Kornimate/medical-research-clean huggingface dataset:
evaluation in stemi patients using fdy-5301

Conditions: Acute Myocardial Infarction; STEMI; Percutaneous Coronary Revascularization

Summary: to assess the effect of fdy-5301 on cardiovascular mortality and acute heart failure events in subjects with an anterior stemi undergoing ppci.

the purpose of this study is to evaluate the efficacy and safety of fdy-5301 compared to placebo on cardiovascular clinical outcomes in subjects with an anterior st-elevation myocardial infarction (stemi) undergoing primary percutaneous coronary intervention (ppci). the study is designed as a randomized double-blind parallel-group comparison of fdy-5301 and placebo. inclusion and exclusion criteria have been designed to ensure a broad population including seriously ill patients, with or without prior myocardial infarction or coronary artery bypass graft. demonstration of efficacy in the anterior stemi population will translate to all stemis agnostic of anatomical location, as the pathophysiology and pharmacology are highly likely to translate from anterior stemis to non-anterior stemis.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. anterior stemi, based on: symptoms of myocardial ischemia (such as chest pain, shortness of breath, jaw pain, arm pain, diaphoresis, or any anginal equivalent) and electrocardiogram (ecg) criteria: * men \> 40 years: ≥ 2 mm of st elevation in v2 and v3 * men ≤ 40 years: ≥ 2.5 mm of st elevation in v2 and v3 * women ≥ 1.5 mm of st elevation in v2 and v3 3. planned primary pci to occur ≤ 6 hours of onset of persistent symptoms that caused the patient to pursue medical care for myocardial infarction 4. institutional review board (irb) / independent ethics committee (iec) approved consent obtained for study participation exclusion criteria: 1. life expectancy of less than 1 year due to non-cardiac pathology 2. known thyroid disease or thyroid disorder, including subjects on thyroid hormone replacement therapy at the time of randomization 3. known allergy to iodine or the excipient of the investigational product (sodium chloride) 4. renal disease requiring dialysis 5. women who are pregnant or breastfeeding. women of reproductive potential must have a negative pregnancy test prior to randomization 6. body weight \> 140 kg (or 309 lbs) 7. use of thrombolytic therapy as treatment for the index stemi event 8. use of investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to randomization or the use of investigational devices within 30 days prior to randomization 9. any clinically significant abnormality identified prior to randomization that in the judgment of the investigator or sponsor would preclude safe completion of the study, or confound the anticipated benefit of fdy-5301
a pilot study to examine the impact of a therapy dog intervention on loneliness and related health outcomes in vulnerable populations

Conditions: Loneliness; Depression; Anxiety; Quality of Life

Summary: the purpose of this research study is to test whether an animal-assisted interaction (aai) intervention is better than conversation with another person or treatment as usual for improving mood, anxiety, loneliness, quality of life, and indicators of health care services such as number of hospitalizations, length of hospital stay, and cost of services. participants will be patients admitted for an inpatient stay at virginia commonwealth university health who meet the study entry requirements.

participants will be randomly assigned (like the flip of a coin) to receive one of the following interventions: 1. animal-assisted interaction (a dog-handler team will visit them in their hospital room) 2. conversational interaction with just participants and the handler 3. treatment as usual (the regular services patients are currently receiving in the hospital) participation in this study will last six months. this includes the three days on which participants will receive one of the interventions described above, plus completing some questionnaires online or by phone one month and six months after the baseline visit. these questionnaires will ask questions about pet ownership, relationship with pets participants have had, loneliness, depression, anxiety, health-related quality of life, significant life events in the past year, and social supports. approximately 180 individuals will participate in this study.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * projected to be admitted to the hospital for the upcoming four days * speak english * able to provide consent. exclusion criteria: * fear of, or allergy to, dogs * documented contact precautions * cognitive impairment that prevents consent or completion of measures.
endothelial injury and development of coronary intimal thickening after heart transplantation

Conditions: Cardiac Allograft Vasculopathy; Antibody Mediated Rejection

Summary: coronary allograft vasculopathy (cav) is the leading cause of late graft failure and second leading cause of late mortality after heart transplantation. cav has been associated with a variety of traditional risk factors for atherosclerosis; however, immune mediated injury from development of de-novo donor-specific antibodies after transplantation also likely plays an important role. similar to the progression of traditional atherosclerosis, it is likely that endothelial dysfunction is the precursor to the development of intimal thickening and cav. the investigators hypothesize that coronary allograft vasculopathy after heart transplantation as defined by progressive neointimal hyperplasia is preceded by endothelial dysfunction, which in turn is at least partly mediated by donor specific antibodies. the investigators are proposing a prospective study in humans to test the above hypothesis and further mechanistically understand how cav progresses. in this study the investigators will test for coronary endothelial function by infusing acetylcholine into the coronary artery and measure intimal hyperplasia by optical coherence tomography (oct) and compare findings in patients with and without donor specific antibodies.


