Kornimate/medical-research-clean huggingface dataset:
endeavor to stop nausea/vomiting associated with pregnancy (e-snap)

Conditions: Pregnancy; Severe Nausea and Vomiting; Hyperemesis Gravidarum

Summary: the primary objective of this proposal is to conduct an early phase 2 clinical trial to determine the acceptability, dosing, tolerability and safety of mirtazapine for severe nausea and vomiting of pregnancy (snvp) that is not adequately responsive to current standard treatments. this plan mirrors clinical practice since commonly prescribed antiemetic/ antinauseant drugs will be tested for efficacy before treating with mirtazapine.

translational research in maternal and pediatric pharmacology and therapeutics (par-20-299) supports research to "enhance the usage of existing drugs or drug repurposing for safer and more effective treatment for pregnant women" for "the early and conceptual stages of these projects. the primary objective of this proposal is to conduct an early phase 2 clinical trial to determine the acceptability, dosing, tolerability and safety of mirtazapine for severe nausea and vomiting of pregnancy (snvp) that is not adequately responsive to current standard treatments. this plan mirrors clinical practice since commonly prescribed antiemetic/ antinauseant drugs will be tested for efficacy before treating with mirtazapine. mirtazapine is a promising drug to repurpose for snvp. it has potent anti-emetic properties and is available as an oral disintegrating formulation. it is used off-label to treat nv during cancer chemotherapy, prevent post-surgical nausea and vomiting and for gastroparesis. it is marketed as the serotonin-norepinephrine reuptake inhibitor antidepressant remeron®. mirtazapine has multiple receptor effects beyond those involved in reducing depressive symptoms. in cancer and chemotherapy patients, it produces rapid resolution of nausea and vomiting by blocking physiologic inputs that coordinate emesis. it is hypothesized that repurposing mirtazapine for obstetric use overcomes the challenges of traditional pathways to develop new agents because its pharmacokinetics, safety and dosing have been established for general populations of patients and exposure data are available because it is prescribed to pregnant persons with depression.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * inpatient or outpatient status * english speaking * obstetrician's evaluation and diagnosis of snvp or hg * tolerance of oral disintegrating tablet at bedtime * puqe score of 10-15; moderate/high or severe * refractory snvp * blood pressure range 70-200 / 45-120 * normal ecg exclusion criteria: * allergic or adverse reaction to mirtazapine * patient has bipolar disorder * subjects with active depression, or history of or current active suicidal ideation or attempt * subjects with renal or hepatic impairment * substance about in last 6 months * use of medicinal or recreational cannabis-derived products in the last 6 months * taking maois, strong cyp3a inducers or inhibitors, and ssris

Keywords: pregnancy severe nausea vomiting
quality of life in postmenopausal women who are receiving either exemestane or anastrozole with or without celecoxib for stage i, stage ii, or stage iiia primary breast cancer

Conditions: Breast Cancer

Summary: rationale: quality-of-life assessment in postmenopausal women who are receiving hormone therapy for breast cancer may help to determine the effects of treatment on these patients and may improve the quality of life for future breast cancer patients. purpose: this clinical trial is studying quality of life of postmenopausal women who are receiving either exemestane or anastrozole with or without celecoxib for stage i, stage ii, or stage iiia primary breast cancer.

