Kornimate/medical-research-clean huggingface dataset:
emma-1 (erbitux for multiple myeloma)

Conditions: Multiple Myeloma

Summary: emma-1 is an open-label, non-randomized, two-stage phase ii study. patients with refractory multiple myeloma stage ii or iii or relapsed disease after at least one line of treatment will receive cetuximab+/-dexamethasone. the planed treatment duration per patient is 16 weeks. patients achieving a response or stable disease after 16 weeks of treatment may continue study medication for 6 more months (patients receiving cetuximab alone) or for 3 more months (patients receiving cetuximab plus dexamethasone). responding patients who relapse during follow-up period of two years may receive a second treatment with cetuximab following initial study guidelines


Eligibility criteria:
inclusion criteria: * multiple myeloma diagnosed according to the durie-criteria in stage ii or iii (salmon and durie) * measurable disease * refractory or relapsed disease after at least one line of treatment * male or female \>= 18 years of age * life expectancy \> 12 weeks * ecog performances status 0-2 * if of childbearing potential, willingness to use effective contraceptive method for the study duration and 6 months post-dosing. * no surgery, radiotherapy or chemotherapy or any investigational agent within 30 days of study entry * signed written informed consent exclusion criteria: * asecretory multiple myeloma * patients eligible and willing to undergo high dose chemotherapy followed by autologous stem cell transplantation * prior allogeneic transplantation * prior antibody or egfr-pathway targeting therapy * severe cardiovascular disease like functionally restricting heart rhythm disturbance or heart malformation or severe hypertension, or cardiac insufficiency \> nyha-ii * hiv infection, hepatitis b or c * brain disorders, psychiatric illness * insufficient bone marrow reserve (leucocytes \< 1500/µl; thrombocytes \< 50000/µl) * creatinine-clearance \ 3.0 mg/dl * bilirubin \> 2 mg/dl; asat, alat \> 100 u/l * pregnancy (absence confirmed by serum/urine beta-hcg) or breast-feeding * fev1 \< 50% of the reference value * active secondary malignancy * legal incapacity or limited legal capacity * having participated in another clinical trial or any investigational agent in the preceding 30 days * known allergic/hypersensitivity reaction to any compounds of the treatment * other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix * medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent * known drug abuse/alcohol abuse

Keywords: multiple myeloma cetuximab
a study to test the long-term safety of bi 655130 in patients with atopic eczema who took part in study 1368-0032

Conditions: Dermatitis, Atopic

Summary: to assess the long term safety and efficacy of treatment with bi 655130 in patients with ad who have completed and have responded to treatment in the parent study 1368-0032


Eligibility criteria:
inclusion criteria: * signed and dated written informed consent in accordance with good clinical practice (gcp) and local legislation prior to the start of any screening procedures * patients who completed the 1368-0032 trial and did not prematurely discontinue treatment prior to week 16, and; in the 1368-0032 re-allocation period (v7 to v11): * if an original non-responder from week 16 (v7), attained at least easi 50 by last infusion (week 28) or by the eos. * if an original responder from week 16 (v7) completed the last visit week 28 (eos) or dropped to a easi 50 score prior to week 28. * women of childbearing potential (wocbp)1 must be ready and able to use highly effective methods of birth control per ich m3 (r2) that result in a low failure rate of less than 1% per year when used consistently and correctly for the duration of the trial and 16 weeks after last study drug administration. a list of contraception methods meeting these criteria is provided in the patient information. exclusion criteria: * women who are pregnant, nursing, or who plan to become pregnant while in the trial. * any new documented active or suspected malignancy except appropriately treated basal cell carcinoma, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix. * use of any restricted medication: or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator. * active systemic infections during the last two weeks prior to first drug administration. * currently enrolled in another investigational device or drug trial, except for 1368-0032. * any condition which would prevent the patient continuing on treatment in this trial 1368-0037 * evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse or any condition) other than ad, surgical procedure, psychiatric or social problems, medical examination finding (including vital signs and ecg), or laboratory value at the screening outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol, comply with all study visits/procedures or to complete the trial, compromise the safety of the patient or compromise the quality of the data. * history of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients
progeni (parkinson's research: the organized genetics initiative) family study of lrrk2 (leucine-rich repeat kinase 2)

