Kornimate/medical-research-clean huggingface dataset:
study evaluating multiple doses of gsi-953 within the elderly population

Conditions: Healthy

Summary: to assess the safety and tolerability of ascending, multiple, oral doses of gsi-953 in healthy elderly subjects.


Eligibility criteria:
inclusion criteria: * men or women, greater than or equal to 65 years of age. * women of nonchildbearing potential (woncp) may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for greater than or equal to 1 year (with fsh greater than or equal to 38 miu/ml) and must have a negative pregnancy test result within 48 hours before administration of test article. women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound. * body mass index (bmi) in the range of 18.0 to 30.0 kg/m2 and body weight \>50 kg. exclusion criteria: n/a

Keywords: alzheimer disease
effect of thickened feeds on clinical outcomes in children with brief resolved unexplained event

Conditions: Brief Resolved Unexplained Event; Apparent Life Threatening Event; Oropharyngeal Dysphagia

Summary: this observational study will examine the effects of thickened feeds on clinical outcomes and healthcare utilization in infants with brief resolved unexplained event (brue).

brief resolved unexplained events (brue) are frightening episodes characterized by the appearance of life-threatening choking, pallor, cyanosis, and limpness in infants. these common events are resource-intensive and current management approaches inadequately address persistent symptoms. infants with brue commonly have oropharyngeal dysphagia with aspiration, which is a modifiable risk factor for persistent symptoms, but there are no studies determining the mechanism behind this swallowing dysfunction and if swallowing interventions reduce morbidity. this is a prospective, longitudinal cohort study of infants who experienced brief resolved unexplained event receiving thickened feedings compared to those not receiving thickened feedings over 1 year.

Eligibility criteria:
inclusion criteria: * less than 1 year of age * admitted to boston children's hospital after experiencing first lifetime brief resolved unexplained event. exclusion criteria: * any pre-existing medical diagnoses that exclude brief resolved unexplained event diagnosis including seizure disorders and cyanotic congenital heart disease * already receiving thickened liquids for treatment of another condition
effect of gip after a meal in patients with type 2 diabetes

Conditions: Type2 Diabetes

Summary: the aim of this study is to investigate the effects of antagonising gip after a meal on plasma levels of glucagon. 10 participants are going through four experimental days each, where they ingest a meal and afterwards receive infusions of either gip receptor antagonist, glp-1, gip receptor antagonist + glp-1 or placebo (saline) in a randomised order. the primary endpoint of the study is plasma levels of glucagon, which we hypothesize will decrease with infusion of gip receptor antagonist and/or with infusion of glp-1.


Eligibility criteria:
inclusion criteria: * caucasians between 18-75 years with diet og metformin treated type 2-diabetes * hba1c \< 75 mmol/mol * bmi \> 27 kg/m2 * stable weight (+/- 5%) during the last 3 months exclusion criteria: * treatment with medicine or dietary supplements that cannot the paused for 12 hours * more than 14 units of alcohol weekly or abuse of drugs * liver disease, estimated at plasma alat levels \> 3 x normal value or inr outside normal range * reduced kidney function (estimated at egfr \< 60 ml/min/1,73 m2) * severe arteriosclerotic heart disease or heart failure (nyha iii or iv) * low red blood cell count (hemoglobin \< 8.3 mmol/l * special diet or planned weight change during the trial period * any disease/condition, which the clinical investigators assess will disturb the participation in the clinical trial
cash benefits and reproductive/perinatal health

Conditions: Maternal Care Patterns; Pregnancy Related; Miscarriage

Summary: during the first two years of the covid-19 pandemic, the city of chelsea, massachusetts held a lottery to allocate cash benefits to its residents for ten months. using data from the chelsea eats program, the investigators propose to study the impact of the cash benefit on reproductive and perinatal health.


Eligibility criteria:
inclusion criteria: * resident of chelsea, massachusetts * household income at or below 30% of the u.s. department of housing and urban development's area median income * childbearing age exclusion criteria: * see inclusion criteria
the use of an anterior chamber maintainer as a sole fluid source in micro incision cataract surgery as compared to a standard phacoemulsification procedure

Conditions: Cataract

Summary: the purpose of this study is to compare the use of an anterior chamber maintainer (acm) as the sole fluid source in phacoemulsification micro incision cataract surgery (using 1.1mm corneal incision) as opposed to conventional coaxial phacoemulsification (using 2.4mm corneal incision).