objectives: primary * compare treatment-related symptoms using the functional assessment of cancer therapy-endocrine symptoms (fact-es) questionnaire in postmenopausal women with receptor-positive stage i, ii, or iiia primary breast cancer undergoing treatment with exemestane vs anastrozole with or without celecoxib on protocol can-ncic-ma27. secondary * compare health-related quality of life using the fact-es questionnaire in patients treated with these regimens. * determine the extent to which differences in treatment-emergent symptoms affect overall quality of life in patients treated with these regimens. outline: this is a multicenter, companion study. patients receive treatment on can-ncic-ma27. health-related quality of life and treatment-related symptoms are assessed using the functional assessment of cancer therapy-endocrine symptoms (fact-es) questionnaire at baseline and at 3, 6, 12, and 24 months. projected accrual: a total of 1,253 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed invasive breast cancer * pt1-3; pnx, pn0-2 or pn3\*; m0 note: \*only when the sole basis for this classification is the presence of 10 or more involved axillary lymph nodes * registered on protocol can-ncic-ma27 within the past week * hormone receptor status: * estrogen receptor- and/or progesterone receptor-positive by immunohistochemistry or tumor receptor content ≥ 10 fmol/mg protein * at least 1 tumor must be receptor-positive in patients with bilateral breast cancer patient characteristics: age * postmenopausal performance status * ecog 0-2 sex * female menopausal status * postmenopausal life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified other * able to read, understand, and complete quality of life questionnaires prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * not specified

Keywords: stage i breast cancer stage ii breast cancer stage iiia breast cancer
study to assess the safety and efficacy of infliximab to treat hidradenitis suppurtativa

Conditions: Hidradenitis Suppurativa

Summary: a study to assess the safety and efficacy of the iv drug infliximab for the treatment of hidradenitis suppurativa


Eligibility criteria:
inclusion criteria: * person must have moderate to severe hidradenitis suppurativa * multiple er or doctors visits related to hs * intralesional kenalog injection \>5/year, but none within 3 months of entry * hs \>1 year duration * failed systemic retinoids, but not within 3 months of entry * failed at least one prior course of antibiotic therapy, which must not have been administered within 3 months of entry to the study (excluding the recommended antibiotic regimen given immediately before randomization for evidence of active infection * history of surgery (reconstructive), but not within 3 months of entry exclusion criteria: * women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion (this includes father's who plan on fathering a child within 6 months after their last infusion * known allergy against infliximab * use of other systemic anti-inflammatory medication except nsaids and low dose systemic steroids (equal or less than 10 mg daily prednisolone or equivalent). * have had any previous treatment with monoclonal antibodies or antibody fragments. * have a known history of serious infections (eg, hepatitis, pneumonia or pyelonephritis) in the previous 3 months. * have or have had an opportunistic infection (eg, herpes zoster \[shingles\], cytomegalovirus, pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than tb) within 6 months prior to screening. * are considered ineligible according to the tb eligibility assessment, screening, and early detection of reactivation rules defined in section 26 on: tuberculosis eligibility assessment, screening, and early detection of reactivation rules. * have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly. * currently have any known malignancy or have a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence. * have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.

Keywords: hidradenitis suppurativa
fluorine f 18 ef5 pet/ct imaging in patients with locally advanced or recurrent/metastatic cervical cancer

Conditions: Cervical Cancer

Summary: rationale: diagnostic procedures, such as fluorine f 18 ef5 pet/ct imaging, may help find oxygen in tumor cells. it may also help doctors predict a patient's response to treatment and help plan the best treatment. purpose: this trial is studying fluorine f 18 ef5 pet/ct imaging to see how well it works in finding hypoxia in tumor cells of patients with locally advanced or recurrent/metastatic cervical cancer.

objectives: * to determine if the presence and heterogeneity of hypoxia can be detected by fluorine f 18 ef5 binding in tumors during pet/ct imaging in patients with newly diagnosed or recurrent carcinoma of the cervix. * to determine if fludeoxyglucose f 18 uptake correlates with fluorine f 18 ef5 uptake. * to assess the relationship between fluorine f 18 ef5 uptake and disease-free and overall survival. outline: patients are stratified according to disease stage (locally advanced vs recurrent or metastatic disease). patients receive fluorine f 18 ef5 iv followed by pet/ct imaging from the base of skull to upper thigh at baseline and during radiotherapy or chemotherapy (i.e., at 3-4 weeks after the initiation of radiotherapy or after the 4th, 5th, or 6th course of chemotherapy). patients also undergo fludeoxyglucose f 18 pet/ct imaging within 7 to 10 days of the second fluorine f 18 ef5 scan. after completion of study treatment, patients are followed up at 30 days and then annually thereafter.

