Kornimate/medical-research-clean huggingface dataset:
cost study of linezolid versus vancomycin among previously hospitalized patients

Conditions: Complicated Skin and Structure Infection; Nosocomial Pneumonia

Summary: this is a retrospective, observational, non-interventional drug study using de-identified data from two administrative claims datasets. the study design and analysis will reflect the perspective of the commercially insured. the objectives of this study are twofold: 1. to compare the rates of re-hospitalization among patients treated with either linezolid orally or iv, or vancomycin iv for complicated skin and skin structure infections (csssi) or pneumonia hospitalization. 2. to compare the total direct medical costs of patients treated with linezolid orally or iv, or vancomycin iv for csssi or pneumonia hospitalization.

a sampling method is not used in this study since it is a retrospective, non-interventional claims database analysis. pre-specified inclusion/exclusion criteria and icd-9, ndc, hcpc codes are applied to identify the study cohorts.

Eligibility criteria:
inclusion criteria: subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: * patients with a hospitalization for csssi or pneumonia for which the discharge date (i.e. index date) is between january 1, 2007 and september 30, 2009. * patient must have a claim for either vancomycin (iv) or linezolid (iv or oral) within 7 days following their csssi or pneumonia hospitalization discharge date (i.e. index date). we will exclude patients who initially receive both vancomycin and linezolid on the same day. we will apply an intention-to-treat approach and use the first drug as the index drug, even if the "comparator drug" (e.g. vancomycin for linezolid and vice-versa) is used subsequently on a future date. if there are both oral and iv formulations of the same index drug on the same index date, the patient will be kept and categorized as an iv user. as with all duplicate claims, for two claims that have both oral and iv index drug as well as the same iv and oral costs on the same index date, the claim with the oral drug will be removed, and the patient will be called an iv user. * 18-64 years of age at index date. * continuous eligibility for six months prior to the index hospitalization date. no minimum of post-index continuous enrolment is required to assure that early mortality patients are included (maximum of 180 days after the index vancomycin or linezolid claim). exclusion criteria: subjects presenting with any of the following will not be included in the study: * patients who were enrolled in medicare. * patients who were over age 65 or younger than 18. * patients with fewer than 3 days of oral therapy. * patients with index hospitalization of greater than 30 days. * patients with osteomyelitis, infective endocarditis, meningitis, joint infections, necrotizing fasciitis, gangrene, prosthetic joint infection, or prosthetic implant/ device infection during index hospitalization.
clinical study of dtx301 aav-mediated gene transfer for ornithine transcarbamylase (otc) deficiency

Conditions: OTC Deficiency

Summary: the primary objective is to evaluate the efficacy of dtx301 on the improvement of ornithine transcarbamylase (otc) function by maintaining safe plasma ammonia levels.

this study is a phase 3, randomized, double-blind, placebo-controlled study of dtx301 in patients with late-onset otc deficiency 12 years of age and older. participants will be randomized 1:1 to dtx301 or placebo and followed closely for 36-64 weeks. between week 36 and week 64, eligible participants will cross over and receive dtx301 if they had previously received placebo, and some who received dtx301 may receive placebo. the planned study duration is up to 324 weeks. upon completion of this study or early withdrawal, all participants who received dtx301 are invited to enroll in the disease monitoring program (dmp) for follow-up for up to an additional 5 years.

