Kornimate/medical-research-clean huggingface dataset:
broncho-adventitial delivery of paclitaxel to extend airway patency in malignant airway obstruction patients

Conditions: Malignant Airway Obstruction Secondary to Non-small Cell Lung Cancer

Summary: assess the safety and feasibility of local oncological drug delivery into the bronchial wall after recanalization of subjects with malignant airway obstruction. safety and feasibility (technical success) will be assessed. this localized delivery is intended as an adjunct therapy and all subjects will receive standard of care oncology therapy as determined by their treating physicians.


Eligibility criteria:
inclusion criteria: * life expectancy of at least 12 weeks * adequate bone marrow, liver, and renal function * scheduled to undergo bronchoscopy for malignant airway obstruction as standard medical care * pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer * measurable disease with obstruction into the airway * pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer * patients undergo recanalization procedure of tumor during bronchoscopy * investigator is able to insert and deploy the blowfish catheter into the airway after recanalization exclusion criteria: * second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer * pregnant or nursing female subjects, or female subjects of child bearing potential who refuse to take a pregnancy test prior to their enrollment in this study * uncontrolled infection * presence or recent history of any systemic disorder or conditions, such as: * uncontrolled hypertension * type 1 diabetes * severe pulmonary hypertension * acute kidney injury * stroke (within the last 6 month) * myocardial infarction (within the last 3 months) * individuals with neurological, mental or psychiatric disorders * concurrent participation in another study involving investigational drugs or investigational medical devices * other (non-cancer) disease not stabilized within 1 month before the screening visit * known hypersensitivity to paclitaxel, cremophor el, or iodinated contrast media * any serious, uncontrolled comorbidity or condition that an investigator believes would interfere with the intent of the study or would make participation not in the best interest of the patient intraoperative exclusion criteria * use of pulmonary airway stents and/or ongoing or initiation of local external beam or brachytherapy radiation * any intraoperative complications that per the investigator's judgment increase the risk to the patient.
vitamin d absorbance study - clinical trial of the absorbance of nano liquid d3

Conditions: Vitamin D Deficiency

Summary: vitamin d is a commonly available essential prohormone humans need to regulate blood calcium and has recently emerged as potentially helpful in combating severe covid-19. despite its importance, some studies estimate as much as 40% of the us population is deficient in vitamin d. most available vitamin d supplements have little absorption data and are nearly all softgels or capsules. this clinical trial is designed as a preliminary pharmacokinetics study to assess the absorbance of a nano liquid d3 supplement that can be taken as an oral spray once daily. preliminary evidence suggests that this nano liquid d3 may be absorbed more readily than commercially available softgel dosage forms of d3. this randomized, double-blind, placebo-controlled trial will compare nano liquid d3 to commonly available d3 oral softgels and a placebo control group over the course of a thirty-one (31) day study period.


Eligibility criteria:
inclusion criteria: * adults, ages 18-70 years old * either male or female * taking less than 2,000 iu of vitamin d daily as a supplement during the 30 days before starting the study * ability to swallow a pill of typical size or a liquid less than 1 ml daily for 30 days * ability to speak, read, and understand english * access to smart phone or smart device with internet access for study-related communications * ability to do 3 at-home vitamin d finger prick blood tests on 3 separate days. the kits and supplies will be given to you. * ability to drop off finished blood tests at a ups store or ups drop box, or schedule a ups pickup at your home, on each of the same days as you do the blood tests exclusion criteria: * females who are pregnant * taking, on average, more than 2,000 iu of vitamin d daily within 30 days before the study * currently have covid-19 infection * history of covid-19 infection or positive covid-19 test in last 60 days * people with a diagnosis of cystic fibrosis * people with a diagnosis of crohn's disease * people diagnosed with celiac disease * people with known diagnosis or history of any kidney related disease including, but not limited to: chronic kidney disease; end stage renal disease; polycystic kidney disease; lupus nephritis; kidney cancer, alport syndrome; amyloidosis; goodpasture syndrome; and wegener's granulomatosis * people with known diagnosis or history of any liver related disease including, but not limited to: hepatitis a; hepatitis b; hepatitis c; fatty liver disease; cirrhosis of the liver; liver cancer; hemochromatosis; wilson disease
procedure for duodenal-ileal diversion with a sleeve gastrectomy for patients with obesity and type 2 diabetes mellitus

