Kornimate/medical-research-clean huggingface dataset:
japanese pediatric h5n1 vaccine study

Conditions: Influenza

Summary: the purpose of this study is to obtain immunogenicity and safety data of an h5n1 pandemic influenza vaccine in a japanese pediatric population aged 6 months to 17 years


Eligibility criteria:
inclusion criteria: * participant is 6 months to 17 years old at time of screening. * participant is born at full term of pregnancy (≥37 weeks) with a birth weight ≥2 kg (for participants aged 6 to 35 months only). * participant is generally healthy, as determined by investigator's clinical judgment through collection of medical history and a physical examination. * if female of childbearing potential, participant has a negative pregnancy test within 24 hours prior to first scheduled vaccination and agrees to employ adequate birth control measures for study duration. * participant and/or their parents/legal guardians is/are willing and able to comply with protocol requirements. exclusion criteria: * participant has a history of exposure to h5n1 virus or a history of vaccination with an h5n1 influenza vaccine. * participant is at high risk of contracting h5n1 influenza infection (e.g. contact with poultry). * participant currently has or has a history of a significant cardiovascular (including hypertension), respiratory (including asthma), metabolic, neurological (including guillain-barré syndrome and acute disseminated encephalomyelitis), hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder. * participant has any inherited or acquired immunodeficiency * participant has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. such treatment includes, but is not limited to: * systemic or inhaled corticosteroids * radiation treatment * or other immunosuppressive or cytotoxic drugs. * participant has a history of severe allergic reactions or anaphylaxis. * participant has a rash, dermatological condition or tattoos which may interfere with injection site reaction rating. * participant has received a blood transfusion, immunoglobulins or other blood derivatives within 90 days prior to study entry. * participant has donated blood or plasma within 30 days prior to study entry. * participant has received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study. * participant has a functional or surgical asplenia. * participant has a known or suspected problem with alcohol or drug abuse. * participant has been exposed to an investigational product (ip) within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an ip or investigational device during the course of this study. * participant is a family member or employee of the investigator. * participant is pregnant or lactating at the time of enrollment. * participant has any other condition that disqualifies his/her participation in the study in the opinion of the investigator.
collaborative urological prosthetics investigation directive research group

Conditions: Erectile Dysfunction; Penile Prosthesis Infection

Summary: the purpose of this study is to determine if an additional 6 days of oral antibiotics decreases the risk of penile prosthesis infection after implantation.

erectile dysfunction is a common problem and the incidence increases with age. penile prosthesis placement for medication refractory erectile dysfunction is well established with high success rates. however, infection remains a dreaded complication with significant patient morbidity requiring device explant. device innovations such as antibiotic coating and adaptations in technique have led to device infection rate reduction to \~1-3% in the hands of high volume implanters in modern series. the study team will perform a non-inferiority trial of post-operative antibiotic prophylaxis for ipp procedures with inhibizonetm coated ams 700 devices to confirm the hypothesis that a prolonged postoperative antibiotic regimen does not influence infection-related outcomes in de-novo ipp placement. the study team will determine potential risk factors for prosthetic infections and which patients would benefit from an extended post-operative oral antibiotic course of 6 days along with other objectives.

Eligibility criteria:
inclusion criteria: 1. males aged 35 to 90 yo with no racial or ethnic restrictions and a diagnosis of erectile dysfunction. 2. males clinically indicated for de-novo inhibizonetm coated ams 700 devices ipp placement procedure per local clinical guidelines who have elected to pursue penile prosthesis as an ed treatment. exclusion criteria: 1. patients with indwelling foreign body in the urinary tract \> 24 hours prior to the procedure (i.e. foley catheter). patients using clean intermittent catheterization will not be excluded. 2. prior history of or current symptomatic urethral stricture. 3. history of cystitis caused by tuberculosis. 4. active cytoxan/cyclophosphamide therapy or immunosuppressive systemic chemotherapy. 5. prior augmentation cystoplasty or cystectomy. 6. systemic neuromuscular disease known to affect the lower urinary tract such as spinal cord injury, multiple sclerosis or other condition leading to neurogenic bladder. 7. antibiotic use within the past 1 week or need for antibiotic management immediately prior to the study. 8. cases where patients have had a prior penile prosthesis. 9. any protected population (i.e. prisoners)

Keywords: erectile dysfunction
evaluation of s-600918 in adults with refractory chronic cough

Conditions: Chronic Cough

Summary: the primary objective of this study is to determine the optimal dose of s-600918 in patients with refractory chronic cough by evaluating the change from baseline in 24-hour cough frequency (coughs per hour) with s-600918 compared with placebo.


