Kornimate/medical-research-clean huggingface dataset:
predicting ventilator-associated lower respiratory tract infection outcomes using sequenced-based early microbiological response

Conditions: Pneumonia, Ventilator-Associated; Respiratory Tract Infections; Prognosis

Summary: we are using a tool called qtngs (quantitative targeted amplicon-based next-generation sequencing ) to measure the abundance of local pathogens in patients with ventilator-associated lower respiratory tract infections. we hypothesize that changes in pathogen abundance before and after treatment are related to patient outcomes. this study aims to evaluate the effectiveness of the tool by analyzing the changes in pathogen abundance and exploring the relationship between these changes and clinical outcomes.


Eligibility criteria:
inclusion criteria: * aged 18 years and above. * previously relied on mechanical ventilation (endotracheal intubation or tracheotomy) for breathing assistance, and the duration of mechanical ventilation was more than 48h. * lower respiratory tract infection based on at least two of the followings: abnormal temperature (body temperature greater than 38.5°c or less than 36.5°c), leucocyte count abnormality (leucocyte count greater than 12\*10\^9/l or less than 4\*10\^9/l), and the presence of purulent tracheal secretions. exclusion criteria: * bronchoscopy and respiratory specimen collection were not performed at screening (day 1) and after 3 days of treatment (day 4). * refusal of patients or families to participate in the study * after initial screening, bronchoscopy was performed to obtain balf for bacterial culture. the results of the culture showed no evidence of infection by study-associated lower respiratory pathogens. note: the evidence of infection was defined as a single positive bacterial culture (pathogen quantification ≥10\^4 cfu/ml or "++" and more) on day1. and the study-associated causative pathogens are pseudomonas aeruginosa, acinetobacter baumannii, klebsiella pneumoniae, and staphylococcus aureus. additionally, the included patient must have single infection with one of these pathogens.
a feasibility and safety study of cd38 car-t cell immunotherapy for relapsed b-cell acute lymphoblastic leukemia after cd19 car-t adoptive cellular immunotherapy

Conditions: Relapsed B-cell Acute Lymphoblastic Leukemia After CD19 CAR-T ACI

Summary: cd19-directed car-t cell therapy has shown promising results for the treatment of relapsed or refractory b-cell malignancies; however, a subset of patients relapse due to the loss of cd19 in tumor cells. cd38 car-t cells can recognize and kill the cd19 negative malignant cells through recognition of cd38. this is a phase 1/2 study designed to determine the safety of the gene-edited specificity cd38 car-t cells and the feasibility of making enough to treat patients with relapsed b-cell acute lymphoblastic leukemia after cd19 car-t adoptive cellular immunotherapy.

1. primary objectives: 1. to evaluate the feasibility and safety of specificity cd38 car-t cells in patients with relapsed or refractory leukemia and lymphoma. 2. to evaluate the duration of in vivo persistence of adoptively transferred t cells, and the phenotype of persisting t cells. real time polymerase chain receptor (rt-pcr) and flow cytometry(fcm) analysis of pb,bm and lymph node will be used to detect and quantify survival of cd38 car-t cells over time. 2. secondary objectives: 1. for patients with detectable disease, measure anti-tumor response due to specificity cd38 car-t cell infusions. 2. the car-t cells will be administered by i.v. injection over 20-30 minutes as a using day 0: 1-5x10e6/kg total dose on day 0.

Eligibility criteria:
inclusion criteria: 1. male or female participant 2. 12 years to 70 years (child, adult, senior) 3. patient with relapsed cd38+ b-cell acute lymphoblastic leukemia after cd19 car-t adoptive cellular immunotherapy 4. estimated life expectancy ≥ 12 weeks (according to investigator's judgement) 5. eastern cooperative oncology group (ecog) performance status ≤ 1 6. adequate organ function exclusion criteria: 1. prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease 2. diagnosis of burkitt's leukemia/lymphoma according to who classification or chronic myelogenous leukemia lymphoid blast crisis 3. richter's syndrome 4. presence of grade ii-iv (glucksberg) or b-d (ibmtr) acute or extensive chronic gvhd at the time of screening 5. subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy 6. severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis is allowed), prophylactic antibiotic, antiviral and antifungal treatment is permissible 7. active hepatitis b, active hepatitis c, or any human immunodeficiency virus (hiv) infection at the time of screening 8. patient has an investigational medicinal product within the last 30 days prior to screening 9. previous treatment with investigational gene or cell therapy medicine products 10. concurrent use of systemic steroids. recent or current use of inhaled steroids is not exclusionary 11. pregnant or nursing women
dentin hypersensitivity following non-surgical periodontal therapy with hand or ultrasonic instruments

