Kornimate/medical-research-clean huggingface dataset:
netherlands 10 ml bronchoscopic lung volume reduction (blvr) phase 1/2 emphysema study - initial formulation

Conditions: Pulmonary Emphysema

Summary: the purpose of this study is to determine the effective dose of the aeris blvr system in patients with advanced emphysema.

emphysema is a progressive, debilitating disease that affects nearly 3 million people in the united states or roughly one percent of the us population. the disease is characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. the most common cause of this condition is cigarette smoking, although genetic and occupational causes account for up to 10% of cases. despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death in the united states. currently there are 46 million smokers in the us. due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality in the united states for years to come. aeris has developed a novel bronchoscopic system for achieving the benefits of lung volume reduction without surgery. the bronchoscopic lung volume reduction (blvr) hydrogel system, a new investigational therapy for emphysema, is intended to reduce lung volume over a period of weeks by collapsing and promoting the remodeling of diseased areas of the lung. the resulting reduction in lung volume is intended to restore a more normal physiological relationship between lung and chest wall, improve breathing and exercise capacity and alleviate symptoms of chronic dyspnea. this study will evaluate the safety and efficacy of the aeris blvr system in patients with advanced emphysema.

Eligibility criteria:
inclusion criteria include: * clinical diagnosis of advanced emphysema * age \> 18 years at the time of initial presentation * clinically significant dyspnea (mrc dyspnea \>/= 2) * laboratory tests within protocol-specified ranges * pulmonary function tests exclusion criteria include: * alpha-1 protease inhibitor deficiency verified by a serum level of \<80mg% or knowledge of pi\*zz genotype * tobacco use within 16 weeks of the initial clinic visit * body mass index \ 35 kg/m2 * clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis * allergy to fish or pork products or sensitivity to tetracycline * fev1 \<20% predicted with dlco \<20% predicted or homogeneous disease

Keywords: emphysema pulmonary emphysema copd cold chronic obstructive pulmonary disease
clinical evaluation of the titan™ total shoulder system

Conditions: Arthritis; Arthritis, Degenerative; Rheumatoid Arthritis; Post-traumatic Arthrosis of Other Joints, Shoulder Region; Rotator Cuff Syndrome of Shoulder and Allied Disorders; Fracture; Avascular Necrosis; Joint Instability; Joint Trauma; Dislocation, Shoulder; Pain, Shoulder

Summary: a post market, non-randomized, multi-center, open-label,clinical study using survivorship to study the safety and efficacy of the integra® titan™ total shoulder system 1.0 (tas) when used for total shoulder arthroplasty.

observational, multi-center, post-market study to provide data on the performance and safety of the titan™ total shoulder system. the study will enroll patients that underwent total shoulder arthroplasty with the titan™ total shoulder system per standard of care less than 5 years ago. available retrospective data up to the 2-year time point will be collected, per the study protocol, from medical record reviews. prospective observational data will be collected from the time of patient enrollment during the following postoperative clinical visits: 1 year, 2 years, 5 years and 10 years post-surgery.

Eligibility criteria:
inclusion criteria: 1. subject has undergone shoulder arthroplasty with the first generation titan total shoulder system. 2. the first generation titan total shoulder system is still intact and the subject has not received any revision surgeries involving the titan total shoulder system. 3. subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures. exclusion criteria: 1. subject, in the opinion of the pi, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study such as mental illness, or drug or alcohol abuse. 2. subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
safety and efficiency of the years algorithm versus computed tomography pulmonary angiography alone for suspected pulmonary embolism in patients with malignancy

Conditions: Pulmonary Embolism; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Cancer; Diagnosis

Summary: the aim of this study is to prospectively validate the safety and efficiency of management according to the years algorithm to safely rule out clinically suspected pe in patients with active malignancy to be compared with 'standard' management by computed tomography pulmonary angiography (ctpa) alone in a randomized study.

recently, the years-algorithm was demonstrated to be a safe and efficient diagnostic strategy for patients with clinically suspected pulmonary embolism (pe). it is recognized that diagnostic algorithms for pulmonary embolism (pe) may not be as effective and safe in patients with malignancy, due to the low specificity of d-dimer test in that setting. a diagnostic algorithm that could safely rule out pe in patients with malignancy without performing computed tomography pulmonary angiography (ctpa) could nonetheless improve patient care.

