Kornimate/medical-research-clean huggingface dataset:
the use of standing powered wheelchairs in spinal cord injury

Conditions: Spinal Cord Injuries

Summary: the purpose of this study was to explore the experiences of standing powered wheelchair users with spinal cord injury.

there is limited research exploring the comfort, satisfaction, adverse effects, need for repair, and benefit in terms of secondary complications in standing powered wheelchair users with spinal cord injury. the purpose of this study was to explore the experiences of standing powered wheelchair users with spinal cord injury.

Eligibility criteria:
inclusion criteria: * ages 18-70 * post-spinal cord injury period \> 1 year exclusion criteria: - having cognitive impairment

Keywords: standing powered wheelchair spinal cord injury satisfaction secondary complication
effects of ps128 on parkinsonian symptoms

Conditions: Parkinson Disease

Summary: the purpose of this study is to examine the short term effects (12 weeks) of lactobacillus plantarum ps128 (ps128) on parkinson's disease (pd) symptoms.

this study is designed to examine the extent to which l. plantarum ps128 can improve symptoms in pd patients. l. plantarum ps128 is a psychobiotic that regulates the level of dopamine in specific brain regions. patients with pd will receive ps128 treatment for 12 weeks. symptoms of pd will be clinically evaluated before and after the treatment, and the results will be compared.

Eligibility criteria:
inclusion criteria: * between ages of 40-80 years old * diagnosed as a patient with parkinson's disease of modified hoehn and yahr stage between 1 and 2.5 as rated during an "on" period exclusion criteria: * patients on antibiotics within the preceding one month * patients using of other probiotic products (sachet, capsule or tablet) within the preceding two weeks * have current or history of inflammatory bowel disease * have history of cancer * have undergone surgery of liver, bladder, or gastrointestinal tract * known allergy to probiotics * patients with comorbid dementia (mini-mental state examination score ≤ 26) or major depression (the beck depression inventory-ii score ≥ 29) * have received deep brain stimulation * patients receiving artificial enteral or intravenous nutrition
presep and vascath interaction study

Conditions: Hemodynamics; Renal Dialysis; Sepsis; Shock

Summary: this is a prospective, observational study to compare presep(tm) catheter central vein mixed venous oxygen saturation before and after dialysis is initiated via the vascath(tm) central venous dialysis catheter to evaluate device interaction.

the central venous oxygen saturation catheter measurement may be influenced by close approximation to the tip of the central venous hemodialysis catheter when hemodialysis is ongoing.

Eligibility criteria:
inclusion criteria: * admitted to the micu * presep venous oxygen saturation central venous catheter already in place * vascath central venous dialysis catheter already in place * planned hemodialysis exclusion criteria: * patient unable to undergo hemodialysis * contraindication for presep or vascath catheters

Keywords: hemodynamics oxygen renal dialysis shock sepsis hypotension lactic acidosis
the cancer of the pancreas screening-5 caps5)study

Conditions: Pancreas Cancer; Peutz-Jeghers Syndrome (PJS); Gene Mutation; Germline Mutation Carrier; Lynch Syndrome

Summary: johns hopkins clinical research office quality assurance group will monitor and audit this study at johns hopkins. the sub investigator at each site will be responsible for internal monitoring at their site.

the sub investigator at each site will be responsible for internal monitoring at their site. the site sub investigator and study team will report any serious adverse events to principal investigator and annually report adverse events.

Eligibility criteria:
inclusion criteria: * hereditary pancreatitis or * peutz-jeghers syndrome or * strong family history of pancreas cancer on one side of the family tree or * confirmed germline mutation carrier (brca2, fammm (cdkn2a/p16), palb2, brca1, atm, hnpcc, lynch syndrome (hmlh1, hmsh2, pms2, hmsh6, epcam) prss1, prss2, r122h, n291l, spink1, cftr * endoscopic evaluation of pancreas scheduled exclusion criteria: * medical comorbidities or coagulopathy that contraindicate endoscopy * prior surgery that prevent optimal endoscopic ultrasound such as partial or complete gastrectomy with bilroth or roux-en-y anastomosis * stricture or obstruction in the upper gi tract that does not allow passage of the echoendoscope * poor performance status * inability to provide informed consent * pregnancy.