three-port micro incision cataract surgery (tri-mics) is a technique suggested by professor assia. the idea (principle) behind the tri-mics technique is the use of a sleeveless phaco needle which is introduced via a tiny incision (1.1mm). an additional corneal incision is made for the introduction of a second surgical instrument, and a third for an acm as an exclusive source for the infusion - this saves the need for an additional instrument. the acm that will be used in this study (avi new york) is a small metal tube with an external diameter of 1.1 mm, and an internal diameter of 0.9 mm and was developed specifically for this use. this type of acm has been used in hundreds of surgeries and has been found to be both effective and safe. this procedure has 4 clear advantages: 1. the implementation of three corneal incisions, 1.1 mm wide with an angle of approximately 120 degrees between them - neutrality regarding astigmatism versus the biaxial-mics. 2. this procedure does not require any special medical instruments, for example; new phaco instruments which are specifically adapted for the mics approach at the cost of tens of thousands of dollars. 3. this procedure allows a free use of the surgeon's second hand. 4. a fixed intraocular infusion keeps the intraocular pressure (iop) and anterior chamber volume constant and stable.

Eligibility criteria:
inclusion criteria: * bilateral cataract * ability to understand and sign on an inform consent form. * whiling to undergo bilateral cataract surgery. exclusion criteria: * mature cataract * pxf * uveitis * corneal pathology * endothelial cell density\<1500 cells/mm * glaucoma * extreme hyperopia / shallow anterior chamber * extreme myopia * s/p ophthalmic trauma / surgery * allergy to penicillin / iod

Keywords: cataract tri-mics acm mics phacoemulsification
early systemic central nervous system prophylaxis in diffuse large b-cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma

Summary: phase 2 single-institution trial of early systemic central nervous system prophylaxis in high-risk diffuse large b-cell lymphoma

this is a prospective phase 2 clinical trial of systemic central nervous system prophylaxis among patients with diffuse large b-cell lymphoma at high risk of central nervous system recurrence. the main objective is to evaluate safety and efficacy of early institution of intensive central nervous system prophylaxis in a high-risk group to minimize the risk of a devastating central nervous system recurrence. patients receive standard primary immunochemotherapy with an addition of planned central nervous system prophylaxis courses on or around day 15 of cycles 2, 4, and 6. growth factor support and pneumocystis jirovecii prophylaxis is required. the primary endpoint of this pilot study is protocol-defined toxicity, whereas efficacy (cumulative incidence of central nervous system recurrence) will be a secondary endpoint.

Eligibility criteria:
inclusion criteria: * new diagnosis of diffuse large b-cell lymphoma, planned first-line therapy using the standard rituximab- and anthracycline-containing regimens * no central nervous system involvement on initial staging * performance status of 0 or 1 (eastern cooperative oncology group scale) * renal function: creatinine clearance \>45 ml/min * not pregnant; agreeable to contraception * written informed consent * high risk for central nervous system recurrence as determined by one of the following high-risk features: 1. high central nervous system international prognostic index, 2. testicular, breast, or uterine involvement, 3. dual expresser or double/triple-hit status, 4. hiv positive status, or 5. molecularly defined high-risk subtype. exclusion criteria: * pregancy * unable to provide informed consent * significant comorbidity in the investigator's judgement
a study to characterize the pharmacokinetics, pharmacodynamics, and safety of anifrolumab in adult type i interferon test high systemic lupus erythematosus subject with active skin manifestations

Conditions: Systemic Lupus Erythematosus

Summary: this study will be conducted to characterize pharmacokinetics, pharmacodynamics, safety, and tolerability of anifrolumab given via the subcutaneous (sc) route of administration in adult systemic lupus erythematosus (sle) subjects with a type i interferon (ifn) test high result and active skin manifestations while receiving standard of care (soc) treatment. in addition, the efficacy of anifrolumab on sle skin manifestations will be characterized.


Eligibility criteria:
inclusion criteria: 1. age 18 through 70 years 2. diagnosis of paediatric or adult sle for \> 24 weeks and fulfilling ≥4 of the 11 american college of rheumatology (acr) classification criteria with at least one being: * positive antinuclear antibody (ana) or * elevated anti-dsdna antibodies or * anti-smith (anti-sm) antibodies 3. interferon high test result 4. cutaneous lupus erythematosus disease area and severity index (clasi) activity score ≥ 10 5. currently receiving at least 1 of the following for treatment of sle: • oral prednisone or equivalent of ≤40 mg/day for a minimum of 2 weeks prior to signing the informed consent form (icf) and with stable dose for at least 2 weeks prior to randomization • any of the following medications for at least 12 weeks prior to signing the icf, and at a stable doses for at least 8 weeks prior to randomization: (i) azathioprine ≤200 mg/day (ii) antimalarials (eg, chloroquine, hydroxychloroquine, quinacrine) (iii) mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 g/day (iv) oral, subcutaneous (sc), or intramuscular methotrexate ≤25 mg/week (v) mizoribine ≤150 mg/day 6. must not have signs of active or latent tuberculosis (tb). 7. must not be pregnant or breastfeeding. exclusion criteria: 1. active severe or unstable neuropsychiatric sle 2. active severe sle-driven renal disease 3. any severe herpes infection at any time 4. hepatitis b virus (hbv), hepatitis c virus (hcv), or hiv infection. 5. known history of a primary immunodeficiency (splenectomy, or any underlying condition predisposing for infection 6. receipt of any investigation product within 4 weeks or 5 half -lives prior to signing of the icf 7. history of cancer, apart from: * squamous or basal cell carcinoma of the skin if successfully treated. * cervical cancer in situ if successfully treated
ascending dose study of genome editing by zinc finger nuclease therapeutic sb-fix in subjects with severe hemophilia b