Eligibility criteria:
inclusion criteria: in order to be eligible to participate in this study, a subject must meet all of the following criteria: * clinically suspected pe as judged by the treating clinician * any type of active malignancy (other than basal-cell or squamous-cell carcinoma of the skin), defined as diagnosis within six months before the study inclusion (as confirmed histologically or high suspicion as judged by the clinician), receiving treatment for malignancy at time of inclusion or during 6 months prior to randomization, including recurrent or local metastatic malignancy * outpatients and hospitalized patients * age ≥ 18 years * signed and dated informed consent, available for start of the trial procedure exclusion criteria: a potential subject who meets any of the following criteria will be excluded from participation in this study: * medical or psychological condition that would not permit completion of the study or signing of informed consent, including life expectancy less than 3 months, or unwillingness to sign informed consent * treatment with full-dose therapeutically dosed anticoagulation that was initiated 24 hours or more prior to eligibility assessment * contraindication to ctpa * contrast allergy hemodynamic instability at presentation (as a consequence of concurrent acute pe or otherwise), indicated by at least one of the following: * systolic blood pressure (sbp) \ 120 beats per minute or sbp drop by \> 40 mm hg, for \> 15 min * need for catecholamines to maintain adequate organ perfusion and a systolic blood pressure of \> 100 mmhg * need for cardiopulmonary resuscitation * inability to follow-up * life expectancy less than 3 months
a study of mdv3100 to evaluate safety, tolerability, pharmacokinetics and efficacy of in prostate cancer patients

Conditions: Prostate Cancer; Prostate Neoplasms; Castration Resistant Prostate Cancer (CRPC)

Summary: this study is to evaluate safety, tolerability pharmacokinetics and efficacy of mdv3100 after oral administration to patients with castration-resistant prostate cancer.

this is a phase1/2, open-label, uncontrolled study, involving dose-escalation cohorts, where dose will be escalated to next dose with the safety, tolerability, and pk being evaluated in metastatic castration-resistant prostate cancer (mcrpc) patients and an expansion cohort, where the efficacy, safety, and pk of mdv3100 in post-chemo mcrpc patients will be evaluated. after evaluation of the safety and tolerability in dose-escalation cohorts, additional patients are included in expansion cohort.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the prostate * ongoing androgen deprivation therapy with a gnrh analogue or a bilateral orchiectomy * progressive disease after prior androgen deprivation therapy (medical or surgical castration) * for expansion cohort, the patient has no more than two prior chemotherapy regimens with at least one regimen containing docetaxel * for expansion cohort, the patient must have measurable lesions by recist exclusion criteria: * metastases in the brain * history of another malignancy except for adenocarcinoma of the prostate within the previous 5 years * use of bicalutamide within 6 weeks prior to study * radiation therapy within 12 weeks prior to study * evidence of serious drug hypersensitivity

Keywords: docetaxel response evaluation criteria in solid tumor (recist) psa level mdv3100
physical activity program and energy intake control in obese adolescents

Conditions: Pediatric Obesity

Summary: acute exercise of high intensity has been shown to induced nutritional adaptations in obese adolescents. indeed, several studies have shown that about 30 minutes of intensive exercise (above 70% of the adolescents maximal aerobic capacities) can favor reduced-energy consumption at the following meal with no modification of their appetite feelings. although it is suggested that chronic physical activity programs can induce energy intake modifications, this has never been clearly studied. the aim of this work is to compare different physical activity programs (low vs. high intensity programs) in terms of energy intake, appetite feelings and appetite-regulating hormones, in obese adolescents.

