Kornimate/medical-research-clean huggingface dataset:
stereotactic body radiotherapy (sbrt) for pulmonary metastases in ewing sarcoma, rhabdomyosarcoma, and wilms tumors

Conditions: Ewing Sarcoma; Rhabdomyosarcoma; Wilms Tumor; Osteosarcoma; Non-Rhabdomyosarcoma Soft Tissue Sarcoma, Nos; Renal Tumor; Rhabdoid Tumor; Clear Cell Renal Cell Carcinoma; Sarcoma; Sarcoma, Ewing; Soft Tissue Sarcoma

Summary: this research study is studying stereotactic body radiotherapy (sbrt) as a possible treatment for lung relapse of ewing sarcoma, rhabdomyosarcoma, osteosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, wilms tumor or other primary renal tumor (including clear cell and rhabdoid). sbrt is a form of targeted radiotherapy that can treat very small tumors using a few large doses.

this research study is a pilot study, also known as a phase i-ii study, which means it is the first time investigators are examining this study intervention for patients with lung recurrence of ewing sarcoma, rhabdomyosarcoma, osteosarcoma, nonrhabdomyosarcoma soft tissue sarcoma, wilms tumor or other primary renal tumor (including clear cell and rhabdoid). this study tests the most appropriate dose, safety and efficacy of sbrt for the treatment of lung recurrence of these cancers in children. standard radiotherapy is typically used to treat ewing sarcoma and is used to treat lung recurrence. sbrt is being used to treat adults with small inoperable lung cancers; in such cases, sbrt has been shown to be effective and well-tolerated. sbrt is also used to treat bone metastases in adults and children.

Eligibility criteria:
inclusion criteria: * diagnosis of ewing sarcoma, rhabdomyosarcoma, osteosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, wilms tumor or other primary renal tumor (including clear cell and rhabdoid) * age ≤ 21 years; * must be capable of treatment without general anesthesia * lesion size 8 mm - 3 cm * subjects who have lesions within 2 cm of central structures, will be eligible on a case by-case basis * pulmonary metastases found at relapse (does not have to be first relapse); no more than 3 lesions per hemi-thorax will be treated but other lesions in the lung may be present * greater than 5 weeks from doxorubicin at the time of consent, with radiation to be initiated no less than 6 weeks from doxorubicin * informed consent/assent * life expectancy \>3 months * pulmonary function fev1 ≥ 50% of predicted; * concurrent immunotherapy is allowed exclusion criteria: * prior whole-lung or hemi-thorax irradiation of greater than 12 gy received less than 6 months prior to consent (focal radiotherapy to the thorax is not an exclusion) * lesion larger than 3 cm in diameter * patients for whom surgery would be deemed appropriate rather than radiotherapy

Keywords: ewing sarcoma rhabdomyosarcoma wilms tumor rhabdomyosarcoma of mediastinum ewing's sarcoma metastatic ewing family of tumors ewing's tumor metastatic osteosarcoma, metastatic osteosarcoma in children rhabdoid tumor lung metastasis radiation for children sbrt for children stereotactic body radiotherapy pulmonary metastasis lung metastasis in children pulmonary metastasis in children comfort care palliative care
effectiveness of ciclesonide versus budesonide in patients with asthma (18 to 75 y) (by9010/m1-136)

Conditions: Asthma

Summary: this trial will compare the effectiveness of one dose of ciclesonide against one dose of budesonide in patients with asthma. the aim of the present trial is to compare the efficacy of ciclesonide versus budesonide on pulmonary function, symptoms and use of rescue medication in patients with asthma. the onset of action and the safety and tolerability of ciclesonide in comparison to budesonide will also be investigated.