Conditions: Parkinson Disease

Summary: the progeni family study is part of a larger consortium that is studying a gene shown to be important in parkinson's disease, called lrrk2. people who have a defect in the lrrk2 gene will often develop parkinson's disease. eligible participants will be asked to complete a single study visit at an affiliated research facility closest to their home.

participants will be asked to complete a family history questionnaire, which will gather information about their family history of parkinson's disease and related disorders. they will be asked to complete a single study visit, during which they will be asked to do some or all of the following: 1. complete questionnaires regarding parkinson's disease symptoms, medical history, mood, sleep, mental status, and activity level. 2. be given a brief standard neurological examination. 3. be given a scratch and sniff smell identification test. 4. be asked to give a sample of approximately 2 tablespoons of blood. 5. be asked to give a urine sample of approximately 1 tablespoon of urine.

Eligibility criteria:
inclusion criteria: positive for a lrrk2 mutation

Keywords: parkinson disease parkinson's disease pd lrrk2 genetics genes
the evaluation and comparison of bcr-abl p210 mrna transcripts (%is unit) results between dr. pcr™ bcr-abl1 major is detection kit (optolane) and qxdx™ bcr-abl %is kit (bio-rad) in chronic myeloid leukemia patients

Conditions: Chronic Myelogenous Leukemia

Summary: today, there are many commercial kits for detecting bcr-abl fusion transcripts. the qxdx™ bcr-abl %is kit (bio-rad, hercules, ca, usa) is the first ddpcr-based in vitro diagnostics (ivd) product with the us food and drug administration clearance and european conformity (ce) mark which launched in 2017. dr. pcr™ bcr-abl1 major is detection kit (optolane, south korea) is one of ce-ivd commercial kits based on digital rt-pcr. both commercial kits are digital pcr-based, also evaluated their correlation, pros and cons in order for users to select a reagents kit that are appropriate for themselves.

today, there are many commercial kits for detecting bcr-abl fusion transcripts. the qxdx™ bcr-abl %is kit (bio-rad, hercules, ca, usa) is the first ddpcr-based in vitro diagnostics (ivd) product with the us food and drug administration clearance and european conformity (ce) mark which launched in 2017. dr. pcr™ bcr-abl1 major is detection kit (optolane, south korea) is one of ce-ivd commercial kits based on digital rt-pcr. both commercial kits are digital pcr-based, also evaluated their correlation, pros and cons in order for users to select a reagents kit that are appropriate for themselves. objectives 1.to evaluate and comparison of bcr-abl p210 mrna transcripts (%is unit) results from two detection kit ; dr. pcr™ bcr-abl1 major is detection kit (optolane) vs qxdx™ bcr-abl %is kit (bio-rad) in chronic myeloid leukemia (cml) patients secondary objective 2.to be used as a standard inspection method of the hematology laboratory at siriraj hospital inclusion criteria 1. leftover rna samples from cml patients were recruited from the hematology laboratory division of hematology department of medicine faculty of medicine, siriraj hospital mahidol university, after tki treatment and regular follow-ups or newly diagnosed. 2. all samples were successively tested by qxdx™ bcr-abl %is kit (bio-rad) which used droplet digital pcr (ddpcr) technique. exclusion criteria 1.in adequate or poor-quality specimen

Eligibility criteria:
inclusion criteria: * leftover rna samples from cml patients were recruited from the hematology laboratory division of hematology department of medicine faculty of medicine, siriraj hospital mahidol university, after tki treatment and regular follow-ups or newly diagnosed. * all samples were successively tested by qxdx bcr-abl %is kit (bio-rad) which used droplet digital pcr (ddpcr) technique. exclusion criteria: * in adequate or poor-quality specimen

Keywords: bcr-abl p210 mrna transcripts dr. pcr™ bcr-abl1 major is detection chronic myelogenous leukemia
efficacy study of cd34 stem cell in chronic stroke patients

Conditions: Stroke; Middle Cerebral Artery Infarction

Summary: the objective of the study is to determine the efficacy of brain transplants of cd34+ stem cells obtained from peripheral blood of patients in the treatment of chronic stroke patients.

