Kornimate/medical-research-clean huggingface dataset:
a study to assess the efficacy and safety of firmonertinib versus placebo for adjuvant treatment in participants with stage ib - iiib nsclc with uncommon epidermal growth factor receptor (egfr) mutations, following complete surgical resection with or without adjuvant chemotherapy（firmost）

Conditions: NSCLC; Adjuvant Treatment

Summary: this is a phase 3, global, double-blind, randomized, controlled multicenter clinical study to assess the efficacy and safety of adjuvant treatment with firmonertinib versus placebo in participants with stage ib-iiib nsclc with uncommon egfr mutations (exon 20 insertions, pacc and classical-like mutations) after complete surgical resection with or without adjuvant chemotherapy. about 338 eligible participants will be enrolled and randomized in a 1:1 ratio to receive either firmonertinib 240 mg qd or placebo qd in 21-day treatment cycles. before randomization, the participant must have undergone complete surgical resection (r0 resection), must have sufficiently recovered from surgery, and must have completed adjuvant chemotherapy (if applicable). the participants will receive firmonertinib or placebo as adjuvant treatment until unacceptable toxicity, withdrawal of informed consent, disease recurrence, initiation of new antitumor treatment, completion of treatment, or other end of treatment reason is met.


Eligibility criteria:
inclusion criteria: 1. sign the informed consent form (icf). 2. aged ≥ 18 years old. participants from japan/taiwan aged ≥ 20 years old. 3. histologically confirmed diagnosis of primary non-small cell lung cancer (nsclc) of predominantly non-squamous histology. 4. underwent complete surgical resection of primary lung cancer and systematic lymph node dissection (r0 resection). 5. classified post-operatively as stage ib, ii, iiia, or iiib (t3n2m0 only) on the basis of pathologic criteria, with the disease staging following the 9th edition tnm staging classification: lung cancer issued by union for international cancer control (uicc) and american joint committee on cancer (ajcc). 6. documented results of the presence of uncommon egfr mutations (exon 20 insertion mutations, pacc mutations, and/or classical-like mutations, either as single mutations or as co-mutations), in tumor tissue or blood via a validated ngs or validated pcr assay. exclusion criteria: a participant would be excluded from the study if he/she meets any of the following: 1. nsclc with egfr exon 19 deletion or l858r or c797s mutation. 2. incomplete resection (r1/r2) or segmentectomy or wedge resection only. 3. prior treatment with any of the following: 1. prior treatment with any antineoplastic therapy other than standard platinum-based doublet adjuvant chemotherapy. 2. prior treatment with neoadjuvant therapy. 4. concurrent malignant tumors other than the primary tumor; participants with cancers that can be treated locally and cured may be eligible. 5. previous ild (including drug-induced ild) or active ild/active radiation pneumonitis.

Keywords: egfr nsclc firmonertinib
initiation of oral feeding at 30 versus 33 weeks postmenstrual age

Conditions: Prematurity

Summary: the purpose of the study is to determine if earlier initiation of oral (by mouth as opposed to tube) feedings in premature infants results in earlier attainment of full oral feedings and/or discharge.

infants will be enrolled and randomized at 30 0/7 weeks postmenstrual age. the earlier oral feeding group will initiate oral feedings at 30 0/7 weeks postmenstrual age. the later oral feeding group will initiate oral feedings at 33 0/7 weeks postmenstrual age. the number of oral feeding attempts will be advanced according to a feeding progression protocol for both groups. successful completion of a feeding is defined as oral completion of the full volume of a feeding within 30 minutes, without a bradycardic episode (heart rate \ 5% from baseline values). if infant does not successfully complete \>95% of the total prescribed volume of a feeding, the remainder of the volume will be supplied via gastric tube. all oral feedings will be performed by bedside nurses, or by a parent with observation by the nursing staff, with continuous cardiorespiratory and pulse oximetry monitoring. individual oral feeding attempts for both groups will continue until one of the following occurs despite appropriate pacing of the feeding: 1) the feeding is completed 2) feeding duration of 30 minutes 3) adverse event during a feeding \[multiple bradycardic episodes (3 episodes of heart rate \<100 beats per minute), bradycardia with choking episode, single severe bradycardia (heart rate \<60)\]. if the infant experiences an adverse event during an oral feeding attempt, oral feeding attempts will be held for 2 days.