Eligibility criteria:
disease characteristics: * diagnosis of carcinoma of the cervix meeting 1 of the following criteria: * pathologically confirmed, newly diagnosed stage ib-iva (locally advanced) disease * imaging evidence of recurrent or metastatic disease * measurable disease, defined as ≥ 1 cm on anatomic imaging patient characteristics: * karnofsky performance status 70-100% * wbc \> 2,000/mm³ * platelet count \> 90,000/mm³ * total bilirubin \< 2.0 mg/dl * creatinine \< 2.0 mg/dl * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no history of allergic reactions attributed to flagyl (metronidazole) * no other condition or personal circumstance that, in the judgment of the investigator, may interfere with the collection of complete, good-quality data prior concurrent therapy: * not specified

Keywords: recurrent cervical cancer stage ib cervical cancer stage iia cervical cancer stage iib cervical cancer stage iii cervical cancer stage iva cervical cancer stage ivb cervical cancer
impact of sleep disorders on innate immunity in covid-19 patients

Conditions: Apnea, Obstructive Sleep; SARS CoV 2 Infection

Summary: sleep is an important modulator of the immune response, whereby sleep disturbances (ie, poor sleep quality, insufficient sleep and/or primary sleep disorder, obstructive sleep apnea (osa)) contribute to inflammatory disease risk and dysregulation of immune response in front of infectious agents. the objective of this study is to evaluate the impact of undiagnosed and non-treated sleep disorders on innate immunity in a cohort of covid-19 patients and the role of trained immunity induced by influenza vaccination in the innate immune response.

sleep and immune system have reciprocal relationship. sleep has a restorative role on immune system, influencing innate and adaptive immunity and sleep disorders can decrease immune response. healthy innate immunity is crucial into regulation of the response against sars-cov-2. the hypothesis of the study is that the innate immunity response is blunted by sleep disorders and, this mitigated immune response, could influence on covid-19 severity. impaired immune response in patients with sleep disorders could be ameliorated inducing trained immunity by influenza vaccine.

Eligibility criteria:
inclusion criteria: * participants over 18 years old with diagnosis of covid-19 during first year of coronavirus pandemic in march-june 2021. exclusion criteria: * \>70 years and \<18 years * recent covid-19 (\<6 months) * other infection (\<3 months) * obstructive sleep apnea in treatment with cpap prior to covid infection. * immunosuppressed

Keywords: obstructive sleep apnea innate immunity sars-cov-2
the standardized management of hypertension in rural shaanxi

Conditions: Hypertension

Summary: the purpose of the study is to build a prevention and management system of hypertension in rural shaanxi, china, which tries to use the standardized and economical methods to improve the outcome of chronic cardiovascular diseases.

hypertension is common in china, but there are low rates of awareness (36.0%), treatment (22.9%) and control (5.7%) in the hypertension population of an estimated 200 million adults, a figure generated from the nationwide china patient-centered evaluative assessment of cardiac events (peace) million person project (mpp) . substantial health and economic burdens are caused by hypertension, and adequate control of blood pressure (bp) has been a national public health priority. in china, nearly half of population are living in rural areas , where lower treatment and control rates of hypertension compared with urban areas. expenditure of antihypertension medications and insufficient professional ability of rural doctors were the major problems facing hypertension management in rural areas of china with backward economies. absence of affordable medications prescribed may be a major barrier to adherence to medications. the rural doctors with insufficient professional ability had not to provide standard management of hypertension. so, an effective, cheap and simple hypertension control strategy was urgently needed in underdeveloped rural areas. my center has been devoted to the study of hypertension in economically backward rural areas of shaanxi province in western china for decades. we provided a cheap and simple hypertension management plan suitable for these areas. because the cost of the management was about $10 dollars per year, the plan was called the ten dollars project (tdp). the tdp included a management system and a cheap treatment plan. the management software for hypertension was designed to help rural doctors with poor professional medical ability standardly manage hypertension adhering to the guidelines. of course, a more effective and affordable treatment costing about ten dollars a year is the core of this system. the aim of this study was to measure whether the tdp can effectively improve the control of hypertension in rural areas.

