Kornimate/medical-research-clean huggingface dataset:
molecular and cellular mechanism in rhinitis allergic patients treated with grazax®

Conditions: Allergic Rhinoconjunctivitis

Summary: the specific clinical trial is a part in which alk- abelló will directly work to explore human immunological mechanisms of sit (observed after grazax treatment).

the main idea of the project was to address the study of some of the most important inflammatory diseases (psoriasis, rheumatoid arthritis, lupus, rhinitis/asthma... ) with the aim of identifying novel inflammatory markers.

Eligibility criteria:
inclusion criteria: * written informed consent obtained before entering the trial. * male and female 18-65 years of age. * a clinical history of relevant rhinitis or rhinoconjunctivitis (with/without concurrent asthma) to grass pollen of at least one year prior to trial entry. * documented positive specific ige against grass pollen (ige ≥ class 2) into the 5 previous years. * positive skin prick test response (wheal diameter ≥ 3 mm) to phleum pratense. * negative pregnancy test for childbearing potential females. * willing and able to comply with the trial protocol regimen. exclusion criteria: * previous treatment by immunotherapy with grass allergen extracts. * a clinical history of symptomatic perennial allergic rhinitis or asthma. * patients with contraindications for immunotherapy as established by the it subcommittee of the eaaci or in the summary of products characteristics of grazax®. * positive pregnancy test (in fertile females). * being immediate family of the investigator or trial staff. * a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the trial, and/or evidence of an uncooperative attitude. * unlikely to be able to complete the trial, for any reason, or likely to move, or travel for extended periods of time during the trial period. * use of an investigational drug within 30 days or 5 half-lives, whichever is longest, prior to screening.
a study of niraparib in patients with ovarian cancer who have received three or four previous chemotherapy regimens

Conditions: Ovarian Neoplasms; Ovarian Cancer

Summary: this is a phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. niraparib is an orally active parp inhibitor. niraparib will be administered once daily continuously during a 28-day cycle. health-related quality of life will be measured by eastern cooperative oncology group performance status (ecog). safety and tolerability will be assessed by clinical review of adverse events (aes), physical examinations, electrocardiograms (ecgs), recist tumor assessments and safety laboratory values.


Eligibility criteria:
inclusion criteria: * patients must agree to undergo tumor hrd testing and blood gbrcamut status testing. * patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed * patients must have histologically diagnosed high-grade (grade 2 or 3) serous epithelial ovarian, fallopian tube, or primary peritoneal cancer with recurrent disease and must have been previously treated with chemotherapy and experienced a response lasting at least 6 months to first-line platinum based therapy. * patients must have completed 3 or 4 previous chemotherapy regimens. * patients must have completed their last chemotherapy regimen \> 4 weeks prior to treatment initiation. * patients must have measurable disease according to recist (v.1.1). * patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer or agree to undergo fresh biopsy prior to study treatment initiation. * patients must agree to blood samples during screening and at the end of treatment for cytogenetic analysis. exclusion criteria: * patients must not have any known, persistent (\> 4 weeks), ≥grade 3 hematologic toxicity during the last cancer therapy. patients must not have any known, persistent (\>4 weeks), ≥ grade 3 fatigue during the last cancer therapy. * patients must not have received pelvic radiotherapy as treatment for primary or recurrent disease within 1 year of the first dose of study treatment. * patients must not have symptomatic uncontrolled brain or leptomeningeal metastases. * patients must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active, uncontrolled infection. * patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment. * patients must not have known history or current diagnosis of myelodysplastic syndrome (mds) or acute myeloid leukemia (aml).

