Kornimate/medical-research-clean huggingface dataset:
recombinant human serum albumin/granulocyte colony stimulating factor fusion protein for breast cancer patients

Conditions: Chemotherapy-induced Neutropenia

Summary: evaluation of the efficacy and safety of recombinant human serum albumin / granulocyte-stimulating factor fusion protein for injection to prevent chemotherapy-induced neutropenia

* brief protocol: treat the patients taking taxotere+epirubicin +cyclophosphamide (tec) treatment or taxotere+epirubicin (te)treatment chemotherapy with the study medicine or positive control during the period between two chemotherapy treatments. * targeted patients: breast cancer * subjects were randomly divided into two groups. the test group received recombinant human serum albumin / granulocyte thorns for injection stimulant fusion protein 2.4mg treatment. positive control group received recombinant human granulocyte colony stimuli factor injection therapy * number of patients: 80

Eligibility criteria:
inclusion criteria: * age 18-65. * diagnosed breast cancer, suitable for tec or te . * ecog performance status 0 or 1. * adjuvant chemotherapy; new adjuvant chemotherapy; newly diagnosed class ⅳ and prior chemotherapy. * no obvious abnormal ecg examination. * tbil, alt, ast≤2.5×uln (≤5×uln if presence of hepatic metastases). * cr, bun≤2.5×uln. * signed informed consent. exclusion criteria: * chemotherapy within past 4 weeks. * uncontrolled inflammatory disease,axillary temperature≥38℃. * merging other malignant tumor. * pregnancy or nursing status. * participation in another clinical trial with and investigational product within 3 months prior to study entry. * severe diabetes mellitus, or poor blood sugar controller. * allergic disease or allergic constitution. history of protein allergy. * history of drug addiction and alcoholism. * hematopoietic stem cell transplantation or organ transplantation. * antibiotics were treated within 72 hours before chemotherapy. * long-term use of hormones or immunosuppressive agents. * severe mental or neurological disease. * chronic disease of severe cardiac, kidney and liver. * other conditions that would be excluded from this study according to doctors'judgment.

Keywords: chemotherapy neutropenia breast cancer
open-label evaluation of relapse prevention in patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this research is to evaluate the relative exposure of iloperidone long-acting injection (lai) compared to oral iloperidone in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * males or females 18 to 65 years of age (inclusive) * diagnosed with schizophrenia per dsm-5 criteria * in need of ongoing psychiatric treatment exclusion criteria: * dsm-5 diagnosis of a psychiatric disorder other than schizophrenia that was the primary focus of treatment within the previous six months

Keywords: schizophrenia antipsychotic agents iloperidone long-acting injection
impact of a community health worker strategy on produce prescription program uptake among people with diabetes

Conditions: Diabetes Type 2

Summary: produce prescription programs (prx) are promising interventions for improving health outcomes for patients with both type 2 diabetes (t2d) and food insecurity, but uptake has been suboptimal. there is a critical need for scalable, evidence-based implementation strategies for improving prx uptake and optimizing the effectiveness and cost-effectiveness of these interventions. this study will co-design and pilot a community health worker (chw) strategy and test the effectiveness of the strategy compared to prx participants without a chw. the overall objective of this study is to test and evaluate a theory-informed, user-centered community health worker (chw) implementation strategy to improve uptake of a prx, among hispanic medicaid-eligible patients with t2d in connecticut (ct). chws will offer participants personalized support by overcoming barriers and leveraging facilitators to prx uptake.

this study will have a small pilot followed by a randomized controlled trial. the focus of this registration is the randomized controlled trial. first, following community co-design of the chw strategy, investigators will conduct a two-month pilot study with an anticipated 10 participants to test the chw strategy, the produce prescription program rx, and overall study procedures. all participants will receive the prx program with chw strategy for two months. second, a randomized controlled trial to evaluate the effectiveness of the chw strategy on barriers to prx uptake, level of prx engagement, and short-term program, behavioral, and health outcomes will be conducted. investigators hypothesize that participants who receive added chw support during their enrollment in the prx program will have reduced barriers to prx uptake, higher prx uptake, and greater improvements in the defined short-term program outcomes compared with participants who do not receive the chw support during their enrollment in the prx.

