Kornimate/medical-research-clean huggingface dataset:
bringing of pet-tdm fdg in the determination of the characteristics of primary mammary tumors triple negatives

Conditions: Breast Cancer

Summary: "triple negative" breast cancers are a heterogeneous group characterized by the absence of hormone receptors to estrogen, progesterone and the absence of expression or amplification of the her-2 gene. this type of cancer is associated with an adverse clinical profile with a high risk of early metastatic relapse. accurate identification of prognostic factors, as well as predictors of therapeutic response, and the contribution of targeted therapies are avenues for improving the management and survival of patients with these cancers. such an approach requires optimal biological characterization, allowing us to understand the complexity of this group of tumors, and requires multidisciplinary collaboration in clinical trials involving anatomopathology, oncology and morpho-functional imaging. the investigator's goal is to characterize by innovative methods (anatomo-pathological in particular of immunohistochemistry, and morpho-functional imaging (tep-tdm fdg) semi-quantitative and texture) in a population of triple negative breast cancer scans better knowledge of this entity that can lead to the development of relevant therapeutic strategies and especially more adapted in the context of precision and personalized medicine.

120 consecutive patients with "triple negative" breast cancers operatable from the outset will be included in the study * to assess the prognostic value of the texture parameters of pet-tdm fdg on event-free survival at 2 years. * to assess the prognostic value of standard parameters (clinical, standard histology, conventional imaging), semi-quantitative pet-tdm fdg and innovative immuno-histochemistry parameters for 2-year event-free survival . * to assess correlations between continuous pet-tdm fdg texture parameters and immuno-histochemistry. * to assess the multivariate prognostic value of standard parameters, pet-tdm fdg imaging parameters and immuno-histochemistry defined as relevant to 2-year event-free survival . * construction of an optimal prognostic nomogram combining independent parameters to isolate different prognostic subgroups.

Eligibility criteria:
inclusion criteria: * patient with biopsy-proven triple-negative breast cancer, newly diagnosed, naïve from any treatment. * age - 18. * performance status (ps) : 0 or 1. * no metastasis on the extension balance. * treatment provided immediately by lumpectomy or mastectomy, and accepted by the patient. exclusion criteria: * severe illness or comorbidity at risk. * a history of cancer within 5 years, with the exception of skin carcinomas (other than melanoma) or in-situ cervical carcinomas. * patient candidate for neo-adjuvant therapy.
anlotinib plus toripalimab as first-line treatment for advanced gastric cancer with ecog 2 (apical-gc)

Conditions: Gastric Cancer; Immunotherapy; Anlotinib; Toripalimab

Summary: this study is designed to evaluate the efficacy and safety of the combination of anlotinib wiht toripalimab in advanced gastric cancer with ecog 2 as first-line regimen.

anlotinib is a new, orally administered tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (vegfr), fibroblast growth factor receptor (fgfr), platelet-derived growth factor receptors (pdgfr), and c-kit. toripalimab is a humanized immunoglobulin (ig) g4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (programmed death-1; pd-1), with potential immune checkpoint inhibitory and antineoplastic activities. in the present study, we design a single-arm, single center phase ii trial to evaluate the efficacy and safety of the combination of anlotinib wiht toripalimab in advanced gastric cancer with ecog 2 as first-line treatment.

Eligibility criteria:
inclusion criteria: * histologically confirmed, uicc stage iv gastric cancer; * no prior systematic anti-cancer treatment and relapse or metastases was occurred more than 12 months after adjuvant chemotherapy; * at least one measurable lesion; * received radiotherapy 3 weeks before recruitment, but the lesion undergoing radiotherapy could not be used to calculate clinical benefit using reciset criteria; * ecog performance status 2; * the main organ function to meet the following criteria: hb ≥ 90g / l, anc ≥ 1.5 × 109 / l, plt ≥ 80 × 109 / l,bil \<1.5 times the upper limit of normal (uln), alt and ast \<2.5 × uln and if liver metastases, bil \< 3 × uln, alt and ast \<5 × uln; serum cr ≤ 1.5 × uln; * patient's written declaration of consent obtained; * estimated life expectancy \> 3 months; exclusion criteria: * harboring her2 positive including ihc 3+ or ihc 2+ with fish positive; * dmmr/msi-h; * myocardial infarction, unstable angina pectoris, grade iii or iv heart failure (nyha classification); * have received anlotinib or other immune checkpoint inhibitor ; * with known or clinically suspected brain metastases, autoimmune disease, organ transplantation ; * severe wounds or surgery 4 weeks before recruitment; * received glucocorticoid (more than 10mg prednisone ) and immunosuppressive agents; * history of a second malignancy during the past 5 years before inclusion in the study or during participation in the study, with the exception of a dermal basal cell or squamous cell carcinoma or cervical carcinoma in situ, if these were treated curatively. * pregnancy or breast feeding; * absent or restricted legal capacity; * a significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study
patient reported outcomes in pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: develop a brief, new, patient reported outcome instrument that is valid for use in clinical practice and clinical trials.

this study will use the clinical impact method to develop a patient reported outcome for use in patients with pulmonary arterial hypertension clinical personnel at the study sites will approach and discuss possible participation in phase i and ii of the study with subjects from the existing pool of patients currently receiving usual and customary care at the site.

