Kornimate/medical-research-clean huggingface dataset:
optimization of individualized therapy for crcs with secondary resistance towards anti-egfr targeted therapy using an avatar model

Conditions: Colo-rectal Cancer; RAS Wild-type; UICC III; UICC II + RF; UICC IV Curative Intent

Summary: in this exploratory phase ii trial, the possibility of a personalized treatment after resistance to cetuximab will be evaluated. therefore, tumor material of all patients shall be obtained, transferred into avatars and treated the same way as in the patient until resistance arises. these resistant tumor cells are subsequently treated by different targeted treatment combinations in the mouse avatar model to find the most active drug or combination of drugs. this drug or combination of drugs may then be offered to the patient after cetuximab resistance has occurred. multiple liquid biopsies shall be obtained in patients during first-line treatment with cetuximab as well as during second line experimental treatment to monitor mutations that may be associated with cetuximab resistance. furthermore at the time of resistance a biopsy should be taken and analyzed to ensure that the mechanism of resistance seen in the avatar model matches with the mechanism of resistance in the individual patient.


Eligibility criteria:
inclusion criteria: * male and female patients age ≥ 18 years * written declaration of consent * ecog performance status 0-1 * life expectancy\> 3 months * histologically confirmed adenocarcinoma of the colon or rectum at stage uicc iii or uicc iv * histologically confirmed adenocarcinoma of the colon or rectum in stage uicc ii with one of the following risk factors: cea\> 200; t4 tumor, emergency surgery, \<12 distant lymph nodes, surgery due to intestinal obstruction (ileus) * patient agrees to the preservation of tumor material for the purpose of molecular analyzes including the determination of the genetic profile of the tumor (participation in the project "resist") exclusion criteria: * preoperative radiotherapy * preoperative chemotherapy * heart failure\> grade ii (functional nyha classification) * existing concomitant disease or condition that would make the patient unsuitable for a study participation or interfere with the safety of the subject * any psychological, familial, sociological or geographical event which does not allow observance of the study protocol * additional carcinoma therapy (chemotherapy, radiation, biological therapy, immunotherapy or hormonal therapy) during the study * known malignant second neoplasia within the last 5 years (except for a basal cell carcinoma or a carcinoma in situ of the uterine cervix).

Keywords: colorectal cancer adjuvant
atg-f vs atg for the prevention of gvhd

Conditions: GVHD in the Setting of Haplo-HSCT

Summary: anti-thymocyte globulin (atg) preparative regimen in the setting of haploidentical stem cell transplantation (haplo-hsct) is vital for inducing immune tolerance.the study aims to compare the efficacy and safety of atg-f vs atg, incorporated into the preparative regimens for haplo-identical transplants.


Eligibility criteria:
inclusion criteria: * signed written informed consent * aged \<65 years * patients undergoing haplo-identical hematopoietic stem cell transplantation. * cardiac: left ventricular ejection fraction ≥ 50% * adequate renal and hepatic function * performance status: karnofsky ≥ 70% exclusion criteria: * pregnant or lactating females. * any co-morbidity precluding the administration of atg or atg-f.
clinical assessment of chitosan nanoparticles on periodontal problems post steroidal inhalation in asthmatic patients: phase i trial

Conditions: Periodontal Diseases

Summary: periodontal problems management is the most important goals of chronic asthmatic patients that adapted to use steroid inhalation for long time. gram negative anaerobic bacteria are generally suggested as the primary cause of periodontal problems and mechanical procedure is the treatment approach, which is performed nonsurgical or surgically. the understanding of the role of bacteria in the initiation and progression of periodontal disease has led to great interest in the use of antibiotics to suppress or eradicate pathogenic macrobiotic. systemic antibiotics have been used in different forms of periodontal disease treatment. systemic antibiotics can penetrate soft tissues and may target invasive organisms, can be used to treat multiple sites simultaneously, and may also affect reservoirs of bacterial reinfection such as saliva, the tonsils, and the oral mucosa. however, there may be problems associated with the use of systemic antibiotics such as the development of resistant bacteria, and potential side effects (hypersensitivity reactions, gastrointestinal discomfort, etc.). so in this study we aimed at to evaluate the effect of chitosan nanoparticle spray in management of dental problems in asthmatic patients receiving corticosteroids inhaler that support the growth of bacteria in periodontal area.