Eligibility criteria:
key inclusion criteria: * confirmed clinical diagnosis of late-onset otc deficiency with historical documentation by enzymatic (ie, liver biopsy), biochemical (ie, hyperammonemia in the presence of elevated plasma glutamine, low citrulline, and elevated spot urine orotic acid), or molecular testing (ie, otc analysis) * free from symptomatic hyperammonemia and has not required emergent active intervention for hyperammonemia within 4 weeks before screening/baseline * if on ongoing daily ammonia scavenger therapy, must be at stable daily dose(s) for ≥ 4 weeks prior to screening * if on a protein-restricted diet, must be on a stable total daily protein intake that does not vary more than 20% for ≥ 4 weeks prior to screening * from the time written informed consent through visit 28, females of childbearing potential and fertile males must consent to use highly effective contraception. if female, agree not to become pregnant. if male, agree not father a child or donate sperm key exclusion criteria: * significant hepatic inflammation or cirrhosis * estimated glomerular filtration rate \< 60 ml/min/1.73 m2 at screening by the 2021 ckd-epi creatinine-based formula (inker et al., 2021) for patients ≥ 18 years of age or the schwartz bedside formula (schwartz and work, 2009) for patients \< 18 years of age * evidence of active hepatitis b virus (hbv) or hepatitis c virus (hcv) infection, documented by current use of antiviral therapy for hbv or hcv or by hepatitis b surface antigen (hbsag) or hcv rna positivity * active infection (viral or bacterial) * detectable pre-existing antibodies to the aav8 capsid * presence or history of any condition that, in the view of the investigator, would interfere with participation, pose undue risk, or would confound interpretation of results * participation (current or previous) in another gene transfer study note: additional inclusion/exclusion criteria may apply, per protocol
safety and tolerability of bl-1020 in hospitalized subjects with chronic schizophrenia or schizo-affective disorder

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: an open-label, multi-center, 6-week, sequential cohort study designed to determine the safety and tolerability of two dose ranges of bl-1020 in hospitalized subjects with chronic schizophrenia or schizo-affective disorder


Eligibility criteria:
inclusion criteria: * male or female * 18 to 65 years of age, inclusive * meet criteria for chronic (diagnosis established \> 1 year ago) schizophrenia with adequate psychotic symptoms as demonstrated by a panss total score \> 60 * current diagnosis of schizophrenia (disorganized type, 295.10; catatonic type, 295.20; paranoid type, 295.30; undifferentiated type, 295.90) or schizoaffective disorder (295.7) in accordance with dsm-iv * agree to be fully hospitalized until at least day 14 of the study * females must be of non-childbearing potential: surgically sterilized (i.e. tubal ligation), have had a hysterectomy prior to the screening phase, or be post-menopausal. females who have been post-menopausal for more than 12 months but less than 24 months must have a fsh \> 40 mu/ml. exclusion criteria: * pregnant or lactating women * administration of clozapine within 60 days prior to baseline * dsm-iv diagnosis of schizophreniform disorder (295.40) or schizophrenia residual sub-type (295.60), or other primary psychiatric diagnoses, such as bipolar disorder or major depressive disorder * severity of psychosis rated severe or higher (cgi-s 6 or 7) * known suicidal risk (modified isst score\>7) * requiring disallowed concomitant psychotropic medication following enrolment into the study * current evidence of clinically significant or unstable illness * clinically significant abnormal laboratory data (e.g. creatinine, ast or alt greater than 3 x the upper limit of normal, tsh\>10 iu) at screening, or any abnormal laboratory values that could interfere with the assessment of safety (e.g. blood cell count, etc.).

Keywords: chronic schizophrenia or schizo-affective disorder
quantitative 18f-av-133 pet imaging in subjects with diabetes and healthy controls

Conditions: Type 2 Diabetes

Summary: to evaluate 18f-av-133 imaging of the pancreas in patients with early type 2 diabetes, late type 2 diabetes, subjects with pre-diabetes and in healthy overweight/obese control subjects. these subjects will also be evaluated for beta-cell function as measured by the insulin and c-peptide response to a challenge with intravenous arginine under basal and glucose enhanced conditions.