Eligibility criteria:
inclusion criteria: * evidence of a personally signed and dated informed consent * subjects aged \>=18 who have documented pah * speak english * subjects who provide written informed consent to participate in the study before being screened for the study. exclusion criteria: * patients with non-pah pulmonary hypertension * physical inability to complete the interview process * subjects who are currently enrolled in an experimental drug study

Keywords: instrument development patient reported outcomes pulmonary arterial hypertension.
efficacy and safety study of sbg vs placebo in head and neck cancer patients undergoing radiation therapy

Conditions: Head and Neck Cancer; Oral Mucositis

Summary: the purpose of this study is to evaluate the efficacy and safety of sbg vs placebo on oral mucositis in head and neck cancer patients undergoing radiation therapy.

the objective of the study is to evaluate the efficacy and safety of soluble beta-1,3/1,6-glucan (sbg) on oral mucositis compared to placebo in head and neck cancer patients undergoing radiation therapy with or without chemotherapy.

Eligibility criteria:
* patients with a normal oral mucosa who is scheduled to receive radiation therapy for their head and neck cancer will be enrolled into the study. * patients with previous head and neck cancer and/or radiation therapy in the head and neck area and history/clinical evidence of active significant acute or chronic conditions that may compromise the ability to evaluate or interpret the effects of the study treatment on mucositis will be excluded.

Keywords: cancer radiation therapy radiotherapy oral mucositis sbg
mycophenolate mofetil versus azathioprine for maintenance therapy of lupus nephritis.

Conditions: Lupus Nephritis

Summary: the purpose of the study is to determine whether mycophenolate mofetil is superior to azathioprine to prevent flares of lupus nephritis.

proliferative glomerulonephritis is a common and severe manifestation of systemic lupus erythematosus (sle) that usually requires intensive therapy with high doses of glucocorticosteroids and cytotoxic drugs, such as intravenous (iv) cyclophosphamide (cyc). the objective of the maintain nephritis trial is to compare mycophenolate mofetil (mmf) and azathioprine (aza), in terms of efficacy and toxicity, as remission-maintaining treatment of proliferative lupus glomerulonephritis, after a remission-inducing therapy with a short-course iv cyc regimen. the hypothesis addressed by the maintain nephritis trial is that mmf is superior to aza.

Eligibility criteria:
inclusion criteria: * sle aged ≥ 14 years * proteinuria ≥ 500 mg/day * biopsy-proven proliferative lupus nephritis exclusion criteria: * recent treatment with high-dose glucocorticoids * recent treatment with immunosuppressive drugs * more exclusion criteria in the protocol

Keywords: lupus nephritis treatment maintenance therapy mycophenolate mofetil azathioprine
a study of mk-2214 in adults with mild cognitive impairment or mild-to-moderate alzheimer's disease (mk-2214-002)

Conditions: Alzheimer Disease

Summary: the purpose of this study is to assess the safety, tolerability, pharmacokinetics (pk) and pharmacodynamics of mk-2214 in adults with mild cognitive impairment (mci) or mild-to-moderate alzheimer's disease (ad). the primary hypothesis (part 1) is that at a generally well tolerated dose level, the true geometric mean concentration at day 85 of mk-2214 in cerebrospinal fluid is \>0.3 nanomolar (nm).