Eligibility criteria:
inclusion criteria: * age from 18-50 years old * both sex male and female * patients diagnosed as asthmatic * patients treated with corticosteroids inhaler or ( beta2-adrenergic agonist inhaler or nebulizer for their symptoms) exclusion criteria: * patients treated with other medication * patients not diagnosed as asthmatic * comorbidity
imatinib mesylate with vincristine and dexamethasone in acute lymphoblastic leukemias with bcr-abl positive

Conditions: Leukemia, Lymphocytic, Acute; Philadelphia Chromosome; Blast Crisis; Leukemia, Myeloid, Chronic

Summary: patients not previously exposed to imatinib and with resistant or refractory ph+ all, lymphoid blast crisis chronic myelogenous leukaemia (lbc cml) or with de novo ph+ all and aged over 55y were eligible in the study. the div regimen consisted in one iv injection of vincristine 2 mg combined with 2 days of dexamethasone 40 mg po repeated weekly for 4 weeks as induction and then monthly for 4 months as consolidation. imatinib was administered at 800 mg per day during the induction period and at 600 mg/d continuously during consolidation. patients in cr not eligible for hsct were allocated to maintenance therapy consisting in weekly sc injection of pegasys 45 µg and continuous administration of imatinib 400 mg per day for 2 years.

gleevec™ is now considered as the gold standard treatment in chronic phase chronic myeloid leukemia (cml), for patients who are not candidate for an allogenic bone marrow transplantation. however, in advanced phase cml and philadelphia chromosome-positive acute lymphoblastic leukemia (ph+ all), development of resistance to imatinib has become the central issue concerning the use of imatinib as a monotherapeutic agent. the response rate (complete hematological remission) at the dose of 600 mg/d in poor prognosis lymphoid blast phase cml and ph+ all was about 20% and median time to disease progression was only 2.2 months. in vitro studies have addressed the question of combined therapy with imatinib. a synergistic or additive activity has been demonstrated with vincristine and dexamethasone, two major drugs for the treatment of acute lymphoblastic leukemia (all). on going clinical studies are also testing gleevec™ in association with daunorubicin and cytarabine (standard dose) in cml in myeloid blast phase (cst571afr01) or with mithoxantrome and cytarabine (intermediate dose) as a consolidation regiment in ph+ all in first cr (csti571afr03). the safety of the combined therapy was excellent in the two studies. therefore, we propose to initiate a study to assess the efficacy and the safety of gleevec™ combined with vincristine and dexamethasone in patients with relapsed or refractory philadelphia chromosome-positive acute lymphoblastic leukemias

Eligibility criteria:
inclusion criteria: * male or female subjects over 18 years, * poor prognosis bcr-abl transcript-positive acute lymphoblastic leukemia (refractory or relapsing ph+ all, bp lymphoid cml, bp lymphoid cml in relapse) exclusion criteria: * pregnant female, * blastic involvement of the cns, * participation in an investigational agent trial within 4 weeks, * high dose therapy within 4 weeks, * gleevec administration within 3 months, * transaminases grade 3 or 4 elevation.

Keywords: imatinib mesylate combination therapy leukemia, lymphocytic, acute philadelphia chromosome blast crisis leukemia, myeloid, chronic
study using genomic, histologic and radiomic analysis to evaluate regional tumor heterogeneity in patients undergoing surgery for newly diagnosed glioblastoma

Conditions: Glioblastoma

Summary: glioblastomas (gbm) demonstrate in vivo genetic and histologic heterogeneity that can be non-invasively identified using imaging phenotypes that identify regionally distinct areas of tumor with genetic alterations that drive tumor resistance pathways. the researchers propose a unique approach to assess initial gbm heterogeneity by performing histological and genomic analysis of biopsies targeted by advanced mri before treatment.


Eligibility criteria:
inclusion criteria: * suspected newly diagnosed or recurrent supratentorial glioblastoma eligible for surgical biopsy and/or resection * patients must be 18 years of age or older * study-specific informed consent approved for this purpose by the irb of the university of michigan exclusion criteria: * patients unable to undergo mri
the use of the cpr to predict adverse outcomes in gdm pregnancies

Conditions: Gestational Diabetes

Summary: the cerebro-placental ratio (cpr) is a tool for assessment of fetal wellbeing in the management of the growth restricted fetus. cpr is the ratio of the fetal middle cerebral artery pulsatility index (pi) to the umbilical artery pi. in gestational diabetes (gdm), the common finding is of accelerated and asymmetric fetal growth. pregnancies complicated by gdm have an increased risk of certain complications such as preeclampsia, intrauterine demise, cs due to fetal distress. these complications have a well known association with fetal growth restriction leading to the hypothesis that there exists a subset of diabetic fetuses that exhibit a growth restriction phenotype despite not being small for gestational age (\ 10%. the primary outcome will be a composite outcome consisting of one or more of the following: caesarean section due to suspected fetal distress, 5 minute apgar \ 24 hours.