Eligibility criteria:
inclusion criteria: * subjects who are 1 year post heart transplantation * subjects will include both male and females * be at least 18 years of age exclusion criteria: * known coronary artery disease after transplantation * evidence of strong or moderate antibodies already present at the time of the transplant * severe renal dysfunction defined as creatinine clearance of \<30 or on hemodialysis. * 3 or more episodes of acute cellular rejection * females who are pregnant * patients requiring endomyocardial biopsy at the time of catheterization * patients unable to tolerate heparin or systemic anticoagulation * history of multi-organ transplant * patients unable to give consent

Keywords: optical coherence tomography oct coronary allograft vasculopathy donor specific antibodies acetylcholine coronary endothelial function brachial artery flow mediated dilation heart transplantation
clinical effects of exercise program added to pulmonary rehabilitation in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the aim of this study is to investigate the effects of postural exercise program added to pulmonary rehabilitation program on quality of life, exercise tolerance and postural stability in children with cystic fibrosis.

cystic fibrosis (cf) is an autosomal recessive, multisystem involvement disease. the most important cause of mortality in cf is pulmonary complications. prevention of pulmonary complications is only possible with pulmonary rehabilitation. pulmonary rehabilitation methods used in cf are called airway cleaning techniques that include postural drainage, breathing techniques and use of devices. these techniques have not been proven to be superior to each other. active cycle of breathing techniques (acbt) is one of the breathing techniques used to remove secretions from the lungs. pulmonary disease progression in cf causes postural impairment and decrease of exercise tolerance, which can reduce effectiveness of pulmonary rehabilitation. the aim of this study is to investigate the effects of postural exercise program added to pulmonary rehabilitation program on quality of life, exercise tolerance and postural stability in children with cf.

Eligibility criteria:
inclusion criteria: 1. be diagnosed with kf 2. be able to understand commands exclusion criteria: 1. fev1 below than %30 2. cor pulmonale 3. advanced gastroesophageal reflux 4. current hospital admission due to lung infection 5. be diagnosed with neuromuscular disease

Keywords: cystic fibrosis postural exercise pulmonary rehabilitation
testing the efficacy of 100mg vitamin-b6 daily for sensory reactivity in autism

Conditions: Autism

Summary: this clinical trial aims to explore the effect of vitamin b6 supplementation on anxiety sensory hyperreactivity in autistic adults. researchers will compare a placebo group to high-dose vitamin-b6 to see if vitamin b6 reduce anxiety and sensory reactivity differences in autism.

the main question it aims to answer is: * does high-dose vitamin b6 supplementation reduce sensory hyperreactivity differences in autism? * does high-dose vitamin b6 supplementation reduce anxiety differences in autism? * explore the effects of vitamin b6 on sleep quality, attention deficit hyperactivity disorder (adhd) scores, and various visual perception tasks that are indicative of gabaergic activity

Eligibility criteria:
inclusion criteria: * between the ages of 18 to 60 * with a diagnosis of autism exclusion criteria: * taking any supplement that contains more than 2mg of vitamin b6 or taking gaba agonist drugs * have a medical history of peripheral neuropathy * lactose intolerance (placebo tablet is lactose based)

Keywords: vitamin b6 sensory hyperreactivity gaba excitation-inhibition balance
study of the short-term mortality and morbidity of newborns born at a gestational age <32 weeks of amenorrhea

Conditions: Premature Birth

Summary: an "outborn" birth is a premature birth that occurs in an unsuitable level center at the end of the child (unlike "inborn" births). this study aims to describe the morbidity and mortality of very premature newborns (gestational age less than 32 weeks of amenorrhea) born outside a maternity hospital of appropriate level between january 1, 2016 and december 31, 2020, and assessment of the preventable or non-preventable nature of these so-called "outborn" births. the aim of this research is to write down the short-term mortality and morbidity of newborns born at a gestational age \<32 weeks of amenorrhea outside a level iii maternity hospital in alsace between january 1, 2016 and december 31, 2020.