Eligibility criteria:
main inclusion criteria: * during the last 4 weeks prior to baseline, treatment with an inhaled steroid (dosage: up to 250 mcg fluticasone propionate or equivalent) * fev1 80 - 105% of predicted * healthy with the exception of asthma * written informed consent has been obtained * outpatients * patients who have a history of persistent bronchial asthma for at least 6 months main exclusion criteria: * concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids * concomitant copd (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function * an asthma exacerbation or an infection of the lower airways prior to entry into the baseline period * pregnancy * intention to become pregnant during the course of the study * breast feeding * lack of safe contraception * patient is current smoker with 10 or more pack-years * patient is ex-smoker with 10 or more pack-years

Keywords: asthma ciclesonide budesonide
inod system human feasibility assessment

Conditions: Solitary Pulmonary Nodule; Biopsy, Fine-Needle

Summary: the purpose of this study is to demonstrate feasibility to access, visualize, and obtain specimens adequate for cytology of lung lesions in subjects with suspected lung cancer when using the inod system.

this protocol is a traditional feasibility study for the sampling of a peripheral pulmonary lesion in the setting of a suspicion of lung cancer. standard of practice radial endobronchial ultrasound (r-ebus) transbronchial needle aspiration (tbna) is visualizing a peripheral lesion on r-ebus, locking the placement of the access sheath, removing the ultrasound catheter from the access sheath and then blindly advancing a sampling device to acquire cellular matter for cytologic evaluation. the inod system performs the same procedure with one fewer device exchange. it provides real-time visualization of the biopsy needle and target peripheral pulmonary lesions during tissue acquisition. the ultrasound probe is not retracted in advance of the sampling maneuver and the sampling is completed under direct visualization. compared to current standard of care methods for transbronchial sampling of pulmonary lesions, this approach is not expected to add additional risk. tissue sampling under real-time visualization may improve the efficiency of tissue sampling.

Eligibility criteria:
inclusion criteria: 1. subject is age 18 years or older. 2. subject is willing and able to comply with study procedures and provide written informed consent to participate in study. 3. subject with a predominantly solid lung lesion, 1 cm to 7 cm in diameter, which has been identified on chest ct (obtained within 6 weeks) with the intention to undergo a clinically indicated bronchoscopic evaluation under routine clinical care. if the lesion is partially solid (i.e. there is a ground glass component) then the solid portion must make up 80% of the lesion. 4. subject for whom the decision to pursue biopsy has been made by the treating physician and agreed upon by the subject. exclusion criteria: 1. subjects with pure ground glass opacity, a subsolid target lesion, and/or a ground glass opacity identified on chest ct. 2. subjects with lesions that include endobronchial involvement, per chest ct. 3. subjects who lack fitness to undergo flexible bronchoscopy and standard of care radial ebus-guided cytological assessment evaluations, as determined by the investigator. 4. subjects with known coagulopathy. 5. subjects who are pregnant or nursing mothers. 6. subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.
shockless implant evaluation

Conditions: Ventricular Fibrillation; Ventricular Tachycardia

Summary: this trial will assess the safety of defibrillator testing and the influence of defibrillation testing on the efficacy of clinical shocks. the trial will test the hypothesis that implantable cardioverter defibrillator (icd) implantation without defibrillation testing (dt) is non-inferior to implantation with testing against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic death. it will also test the hypothesis, that defibrillation testing increases the peri-operative (30 days) complication rate of icd implantation.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients undergoing initial implant of an icd or crt-d device (can be upgrade from a pacemaker) exclusion criteria: * patients, who in the opinion of their treating physicians are ineligible for either strategy (dt or no dt) * patients on active transplant list * patients unwilling to provide informed consent * patients not available for follow-up * pregnancy or women of child bearing potential not following an effective method of contraception * anticipated right sided implantation of the icd generator
efficacy and tolerability of anacetrapib added to ongoing lipid-lowering therapy in adult participants with homozygous familial hypercholesterolemia (hofh) (mk-0859-042)

Conditions: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia

Summary: this study will evaluate the safety and effect of anacetrapib on low-density lipoprotein-cholesterol (ldl-c) when added to ongoing lipid-lowering therapy. the primary hypothesis is that treatment with anacetrapib 100 mg for 12 weeks will lower ldl-c to a greater extent than treatment with placebo.