Keywords: gbrcamut brca parp inhibitor hrd ovarian cancer serous epithelial fallopian tube primary peritoneal
estrogen, diet, genetics and endometrial cancer

Conditions: Cancer; Endometrial Cancer; Ovarian Cancer; Corpus Uteri; Endometrium

Summary: the purpose of this study is to see how people's diets, other aspects of their lifestyles, and their individual genetic makeup affect their chances of getting endometrial cancer (cancer of the uterus). this survey will enroll several hundred women who have or have had endometrial cancer and several hundred who do not. we will compare these two groups of women to see what factors may lead to endometrial cancer.

we will conduct a population-based case-control study in six counties of new jersey. cases will be women with newly-diagnosed endometrial or ovarian cancer. controls will be matched by 5-year age groups and selected by random digit dialing (for those under 65), from centers for medicare and medicaid services (cms) files (for those 65 and over), or from neighborhood sampling. controls will not have had a hysterectomy. there will be 400 cases with endometrioid tumors, 60 with serous tumors or clear cell tumors, 300 with ovarian cancer, and 400 controls. in addition, there will be a small group of black women included from mskcc. we will interview participants about known and potential risk factors for endometrial and ovarian cancer and obtain information on diet. we will obtain dna for genetic analysis from buccal specimens collected using a mouthwash rinse method. we will use logistic regression to determine odds ratios for disease with various exposures. for endometrial cancer, we will examine the association of risk with genotypes in strata defined by body mass index and dietary fat consumption.

Eligibility criteria:
inclusion criteria: * diagnosed with epithelial endometrial or ovarian cancer within the year before being contacted (cases) * aged 21 and over * residents of essex, union, morris, middlesex, bergen, or hudson counties, nj * black women with and without endometrial cancer who are seeing gynecologists at mskcc exclusion criteria: * unable to sign informed consent * consent withheld by physician (cases) * hysterectomy (controls) * do not speak english or spanish

Keywords: cancer endometrial cancer ovarian cancer corpus uteri endometrium
the application value of spectral ct in the accurate staging of gastric cancer

Conditions: Gastric Cancer

Summary: spectral ct was used to prospectively collect medical images and clinical data related to gastric cancer, evaluate the effect of image quality in the diagnosis of gastric cancer, and evaluate the application value in the accurate staging of gastric cancer, so as to provide a more accurate clinical basis for diagnosis, promote the development of individualized treatment, and ultimately improve the prognosis of patients.


Eligibility criteria:
inclusion criteria: * (a)patients with pathologically confirmed gastric cancer; * (b) aged ≥ 18 years old; * (c) have not received chemoradiotherapy or surgery. exclusion criteria: * (a)combined with other primary tumors; * (b) the image quality does not meet the diagnostic criteria; * (c)those who cannot tolerate ct examination.
safety and efficacy of dc-cik in patients with advanced non-small-cell lung cancer with bone metastases

Conditions: Non-Small-Cell Lung Cancer With Bone Metastases

Summary: the purpose of this phase i/ii study is to evaluate the safety and efficacy of dendritic cells(dc) vaccine combined with cytokine-induced killer (cik) cells in patients with advanced non-small-cell lung cancer with bone metastases. experimental dc was transfected ad5 vector coding mrnas including suppressor of cytokine signaling (socs) 1, muc1 and survivin,are used for dc-based immunotherapy. based on the results of our previously preclinical study with dc vaccine combined with cik cells, the investigators plan to perform the clinical trial.


Eligibility criteria:
inclusion criteria: * histopathologically confirmed diagnosis of non-small cell lung cancer * age \>18 years at time of consent * received standardized treatment of non-small-cell lung cancer with bone metastases * kps (karnofsky performance scale) \>60 * patient's written informed consent * no severe viral or bacterial infections * predicted survival \>3 months exclusion criteria: * clinically relevant diseases or infections (hbv, hcv, hiv) * females who are pregnant or nursing * immunosuppressant treatment * currently participating in another clinical trial
comparative study of 99mtc-fapi spect/ct and 68ga-fapi pet/ct

Conditions: 99mTc-FAPI-positive Gastrointestinal Tumor

Summary: the purpose of this study is to compare the similarities and differences of 99mtc-fapi quantitative spect/ct and 68ga-fapi pet/ct in the diagnosis and staging of gastrointestinal tumors, and clinical diagnosis and economic value of 99mtc-fapi quantitative spect/ct for the gastrointestinal tumors.