Eligibility criteria:
key inclusion criteria: * having refractory chronic cough (including unexplained chronic cough) for at least 1 year. * if female and of childbearing potential, agreement to use one of the allowed contraceptive methods. * capable of giving signed informed consent. key exclusion criteria: * currently smokes or uses potentially irritating inhalational agents (eg, e-cigarettes, smokeless cigarettes, vaping); stopped smoking or using potentially irritating inhalational agents within the last year; or has a smoking history of 20 pack-years or more. * has chronic obstructive pulmonary disease or uncontrolled asthma. * has a clinically unstable medical condition. * history of or ongoing significant psychiatric disorder. * history of respiratory tract infection or significant change in lung function or a pulmonary condition in the last 4 weeks. * history of malignancy in the last 5 years. * history of severe drug allergy. * history of alcohol or drug abuse in the last year or currently uses any form of marijuana or illicit drugs. * has a clinically significant finding on a chest x-ray or chest computed tomography (ct) scan in the last year. * has systolic blood pressure \> 160 mm hg or diastolic blood pressure \> 90 mm hg. * received s-600918 previously. * received an investigational drug in the last 3 months. * received an angiotensin converting enzyme (ace) inhibitor in the last 3 months or requires such treatment. * has a positive serologic test for human immunodeficiency virus (hiv) antigen or antibody, hepatitis b virus surface antigen, or hepatitis c virus ribonucleic acid (rna). * if female, pregnant or trying to become pregnant or breastfeeding.

Keywords: p2x3 receptor antagonist refractory chronic cough s-600918
strain-encoded cardiac magnetic resonance imaging for dobutamine stress testing

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to compare the diagnostic value of senc to that provided by conventional wall motion analysis for the detection of inducible ischemia during ds-mri.high-dose dobutamine stress magnetic resonance imaging (ds-mri) is safe and feasible for the diagnosis of coronary artery disease (cad) in humans. however, the assessment of cine scans relies on the visual interpretation of regional wall motion, which is subjective. recently, strain-encoded mri (senc) has been proposed for the direct color-coded visualization of myocardial strain.

the assessment of inducible regional wall motion abnormalities during high-dose dobutamine stress magnetic resonance imaging (ds-mri) is an established clinical method with high diagnostic and prognostic value for the evaluation of patients with coronary artery disease (cad). however, the assessment of cine images relies on the visual interpretation of regional wall motion, which is subjective, and objective approaches for the detection of inducible ischemia with ds-mri are still lacking. in our study strain-encoded-mri (senc) is used for the objective color-coded evaluation of regional myocardial strain during ds-mri in patients with intermediate to high pretest probability for cad. we anticipated that this technique would exhibit enhanced sensitivity for the detection of anatomically significant cad compared to conventional wall motion reading, with invasive coronary angiography used as the standard reference.

Eligibility criteria:
inclusion criteria: * suspected or known coronary artery disease exclusion criteria: * general contraindication for a dobutamine stress or for an mri examination * age \< 18 yrs

Keywords: myocardial strain strain-encoded mri dobutamine stress mri ischemia strain rate reserve
rehabilitation for thoracoscopic lobectomy

Conditions: Lung Neoplasms; Rehabilitation; Exercise; Pain, Postoperative; Post Discharge

Summary: the main aim of this research is to compare the functional recovery after discharge with the preoperative physical activity as a hypothesis generating study.


Eligibility criteria:
inclusion criteria: * vats-l * speaks and understands danish or english. * informed consent obtained exclusion criteria: * co-vats-l. * on the wheelchair. * living in nurse home. * using rollator to assist to walk. * unwilling to place the actiwatch 2 or execute ppe.

Keywords: functional recovery enhanced recovery after surgery video-assisted thoracoscopic surgery lobectomy
the effects of inhalational anaesthetics in cognitive functions in down syndrome patients

Conditions: Down Syndrome

Summary: recovery of the cognitive functions and recovery features after general anaesthesia in down syndrome patients. a comparison of sevoflurane and desflurane.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) classification i, ii or iii * down syndrome patients * must be able to undergone general anaesthesia * dental surgery necessity exclusion criteria: * severe dementia * severe hearing, vision, speaking problems

Keywords: cognitive functions anaesthesia recovery sevoflurane desflurane
pf 06412562 in subjects with advanced stage parkinson's disease