Conditions: Obesity; Type 2 Diabetes Mellitus

Summary: study will monitor weight loss and metabolic indicators for subjects in multi-center, single arm trial.

multi-center, open-label pilot study to evaluate the safety and effectiveness of the gi windows single neodymium magnet anastomosis procedure when used to create a duodenal-ileal diversion with a sleeve gastrectomy (snap-s) for subjects with obesity and type 2 diabetes mellitus (t2dm)

Eligibility criteria:
inclusion criteria: * age 19-65 years at screening * body mass index (bmi) ≥35 and ≤50 * t2dm diagnosis ≥6 months but \< 10 years, with 1 or more oral diabetes medications, hba1c ≥ 6.5% but \< 10.0% at time of enrollment. * hba1c must be stable over a 3-month period. * weight stable over 3-month period * obesity-related comorbidities (hypertension, dyslipidemia, sleep apnea) must be well-controlled * agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for a duration of 2 years * if female, subject must commit to not becoming pregnant for 24 months and agree to use contraception during this period * able to understand and sign informed consent documents. exclusion criteria: * known or suspected allergy to nickel or titanium or nitinol * type 1 diabetes or poorly controlled type 2 diabetes * use of injectable insulin * any documented conditions for which endoscopy would be contraindicated * contraindication to general anesthesia * history of chronic gastrointestinal disease * congenial or acquired anomalies of the gi tract * any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon. * uncontrolled hypertension * pre-existing severe comorbid cardio-respiratory disease * history of chronic gastrointestinal disease * specific genetic or hormonal cause of obesity * recent tobacco/nicotine product cessation (within 3 months prior)

Keywords: obesity diabetes mellitus diabetes mellitus, type 2 metabolic disease sleeve gastrectomy
tacs and trns studies on brain control of swallowing

Conditions: Dysphagia; Swallowing Disorder

Summary: transcranial alternating current stimulation (tacs) and transcranial random noise stimulation (trns) are two (ce marked medical devices) new, non-invasive (over the scalp) brain stimulation (nibs) techniques. both tacs and trns deliver a weak current continuously across the brain using pads placed over the scalp, which has been shown safe and well-tolerated by healthy adults and patients. these two techniques are able to softly alter physiological function within the brain. tacs can influence the brainwaves which have been demonstrated to play important roles in movement, sensation, and thinking functions. tacs and trns have been investigated for several years and have been shown to be safe, well tolerated and produce beneficial results in hand movement, hearing, and working memory. swallowing problems are life-threatening symptom among patients with brain impairments and elderly people. until now, there are no studies investigating whether tacs and trns can have a beneficial effect on swallowing function in human. our aim is to examine the effects of different strengths of tacs and trns to determine the best approach for brain stimulation that controls swallowing action, before using these techniques in patients with (neurological) swallowing disorders. participants: healthy adults who are aged 18 years old or above with no medical complications or significant past medical history will be recruited in the study.


Eligibility criteria:
inclusion criteria: * healthy adults who are aged 18 years old or above with no medical complications or significant past medical history exclusion criteria: * a history of epilepsy * cardiac pacemaker * previous brain surgery * previous swallowing problems * risk of potential pregnancy * metal in the head or eyes * use of medication that acts on the central nervous system.

