Kornimate/medical-research-clean huggingface dataset:
phase 3 clinical trial to evaluate paracetamol /fexofenadine /phenylephrine in flu and cold treatment

Conditions: Cold; Flu Symptom

Summary: a phase 3, multicenter, randomized, double-blind, comparative clinical trial to evaluate the association of paracetamol 500mg + fexofenadine 60mg + phenylephrine 20mg in the flu and common cold treatment. ⚠️study will only be conducted in research centers in brazil (please do not send e-mail if your center is outside brazil).

a multicenter, randomized, double-blind, parallel-group, superiority, placebo control clinical trial. adult patients (aged ≥ 18 years) of both sexes with common cold or flu will be randomized in a 1:1 ratio to receive the experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg) or placebo, in the dosage of one (01) film-coated tablet every eight (08) hours, for 3 to 7 days. the primary superiority assessment will be carry out compared the experimental drug to placebo in the relief of cold and flu symptoms through the absolute variation of the overall score obtained in the symptom assessment questionnaire after treatment start. ⚠️study will only be conducted in research centers in brazil (please do not send e-mail if your center is outside brazil).

Eligibility criteria:
inclusion criteria: * common cold: presence of moderate to severe nasal congestion and moderate to severe runny nose and at least one (01) of the following moderate to severe symptoms: sneezing, headache, myalgia, sore throat, throat pain, dysphonia, cough and fever. duration of symptoms ≤ 48 hours at screening. informed consent form (icf) signed before carrying out any study procedure. exclusion criteria: * presence of significant septum deviation, compatible with impaired nasal ventilatory function, at the investigator's discretion. * presence of nasal polyposis to previous rhinoscopy. * known hypersensitivity to any component of the experimental drug formulation. * required antibiotic therapy for upper airway infection treatment
a study of the effects of roactemra/actemra (tocilizumab) on neutrophils in patients with active rheumatoid arthritis who have an inadequate response to biologic and/or non-biologic dmards.

Conditions: Rheumatoid Arthritis

Summary: this open-label, single arm study will assess the effect of roactemra/actemra (tocilizumab) on neutrophils and monitor safety and benefit-risk of roactemra/actemra treatment in patients with active rheumatoid arthritis who have an inadequate response to current biologic or non-biologic disease-modifying antirheumatic drugs (dmards). patients will receive roactemra/actemra at a dose of 8 mg/kg intravenously every 4 weeks, either as monotherapy or in combination with their current non-biologic dmard. anticipated time on study treatment is 52 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * moderate to severe active rheumatoid arthritis of \>/= 6 months duration * das28 \>/= 3.2 at screening and baseline * inadequate response to biologic or non-biologic dmards * biologic dmards must be withdrawn (approximately 5 half-lives for the agent) before first dose of study drug * if continuing on a non-biologic dmard, dose should be stable for at least 8 weeks * oral corticosteroids must have been at stable dose for at least 25 out of 28 days prior to baseline exclusion criteria: * major surgery (including joint surgery) within 8 weeks prior to screening or not recovered from prior surgery * rheumatic autoimmune disease other then ra * functional class iv as defined by the american college of rheumatology (acr) classification * prior history of or current inflammatory joint disease other than ra * previous treatment with any cell-depleting therapies * intraarticular or parenteral corticosteroids within 4 weeks prior to baseline * active infection or history of recurrent infection * positive for hiv or hepatitis b or c * history of or current primary or secondary immunodeficiency
quantitative analysis of global proteome in bone samples from patients with osteoporotic and nonosteoporotic fracture

Conditions: Femoral Neck Fractures

Summary: rationale: collecting and storing bone samples from patients with osteoporotic and nonosteoporotic fracture to quantitatively analyze the differentially expressed proteins to further explain the relationship between bone iron content and bone mineral density (bmd). purpose: this research study is looking at changes of iron content and differentially expressed proteins in bone samples from patients with osteoporotic and nonosteoporotic. fracture.

objectives: 1. establish the iron content in bone specimen in patients with hip fracture. 2. explore the correlation of bmd and differentially expressed proteins. outline: 1. collect human bone specimens from patients with osteoporotic and nonosteoporotic fracture. 2. provide a repository for storage of tissue and make these specimens available for approved projects by laboratory-based investigators. 3. collect clinical data on these patients including bone mineral density. 4. to examine the bone iron content using icp/ms. 5. investigate the differentially expressed proteins through quantitative analysing the global proteome of osteoporotic and nonosteoporotic fracture bone specimens.