Eligibility criteria:
inclusion criteria: * primary hypertension; * age ≥ 18 years old; exclusion criteria: * secondary hypertension; * the acute onset of cardiovascular events within three months; * severe liver disease (alt increased 2-fold greater than creatinine 2.5mg/dl); * severe cardiomyopathy, congenital heart disease, rheumatic heart disease * malignancies * allergic to study drugs * with clear contraindications on study drugs

Keywords: hypertension management; rural areas; control rate
ai-screendcm decentralized clinical trial - pilot study

Conditions: Cardiomyopathy

Summary: the purpose of this study is to assess the feasibility and impact of screening fdr of dcm probands using a mobile ecg with the ability to transmit the ecg for cloud-based ai analysis to detect reduced left ventricular ejection fraction (lvef). this protocol will examine the impact of incorporating the screening ai enhanced ecg into standard of care recommendations.


Eligibility criteria:
inclusion criteria (proband) * male or female age ≥ 18 years * confirmed diagnosis of dcm determined at the discretion of the treating physician and defined as lvef ≤ 45% at any time during the clinical course of the patient * must have at least one living ≥ 18 years fdr * able to provide informed consent inclusion criteria (fdr) * male or female age ≥ 18 years who are first-degree relatives of patients with dcm * proband has provided informed consent * fdr able to provide informed consent * access to a smartphone or digital tablet with cellular data or wi-fi access exclusion criteria (proband) * dcm attributed to any other secondary form of cardiomyopathy per the investigator's determination * proband has previously informed fdr to undergo cardiac screening * ischemic cause of reduced lvef * evidence of myocardial infarction, inducible ischemia or chest pain on stress testing in absence of coronary angiogram to rule out ischemic disease * history of acute coronary syndromes (stemi, nstemi or unstable angina) revascularization or ≥75% stenosis of either left main or lad or ≥75% stenosis of 2 major epicardial vessels on angiogram * moderate or greater primary valvular abnormality not due to underlying cardiomyopathy * congenital structural heart disease * severe and untreated or untreatable hypertension * cardiomyopathy due to acute or reversible conditions; examples include tachyarrhythmias, thyroid disorders, iron overload * any secondary cause of reduced lvef such as pregnancy, myocarditis, amyloidosis, sarcoidosis, exposure to toxins including alcohol, substance abuse or chemotherapeutic drug * (cpc participants only) home address outside of traveling range exclusion criteria (fdr) * previously informed about cardiac screening or has completed cardiac screening by tte * previously diagnosed with reduced lvef * (cpc participants only) home address outside of traveling range

Keywords: artificial intelligence
comparisons between isoperistaltic and antiperistaltic gastrojejunostomy in laparoscopic distal gastrectomy

Conditions: Stomach Neoplasms

Summary: billroth-ii (gastrojejunostomy) is one of major option after gastrectomy for gastric cancer. the investigators hypothesized that isoperistaltic anastomosis lead to higher incidence of dumping syndrome but antiperistaltic (anisoperistaltic) anastomosis have relevance to gastric stasis or obstruction. the investigators will assess complications, dumping syndrome and quality of life between isoperistaltic and antiperistaltic after distal gastrectomy for gastric cancer.

recently, laparoscopic approach has been a option for gastric cancer, especially early gastric cancer. there are growing interest in quality of life in addition to recurrence or survival. there are few report about peristalsis and no report for quality of life according to a direction of peristalsis.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma in stomach * scheduled as laparoscopic distal gastrectomy (tumor located lower or middle third) * planned with gastrojejunostomy after gastrectomy * clinical stage t1n0m0 or t2n0m0 * ecog 0 or 1 (the eastern cooperative oncology group) * asa score class i-iii (the american society of anesthesiologists) * patient has given their written informed consent to participate in the study exclusion criteria: * simultaneously combined resection of other organ (including cholecystectomy) * active other malignancy * requiring total gastrectomy * chronic inflammatory bowel disease or other chronic disease related to bowel motility * uncontrolled diabetes or patients with diabetic complications * vulnerable patients