30 patients are divided into 2 groups, one treatment group and one control group.treatment group will be implanted with peripheral blood stem cell and receive convention stroke therapy ,and control group only receive convention stroke therapy. we expect that transplantation of the peripheral blood cd34+ cells has the potential of significant benefit to neurological recovery. in a previous phase i clinical trial, we have shown that transplantation of cd34+ cells obtained from the peripheral blood of the chronic stroke patients was safe and beneficial for neurological recovery. we expect this trial can further prove the efficacy of this treatment method.

Eligibility criteria:
inclusion criteria: * aged 35-70 chronic stroke adult patient, * with stroke history of more than 6 months, less than 60 months， * with stable hemiplegia condition, and * nihss (nih stroke scale) score is between 9-20. exclusion criteria: * patients aged less than 35 or more than 70, * hemorrhage stroke or mri show the occlusion is not in the middle cerebral artery territory，nihss is not in the range of 9-20, * pregnant women, * impaired liver function, abnormal blood coagulation, aids, combine other tumor or special condition.

Keywords: stroke stem cell cell therapy cd34 stem cell peripheral blood stem cell
quality of life intervention to inform patient decision-making in early-stage lung cancer

Conditions: Lung Non-Small Cell Carcinoma; Stage I Lung Cancer AJCC v8; Stage IA1 Lung Cancer AJCC v8; Stage IA2 Lung Cancer AJCC v8; Stage IA3 Lung Cancer AJCC v8; Stage IB Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage IIA Lung Cancer AJCC v8; Stage IIB Lung Cancer AJCC v8

Summary: this clinical trial studies the effect of a quality of life intervention on decision-making in patients with early-stage lung cancer who are undergoing standard of care surgery or stereotactic body radiation therapy (sbrt). providing quality of life outcome data to patients deciding between surgery and sbrt may help decrease decision regret and increase patient satisfaction with their care.

primary objective: i. determine the effect of provision of quality-of-life (qol) information versus usual care for standard of care surgery or sbrt treatment on decision regret. secondary objectives: i. determine the effect of provision of qol information versus usual care for standard of care surgery or sbrt treatment on qol measures. ii. determine the influence of socioeconomic status on the relationship between decision regret and qol information associated with each treatment modality. outline: patients are randomized to 1 of 2 groups. group a: patients receive study qol intervention fact sheet during the initial consult that occurs 4 weeks prior to the standard of care surgery or sbrt. patients have an opportunity to review the qol fact sheet in person and discuss any questions with the treating physician(s). group b: patients receive usual care during the initial consult that occurs 4 weeks prior to the standard of care surgery or sbrt. patients are followed up at 1, 3, and 6 months after standard of care surgery or sbrt.

Eligibility criteria:
inclusion criteria: * age \>= 18 years * radiographic stage i-ii non-small cell lung cancer (nsclc) * eligible for both surgery and sbrt * able to provide informed consent in english * have verbal fluency in english * participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure exclusion criteria: * radiographic stage iii-iv nsclc * eligible for either only surgery or sbrt, but not both * eligible for palliative-intent treatments or supportive care only. * pregnant female participants. * unwilling or unable to follow protocol requirements * any condition which in the investigator's opinion deems the participant an unsuitable candidate * cognitively impaired adults/adults with impaired decision-making capacity * individuals who are not yet adults (infants, children, teenagers) * prisoners
characteristics of patients with missed pulmonary embolism in the ed: a three year experience