Keywords: familial pancreas cancer (peutz-jeghers syndrome) pjs breast cancer (brca) 2 partner and locator of brca2 (palb2) familial atypical multiple mole- melanoma (fammm) p16, cdkn2a breast cancer (brca)1 (hereditary non-polyposis colorectal cancer or lynch syndrome) hnpcc lynch syndrome hereditary pancreatitis protease serine (prss) chymotrypsin c (ctrc) ataxia telangiectasia mutated(atm)
a study evaluating the safety, efficacy, and pharmacokinetics of miricorilant in patients with presumed nonalcoholic steatohepatitis (nash)

Conditions: Nonalcoholic Steatohepatitis (NASH)

Summary: this phase 1b, open-label study is to assess the safety, efficacy of miricorilant in patients with presumed nonalcoholic steatohepatitis (nash)

this phase 1b, open-label study will assess the safety, efficacy and pharmacokinetics (pk) of miricorilant in patients with presumed nonalcoholic steatohepatitis (nash). patients who meet the criteria for the study cort-118335-861 will be enrolled on day 1 into 1 of 11 cohorts and receive: * cohort 1 - a daily dose of 150 mg of miricorilant over 24 weeks. * cohort 2 - a daily dose of 150 mg of miricorilant over 12 weeks. * cohort 3 - a daily dose of 100 mg of miricorilant over 2 weeks, followed by 10 weeks of dosing at 100 mg miricorilant every monday, wednesday and friday. * cohort 4 - a daily dose of 100 mg of miricorilant over 2 weeks, followed by 10 weeks of dosing at 100 mg miricorilant every monday and friday. * cohort 5 - a thrice weekly dose of 100 mg of miricorilant over 12 weeks every monday, wednesday, and friday. * cohort 6 - a twice weekly dose of 100 mg of miricorilant over 12 weeks every monday and friday. * cohort 7 - a daily dose of 50 mg of miricorilant over 12 weeks. * cohort 8 - a daily dose of 100 mg of miricorilant over 12 weeks. * cohort 9 - a daily dose of 30 mg of miricorilant over 12 weeks. * cohort 10 - a once weekly dose of 200 mg of miricorilant over 12 weeks. * cohort 11 - a twice weekly dose of 150 mg miricorilant over 12 weeks.

Eligibility criteria:
inclusion criteria: have a diagnosis of nash based on a biopsy obtained within the last year or have a diagnosis of presumed nash based on blood tests and scans exclusion criteria: * have participated in another clinical trial within the last year and received active treatment for nash * have participated in another clinical trial for any other indication within the last 3 months * are pregnant or lactating women * have a bmi \<18 kg/m2 * have had liver transplantation or plan to have liver transplantation during the study * have type 1 diabetes or poorly controlled type 2 diabetes.

Keywords: nonalcoholic steatohepatitis nash nonalcoholic fatty liver disease
thin versus thicker strut thickness stents in primary percutaneous intervention

Conditions: Primary Percutaneous Coronary Intervention

Summary: 1. to evaluate clinical safety of the device in terms of deaths, any stroke and myocardial infarction up to 1 year in both study groups to prove non inferiority of biomime stent 2. to evaluate presence of target lesion and target vessel revascularization in in both study groups prove non inferiority of biomime stent 3. to evaluate target vessel non-target lesion revasularization in both study groups prove non inferiority of biomime stent

• drug-eluting stents (des) represent a key advance in percutaneous coronary interventions (pci) owing to their ability to inhibit neointimal proliferation, which lowers the need for repeat revascularisation however, older-generation des have been shown to increase the risk of late restenosis and stent thrombosis. efforts to reduce these risks include improvements in stent platforms, polymer carriers, and drug selection. thinner struts reduce vessel wall injury, decrease inflammation and promote fast endothelialisation.the second-generation thin-strut des have been shown to reduce the risk of restenosis, stent thrombosis and myocardial infarction (mi) or possibly death when compared with older-generation des or bare metal stents. moreover, the newer generation of biodegradable polymer stents has the potential to reduce the inflammatory reaction of the arterial wall and minimise the risk of late restenosis and thrombus formation more recently, ultra-thin (\<70 μm) des have been shown to improve outcomes further compared with second-generation des.the biomime™ (meril life sciences pvt. ltd., vapi, india) is an ultra-thin sirolimus-eluting coronary stent (ses) with an established preliminary safety and efficacy record in the previous merit-1, merit-2, merit-3 and merit-4 trials in treating single de novo and complex lesions.the biomime is an ultra-thin strut (65 µm) ses that uses a cobalt-chromium platform with a unique hybrid design of open cells in the mid segment and closed cells at the edges which lead to lesser edge dissections during expansion and adequate side branch access, coated with biocompatible and bioabsorbable polymers, plla (poly-l-lactic acid) and plga (poly-lactic-co-glycolic acid) for faster healing

Eligibility criteria:
inclusion criteria: •all patients with st-segment elevation myocardial infarction and diagnosed according to the last guidelines. exclusion criteria: * left ventricular ejection fraction ≤30%. * killip class iii or iv at presentation. * extreme vessel tortuosity or lesion angulation (˂45˚). * severe calcification proximal to or within the target lesion. * bifurcation lesions with side branch diameter \>2 mm. * mechanical complication of stemi. * severe comorbidity such as malignancy