Conditions: Hemophilia B

Summary: the purpose of the study is to evaluate the safety, tolerability and effect on fix antigen and activity levels of ascending doses of sb-fix. sb-fix is an intravenously delivered zinc finger nuclease (zfn) therapeutic for genome editing. it inserts a correct copy of the factor 9 gene into the albumin locus in hepatocytes with the goal of lifelong therapeutic production of the factor ix clotting factor.

the objective of the study is to provide long term expression of factor ix in subjects with severe hemophilia b. sb-fix is a therapeutic for zfn-mediated genome editing which will be delivered by adeno-associated virus (aav)-derived vectors. sb-fix is intended to function by placement of a corrective copy of the factor ix transgene into the genome of the subject's own hepatocytes, under the control of the highly expressed endogenous albumin locus, and is expected to provide permanent, liver-specific expression of factor ix for the lifetime of a hemophilia b subject.

Eligibility criteria:
inclusion criteria: * male \>18 years of age * severe hemophilia b (native circulating fix activity \<1%, with or without cross reactive material) exclusion criteria: * presence of neutralizing antibodies * history of hypersensitivity response or an allergic reaction to fix or fix products * currently receiving long acting fix replacement therapy * fix mutations known to be associated with fix inhibitors * polymorphisms in the zfn target region * presence of any liver mass on mri, or elevated alpha-fetoprotein (afp) * any contraindication to the use of corticosteroids for immunosuppression * currently receiving antiviral therapy for hepatitis b or c or with history or active hepatitis b or hepatitis c or hiv-1 or hiv1/2 antibody positive. * chronic anemia, leukopenia, or thrombocytopenia * past medical history of active tuberculosis or significant fungal disease * symptomatic cardiovascular disease as a co-morbid condition * markers of hepatic inflammation or overt or occult cirrhosis * history of chronic renal disease or creatinine ≥ 1.5 mg/dl * systemic (iv or oral) immunomodulatory agent or steroid use (topical treatment is allowed) * history of chronic infection or other chronic disorder considered an unacceptable risk * history of malignancy except for treated basal cell or squamous cell carcinoma * history of alcohol or substance abuse * previously received gene therapy product * participation in prior investigational drug or medical device study within the previous 3 months * history of therapeutic non-adherence * any other reason that, in the opinion of the investigator or medical monitor, would render the subject unsuitable for participation in the study
study of lee011, byl719 and letrozole in advanced er+ breast cancer

Conditions: Breast Cancer

Summary: the purpose of this trial is to inform the future clinical development of the two investigational agents in er+ breast cancer, lee011 (cdk4/6 inhibitor) and byl719 (pi3k-alpha inhibitor). this is a multi-center, open-label phase ib study. the phase ib dose escalation will estimate the mtd and/or rp2d for three regimens: two double combinations, lee011 with letrozole and byl719 with letrozole, followed by triple combinations of lee011 + byl719 with letrozole (arms 3 and 4). the phase ib dose escalation part will be followed by phase ib dose expansions to further characterize the safety, tolerability, pk and preliminary clinical anti-tumor activity of the combinations. optional crossover for patients who have progressed while on dose escalation or dose expansion with doublet treatment on arms 1 or 2 to be treated with the triplet combination (arm 3) after the determination of the rp2d for arm 3; is no longer permitted after protocol amendment 6. approximately 270 adult women with er+/her2- locally advanced or metastatic breast cancer will be enrolled.