Eligibility criteria:
inclusion criteria: 1. ages eligible for study: 55-90 years 2. genders eligible for study: woman 3. accepts healthy volunteers: no 4. study population: female patients with hip fracture. exclusion criteria: 1. malignancy or benign ovarian cysts 2. known chronic or systemic diseases 3. hormone therapy in the previous 3 months 4. bone metabolism and drug therapy
study of ranexa in patients with coronary artery disease and painful polyneuropathy

Conditions: Coronary Artery Disease; Pain; Peripheral Nervous System Diseases; Polyneuropathy

Summary: this study was to determine whether ranolazine was effective in the treatment of neuropathic pain in patients with coronary artery disease. eligibility required neurological examination by the study doctor and assessment of the patient's pain. eligible participants were randomized to receive blinded study medication for a total of 12 weeks.


Eligibility criteria:
inclusion criteria: * males or females aged ≥ 18 years * coronary artery disease with a clinically diagnosed peripheral neuropathy * willing and able to provide signed informed consent and health insurance portability and accountability act (hipaa) authorization * willing and able to comply with the requirements of the protocol and follow directions from the clinic staff exclusion criteria: * history of allergy or intolerance to ranolazine * any condition or concomitant medication that would have precluded the safe use of ranolazine as outlined in the prescribing information sheet (see appendix e) * in the judgment of the investigator, any clinically-significant ongoing medical condition that might jeopardize the patient's safety or interfere with the absorption, distribution, metabolism or excretion of the study drug * in the judgment of the investigator, clinically-significant abnormal physical findings during screening (excluding the patient's peripheral neuropathy condition) * use of any experimental or investigational drug or device within 30 days prior to screening * pregnant or breast feeding, or (if premenopausal), not practicing an acceptable method of birth control (as detailed in inclusion criterion 4) * had received prior treatment with, or investigational exposure to, ranolazine within 7 days prior to randomization * clinically significant hepatic impairment * had end-stage renal disease requiring dialysis * psychological or addictive disorders (not limited to, but including drug and/or alcohol dependency) that may have precluded patient consent or compliance, or that may have confounded study interpretation * positive pregnancy test at baseline (pre-randomization, day 0)

Keywords: coronary artery disease pain peripheral neuropathy polyneuropathy
study of a communication training intervention for large b-cell lymphoma providers

Conditions: Lymphoma, B-Cell; Lymphoma; Large-cell Lymphoma; Large B-cell Lymphoma; DLBCL - Diffuse Large B Cell Lymphoma; Mediastinal B-Cell Diffuse Large Cell Lymphoma

Summary: the purpose of this study is to develop and test a new communication training intervention called hematolo-gist to help oncologists communicate with patients about their lymphoma diagnosis and advance care planning.


Eligibility criteria:
inclusion criteria: hematologists * currently a hemotologic oncologist providing care to patients with dlbcl patients * per medical record, is being treated by a hematologic oncologist participating in this study * per medical record, has a diagnosis of dlbcl including dlbcl-transformed follicular lymphoma (tfl) and primary mediastinal b-cell lymphoma (pmbcl) which are histologically similar and clinically treated as large-cell lymphoma * per medical record, relapse/ refractory disease within 12 months of 4 cycles of first line therapy or relapse after 2 cycles of later line therapy or autologous stem cell transplant (asct) * self-identify as black and/or white * per medical record, 18 years of age or older * per self-report, fluent in english\*\* \*\* language verification: prior to enrollment, patients will be asked the following two questions by a clinical research coordinator (crc) to verify english fluency necessary for participation in the study: 1. how well do you speak english? (must respond "very well" or "well" when given the choices of very well, well, not well, not at all, don't know, or refused) 2. what is your preferred language for healthcare? (must respond english) exclusion criteria: hematologists * per self-report, planning to leave the cancer center in the next 12 months patients * cognitively impaired as demonstrated by (blessed orientation- memory- concentration (bomc) score of ≥ 11 * per research staff judgment and/or self-report, too ill or weak to complete study procedures * per medical record or self-report, receiving hospice care at the time of enrollment