Eligibility criteria:
inclusion criteria: * participant is in overall good health based on medical history and laboratory safety tests * bmi between 18.5 and 35 kg/m\^2 part 1 (mci and mild to moderate ad) only: * history of cognitive and functional decline with gradual onset and slow progression for at least one year before screening * have an mini-mental state examination (mmse) \>12 at the prestudy visit * modified hachinski ischemic score (mhis) score \<4 at the prestudy visit exclusion criteria: * based on clinical interview and columbia-suicide severity rating scale (c-ssrs), has reported suicidal ideation with intent, with or without a plan or method * history of unstable or poorly controlled endocrine, gastrointestinal (gi), cardiovascular, hematological, hepatic, renal, respiratory, or genitourinary abnormalities or diseases * history of clinically significant active neurological disease (except for ad or mci for participants in part 1) * history of clinically significant active autoimmune disease requiring ongoing systemic immunosuppressant therapy * history of cancer (malignancy) * history of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food * positive test(s) for hepatitis b surface antigen (hbsag), hepatitis c antibodies or human immunodeficiency virus (hiv) * has had a major surgery and/or donated or lost 1 unit of blood (approximately 500 ml) within 4 weeks prior to the prestudy visit * has a contraindication to lumbar dural puncture, such as coagulopathy, concomitant anticoagulation beyond low dose aspirin, thrombocytopenia, or other factors that could preclude safe lumbar puncture * currently receiving or has received aducanumab or another anti-amyloid therapy within the last 6 months * has a history of receiving biological therapy within 3 months or 5 half-lives (whichever is longer) or any human immunoglobulin preparation within the last year * has received any non-live vaccine starting from 14 days prior to first study intervention or is scheduled to receive any non-live vaccine through 14 days following the final dose of study intervention. exception: covid-19 and influenza vaccines may be administered * is receiving systemic immunosuppression, including corticosteroids exceeding physiologic replacement doses
sy-005 （recombinant human annexin a5）in patients with sepsis

Conditions: Sepsis

Summary: this phase iia randomized, double-blind, parallel group, placebo-controlled, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of multiple intravenous injection of sy-005（recombinant human annexin a5） in sepsis subjects. 96 patients will be entered into the study and randomised in a 1:1:1:1 ratio to receive sy-005 2.5mg or sy-005 5mg or sy-005 10mg or placebo.


Eligibility criteria:
key inclusion criteria: * patients are diagnosed with sepsis and receive study treatment within 48 hours * sepsis-related organ failure assessment（sofa）score range from 2 to 13 * the informed consent form signed by the patient or the patient's legally acceptable representative key exclusion criteria: * pregnant or breastfeeding women ; women of childbearing potential (wocbp) could not take effective method of contraception * moribund, and death is considered imminent within 24 hours or patient expected survival time is less than 6 months due to the underlying disease * absolute neutrophil count (anc) \<0.5 x 10\^9/l * new york heart association (nyha) classification iv * patient with end-stage lung disease * egfr \<60ml/min * alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) \>3.0 times the upper limit of normal (uln) * immunosuppressed patients with following situations: 1. human immunodeficiency virus (hiv) infection 2. patients undergoing active radiation or chemotherapy treatment within the past 3 months 3. any organ or bone marrow transplant and related immunosuppressive therapy 4. high dose steroids (eg, \> 0.5 mg/kg prednisone or a steroid with equivalent activity, daily for a month) within 3 months before provision of written informed consent for the study * patients with high bleeding risk: 1. recent surgery \<72 hours, or a planned surgical procedure in the next 24h 2. severe thrombocytopenia (\< 30 x 10\^9/l, before platelet transfusion) 3. recent trauma \<72 hours 4. history of gastrointestinal bleeding or intracranial hemorrhage in the past 6 weeks. 5. stroke or head injury in the past 3 months 6. on-going therapeutic anticoagulants that could not be interrupted (except prophylactic heparin treatment that can be continued） 7. any history of chronic liver disease with a child score b or c 8. any condition at risk of bleeding, as appreciated by the physician in charge of the patient * severe anemia (hemoglobin \<5.9 g/dl)
bioequivalence study of ibuprofen 200 mg + pseudoephedrine hcl 30 mg tablets under fed conditions

Conditions: Healthy

Summary: the purpose of this study is to assess the bioequivalence of ibuprofen 200 mg + pseudoephedrine hcl 30 mg under fed conditions.

this study assess the bioequivalence of ibuprofen 200 mg + pseudoephedrine hcl 30 mg tablets of dr. reddy's and advil® cold and sinus caplets of wyeth consumer healthcare in healthy human adult subjects with the single oral administration under fed conditions with a washout period of 7 days.

