Kornimate/medical-research-clean huggingface dataset:
treatment with mk6592 and an anti-cancer drug in patients with advanced solid tumors (6592-001)

Conditions: Advanced Solid Tumors

Summary: a study to evaluate safety and tolerability of mk6592 in combination with an anti-cancer drug in adult patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * patients with advanced solid tumors (metastatic or local) unresponsive to standard therapy, progressed on standard therapy, or no standard therapy exists. no limit to the number of prior treatment regimens * patients may be fully active without physical restrictions, ambulatory with restrictions on strenuous physical activity, or ambulatory and capable of self-care but not work activities (i.e., eastern cooperative oncology group performance status of greater than or equal to 2) * demonstrates adequate organ function (liver, kidneys, hematologic) exclusion criteria: * chemotherapy or radiation therapy within 2 weeks of dosing; or unresolved side effects(s) from prior treatment regimen * participation in an investigational study within 14 days of dosing * primary central nervous system tumor * active brain or spinal cord metastases. patients who completed a course of therapy for cns metastases may be eligible if considered clinically stable for 3 months prior to study entry * symptoms from fluid in the abdomen or around the lungs * requires certain drugs or other products known to be metabolized by the liver enzyme cyp3a4
chinese herbal medicine for immune reconstitution following hsct in acute leukemia patients

Conditions: Acute Leukemia

Summary: the treatment options for high-risk acute leukemia patients are limited and these patients are often opt for hematopoietic stem cell transplant (hsct). however studies show that prognosis following this last-resort therapy is bleak. at times, less than 70% of post-hsct relapsed aml and all patients even achieve complete remission; median overall survival of these cohorts might not reach one year; and 3-year post-hsct survival rates might be less than 20%. the investigators plan to recruit acute leukemia patients from cmuh which are planned to receive hsct, and follow the rate and quality of their immune reconstitution. as intervention, part of the patients will receive a chinese medicine herbal formula, which they will take for 6 months.differences between the 1-year post-hsct condition of patients will be examined.

we hope to enroll 50 high-risk acute leukemia patients after receiving hsct at china medical university hospital. thereupon, patients will be consecutively recruited to treatment group (25 patients) where they will be prescribed sheng yu tang (聖愈湯, syt) 2 months following hsct, for a period of 6 months, in conjunction with the standard-care treatment. we predict that not all patients will be interested in taking syt, patients which are not interested in entering treatment group will be offered to join a control group (25 patients) which will receive standard-care treatment. since hsct patients go through routine blood examinations, this study will request to extract a further 20ml of peripheral blood once a month and an additional 20ml of bone marrow at beginning of hsct and the following routine aspirations (est.:0, +3, +6, +9, +12 month). both treatment and control group will be required to contribute peripheral blood and bone marrow sample.blood samples will be collected until patients reach 1-year post-hsct, and flow cytometry will be used to examine the difference in immune reconstitution rate between the two groups. as secondary outcome measurements, this study will make use of the minimal residual disease (mrd) measured, frequency of opportunistic infections, hospitalizations and results of other routine check-up which recorded in patient history.

Eligibility criteria:
inclusion criteria: * discharged from hospital. * diagnosed with all, aml or mds-aml. * received allogeneic or haploidentical peripheral blood hsct. * willing to supply blood samples for analysis. * willing to comply with all study interventions and follow-ups. exclusion criteria: * unable, due to known allergy or any other reason, to orally take chinese herbal medicine.

Keywords: hematopoietic stem cell transplant chinese herbal medicine immune reconstitution clinical trial all aml
genetic epidemiological study of lung cancer in taiwan and clinical applications

Conditions: Lung Cancer

Summary: lung adenocarcinoma in chinese females is hypothesized to be determined by both genetic and environmental factors. in this grant proposal, we propose to map the loci of susceptibility genes of female lung adenocarcinoma based on multiplex families recruited in taiwan. we focus on a unique pathological type of a unique population in order to reduce heterogeneity of the genetic background. compared with western women, female chinese population has a high prevalence of lung adenocarcinoma. our reasoning is that if we focus on a specific sub-type, which has a familial basis, we will increase the probability of identifying genes associated with female lung adenocarcinoma. the primary goal of this study is to identify the genetic and environmental determinants of female lung adenocarcinoma, and study the relationship between gene polymorphisms and clinical manifestation profiling of lung cancer.

this research proposal intends to integrate epidemiologists, biostatisticians, clinicians, molecular biologists/geneticists to identify susceptible genes for lung cancer, especially for female lung adenocarcinoma, and to study the relationship between gene polymorphisms and clinical outcomes of lung cancer patients. our objective is to find gene markers for developing useful screening tools for the high risk group in order to prevent or early detect lung cancer, especially female lung adenocarcinoma. the specific aims of this subproject include: 1. establish and maintain the research network that will recruit and follow up the subjects and families for the geflac study; keeping control of the progress of the study. 2. coordinate all the subprojects such as integrating genotyping data with clinical data and environment data. 3. continue to employ the candidate gene approach to examine the contribution of specific genes to the lung cancer. 4. generate genotyping data for candidate genes in the exploring stage and prioritize snps of candidate genes for large scale studies. 5. identify susceptible genes/candidate genes to develop multiplex pcr for screening.

