Kornimate/medical-research-clean huggingface dataset:
feasibility and safety of physical exercise in men with prostate cancer

Conditions: Prostate Cancer; Androgen Deprivation Therapy; Radiotherapy

Summary: prostate cancer (pca) is among the most widespread in the male population and represents 19% of all cancers diagnosed from the age of fifty, in italy. androgen deprivation therapy (adt) and radiotherapy (rt) are used for increase survival. however, both therapies are associated with significant side effects, such as fatigue, loss of muscle mass and strength, cognitive decline that together lead to an increase risk of accidental falls and fractures. guidelines for cancer survivors recommend physical exercise (pe) as a strategy to reduce several side effects of therapies. however, most people living with cancer do not meet current exercise recommendations. indeed, an effective pe program requires the application of long-term, moderate to high intensity activity. thus it may be difficult to implement this type of recommendation in patient with pca. therefore, this study aims to develop an experimental pe intervention testing their feasibility and safety and the patients' satisfaction, aimed at improving the health conditions of the patients with pca receiving adt and rt. furthermore, long-term falls and fracture events will be monitored.

the non-randomized feasibility and pilot study aims to evaluate the feasibility and safety of a structured, multicomponent, supervised and unsupervised exercise program. secondary outcome will be evaluate the change in the health condition, in particular muscle strength, cognitive function, fatigue, balance, anxiety and depression level, and quality of life. the pe program will be conducted at the "virgilio camparada" municipal athletic track in the city of reggio emilia (it). patients will be participate in a supervised exercise program with three sessions per week, for eight weeks. subsequently, the intervention will continue further for four weeks maintaining one supervised session and two unsupervised sessions a week. finally, sessions will be performed without supervision for further eight weeks. the overall duration of the intervention will be twenty weeks. in addition, an evaluation will be performed at one year from baseline to monitor long-term fall and fracture events. at baseline will be the following assessment: - clinical and anthropometric data and the six minute walking test (6mwt) to determine the intensity of aerobic exercise.

Eligibility criteria:
inclusion criteria: * histologically documented diagnosis of pca; * undergo adt and rt during the study period; * at least 18 years old; * willing and able to give written informed consent; * able to read and understand italian language; exclusion criteria: * musculoskeletal, cardiovascular, neurological or psychiatric disorders that contraindicate participation in an exercise program.

Keywords: exercise feasibility safety
multicenter unsustained tachycardia trial (mustt)

Conditions: Arrhythmia; Cardiovascular Diseases; Coronary Disease; Death, Sudden, Cardiac; Heart Diseases; Myocardial Ischemia; Tachycardia, Ventricular

Summary: to determine the value of electrophysiologic (ep)-guided antiarrhythmic therapy in coronary heart disease patients at increased risk for sudden death. the study included a controlled clinical trial and a registry.

background: cardiac arrest (sudden cardiac death) occurs relatively frequently in asymptomatic patients who have had myocardial infarctions, have ejection fractions less than 40 percent, and non-sustained ventricular tachycardia. however, it is not possible to predict who will die suddenly or when cardiac arrest will occur. current efforts to reduce sudden death in such long-term survivors of myocardial infarction or in patients with coronary disease have produced results that are not very encouraging. such patients may feel quite well. they survived their myocardial infarction and may have slight or even moderate reduction of exercise ability, but by 'pacing' themselves, such patients can lead relatively normal lives. they may be aware of their arrhythmia because of short periods of palpitations which may only trouble them transiently. consequently, this group of patients, many still in the prime of their lives, are at relatively high risk of dying suddenly. the multicenter trial may reveal the most effective treatment for such patients, the value of electrophysiologic studies in predicting who is most at risk of sudden cardiac death, and whether electrophysiologic studies can help select the best mode of treatment. the protocol for performing programmed stimulation and serial drug testing is designed to mirror those currently in use by many practicing electrophysiologists. design narrative: randomized, non-blind. patients were assigned to standard therapy or to an aggressive arm consisting of electrophysiologic-guided antiarrhythmic therapy. patients in the aggressive arm whose ventricular tachycardia was suppressible or who were still inducible, but who were hemodynamically stable in ventricular tachycardia, were followed on drug therapy. otherwise, patients in the aggressive arm received an implantable defibrillator. the primary endpoint was sudden cardiac death or cardiac arrest. patients without inducible sustained ventricular tachycardia were followed in a registry. recruitment ceased on october 31, 1996 after a recommendation from the dsmb. the study completion date listed in this record was obtained from the "end date" entered in the nih query view report (qvr).

Eligibility criteria:
men and women patients with documented coronary artery disease, ejection fraction less than or equal to 40 percent, and nonsustained asymptomatic ventricular tachycardia.
pilot study to verify effect of smartpen coordinated with glucose sensor.