Eligibility criteria:
inclusion criteria: * all women over the age of 18 years old with singleton pregnancies and a diagnosis of gdm at 24 weeks of gestation and beyond. exclusion criteria: * pre-gestational diabetes, hypertensive disease of pregnancy at time of recruitment, fetus with a known major anomaly, fetal efw \< 10% or suspected fetal anemia (and thus requiring a clinically indicated cpr measurement) poor grasp of english
study phase iii study to assess the efficacy and safety of sotb07 in asthma patients

Conditions: Asthma

Summary: the objective of this study is to assess the efficacy and safety of sotb07 in asthma patients by observing changes fev1 (% predicted) as the primary efficacy endpoint after oral administration of sotb07 200mg, 400mg, placebo for 12 weeks.

a 12-week, multi-center, randomized, double blinded, parallel group, placebo-controlled study to assess the efficacy and safety of sotb07 in asthma patients

Eligibility criteria:
inclusion criteria: 1. male or eligible female subjects aged 15 years or more 2. a female is eligible if she is of: * non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal * child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly * negative pregnancy test at screening 3. non-smoker for at least 1 year, a pack history of ≤ 10 pack years 4. symptom of persistent asthma, as defined by the national institute of health (nih) 5.50% ≤ fev1 ≤ 80% predicted at screening visit (withholding inhaled, short acting ß-agonist for 6 hours) 6.fev1 reversibility ≥ 12% and 200 ml at 20-30 minutes after inhalation of a short acting ß-agonist (salbutamol 2 puffs; 200㎍) at visit 1 or within 6 months before visit 1 7.capable of withholding salbutamol use for ≥ 6 hours prior to clinic visits 8.appropriately signed and dated informed consent has been obtained exclusion criteria: 1. active upper or lower respiratory tract infection within 3 weeks before visit 1 2. emergency room treatment for asthma within 1 month or hospitalization for asthma within 3 months before visit 1 3. any evidence of infectious, oncologic, or other active pulmonary disease obtained by chest radiography within 12 months before visit 1 4. clinically significant, in the opinion of the investigator, hematological, liver, renal, heart, neurological disease, or other serious disease 5. hypersensitivity to any β2-agonist, sympathomimetic drug, leukotriene receptor antagonist or sophora tonkinensis radix rhizoma 6. clinically significant and uncontrolled psychiatric disease 7. history of drug or alcohol abuse 8. inhaled, oral or parenteral corticosteroids within 4 weeks before visit 1 9. change of immunotherapy within 6 months before visit 1 10. administration of the antiasthma agent within 1 week of visit 1 11. administration of any other medication which may affect the course of asthma, or interact with sympathomimetic amines 12. participation in study using an experimental medication within 1 month before visit 1 13. other ineligible subject in the opinion of the investigator

Keywords: asthma sotb07
evaluating panitumumab (abx-egf) plus best supportive care versus best supportive care in patients with metastatic colorectal cancer

Conditions: Colorectal Cancer; Metastases

Summary: the purpose of this study is to determine that panitumumab, using the proposed regimen, will safely increase progression free survival in patients with metastatic colorectal cancer who have failed available treatment options (i.e., patients who developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy).


Eligibility criteria:
inclusion criteria: * pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy) * metastatic colorectal carcinoma * eastern cooperative oncology group (ecog) performance status of 0, 1 or 2 * documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer * radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen * unidimensionally measurable disease * tumor expressing epidermal growth factor receptor (egfr) by immunohistochemistry * at least 2 but not more than 3 prior chemotherapy regimens for colorectal cancer * adequate hematologic, renal and hepatic function exclusion criteria: * symptomatic brain metastases requiring treatment * history or evidence of interstitial pneumonitis or pulmonary fibrosis * use of systemic chemotherapy or radiotherapy within 30 days prior to enrollment * prior epidermal growth factor receptor (egfr) targeting therapies * prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than a week) serum half life within 30 days before enrollment, or prior experimental or approved proteins within 3 months before enrollment.

Keywords: metastatic colorectal cancer, colon colorectal, rectal cancer, cancer metastatic, egfr, clinical trial panitumumab, abx-egf immunex, abgenix, amgen
a study of oral sapacitabine in patients with previously treated non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: a phase ii study to evaluate the safety and efficacy of oral sapacitabine in previously treated advanced non-small cell lung cancer (nsclc).

this is an open label, single arm, phase ii study to evaluate the safety and efficacy of oral sapacitabine administered twice daily for 5 consecutive days every week for 2 weeks followed by 7-day rest in patients who have had one prior chemotherapy regimen for advanced non-small cell lung cancer (nsclc).