Conditions: Periodontal Disease; Dentin Sensitivity

Summary: periodontal instrumentation aims to remove plaque and calculus from the root surface. both manual and ultrasonic instruments have been used for such decontamination; however, establishing a healthy periodontium can result in adverse effects, such as dentin hypersensitivity. the aim of this study was to evaluate the effects of hand or ultrasonic instrumentation on dentin hypersensitivity in patients undergoing non-surgical periodontal treatment. for this controlled clinical trial of a "split mouth" design, 14 patients were selected with homologous teeth in the incisor to premolar region and probing depth ≥ 5 mm on the buccal aspect of the teeth. one side (control) was instrumented with hand instruments and the other side (test) with ultrasonic instruments. dentin hypersensitivity was assessed in the baseline and during the follow 4 weeks after treatment, with a periodontal probe scratching the root surface and with an air jet. the patient's response was detected by a visual analog scale (vas) of 10 cm.


Eligibility criteria:
inclusion criteria: * patients diagnosed with chronic or aggressive periodontitis, according to the american academy of periodontology classification15, requiring non-surgical periodontal treatment in at least two quadrants. these quadrants should present two contralateral and homologous teeth in the incisor to premolar region with probing depth ≥ 5 mm and bleeding on probing on the buccal surface. exclusion criteria: * presence of systemic illness or medication use (six months preceding the research), which could influence the response to periodontal treatment, * performance of periodontal treatment including subgingival instrumentation in the six months preceding the study, * performance of treatment for dentin hypersensitivity in the three months previous to the study, * presence of periapical or pulpal changes, * being under orthodontic treatment, * smoking and * pregnancy.

Keywords: dentin sensitivity dental scaling ultrasonic manual and ultrasonic instrumentation
a study of the effects of ziprasidone for the treatment of schizophrenia or schizoaffective disorder in patients who were switched from other antipsychotic drugs

Conditions: Schizoaffective Disorder; Schizophrenia

Summary: the purpose of this study is to see if differences exist in outcome in patients with schizophrenia or schizoaffective disorder who were switched from other antipsychotics to ziprasidone.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or schizoaffective disorder * outpatients for at least 3 months on treatment with sulpiride, olanzapine, quetiapine, or risperidone and at least a partial beneficial response to typical antipsychotic treatment including for the current episode * partial improvement in symptoms that justified a switch to ziprasidone exclusion criteria: * diagnosis of major depression or occurrence of moderate depressive symptoms * resistance to conventional antipsychotic drugs * treatment with other drugs such as antiseizure medications, antipsychotics, antidepressants, or mood stabilizing agents that might interfere with the assessement of the efficacy of ziprasidone
adapalene-bpo gel associated with doxycycline hyclate 100 mg in the treatment of severe acne vulgaris

Conditions: Severe Acne Vulgaris

Summary: the purpose of this study is to demonstrate the efficacy of adapalene 0.1% / benzoyl peroxide (quoted as bpo) 2.5% gel associated with doxycycline hyclate 100 mg tablets compared to adapalene 0.1% /benzoyl peroxide 2.5% vehicle gel associated with doxycycline hyclate 100 mg tablets, in the treatment of severe acne vulgaris. the safety of the two treatment regimens will also be evaluated.

further to this study, eligible subjects with at least good global assessment of improvement at week 12 will be randomized in a maintenance study (spr.29075)

Eligibility criteria:
inclusion criteria: * male or female subjects of any race, aged 12 to 35 years inclusive * subjects with severe facial acne (global severity score of 4) * subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, excluding the nose * subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose exclusion criteria: * subjects with more than 3 nodules or cysts on the face, * subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)

Keywords: acne
combination of active or placebo attentional bias modification treatment (abmt) to either cognitive behavioral group therapy (cbgt) or psychoeducational control intervention (pci) for anxiety disorders in children

Conditions: Generalized Anxiety Disorder; Separation Anxiety Disorder; Social Anxiety Disorder

Summary: the objective of this project is to test the combination of active or placebo attentional bias modification treatment (abmt) to either cognitive behavioral group therapy (cbgt) or psychoeducational control intervention (pci) for anxiety disorders in children.