5 healthy volunteers with whole body 99mtc-fapi quantitative spect/ct scans at 1, 2, 4, 6 and 24 hours after tracer injection (mean dose, 20.0 ± 2.0 mci) will be performed. during the imaging period, 1 ml blood samples will be obtained specifically at 1, 2, 4, 6 and 24 hours after the injection, for time-activity curve calculations. the estimated radiation doses will be calculated by using olinda/exm software. forty patients with confirmed or suspected gastrointestinal tumors, whole body 99mtc-fapi quantitative spect/ct scans will be performed on the first day, and whole body 68ga-fapi pet/ct scans will be performed on the next day.according to the scans results of the two agents, with suvmax and suvmean as the analysis indicators, the number and uptake difference of primary tumor and metastatic lesions will be compared and analyzed.

Eligibility criteria:
inclusion criteria: * patients with gastrointestinal tumors: diagnosed by pathological needle biopsy exclusion criteria: * refuse or cannot endure surgery pregnant women
an observational study to assess change in disease activity when ubrogepant tablets are combined with atogepant tablets to treat migraine in adult participants

Conditions: Migraine

Summary: migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. this study will how effective the combination use of ubrogepant and atogepant is in treating adult participants with migraine. change in migraine activity will be assessed. urogepant (ubrelvy) and atogepant (qulipta) are approved drugs for treatment of migraine in adults in the us. approximately 432 adult participants who are prescribed ubrogepant and atogepant by their doctors will be enrolled in this study in the united states. participants will receive ubrogepant oral tablets and atogepant oral tablets as prescribed by their physician. participants will be followed for 30 days. there is expected to be no additional burden for participants in this trial. participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility criteria:
inclusion criteria: * reports meeting migraine diagnostic criteria consistent with international classification of headache disorders (ichd) (i.e., they report symptoms accompanying their headaches that meet migraine criteria22 at screening). * currently using ubrogepant for acute treatment of migraine. * experienced at least 3 migraine attacks in the last 30 days. * currently taking atogepant for preventive treatment of migraine and has been taking atogepant, at the same dose, for at least 30 days. exclusion criteria: * report currently taking rimegepant (nurtec®) for migraine treatment (acute or preventive). * report currently taking any of the anti-cgrp mabs for preventive treatment of migraine: * erenumab (aimovig®) * galcanezumab (emgality®) * fremanezumab (ajovy®) * eptinezumab (vyepti®)

Keywords: migraine ubrogepant ubrelvy atogepant qulipta
hba1c prediction model in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: patients with type 2 diabetes who have poor blood glucose control are enrolled to evaluate the efficacy and safety of the hba1c prediction model for adjust the hypoglycemic treatment regimen, compared with the conventional treatment using self-monitoring blood glucose or glycated albumin.


Eligibility criteria:
inclusion criteria: * age ≥18 years old; * diagnosed with type 2 diabetes mellitus, and the hypoglycemic treatment was not limited; the study physicians judged that the hypoglycemic treatment regimen was stable in nearly 8 weeks; * have hba1c results within 4 weeks, and the range was 7.5-11%; * willing and able to conduct self-glucose monitoring; * have not participated in any other research program in the past 4 weeks. exclusion criteria: * type 1 diabetes mellitus; * severe hypoglycemia ≥1 time or fasting c-peptide ≤0.80 ng/ml in the past 6 months; * diabetic ketosis in the last 1 week; * oral or inhaled corticosteroids for more than 14 days within the last 8 weeks; * anemia, recent blood transfusion, hemoglobinopathy (hemoglobinosis and thalassemia), use of erythropoietic drugs, undergoing dialysis; * pregnancy or breastfeeding; * receiving chemotherapy or radiation therapy; * have a severe mental illness and cannot complete the trial.