Eligibility criteria:
inclusion criteria: * be a current primary or specialty care patient at hartford hospital * live in hartford county * identify as hispanic * have a current diagnosis of type ii diabetes * be eligible for medicaid based on household income and size. exclusion criteria: * does not speak english or spanish * has a diagnosis of gestational diabetes * individuals who are members of vulnerable populations, such as individuals who are incarcerated and individuals who are not able to consent. participants who are pregnant will be eligible for the study if they meet all of the inclusion criteria and do not have any of the exclusion criteria, as the study activities (additional funds to purchase fruits and vegetables, nutrition education, and support from a community health worker) does not pose any additional risk to this group.
interactions between diet, intestinal microbiota and metabolomics

Conditions: Nutrition Disorders

Summary: it is widely known that the quality of the diet is able to modify the expression of many bacterial genes populating the intestine of the host, as well as the type of bacteria themselves. this is also expressed with a more or less evident and troublesome after meals symptomatology that many patients complain to the health care staff. a good composition of the microbiota is crucial for the health of the individual, both at the intestinal level as well as at the systemic level because, depending on the type of food substrate available at the intestinal level, metabolites will be produced capable of positively or negatively affect the health of the individual. in fact, scientific evidence shows the existence of the causal link between the health of the microbiota and the genesis of inflammatory diseases not only intestinal, but also systemic, and even of cancer, obesity, metabolic syndrome and atherosclerosis. the recent diffusion of gene sequencing techniques has brought significant developments in the study of the human and bacterial genome, which allow to produce enormous quantities of sequences at a lower cost and at a higher speed than previous techniques. therefore the clinical nutrition clinic of the irccs de bellis in castellana grotte (ba) proposes to check if changes in the intestinal microbiota correlate, not only with anthropometric and clinical-laboratory parameters, but also with the typical symptoms of irritable bowel syndrome (ibs), a functional pathology very widespread with the advent of the modern era, in which, a diet rich in sugars and proteins of animal origin and poor in plant foods, is unfortunately common also in the areas of the mediterranean basin.


Eligibility criteria:
inclusion criteria: * no major comorbidities with a life expectancy less than 12 months; * bmi between 29 and 33 kg/m2 * serum cholesterol 200-260 mg/dl * serum triglycerides \> 150 mg/dl exclusion criteria: * antibiotics or prebiotics in the 3 months before the enrollment; * use of statins or other medications for lowering cholesterol; * menopause; * previous history of cancer.
colorectal cancer awareness, research and education and screening - rural expansion, access and capacity for health

Conditions: Colorectal Cancer

Summary: this study is to assess the impact of the cares-reach intervention on colorectal cancer screening rates.

this study will not accrue individual patients. instead, the investigators are collecting process data from health care providers to determine the procedures that impact or help to increase colorectal cancer screening rates.

Eligibility criteria:
inclusion criteria: * staff and providers working in a clinic within one of the two participating systems * involved in adult patient care exclusion criteria: * staff and providers who are not engaged in directing or decisions related to colo-rectal cancer screening

Keywords: fecal immunochemical test f.i.t.
cisplatin-induced cochlear and vestibular damage in head and neck cancer

Conditions: Ototoxic Hearing Loss; Ototoxicity, Drug-Induced; Cisplatin-induced Hearing Loss; Cisplatin Ototoxicity; Head and Neck Cancer; Dizzyness; Inner Ear Hearing Loss; Vestibular Disease; Squamous Cell Carcinoma of the Head and Neck; Deafness; Hearing Loss

Summary: the goal of this observational study is to learn about the occurrence of and to identify suitable strategies for screening and monitoring of inner ear damage in patients receiving cisplatin chemoradiotherapy for head and neck cancer. researchers will compare patients who are receiving cisplatin chemoradiotherapy to patients who are only receiving radiotherapy. patients will undergo standardized testing for hearing loss, tinnitus and vestibular dysfunction at baseline, during and after treatment. optional genetic analyses will aim to identify genes known to predispose to cisplatin-induced ototoxicity.