Eligibility criteria:
inclusion criteria: * diagnosed with hofh by genotyping * if female, cannot be of reproductive potential * have been stabilized on statin monotherapy or statin therapy coadministered with other lipid medications for at least 6 weeks exclusion criteria: * severe chronic heart failure defined by new york heart association (nyha) classes iii or iv * uncontrolled cardiac arrhythmias, myocardial infarction (mi), percutaneous coronary intervention (pci), coronary arterial by-pass graft (cabg), unstable angina or stroke within 3 months prior to visit 1 or has planned procedures scheduled within first 12 weeks of study * uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins * active or chronic hepatobiliary or gall bladder disease * history of ileal bypass, gastric bypass, or other significant condition associated with malabsorption * human immunodeficiency virus (hiv) positive * donated blood products or has had phlebotomy of \>300 ml within 8 weeks or intends to donate 250_ml of blood products or receive blood products within the projected duration of the study * taking medications that are potent inhibitors or inducers of cytochrome p450 3a4 (cyp3a4), including but not limited to cyclosporine, systemic itraconazole or ketoconazole, erythromycin, clarithromycin, or telithromycin, nefazodone, protease inhibitors, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, st john's wort) or has discontinued treatment \ 1 liter of grapefruit juice per day is also prohibited. * currently participating or has participated in a study with an investigational compound or device within 3 months * consume more than 2 alcoholic drinks per day * receiving treatment with systemic corticosteroids or systemic anabolic agents

Keywords: hofh
safety and efficacy of vaniprevir (mk7009) administered with pegylated-interferon and ribavirin (mk-7009-007)

Conditions: Hepatitis C

Summary: a study to evaluate how effective different levels of vaniprevir (mk-7009), when administered with pegylated-interferon (peg-ifn) and ribavirin, are at achieving rapid viral response (rvr) i.e., undetectable hepatitis c virus \[hcv\] viral ribonucleic acid \[rna\] at week 4 in participants with chronic hcv infection. the primary hypothesis was that the proportion of participants in one or more of the vaniprevir treatment groups achieving rvr would be greater than the proportion of placebo participants achieving rvr when vaniprevir and placebo were co-administered with peg-ifn/ribavirin.


Eligibility criteria:
inclusion criteria: * patient has chronic genotype 1 hepatitis c infection exclusion criteria: * subject has been previously treated for hcv * has human immunodeficiency virus (hiv) * has hepatitis b * has a history of clinically significant medical condition that may interfere with the study (e.g., stroke or chronic seizures or major neurological disorder) or is contraindicated for treatment with peg-ifn and ribavirin
observational study of glycaemic control in patients uncontrolled on oral antidiabetic agents and starting with 1 (once) daily levemir® (insulin detemir) as the treatment of type 2 diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. an observational study evaluating glycaemic control in patients using levemir® as initiation insulin therapy as the treatment of type 2 diabetes in slovakia.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes * patients inadequately controlled by oad * patients willing to sign informed consent * selection of study participants at the discretion of the physician * particular attention should be paid to the drug interactions that are listed within the product label exclusion criteria: * subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit; * subjects who were previously enrolled in this study * subjects with a hypersensitivity to insulin detemir or to any of the excipients. * women who are pregnant, breastfeeding or have the intention of becoming pregnant within next 6 months
open label study for the evaluation of tolerability of five dose levels of cand5

Conditions: Macular Degeneration

Summary: to establish the tolerability and preliminary efficacy of cand5 by a single intravitreal injection in patients with wet age-related macular degeneration.


Eligibility criteria:
inclusion criteria: * patients with subfoveal predominantly classic, minimally classic and purely occult lesions, secondary to age related macular degeneration, with a total lesion size (including blood, atrophy/scar and neovascularization) of \< 12 total disc areas, of which at least 50% are active cnv. * patients must have visual acuity 20/50 to 20/320 in the study eye. * patients must have better visual acuity in the fellow eye than the study eye. * subretinal hemorrhage (if any) must comprise no more than 50% of total lesion size. exclusion criteria: * patients with concomitant eye disease, including glaucoma, uveitis, diabetic retinopathy, presence of pigment epithelial tears or rips, acute ocular or periocular infection in the study eye. * patients with \> 3 prior pdt treatments with visudyne in the study eye. * patients who received pdt in the study eye within eight weeks prior to the baseline angiography/photography.

