Kornimate/medical-research-clean huggingface dataset:
evaluating the pharmacokinetic interaction between ad-2101 and ad-2102

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the pharmacokinetic interaction between ad-2101 and ad-2102 in healthy male subjects.

to evaluate the pharmacokinetic interaction, safety and tolerability of the combination compared with the administration of ad-2101 and ad-2102.

Eligibility criteria:
inclusion criteria: * healthy male between 19 and 50 years of age at the time of screening * weight above 50 kg and body mass index (bmi) between 17.5 kg/m2 and 30.5 kg/m2 exclusion criteria: * clinically significant disease or history of clinically significant disease such as cardiovascular, respiratory, liver, kidney, digestive, hematologic/oncologic, endocrine, immunologic, urinary, psychiatric * gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery * a person who has a history of drug abuse * ast, alt, total bilirubin values over than 2 times of unl at screening * creatinine clearance under 80ml/min
use of local intraoperative steroid in mis tlif

Conditions: Dysphasia

Summary: the purpose of this study is to determine if the frequency and duration of postoperative pain are improved in participants receiving a local steroid injection (methylprednisolone) plus a systemic (intravenous (iv, by vein)) steroid (dexamethasone) when compared to those receiving a systemic (iv) steroid (dexamethasone) alone. both of these steroid injections are already currently used at rush and are considered standard of practice. it is well established that steroids have an anti-inflammatory (decreased swelling) effect on the soft tissue and it is routinely used in many types of surgery, but it is not known whether two steroids are better than one. the medications provided in this study are approved by the food and drug administration (fda).

postoperative pain is a well-known complication following minimally invasive transforaminal lumbar interbody fusion (mis tlif). it has been found that up to 40% of lumbar spinal patients will have either recurrent or persistent postoperative pain. several studies have demonstrated reduced patient reported pain scores following steroid administration. however, few studies have investigated intraoperative local injection of corticosteroid at the surgical site in an effort to reduce the incidence and duration of postoperative pain for mis tlif patients. the purpose of this study is to determine if the incidence and duration of postoperative pain is improved in participants receiving a local injection of methylprednisolone with systemic dexamethasone when compared to those receiving the usual systemic dexamethasone undergoing mis tlif. the investigators hypothesize that participants undergoing mis tlif who receive local methylprednisolone along with the systemic dexamethasone will have: 1. reduced incidence and duration of postoperative pain compared to participants receiving only systemic dexamethasone. 2. shorter hospital stay compared to participants receiving only systemic dexamethasone. 3. better short- and long-term outcomes compared to participants receiving only systemic dexamethasone

Eligibility criteria:
inclusion criteria: * patients undergoing a primary 1- to 2-level mis tlif * diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis * patients able to provide informed consent exclusion criteria: * allergies or other contraindications to medicines in the protocol including: (a) existing history of gastrointestinal bleeding * current smokers * lumbar spine trauma * bilateral cages * lack of consent

Keywords: transforaminal lumbar interbody fusion, methylprednisolone
remodeling of distal coronary vessel in chronic total occlusions: prediction based on hemodynamic coronary parameters

Conditions: Chronic Total Occlusion (CTO); Percutaneous Coronary Intervention (PCI); Fractional Flow Reserve; Quantitative Coronary Analysis; Absolute Flow Measurement; Optical Coherence Tomography (OCT)

Summary: background revascularization of a chronic total occlusion (cto) has gained popularity last decade. after recanalization there is an acute gain in vessel diameter, as well as a late lumen gain distal to the stent as a result of positive remodeling. the evolution of a recanalized cto-vessel is however diverse. several studies are performed to measure distal lumen gain and hemodynamic coronary parameters of a recanalized cto, including the novel measurement absolute flow. although the results seem promising, an association between those parameters and distal vessel lumen gain has never been found. the aim of this study is to understand the remodeling of the distal coronary vessel in relation with hemodynamic coronary parameters, establishing baseline predictive factors, adding new information about coronary physiology. objectives: to establish baseline predictive factors for acute and late lumen growth after successful opening of chronic total occlusions. secondary objectives are 1) identifying the relation between change in absolute microvascular resistance and late change distal lumen diameter at the end of the index procedure and at 3 months follow-up, 2) identifying the relation between late lumen growth and stent malapposition, assessed using optical coherence tomography (oct) and 3) identifying the relation between angina-related symptoms, assessed using the seattle angina questionnaire-7 (saq-7), and absolute microvascular resistance. hypothesis: acute and late lumen growth are dependent on preprocedural distal coronary artery perfusion pressure, decrease in microvascular resistance and growth of absolute antegrade flow. late lumen growth predisposes for late stent malapposition. study design: a single-center, prospective, observational cohort study. the center performing this study will be the radboudumc. study population: 30 patients scheduled for an elective revascularization procedure of a cto and heart-team consensus for the indication of a cto treatment.