Keywords: transcranial alternating current stimulation transcranial random noise stimulation frequency full spectrum
a clinical study on levosimendan improvement of prognosis of ards patients by optimizing pulmonary hemodynamics

Conditions: ARDS, Human

Summary: the purpose of this study was to evaluate the curative effect of levosimendan on ards patients through omni-directional and multi-angle objective quantitative indexes, and to study the responsiveness of ards with or without right ventricular insufficiency to the treatment of levosimendan, and to indirectly confirm whether levosimendan had lung protective mechanism other than calcium sensitization to ards patients, such as inhibiting inflammatory reaction to reduce pulmonary capillary leakage and alveolar epithelial cell injury. relaxation of bronchial smooth muscle improves pulmonary ventilation function. to provide new methods and ideas for clinical treatment of ards.

on the basis of the above research, the investigators speculate that levosimendan can improve cardiac function, enhance diaphragm contractility and decrease pulmonary artery through this sensitizing effect, and protect ards lung function by regulating the release and oxidation of inflammatory mediators and nitroso oxidative stress. the hemodynamic and pulmonary protective effects of ards patients were improved by regulating k-atp channels, relieving blood vessels and bronchospasm and improving ventilation and diffusion function in ards patients, so as to further improve the survival rate of these patients and shorten the mechanical ventilation time and icu stay time. the purpose of this study was to observe the effect of levosimendan on pulmonary circulation and right ventricular function in patients with ards, to determine whether it can reduce the fatality rate of ards and shorten its icu residence time, and to evaluate the evaluation of ards with or without right ventricular insufficiency and to provide a new idea and method for drug treatment of ards.

Eligibility criteria:
inclusion criteria: clinical diagnosis of ards; joined this study with informed consents exclusion criteria: neurological and muscle diseases; chronic severe liver and kidney failure; advanced malignant tumor; primary left ventricular insufficiency;

Keywords: levosimendan
clage sequential with flu-bu conditioning for refractory acute leukemia

Conditions: Refractory Hematologic Cancer; Allogeneic Stem Cell Transplantation

Summary: for patients with refractory acute leukemia, allogeneic stem cell transplantation is the only curative therapy. only 20% of patients may achieve long-term survival mostly due to relapse or nor-relapse mortality (nrm). in previous study, we demonstrated that intensive leukemia debulking chemotherapy flag-ida sequential with flu-bu conditioning is feasible with \~40% long-term survival. in the study, we further modified the chemotherapy with cladribine replacing fludarabine aiming a more potent anti-leukemia effect. meanwhile, we reduce the dose of busulfan for patients with poor performance status and age over 45 aim to reduce the nrm. all patients will also receive post-transplantation maintenance therapy with low-dose decitabine to prevent relapse.

for patients with refractory acute leukemia, allogeneic stem cell transplantation is the only curative therapy. only 20% of patients may achieve long-term survival mostly due to relapse or nor-relapse mortality (nrm). in previous study, we demonstrated that intensive leukemia debulking chemotherapy flag-ida sequential with flu-bu conditioning is feasible with \~40% long-term survival. the most important cause of treatment failures were relapse and non-relpase mortality. the further analysis demonstrated that patients with higher bone marrow blast before allo-hsct was associated with treatment failure and patients with poor perforce status or age over 45 had increased rate of nrm. to further optimization the protocol, we modified the chemotherapy with cladribine replacing fludarabine aiming a more potent anti-leukemia effect and replace idarubicin with vp-16. all patients will also receive post-transplantation maintenance therapy with low-dose decitabine (5mg/m2 daily for 5 days) to prevent the further reduce the relapse incidence. we anticipate lfs at 1 year should be above 50% and 1-year lfs of 20% is considered unacceptable.

Eligibility criteria:
inclusion criteria: * refractory myeloid malignancies including acute myeloid leukemia (aml) or chronic myeloid leukemia in blastic crisis (cml-bc) * hla matched sibling，unrelated donor, or haplo-identical donor * patients with bone marrow blast \>5% and positive measurable disease via flowcytometry or pcr. exclusion criteria: * patients with active infection * liver function damage: alt/ast above 2x normal range; and renal function damage scr\>160µmol/l; insufficient pulmonary function (fev1，fvc，dlco\<50%）and heart failure or with ef \<50% * mental instability * unwilling to give inform consent
to evaluate the efficacy and safety of anlotinib combined with furmonertinib mesylate in lung cancer