Eligibility criteria:
inclusion criteria: * gestational age \<= 29 weeks at birth * tolerating enteral feedings for at least 3 days before 30 weeks postmenstrual age exclusion criteria: * neurologic, cardiac, respiratory, or gastrointestinal disorders that interfere with oral feeding
integrated care pathways in a community setting

Conditions: Chronic Illness

Summary: the ambition of this study is to raise the quality of care for old and chronically ill patients by establishing a sustainable, systematic prevention and integrated care model for users of home care services. in this cluster randomized study the intervention will be carried through in five municipalities and three general hospitals. the home care units in every municipality will be randomized to either intervention og control units.

the primary objective of this study is to develop a functional and integrated care model between primary and secondary health care that will meet the needs both in the city and in smaller rural areas. the secondary objective of this study is to reduce the need of care at primary and secondary level through a a systematic and integrated follow-up by home care nurses and general practitioners to: * enable these patients to manage their health needs more efficiently and independently * achieve better collaboration within primary care * achieve better collaboration between primary- and secondary health care professionals * achieve increased satisfaction and confidence with the health care services by the users and their relatives both for included patients and other patients receiving home care services. * promote health and prevent unnecessary decline in health * strengthen the patients' ability to manage their daily activities.

Eligibility criteria:
inclusion criteria: * person 70 years or above being discharged from the general hospital * will receive home care services within four weeks after being discharges from the hospital. exclusion criteria: * do not agree or are not able to agree to participate * is already involved in other research studies affecting the home care services.

Keywords: frail elderly chronic illness integrated care model clinical pathways home care services
an interactive informed consent and education program for pregnant women

Conditions: Pregnancy; Down Syndrome

Summary: the purpose of this study is to determine whether an interactive education program for prenatal testing is effective in improving pregnant women's understanding of and expectations towards prenatal screening and diagnosis.

women face a variety of medical decisions during pregnancy and childbirth. while there are extensive educational resources for pregnant women, modern medicine presents decisions that many women are poorly equipped to make. issues such as prenatal screening and mode of birth after a cesarean delivery require a significant degree of patient education to enable a truly informed medical decision. studies have shown that women have a poor understanding of screening for birth defects and mode of birth after a cesarean delivery. women with a low level of education or poor health literacy are significantly more likely to demonstrate inadequate understanding of prenatal screening. archiemd, inc. has developed a comprehensive interactive medical simulation environment which has the potential to visually convey complex information to patients to improve understanding of medical procedures and educate patients on the consequences of their behavior. we hypothesize that such an interactive medical simulation patient education program can improve patient understanding allowing pregnant women to make informed decisions. in phase i, we will prototype an interactive patient education program for prenatal screening and amniocentesis.

Eligibility criteria:
inclusion criteria: * pregnant woman (6-26 weeks gestation) * over 18 years of age exclusion criteria: * non-english speaking

Keywords: amniocentesis chorionic villus sampling first trimester screening down syndrome
prospective study of diet and cardiovascular disease

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Cerebrovascular Accident

Summary: to examine associations between various dietary elements and the risk of coronary heart disease and stroke.

background: cardiovascular disease is the leading cause of death among residents of the united states. the effect of dietary cholesterol and fat on risk of coronary heart disease (chd) and stroke has been examined extensively in epidemiologic studies. however, the results from these studies are inconsistent. furthermore, the association between some other key elements of diet and risk of chd and stroke has been insufficiently studied in epidemiologic studies. design narrative: the study examines prospectively the association between: 1) dietary intake of trans-unsaturated fat and the risk of coronary heart disease and 2) dietary intake of total, saturated and unsaturated fats and risk of stroke; 3) dietary intake of vegetable and animal protein and risk of stroke; 4) dietary intake of total and water-soluble fiber and risk of coronary heart disease and stroke; 5) dietary intake of sodium and potassium and risk of coronary heart disease and stroke; 6) dietary intake of vitamin c, carotenoids, vitamin e, and folic acid and the risk of coronary heart disease and stroke; and 7) specific foods, such as fish, beans, fruits, and vegetables and the risk of coronary heart disease and stroke. in addition, the association of baseline serum vitamin a, vitamin c, and folate to the risk of coronary heart disease and stroke will be investigated. data from the nhanes1 epidemiologic follow-up study (nhefs) will be used to test the hypotheses. the nhefs is an on-going prospective cohort study being conducted in 14,407 united states men and women aged 25 to 74 years by the national center for health statistics (nchs). the baseline data, including a 24-hour dietary recall and food frequency questionnaire, as well as important cardiovascular risk factors were collected during 1971-75. the follow-up data were collected during 1982 to 1984, 1986, 1987, and 1992. the follow-up data were obtained by means of an interview, medical records from health care facilities, and death certificates for all decedents. in the study, the investigators will re-code dietary data and calculate dietary nutrients using the esha nutrient database. they will also analyze the relationship of dietary nutrients and specific foods to risk of chd and stroke. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
study of the variations of the blood pressure after nephrectomy for renal cancer (vapancr)

Conditions: Renal Cancer; Nephrectomy; Blood Pressure

Summary: this study evaluates the impact of nephrectomy in renal cancer on blood pressure and renal function. the patients will have a follow-up of their blood pressure and renal function until 6 months after their operation.