after an first medical visit to ensure that the adolescents have the ability to complete the whole study, the participants will have to complete several clinical examinations: * anthropometric measurements * body composition assessed by dxa * maximal aerobic test * blood samples (appetite-regulating hormones) * daily energy intake assessment during a 24h intake exploration. the adolescents recruited will then be randomly assigned to one of the two intervention groups: - high intensity program or moderate intensity program. those two physical activity programs will last 4-months and will be composed of 3 to 4 exercise sessions per week. the high intensity program will consists in high intensity interval exercises starting at 70% of the adolescents' capacities at the beginning to end around 95%. the moderate intensity program will propose continuous exercises set between 50-65% vo2max. no energy intake intervention will be performed. by the end of the 4-months intervention, all the clinical examinations performed before the intervention will be repeated.

Eligibility criteria:
inclusion criteria: * 12 to 15 years old adolescents * obese according to international values for bmi * being registered to the national social security insurance * no eating disorders * no medications * metabolic disorders exclusion criteria: * metabolic disorders * food disorders * physical disability
respiratory aerosols in patients with covid-19 and healthy controls

Conditions: SARS-CoV-2 Infection; Covid19

Summary: the proposed study will investigate respiratory aerosols in sars-cov-2 (severe acute respiratory syndrome corona virus 2) positive and negative children and adults with the resp-aer-meter (palas gmbh). for this purpose, first, the measurement of respiratory aerosols (particle sizes and concentration) with the resp-aer-meter will be established. thereafter, a comparison between polymerase chain reaction (pcr) sars-cov-2 positive and negative participants (children and adults) will be conducted. in addition to the measurement of aerosols, the clinical symptoms, lung function (fev1) and laboratory inflammatory markers will be analyzed.

corona virus disease 2019 (covid-19) is a viral illness caused by sars-cov-2. current research suggests that the sars-cov-2 infection is primarily spread through droplets and aerosols. as per current literature, the spread through asymptomatic carriers, as well as highly contagious carriers ('super spreader') play an important role in the infectiousness of the virus. it is currently unclear, if the contagiousness of children differs from adults. in the proposed investigation, measurement of the particle size and concentration in respiratory aerosols will be conducted via the resp-aer-meter (palas gmbh). first step will be to establish the measurements with this new device. thereafter, a comparison between pcr sars-cov-2 positive and negative participants, as well as between children and adults, will be conducted. in addition to the measurement of aerosols, the clinical symptoms suggestive of covid-19, lung function (fev1) and laboratory inflammatory markers, if available, will be analyzed.

Eligibility criteria:
inclusion criteria: * age 6 years or older * sars-cov-2 pcr testing within the last 3 days * ability to capture extend and consequences of the study * written informed consent of patient and, if applicable, of caregiver exclusion criteria: * age under 6 years * inability to participate in aerosol measurement * inability to participate in spirometry * inability to capture extend and consequences of the study * only for arm 1 (pcr sars-cov-2 negative adults): chronic disease with immunosuppressive therapy

Keywords: covid-19 aerosol sars-cov-2
observational study on the impact of obstructive sleep apnea on executive function and empathy development in children

Conditions: Pediatric Obstructive Sleep Apnea; Cognition; Empathy; EEG

Summary: this study aims to investigate the effects of obstructive sleep apnea (osa) on executive function and empathy development in children aged 3-12 years. the study will compare the outcomes of different treatment approaches (surgical vs. pharmacological) in children with mild osa and track the progression of cognitive and emotional functions over 12 months. the study will also explore potential eeg biomarkers for assessing neurological damage in osa children.

this is a prospective observational cohort study conducted at the sleep center of the respiratory department and the department of child and adolescent healthcare, children's hospital of soochow university. children diagnosed with osa will be divided into groups based on disease severity (mild, moderate, severe) and treatment choice (surgical or pharmacological). the study will assess executive function and empathy levels at baseline, 6 months, and 12 months post-intervention using behavioral tests, eeg, and parent-reported questionnaires. the study aims to provide evidence for treatment selection in mild osa children and identify eeg biomarkers for neurological damage.