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed recurrent nsclc * age of 18 years or older * eastern cooperative oncology group (ecog) performance status 0-2 * measurable disease according to recist * had only 1 prior chemotherapy regimen for metastatic or recurrent disease; patients who have received more than one prior chemotherapy regimens may participate in part a of the study only. * adequate bone marrow function * adequate renal function * adequate liver function * at least 3 weeks from prior systemic treatments including investigational anti-cancer therapy; at least 7 days from prior radiation therapy; and have recovered from prior toxicities * at least 3 weeks from major surgery * patient must be able to swallow capsules * agree to practice effective contraception during the entire study period and for one month after being discontinued from the study unless documentation of infertility exists. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * ability to understand and willingness to sign the informed consent form exclusion criteria: * nsclc histology contains a component of small cell lung cancer * previously untreated cns metastasis or progressive cns metastasis documented by mri scan performed at 4 weeks or longer after the last treatment for cns metastasis * currently receiving radiotherapy, biological therapy, or any other investigational agents * uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * cancer other than nsclc that has been treated with chemotherapy or biological therapy in the past 5 years with the exception of adequately treated in situ cervical cancer, and basal or squamous cell skin cancer; patients who received only hormonal therapy in the neoadjuvant or adjuvant setting in the past 5 years may participate in this study * pregnant or lactating women * known to be hiv-positive
trialling an online uk dementia awareness for caregivers course

Conditions: Dementia; Caregiver Burden

Summary: the purpose of this study is to investigate whether an online dementia awareness course is feasible for delivery and acceptable to informal caregivers of people living with dementia in the uk. it will also explore the impact of the course on different caregiver outcomes.

all participants were given information on the study before providing informed consent. the participants were screened against eligibility criteria before being randomly allocated to either the treatment condition of attending the course, or the control condition of treatment as usual. participants completed 5 outcome measures and a demographics questionnaire at baseline. the treatment group then attended a one-off half-day dementia awareness course online, delivered by one trainee clinical psychologist. a month later, all participants completed the same 5 outcome measures and those who attended the course also attended a one-to-one half an hour online semi-structured interview.

Eligibility criteria:
inclusion criteria: * self-identified informal caregiver of a person living with dementia in the community. * residing in the u.k. * ability to engage in a course delivered in english * have access to an internet-connected device capable of videoconferencing (camera and microphone functioning) * available to attend pre-specified dates for dac-uk delivery. exclusion criteria: * person living with dementia residing in residential care * professional caregiver of people living with dementia.

Keywords: dementia caregiver intervention biopsychosocial
a study of people with multiple myeloma (mm) in portugal (charismma-portugal)

Conditions: Relapse and/or Refractory Multiple Myeloma

Summary: the main aim of this study is to see how people with mm respond to previous or current treatment. participants will be treated according to their clinic's standard practice. each participant will fill out a study questionnaire during a routine doctor visit. information collected from past medical records will also be used.

this is a non- interventional, retrospective epidemiological study of participants with mm. the study will characterize mm participants with symptomatic relapse and/or refractory (r/r) disease. the study will enroll approximately 151 participants. the study will have a retrospective data collection referring to previous 5 years from participants' records and medical charts regarding diagnosis, disease activity, treatment patterns, and healthcare resources while quality of life (qol) will be obtained from european organization for research and treatment of cancer quality of life questionnaire (eortc qlq)-c30 and eortc qlq-my20 questionnaires. all participants will be enrolled in one observational group. this multi-center trial will be conducted in portugal. the overall time to participate in this study is limited to completion of a questionnaire at the time of joining the study.

Eligibility criteria:
inclusion criteria: 1. at least one previous treatment line. 2. symptomatic r/r disease in the previous 6 months to study enrolment. 3. receiving treatment with an accurate and thorough data fulfilled in their participant's medical records available at the study site. 4. on regular follow-up for relapse and/or refractory disease during the recruitment period at the study site. 5. capable of understanding and completing both qol questionnaires (eortc qlq-c30 and eortc qlq-my20). exclusion criteria: 1. diagnosed with mm more than 5 years previous to inclusion in this study. 2. diagnosed with any malignancy other than mm or its complications within the past 5 years. 3. currently participating in a clinical trial for his mm or having participated in a clinical trial within 5 years before inclusion. 4. diagnosed with any hematological disease other than mm or its complications.

Keywords: multiple myeloma