Eligibility criteria:
inclusion criteria: * nephrectomy programmed for located renal cancer exclusion criteria: * patients with metastatic renal cancer * incapacity to use a self-measurement tensiometer * patients treated for high blood pressure * patients with laxative
pharmacokinetic, immunological and biochemical sample collection and analysis of a tysabri patient cohort

Conditions: Multiple Sclerosis; Relapse

Summary: this is an open-label study of patients with relapsing forms of multiple sclerosis designed to assess the biochemical, immunological and pharmacokinetic profiles of a large, actively infusing natalizumab patient population. a duration effect for progressive multifocal leukoencephalopathy (pml) risk associated with natalizumab therapy appears to exist. there is minimal data available to understand this effect at the biochemical and cellular level. the purpose of this study is to gather preliminary data on several parameters to guide in more focused research on the duration effect.


Eligibility criteria:
inclusion criteria: 1. ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (phi) in accordance with national and local subject privacy regulations. 2. aged 18 to 75 years old, inclusive, at the time of informed consent. 3. must be a patient with a relapsing form of multiple sclerosis enrolled in the touch prescribing program who is not expected to discontinue tysabri® therapy prior to completion of the requirements of this study. 4. must have been treated with monthly iv infusions of tysabri® 300 mg for at least 1 month. 5. must have a magnetic resonance imaging (mri) brain scan, performed prior to the initiation of treatment with tysabri®, on file. 6. must weigh between 42 and 126 kg, inclusive. 7. fifteen patients who are 1 month to-12 months of natalizumab therapy, fifteen patients who are 24 months and over of natalizumab therapy will be asked to participate in the tnf alpha subset. exclusion criteria: medical history: 1. history of, or abnormal laboratory results indicative of, any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, and renal, or other major disease, as determined by the investigator. 2. if subject answers 'yes" to any question on the pml questionnaire that is not resolved prior to infusion as per standard operating procedure for natalizumab infusion.

Keywords: multiple sclerosis, relapsing forms
echocardiography guided fluid resuscitation in critically ill patients.

Conditions: Fluid Responsiveness; Echocardiography

Summary: to compare between the impact of echocardiography guided fluid resuscitation and clinically guided fluid resuscitation on critically ill patients in hospital outcome.

resuscitation often requires the infusion of intravenous fluid in an effort to reverse organ dysfunction. the harms of inappropriate use of fluid are becoming increasingly apparent the question of whether the patient improves with fluid, additional vasopressors or inotropes can be difficult to answer. the gold standard for assessing fluid responsiveness to guide fluid administration in critically ill patients is to perform a fluid challenge. the rationale for volume expansion is to increase the cardiac output (co) and oxygen delivery to ultimately improve tissue oxygenation. this involves the infusion of a specific amount of intravenous fluid to assess ventricular preload reserve and subsequent systemic haemodynamic effects. in a patient with acute hemodynamic instability, a fluid challenge will cause an increase in stroke volume, according to the frank-starling curve. this increase in stroke volume has a salutary effect because it improves tissue perfusion. in contrast, higher hydrostatic pressures in the vascular system predispose the patient to edema, organic dysfunction, and increased risk of in-hospital mortality. fluid responsiveness is conventionally defined as an increase of at least 10% to 15% in sv in response to a fluid challenge, which is a reflection of the limits of precision of the technology used. assessment of the response in flow to a fluid challenge can be guided with echocardiography. it is achieved by measuring left ventricular outflow tract velocity time integral (lvot vti) immediately before and after fluid challenge.