Eligibility criteria:
inclusion criteria: * healthy human subjects between 18-50 years of age (inclusive), weighing as per the standard height and weight chart of life insurance corporation of india (ii underweight and overweight min. \& max. chart) * subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21 days to commencement of the study. * subjects whose screening laboratory values are within normal limits or considered by the physician/principal investigator to be of no clinical significance. * informed consent given in written form according to section 10.3 of the protocol. * female subjects: 1. of child bearing potential practicing an acceptable method of birth control for the duration of study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (iud), or abstinence. 2. postmenopausal for at least 1 year. 3. surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject. exclusion criteria: 1. history or presence of significant: i. cardiovascular, pulmonary, hepatic, renal hematological; gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. * alcohol dependence, alcohol abuse or drug abuse within past one year. * moderate to heavy smoking (\> 10 cigarettes/day) or on assumption of tobacco products. * history of difficulty in swallowing. * clinically significant illness within 4 weeks before the start of the study * asthma, urticaria or other allergic type reactions after taking any medication. 2. subjects who, through completion of the study, would have donated in excess of * 500 ml of blood in 14 days, or * 500 - 800 m l of blood in 14 days (unless approved by the principal investigator) * 1000 ml of blood in 90 days * 1250 ml of blood in 120 days * 1500 ml of blood in 180 days * 2000 ml of blood in 270 days * 2500 ml of blood in 1 year 3. participation in another clinical trial within the preceding 28 days of study start. 4. subjects who have: * systolic blood pressure less than 90 mm of hg and more than 150 mm of hg * diastolic blood pressure less than 60 m of hg and more than 95 mm of hg. minor deviations (1-3 mm hg) at check-in may be acceptable at the discretion of the physician/investigator * pulse rate below 50/min. and above 105/min. 5. female volunteers demonstrating a positive pregnancy screen or currently breast-feeding.

Keywords: bioequivalence crossover ibuprofen and pseudoephedrine
antibiotic prophylaxis in laparoscopic cholecystectomy

Conditions: Cholelithiasis

Summary: the trial aims to assess the value of two-regimen antibiotic prophylaxis versus placebo in elective laparoscopic cholecystectomy.

all patients enrolled will be submitted to laparoscopic cholecystectomy. the primary aim of the trial will be to assess the role of prophylactic i.v. infusion of ampicillin-sulbactam, ciprofloxacin, and placebo to reduce the rate of surgical site infection.

Eligibility criteria:
inclusion criteria: * elective laparoscopic cholecystectomy; * patients suffering from gallbladder stones,chronic cholecystitis, cholesterolosis, or gallbladder polyps. exclusion criteria: * acute cholecystitis; * acute cholangitis; * acute pancreatitis; * pregnant or lactating women; * antibiotic allergy; * antibiotic therapy within 48 hours to 7 days prior to surgery; * clinically active infection at the moment of surgery; * evidence of common bile duct stones; * contraindications for laparoscopic cholecystectomy; * no other additional procedure; * indication of obligatory antibiotic prophylaxis because the medical condition was different from biliary disease (immunosuppression, corticoid use, etc). * patients unable to give informed consent.

Keywords: laparoscopic cholecystectomy prophylactic antibiotics
evaluation of efficacy and safety of recombinant somatroipn in patients with growth hormone deficiency

Conditions: Growth Hormone Deficiency

Summary: the purpose of this study is to evaluate the efficacy and safety of recombinant human growth hormone on adult growth hormone deficiency


Eligibility criteria:
inclusion criteria: * patients aged 18 and up * patients with maximum serum growth hormone concentration of less than 5 ng/ml * patients who can successfully complete this study based on appropriate medical judgment or who expect to benefit from this study * persons who have agreed in writing to participate in this study exclusion criteria: * persons who are currently under treatment after being diagnosed with a malignant tumor * hepatosis * renal function disorder * intra-cranial hypertension * proliferative diabetic retinopathy * persons who carry acromegaly activity * fertile women who are not pregnant or who do not take appropriate contraceptive measures and whose urine tested positive for hcg (human chorionic gonadotropin) * mental patients and/or drug addicts and alcoholics * patients who had participated in the other drug study within the last 30 days prior to participating in this study * patients considered unfit for this study by the attending physician
safety, efficacy, & use of vivigen cellular bone matrix allograft in orthopaedic fracture care

Conditions: Fractures, Bone; Nonunion of Fracture; Fractures, Open; Fractures, Ununited; Fracture, Tibial; Fracture of Femur; Fracture Arm

Summary: prospective registry and retrospective data collection study to assess the efficacy and safety of vivigen cellular bone matrix (vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.

the prospective registry study and retrospective data collection study is planned to assess the efficacy and safety of vivigen cellular bone matrix (vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings. patients will be assessed at hospital discharge, 6 weeks, 3 months, 6 months, 12 months and 24 months after treatment of a traumatic fracture with a bone graft.

Eligibility criteria:
prospective cohort inclusion criteria: * any skeletally mature patient treated with vivigen bone graft in the setting of an acute fracture, delayed, non-union or fusion setting will be eligible for inclusion. retrospective cohort inclusion criteria: - any skeletally mature patient treated with adjunct bone graft in the setting of an acute fracture, delayed, non-union or fusion setting will eligible for inclusion. prospective cohort exclusion criteria: 1. patients unable to understand either an english or spanish consent will be excluded. 2. patients unable to consent secondary to dementia and/or other mental/psychiatric diagnoses will be excluded.

Keywords: fracture nonunion allograft