Conditions: Diabetes Mellitus, Type 1

Summary: the aim of this interventional study in to assess the effect of the use of a smartpen connected by an app to continuous glucose sensors in a cohort of diabetic adolescents in not good metabolic control. primary endpoint: time in range secondary endpoints: other glucometrics, hba1c, treatment satisfaction.


Eligibility criteria:
inclusion criteria: 1. age between 12 - 18 years 2. a clinical diagnosis of diabetes type 1 as determined by investigator for at least 12 months. 3. hba1c \>7.5% (dca) 4. subject is on multiple daily injection therapy (3 or more insulin injections per day one of which is a long acting insulin injection), is currently using or is willing to use insulin pens and pen cartridges and are not willing to use an insulin pump or ahcl system 5. subject is currently using a cgm or is willing to use the guardian 4 system during the study. 6. subject and parents agree to comply with the study protocol requirements 7. subject and parents provide their signature on the informed consent form exclusion criteria: 1. subject is unwilling or unable to use insulin pen(s). 2. subject is in plans to use or is already using an insulin pump. 3. subject is currently using a non-medtronic standalone cgm system and unwilling to use only the guardian 4 system during the study. 4. subject has any unresolved adverse skin condition in the area of device placement (e.g. psoriasis, rash, staphylococcus infection). 5. subject is actively participating in or plans to enroll in an investigational study (e.g. drug or device), other than this study, wherein they have received treatment from an investigational drug or device. 6. subject has a positive urine pregnancy test at time of screening. 7. subject is unwilling to participate in study procedures. 8. subject is directly involved in the study as research staff. 9. subject with poorly controlled thyroid or celiac disease. 10. subject with any risk of exposure to mri equipment, diathermy devices or other devices capable of generating strong magnetic fields
tavns cold pressor

Conditions: taVNS; Brain Stimulation

Summary: this study explores the use of transcutaneous auricular vagus nerve stimulation (tavns), a new form of neuromodulation which stimulates the ear. 24 healthy subjects without a past medical or psychiatric history will be recruited to participate in a phone screen followed by 1 lab visit. during the lab visit, subjects will participate twice in a validated stress induction technique called the cold pressor test, while concurrently receiving either active or sham tavns. the cold pressor test consists of subjects placing their feet in an ice bath for a short period of time. researchers will measure participant's heart rate while they receive tavns (ear stimulation) and participate in the cold pressor test. assessments of mood, anxiety, and stress will be collected at the beginning and end of the visit.


Eligibility criteria:
inclusion criteria: * ages 18-65 years * english speaking * non-treatment-seeking community members exclusion criteria: * diagnosis of covid-19 in the past 14 days * facial or ear pain or recent ear trauma. * metal implant devices in the head, heart or neck. * history of brain stimulation or other brain surgery. * history of myocardial infarction or arrhythmia, bradycardia. * use of b-blockers, antiarrhythmic medication (sodium/potassium/calcium-channel blockers), or blood pressure medications. * active respiratory disorder. * personal or family history of seizure or epilepsy or personal use of medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium). * personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury. * individuals suffering from frequent/severe headaches. * individuals with a reported history of any mental health disorder or taking any psychotropic medications. * moderate to severe alcohol or substance use disorder. * pregnancy
treatment sleep bruxism with the luco hybrid osa appliance

Conditions: Sleep Bruxism; Tension Headache; Migraine Headache

Summary: to determine the effectiveness of the luco hybrid osa appliance in the treatment of sleep bruxism and to aid in the treatment of associated tension/migraine type headaches in adults.

51 subjects were selected and separated into two groups: those new to the treatment (group 1)and those who had been in treatment for more than 1 year (group 2). there were 32 participants in group 1 and 19 in group 2. mean age for group 1 was 41.7 and group 2 was 50.5. the age range for group 1 was 21 to 66 and in group 2 34 to 73. group 1 subjects were fitted with a luco hybrid osa appliance (lhoa). they were followed over a 14 day period with adjustments made to the device as required. the second study \[milestone\] was completed at that time. group 2 subjects, who had previously been in treatment with the device for and mean of 4.1 years, had an initial study with the device and a second study following 48 hours without the device. both groups were studied again at 60 days and results compared.

Eligibility criteria:
inclusion criteria: * 18 years of age (adult) * capable of giving informed consent * met the aasm criteria for sleep bruxism * had sound dentition * did not have active obstructive sleep apnea(osa)/upper airway resistance syndrome (uars) exclusion criteria: * younger than 18 * incapable of informed consent * did not meet the aasm criteria for sleep bruxism * discovered osa or uars in the initial study * did not have sound dentition (active caries, periodontal disease, inadequate number of teeth * had obstructive sleep apnea/uars * did not complete the study * completed the study but did not complete all aspects of the study
a dose response trial to evaluate clinical and mycological effect of nitric oxide in subjects with tinea pedis

Conditions: Tinea Pedis

Summary: a multi-arm trial to evaluate the efficacy and safety of using gaseous nitric oxide to treat moderate to severe tinea pedis.


