration of systemic immunotherapy, chemotherapy (exception: 5-fu as adjuvant treatment \> 12 months following conclusion of treatment) evidence of allergic reaction to any of the treatment components clinically relevant myocardial disease or history of myocardial infarction in the past 12 months documented or suspected cerebral and/or leptomeningeal metastases. prior malignant tumour in past 5 years, except history of basal cell skin carcinoma or pre-invasive cervical carcinoma. neutrophil count \ 1.5 x uln. total bilirubin count \> 2 x uln alkaline phosphatase \> \> 2.5 x uln (\> 5 x uln if there are hepatic metastases) aspartate aminotransferase (ast/sgot) and alanine aminotransferase (alt/sgpt) \> 2.5 x uln (\> 5 x uln if there are hepatic metastases, \> 10 x uln if there are bone metastases) creatinine clearance \< 30 ml/min surgery within 4 weeks prior to enrollment in the study. any investigational drug during the 4 weeks prior to enrolment. uncontrolled active infection any medical or psychological disorder which, in the opinion of the investigator, does not allow the patient to conclude the study or sign the informed consent -

Keywords: colorectal cancer, capecitabine, oxaliplatin, 5-fluorouracil
genetic analysis of pheochromocytomas, paragangliomas and associated conditions

Conditions: Pheochromocytoma; Paraganglioma; Inherited Cancer Syndrome; Associated Conditions; Kidney Neoplasms; Bone Cancer; Thyroid Neoplasms; Other Cancer

Summary: pheochromocytomas and paragangliomas are neural crest-derived tumors of the nervous system that are often inherited and genetically heterogeneous. genetic screening is recommended for patients and their relatives, and can guide clinical decisions. however, a mutation is not found in all cases. the aims of this proposal are to: 1) to map gene(s) involved in pheochromocytoma, and 2) identify genotype-phenotype correlations in patients with pheochromocytoma/paraganglioma of various genetic origins.

pheochromocytoma and paragangliomas are tumors originated from neuroectoderm cells located in the adrenal or extra-adrenal paraganglia, often leading to increased secretion of hormones known as catecholamines. these tumors represent a potentially curable cause of hypertension and are malignant in about 10-15% of the cases. approximately 40% of patients with pheochromocytomas and/or paraganglioma have an inherited mutation. in addition, some patients and/or their relatives that are mutation carriers can develop other tumors as part of inherited cancer susceptibility syndromes. therefore, detection of the susceptibility mutation is important for diagnosis and follow up. however, the susceptibility gene mutation cannot be identified in all cases. studies that aim to identify novel susceptibility genes for pheochromocytoma are required. the fist aim of this study is to identify novel pheochromocytoma susceptibility genes. characterization of such gene(s) can improve our understanding of the pathogenesis pheochromocytoma and paraganglioma and have an impact in diagnosis, therapeutic planning and genetic screening of relatives. the second aim of this project is to characterize relationships between mutations and clinical features that can provide insights into clinical surveillance and screening of at-risk individuals.

Eligibility criteria:
inclusion criteria: * diagnosis of pheochromocytoma and or paraganglioma * family member with diagnosis of pheochromocytoma and or paraganglioma * diagnosis of a pheochromocytoma- and or paraganglioma-associated condition * family member with diagnosis of a pheochromocytoma- and or paraganglioma-associated condition exclusion criteria: * unconfirmed diagnosis of pheochromocytoma and/or paraganglioma or associated condition

Keywords: tumor suppressor gene oncogene mutation susceptibility gene
gene polymorphisms and symptoms in lung cancer patients

Conditions: Lung Cancer

Summary: primary objectives: * construct a prospective cohort of patients diagnosed with lung cancer and dispositioned for treatment and collect information on symptoms and symptom treatments at baseline and on follow-up. * develop preliminary statistical models incorporating genetic data (which will be obtained from an existing protocol, cpn 91-001, margaret spitz), disease-related variables (e.g., stage of disease, location of tumor), clinical health status (e.g., performance status, comorbid conditions), and sociodemographic characteristics (e.g., age, sex, race) for predicting the risk of severe and persistent symptoms. analytical aim: to determine if symptoms (e.g., fatigue, depression, lack of appetite) will differ in severity by il-6 gene polymorphisms (-174g/c, -597g/a, -572g/c, -373an/tn). this study (nih-ca109043, reyes-gibby, 2004-2009) builds upon an nih-funded (nih-ca55769, spitz, 2003-2008) study of the molecular epidemiology of lung cancer.