Keywords: amd macular degeneration opko health acuity pharmaceuticals bevasiranib cand5 age-related
under water seal versus negative pleural suction in chest trauma patients

Conditions: Chest Injury Trauma

Summary: :the investigators aim to provide trauma patient with the best and most efficient managment options and long-term stability with the least complications by comparing the effect of under water seal alone of chest tube in one groups of trauma patients and the effect of both under water seal and suction in other group and the benefits of one versus the other in duration of hospital stay and to assess short-term post-traumatic complications ,also to assess effectiveness of adding suction and patient satisfaction.

traumas are the leading cause of death in the first four decades of life and are mostly caused by traffic accidents. thoracic traumas might lead to severe consequences, even though less than 50% of them required a surgical revision. thoracic traumas can be divided in blunt or penetrating, according to the presence of open wound in the chest. blunt traumas are the most frequent type of chest trauma with or without rib fractures that might be associated with haemothorax, pneumothorax or haemopneumothorax that are the most typical lesions or laceration. pleural chest tubes are used to reestablish negative intrathoracic pressure after disruption of the pleural space. chest tube positioning is considered necessary in case of a pleural disruption with pneumothorax; intrapleural bleeding causing haemothorax; or in case of pneumo-haemothorax . the management of pleural chest tubes with primarily under water seal or added suction is the subject of debate, and the benefits of one versus the other in regards to duration of air leak, amount of time the chest tube is in place, length of hospital stay and incidence of complications are unclear. all of the previous made us interesting to examine the effect of under water seal alone of chest tube in one groups of trauma patients and the effect of both under water seal and suction in other group, the investigators think that power of suction will give the patient better results with less complications and excellent immediate relief with good quality of life, rapid return to normal life .

Eligibility criteria:
inclusion criteria: * • 1-pneumothorax after penetrating or blunt chest trauma * 2-hemothorax after penetrating or blunt chest trauma * 3-hemopneumothorax after penetrating or blunt chest trauma 4-all patients of all ages and genders are included exclusion criteria: * 1-anyperson associating with body trauma outside chest. * 2-invasive mechanical ventilation * 3-emergent surgery (thoracoscopy, open thoracotomy) * 4-chronic pulmonary diseases (copd, crpd)
immunological parameters between mronj stages

Conditions: Medication-Related Osteonecrosis of Jaw

Summary: this study aims to conduct a detailed analysis of the immunological response profiles that emerge at different clinical stages of medication-related osteonecrosis of the jaw (mronj). the research seeks to understand how these responses influence the pathogenesis, staging, and treatment of mronj. throughout the study, cytokine levels, inflammation markers, and other immunological parameters observed at various stages will be comprehensively assessed. the results of these analyses are expected to provide insights into how stage-specific immunological variables could play a role in the diagnosis and treatment of mronj.


Eligibility criteria:
inclusion criteria: * individuals aged 18 and over * both male and female participants * individuals who apply to the oral and maxillofacial surgery clinic at marmara university faculty of dentistry due to medication-related osteonecrosis of the jaw during the study period * individuals or their legal representatives who have provided written consent to participate in the study exclusion criteria: * non-drug-related osteonecrosis/osteomyelitis * osteoradionecrosis * metastasis to the oral region * individuals who have not given written consent to participate in the study
a study to compare the results of fgfr testing by either ctdna blood testing or standard tumor tissue testing

Conditions: Metastatic Bladder Cancer; Metastatic Urothelial Carcinoma

Summary: a new drug, erdafitinib, became available for some patients with bladder cancer that has spread to other organs. to qualify, patients must have specific genetic changes in their tumors. currently, doctors use tumor tissue samples to check for these genetic changes, but these samples might not accurately reflect the current state of the patient's cancer. in this study, investigators will test the patient's blood for these genetic changes in addition to the tumor tissue samples. it is thought that the blood test will give a more accurate result. investigators hope this study will help to find out if more patients can benefit from erdafitinib than the ones identified by tissue testing only.