Eligibility criteria:
inclusion criteria: * scheduled elective revascularization procedure of a cto, defined as a complete obstruction of a coronary artery with timi-0 or timi-1 flow and occlusion duration of at least 3 months * heart-team consensus for the indication of a cto treatment, based on viability and ischemia testing (using tte or mri) * able to give valid, written informed consent exclusion criteria: * unsuccessful crossing of the lesion during pci * renal insufficiency defined as egfr \< 30 ml/min * contra-indications to intravenous adenosine * \< 18 years of age * pregnancy

Keywords: chronic total occlusion percutaneous coronary intervention quantitative coronary analysis absolute flow measurement optical coherence tomography
a cohort study on the pathogen spectrum of liver transplant recipients complicated with infection

Conditions: Liver Transplantation; Transplant Recipients

Summary: the goal of this observational study is to map the pathogen profile of secondary infections in liver transplant recipients, to correlate the basic immune status with the characteristics of the secondary infection pathogen profile, and to establish an early warning system for monitoring secondary infections, so as to explore safe and effective therapeutic modalities to further reduce the morbidity and mortality of liver failure. the main questions it aims to answer are: * characterize the distribution of pathogenic bacteria infecting liver transplant recipients. * establish a monitoring and early warning system for secondary infections.

liver transplantation is recognized as the most effective treatment for end-stage liver disease, and china's liver transplantation technology has reached the international level, with survival rates of 90%, 80%, and 70% at 1, 5, and 10 years after surgery, respectively. during the perioperative period of liver transplantation, transplant recipients with preoperative organ dysfunction, high surgical trauma, postoperative application of immunosuppressive drugs, and low anti-infective capacity are highly susceptible to associated infections, which are more likely to occur than in other transplant recipients, and have become an important factor affecting the prognosis of liver transplantation. foreign studies reported that 18% of postoperative liver transplantation deaths were caused by infections, of which bacterial infections were the most common, followed by viral and fungal infections. in the first month after liver transplantation, the incidence of infection is the highest, and bacterial pneumonia is the most common infection, with a high case fatality rate, and the hospitalization time of the patient is significantly prolonged, and the economic expenditure is increased. early clarification of the type and distribution of pathogenic bacteria infecting liver transplant recipients and prompt initiation of appropriate anti-infective therapy are essential to improve the survival of liver transplant recipients.

Eligibility criteria:
inclusion criteria: 1. agree to participate in this study and sign the informed consent form; 2. be of any gender and aged 18-70 years old; 3. no life-threatening underlying diseases and complications during the perioperative period. 4. undergo liver transplantation within 24 hours. exclusion criteria: 1.patients deemed unsuitable by the investigator to participate in the study.

Keywords: liver transplant recipients infection pathogen spectrum cohort study
symptomatic treatment of patients with neuropathic pain with lyrica

Conditions: Neuropathic Pain

Summary: a non-interventional, post-marketing surveillance (ni-pms) study whose objectives were to assess the impact of pregabalin on subjects' pain, quality of sleep, and their general wellbeing, as well as the tolerance and safety of pregabalin in subjects with neuropathic pain.

a non-interventional study of patients diagnosed with neuropathic pain administered pregabalin and followed up for 8 weeks

Eligibility criteria:
inclusion criteria: * clinical diagnosis of neuropathic pain and inclusion according to the current summary of product characteristics. exclusion criteria: * the patients were excluded according to the current summary of product characteristics.

Keywords: neuropathic, pain, pregabalin, lyrica
study of de-089 ophthalmic solution in patients with dry eye

Conditions: Dry Eye

Summary: safety and efficacy of de-089 ophthalmic solution in patients with dry eye will be evaluated in comparison with sodium hyaluronate ophthalmic solution.