Eligibility criteria:
inclusion criteria: * lung adenocarcinoma exclusion criteria: -

Keywords: lung adenocarcinoma genetic epidemiology environmental factors genetic map coordination center
perceptual assessment of the tracheoesophageal voice

Conditions: Tracheo-Esophageal Fistula Following Tracheostomy

Summary: aim of this study was to validate the sunderland tracheoesophageal perceptual scale (stops) in italian language by checking the inter- and intra-rater reliability. the validation of the tool involved the following steps: 1) translation and adaptation of the stops into italian language; 2) recruitment of participants (43 laryngectomized patients with a voice prosthesis and 12 health professionals - 6 speech and language therapists (slts) and 6 ear, nose, and throat (ents) surgeons - classified into experienced or not at assessing voice; 3) recording of patients' speech samples; 4) perceptual evaluation of recorded speech samples (test and re-test) performed by the 12 health professionals; 5) statistical analysis (quadratic weighted cohen kappa and weighted kappa of light coefficients). slts with specific experience in tracheo-esophageal and laryngeal voice rated more reliably than the others raters. for all groups of raters, the inter-rater agreement was worse than the intra-rater one for 9/10 parameters. exclusively for experienced slts, only the "impairment of social acceptability" parameter reached a good level of inter-rater agreement. in conclusion, the italian version of stops can be considered a reliable tool. as in the original version, expert slts may be considered the optimal judges for tracheoesophageal voice assessment.


Eligibility criteria:
inclusion criteria: * native italian speakers; * ability to produce te voice. exclusion criteria: * reading difficulties; * presence or suspicion of disease recurrence; * other communication problems not related to total laryngectomy.

Keywords: voice prosthesis perceptual evaluation
open label study to evaluate effect, safety and tolerability of betaferon standard dose of 250µg in patients of chinese origin with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to determine if the study drug is effective and safe in the treatment of multiple sclerosis (ms) in patients of chinese origin.

the study has previously been posted by schering ag, germany. schering ag, germany has been renamed to bayer healthcare ag, germany. bayer healthcare ag, germany is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * chinese origin * diagnosis of relapsing remitting multiple sclerosis or secondary progressive multiple sclerosis exclusion criteria: * any disease other than multiple sclerosis (ms) that could better explain the patients signs and symptoms * hiv (human immunodeficiency virus) infections * hepatitis a * syphilis * immunodeficiency * rheumatic disease or sjogren syndrome * heart disease * severe depression * pregnancy or lactation * conditions interfering with magnetic resonance imaging (mri) * gadolinium dtpa (gadovist, contrast agent) allergy * allergy against human proteins, paracetamol, acetaminophen and ibuprofen intolerance * participation in other trial

Keywords: ms
abemaciclib for the treatment of luminal metastatic breast cancer in the real-life clinical practice in russia.

Conditions: HR+/HER2- Breast Cancer; Metastatic Disease; Аdvanced Disease

Summary: the atlant study is prospective, multicentre, non-interventional, observational study. patients with hr+/her2-negative metastatic breast cancer received abemaciclib as monotherapy or in combination with endocrine therapy.

the atlant study is prospective, multicentre, non-interventional, observational study. 136 patients with hr+/her2-negative metastatic breast cancer received abemaciclib as monotherapy or in combination with endocrine therapy in different line therapy. the purpose of this study is to better understand how abemciclib combinations are used in real-life conditions and their clinical impact for the treatment of russian patients affected by (hr+)/ (her2-) advanced breast cancer (abc) or metastatic breast cancer (mbc).