recently, the first targeted therapy for patients with metastatic urothelial cancer (muc) received approval, i.e. erdafitinib. erdafitinib is a pan-fgfr small molecule inhibitor. approximately twenty percent of muc patients' tumors harbor qualifying alterations in fgfr2 or fgfr3. currently, standard testing uses archival tumor tissue. however, this type of testing may not be representative of a patient's clinically dominant tumor clone at the time of treatment initiation due to temporal and spatial biopsy bias of archival tissue testing. in this study, patients will undergo circulating tumor dna testing, in addition to conventional tissue testing, for treatment eligibility. investigators hypothesize that blood-based ctdna testing will provide a more accurate assessment of somatic fgfr status than same patient archival primary tissue. this study's objectives are: objective 1 (primary): to evaluate the diagnostic value of ctdna testing against the "gold standard" of tissue testing. objective 2 (secondary): to evaluate whether ctdna may be a superior predictive marker by identifying actionable fgfr alterations that are currently missed on tissue assays. procedures: * medical history will be reviewed, including all previous anti-cancer treatments. * a blood sample will be collected for ctdna testing at the time of screening for fgfr alterations and at progression under erdafitinib therapy. test results will be compared to archival tissue testing.

Eligibility criteria:
inclusion criteria: * patients with metastatic bladder cancer who are about to undergo tissue testing for fgfr mutations and who have blood samples drawn during the management of their disease are eligible to be included in this analysis. exclusion criteria: * metastatic bladder cancer patients who will not have tissue sent for fgfr testing will be excluded from this study.

Keywords: ctdna-fgfr fgfr biomarker erdafitinib
a study of the efficacy and safety of etc-1002 in participants with statin intolerance

Conditions: Hypercholesterolemia

Summary: this study will assess the low-density lipoprotein-cholesterol (ldl-c) lowering efficacy and safety of etc-1002 versus placebo in participants with hypercholesterolemia and a history of statin intolerance.


Eligibility criteria:
key inclusion criteria: * a history of statin intolerance that began during statin treatment and resolved within 4 weeks of stopping the statin treatment * for participants on current lipid-regulating drugs - ldl-c 100-220 milligrams per deciliter (mg/dl) and triglycerides \<350 mg/dl (prior to wash-out of all lipid-regulating drugs and supplements) * for participants not on current lipid-regulating drugs - ldl-c 115-270 mg/dl and fasting tg \<400 mg/dl key exclusion criteria: * acute significant cardiovascular disease * poorly controlled hypertension

Keywords: lipid-lowering drugs statin intolerance
comparison of ipx054 and immediate-release carbidopa-levodopa in patients with parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to compare the clinical efficacy of ipx054 to immediate-release carbidopa-levodopa in subjects with parkinson's disease.

ipx054 contains two different drugs called levodopa and carbidopa in one tablet. * levodopa turns into a material called 'dopamine' in your brain. the dopamine helps to improve the symptoms of your parkinson's disease. * carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. it helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.

Eligibility criteria:
inclusion criteria: * diagnosed with idiopathic parkinson's disease based on capit (core assessment program for intracerebral transplantations) criteria. * currently being treated with immediate-release carbidopa-levodopa with a stable dosing regimen over the past 4 weeks. exclusion criteria: * diagnosed with atypical parkinsonism. * allergic or non-responsive to previous carbidopa-levodopa therapy. * active or history of narrow-angle or wide-angle glaucoma. * history of seizure or epilepsy, or is currently taking an anti-convulsant for treatment of seizure. * requires concomitant therapy with tricyclic antidepressants, mao-b inhibitors, comt inhibitors or anticholinergics. * treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 6 months. * treatment with any dopaminergic blocking agent within the previous 6 months.