Eligibility criteria:
inclusion criteria: * children aged 3-12 years. * diagnosed with osa due to adenoid and/or tonsillar hypertrophy. * iq ≥ 85. * parental consent for participation. exclusion criteria: * other primary sleep disorders (e.g., narcolepsy, restless leg syndrome). * developmental delay, epilepsy, or other neurological/metabolic disorders. * chronic diseases or history of head trauma.

Keywords: obstructive sleep apnea executive function empathy children eeg biomarkers cohort study neurodevelopment adenotonsillectomy
a study of the clinical application of [18f]rccb6 and [68ga]ga-nota-rccb6 pet/ct imaging in the diagnosis of cd70-expressing multiple tumors

Conditions: Kidney Cancer; Lymphomas; Positron Emission Tomography

Summary: the aim of this study was to establish and optimize the \[18f\]rccb6 and \[68ga\]ga-nota-rccb6 pet/ct imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in renal cancer (especially clear cell renal cell carcinoma) and lymphoma was evaluated.


Eligibility criteria:
inclusion criteria: 1. be between 18 and 65 years of age and of either sex. 2. affected with renal cancer or lymphoma confirmed by puncture or surgical pathology. 3. informed consent must be signed in writing by the subject or his/her legal guardian or caregiver. 4. willingness and ability to cooperate with all programs of this study. exclusion criteria: * subjects meeting any of the following criteria will be excluded from the study: 1. severe hepatic and renal insufficiency; 2. targeted therapy prior to radiotherapy or pet/ct scan. renal function: serum creatinine less than or equal to the upper limit of the normal range; 3. liver function: bilirubin, ast(sgot)/alt(sgpt) less than or equal to the upper limit of the normal range. 4. history of serious surgery in the last month. 5. those who have participated in other clinical trials during the same period.
registry of cytosorb therapy in covid-19 icu patients

Conditions: COVID-19

Summary: the ctc registry collects patient-level clinical data on cytosorb hemoadsorption provided to covid-19 icu patients via integration of the cytosorb device into ecmo, crrt, or hemoperfusion extracorporeal circuits. the intent of the registry is to gain understanding on how cytosorb hemoadsorption provides clinical benefit to covid-19 icu patients.


Eligibility criteria:
inclusion criteria: 1. confirmed covid-19 2. provision of cytosorb therapy per instructions for use (ifu) of the cytosorb device. exclusion criteria: 1. cytosorb therapy for diseases other than covid-19 2. survival unlikely within 24 hours (for prospectively enrolled patients)
the ufim (ultraprocessed foods in breast milk) project

Conditions: Child Malnutrition; Child Allergy; Maternal Exposure

Summary: in last decades, a change in dietary habits has been observed in industrialized countries characterized by a drastic increase in the consumption of ultra-processed foods (upf, ultra-processed foods). as defined by the nova classification, upfs are industrial formulations of food substances added with colourings, flavourings, emulsifiers, thickeners and other additives. among the main compounds of upfs are the advanced glycation end-products (ages). increasing evidence suggests an association between dietary exposure to ages and the development of chronic non-communicable diseases, such as obesity and allergies, in the general population, through increased oxidative stress and inflammation. preliminary evidence suggests that a maternal diet rich in ages during pregnancy and lactation could negatively influence the composition of breast milk and have a negative impact on the infants health. however, data regarding the presence of derivatives of upfs in breast milk are not available. the ufim (ultraprocessed foods in breast milk) study aims at evaluate the presence of upfs-derivatives compounds in breast milk.