Conditions: Lung Cancer

Summary: this study is to evaluate the efficacy and safety of anlotinib hydrochloride capsule combined with furmonertinib mesylate in first-line treatment of advanced no-squamous and no-small cell lung cancer with epidermal growth factor receptor mutation.

this study is to evaluate the efficacy and safety of anlotinib hydrochloride capsule combined with furmonertinib mesylate in first-line treatment of advanced no-squamous and no-small cell lung cancer with epidermal growth factor receptor mutation. this study is a single arm, phase ii study, including 18 to 36 subjects; common terminology criteria for adverse events 5.0 standard was used to evaluate adverse events of drugs, and response evaluation criteria in solid tumors 1.1 was used to evaluated efficacy.

Eligibility criteria:
inclusion criteria: 1. locally advanced and/or metastatic nsclc diagnosed histologically and/or cytologically; 2. age 18 and above; eastern cooperative oncology group physical condition: 0\~1; the expected survival time is more than 3 months; 3. the previous report confirmed the presence of an egfr gene exon 19 deletion mutation or exon 21 l858r mutation, and the investigator verified that the report reflects the patient's current genetic status. 4. there is at least one measurable lesion other than brain lesion defined by response evaluation criteria in solid tumors 1.1 standard; 5. the main organs are functioning well,adequate laboratory indicators. 6. women of childbearing age should agree to use contraceptives during the study period and for a period of six months after the study; negative serum or urine pregnancy test within 7 days prior to study inclusion, and must be non-lactating; male patients should agree to use contraception during the study period and for six months after the end of the study period; 7. patients voluntarily participated in this study, signed informed consent, and had good compliance. exclusion criteria: 1. prior history of targeted epidermal growth factor receptor therapy and anti-angiogenic drugs 2. received chemical or biological drugs after the diagnosis of advanced stage; 3. subjects had undergone surgery , radiation therapy or other anticancer therapies within 4 weeks prior to the commencement of study treatment; subjects who have previously received local radiation therapy may be enrolled if the following conditions are met: more than 4 weeks after the end of radiation therapy ; 4. within 2 weeks before the start of the study, patients were treated with chinese medicines 5. imaging shows that the tumor has invaded the periphery of important blood vessels or the investigator has determined that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study. 6. uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage ; 7. brain metastases with symptoms or symptom control time less than 2 weeks;
observational study in preterm infants with intracranial hemorrhage

Conditions: Intracranial Hemorrhage; Intraventricular Hemorrhage; Cerebral Hypoxia

Summary: intracranial hemorrhage (ich) is an important morbidity affecting premature infants and can have considerable effects on neurodevelopmental outcome. the investigators showed that preterm infants with severe ich have decreased cerebral oxygenation several weeks after the hemorrhage. the mechanisms involved in this state of decreased cerebral oxygenation in preterm infants and the effects on cerebral function are unknown. this longitudinal observation study will evaluate physiologic parameters to determine trends in cerebral oxygenation and function in preterm infants with ich in comparison to infants without ich.


Eligibility criteria:
inclusion criteria: * preterm infants born between 23 and 28 weeks of gestation * diagnosed with ich grades ii or higher during the first week after birth * matched control infants without ich. exclusion criteria: * major congenital malformations * birth asphyxia * not expected to survive

Keywords: premature infants intracranial hemorrhage intraventricular hemorrhage cerebral oxygenation brain function cerebral perfusion
acceptability and tolerance of a protein and micronutrient fortified food

Conditions: Poor Nutrition

Summary: acceptability and tolerance of a new food product in adults and children.

acceptability and tolerance testing will be conducted in 10 healthy male adult volunteers and 10 (40 - 60 years of age), and in children (9-13 years of age). all participants will be asked to consume 50g of a test product every day for 2 weeks for the adult volunteers, while the children will be asked to consume the same product every day for one week. the participants will record amount of daily intake, and will be given an entry and exit surveys. these surveys will include the assessment of potential gastrointestinal changes with daily product intake, and will include questions on how they liked the product. acceptability will be measured as the number of servings and portion of serving completed each day over the trial period. in adults only, fasting blood samples and a spot urine will be collected towards preliminary work on potential changes in the metabolome and lipidome with the inclusion of the test product within the habitual diet.