Eligibility criteria:
inclusion criteria: * male and/or female subjects of non-childbearing potential between the ages of 30 and 65 years inclusive. * able to tolerate pet, pet/ct and mr imaging * estimated creatinine clearance \>= 60ml/min * informed consent documents signed and dated by subject * subjects must be willing and able to comply with all scheduled visits, treatments laboratory tests, scans and other study procedures. * in addition, subjects must meet classification requirements for one of the following 1. healthy overweight 2. pre-diabetes 3. t2dm * (t2dm only) subjects with other chronic medical conditions (besides diabetes) that are well controlled and stable on medication are acceptable for inclusion in this study. exclusion criteria: * subjects who are affiliated with or relatives of staff members of either the site or pfizer directly involved in the conduct of the trial. * conditions which in the opinion of the study investigator may interfere with the subject's ability to participate in the study * history of allergic reaction to drug/contrast agent or history of drug/alcohol abuse * subjects who have received investigational medications within the last 30 days or a radiopharmaceutical in the past 7 days. * pregnant or nursing females; females of childbearing potential.
phase i study to evaluate basic pharmacodynamic, pharmacological and toxicological effects of the newly developed crimean-congo hemorrhagic fever vaccine for humans

Conditions: Crimean-Congo Hemorrhagic Fever

Summary: this study covers the first trial of the crimean-congo hemorrhagic fever virus (ckka) vaccine on humans (healthy volunteers), which has been developed in turkey and has completed preclinical toxicology studies to be performed on experimental animals. also, this study is a phase i, randomized, double-blind, national, single-center, placebo-controlled study that is designed to evaluate the safety and efficacy of the ckka vaccine. a total of 60 (12 + 48) healthy male and/or female volunteers will be participating in this study, and the study is planned to last approximately one year.


Eligibility criteria:
inclusion criteria: * healthy, white in the 18-55 age range, men and/or women who agree not to become pregnant until 2 months after the start of the last vaccination * body weights are at limits to exclude anorexia or obesity (the bmi limits accepted for this study are 18.5-30 kg /m2) * according to clinical and standard laboratory tests, physical and spiritually healthy volunteers. exclusion criteria: * the 20 days before the study any vaccination applied volunteers * persons with clinically significant liver, kidney, gastrointestinal, cardiovascular, psychiatric, pulmonary, hematologic, endocrinological, or other significant acute or chronic abnormalities in the medical history of the volunteer or in the examination. * volunteers who have previously had any pulmonary infection or have previously used immunosuppressive drugs (including corticosteroids) for any reason

Keywords: crimean-congo hemorrhagic fever vaccine human phase i
advanced imaging for pulmonary fibrosis

Conditions: Pulmonary Fibrosis

Summary: the purpose of this study is to determine if measurements of active collagen deposition using \[68ga\]cbp8 positron emission tomography (pet) and tissue injury using dynamic contrast-enhanced magnetic resonance imaging (dce-mri) can predict an individual patient's pace of disease progression in non-idiopathic pulmonary fibrosis interstitial lung disease (non-ipf ild) and identify which individuals will develop progressive pulmonary fibrosis.

60 participants with non-idiopathic pulmonary fibrosis interstitial lung disease (non-ipf ild) on stable dose immunosuppression treatment will be enrolled. participants will undergo combined \[68ga\]cbp8 positron emission tomography (pet) and dynamic contrast-enhanced magnetic resonance imaging (dce-mri) at baseline. the investigators will compare the ability of pet and mri measurements performed over the whole lung and within regions of interest to identify participants who subsequently develop progressive pulmonary fibrosis as determined by changes in pulmonary function testing, quantitative fibrosis on high-resolution computed tomography, and respiratory symptoms over 24 months. the investigators will also test whether combining the pet and mri measurements results in more accurate prediction of progression than either modality alone.