Conditions: Missed Pulmonary Embolism at the Emergency Department

Summary: the clinical presentation of acute pulmonary embolism ranges from mild dyspnea and cough to shock or sustained hypotension but it also may even be asymptomatic and diagnosed by imaging procedures performed for other purposes. (1) depending on the clinical presentation, the case fatality rate for acute pulmonary embolism ranges from 1% up to 60%. due to the often non-specific presentation, especially in mild to moderate acute pulmonary embolism pe is often underdiagnosed. chest pain and shortness of breath are the two most common symptoms associated with pulmonary embolism, together these symptoms are responsible for approximately 10 million emergency department visits in the united states of america (us) (2). the aim of this study was to determine the sensitivity and specificity of diagnosing pulmonary embolism (pe) at the emergency department (ed) of the university hospital basel and the investigators have therefore retrospectively analyzed all cases with excluded or proven pe in our institution in the last three years. data sets from the institute of radiology, the institute of pathology and the ed are consistently available from january 2011 until the present day and were screened for pulmonary embolism in discharge reports. data from the ed include all patients between january 2011 and december 2013 that presented to the ed and received either an ecg or any form of thoracic imaging. particular attention was paid to patients with pe in the discharge report. the third set of data includes all patients with pe as cause of death or as a secondary diagnosis in the autopsy report. after comparing the three sets of data to each other the investigators tried to determine the sensitivity and specificity of pe diagnosis at the ed respectively the rate of missed diagnoses. a pe was seen as missed if it is detected 24h after the patient presented to the ed or if it was detected at another department after the patient was transferred from the ed.


Eligibility criteria:
inclusion criteria: * patients 18 years of age or older, * presented to the ed between january 2011 and march 2014, * who received an ecg or any form of thoracic imaging. exclusion criteria: * patients below 18 years of age, as well as patients referred to the ed with suspected pe by departments within uhbs, other hospitals, or other healthcare providers

Keywords: pulmonary embolism emergency department
mifepristone versus laminaria insertion for cervical preparation prior to surgical abortion at 14-16 weeks

Conditions: Abortion

Summary: women who are requesting pregnancy termination at 14-16 weeks, who would normally have osmotic dilator insertion the day before their procedure, would be asked if they wanted to participate. participants would be randomized to two groups: first, dilator insertion as usual, or second, mifepristone taken the day before the procedure.


Eligibility criteria:
inclusion criteria: * women aged 18-45 having pregnancy termination at 14-16 weeks exclusion criteria: * multiple gestation, pre-existing infection, contraindication to osmotic dilators, unable to obtain proper consent

Keywords: length of time for procedure to be completed need for additional dilation subject satisfaction with procedure
high dose vitamin b1 to reduce abusive alcohol use

Conditions: Alcoholism

Summary: b1as tests the hypothesis that increased vitamin b1 (thiamine) intake can repair brain systems damaged by alcohol and help people with alcohol problems control their alcohol use. a strong, man-made form of thiamine (benfotiamine) is used to increase blood thiamine to much higher levels than can be achieved using normal vitamin supplements. drinking patterns are examined over 6 months of continued supplement use. men and women with a recent history of alcohol problems are eligible to participate.

b1as is a randomized, double-blind placebo-controlled clinical trial of the effectiveness of benfotiamine at reducing abusive drinking patterns in individuals with recent alcohol problems. subjects consume 4 tablets of benfotiamine (600 mg) or placebo daily for 6 months. monthly follow-ups track alcohol use and alcohol-related problems over the 6 months. blood tests are also conducted to determine the frequency of an inherited abnormality in thiamine processing that may be related to the risk of developing alcoholism.

Eligibility criteria:
inclusion criteria: * problem drinking in the last 30 days exclusion criteria: * prolonged abstinence * serious medical problems

Keywords: alcoholism benfotiamine thiamine
bovine reinforcement in stomach, colorectal and lung operation

Conditions: Rectal Cancer Stage III; Lung Cancer Stage III

Summary: the primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of stomach,colorectal and lung anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced techniques with respect to the incidence of postoperative hemorrage rate, anastomotic leakage, if applicable.

this is a randomized prospective trial that compares the use of cingular bioabsorbable staple line reinforcement to standard stapling techniques in tissue resections. the potential exists to utilize staple line reinforcement as a means of lowering the rate of post-operative hemorrage rate, anastomotic leakage.