Eligibility criteria:
inclusion criteria: * diagnosis of head and neck squamous cell carcinoma * cisplatin-based chemoradiotherapy (monotherapy or combination-therapy, adjuvant or neo-adjuvant) or only radiotherapy (control group) * age 18 to 85 years * signed agreement and willingness to participate in the study and adhere to the study protocol exclusion criteria: * severe hearing impairment (who grade 3 or 4, corresponding to an audiometric iso value of ≥61 db in the better ear at frequencies of 500, 1000, 2000 and 4000 hz) * self-reported tinnitus or vestibular dysfunction in the last 3 months (only lead to exclusion of the corresponding secondary objectives, not to complete exclusion from the study) * current cochlear implant * concurrent treatment with loop diuretics (e.g. furosemide), aminoglycoside antibiotics or other known ototoxic substances in the last three months * acute psychosis or serious psychiatric illness * addiction disorder
hybrid capture test on mobile unit program to improve cervical cancer screening in brazilian rural and remote areas

Conditions: Cervical Cancer Squamous Cell; Human Papilloma Virus Infection; Human Papilloma Virus-Related Carcinoma; Prevention

Summary: this study evaluates the women cervical samples through molecular tests in order to: 1. deploy the test carehpv (hybrid capture test) in mobile unities of the barretos cancer hospital to evaluate their performance;

step1: ambulatory samples first of all the carehpv cervical sample will be collected in specifically tubes, after this, make the cervical sample surepath collect. each patient will have two cervical samples. in this moment will be collected 2,000 samples at the gynecology department of barretos cancer hospital and the women who be attended in the mobile unit of barretos surrounding. sample1: carehpv the collect will be randomized where 1000 will be collected by the doctor and 1000 by self-sampling. the patient will be oriented by nurse with illustrative material. the self-sampling will be realized like the manufacturing protocol (qiagen inc., gaithersburg, md). the cervical sample to cytology (surepath) will be realized by doctor like a complementary test. the conditions to store the samples are 15˚c to 30˚c by 2 weeks; 2˚c to 8˚c by 4 weeks; or -20˚c by 2 months to research. sample2: surepath® cytology the cervical sample will be realized like the manufacturing protocol, by doctor. the lamina will be prepared like the equipment manufactory (becton, dickinson and company). the cytological findings will be classifieds like the bethesda system. the positives women in carehpv/cytology and the negative carehpv but positive cytology (asc-us+) will be referred to do the colposcopy (or biopsy) at the barretos cancer hospital. step2: mobiles unities samples this step will be collected 3,000 samples to carehpv test and surepath cytology like a complementary test. the self-sampling won't be made in this step. the samples will be analyzed in the own mobile unit, during the cities visited. the units involved in the project are that attended mato grosso, goiás, minas gerais and rondônia states, because the significantly number of population assisted. step3: hpv genotyping all the positives cases to carehpv test will be submitted to identify the hpv types, then realized at the molecular oncology research center in the barretos cancer hospital.

Eligibility criteria:
inclusion criteria: * any women who come to do the papanicolaou test at the barretos cancer hospital and in the mobile units on the remote brazilian areas. exclusion criteria: * not applicable.