Eligibility criteria:
inclusion criteria: 1. age 18-80 with a diagnosis of chronic hypersensitivity pneumonitis, connective tissue-associated ild (due to rheumatoid arthritis, systemic sclerosis, mixed connective tissue disease), or undifferentiated ild. 2. on stable dose immunosuppression treatment (with prednisone, mycophenolate mofetil, and/or rituximab) for at least 3 months. 3. pulmonary fibrosis, defined as honeycombing, traction bronchiectasis, or reticular opacities on hrct performed within 1 year to or at visit 1. 4. fvc of \>/= 45% and dlco \>/= 25% predicted on pfts performed at visit 1. exclusion criteria: 1. current or prior exposure to fda approved anti-fibrotic therapy. 2. extent of emphysema greater than extent of fibrosis. 3. pregnancy or plans to become pregnant at baseline or during follow-up. 4. contraindications to mri. 5. contraindications to receiving gadolinium-based contrast agents. 6. research-related radiation exposure exceeds 50 msv in the prior year. 7. estimated glomerular filtration rate (egfr) \< 30 ml/min (only for individuals with a history of chronic kidney disease). 8. clinically significant ph defined by use of pulmonary vasodilatory therapy. 9. respiratory infection within the prior 6 weeks. 10. smoking of any kind within the prior 6 months.
a phase i clinical study of hrs-7058 in patients with advanced malignant tumour

Conditions: Advanced Malignant Tumour

Summary: this study is a multicentre, open phase i clinical study of dose escalation, dose extension and efficacy extension of hrs-7058 in subjects with advanced malignant tumour. to evaluate the safety, tolerability, pharmacokinetics and efficacy of hrs-7058.


Eligibility criteria:
inclusion criteria: 1. the subjects gave informed consent to the study before participating in, and voluntarily signed informed consent; 2. 18 to 75 years old (including both ends), gender is not limited; 3. subjects with locally advanced or metastatic solid tumour confirmed by histopathology; 4. having at least one evaluable or measurable lesion according to the solid tumour response evaluation criteria (recist 1.1); 5. ecog performance status of 0 or 1; 6. the expected survival time is more than 3 months; 7. be able to ingest drugs and be able to comply with trial and follow-up procedures; 8. adequate bone marrow and organ function; 9. fertile women must agree to abstain from sex (abstaining from heterosexual intercourse) or use a highly effective method of contraception for at least one week from the time they sign an informed consent form until the last dose of the study drug. the blood hcg test must be negative within 7 days before the start of the study treatment, and must be non-lactating; 10. for male patients whose partner is a woman of reproductive age, they must agree to abstain from sex for at least one week from signing the informed consent until the last dose of the study drug, or to use a highly effective method of contraception. exclusion criteria: 1. accompanied by untreated or active central nervous system (cns) tumour metastasis; 2. had other malignancies within five years prior to first use of the investigational drug; 3. with severe cardiovascular and cerebrovascular disease； 4. refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications; 5. the presence of uncontrolled pleural, abdominal or pericardial effusion; 6. severe infection within 4 weeks prior to initiation of study treatment; 7. history of immune deficiency; 8. the adverse reactions of previous anti-tumour therapy have not recovered to ctcae ≤ grade 1; 9. antitumor therapy such as chemotherapy, biotherapy, targeted therapy, immunotherapy, or other unmarketed investigational drug therapy within 4 weeks prior to initial use of the investigational drug; 10. had undergone major organ surgery within 4 weeks prior to the first use of the study drug; 11. women who are pregnant, breastfeeding, or who plan to become pregnant within one week of their last use of the study drug during the study period; 12. known allergies and contraindications to the investigational drug or any of its components; 13. in the investigator's judgment, the subjects had other factors that could have affected the study results or led to the forced termination of the study.
morbidity in open versus minimally invasive esophagectomy

Conditions: Esophageal Cancer

Summary: the miomie trial is a prospective randomized controlled study comparing open and laparoscopic gastric tube formation in ivor lewis esophagectomy. aim of this trial was to compare the minimally invasive approach with the standard open procedure regarding morbidity and mortality.