Keywords: blood glucose self-monitoring hba1c prediction model ridge regression
the effects of dis/reconnection of implant abutments on peri-implant bone levels

Conditions: Bone Loss; Implant Complication; Gingival Recession

Summary: the aim of this study was to evaluate the effects of definitive abutment connection at the time of implant placement on peri-implant bone levels and soft tissue changes in posterior maxilla and mandible regions.

a total of 38 implants were placed in 17 patients with at least 2 missing posterior teeth in the maxilla or the mandible for this study. each patient received 2 or 4 implants. a definitive prefabricated abutment (test group) was randomly connected to one implant at implant placement (t0) and left undisturbed throughout the duration of the study. on the other implant, a healing abutment (control group) was connected and subjected to go through three disconnections and reconnections at 3 months (t3), 6 months (t6), and 12 months (t12) after the implant placement. throughout the study period (1 year), all implants remained unrestored. marginal bone level changes (mblc) were assessed using standardized periapical radiographs taken at t0 and t12. peri-implant soft tissue parameters including the keratinized mucosa width and lingual mucosa thickness were also recorded and evaluated.

Eligibility criteria:
inclusion criteria: * minimum age 18 * good oral hygiene * healed site that possess two or more missing teeth in the maxillary or mandibular posterior region (excluding third molars) * adequate bone to accommodate at least a 4.3 mm diameter and 8mm length implant at each site * have at least 8mm interocclusal restorative space * willing to participate and attend the planned follow-up visits. exclusion criteria: * history of alcohol/drug dependency, or any medical, physical, or psychological factor that might affect the surgical or prosthodontic procedures and follow-up examinations * history of radiation therapy to the head and neck region * history or current habit of smoking * history or current habit of bruxism * no opposing occluding dentition or prostheses * need for bone augmentation during implant placement * implant insertion torque value \<35 ncm

Keywords: one abutment one time disconnection and reconnection definitive abutment
nursing students' personality traits and competence in workplace violence management

Conditions: Exposure to Violent Event; Nursing Student; Personality; Violence; Workplace Bullying

Summary: aim: the aim of this study was to determine the relationship between nursing students' personality traits and competence in workplace violence management. background: violence against nursing students is a growing concern in nursing education, clinical practice, and professional development and needs to be managed. design: a cross-sectional study. methods: this study was conducted with 321 nursing students in the summer of 2022.


Eligibility criteria:
inclusion criteria: * being in the nursing students at the research university, * being in the \>18 years age, * agree to participate in the study exclusion criteria: * being in the \<18 years age, * disagree to participate in the study

Keywords: exposure to violence nursing student personality violence workplace
epoetin alfa in treating chemotherapy-related anemia in women with stage i, stage ii, or stage iii breast cancer

Conditions: Anemia; Breast Cancer; Fatigue

Summary: rationale: epoetin alfa may stimulate red blood cell production to treat patients who have anemia following chemotherapy. purpose: phase iv trial to study the effectiveness of epoetin alfa in treating chemotherapy-related anemia in women who have stage i, stage ii, or stage iii breast cancer.

objectives: i. determine the effectiveness and safety of epoetin alfa in patients receiving adjuvant chemotherapy for stage i, ii, or iii breast cancer. ii. determine the clinical outcomes in these patients receiving this drug. outline: this is a multicenter study. patients receive epoetin alfa subcutaneously once weekly for up to 24 weeks in the absence of unacceptable toxicity. quality of life is assessed at baseline, at week 13, and at study completion. projected accrual: a maximum of 2,500 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed stage i, ii, or iii breast cancer planned adjuvant anthracycline-based chemotherapy with or without a taxane for 3-6 months hemoglobin 10-14 g/dl (independent of transfusion) no anemia due to factors other than cancer/chemotherapy (i.e., iron, cyanocobalamin, or folate deficiency; hemolysis; gastrointestinal bleeding; or myelodysplastic syndrome) hormone receptor status: not specified patient characteristics: age: 18 and over sex: female menopausal status: not specified performance status: ecog 0-2 life expectancy: at least 9 months hematopoietic: see disease characteristics hepatic: not specified renal: not specified cardiovascular: no uncontrolled or severe cardiovascular disease no myocardial infarction within the past 6 months no uncontrolled hypertension no congestive heart failure other: no hypersensitivity to mammalian cell-derived products no hypersensitivity to human albumin not pregnant or nursing negative pregnancy test fertile patients must use effective contraception prior concurrent therapy: biologic therapy: at least 6 months since prior epoetin alfa or any investigational forms of erythropoietin (e.g., gene-activated erythropoietin or novel erythropoiesis- stimulating protein) no transfusion within the past 30 days no other concurrent epoetin alfa chemotherapy: see disease characteristics endocrine therapy: not specified radiotherapy: not specified surgery: not specified other: no other concurrent investigational drugs no other concurrent treatments for anemia