Eligibility criteria:
inclusion criteria: - newborn under 32 weeks of amenorrhea at the time of birth, born in alsace in one of the level i, iia, or iib maternity hospitals, between january 1, 2016 and december 31, 2020 exclusion criteria: - fetal death in utero

Keywords: premature birth outborn newborns gestational age
knowledge and perception of smoking risks/consequences

Conditions: Cigarette Smoking; Schizophrenia

Summary: this proposed 2-year questionnaire study examines views and attitudes regarding health risks of cigarette smoking, smoking patterns and motivators for cessation in smokers who suffer from schizophrenia compared to a sample of smokers without a major psychotic disorder.

this proposed 2-year questionnaire study examines views and attitudes regarding health risks of cigarette smoking, smoking patterns and motivators for cessation in smokers who suffer from schizophrenia compared to a sample of smokers without a major psychotic disorder. the specific goals of this study are to 1) examine differences in the perceived consequences of smoking, smoking habits, and motivation to quit between adults with and without schizophrenia and 2) identify clinical and demographic variables (e.g., age, race, sex, age of smoking onset, knowledge of smoking consequences, insurance status, family support, co-occurring substance abuse, education level, current health status) associated with motivation to quit smoking among individuals with and without schizophrenia. this secondary goal is exploratory in nature. we will identify potential predictors in each group separately and also assess if these potential predictors differ between groups. the study will consist of one 2-hour visit, where each subject, after signing consent, will participate in a semi-structured interview as well as answer clinical and demographic information. patient volunteers will be recruited from the mprc outpatient and inpatient programs and through nida. control subjects will be recruited by mprc and nida via newspaper advertisements from the baltimore metropolitan area. we anticipate recruiting up to 110 schizophrenia patients for a total of 100 completers and up to 110 normal controls for a total of 100 completers. all participants will be 18-65 years old, will smoke cigarettes daily, and must not be interested in reducing or quitting tobacco use.

Eligibility criteria:
inclusion criteria: * males and females between 18-65 years * minimum of 5 cigarettes daily. * expired co measurement of \> 8 ppm to confirm cigarette smoking * for the schizophrenia group, must have a dsm-iv diagnosis of schizophrenia or schizoaffective disorder. exclusion criteria: * for the normal control group, must be free from axis i psychotic disorder. (other psychiatric comorbidity will not be excluded) * for all subjects, anyone actively trying to quit smoking at the time of the interview.

Keywords: perception of risk smoking risks smoking consequences quitting smoking motivation to quit smoking schizophrenia
group cognitive behavioral therapy and acupressure for insomnia

Conditions: Insomnia

Summary: this study will examine the use of cognitive behavioural therapy (cbt) and acupressure in treating insomnia in chinese adults. the main components of cbt for insomnia (cbt-i) includes psychoeducation, sleep restriction, stimulus control, cognitive restructuring, and relaxation. cbt-i is widely used in western countries but it fails to address patient preference among chinese adults with insomnia, as demonstrated in a previous study examining the subjective experience of chronic insomnia in hong kong chinese adults. the study revealed that chinese adults showed distrust in hypnotics and preferred traditional chinese medicine (tcm) which was believed to be more natural. in order to maximize the therapeutic effects of psychological interventions for insomnia, integrative medicine with a combination of cbt-i and tcm could be an alternative to address insomnia in the chinese population. acupressure, a non-invasive therapy, is commonly used in tcm. it is suggested that acupressure can induce relaxation and improve sleep quality. some studies have demonstrated the separate efficacy of cbt-i and acupressure in treating insomnia. however, few studies have examined the effect of their combination.


Eligibility criteria:
inclusion criteria: 1. hong kong residents who are able to communicate in cantonese; 2. aged ≥ 18 years; 3. a current clinical dsm-5 diagnosis of insomnia disorder according to the sleep condition indicator (sci) ≥ 21; 4. insomnia severity index (isi) score ≥ 8; and 5. willing to give informed consent and comply with the trial protocol. exclusion criteria: 1. have suicidal ideation based on beck depression inventory (bdi-ii) item 9 score ≥ 2 ; 2. receiving psychotherapy, acupuncture, and/or practitioner-delivered acupressure treatment for insomnia in the past 6 months; 3. pregnancy; and 4. taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within 2 weeks prior to the baseline assessment.

Keywords: insomnia cognitive behavioral therapy cbt-i acupressure traditional chinese medicine
a trial of intravenous hrs9432 in the treatment of subjects with candidemia and/or invasive candidiasis

Conditions: Patients With Candidemia and/or Invasive Candidiasis

Summary: the purpose of this study is to evaluate the efficacy and safety of intravenous hrs9432 in patients with candidemia and/or invasive candidiasis


