Kornimate/medical-research-clean huggingface dataset:
taxol(paclitaxel),uft and leucovorin in patients with advanced gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to evaluate the response rate of paclitaxel combination chemotherapy with uft and leucovorin in patients with advanced gastric cancer.

since 1982,cancer has been the leading cause of death in taiwan. in particular,gastric cancer is the fourth leading cause of death in male cancer patients and the sixth for female patients in 2000,accounting for an estimated 2,374 deaths. in recent years, the treatment of gastric cancer patients has gradually been improving due to advances in early diagnosis and surgical techniques. although chemotherapy and radiation therapy have been used in either the adjuvant or palliative setting, their values are still limited due to their unacceptable toxicity or inadequate efficiency.

Eligibility criteria:
inclusion criteria: 1. at least 18 years old 2. patients with histologically confirmed gastric adenocarcinoma, defined as locally advanced unresectable or metastatic or recurrent disease 3. patients with at least one measurable lesion 4. ecog performance status of 0,1 or 2 5. patients with no prior chemotherapy and radiotherapy for metastatic disease (patients who have received and completed prior adjuvant chemotherapy at least 6 months prior to study enrollment may be enrolled into the study, prior taxane chemotherapy should be excluded) 6. patients with physiological functions (bone marrow, heart, liver, kidney, etc.) meeting the following criteria: wbc \>4000/mm3, anc \>1500/mm3, plt \>100,000/mm3, hb \>9.0g/dl, alt\<3 times the uln (\<5 times the uln for liver metastasis cases), total bilirubin \<1.5mg/dl, creatinine \<the upper limit of normal 7. accessible for treatment and follow-up 8. give written informed consent 9. women of child bearing potential must have a negative plasma or urine pregnancy test within 72 hours prior to start of the study medication exclusion criteria: 1. patients who received surgery within 14 days prior to enrollment 2. patients with cns metastasis 3. history of hypersensitivity related to the administration of polyoxyethylated-castor-oil (cremophor el)-containing preparation (e.g. cyclosporin,etc.) or hardened-castor-oil-containing preparation (e.g. vitamin preparation for injection,etc.) 4. patients with a history of severe hypersensitivity 5. active infectious symptoms 6. patients with active gastrointestinal bleeding, intestinal obstruction or other situation that dose not allow oral intake of medication 7. patients with ascites that adversely affects performance status 8. pre-existing ctc grade 2 or greater neuropathy (motor or sensory) 9. pregnant or nursing females 10. patients who have participated in other clinical trials within 30 days prior to the first dose of the study drug

Keywords: combination,chemotherapy,advanced gastric cancer
neomend progel™ pleural air leak sealant post-approval study

Conditions: Lung Cancer; Lung Tumor

Summary: the purpose of this post approval study is to further characterize the safety profile of the progel™ pleural air leak sealant in commercial use, with specific reference to long-term safety over 90 days of follow-up.

patients having open thoracotomy involving lung resection surgery will be considered for the study. subjects will be examined for adverse events and complications from either the treatment or the procedure. follow-up visits are required at 30 days and 90 days after the surgery.

Eligibility criteria:
inclusion criteria: * scheduled for an open thoracotomy for lung resection * has at least one or more intraoperative visible air leak \>= 2 mm following the lung resection surgery exclusion criteria: * pregnant or breast feeding * history of an allergic reaction to human serum albumin * has a significant clinical disease or condition * had previous open thoracotomy procedures * unable to participate in all necessary study activities due to physical or mental limitations

Keywords: pleural air leak pulmonary resection open thoracotomy
using virtual reality to prevent pre-operative anxiety in ambulatory surgery patients

Conditions: Hallux Valgus; Surgery

Summary: the primary objective is to evaluate the impact on pre-operative anxiety management of using the virtual reality mask for surgery of hallux valgus.

as secondary objectives, the study aims * to evaluate post-operative analgesic according to non-drug pre-operative hypnosis, measured by reduction in analgesic intake, and by evaluate of pain; * to evaluate factors which permitting discharge rapidly from hospital in case of hypnosis with virtual reality.