Eligibility criteria:
inclusion criteria: caucasian women who are breastfeeding full-term infants exclusion criteria: * non-caucasian ethnicity; * age \ 35 years; * mothers of preterm children; * non-exclusive breastfeeding; * mothers suffering from chronic, malignancies, immunodeficiencies, chronic infections, autoimmune, inflammatory bowel disease, celiac disease, genetic-metabolic diseases, cystic fibrosis and other chronic lung diseases, cardiovascular / respiratory / intestinal malformations, neuropsychiatric disorders and pathologies neurological, vegetarian and vegan diet; * mothers with tattoos, scars, moles or skin lesions on both forearms.
effect of duloxetine and venlafaxine on the pharmacokinetics and pharmacodynamics of oral tramadol: a three-phase randomized balanced cross-over study in healthy volunteers

Conditions: Healthy

Summary: tramadol is an opioid analgesic, which is widely used in the treatment of acute and neuropathic pain. after oral administration, tramadol is rapidly and almost completely absorbed. tramadol is extensively metabolised by o- and n-demethylation, which are catalysed by the liver cyp-450 enzymes. o-desmethyltramadol is an active metabolite and its formation is catalysed by cyp2d6. this study is aimed to investigate the possible interaction of oral tramadol with duloxetine and venlafaxine. duloxetine is known to inhibit cyp2d6. twelve healthy male or female adult non-smoking volunteers aged 18-40 years with body weights within ±15% of the ideal weight for height are taken into the study. primary endpoints of the study are plasma concentrations of tramadol and its metabolites.


Eligibility criteria:
inclusion criteria: * healthy volunteers * age 18-40 * body weight within ±15% of the ideal weight for height exclusion criteria: * a previous history of intolerance to the study drugs or to related compounds and additives * concomitant drug therapy of any kind for at least 14 days prior to the study * existing or recent significant disease * history of hematological, endocrine, metabolic or gastrointestinal disease, including gut motility disorders * history of asthma or any kind of drug allergy * previous or present alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements * a positive test result for urine toxicology * a "yes" answer to any one of the abuse questions * pregnancy or nursing * donation of blood for 4 weeks prior and during the study * special diet or life style conditions which would compromise the conditions of the study or interpretation of the results * participation in any other studies involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study * smoking for one month before the start of the study and during the whole study period * any history of coagulation abnormality, also in first degree relatives

Keywords: pharmacokinetics pharmacodynamics
clarify of predictive risk factors of chemotherapy-induced liver injury

Conditions: Liver Injury, Drug-Induced

Summary: the most common toxicity of tp (docetaxel and cisplatin) chemotherapy is chemotherapy-induced liver injury. however, patients don't always experience same chemotherapy-induced liver injury for the same drugs. therefore, the investigators designed the present study to clarify risk factors associated with the development of severe hepatotoxicity after therapy with docetaxel and cisplatin for nasopharyngeal carcinoma (npc).

nasopharyngeal carcinoma (npc) is one of the most common malignancies in southern china , with an annual incidence of 15 to 50 cases per 100,000 people. npc is both radiosensitive and chemosensitive. recently, many new drugs including docetaxel and cisplatin have been incorporated in the induction chemotherapy phase of npc. the most common toxicity of tp (docetaxel and cisplatin) chemotherapy is chemotherapy-induced liver injury, and appropriate management of these toxicities can help patients improve tolerance for chemotherapy. however, patients don't always experience same chemotherapy-induced liver injury for the same drugs. therefore, it is important to determine the risk factors to predict chemotherapy-induced liver injury. the investigators designed the present study to clarify risk factors associated with the development of severe hepatotoxicity after therapy with docetaxel and cisplatin for nasopharyngeal carcinoma (npc).

Eligibility criteria:
inclusion criteria: * patients with advanced nasopharyngeal carcinoma. * patients scheduled to receive the first line, first cycle tp (docetaxel and cisplatin) chemotherapy. * normal liver function biomarkers including alt,ast,alp,tbil before recruitment. * minimum age of 18 years. * life expectancy at least 3 months. exclusion criteria: * patients previously received chemotherapy * patients who have liver metastases. * patients who take other drugs that may affect liver function