Keywords: cervical cancer hpv secondary prevention
external dcr versus canalicular si with mmc in nldo

Conditions: Primary Acquired Nasolacrimal Duct Obstruction

Summary: while external dcr is the gold standard procedure for primary nldo as well as complicated cases, si with mmc could achieve comparable success rates in primary acquired nldo, hence should be considered as an alternative as a safe and minimally invasive procedure.

purpose: to compare external dacryocystorhinostomy versus canalicular silicone intubation with the use of mitomycin c (mmc) in primary acquired nasolacrimal duct obstruction (nldo). methods: the study was carried out at the department of ophthalmology, menoufia university hospital, egypt, between june 2012 to july 2014. fifty-six patients who were diagnosed with primary acquired nldo. patients were randomly allocated into two groups: thirty cases underwent external dcr and twenty-six cases underwent silicone intubation with mmc.

Eligibility criteria:
inclusion criteria: * primary acquired nldo exclusion criteria: * all other secondary causes of nldo

Keywords: external dcr, canalicular silicone intubation, mitomycin c
myocardial flow reserve in severe as without obstructive coronary artery disease

Conditions: Chest Pain; Severe Aortic Stenosis

Summary: exertional angina is common symptom in patients with severe aortic stenosis (as) without obstructive coronary artery disease (cad). although reduced myocardial flow reserve is one of the proposed explanations for angina, little is known about the pathophysiology. this study aimed that adenosine-stress cardiac magnetic resonance can be used for the assessment of myocardial perfusion reserve and suggest the pathophysiology of development of angina in patients with severe as without obstructive cad.


Eligibility criteria:
inclusion criteria: 1. severe as 2. normal lv ejection fraction (ef ≥ 50%) exclusion criteria: 1. age \<18 2. lvef \< 50% in echocardiography 3. concomitant other valvular disease of moderate or severe severity 4. previous aortic valve replacement 5. symptomatic patients other than chest pain 6. obstructive cad (\>30% luminal stenosis in at least one coronary artery on coronary angiography) 7. history of myocardial infarction or acute coronary syndrome 8. contraindication to adenosine 9. any absolute contraindication to cmr 10. estimated glomerular filtration rate \<30 ml/min/1.73m2.
phase i/ii study of different doses and dose schedules of milatuzumab (hll1) in cll

Conditions: Chronic Lymphocytic Lymphoma

Summary: this study will test different doses of anti-cd74 antibody in patients with nhl and/or cll.

milatuzumab (hll1, immu-115), a humanized anti-cd74 monoclonal antibody. dose escalation will utilize 4 planned dose regimens with 4.0 or 8.0 mg/kg doses administered intravenously either twice weekly (days 1 and 4) or thrice weekly (days 1, 3 and 5) for 4 consecutive weeks. the four planned dose regimens will be labeled as dose level 1 to 4 corresponding to increasing levels of the total dose of milatuzumab.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of recurrent chronic lymphocytic leukemia (by nci criteria) * received at least one prior treatment with standard therapy (previous antibody therapy is acceptable) * measurable disease (wbc \> 5,000 for cll) * see protocol for full list exclusion criteria: * pregnant or lactating women. women of childbearing potential must have a negative pregnancy test pregnancy testing is not required for post-menopausal or surgically sterilized women * women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study until at least 12 weeks after the last milatuzumab infusion * prior therapy with other human or humanized monoclonal antibodies, unless haha tested and negative; * bulky disease by ct, defined as any single mass \>10 cm in its greatest diameter * known hiv positive or active hepatitis b or c, or presence of hepatitis b surface antigens or presence of hepatitis c antibody * known autoimmune disease or presence of autoimmune phenomena * at least 7 days beyond any infection requiring antibiotic use. * systemic corticosteroids within 2 weeks, except low dose regimens (prednisone, \<20 mg/day, or equivalent) which may continue if unchanged. * substance abuse or other concurrent medical or psychiatric conditions that, in the investigator's opinion, could confound study interpretation or affect the patient's ability to tolerate or complete the study.