Eligibility criteria:
inclusion criteria: * patient ≥ 18 years; * autonomous patient living at home; * affiliated to a social security scheme; * informed consent signed by patient; * patient will undergo a planned ambulatory surgery for hallux valgus. exclusion criteria: * inability to understand stai-a questionnaire; * patient refusal; * patient underwent a bilateral surgery; * patient judicial decision; * covered by french ame health system.

Keywords: hallux valgus hypnosis pre-operative anxiety surgery
awareness during blended anaesthesia

Conditions: Consciousness, Level Depressed; Intraoperative Awareness

Summary: the aim of this study was to estimate the relations between bispectral index values and explicit or implicit memory or dreams during two different minimal alveolar concentration (mac) of sevoflurane in patients undergoing blended anaesthesia for major abdominal surgery and ,in this way, estimate the possibility to reduce, in presence of a deep analgesia, like epidural analgesia, the requirement of halogenated volatile anesthetics.

the decreased responsiveness to stimulation defines depth of anaesthesia which is a balance between effects of anaesthetic drugs and surgical stimulations. awareness is a rare occurrence with an incidence of 0,1-0,2 % , defined as postoperative recall of events occurring during general anaesthesia. different stages of awareness should be defined: conscious awareness with explicit recalls with pain; conscious awareness with explicit recalls without pain; conscious awareness without explicit recall and possible implicit recall; subconscious awareness without explicit recall and possible implicit recall; no awareness . this memory can be traumatic and may result in developing a chronic posttraumatic stress disorder (ptsd) in more than half of subjects . some cases of awareness are caused by inadequate anesthesia and are potentially avoidable through the assessment of depth of hypnosis by an intraoperative monitoring , especially when muscle relaxants are used. the bispectral index ( bis ), one of the devices designed to monitor brain activity, through a proprietary algorithm , elaborates eeg and provides an index of hypnotic level. thus, several variables, derived from eeg time and frequency domain, are combined into a single index indicating the patient's level of consciousness. a range between 40 and 60, during surgery, permits both to prevent awareness and to reduce the dose of anesthetic agent administered . in this study, during major abdominal surgery, an epidural analgesia was performed to suppress afferent noxious stimuli and combined with a general anaesthesia based on halogenates. thereby the aim of this study was to estimate the relations between bispectral index values and explicit or implicit memory or dreams during two different minimal alveolar concentration (mac) of sevoflurane in patients undergoing blended anaesthesia for major abdominal surgery and ,in this way, estimate the possibility to reduce, in presence of a deep analgesia, like epidural analgesia, the requirement of halogenated volatile anesthetics.

Eligibility criteria:
inclusion criteria: native italian speakers american society of anaesthesiologist physical status i-ii - exclusion criteria:refusal of placement of epidural catheter neurological or psychiatric diseases hearing impairment use of drugs know to affect central nervous system coagulopathy heart conditions infections allergy to local anaesthetics liver or renal disease -

Keywords: cerebral state index monitor
study of cabozantinib as monotherapy or in combination with nivolumab in patients with advanced or metastatic renal cell carcinoma under real-life clinical setting in 1st line treatment.

Conditions: Advanced Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma

Summary: the purpose of the protocol, is to describe the use of cabozantinib tablets as monotherapy or in combination with nivolumab including the number of dose reductions, dose interruptions and terminations due to (serious) adverse events in subjects with advanced or metastatic renal cell carcinoma (mrcc) treated in real-life clinical setting in 1st line treatment.


Eligibility criteria:
inclusion criteria: * males or females aged 18 years and older with capacity to consent. * subjects receiving cabozantinib as monotherapy or in combination with nivolumab as a first line treatment for advanced or metastatic renal cell carcinoma * subjects with the intention to be treated with cabozantinib tablets as monotherapy or in combination with nivolumab according to the current local summary of product characteristics (smpc); decision has to be taken before entry in the study. * signed written informed consent exclusion criteria: * participation in an interventional study at the same time and/or within 3 months before baseline. * previous participation in this study
lipid profile in diabetic and non diabetic ckd patients

Conditions: Chronic Kidney Disease Patients

Summary: the goal of this observational study is to compare blood lipid (fat) levels in participants with chronic kidney disease (ckd) with diabetes and without diabetes and who over 20 years old. the main question this study aims to answer is: does having diabetes make fat problems worse in people with chronic kidney disease (ckd), or is there no connection between them? researchers will compare the blood lipid (fat) levels in people with chronic kidney disease (ckd) who have diabetes and those without diabetes to see if having diabetes makes lipid problems worse in ckd patients, or if there is no connection between diabetes and changes in lipid levels. participants will need to fast for 10 hours before undergoing this test. this means not eating any food or drinking anything except water. samples will be taken and sent to laboratory immediately.