Keywords: stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer anemia fatigue
china cimicifuga trial of climacteric complaint control

Conditions: Climacteric Symptoms

Summary: this study is designed to determine whether an extract of cimicifuga foetida l. is safe and efficacious to relieve the climacteric symptoms of chinese women

extracts of cimicifuga racemosa (black cohosh) have been widely used in north america and europe for decades for the treatment of menopause related problems, either as nutritional supplements or as pharmaceutical products. previous clinical trials had shown that an extract of cimicifuga foetida l.(ximingting, luyepharm), which was standardized to have similar components of an extract of cimicifuga racemosa, was safe and efficacious to relieve the climacteric symptoms and signs in chinese women who were recruited according to criteria categorized by theory of traditional chinese medicine.we are interested to know whether it may have the same efficacy and safety profiles when judged with method and standard commonly accepted in western medicine.

Eligibility criteria:
inclusion criteria: * having climacteric symptoms with hot flushes \>= 3 time per day * score of kupperman index at baseline \>= 20 * in addition to these criteria, women who had menopause longer than 2 months but less than 12 months, with fsh \> 15u/l were enrolled into the perimenopausal group. women having menopause longer than 12 months but less than 5 years, with fsh \>= 40u/l and e2 \<= 30pg/ml, were assigned into early staged postmenopausal group. exclusion criteria: * having history of hysterectomy * having hrt within 6 weeks * having other drugs or nutritional supplements of relieving climacteric symptoms within one week * having psychological counseling within one week * having medical history of estrogen-dependent tumors * the result of pap smear exam at stage iii and above * having an uterine leiomyoma lager than 4 cm * the endometrial thickness lager than 0.5 cm * having abnormal cardiac, liver or kidney functions * having abnormal thyroid function * having hypertension, diabetes and coronary heart diseases that were not under control * pregnant or suspected pregnant woman * having severe mental disorders that inhibit to understand the research purpose * other conditions the investigators believed not suitable for enrollment
constrictive pericarditis in the adult congenital cardiac population

Conditions: Congenital Disorders

Summary: the primary aim of this study is to determine the clinical and radiographic findings with constrictive pericarditis in the adult congenital population and determine the degree of right heart failure and dilation from pulmonary insufficiency in the presence of constrictive pericarditis the secondary aim is to elucidate ways to better diagnose constrictive pericarditis and elucidate ways to diagnose right heart failure in the presence of constrictive pericarditis.

constrictive pericarditis is a notoriously difficult diagnosis to reach. there are no signs, symptoms or pathognomonic diagnostic tests for pericardial constriction. in the adult congenital patients, it is also difficult. in addition, with pulmonary insufficiency, constrictive pericarditis may mask the findings of progressive right sided ventricular dilation and heart failure. the primary aim of this study is to determine the clinical and radiographic findings with constrictive pericarditis in the adult congenital population and determine the degree of right heart failure and dilation from pulmonary insufficiency in the presence of constrictive pericarditis the secondary aim is to elucidate ways to better diagnose constrictive pericarditis and elucidate ways to diagnose right heart failure in the presence of constrictive pericarditis. study design and methodology: retrospective chart review - approximately 15 patients preoperative data: echo and cath findings operative data: operative findings postoperative data: echo and cath findings

Eligibility criteria:
inclusion criteria: * patients in the adult congenital heart disease clinic who have been diagnosed or operated on with constrictive pericarditis exclusion criteria: * those who do not meet the inclusion criteria

Keywords: constrictive pericarditis adult congenital patients pulmonary insufficiency