Conditions: Parkinson Disease

Summary: the purpose of this study is to test the safety and tolerability of the investigational drug pf-06412562 compared to the current medical standard of care medication for parkinson's disease, carbidopa/levodopa. this research also is being done to find out if the investigational drug pf-06412562 can help improve the motor (movement) function, alertness, and cognitive (thinking) skills of people who are considered to be in the advanced-stage of parkinson's disease. in this study, pf06412562 is 'investigational,' which means that it is experimental and has not been approved by the us food and drug administration (fda), but can be used in clinical research studies such as this one.

the investigators are conducting a randomized, double-blind, carbidopa/levodopa-controlled crossover safety, tolerability, and efficacy study of the investigational compound, pf-06412562, in advanced parkinson's patients. the primary purpose of this study is to test the safety and tolerability of the investigational drug pf-06412562 compared to the current medical standard of care medication for parkinson's disease, carbidopa/levodopa, in these patients. this secondary purpose of this research is to find out if the investigational drug pf-06412562 can help improve the motor (movement) function, alertness, and cognitive (thinking) skills of people who are considered to be in the advanced-stage of parkinson's disease. this study will inform the field as to whether pf-06412562 is safe and well-tolerated in advanced parkinson's patients, and also may provide preliminary data on its efficacy in several domains.

Eligibility criteria:
inclusion criteria: * diagnosis of classic pd with history of clinically meaningful response to levodopa * disease duration \>15 years since diagnosis * hoehn \& yahr stage \>iv "on" or "off" levodopa * consent signed by subject, if possible * if subject is cognitively impaired, consent signed by power of attorney or legally authorized subject representative * assent from the study subject, if possible * stable dose of all medications for 60 days prior to day 1 of first week of study exclusion criteria: * atypical parkinsonian syndrome (e.g., never responded to levodopa, and/or atypical signs) * acute or unstable medical condition such as heart disease, kidney and liver failure * history of hiv, hepatitis b and c * use of moderate to strong cyp 3a4 modulators (see both inhibitors and inducers in appendix bb)

Keywords: parkinson's disease parkinson disease end-stage progressed advanced parkinson's disease end-stage parkinson's disease clinical intervention double-blind, randomized
effectiveness of cognitive behavioral therapy vs. prescriptive diet in short and medium-term control of body weight

Conditions: Obesity

Summary: comparison between different treatments of obesity in the short and medium term: prescriptive diet therapy compared to to cognitive-behavioral approach in the treatment of obesity according to the method of clinical trial. according to the italian guidelines on obesity, the target to reach is the weight loss of 10% compared to the initial weight, obtained in six months and maintained for the next 5 years. the guideline considers six months as the time required to lose weight, but many patients are not able to achieve this result. since in clinical practice many patients fail to achieve this weight loss in six months, it was decided to extend to 12 months the time to reach the target. as an intermediate goal it has been proposed to achieve a weight loss of at least 5% on respect of the basal weight in six months.

the hypotheses to be tested is that the addition of a short cbt, as it can be applied in a public outpatients, is able to improve the percentage of responders and to raise the proportion of subjects able to maintain the result over time.

Eligibility criteria:
inclusion criteria: subjects with severe overweight (bmi 27-29.9) or obesity of first step (bmi 30-34.9kg/h2 and obesity of second step (bmi 35-39.9 9kg/h2). patients with dyslipidemia, hypertension, slight organ damage were eligible in the study; exclusion criteria: patients treated with anorectic, estrogen or progestin and patients with diabetes or eating disordes were excluded.

Keywords: cognitive-behavioral approach obesity treatment
a safety and efficacy study of bevacizumab, paclitaxel, carboplatin compared to avastin® in non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: bev-iii/2022 is a double-blind randomized multicenter clinical trial comparing efficacy of bevacizumab (manufactured by mabscale, llc) and paclitaxel plus carboplatin to avastin® and paclitaxel plus carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous nsclc. the purpose of the study is to demonstrate equivalence of efficacy and safety of bevacizumab (manufactured by mabscale, llc) to avastin®. study includes pharmacokinetics assessment.

bevacizumab is a monoclonal antibody currently being developed by mabscale llc, as a proposed biosimilar to avastin®, which is approved as first line treatment in combination with carboplatin and paclitaxel for patients with unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer. this randomized equivalence study is designed to meet the regulatory requirement for approval of a biosimilar product.