Eligibility criteria:
inclusion criteria: * patients of chronic kidney disease (ckd) presenting to the sohag university hospital * patients aged above 20 years of age. * all patients who have given consent for enrolling into the study. exclusion criteria: * patients aged 20 years of age or below. * patients on lipid-lowering drugs. * kidney transplanted patients.
strain x cardiopulmonary test

Conditions: Heart Failure

Summary: introduction : patients with heart failure (hf ) with systolic dysfunction of moderate to severe exhibit significant reduction in the ability to exercise compared to those with mild dysfunction , and have worse prognosis. however, some clinical markers of severity and diagnosis widely used in this population such as ejection fraction (ef) , are not always able to translate the actual degree of cardiac damage as well as their relationship with the cardiorespiratory fitness of these individuals and prognosis . objective: to evaluate the ability of the global longitudinal strain ( gls ) in predicting exercise tolerance in heart failure patients with moderate and significant systolic dysfunction.


Eligibility criteria:
inclusion criteria: * moderate and significant systolic dysfunction (lvef \< 45%) assessed by transthoracic echocardiography recent ( last month before evaluation ) teichholz method , or when in the presence of contractile deficit target , by the simpson method. exclusion criteria: * deformity in the face to prevent the coupling of the mask to perform the cpet , * orthopedic and neurological diseases that could make it impossible to perform the tests , * patients with psychiatric disorders that restricted them to respond to the questionnaire , * hf fc iv or hospitalization in the last three months , * angina unstable; * myocardial infarction or heart surgery up to three months before the survey ; * fev1 / fvc \<70 % predicted characterizing obstructive respiratory disorder .
optimal stents during renal colic

Conditions: Ureteral Stent Occlusion

Summary: from june 2018 to october 2018, patients from two distinct clinical centers were prospectively enrolled in the study and stratified (non-randomly) into either control group a, patients who received polyurethane stents (rüsch, teleflex), or experimental group b, patients who received silicone stents (cook medical). each participant completed a survey one hour after stent insertion, in the middle of the stent dwelling period, and before stent removal or ureteroscopy noting body pain and overactive bladder via the visual analog scale pain (vasp) and overactive bladder (oab) awareness tool, respectively. additionally, the successfulness of stent placement, hematuria, number of unplanned visits, and stent encrustation rates were assessed within each group.


Eligibility criteria:
inclusion criteria: * inclusion criteria included age (18 to 60 years old), * confirmed ureteral stone * prescribed ureteral stent placement for pain syndrome relief exclusion criteria: * an active urinary tract infection.
option 2: a trial to assess the safety and efficacy of ms1819 in enteric capsules in patients with cystic fibrosis

Conditions: Exocrine Pancreatic Insufficiency (EPI); Cystic Fibrosis (CF)

Summary: the primary objectives of this study are to assess the safety and efficacy of ms1819 in enteric capsules vs porcine pancreatic enzyme replacement therapy (pert) in patients with exocrine pancreatic insufficiency (epi) due to cystic fibrosis (cf). the exploratory objective of the extension phase (ep) is to find a dose of ms1819 in immediate release capsules that is safe and results in cfa values in a therapeutic range.

this is a phase 2, open-label, multicenter, 2, 2x2 crossover study assessing the safety and efficacy of ms1819, 2240 mg/day vs porcine pert, and 4480 mg/day vs porcine pert given at the same dose and dosing regimen that was being administered during the pre-study period. ms1819 will be administered in enteric capsules. ms1819 will be assessed in a 2x2 crossover including approximately 30 patients completing both periods. fifteen patients will be randomized to the ms1819 2240 mg/day vs pert arm, and 15 patients will be randomized to the ms1819 4480 mg/day vs pert arm. patients in each arm will further be randomized to receive either the sequence consisting of ms1819 for 3 weeks followed by pert for another 3 weeks or the opposite sequence of treatments, pert for 3 weeks followed by ms1819 for another 3 weeks.the coefficient of fat absorption (cfa) will be measured at the end of each 3 week study period. patients enrolled into the extension phase (ep) will be composed of patients who have completed the crossover phase of option 2.