Keywords: oncologist hemotologic oncologist lymphoma large cell lymphoma large b-cell lymphoma dlbcl diffuse large b cell lymphoma mediastinal b-cell diffuse large cell lymphoma hematolo-gist 23-164 memorial sloan kettering cancer center
cytotoxic t cells and interleukin-2 in treating adult patients with recurrent brain tumors

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: biological therapy uses different ways to stimulate the immune system and stop cancer cells from growing. cytotoxic t cells combined with interleukin-2 may be an effective treatment for recurrent brain tumors. purpose: phase i trial to study the effectiveness of cytotoxic t cells and interleukin-2 in treating adults with recurrent brain tumors.

objectives: i. evaluate the toxicity of allogeneic cytotoxic t lymphocytes (ctl) when repeatedly instilled directly into the brain to treat recurrent primary brain tumors. ii. evaluate the response produced by allogeneic ctl and interleukin-2. iii. correlate ctl surface phenotype and degree of patient/donor hla mismatch to response and toxicity. outline: surgery plus biological response modifier therapy. tumor resection; plus intracavitary cytotoxic t lymphocytes, ctl; intracavitary interleukin-2 (chiron), il-2, nsc-373364. ctl are generated in vitro by mixing irradiated patient lymphocytes (cultured with il-2 and monoclonal antibody okt 3, moab okt 3, nsc-618843) with allogeneic lymphocytes and culturing the mixture with il-2. projected accrual: 10 patients will be treated. if severe toxicity occurs in the first 5 patients, the study will close.

Eligibility criteria:
disease characteristics: kernohan grade iii/iv primary malignant brain tumor that has failed conventional surgical resection and radiotherapy evidence of recurrent tumor on gadolinium-enhanced mri following completion of radiotherapy (minimum 5,000 cgy for adults) required the following histologies are eligible: anaplastic astrocytoma anaplastic oligodendroglioma glioblastoma multiforme mixed anaplastic glioma surgical resection of progressing brain tumor feasible no evidence of tumor extending across the midline from one hemisphere to the other no multifocal tumor or leptomeningeal spread patient characteristics: age: over 18 performance status: karnofsky 60-100% life expectancy: at least 2 months hematopoietic: wbc greater than 2,000 platelets greater than 100,000 hct at least 28% hepatic: bilirubin less than 1.5 mg/dl renal: creatinine less than 1.5 mg/dl cardiovascular: no major cardiovascular problems pulmonary: no major pulmonary problems other: seronegative for htlv/hiv, syphilis, and hepatitis b and c no concurrent systemic infection ability to maintain proper nutrition (orally or intravenously) during the study period required no pregnant women prior concurrent therapy: biologic therapy: not specified chemotherapy: more than 4 weeks since systemic chemotherapy (6 weeks since carmustine), with the wbc increasing on 2 consecutive determinations at least 3 days apart endocrine therapy: not specified radiotherapy: at least 8 weeks since radiotherapy surgery: see disease characteristics

Keywords: recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult mixed glioma adult giant cell glioblastoma adult gliosarcoma
multicentric retrospective study of perinatal mortality

Conditions: Perinatal Morbidity; Morbidity;Perinatal; Stillbirth; ICD

Summary: background: perinatal mortality ranges mortality from 22 gestational weeks up to the first 7 days of life and extended mortality goes up to 28 days of life. the perinatal mortality rate is the most sensitive index of the health status of women and their offspring and of the quality of maternal and child health services. per our knowledge, there is no study that evaluates perinatal mortality in catalonia, although household data are available from each hospital. moreover, the official records usually do not match with the household surveys due to lack of clarity on the definitions. aim: the aim of the study is to compare the who perinatal mortality classification following the icd-pm in comparison with the used classification. methodology: multicentric retrospective study. data from sant joan de déu, maternitat clinic and parc taulí hospitals.