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. patients must have a diagnosis of hr+ breast cancer. to fulfill the requirement of hr+ disease, a breast cancer must express, by immunohistochemistry (ihc), at least one of the hormone receptors (er, progesterone receptor \[pgr\]) as defined in the relevant american society of clinical oncology/college of american pathologists guidelines: for er and pgr assays to be considered positive, ≥1% of tumor cell nuclei must be immunoreactive by immunohistochemistry (ihc) 3. patient has her2-negative breast cancer defined as a negative in situ hybridization test or an ihc status of 0, 1+ or 2+. if ihc is 2+, a negative in situ hybridization (fish, cish, or sish) test is required by local laboratory testing. 4. patients with advanced (loco-regionally recurrent, or metastatic) breast cancer not amenable to curative therapy. 5. who performance status of 0-2 6. the patient has adequate organ function 7. any number of prior therapies (including none) is permitted 8. рatients who will start abemaciclib as a single agent or in combination with endocrine therapy exclusion criteria: 1. uncontrolled intercurrent illness including, but not limited to, known ongoing or active infection, including hiv, active hepatitis b or c, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (specifically, atrial fibrillation or ventricular dysrhythmias except ventricular premature contractions), or psychiatric illness/social situations that would limit compliance with study requirements. 2. participants must not be pregnant or breastfeeding

Keywords: hr+/her2- breast cancer abemaciclib
a study to evaluate act-132577 in healthy subjects and in people with severe kidney disease

Conditions: Severe Renal Impairment; Healthy Subjects

Summary: the primary purpose of this study is to investigate the fate of act-132577 in healthy subjects and in people with severe kidney disease


Eligibility criteria:
inclusion criteria: all subjects: * signed informed consent in the local language prior to any study-mandated procedure; * male/female aged 18 to 65 years (inclusive) at screening; * body mass index of 18.0 to 32.0 kg/m2 (inclusive) at screening. body weight at least 50 kg; * women of childbearing potential must have a negative serum pregnancy test and use reliable birth controls up to 30 days after the end of study treatment. healthy subjects: * normal renal function confirmed by the estimated glomerular filtration rate (egfr) determined at screening; * healthy on the basis of physical examination, cardiovascular assessments and laboratory tests. severe renal function impairment subjects: - severe renal function impairment is defined by egfr estimated at screening between 15 ml/min/1.73 m2 and 29 ml/min/1.73 m2 (inclusive). exclusion criteria: all subjects: * pregnant or lactating women; * known hypersensitivity to act-132577 or drugs of the same class, or any of their excipients; * known hypersensitivity or allergy to natural rubber latex; * any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol. severe renal function impairment subjects: * end-stage renal disease that requires dialysis; * hemoglobin concentration \< 9 g/dl; * history of severe renal stenosis; * serum potassium concentration \> 5.5 mmol/l; * presence of severe cardiac disease; * history of clinically relevant bleeding disorder; * presence of any organ disorder, with the exception of renal function impairment, or use of any medication which might interfere with the pharmacokinetics of act-132577; * known life-threatening disease with a life expectancy of less than 1 year; * presence of unstable diabetes mellitus.
study on children henoch-schönlein purpura nephritis with tcm multistep treatment

Conditions: Henoch-Schönlein Purpura Nephritis

Summary: the purpose of this study is to determine the optimum dosage and application method of glycosides of tripterygium wilfordii hook(gtw) for henoch-schönlein purpura nephritis(hspn) in children, and develop into the normal treatment protocols for henoch-schönlein purpura nephritis in children.

based on chinese eleventh five-year plan for science and technology program, this study follows a large-sample multicenter centerrandom open-label controlled perspective method, enrolls hspn children with hematuria associated with proteinuria and isolated proteinuria from 2 to 18 years of age, classifys five traditional chinese medicine patterns of syndrome: wind-heat complicated with blood stasis, blood-heat complicated with blood stasis, yin deficiency complicated with blood stasis, both qi and yin deficiency complicated with blood stasis,damp-heat complicated with blood stasis. for tcm group,according to the severity of hspn, stepped treatment should be taken. the initial dosage of gtw for severe hspn is 2mg/kg/d, continued with 1.5mg/kg/d and 1mg/kg/d; the initial dosage of gtw for light hspn is 1.5mg/kg/d, continued with 1mg/kg/d. on the above base, the comprehensive treatment are taken combined with tcm syndrome differentiation, medicated with sulfotanshinone sodium injection.for controlled group,the treatment for severe hspn is prednisone combined with heparin plus lotensin and dipyridamole tablets;for light hspn is heparin plus lotensin and dipyridamole tablets.12 weeks after treatment, the third-party statistics evaluate the efficacy and effect,and a follow-up lasting 36 weeks will go on.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of henoch-schönlein purpura nephritis disease * age form 2-18 years old * disease onset within 2 months exclusion criteria: * nephritis not causing by hspn * being alergic to the medicine in the treatment * no compliance

Keywords: children， henoch-schönlein purpura nephritis integrated and stepped treatment in tcm
efficacy study of tkcell in advanced colorectal cancer

Conditions: Advanced Colorectal Cancer

Summary: the purpose of this study is to determine efficacy of nkcell in colorectal cancer