Eligibility criteria:
inclusion criteria: 1. cystic fibrosis, based on 2 clinical features consistent with cf, plus either a new/historic sweat chloride ≥60 mmol/l (measured while not on a cftr modulator) or genotype. 2. under stable dose of porcine pert 3. a fair or better nutritional status 4. fecal elastase \<100 µg/g 5. standard-of-care medications including cftr modulators are allowed exclusion criteria: 1. history or diagnosis of fibrosing colonopathy 2. any chronic diarrheal illness unrelated to pancreatic insufficiency 3. alanine aminotransferase (alt) or aspartate aminotransferase (ast) level ≥5 ×upper limit of normal (uln), or total bilirubin level ≥1.5 ×uln at the screening visit 4. feeding via an enteral tube during 6 months before screening 5. forced expiratory volume ≤30% at the screening visit

Keywords: exocrine pancreatic insufficiency epi cystic fibrosis cf
blood and cerebrospinal fluid for pediatric brain tumor research

Conditions: Hydrocephalus

Summary: in normal patients, blood and cerebrospinal fluid (csf) contain circulating cells and other molecules such as proteins and nucleic acids. in patients with central nervous system (cns) and other conditions, the levels of these molecules may be altered. in several other studies at our institution, the investigators are investigating such molecules in tumor specimens as well as the blood and cerebrospinal fluid of pediatric patients with cns tumors. however, these levels are difficult to interpret without comparing them to levels in patients without cns tumors. the investigators propose a study to collect small amounts of blood and cerebrospinal fluid from pediatric patients without cns tumors who are undergoing a diagnostic or therapeutic neurosurgical procedure aimed at addressing altered csf dynamics.


Eligibility criteria:
inclusion criteria: * children without central nervous system tumors who are undergoing a neurosurgical procedure to address hydrocephalus during which csf will be obtained * between the ages of 1 year and 21 years * patients must be having blood draws, lumbar punctures or csf sampling from ommaya reservoirs or vps as part of routine clinical care. exclusion criteria: * patients who do not require routine blood draws and/or csf collection as part of their routine clinical care * patients who are considered too ill to participate as determined by their treating physician * patients with documented bacterial of viral infections of the csf, brain parenchyma and/or neurosurgical devices and/or * patients with suspected de-myelinating conditions * patients who are pregnant or lactating.

Keywords: hydrocephalus survivin mirna
flipped classroom for weight management

Conditions: Obesity; Weight Loss

Summary: this study is a 24-week, single-arm trial investigating the feasibility of a flipped classroom behavioral intervention for weight management. the investigators will recruit up to 30 adults ages 18+ with a body mass index greater than or equal to 25 kg/m2 to participate in weekly, 1-hour group weight management education delivered remotely via zoom with a trained health educator. participants will receive a dietary prescription of 1200-1500 calories/day (5 portion-controlled meals and 5+ servings of fruits and vegetables) and exercise prescription of 150-300 minutes exercise/week. additionally, participants will be asked to self-monitor diet and exercise adherence weekly. feasibility outcomes will be collected at baseline, 12-weeks, and 24-weeks.