Eligibility criteria:
inclusion criteria: * stillbirths more than 22 weeks of gestation * neonatal deaths up to 28 days of life exclusion criteria: - avortions more than 22 weeks of gestation

Keywords: perinatal mortality icd perinatal death stillbirth neonatal mortality cause of death risk factors
synovial proliferation on routine ultrasound: active or inactive?

Conditions: Haemophilia; Hemophilia A; Hemophilia B

Summary: there is cumulating evidence for the presence of non-observed or subclinical joint bleeding in patients with haemophilia. early detection of active subclinical synovial proliferation would allow early intervention in order to prevent deterioration of joint health. patients with subclinical (=non-observed) signs of synovial proliferation in knee(s), ankle(s) and/or elbow(s) will be invited to participate in this study to further characterize the synovial proliferation status (active or inactive) by means of physical examination, mri, ultrasound and elastography. synovial proliferation status will be monitored for a maximum period of 12 weeks, during which participants will also receive standard-of-care treatment, i.e. administration of optimized coagulation factor replacement therapy and prescription of the nsaid celecoxib (optional).

to be completed

Eligibility criteria:
inclusion criteria: * gender: male * patients with severe haemophilia a or b * treated with registered prophylaxis medication including coagulation factors and by- passing agents. * age ≥ 12 years * subclinical synovial proliferation in ≥1 joint (ankle, knee and/or elbow), defined as the presence of hypertrophic synovium, score \>0 according to the head-us protocol, as confirmed during routine ultrasound screening. * able to give written informed consent. exclusion criteria: * a major bleed ≤ 3 months or a minor bleed ≤ 1 month prior to inclusion in the joint of interest. * on demand therapy. * currently treated with any type of haemophilia prophylaxis medication. * joints with prosthesis or treated with arthrodesis will not be included for physical examination and ultrasound analysis. however, participants may still be included in the study with their other joints. * confirmed inflammatory joint diseases such as rheumatoid arthritis or psoriatic arthritis. * history of inhibitor development (≥ 5 bethesda units\* (bu) at any time or 1-5 bu for * 1 year prior to inclusion. * contra-indication for treatment with nsaids, (allergy, severe liver failure, renal failure (gfr \<30ml/min), congestive heart failure (nyha ii-iv), peripheral arterial disease and/or cerebrovascular disease.

Keywords: subclinical synovial proliferation ultrasound mri elastography
effect of g6pd deficiency on red blood cell storage

Conditions: G6PD Deficiency

Summary: the proposed study will determine whether g6pd-deficient rbcs store differently than normal rbcs under standard blood banking conditions. the investigators plan to screen a large number of healthy male volunteers for g6pd deficiency in order to identify 10 g6pd deficient and 30 matched normal individuals using a blood sample obtained from a finger-stick. the identified individuals will then be asked to donate a unit of blood that will be stored for up to 42 days and various tests will be performed on these units during storage. at 6 weeks of storage a portion of the unit will be radioactively labeled and re-infused into the volunteer. blood samples will be drawn before, during, and after the infusion to measure how well or poorly the red blood cells survive after transfusion.

glucose-6-phosphate dehydrogenase (g6pd) deficiency is the most common enzyme deficiency, affecting approximately 400 million people world-wide. it manifests as red blood cell (rbc) destruction in response to oxidative stress, which can be precipitated by infection, and by the ingestion of certain medications and foods. the prevalence of g6pd deficiency varies among populations and is most commonly found in individuals from sub-saharan africa, the mediterranean region, and south-east asia. although in most studies g6pd-deficient individuals have normal rbc survival at steady-state, this may vary based upon the g6pd variant present, and some individuals may have shortened rbc survival. while it is not routine practice to screen blood donors for g6pd deficiency, g6pd deficient donor rbcs may store more poorly than normal rbcs. in addition, the transfusion of stored g6pd-deficient rbcs may result in decreased rbc survival after transfusion compared to rbcs from normal donors.