Eligibility criteria:
inclusion criteria: * postmenopausal, estrogen-receptor positive and/or progesterone-receptor positive breast cancer * phase ib dose escalation only: any number of prior lines of endocrine therapy is allowed with the exception of cytotoxic therapy which is limited to one prior line administered in the advanced (metastatic or locally advanced) setting. * phase ib dose expansions arms 1, 2 and 3 * no prior systemic treatment in the advanced (metastatic or locally advanced) setting with the exception of treatment with letrozole for a maximum of one month prior to starting study treatment. * patients who received (neo)adjuvant therapy for breast cancer are eligible. prior therapy with letrozole or anastrozole in the (neo)adjuvant setting is permitted if the disease-free interval is greater than 12 months from the completion of treatment. exclusion criteria: * her2-overexpression in the patient's tumor tissue * patients with active cns or other brain metastases * major surgery within 2 weeks * acute or chronic pancreatitis * bilateral diffuse lymphangitic carcinomatosis * another malignancy within 3 years * receiving hormone replacement therapy that cannot be discontinued * impaired cardiac function * patients with clinically manifest diabetes mellitus (treated and/or clinical signs or with fasting glucose ≥ 126 mg/dl / 7.0 mmol/l or hemoglobin a1c \>6.5%), history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus. * other protocol-defined inclusion/exclusion criteria may apply

Keywords: hormone-receptor positive
adopting the mrd strategy to optimize post-operation adjuvant therapies for early stage breast cancer

Conditions: Early-stage Breast Cancer

Summary: this study is a prospective, multi-center, open-label cohort study, with 3 years disease free survival(dfs) as the primary endpoint. we optimize post-operation adjuvant therapy for early stage breast cancer based on the mrd strategy: patients with clinical high risk or post-operation 1st mrd tested positive will receive intensive adjuvant therapy, while patients with low clinical risk and post-operation 1st mrd tested negative will receive standard adjuvant therapy, and the treatment regimens will be adjusted every 3 months according to the change of mrd status. about 100 tnbc patients, 100 her2+ patients, and 100 er+ patients are planned to be enrolled.

mrd will be tested with tumor-informed personalized panel in this trail. the adjuvant therapies in the mrd strategy are all standard therapies in guidelines of china or abroad.

Eligibility criteria:
inclusion criteria: * subjects aged ≥18 years (inclusive). * histologically confirmed, perioperative invasive breast cancer that is resectable without metastasis(stage i-iii). * no anti-breast cancer systematic therapy received, and planning to receive surgery and systemic therapy. * eastern cooperative oncology group (ecog) performance status of 0-2. * with adequate organ function: a. bone marrow function: hemoglobin ≥ 10 g/dl; absolute leucocyte count ≥ 4×10\^9/l; absolute neutrophil count ≥ 1.5×10\^9/l; platelets ≥ 100 × 10\^9/l; b. liver function (based on the normal values specified by study site): serum total bilirubin ≤ 1.5 × the upper limit of normal (uln); alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 2.5 × uln; c. renal function (based on the normal values specified by study site): serum creatinine ≤ 1.5 × uln. * the patients voluntarily signed an informed consent form. exclusion criteria: * known to have other aggressive malignant tumor that is progressing or requires systemic treatment in the past 5 years (does not exclude subjects with skin basal cell carcinoma, skin squamous cell carcinoma, breast ductal carcinoma in situ or cervical cancer in situ that has received curative treatment). * have a clear history of neurological or mental disorders, including epilepsy or dementia, etc.; have a history of psychotropic drug abuse or drug abuse. * known history of allergy to the drug components in mrd strategy; history of immunodeficiency, or history of organ transplantation. * there are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia. * female patients during pregnancy or lactation. * the investigator determines that subjects are not appropriate to participate in the study due to other factors.
risk factors for staphylococcus aureus surgical site infections in orthopedic and trauma surgery

Conditions: Staphylococcus Aureus; Surgical Wound Infection; Orthopedic Disorder; Traumatology

Summary: the most commonly identified organism for surgical site infection (ssi) in orthopedic surgery is staphylococcus aureus but risk factors for mono microbial s.aureus ssi are not well-known. the aim of this study was to evaluated the incidence rate of s. aureus ssi over the years and risk factors of these infections in a french university hospital.

surgical site infections (ssi) in orthopedic surgery are responsible for reduced quality of life, increased length of hospital stay and costs. the most commonly identified organism is staphylococcus aureus but risk factors for mono microbial s.aureus ssi are not well-known.the aim of this study was to evaluate the incidence rate trend of s. aureus ssi over the years and risk factors of theses infections in a french university hospital. the knowledge obtained by this study will enable identification of the surgical patients most at risk of developping s. aureus ssi, and who would probably benefit most from new interventions given prophylactically and specifically to prevent s. aureus infections.

Eligibility criteria:
inclusion criteria: * orthopedic or traumatology surgeries performed in grenoble university hospital, * from january 1st 2012 to april 30th 2015, * the subject is undergoing one of the following surgical procedures : knee and hip arthroplasties, osteosynthesis of proximal femur and other osteosynthesis except skull and spine. * the subject is 16 years of age or older exclusion criteria: * non orthopedic or trauma surgery performed in grenoble university hospital, * spine surgeries, * surgeries of the hand, scaphoid and carpal bones.

Keywords: infection wound infection surgical wound infection staphylococcal infections wound and injuries postoperative complications gram-positive bacterial infections bacterial infections