Eligibility criteria:
inclusion criteria: * body mass index greater than or equal to 25 * age 18 to 75 years * wireless internet connection in the home * ability to engage in moderate to vigorous intensity exercise exclusion criteria: * unable to commit to weekly group education * food allergy/intolerance that would hinder ability to adhere to dietary prescription
febrile illness in kinshasa and kimpese

Conditions: Febrile Illness

Summary: this is a bi-centric prospective observational cohort study of adults and children presenting to the emergency room or outpatient department with community febrile illness (with or without signs of focalization) in 2 clinical sites (hospitals) in the drc. the study will describe the epidemiology, clinical aspects, severity, management and outcome of febrile illnesses using data collected during routine diagnostic and therapeutic procedures. each patient will be followed for 21 days. the follow-up will include * daily visits for hospitalized patients, * telephone calls (or study center visit or home visit) on days 7, 14 and 21 for outpatients and discharged patients. the study has been amended (ec uza approval in june 2021) to perform a set of laboratory analyses in the partners institutions and at the itm. we aim as a new primary objective at describing the profile of different biomarkers (c-reactive protein and white blood cell count with differentiation) in participants enrolled with febrile illness, and as secondary objectives to correlate them with outcome (assessed at day 21) and with several etiological diagnoses, especially malaria (as assessed by rapid diagnostic test and blood smear). the purpose is to investigate the potential diagnostic and prognostic value of these biomarkers which are increasingly available at the point-of-care.


Eligibility criteria:
inclusion criteria: 1. ongoing and objectified fever at presentation, or documented at home or other health center within 24 hours prior to presentation, defined by: * axillary or tympanic temperature \> 37.5°c or * oral or rectal temperature \> 38°c 2. possibility of contact between the patient (or designated relative) and the study team on days 7, 14 and 21 3. informed consent signed by the patient (adults) or a legally acceptable representative (children or patients whose condition does not allow them to sign informed consent), with the consent of children as young as 12 years of age, whenever possible. exclusion criteria: 1. children less than two months old 2. hospitalization \> 48 h in the last 14 days (to exclude nosocomial fevers)
stem cell transplantation (sct) for genetic diseases

Conditions: Thrombocytopenia; Metachromatic Leukodystrophy; Fanconi's Anemia; Thalassemia Major; Pure Red-Cell Aplasia; Inborn Errors of Metabolism

Summary: objectives: i. ascertain whether stem cell transplantation (sct) is an effective method by which missing or dysfunctional enzymes can be replaced in patients with various inborn errors of metabolism. ii. determine whether clinical manifestations of the specific disease may be arrested or reversed by this treatment.

protocol outline: patients receive either cyclophosphamide and high dose total body irradiation (tbi) or busulfan and cyclophosphamide. cyclophosphamide iv is given on days -5 and -4 and tbi on days -2, -1, and 0. busulfan is given orally every 6 hours on days -9 through -6 and cyclophosphamide iv on days -5 through -2. patients rest on day -1. patients receive bone marrow infusion on day 0. for gvhd prophylaxis, patients receive methotrexate on day 1, then on days 3, 6, and 11. cyclosporine iv begins on day -2 over 12 hours, followed by continuous infusion for 21 days. then, oral doses of cyclosporine are given every 12 hours to patients who tolerate oral feeding. cyclosporine is continued 6 months posttransplant, then tapered 10% per week and stopped. patients who receive genotypically hla nonidentical stem cells undergo additional gvhd prophylaxis with methylprednisolone (iv or po) or its equivalent every 12 hours on days 3 to day 100. dose is then tapered as tolerated over 1 month. patients who receive cord blood stem cells receive methylprednisolone instead of methotrexate for ghvd prophylaxis. methylprednisolone is given 3 times daily beginning on day 5 and continuing until day 17. then, methylprednisolone is tapered 10% per week as clinically tolerated. to accelerate engraftment, patients receive filgrastim im daily beginning on day +1 and continuing until anc equals 5000.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * hereditary enzymopathies, such as: metachromatic leukodystrophy * congenital immunodeficiencies * heritable hematologic disorders, such as: thalassemia major refractory diamond-blackfan anemia fanconi anemia amegakaryocytic thrombocytopenia --patient characteristics-- * age: under 18 * other: sct is performed using a histocompatible related donor, an unrelated donor, or an unrelated cord blood donor haploidentical donors are accepted for patients with severe congenital immunodeficiency

Keywords: fanconi's anemia amegakaryocytic thrombocytopenia aplastic anemia congenital pure red cell aplasia genetic diseases and dysmorphic syndromes hematologic disorders inborn errors of metabolism metachromatic leukodystrophy pure red cell aplasia rare disease sphingolipidoses thalassemia major