Eligibility criteria:
inclusion criteria: * those who show: * keratoconjunctival disorder confirmed with vital dye staining * abnormal schirmer score results exclusion criteria: * eye disease that needs therapy other than that for dry eye * those who need to wear contact lenses during the clinical study
impact of hindmilk on weight gain among moderate to very preterm infants in zambia

Conditions: Postnatal Growth Restriction

Summary: the primary hypothesis is that very preterm infants between 28 0/7 to 31 6/7 weeks with a birth weight from 1000-1999 grams allocated to the hv breastmilk group (200-240 ml/kg/day) until hospital discharge or 40 weeks' post-menstrual age (pma), whichever comes first, will have increased growth velocity compared to those given uv breastmilk (140-180 ml/kg/day).

the proposed study is a non-blinded randomized controlled trial with a 1:1 parallel allocation of infants to higher-volume feedings (200-240 ml/kg/day) or usual-volume feedings (140-180 ml/kg/day) using computer-generated random-block sequences. the study will enrol a total of 214 study participants including 190 preterm infants randomized controlled trial of hv feedings and 24 mothers of enrolled infants and healthcare workers for in-depth interviews. we will also screen mothers to study participants for postpartum depression using the edinburgh postnatal depression scale (epds) screening tool. study aims are: aim 1: to evaluate the impact of high volume (hv) feedings using additionally expressed milk at the end of feeding (hind-milk) vs usual volume (uv) feedings on growth velocity from birth to discharge or 40 weeks' pma, whichever comes first, among very preterm infants. through a 1:1 randomization, the study will enrol 190 preterm infants weighing between 1,000g - 1,999g in both study arms and follow them until hospital discharge or 40 weeks' pma, whichever comes first. aim 2: to evaluate the impact of hv vs uv breastfeeding until 40 weeks' pma on all-cause neonatal mortality and morbidity (including sepsis, nec, intestinal perforation, and hypoglycaemia). all study participants (n=190) will be until 40 weeks' pma to estimate its impact on all-cause neonatal mortality and morbidity. aim 3: to characterize the acceptability, feasibility, and feeding tolerance among hv breastfeeding women and their infants at the hospital and its feasibility by healthcare workers. a total of 24 mothers and healthcare workers will be interviewed through in-depth interviews (idis) to better understand the acceptability of this intervention by the feeding mothers, the feeding tolerance by their newborns, and the feasibility of the same by the healthcare workers.

Eligibility criteria:
inclusion criteria: * between 28 0/7 to 31 6/7 weeks of age or weighing between 1000-1999 grams, * admitted to the uth nicu within 24 hours after birth, and * infants who have reached feeding volume ≥120 ml/kg/day at time of randomization exclusion criteria: * who are deemed unstable by the neonatologist, * with necrotizing enterocolitis or intestinal perforation * known gastrointestinal malformations, * major malformations or congenital anomalies, and * whose parents do not provide informed consent

Keywords: breastmilk hindmilk high-volume breastfeeding postnatal growth restriction preterm
a bridge to treatment: the therapeutic workplace and methadone treatment

Conditions: Opiate Dependence

Summary: the purpose of this study is to evaluate the effectiveness of the therapeutic workplace in promoting methadone treatment and increasing abstinence in unemployed, out-of-treatment injection heroine users.

a randomized study is planned for 5 years to evaluate the effectiveness of the therapeutic workplace in promoting methadone treatment and abstinence in unemployed injection drug users. participants will be recruited through street outreach, at agencies that serve the target populations, and informal word-of-mouth referrals. participants will be invited to attend the workplace and to enroll in the methadone treatment. to engage participants in the workplace, they will be allowed to work independent of whether they enroll in methadone treatment and independent of their drug use. the workplace participants (n=162) will be randomly assigned to three groups. the "usual care control" participants will be allowed to work independent of their methadone use or urinalysis results. the "methadone contingency" participants will be required to take methadone to attend work, and will receive a brief pay decrease for failing to take their medication. the "methadone \& abstinence contingency" participants will be required to take their medication in order to attend work, as well as receive a brief pay decrease for any positive urine samples for both cocaine and methadone.

Eligibility criteria:
individuals were eligible if they were: * at least 18 years old, * reported injection drug use in the past 30 days, * met the diagnostic and statistical manual (dsm)-iv criteria for opioid dependence, * reported using heroin at least 21 out of the past 30 days, * provided an opiate-positive urine sample, * showed visible signs of injection drug use (i.e., track marks), * reported not receiving substance abuse treatment in the past 30 days, * lived in baltimore, * and were unemployed. participants were excluded if they * had current severe psychiatric disorders or chronic medical conditions that would interfere with their ability to participate in the workplace, * reported current suicidal or homicidal ideation, * had physical limitations that would prevent them from using a keyboard, * had medical insurance coverage (as this would disqualify them from receiving interim methadone treatment), * were pregnant or breastfeeding, * or were currently considered a prisoner. eligible participants were invited to participate in a 4-week induction. participants who attended the workplace for at least five minutes on two out of five workdays in the last week of induction were randomly assigned to one of three conditions and were invited to attend the workplace for an additional 26 weeks
chronic periodontitis in critically ill patients: diagnosis and epidemiology