Eligibility criteria:
inclusion criteria: 1- all critical ill-patients with acute physiologic assessment and chronic health evaluation ii score (apache ii score)≥ 25 exclusion criteria: 1. bad echocardiographic window 2. apache ii score \< 25.
post partum maternal and neonatal intervention package

Conditions: Early Postpartum and Newborn Care; Maternal Mortality; Neonatal Mortality

Summary: introduction of a community-based intervention package including prevention strategies, early recognition and management of common postpartum \& neonatal problems, as well as prompt referral of high risk/complicated cases through trained first level primary health care workers, will result in a significant reduction in postpartum maternal and neonatal mortality in pakistan

introduction of a community-based intervention package including prevention strategies, early recognition and management of common postpartum \& neonatal problems, as well as prompt referral of high risk/complicated cases through trained first level primary health care workers, will result in a significant reduction in postpartum maternal and neonatal mortality in pakistan.

Eligibility criteria:
inclusion criteria: * neonates delivered within the study area exclusion criteria: * neonates delivered outside the study area

Keywords: post partum neonate community health care workers
results of surgical treatment of the hepatobiliopancreatic surgical unit

Conditions: Pancreas Disease; Liver Diseases; Surgical Procedure, Unspecified; Bile Duct Diseases

Summary: the main aims of this study are: 1. - to evaluate post-surgical morbidity and mortality outcomes, following the criteria and the definitions from claven-dindo and isgps international classifications, of the patients operated by the hpb surgical unit. 2. - to evaluate survival and disease-free survival rates of the patients operated by the hpb surgical unit due to tumoral cause.


Eligibility criteria:
inclusion criteria: * all patients operated by the hpb surgical unit in the last 10 years (retrospective) * all patients being operated by the hpb surgical unit from january 2019 onwards who provide inform consent (prospective). exclusion criteria: * patients not eligible for surgery * patients not interested in taking part in the study

Keywords: hepatobiliopancreatic surgery
drug-drug interaction between simvastatin and shr3824

Conditions: Type 2 Diabetes

Summary: the purpose of thr study is to investigate the potential interation between multiple oral doses of shr3824 and single oral dose of simvastatin in healthy adult volunteers.


Eligibility criteria:
inclusion criteria: * healthy male volunteers with a body mass index (bmi, a measure of a person's weight in relation to height) between 19 and 26 kg/m2 exclusion criteria: * history of hypoglycemia * history of urinary tract infections,or genital infections * history of current clinically significant medical illness as determined by the investigator * known allergy to shr3824 or simvastatin or any of the excipients of the formulation of shr3824 or simvastatin

Keywords: shr3824,simvastatin, drug-drug interaction
study: treatment of relapsed lymphoid malignancies with an anti-angiogenic approach

Conditions: Non-Hodgkin's Lymphoma; Cancer

Summary: 1.1 to determine the efficacy of a combination treatment of vp-16, chlorambucil, dexamethasone, and vincristine in patients with relapsed/refractory hematological malignancies. 1.2 to determine the toxicity profile of the above regimen in this patient population. 1.3 evaluate the effect of low dose administration of chemotherapy on angiogenesis, and correlate this with tumor responses.

the purpose of the study is to see how effective the combination of chemotherapy drugs vp-16, chlorambucil, dexamethasone, and vincristine is for patients who have blood cancers that have returned or not responded to prior treatment. some patients may also receive a medication called rituximab if their doctor thinks it is appropriate. this drug combination will be given to study participants in a low dose continuous basis. the study will also collect information about the side effects of the above drug combination on patients with these types of cancers. previous studies on patients with non-hodgkin's lymphoma indicate that some patients treated with this drug combination achieved a high response. the aim of this study is to test this drug combination in a controlled setting.

Eligibility criteria:
inclusion criteria: * all patients, 18 years of age or older, with hodgkin's lymphoma, non-hodgkin lymphoma (nhl), multiple myeloma (mm), or chronic lymphocytic leukemia (cll) are eligible. * patients must have a life expectancy of at least 12 weeks. * patients must have a zubrod performance status of 0-2. * patients must sign an informed consent. * patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of \> 1,000 or cells/mm3 and platelet count \>50,000/mm3 and absence of a regular red blood cell or platelet transfusion requirement. * patients should have adequate hepatic function with a total bilirubin \< 2 mg/dl and sgot or sgpt \< two times the upper limit of normal, and adequate renal function as defined by a serum creatinine \< 2.0 x upper limit of normal. * patients must have received at least two previous chemotherapy regimens for their disease. * patients must have measurable disease (nhl) or evaluable disease (mm, cll). exclusion criteria: * patients with symptomatic brain metastases are excluded from this study. * pregnant women or nursing mothers are not eligible for this trial. patients of child bearing potential must use adequate contraception. * patients may receive no other concurrent chemotherapy or radiation therapy during this trial. * patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.

Keywords: non hodgkin's lymphoma phase ii lymphoid malignancies