Eligibility criteria:
inclusion criteria: * positive clinical findings (moderate to severe, indicated by a csss ≥ 6) for interdigital or bullous tinea pedis as determined by clinical examination (subjects with moccasin symptoms in addition to above may also be included at the discretion of the investigator). * written informed consent must be obtained from the subject. * must ≥ 18 years of age, unless local laws dictate otherwise. * must agree to avoid professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit until the conclusion of the trial. * must not be pregnant or nursing, and if of childbearing potential, agree to take measures to avoid pregnancy during the study period exclusion criteria: * has a diagnosis of either psoriasis or eczema, in or immediately around the area under evaluation. * has a visual diagnosis, by the investigator, of onychomycosis at a level, which in the opinion of the investigator would compromise the integrity of the study. * use of topical antifungals e.g. (clotrimazole, ketoconazole,miconazole, oxiconazole- (oxistat®, glaxo smith kline), sulconazole, naftifine (naftin®, merz), terconazole, econazole nitrate (spectazole®, ortho-mcneil), butoconazole ,fluconazole, ciclopirox olamine-(loprox®, medicis), tolnaftate, haloprogin), zeasorb-af , antibacterials and corticosteroids in the preceding 14 days of screening visit (day 1), on or immediately around the area under evaluation. * use of oral or injectable systemic corticosteroids in the preceding 7 or 30 days respectively, of screening visit (day 1) * use of systemic antifungals in the preceding 30 days of screening visit (day1) including - (terbinafine - (lamisil®, novartis), itraconazole - (sporanox®, janssen), fluconazole- (diflucan®, pfizer), ketoconazole, miconazole, griseofulvin (gris-peg®, pedinol), butoconazole, terconazole, potassium iodide) * has used any investigational drug(s) within 30 days preceding screening visit (day 1) * is pregnant or is a nursing mother * is a woman of child bearing potential who is not using an adequate form of contraception (or abstinence) * is \< 18 years of age, unless local laws dictate otherwise. * is immunosuppressed (undergoing chemotherapy, neutropenia (pmns , \< 500/mm3), hiv with cd4+ \< 200/mm3. * suffers from a condition, which, in the opinion of the medical investigator, would compromise his/her safety and / or the quality of the data. such conditions may include collagen vascular disease, diabetes mellitus, cushing's disease, hematological malignancy, chronic mucocutaneous candidiasis or atopy statistics this clinical evaluation is intended to demonstrate

Keywords: tinea pedis athletes foot nitric oxide
safety of autologous cord blood cells in hlhs patients during norwood heart surgery

Conditions: Hypoplastic Left Heart Syndrome; Heart Defects, Congenital; Pediatric Disorder

Summary: this study aims to evaluate the safety and feasibility of coronary infusion of autologous placental cord blood mononuclear cells during the norwood heart operation in newborn hypoplastic left heart syndrome (hlhs) patients.

this is a phase i, open label safety study. autologous cord blood mononuclear cells (stem cell containing, cord blood buffy coat fraction) was delivered by coronary infusion during the norwood cardiopulmonary bypass operation in 10 antenatally diagnosed hlhs patients within 2-3 days of birth. safety and clinical status monitoring was performed to stage ii surgical intervention for hlhs (at approximately 3 months of age). treated patients will continue to be assessed beyond the trial during follow up between stage ii and iii (fontan) surgical interventions.

Eligibility criteria:
inclusion criteria: * male and females with antenatally diagnosed hypoplastic left heart syndrome (all types requiring norwood operation) * written informed consent by parents/legal guardian * successful aseptic collection of autologous cord blood unit and transfer of buffy coat mononucleocyte fraction to cold storage pending cardiac surgery within 2-4 days exclusion criteria: patient: * does not have autologous cord blood cells available at the time of cardiopulmonary bypass surgery * has evidence of arrhythmia requiring anti-arrhythmia therapy * has an additional congenital diagnosis that contributes to conditions such as an immune system disorder, immune deficiency, complex metabolic disorder, brain dysplasia or progressive neurological degenerative disorder * has other clinical complexity deemed by the cardiac surgeon to make the patient unsuitable for inclusion in the trial mother: • is serum positive for hiv, hepatitis or other significant pathogen and has known allergies to penicillin, streptomycin or other antibiotic