Eligibility criteria:
inclusion criteria: * written informed consent. * diagnosis of histologically confirmed adenocarcinoma of the colorectal * ecog performance status of 0 - 2 * at least one definite measurable lesion(s): ≥ 1 cm on spiral ct scan or ≥2cm in physical examination * adequate liver, renal, bone marrow functions as evidence by the following; * absolute neutrophil count \> 1.5 x 109/l; platelets \> 7.5 x 109/l; bilirubin less than 2 mg/dl asat and/or alat \< 5 unl; serum creatinine ≤ 2 uln * minimum life expectancy of 12 weeks * effective contraception for both male and female subjects if the risk of conception exists exclusion criteria: * brain metastasis and/or leptomeningeal disease (known or suspected) * previous chemotherapy for gastric cancer except adjuvant treatment with progression of disease documented \> 6 months after end of adjuvant treatment. * previous oxaliplatin-based chemotherapy * surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to randomization and chemotherapy * hiv antibody (+), chronic hepatitis * uncontrolled infection * concurrent or previous chronic systemic immune therapy, targeted therapy, hormonal therapy not indicated in the study protocol except for contraception * clinically relevant coronary artery disease, history of myocardial infarction, high risk of uncontrolled arrhythmia * known hypersensitivity reaction to any of the components of the treatment. * pregnancy (absence to be confirmed by ß-hcg test) or lactation period * participation in another clinical study within the 30 days before randomization * significant disease which, in the investigator's opinion, would exclude the subject from the study

Keywords: nkcell folfox-4 advanced or unresectable colorectal cancer
psychological counselling in diagnostic screening

Conditions: Cancer

Summary: diagnostic tests have a deep emotional impact on oncology patients. anxiety and worries can lead people to avoid screening tests, with high risks for health. a single arm, pilot study was organized to evaluate the feasibility and efficacy of psychological counselling for cancer patients who demonstrated anxiety for diagnostic tests. the hypothesis was that taking part in psychoeducative training could offer a new modality to reduce anxiety, before and during tests, and also the possibility to reinforce coping strategies.

the psychoeducative training was organized in 6 weekly meetings lasting two hours. each group was composed of 6 participants. the training follows the cognitive-behavioural model. in the first part of every meeting, theoretical aspects about stress and anxiety were explained, while in the second part some relaxation techniques were taught. during relaxation, we used a selected music that was also going to be used during the diagnostic tests. since the first meeting, patients experienced these relaxing techniques in order to learn them. in order to support the adaptability, at the end of every meeting the participants received some homework. they had to take notes on how many times they repeated the relaxation exercises and on the anxiety level before and after the training. for the study, 43 people were recruited. anxiety was measured with beck anxiety inventory (bai); it values the seriousness of the physiological behaviour connected with anxiety. this test an "anxiety gauge", which allows us to obtain numerical data on emotional changes. the test is composed of 4 interpretative levels: serious, moderate, small and minimal anxiety. the coping style was measured with coping orientation to problems experienced-new italian version (cope-niv); this test evaluates the way in which people resolve and face traumatic or usual stressful situations. the research project was approved by the ethics committee of veneto institute of oncology. every patient signed a written informed consent to process the data for research purposes and to publish it. forty-three patients who had to undergo one or more diagnostic tests (pet, tac, fmri, mammography, endoscopy, colonoscopy) took part in the study. the average age was 52.4 and 61.5% were married.

Eligibility criteria:
inclusion criteria: * age: 25 to 65 years cancer patients who must undergo diagnostic tests: tac, pet, fmri, mammography, endoscopy and colonoscopy. * an anxiety level greater than 5 (in a scale from 0=very calm to 10=very anxious; using a self-reporting instrument created ad hoc) * signed informed consent exclusion criteria: * healthy people

Keywords: anxiety psychoeducational training coping relaxation
the effects of cervical stabilization exercise training with telerehabilitation in individuals with migraine

Conditions: Migraine

Summary: the aim of our study is to investigate the effects of cervical stabilization exercise training applied with telerehabilitation in individuals with migraine.

cervical muscles are adversely affected in individuals with migraine. it is important to investigate the effects of cervical muscle training in these individuals. telerehabilitation applications have been used frequently in many patients in recent years. it is necessary to examine the effects of cervical stabilization exercises applied with telerehabilitation in individuals with migraine.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-55, * to be diagnosed with migraine by a neurologist according to international headache society criteria, * having at least 3 migraine attacks per month, * volunteering to participate in the study, * having the opportunity to access devices such as computers, phones and tablets with internet connection, * not having any problems that prevent cooperation and understanding exclusion criteria: * having other accompanying headache types, * being pregnant, * being in the breastfeeding period, * having a history of trauma, fracture or surgery in the craniocervical region, * presence of concomitant neurological and/or inflammatory rheumatic disease * presence of serious psychiatric problems, * history of malignancy, * changes in medical treatment during the study period, * receiving physiotherapy for the cervical region in the last 6 months