Eligibility criteria:
inclusion criteria: * male * weight greater than 110 pounds * hemoglobin greater than 11.5 g/dl * african (e.g., afro-american, afro-caribbean, sub-saharan), asian, hispanic, middle eastern, or mediterranean (e.g., italian, greek) based on mother's ancestry * english speaking exclusion criteria: * presence of hemoglobin variant * ineligible for donation based on the new york blood center donor autologous questionnaire * systolic blood pressure \>180 or \ 100 or \<50 mm hg * heart rate \ 100 * temperature \>99.5°f prior to donation * temperature \>100.4°f or subjective feeling of illness prior to transfusion (this criterion is to avoid concurrent illness affecting post-transfusion measurements) * positive results on standard blood donor infectious disease testing

Keywords: transfusion post-transfusion recovery
vegf signaling promotes cell growth and metastasis in hepatocellular carcinoma in a vegf receptor mediated pathway

Conditions: Hepatocellular Carcinoma

Summary: the investigators study the vegf signaling in hcc cell lines and its mechanism in hcc growth, proliferation and apoptosis.

several studies have documented the elevated expression of vegf, vegfr1 and vegfr2 in hcc cell lines and tumor tissues. another study observed a sequential elevation of vegf in low-grade dysplasia, high-grade dysplasia and early stage hcc. clinical analyses have discovered the high expression of vegf is correlated with tumor progression, vascular invasion, distal metastasis and poor prognosis. however, few studies have been conducted to investigate the vegf signaling in hcc cells and its possible mechanism in regulating hcc growth.therefore,we try to clarify the mechanism of vegf signal in hcc growth,proliferation and apoptosis.

Eligibility criteria:
inclusion criteria: 1. hepatocellular patients diagnosed through biopsy;or either dynamic imagine with a diagnosis of hepatocellular carcinoma and alphafetoprotein\>400μg/l；or two or more dynamic imagine with a diagnosis of hepatocellular carcinoma 2. child-pugh a or b 3. well preserved renal and hematopoietic function 4. receive surgical therapy 5. achieve complete section accessed by contrast-enhanced ct exclusion criteria: 1. incomplete section 2. remote metastasis 3. child-pugh c 4. combination with other hepatobiliary disease 5. suffer from other tumors concurrently or in last five years

Keywords: hepatocellular carcinoma hcc vegf signaling pathway
impact of intrahepatic cholestasis of pregnancy on neonatal respiratory outcomes

Conditions: Intrahepatic Cholestasis of Pregnancy; Respiratory Distress Syndrome, Newborn

Summary: intrahepatic cholestasis of pregnancy is a liver condition in late pregnancy, causing itching and high bile acid levels that return to normal after birth. babies born to mothers with this condition may have a higher risk of breathing issues. researchers suspect bile acids might lead to a specific type of lung problem in newborns, but more studies are needed to confirm this.

intrahepatic cholestasis of pregnancy is a hepatic complication that predominantly arises during the second or third trimester. it is characterized by serum bile acid levels above 10 micromol/l and persistent pruritus, which resolves after delivery. to date, it has been observed that respiratory distress syndrome occurs more frequently in neonates born to mothers with cholestasis of pregnancy, and a potential new entity, 'acute bile acid-induced pneumonia,' has been proposed, though statistical confirmation is lacking. therefore, the investigators deem it imperative to conduct a study in the neonatal population to establish a definitive conclusion regarding neonatal pulmonary impairment secondary to maternal bile acid accumulation.

Eligibility criteria:
case inclusion criteria: * mother with recent diagnosis of intrahepatic cholestasis of pregnancy (serum bile acids over 10 micromol/l in the last 7 days before birth), with informed consent given a few hours before giving birth * ursodeoxycholic acid, independent of dosage or initiation of treatment * neonates born in clinical hospital of obstetrics and gynecology "prof.dr. panait sirbu" exclusion criteria: * no informed consent * serum bile acids under 10 micromol/l in the last 7 days before birth * newborns transferred from other neonatal units control inclusion criteria: * mother with no history of hepatic disease during or before the current pregnancy, with informed consent given a few hours before giving birth * neonates born in clinical hospital of obstetrics and gynecology "prof.dr. panait sirbu", of similar gestational age/weight/sex at birth to corresponding neonates in the cholestasis group exclusion criteria: * ursodeoxycholic acid, independent of dosage or initiation of treatment (suspected hepatic disease/elevated transaminases) * newborns transferred from other neonatal units, with different gestational age/weight/sex than cases

Keywords: bile-acid pneumonia cholestasis of pregnancy intrahepatic cholestasis rds respiratory distress syndrome