Eligibility criteria:
inclusion criteria: * primary diagnosis of generalized anxiety disorder (gad), separation anxiety disorder (sead) or social anxiety disorder (soad) according to ksads-pl psychiatric interview exclusion criteria: * other psychiatric disorder that causes more impairment and suffering than gad, sead or soad in the clinical evaluation * current or previous treatment (behavioral or pharmacological) for a psychaitric disorder in childhood * iq \< 70 (raven)

Keywords: generalized anxiety disorder (gad) separation anxiety disorder (sead) social anxiety disorder (soad)
molecular characteristics of hepatitis b virus integration, mutation, and drug resistance

Conditions: Chronic Hepatitis B

Summary: patients with a confirmed diagnosis of chronic hepatitis b (chb) who have complete clinical data and retained blood or liver tissue samples will be enrolled. all patients will be grouped based on cohort sources: the antiviral treatment cohort and the cross-sectional epidemiological survey cohort. patients in the antiviral treatment cohort have received antiviral treatment and are followed every six months. during follow-up, hbv-related endpoint events, including cirrhosis decompensations (such as ascites, esophageal variceal bleeding, and hepatic encephalopathy), hepatocellular carcinoma (hcc), liver transplantation, and liver-related death, will be collected. in the cross-sectional epidemiological survey cohort, clinical data will be collected at a single time point, with some patients not receiving antiviral treatment. in both cohorts, retained blood and liver tissue samples will be used to further analyze hbv genotypes, viral integration, drug resistance, and the molecular characteristics of mutations. finally, a detailed description will be provided regarding the correlation between these hbv genetic molecular features and demographic distribution, clinical phases, and various clinical outcome events.

to identify hbv genotypes, viral integration, drug resistance, and molecular characteristics of mutations associated with clinical immune phases and different clinical outcome events based on a representative hepatitis b clinical cohort.

Eligibility criteria:
inclusion criteria: * patients with hepatitis b surface antigen positive. * patients who have complete demographic information, clinical data and retained blood samples or liver tissue samples exclusion criteria: * subject who without blood samples or liver tissue samples

Keywords: hbv hbv mutation hbv integration hbv resistance
br55 in characterization of ovarian lesions

Conditions: Ovarian Cancer

Summary: this is an exploratory phase ii, single center, open label, prospective study of br55 ceus for characterization of ovarian lesions in subjects with suspected ovarian cancer.

a total of sixty (60) subjects scheduled to undergo salpingo-oophorectomy within 30 days of br55 ceus examination will be enrolled to obtain approximately 30 subjects with benign ovarian lesions and 30 with malignant ovarian lesions based on the truth standard (ts). the first 10 subjects will receive br55 at a dose of 0.03 ml/kg. assuming these first 10 subjects will show technically adequate images, subsequent subjects enrolled in the study will continue to receive 0.03 ml/kg dose of br55; otherwise, subjects will be switched to a 0.05 ml/kg dose of br55. the final cancer diagnosis will be obtained for all subjects by histopathology.

Eligibility criteria:
inclusion criteria: enroll a subject if he/she meets the following inclusion criteria: * is at least 18 years of age; * has an ovarian lesion that is visible and assessable with trans-vaginal ultrasound; * is scheduled to undergo salpingo-oophorectomy for suspected ovarian cancer not earlier than 24 hours and not later than 30 days following br55 administration; * provides written informed consent and is willing to comply with protocol requirements. exclusion criteria: exclude a subject if the subject does not fulfill the inclusion criteria, or if any of the following conditions are observed: * is a pregnant or lactating female. exclude the possibility of pregnancy: * by testing on site at the institution (serum βhcg) within 24 hours prior to the start of investigational product administration, * by surgical history (e.g., tubal ligation or hysterectomy), * by post-menopausal status with a minimum 1 year without menses; * has undergone prior systemic therapy for ovarian cancer; * has history of concurrent malignancy; * has history of any clinically unstable cardiac condition including class iii/iv congestive heart failure; * has had any severe cardiac rhythm disorders within 7 days prior to enrolment; * has severe pulmonary hypertension (pulmonary artery pressure \>90mmhg) or uncontrolled systemic hypertension and/or respiratory distress syndrome; * has open and/or non-healing wounds in the chest, abdomen and pelvis; * has other systemic vascular abnormalities associated with neovascularization, such as macular degeneration, that in the opinion of the investigator could significantly affect the ability to evaluate the effects of br55; * is participating in a clinical trial or has participated in another trial with an investigational compound within the past 30 days prior to enrolment; * has previously been enrolled in and completed this study; * has any known allergy to one or more of the ingredients of the investigational product or to any other contrast media; * is determined by the investigator that the subject is clinically unsuitable for the study; * has had major surgery, including laparoscopic surgery, within 3 months prior to enrolment; * has history of surgery to the ovaries or pelvic inflammatory disease.
nudging guideline-concordant antibiotic prescribing using public commitments

Conditions: Acute Respiratory Infections (ARIs)

Summary: inappropriate antibiotic prescribing for acute respiratory infections (aris) persists despite decades of intervention efforts. negative outcomes of inappropriate antibiotics include increased costs of care, adverse drug reactions, and rising prevalence of antibiotic-resistant bacteria. to address this public health problem, we apply the principles of commitment and consistency in an effort to influence clinician decision-making through the implementation of a low-cost behavioral "nudge" in the form of a simple public commitment device. clinicians were asked to post in their exam room a signed letter indicating their commitments to reducing inappropriate antibiotic use for aris. our hypothesis is that clinicians displaying the poster-sized commitment letters will decrease their inappropriate antibiotic prescribing for aris as compared to clinicians in the control condition (with no posted letter).