Conditions: Chronic Periodontitis; Intensive Care Unit

Summary: this study evaluates the diagnostic performances of point of care p. gingivalis test in saliva with serum igg p. gingivalis, in reference to dental examination as a gold standard in patients hospitalised in intensive care unit (icu)

chronic periodontitis (cp) is a common but under diagnosed chronic infection and inflammation of the periodontal tissue. porphyromonas gingivalis is one of the most common pathogens associated with cp. in patients hospitalised in intensive care unit (icu), p. gingivalis has been reported to be associated with ventilator-associated pneumonia (vap). this pilot study evaluate an easily accessible method the point of care p. gingivalis tests on saliva and detection of antibodies against p. gingivalis in sera (already validated to diagnose cp in the general population) to dental examination as a gold standard, in icu patients. a biobank from critically ill patients will be establish for future oral health research in this patient population: for about 50 patients with both samples available, at enrolment and at day 5 +/-2 days after enrolment. oral pathogens of different sites (tongue, saliva, dental plaque, internal jaw) at enrolment and at day 5 +/- 2 days after enrolment. samples of periodontal pocket will be collected only for patients diagnosed with cp. when patients will have a pulmonary sample performed in routine, pulmonary sample will also be stored. plasma and sera will also be taken at enrolment and stored for further research on p. gingivalis and inflammation in icu patients patients will be enrolled and will be contacted after 3 months.

Eligibility criteria:
inclusion criteria: * patient aged 18 years or older * admitted to medical or surgical intensive care unit * invasive mechanical ventilation for an anticipated duration of at least 48 hours exclusion criteria: * edentulous * known to be pregnant * icu stay\<48 hours * high risk of infectious endocarditis * patient under guardianship

Keywords: intensive care unit invasive mechanical ventilation chronic periodontitis point of care p. gingivalis test
a study of ak130 in patients with advanced malignant tumors

Conditions: Advanced Malignant Tumors

Summary: a phase i open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of ak130 (tigit/tgf-β bifunctional fusion protein) in patients with advanced malignant tumors.


Eligibility criteria:
inclusion criteria: 1. written and signed informed consent and any locally required authorization obtained from the subject/legal representative. 2. eastern cooperative oncology group (ecog) performance score of 0 or 1. 3. life expectancy ≥3 months. 4. histologically or cytologically documented unresectable advanced or metastatic malignant tumor that has failed or intolerant of standard therapy, or for which no effective standard therapy is available. 5. subject must have at least one measurable lesion according to recist version1.1. 6. adequate organ function. exclusion criteria: 1. any malignancy other than the disease under study within the past 3 years except for radically cured local cancers, such as basal cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of breast. 2. receipt of any anti-tigit, anti-tgf-β treatment. 3. experienced a toxicity that led to permanent discontinuation of prior immunotherapy. all aes while receiving prior immunotherapy have not completely resolved or resolved to grade 1 prior to screening, required the use of additional immunosuppression other than corticosteroids. 4. unresolved toxicities from prior anticancer therapy, defined as having not resolved to nci ctcae v5.0 grade 0 or 1，or to levels dictated in the inclusion/exclusion criteria, except toxicities not considered a safety risk (e.g., alopecia, neuropathy, or asymptomatic laboratory abnormalities). 5. major surgical procedure within 4 weeks prior to the first dose of ak130 or still recovering from prior surgery. 6. history of organ transplant. 7. known allergy or reaction to any component of the ak130 formulation. history of severe hypersensitivity reactions to other mabs.
explore: a natural history study of acute hepatic porphyria (ahp)

Conditions: Acute Hepatic Porphyria

Summary: the purpose of this study is to characterize the natural history and clinical management of acute hepatic porphyria (ahp) patients with recurring attacks.


Eligibility criteria:
inclusion criteria: * males and females aged \>/= 12 years * diagnosis of ahp \[acute intermittent porphyria (aip), variegate porphyria (vp), hereditary coproporphyria (hcp) and aminolevulinic acid dehydratase (alad) deficient porphyria (adp)\] * porphyria attacks in the past 12 months or receiving treatment to prevent attacks * willing to provide written informed consent, medical records, and to comply with study requirements exclusion criteria: • current participation in a clinical trial of an investigational product

Keywords: porphyria aip vp hcp variegate coproporphyria