Eligibility criteria:
inclusion criteria: * written informed consent * male and female patients at least 18 years of age * newly diagnosed stage iiib/c or iv non-small cell lung cancer (according to revised cancer staging by american joint committee on cancer (ajcc) and the international union against cancer (uicc) 8th edition) or recurrent non-small cell lung cancer (nsclc) * histologically or cytologically confirmed diagnosis of predominately non-squamous nsclc * eastern cooperative oncology group (ecog) performance status 0 or 1 * be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin based on local standard of care, for the treatment of advanced or metastatic non-squamous nsclc * presence of at least 1 measurable tumour as defined by modified response evaluation criteria in solid tumors (recist 1.1) * neutrophils ≥ 1,5 × 10\^9/l * platelets ≥ 100 × 10\^9/l * haemoglobin ≥ 90 g/l * bilirubin level ≤ 1.5 × upper limit of normal (uln) * aspartate-aminotransferase (ast) and alanine-aminotransferase (alt) levels \< 3 × uln (\< 5 × uln for patients with liver metastases) * alkaline phosphatase level \< 3 × uln (\< 5 × uln for patients with liver or bone metastases) exclusion criteria: * known sensitizing egfr mutations or alk translocation positive mutations * evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that is likely to bleed * major surgery 28 days before inclusion into the study * minor surgery 7 days before inclusion into the study * stage ii or higher of neuropathy or ototoxicity according to common terminology criteria for adverse events (ctcae) v.5.0, excluding trauma * life expectancy less than 6 months * metastases to central nervous system or carcinomatous meningitis * pregnancy or lactation
anne diagnostic agreement with home sleep testing

Conditions: Obstructive Sleep Apnea of Adult

Summary: the main objective of this study is to provide an adequately powered study that would provide evidence on the non-inferiority of anne to a home sleep test (hst).

the main objective of this study is to provide an adequately powered study that would provide evidence on the non-inferiority of anne to a home sleep test (hst) for the diagnosis of moderate to severe osa. other study objectives include: * determining diagnostic yield from multiple nights and better usability compared to current hst in the intended population. this will include all subjects and a focus on olders 65 and older. * gathering participant feedback on the use of the sensors and use of the application elicited through focus groups

Eligibility criteria:
inclusion criteria: * 22 years old. * subjects with suspected osa based on history and physical. subjects with self-reported symptoms of osa based on the stop-bang questionnaire indicating affirmative answers to any of the following: snoring, daytime fatigue/sleepiness/tiredness, partners who have observed the subject stopping breathing or choking/gasping during sleep. persons with a previous diagnosis of osa are also eligible. * willingness to give written consent and comply with study procedures exclusion criteria: -an unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related to this trial or interferes with the clinical trial and data collection based on the opinion of the investigator, this includes but is not limited to: a. significant cardiorespiratory disease: patients that are oxygen dependent, previous hospitalization for cardiorespiratory issues, or left ventricular ejection fraction ≤ to 40% b. respiratory muscle weakness due to a neuromuscular condition c. awake hypoventilation or suspicion of sleep related hypoventilation d. chronic opioid medication use e. history of stroke f. history of severe insomnia * inability to understand instructions * has a skin abnormality that precludes assessment * has a history of dementia * patients with implanted pacemakers or defibrillators
effect of bio-electromagnetic energy regulation therapy on erectile dysfunction in patients with multiple sclerosis

Conditions: Erectile Dysfunction Due to Diseases Classified Elsewhere; Multiple Sclerosis, Relapsing-Remitting

Summary: multiple sclerosis (ms) is an inflammatory disease that affects the brain and spinal cord. there are potential impacts on neurological functions, including sensory and autonomic functions. the primary observed in males with ms is erectile dysfunction (ed), which substantially impacts the quality of life. there is increasing literature on electromagnetic fields' biological and clinical effects, particularly on ed.

the study aims to examine the bio-electromagnetic energy regulation therapy (bemer) on erectile dysfunction with ms. we will recruit participants with ms having ed in a triple-blind randomized clinical trial study. all participants will be randomly assigned to either an experimental group (receive the bemer therapy) or a comparison group (receive placebo bemer therapy) for five days/week for three weeks. participants will also receive pelvic floor exercises in both groups.

Eligibility criteria:
inclusion criteria: * diagnosis of ms according to the mcdonald revised criteria. * score 6-25 on the international index of erectile function 15 (iief-15) will be recruited. * had sexual activity in the past month. * have relapsing-remitting ms (rrms) type and one month of clinical relapse, at least before the experimental study date. exclusion criteria: * if they have cognitive impairment that causes problems in answering the questionnaire. * history of major chronic illness or other neurological disorders. * received any treatment for ed in the past seven days * previous therapy with a pulsed electromagnetic field, epilepsy, pacemaker, and acute bacterial infection with fever.

Keywords: bemer erectile dysfunction multiple sclerosis bio-electromagnetic energy regulation therapy