esophageal resection is still associated with considerable morbidity and mortality. standardized preoperative efforts could increase the outcome of these patients. while early reports of medical pioneers focused particularly on safety and feasibility, more recent studies showed that implementation of minimally invasive esophagectomy (mie) was widely accepted. since first reports of mie, different techniques and adjustments have been discussed. a recent publication of a large prospective trial in phase ii showed the safety of a total minimally invasive approach (video assisted thoracoscopic surgery (vats) and laparoscopy). surgical technique however is still a subject of debate and the level of evidence remains still low. proving feasibility does not warrant a paradigm shift, as experience is an important factor for safety and patient benefit. the aim of this study was to evaluate morbidity and mortality of open esophagectomy (oe) versus hybrid-mie in a randomized controlled setting. prior to surgery patients will be randomized either the minimally invasive surgery group (laparoscopic gastric tube formation and thoracotomy) or the the open surgery group (open gastric tube formation with an open laparotomy approach). randomizing tool is the "randomizer" of the medical university of vienna. (link is attached below)

Eligibility criteria:
inclusion criteria: * adenocarcinoma of the esophagus and the esophagogastric junction in (siewert) type i and ii position * esophageal squamous cell cancer * patients, who require esophageal resection due to above mentioned diagnosis * patients, who gave their informed consent exclusion criteria: * individuals who did not meet the inclusion criteria were excluded from the study. * patients with tumor localization in the upper third of the esophagus and requiring cervical resection were excluded. * patients, presenting other than ac or escc or showed contraindication for laparoscopy (history of large abdominal surgery or signs of hostile abdomen) * patients with a history or presence of any other malignancy, except carcinoma in situ or basalioma

Keywords: minimal-invasive esophagectomy esophageal resection hybrid esophagectomy
a phase 1, open-label study of the absorption, metabolism, excretion and absolute bioavailability of als-008176

Conditions: Respiratory Syncytial Virus Infections

Summary: the purpose of this study is to see how als-008176 is taken up, broken down, and removed from the body.


Eligibility criteria:
inclusion criteria: * body mass index 18.0 to 32.0 kg/m2 (inclusive) and a total body weight \>50 kg exclusion criteria: * creatinine clearance as calculated by the cockroft-gault formula of less than 60 ml/min * clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator or the sponsor medical monitor. reticulocyte count, haemoglobin and platelet counts must not be less than the lower limit of normal for the subject. * history of clinically significant cardiovascular, renal, hepatic, chronic respiratory, gi, haematological, neurological, endocrinological, immunological, musculoskeletal disease or any uncontrolled medical illness (eg active infection) or psychiatric disorder, as judged by the investigator or medical monitor. * clinically significant abnormal electrocardiogram (ecg) findings
community engaged colon cancer screening patient navigator program

Conditions: ColoRectal Cancer

Summary: the goal of the project is to increase colorectal cancer screening within the priority population of female and male adults age 50 to 85 in northern nevada. a successful community-based cancer patient navigator program will be modified in partnership with the community into a multi-level screening intervention.

the goal of the project is to increase colorectal cancer screening within the priority population of female and male adults age 50 to 85 in northern nevada. a successful community-based cancer patient navigator program will be modified in partnership with the community into a multi-level screening intervention. a well-tested behavioral change theory (the health belief model; hbm) will guide the intervention and the relative efficacy of a) the theory's constructs and b) evidence-based intervention practices on increasing screening rates will be examined. although increased screening rates are associated with program navigators, it is unclear which program components are related to the outcome. in addition, there is ambiguity surrounding a) the temporal impact of the hbm on cancer screening and b) the relationships among the model's constructs. a quasi-experimental time-series design will be used to evaluate the outcome objective of increased screening rates by comparing screening rates one year pre- and post-intervention and whether navigated patients are better prepared for screening than non-navigated patients. a minimum of 315 participants (to correspond with a power level of .80) in the navigator program will be surveyed on knowledge about colorectal cancer, and satisfaction with and usefulness of the program. the anticipated contribution of the project will be to increase community efficacy, colorectal cancer screening in the project area, and to reduce cancer morbidity and mortality.

Eligibility criteria:
inclusion criteria: * insurance, no history of colon cancer, exclusion criteria: * no experience of relevant gi symptoms

Keywords: community engagement, navigation, cancer screening