Keywords: primary percutaneous coronary intervention ultrathin stents
comparison of three pre-oxygenation strategies

Conditions: Emergencies; Anesthesia

Summary: study objective: comparing the efficacy of three different preoxygenation strategies, i.e. non-rebreather face mask (nrm), bag-valve-mask (bvm) with and bvm without additional positive end-expiratory pressure (peep) in three subgroups of spontaneously breathing volunteers. study endpoints primary endpoint: difference in expiratory oxygen concentration (feo2) at the end of the 3 min preoxygenation sessions. secondary endpoints: * difference in oxygen reserve index (ori) at the end of the 3 min preoxygenation sessions. * changes in regional ventilation from baseline to 1.5 min and 3 min into the preoxygenation sessions, assessed using electrical impedance tomography (eit) * time to reaching an oxygen reserve index (ori) ≥ 0.5 * time to reaching an oxygen reserve index (ori) =1 * time to oxygen reserve index (ori) back to baseline after the 3 min preoxygenation sessions. number of participants 15 participants per subgroup, i.e. 45 participants in total. inclusion criteria * normal-weight adults (body mass index, bmi 18.5-24.9 kg/m2) with an "american society of anesthesiologists physical status classification system (asa) " score of i or ii * adults with a bmi 25-39.9 kg/m2 with and asa score \<3 * healthy (asa i) children aged 6-12 years exclusion criteria asa 3, age \< 6 and age 12-18, pregnant women, missing informed consent, signs and symptoms of an acute respiratory illness on the study day. after informed consent and a medical check-up, baseline measurements will be done for 10 minutes (peripheral oxygen saturation spo2, ori, regional ventilation). then the participants will undergo 3 different preoxygenation sessions with the 3 interfaces (i.e. non-rebreather facemask with reservoir and a bag-valve-mask with and without peep) in a randomized order and a 20 min washout between the sessions. each preoxygenation session is conducted in a supine position and will be proceeded until the measured feo2 (end expiratory o2 fraction) reaches 90% or up to a maximum time of 3 min. afterwards 10 min of spo2, ori and regional ventilation measurements will follow.


Eligibility criteria:
inclusion criteria: * normal-weight adults (bmi 18.5-24.9 kg/m2) with an "american society of anesthesiologists physical status classification system (asa) " score of i or ii * adults with a bmi 25-39.9 kg/m2 with and asa score \<3 * healthy (asa i) children aged 6-12 years exclusion criteria: * asa 3 * age \< 6 and age 12-18 * pregnant women * missing informed consent * signs and symptoms of an acute respiratory illness on the study day
the role of melatonin in the regulation of blood coagulation

Conditions: Spinal Cord Injured, Tetraplegia

Summary: the main aim is to examine the influence of daylight and melatonin on the temporal variations of hemostatic factors with key roles in the hemostatic process and its regulation. particular emphasis will be on exploring the role of melatonin in hemostasis by comparing subjects with tetraplegia with able-bodied control subjects.


Eligibility criteria:
inclusion criteria: intervention group: * a diagnosis of tetraplegia for at least 2 years, and otherwise healthy. * must not use drugs permanently (except anti-spasmolytics). * must be able to swallow tablets. * must give written consent to participate. control group: * must be healthy. * must not use drugs permanently. * must give written consent to participate. exclusion criteria: both groups: * those with acute or chronic co-morbidity. * unable to cooperate. * not provided written consent to participate.

Keywords: circadian variation, hemostasis, melatonin, tetraplegia
evaluation of the covidseq test in saliva specimens from covid-19 asymptomatic illumina personnel

Conditions: SARS-CoV-2

Summary: "this is a prospective, multi-center specimen collection study. subjects 18 years of age or older who do not have symptoms of covid-19 will be enrolled. two nasal swab samples and one saliva sample will be collected from each subject. the saliva sample will be tested with the covidseq test and one nasal swab will be tested with an eua approved covid test. the other nasal swab sample will be stored and a subset (approximately 250 specimens) will be tested with the covidseq test. results of all testing will be provided to the sponsor for statistical analysis. positive results from covidseq test using saliva and/or the comparator eua test will be provided to subjects so participants can be referred for further evaluation (outside the study). no medical treatment, guidance on treatment decisions, nor medical care will be provided. "