Eligibility criteria:
inclusion criteria: * medical professionals licensed to provide care and prescribe medications (including antibiotics) * treating adult patients (18 years of age and older) from 5 los angeles community clinics exclusion criteria: * none

Keywords: aris, antibiotics, public commitment, quality improvement
pattern - reach aim 2

Conditions: Obesity

Summary: the purpose of this research study is to learn about different approaches to promoting healthy growth among infants, and understanding parents' likes and dislikes of an approach to reducing risk factors for obesity later in life. the study includes filling out some forms with questions about your baby and your thoughts about your baby's growth and health, and engaging in a pattern of changes in or prevention of risk factors in the first year of life. parents will receive information about changes and some tools and materials to take home with them. some parents may receive phone calls between visits as well. the study takes place from soon after birth through the infant's age of 9 months. the estimated total time of interaction between the study staff and parents during the study period is 4 hours.

as this is a dyad study, each dyad is considered to be a participant and demographic information will reflect the infant in the dyad, per parent report.

Eligibility criteria:
inclusion criteria: * non-hispanic black (as documented in maestrocare) parents/caregivers with; infants ages 2 weeks to 2 months of age; infant birthweight between 2500g and 4000g; infant gestational age is at least 36 weeks exclusion criteria: * non-english-speaking; infant with serious disease or disorder affecting growth and nutrition

Keywords: infant mother-baby
multicentre sms study - fr

Conditions: Dysplasia of Hip Joint; Hip Osteoarthritis; Traumatic Arthritis of Hip; Avascular Necrosis of Femur Head

Summary: prospective, multicentre, non controled, non randomised, clinical study to assess the performance and the stability of sms femoral stem


Eligibility criteria:
inclusion criteria: * patient suffering from a severely painful and/or disabling hip joint due to osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, or avascular necrosis of the femoral head, and requiring a total hip replacement. * patient who will receive a medacta sms femoral stem. * patient agrees to comply with the study requirements. * patient has signed the consent form. * patient is affiliated with a social security system. * patient aged 18 to 75 years exclusion criteria: * participation in biomedical research. * minor patient. * protected adult patient. * vulnerable individuals as defined by article l1121-6 of the public health code. * pregnant or breastfeeding women. * patient unable to express their non-opposition. * patient refusing the collection of their personal data. * acute, systemic, or chronic infection. skeletal immaturity. * grossly deformed anatomy (at the surgeon's discretion). * osteomalacia for which the fixation of an uncemented implant is contraindicated. * patient suffering from active rheumatoid arthritis or osteoporosis. * patient with metabolic disorders likely to impair bone formation when the fixation of an uncemented implant is contraindicated. * patient suffering from muscle atrophy or neuromuscular disease. * patient with an allergy to the implant material. * any patient who cannot or does not wish to give their informed consent to participate in the study. * patient whose prospects of regaining independent mobility would be compromised by known coexisting medical problems. * any contraindication mentioned in the instructions for use of the investigational medical device.
this study tests how bi 655130 works in patients with active ulcerative colitis. the study also tests how well bi 655130 is tolerated and whether it helps the patients

Conditions: Colitis, Ulcerative

Summary: the primary objective of this trial is to understand the mechanism of action of bi655130 in patients with uc secondary objectives are to explore clinical effect, safety and tolerability (including immunogenicity) of bi 655130 treatment


Eligibility criteria:
inclusion criteria: * 18 - 75 years at screening * diagnosis of uc \>= 3 months prior to screening. * moderately to severely active uc as confirmed by mayo score ≥6 * receiving conventional, non-biologic therapy for uc. * negative colon cancer screening * further inclusion criteria apply exclusion criteria: * prior use of any biological treatment in the past (e.g.integrin inhibitors, il12/23 or il23 inhibitors, any investigational biological drugs) * extensive colonic resection * evidence of infection with c. difficile or other intestinal pathogen \< 30 days prior to screening * active or latent tuberculosis * further exclusion criteria apply