Eligibility criteria:
° inclusion criteria: * male, 40-60 years old * male or female 9-13 years old * subject is willing and able to comply with the study protocols * subject is willing to consume the test products exclusion criteria: * allergies or intolerances to peas, legumes, pulses, soy, dairy or wheat/gluten * under current medical supervision * non-english speaking * self-reported history of cardiovascular disease, stroke, cancer, renal, hepatic, or thyroid disease, gi tract disorders, previous gi surgery * currently taking prescription drugs or supplements * daily use of aspirin and or non-steroidal anti-inflammatory medicines. * indications of substance or alcohol abuse within the last 3 years * any supplement use, including multi-vitamin/ mineral, herbal, plant or botanical, fish oil, and oil supplements. * self-reported malabsorption * current enrollee in a clinical research study.
vaginal progesterone to prevent preterm delivery in women with preterm labor

Conditions: Preterm Delivery; Morbidity; Perinatal Mortality

Summary: the administration of vaginal progesterone, in addition to standard tocolysis, will decrease the risk of delivering prematurely and of recurrent preterm labor. we also hypothesize that the reduction in preterm delivery will be associated with a decrease in infant mortality and morbidity.

the principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation. secondary aims are to show that progesterone 1) reduces preterm birth before 32 and before 34 weeks of gestation 2) reduces the number and duration of recurring episodes of preterm labor and 3) reduces infant mortality and morbidity.

Eligibility criteria:
inclusion criteria: * gestational age between 240/7 et 336/7 weeks of gestation (based on a reliable estimate by ultrasound performed before 22 weeks) * singleton pregnancy * intact membranes * preterm labor defined as: * 2 or more regular and painful uterine contractions in 10 minutes plus one or plus of the following criteria: * short cervix detected by vaginal ultrasound scanning (cervical length less than 30 mm until 31 weeks and less than 25 mm from 32 weeks) * cervical changes detected clinically (cervical length less or equal 10 mm or bishop score less than 6 * cervical changes during hospitalization (more or equal 5 mm between two clinical or us exams) * positive fetal fibronectin * age ≥ 18 years old * signed informed consent * possible and accepted follow-up exclusion criteria: * multiple gestation * cervical cerclage * hydramnios (afi \>95th percentile for gestational age or greatest pocket \>8 cm) * premature rupture of membranes * chorioamnionitis (criteria for clinical diagnosis are: elevated wbc, elevated crp, maternal tachycardia, fetal tachycardia, uterine tenderness and/or amniotic fluid foul odor) * cervical dilatation \> 3 cm * placenta praevia or abruptio placentae * intra-uterine growth restriction or non-reassuring fetal status * pre-eclampsia or severe hypertension * any other maternal or fetal pathology which should indicate medically preterm delivery

Keywords: preterm delivery preterm labor perinatal morbidity perinatal mortality
a non-interventional pilot study to explore the role of gut flora in clostridoides difficile infection

Conditions: Clostridium Difficile; Clostridium Difficile Infection; Microbiome; CDI

Summary: this study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

the goal of this research study is to better understand how the genetic information in subject's microbiome correlates to infection with c. diff.

Eligibility criteria:
inclusion criteria: * willingness to sign informed consent * diagnosis of c. difficile infection * age of 18 and older exclusion criteria: * refusal by patient to sign informed consent form * treatment with antibiotics 2 weeks prior to screening * treatment with probiotics 6 weeks prior to screening * history of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. * postoperative stoma, ostomy, or ileoanal pouch * participation in any experimental drug protocol within the past 12 weeks * treatment with total parenteral nutrition * any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial * inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study