Keywords: gastric cancer gastrojejunostomy isoperistaltic antiperistaltic
early exposure to lead and adolescent development

Conditions: Lead Poisoning

Summary: this prospective cohort study examines the role of prenatal and early postnatal lead exposure on the neuropsychological status and social adjustment of adolescents enrolled in the cincinnati lead study. we are examining the relationship between moderate exposure to lead and neuropsychological deficits, difficulties in peer relationships, personality disturbances and juvenile delinquency. this birth cohort of approximately 300 subjects has been followed since 1980 with regularly scheduled assessments of blood lead concentrations, health history, social and hereditary factors, and neurobehavioral development.


Eligibility criteria:
subjects for the cincinnati lead study were recruited prenatally if their mothers resided in areas within cincinnati, ohio where there has historically been a high incidence of lead poisoning. infants were eligible for follow-up if they were greater than 1500 grams at birth and had no disqualifying medical conditions such as defined genetic syndromes or other serious complications that may adversely affect neurobehavioral development.

Keywords: lead prenatal development children psychology toxicology teratology
prevention of venous and arterial thromboembolism, in cancer patients undergoing chemotherapy, with a low molecular weight heparin (nadroparin calcium)

Conditions: Advanced Cancer; Metastatic Cancer

Summary: in this phase iii, multicenter study, 1200 patients with lung, breast, gastrointestinal (stomach, colon-rectum, pancreas), ovarian or head and neck cancer undergoing chemotherapy will be randomly assigned (at the beginning of cytotoxic therapy) in a 2:1 ratio and in double-blind conditions to a treatment with subcutaneous low molecular weight heparin (nadroparin calcium, one injection/day) or placebo for the overall duration of chemotherapy or up to a maximum of 4 months (+/- 10 days).


Eligibility criteria:
inclusion criteria: * both sexes;aged\>18 years; * suffering from different types of malignancies(lung, breast,gastric,colon- rectum,pancreatic,ovarian,head and neck cancer)undergoing systemic chemotherapy, * having signed informed consent prior to initiation of any study procedure. exclusion criteria: * adjuvant and neo-adjuvant chemotherapy; * objectively confirmed venous or arterial thromboembolism in the last three months; * antithrombotic treatment for other indications; * life expectancy of less than 3 months; * performance status\>2(ecog); * active bleeding or bleedings in the last four weeks requiring hospitalization,transfusion or surgical intervention; * bleeding diathesis(prothrombin time\ 1.3),or platelet count\<50x10\^9/l; * cerebrovascular hemorrhage in the last six months; * known active gastric or duodenal ulcer; * known cerebral metastasis; * cerebral aneurysm; * iii-iv grade diabetic retinopathy; * severe and uncontrolled hypertension(systolic blood pressure\>180 mmhg or diastolic blood pressure\>110 mmhg); * chronic atrial fibrillation; * acute endocarditis; * acute pancreatitis; * known hypersensitivity to unfractionated heparin or lmwh; * previous occurrence of heparin-induced thrombocytopenia; * renal impairment (dependent on dialysis or creatinine higher than 2.5mg%); * liver insufficiency (alanine aminotransferase,aspartate aminotransferase,alkaline phosphatase levels\>3 times the upper limit of the normal ranges and/or total bilirubin \>3.0 mg/ml); * pregnancy or childbearing potential without adequate contraception; * treatment with other investigational drugs or patient inclusion in other clinical trials; * patients who are unable to fulfill the study requirements in terms of visits/compliance to treatment.

Keywords: thromboembolism cancer chemotherapy low-molecular-weight-heparin nadroparin