Keywords: cll
univrse: vr-cbt for students with social anxiety

Conditions: Social Anxiety

Summary: the goal of this pilot randomised controlled trial is to evaluate the effectiveness of the univrse vr-cbt programme in students with social anxiety. the aims of this trial are: 1. to determine whether a full trial is justified; 2. to establish the effect size on the co-primary outcomes for a sample size calculation for a definitive trial; 3. to address questions concerning study recruitment, retention, and acceptability. participants will complete a baseline assessment (t0) and then be randomly allocated to receive either univrse vr-cbt or join the wait-list control group. univrse vr-cbt uses graded exposure techniques delivered using vr to help students feel more confident in university-based situations. data will be collected post-intervention (t1) along with exit interviews to assess participant experience.


Eligibility criteria:
inclusion criteria: for participants to be eligible to take part, they must be: * a current student at the university of westminster; * able to read and communicate in english; * wanting help to feel more confident at university; * deemed to have context-specific social anxiety as defined by a response of 'moderate' or 'often' on one of the subscales from any one of the following items from the mlsas-sr: 5, 12, 17, and 9. these items reflect the highest level (i.e. most anxiety-invoking) of each of the four scenarios within the univrse programme: * asking a question in a lecture in person * delivering a presentation on your own in front of the class * speaking using my mic during online seminars * speaking up during small group discussions in person exclusion criteria: persons will be excluded from the study if meet any of the following criteria: * have photosensitive epilepsy; * have a visual impairment that cannot be corrected with glasses; * have a balance disorder; * have a significant auditory impairment; * have current and active suicidal plans; * are currently accessing or have confirmed plans to access another psychological intervention during the course of the study. participants will be excluded from providing a saliva sample (required for the cortisol measurement) if they meet any of the following criteria: * are pregnant; * currently breastfeeding; * taking any medications; * have any other serious medical condition; * think that they currently have covid-19. these participants may still participate in the wider univrse trial if they meet all of the aforementioned main trial inclusion/exclusion criteria.

Keywords: social anxiety students university virtual reality cognitive behaviour therapy
mtx and steroid for agvhd treatment

Conditions: Acute GVH Disease

Summary: the aim of the study is to identify the efficacy and safety of methotrexate (mtx) combined corticosteroid treatment for acute graft-versus-host disease (agvhd) after allogeneic hematopoietic stem cell transplantation (allo-hsct).

allo-hsct is an effective treatment of malignant hematopoietic diseases. however, agvhd remains a major complication after allo-hsct and the destruction of recipient tissues by alloantigen-activated t cells is a key event in the development of agvhd. corticosteroid is the standard first-line therapy for agvhd due to their roles in suppressing t cell responses. however, the response rate of corticosteroid was approximate 50%, and the clinical outcomes of patients with corticosteroid refractory gvhd were poor. thus far, no combination therapy had been prove to be superior to corticosteroid alone as initial therapy for agvhd. the study hypothesis: mtx combined corticosteroid treatment could help to further ameliorate the activity of t cells and control agvhd.

Eligibility criteria:
inclusion criteria: 1. patients who are fully informed and sign informed consent by themselves or their guardians; 2. patients receiving allogeneic hematopoietic stem cell transplantation; 3. patients with acute graft-versus-host disease of grade ii-iv were diagnosed after transplantation; 4. patients with stable implantation of granulocytes and platelets. exclusion criteria: 1. patients who have received more than one transplant; 2. patients with overlap syndrome; 3. patients within six months after the failure of the first transplantation; 4. patients with uncontrollable active infection; 5. patients with recurrence of primary malignant hematopathy; 6. patients with dli or induced graft-versus-host disease after first intervention; 7. patients with serious respiratory diseases; 8. patients with severe renal insufficiency; 9. patients with serious and uncontrolled heart disease; 10. patients with severe hepatobiliary diseases unrelated to graft-versus-host disease; 11. within one week patients who need to use more than 1mg/kg/d methylprednisolone for reasons other than graft-versus-host disease; 12. patients who have participated in other clinical trials within 1 month; 13. the researcher judges that there are other factors that are not suitable for participating

Keywords: acute gvhd mtx corticosteroid