if you agree to take part in this study, upon being admitted for treatment, you will be asked about your symptoms (how severe they are and to what degree they affect your day-to-day functioning). you will be asked to fill out a symptoms questionnaire each time you are at the clinic for your treatment and for your follow-up visits. the questionnaire will take about 5 to 10 minutes to complete each time. you may also be contacted at home so that researchers can follow-up on your experience with symptoms (only if you are not able to come to the clinic for your chemoradiation treatment or follow-up visits). if you are contacted by phone, the call should last about 5 to 10 minutes each time. researchers will also try to collect some of your leftover blood (that was already drawn and stored for research studies) from a previous lung cancer study (ecogenetics of lung cancer) that you participated in at m. d. anderson. researchers will use your leftover blood sample to look at certain genes in your blood that may affect your symptoms. if you did not have blood collected in the previous lung cancer study, you will have a blood sample (one tablespoon) drawn when you first agree to participate in this study. this is an investigational study. up to 320 patients will take part in this study. all will be enrolled at m. d. anderson.

Eligibility criteria:
inclusion criteria: * patient has lung cancer and is being treated at m. d. anderson. * at least 18 years of age * currently living in the united states * enrolled in cpn 91-001 (molecular epidemiology of lung cancer) * english or spanish speaking exclusion criteria: * patient is unable to understand the intent of the study.

Keywords: lung cancer epidemiology symptoms gene polymorphisms questionnaire survey
covid-19 in the swedish icu-cohort: risk factors of critical care admission and intensive care mortality

Conditions: COVID-19; Critical Illness

Summary: the corona virus disease 2019 (covid-19) pandemic is currently involving all parts of the world. several risk factors for critical illness and death from the disease have been proposed. however, the observed associations between different comorbidities and chronic medications have not fully been related to the frequencies of the same comorbidities and chronic medications in age- and sex-matched controls from the general population. this is important since some of the proposed risk factors are very common in the aged who, by age alone, are more prone to a more severe course of the disease. by combining several registries, we will compare, on several comorbidities such as hypertension and diabetes and several medications such as immunosuppressant drugs and angiotensin converting enzyme (ace)-inhibitors, the first 2000 cases of covid-19 patients receiving critical care in sweden to a set 8000 age- and sex-matched controls.

the covid-19 pandemic is currently involving all parts of the world. several risk factors for critical illness and death from the disease have been proposed. however, the observed associations between different comorbidities and chronic medications have not fully been related to the frequencies of the same comorbidities and chronic medications in age- and sex-matched controls from the general population. this is important since some of the proposed risk factors are very common in the aged who, by age alone, are more prone to a more severe course of the disease. by combining several registries, we will compare, on several comorbidities such as hypertension and diabetes and several medications such as immunosuppressant drugs and ace-inhibitors, the first 2000 cases of covid-19 patients receiving critical care in sweden to a set 8000 age- and sex-matched controls. data sources: registries of the swedish board of health and wellfare: 1. the patient registry containing information including diagnostic codes from all specialized healthcare contacts in sweden. reporting i governed by law. 2. the swedish prescribed drug register to which all dispensations from pharmacies of prescribed drugs are reported. statistics sweden is the agency responsible for the official population statistics of sweden. they will draw our controls from the registry of the total population. the swedish intensive care registry (sir) contains all intensive care episodes in sweden. they have information on intensive care (icu) admission, diagnoses, interventions and outcomes. the study design is combined prospective ond retrospective. the data is prospectively collected to the registries but the study protocol is retrospectively designed.

Eligibility criteria:
inclusion criteria: -included in the sir with covid-19 any time until data acquisition exclusion criteria: -age below 18 years.
lanadelumab in long-term prophylaxis of acquired angioedema

Conditions: Angioedema

Summary: use of lanadelumab in patients with acquired angioedema


Eligibility criteria:
inclusion criteria: * a diagnosis of aae with recurrent attacks without urticaria (decreased c1inh functional, quantitative levels, decreased c4 and decreased c1q levels, no family history of angioedema), presence of anti-c1inh antibody and/or paraproteinemia (e.g. monoclonal gammopathy of unknown significance) * historical attack rate of \>= on attack per month prior to starting tranexamic acid (taa) exclusion criteria: * history of anaphylaxis or hypersensitivity to biologics * history of major systemic disease not well controlled in opinion of the pi * women who are pregnant or breast feeding * concurrent participation in other clinical trials * hae type 1 or 2 and normal complement hae