Eligibility criteria:
inclusion criteria: * subjects who will undergo operation with stapled stomach, colorectal anastomosis with or without reinforcement * subjects willing to accept informed consent and willing to attend the follow up exclusion criteria: * subjects who have significant intraoperative hypotension or cardiac events. * subjects with collagen vascular disease, coagulopathy, significant renal or hepatic dysfunction (creatinine \>1.6 or liver enzymes \> 50% upper limit of normal values). * subjects have uncontrolled intra-abdominal infection
the diagnostic value of bronchoscopic needle-based confocal laser endomicroscopy (ncle) as a real-time detection tool for diagnosing peripheral lung cancer: a multi-centre randomised controlled trial

Conditions: Lung Cancer, Non-Small Cell; Lung Cancer, Small Cell

Summary: the goal of this prospective, multi-centre, randomised controlled clinical study is to evaluate the diagnostic efficacy and safety of ncle guided lung biopsy in patients with for peripheral lung nodules under the assistance of navigation bronchoscopy (nb) and radial endobronchial ultrasound (rebus), and assess whether the biopsy techniques, namely transbronchial crybiopsy (tbcb) and transbronchial forceps biopsy (tbfb), would influence the diagnostic efficacy and safety of ncle guided biopsy. participants will divided into ncle-nb-rebus-forcep biopsy group, ncle-nb-rebus-tbcb group, nb-rebus-forcep biopsy group, and nb-rebus-tbcb group at a 1:1:1:1 ratio by using central, computerized random sequence, and then undertake ncle-nb-rebus-forcep biopsy, ncle-nb-rebus-tbcb, nb-rebus-forcep biopsy, and nb-rebus-tbcb according to the group. researchers will compare the diagnostic yield and incidence of adverse events of the four biopsy techniques.


Eligibility criteria:
inclusion criteria: * patients with peripheral lung nodules suspected of lung cancer based on ct scan (10mm≤size\<30mm); * patients requiring diagnostic bronchoscopy procedure to determine the benign or malignant nature of the lung nodule; * patients who can understand the purpose of the trial, participate voluntarily and sign an informed consent form. exclusion criteria: * inability or non-willingness to provide informed consent; * endobronchial visible malignancy on bronchoscopic inspection; * target lesion within reach of the linear ebus scope; * failure to comply with the study protocol; * known allergy or risk factors for an allergic reaction to fluorescein; * pregnancy or breast feeding; * haemodynamic instability; * refractory hypoxaemia; * therapeutic anticoagulant use that cannot be withheld for an appropriate interval before the procedure; * unable to tolerate general anaesthesia according to the anaesthesiologist; * undergoing chemotherapy as several chemotherapies have fluorescent properties at the same wavelength (eg, doxorubicin).

Keywords: needle-based confocal laser endomicroscopy peripheral lung cancer peripheral lung nodules lung biopsy
pulsed field ablation for paroxysmal supraventricular tachycardia（psvt）

Conditions: Paroxysmal Supraventricular Tachycardia

Summary: the purpose of this study was to explore the safety and efficacy of a pulsed field ablation device and force sensing pulsed field ablation catheter in the treatment of paroxysmal supraventricular tachycardia.

the primary endpoint for efficacy is the number of subjects where ablation of each psvt resulted in confirmation of electrical isolation of the psvt 15 minutes following the last index pfa application with the investigational device

Eligibility criteria:
inclusion criteria: 1. patients with symptomatic paroxysmal supraventricular tachycardia including:atrioventricular nodal re-entrant tachycardia, atrioventricular arrhythmias; 2. willingness to undergo an evaluation to validate the requirements of the protocol. 3. voluntary signed informed consent and willingness to undergo the tests and procedures required by the protocol. exclusion criteria: 1. patients with structural heart disease 2. history of any cardiac surgery 3. failure of prior ablation of psvt 4. presence of any implantation, such as artificial valves, permanent pacemakers, etc 5. patients with active systemic infections 6. any condition contraindicating septal puncture or retrograde transaortic approach for procedures 7. any condition contraindicating heparin or aspirin 8. patients with advanced malignant tumor 9. any woman known to be pregnant or breastfeeding 10. unwilling or unable to comply fully with study procedures and follow-up 11. unable to provide own informed consent 12. coexistence with other arrhythmias

Keywords: psvt pfa avnrt avrt