Eligibility criteria:
subject inclusion criteria: an individual must meet the criteria below to be eligible. * individual is illumina us personnel (eg, employee, contractor, consultant) and was invited to participate in the study. * individual is 18 years or older at the time of consent. * individual is feeling well and, at the time of consent or specimen collection, does not have any of the following symptoms of covid-19: cough, shortness of breath or difficulty breathing, fatigue, fever or chills, muscle or body aches, headache, sore throat, new loss of taste or smell, congestion or runny nose, nausea or vomiting, or diarrhea. \[1\] * individual is willing to participate in study procedures and able to provide written informed consent in the english language. subject exclusion criteria: an individual cannot meet the below criteria. * individual is confirmed to have covid-19 and continues to require home isolation in accordance with current cdc guidelines at the time of consent or specimen collection. * individual is asymptomatic but suspected to have covid-19 due to recent close contact (as currently defined by the cdc) with a person with covid-19 and continues to require quarantine in accordance with current cdc guidelines at the time of consent or specimen collection. \[4\] * individual had symptoms of covid-19 less than 10 days before time of consent or less than 10 days before time of any subsequent specimen collection visit."
das181 for severe covid-19: compassionate use

Conditions: COVID-19

Summary: the objective of the study is to investigate the safety and potential efficacy of das181 for the treatment of severe covid-19.

each eligible subject is treated with das181 for 10 days and observed for 28 days from the first day of administration. from day 1 to 10, once or twice a day, for 10 consecutive days, a total of 9 mg (7 ml) nebulized das181 is given. if das181 is given by twice a day, one vial containing 4.5 mg (3.5m1) das181 should be delivered with about 12-hour interval.

Eligibility criteria:
key inclusion criteria: 1. positive for rna of sars-cov-2 from respiratory specimens or blood specimens 2. hypoxemic 3. severe covid-19 4. if female, subject must not be pregnant or nursing. 5. non-vasectomized males are required to practice effective birth control methods 6. capable of understanding and complying with procedures as outlined in the protocol as judged by the investigator and able to sign informed consent form prior to the initiation of any screening or study-specific procedures. exclusion criteria: 1. alt or ast\> 8 x uln 2. (alt or ast\> 3 x uln) and (total bilirubin\> 2.5 x uln or inr\> 2.0 x uln) 3. female subjects who have a positive pregnancy test and are breastfeeding 4. subjects using any other investigational antiviral drugs during the hospitalization before enrollment. 5. subjects participating in other clinical trials 6. subjects may be transferred to a non-participating hospital within 72 hours 7. people who cannot cooperate well due to mental illness, have no self-control, and cannot express clearly 8. severe underlying diseases affecting survival 9. critical covid-19 requiring mechanical ventilator at the time enrolled

Keywords: covid-19 sars-cov-2 das181 hypoxemia
a qualitative case study of the experiences of children with cancer as they learn about their diagnosis and treatment

Conditions: Sarcoma

Summary: thousands of children are diagnosed with cancer each year, many of whom will achieve long term survival due to advances in treatments and technologies. however, when a child is first diagnosed, they are confronted with a wealth of new and unfamiliar medical information that they must integrate in order to understand their diagnosis and treatment plan. little is yet known about how children with cancer experience learning about their diagnosis and treatment in the hospital setting, or the individuals and materials that may help to facilitate the child's developing understanding. this information could help to identify or guide educational and supportive child life interventions to help children with cancer better understand their illness and its treatment. this observational study will collect data about how children currently learn about their cancer diagnosis and treatment in the hospital setting. the interventions used do not seek to change the health outcomes of the participants in this study. the observational data collected may serve to improve how future patients learn about their cancer-related diagnosis.

this is a longitudinal qualitative case study, and no randomized interventions will be used. instead, participants will complete two interview sessions, three guided activities, and observations with the primary investigator to explore their experiences of learning about their diagnosis and treatment in the hospital setting. primary objective: * the primary objective of this qualitative case study is to describe the ways in which children with cancer learn about their cancer diagnosis and treatment in the hospital setting.

Eligibility criteria:
inclusion criteria: * the child is between the ages of 7 and 11 years on the day of their initial arrival to the hospital * the child has a working diagnosis or initial diagnosis of a bone or soft tissue sarcoma that will require multimodal therapy to include chemotherapy, plus or minus surgical resection, plus or minus radiation therapy. * both the child and parents speak english as their primary language * parents are willing to give consent and child is willing to give assent exclusion criteria: * the child has a pre-existing, documented learning disability or cognitive impairment and has previously received learning accommodations under an individualized education plan (iep). * the child has a pre-existing, documented diagnosis of autism spectrum disorder (including autism and asperger's disorder). * child has previously received treatment for a cancer diagnosis either at st. jude or another institution. * parent and/or child are unwilling or unable to give consent/assent.

Keywords: children cancer learning education qualitative
a safety study of spx-101 inhalation solution in subjects with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: ascending dose, 7-day, open label safety trial of spx-101 inhalation solution in adult subjects with cystic fibrosis.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cf * fev1 ≥ 40% predicted normal * stable cf lung disease * non-pregnant, non-lactating females exclusion criteria: * significant unstable co-morbidities within 28 days of screening as judged by the investigator. * has received an investigational drug within the past 30 days