Keywords: cord blood stem cell norwood heart surgery congenital heart
correlation of intra-abdominal pressure with gastric and urinary bladder pressures in patients with morbid obesity

Conditions: Morbid Obesity; Intra-Abdominal Hypertension; Bariatric Surgery Candidate

Summary: the correlations between gastric and urinary bladder pressures with intra-abdominal pewssure have not been addressed

intra-abdominal pressure (iap) affects cardio-respiratory hemodynamics and can be assessed either directly, or by measuring gastric or urinary bladder pressure. however, in patients with morbid obesity, the correlations between gastric and urinary bladder pressures with iap have not been addressed. the investigator's aim was to assess the correlations between iap and gastric and urinary bladder pressure in patients with morbid obesity, at normal and elevated levels of iap, and to examine the effects of increasing iap and patient position on hemodynamic and respiratory parameters.

Eligibility criteria:
inclusion criteria: * age \>18 years * morbid obesity * candidate for bariatric surgery exclusion criteria: * contraindication to laparoscopy * advanced copd * advanced chf
long- and midterm outcomes of osteoarticular infections in paediatric patients

Conditions: Acute Haematogenous Osteomyelitis; Septic Arthritis

Summary: multi-centre clinical follow-up study on patients with a history of acute haematogenous osteomyelitis and/or septic arthritis. the aim is to describe the frequency of sequelae in these former patients with osteoarticular infections. patients will be invited to participate in a single follow-up visit including a standardised interview and a clinical examination. the collected data will be analyzed together with data from the patient's hospital stay.

clinical follow-up study on patients with a history of acute haematogenous osteomyelitis and/or septic arthritis and were admitted to one of the participating centres between 2005 and 2014. former patients will be invited to participate in a single-follow-up visit which comprises a standardised interview (pain, disabilities in daily life and regarding sports) and a standardized clinical examination of the previously affected body part. this includes assessment of range of motion in affected and adjacent joints and in case of previously affected lower extremity leg axis, gait and body height (percentile). the data collected during the follow-up visit will be analyzed in a descriptive manner together with data of the patient's hospital stay including baseline data, laboratory works, microbiological results and both antibiotic and surgical treatment.

Eligibility criteria:
inclusion criteria: * patients who were previously admitted to the participating centres between january 2005 and november 2014 * patients with an international classification of disease code (icd-10) discharge code of acute osteomyelitis (m86.00-m86.99) and/or septic arthritis (m00.00-m00.99) exclusion criteria: * onset of symptoms \> 2 weeks before admission * history of penetrating wound or prior surgery at affected limb * incorrect icd-10 coding * chronic or severe underlying disease or treatment at time of infection that possibly compromises the patient's immunologic response (e.g. cancer, immunodeficiency, immunosuppressive therapy) * insufficient command of german language to understand patient information and informed consent

Keywords: acute haematogenous osteomyelitis septic arthritis outcome osteoarticular infections follow-up
a study of the safety and efficacy of rhgaa in patients with infantile-onset pompe disease

Conditions: Glycogen Storage Disease Type II

Summary: pompe disease (also known as glycogen storage disease type ii, "gsd-ii") is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (gaa). normally, gaa is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. in patients with pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. this study is being conducted to evaluate the safety and effectiveness of recombinant human acid alpha-glucosidase (rhgaa) as a potential enzyme replacement therapy for pompe disease. patients diagnosed with infantile-onset pompe disease who are less than or equal to 6 months old will be studied.


Eligibility criteria:
inclusion criteria: * the patient or the patient's legal guardian(s) must provide written informed consent prior to any study-related procedures being performed; * the patient must have clinical symptoms (documented in his or her medical record) of infantile-onset pompe disease. in addition, the patient must have: a. an endogenous gaa activity less than 1% of the mean of the normal range as assessed in cultured skin fibroblasts; and b. cardiomyopathy (lvmi greater than 65 g/m2) by echocardiography; * the patient must be no older than 26 weeks and 0 days, when he/she receives the first dose of rhgaa; * the patient and his/her legal guardian(s) must have the ability to comply with the clinical protocol. exclusion criteria: * symptoms of respiratory insufficiency, including: a. oxygen saturation less than 90% in room air as measured by pulse oximetry; or b. venous pco2 greater than 55 mmhg on room air or arterial pco2 greater than 40 mmhg on room air; c. any ventilator use at the time of enrollment; * major congenital abnormality; * clinically significant organic disease (with the exception of symptoms relating to pompe disease), including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the trial or potentially decrease survival; * use of any investigational product within 30 days prior to study enrollment; * received enzyme replacement therapy with gaa from any source.

Keywords: pompe disease glycogen storage disease type ii gsd-ii acid maltase deficiency disease glycogenosis 2