Eligibility criteria:
inclusion criteria: 1. males or females ≥18 years； 2. established or clinical diagnosis of candidemia and/or ic ； 3. present of 1 or more systemic signs attribute to candidemia and/or ic 4 days prior to randomization; 4. women of childbearing potential or male subjects whose partner is a fertile female agree to use highly effective form of contraception from the time of signed icf till 6 months after end of treatment； 5. able and willing to provide a written informed consent exclusion criteria: 1. any of the following forms of ic: including osteomyelitis, endocarditis or myocarditis, meningitis, endophthalmitis, or any central nervous system infection, urinary tract infection or chronic disseminated candidiasis； 2. severe hepatic impairment in subjects with a history of chronic cirrhosis； 3. history of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement; 4. laboratory abnormalities in baseline specimens obtained at screening; 5. ecg with clinical significance and may cause obvious safety risk to the subjects at screening; 6. received systemic treatment with an antifungal agent at approved doses for treatment of candidemia or ic for \>48 hours; 7. vascular catheter or device that cannot be removed, or abscess that cannot be drained, and may be the source of candidemia or ic; 8. a history of drug use, alcohol, or drug abuse within 1 year prior to randomization; 9. participated in, any other clinical study involving the administration of active investigational or experimental medication prior to the randomization, or 5 half-lives, whichever is longer, prior to screening; 10. females who are in gestation or lactating period or planned pregnancy during the study 11. known history of hypersensitivity or allergic reaction to hrs9432, caspofungin etc echinocandins drugs; 12. in the judgment of the investigator, other reasons unsuitable for study.
does fidaxomicin therapy reduce spread of clostridium difficile?

Conditions: Clostridium Difficile Infection

Summary: this study evaluates whether patients with clostridium difficile infection (cdi) who are treated with fidaxomicin have less contamination of their skin and surrounding environment with spores of c. difficile than patients treated with other drugs (metronidazole or vancomycin)

fidaxomicin is a newly licensed drug for the treatment of cdi. patients treated with fidaxomicin have a significantly lower c. difficile spore count in their faeces than patients who receive alternative drugs (metronidazole or vancomycin). in vitro evidence has shown that the drug persists in the gut for several weeks after treatment has finished and also prevents the outgrowth of spores. these findings suggest that fidaxomicin therapy could be associated with less contamination of cdi patient's skin and their surrounding environment than metronidazole or vancomycin therapy. this prospective, case control study aims to investigate this hypothesis by measuring c. difficile spore counts in patient's stool samples, on their skin and in the surrounding environment. results for patients receiving fidaxomicin will be compared with those on either metronidazole or vancomycin. if fidaxomicin therapy does reduce contamination levels, it might be a useful adjunct to existing measures used to control cdi in healthcare settings, particularly in outbreak situations.

Eligibility criteria:
inclusion criteria: * diagnosis of cdi (see above) * prescribed fidaxomicin, vancomycin or metronidazole by attending physician exclusion criteria: * patients whose clinical care team indicates it would be inappropriate to include him/her in the study (e.g. due to terminal illness) * in a patient receiving metronidazole or vancomycin, receipt of fidaxomicin within the previous 3 months * patients unable to give informed consent for whom no consultee is available to give approval * non-english speakers

Keywords: clostridium difficile environment contamination fidaxomicin
apnex clinical study of the hypoglossal nerve stimulation (hgns®) system to treat obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the apnex medical hypoglossal nerve stimulation (hgns) system as a potential therapeutic option for individuals with moderate to severe obstructive sleep apnea (osa) that have failed or do not tolerate positive airway pressure (pap) therapy.


Eligibility criteria:
inclusion criteria: * age 21 to 80 years * body mass index (bmi) ≤ 35 kg/m² * previously diagnosed with moderate to severe osa * individual has failed or does not tolerate pap therapy

Keywords: apnea osa sleep apnea syndromes sleep apnea, obstructive hypoglossal nerve stimulation sleep disorders tongue
non-interventional, long-term follow-up of subjects who completed apograft-01 study

Conditions: Acute Myelogenous Leukemia (AML); Acute Lymphoblastic Leukemia (ALL); Non Hodgkin Lymphoma (NHL); Hodgkin Lymphoma, Adult

Summary: this is a non-interventional, long-term follow-up study in subjects who received apograft in study apograft-01. up to 12 subjects who completed apograft-01 study will be offered to participate in this follow-up study. subjects who completed apograft-01 study and have signed informed consent for this follow-up study will be eligible to enroll. subject will attend in-clinic visits up to 2 years post transplantation, and will undergo the following evaluations: acute and chronic graft versus host disease (gvhd) assessments, survival status (overall, relapse-free), disease status (disease relapse/recurrence), physical examination, safety laboratory and concomitant medication use.


Eligibility criteria:
inclusion criteria: 1. subjects who completed study apograft-01 through 180 days (6 months) post-transplantation 2. ability to comply with the requirements of the study. 3. signed written informed consent