Kornimate/medical-research-clean huggingface dataset:
prospective collection of biological data of prognostic relevance in patients with b-cell chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia Stage A(0); Chronic Lymphocytic Leukemia Stage A(I); Chronic Lymphocytic Leukemia Stage A(II)

Summary: the purpose of the present study is to develop a biological prognostic index in patients with binet stage a chronic lymphocytic leukemia (cll) who do not necessitate therapy according to nci guidelines and to prospectively validate the proposed score system based on the absence/presence of 1, 2 or 3 unfavorable prognostic markers such as cluster of differentiation 38 (cd38) expression, zap-70 expression and immunoglobulin heavy chain variable region (igvh) configuration.

clinical data including information on disease localization and laboratory parameters will be collected at study entry, during follow up and at disease progression (or after 36 months after registration) biological markers will be evaluated at centralized laboratory, at study entry and at time of disease progression (or after 24 months of follow-up for non progressed patients) using the scoring system, patients can be separated into 3 risk groups: low-risk (score 0), intermediate-risk (score 1) and high-risk (score 2-3), with significantly different clinical courses.

Eligibility criteria:
inclusion criteria: * established diagnosis of b-cll by nci criteria, performed by local haematologist. (diagnosis will be confirmed by the biological review committee according to flow cytometry analysis (positive clusters of differentiation antigen 5 (cd5), 19 (cd19),23 (cd23)). * age \> 18 years and \< 70 years. * eastern cooperative oncology group (ecog)\<=2. * binet stage a. * diagnosis performed within 12 months before inclusion in the study. * patients who do not necessitate therapy by nci guidelines (watch and wait policy). * shipment of peripheral blood sample to centralized laboratory for biological assessment. * clinical data including baseline information on disease localization and laboratory parameters at staging and assurance of follow up updating for at least 3 years are requested. * written informed consent. exclusion criteria: * patients with cll whose diagnosis exceed 12 months before registration. * patients with leukemic phase of lymphoproliferative disorders of b origin cd5- and/or cd23- according to flow cytometry analysis. * clinical binet stage b or c. * patients who necessitate therapy according to nci guide-lines (no watch and wait policy). * age \> 70 years. * without a written informed consent.
a trial of shr - 1906 in healthy subjects

Conditions: Idiopathic Pulmonary Fibrosis

Summary: this study is a phase 1 single dose escalation study of shr-1906 in healthy subjects. the purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of shr-1906 in healthy subjects.


Eligibility criteria:
inclusion criteria: 1. ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent, be able to comply with all the requirements and able to complete the study. 2. male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form. 3. total body weight ≥ 45 kg. 4. no clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function and thyroid function) and ecg at the investigator's discretion during screening and baseline 5. men and women of childbearing potential (wocbp) must agree to take effective contraceptive methods exclusion criteria: 1. history of serious cardiovascular, liver, kidney, digestive tract, psychiatric, hematology, metabolic disorders, primary immunodeficiency disease or acquired immune deficiency syndrome, or organ transplantation. 2. severe infections, injuries or major surgeries (as determined by the investigator) within 6 months prior to screening, or plan to do any surgery during the trial. 3. positive testing for human immunodeficiency virus (hiv-ab), or hepatitis b surface antigen (hbsag), or tp-ab , or hepatitis c antibodies (hcv-ab). 4. screening/baseline systolic blood pressure (bp) ≥140 mmhg or ≤90 mmhg; diastolic bp ≥90 mmhg or \<60 mmhg on a single measurement 5. positive urine drug screening at baseline; 6. use of any medicine within 1 monthes (including any prescription, or over-the-counter medicine, herbal remedy or nutritional supplement, except for vitamins and occasional use of acetaminophen with recommended dose), or within 5 half-lives of any drugs whichever is longer prior to dosing, or plan to use any medicine during the trial. 7. participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of any drugs during screening visit, or in the follow-up period of a clinical study whichever is longer (according to the date of signed consent form) which is defined as having consented and used other investigational drugs (including placebo) or trial medical devices. 8. blood donation or loss of ≥ 400 ml of blood within 1 months; or received blood or blood products within 2 months prior to screening. 9. any other circumstances that, in the investigator's judgment, may increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response. 10. researchers and relevant staff of the research center or other persons directly involved in the implementation of the program.
comparative effects of action observation and motor imagery on upper limb in chronic stroke patients

Conditions: Stroke; Upper Extremity Paresis; Motor Activity

Summary: to compare effects of action observation and motor imagery training on upper limb function in chronic stroke patients.

the study is randomized controlled trial. the study will be conducted on 44 stroke patients. the study will be conducted in civil hospital shujaabad and riphah rehabilitation centre lahore. patients will be divided into group a (n = 20) and group b (n = 20) using a randomization through computer generated numbers program. patients in group a will receive action observation training with conventional treatment. all participants will undergo the training for 25 minutes per session, 5 days per week for 8 weeks. patients in group b will receive motor imagery with conventional treatment. all participants will receive interventions for twenty-five minutes per session, five times a week, for eight weeks. for the pre- and post-evaluation of all participants, fugl-meyer assessment upper extremity (fma ue) and wolf motor function test (wmft) will be used. data will be analyzed by using spss (statistical package for social sciences) 25 version.

Eligibility criteria:
inclusion criteria: * diagnosed with chronic stroke by a neurologist * 03 months post stroke * score 1+ on modified ashworth scale * having a score of 24 or higher in the mini-mental state examination exclusion criteria: * patient with neurological condition other than stroke e.g. parkinson's or multiple sclerosis * presence of an attached artificial pacemaker * presence of a metal implant in the brain * presence of visual impairment * presence of unilateral neglect in line bisection test (25) * use of antipsychotic drugs

Keywords: stroke upper extremity paresis motor activity
behavioral effects of pregabalin and cannabis

Conditions: Cannabis-use Disorders

Summary: cannabis is the most commonly used illicit drug in the united states, and its use is associated with rates of development of abuse and dependence, treatment admission and relapse that are comparable to other illicit drugs. currently there is no effective pharmacological treatment for cannabis-use disorders. the purpose of the present study is to evaluate the ability of pregabalin to reduce cannabis use thereby evaluating its effectiveness as a medication for cannabis-use disorders.


Eligibility criteria:
inclusion criteria: * regular cannabis use * good health other than cannabis use * willingness to attempt abstinence * effective form of birth control in female subjects * available for up to 6 hrs every day for two 2-week test periods with an intervening break of 7-10 days each * located in close proximity to university of kentucky exclusion criteria: * medical screening outcomes outside normal ranges or deemed clinically insignificant * medical history that would contraindicate pregabalin administration

Keywords: marijuana addiction treatment pharmacotherapy cannabinoid
reach svs control patient cross-over study

Conditions: Emphysema

Summary: this is a multicenter, prospective study designed to evaluate performance of the svs in the reach svs control patients. the study is expected to enroll up to 20 patients at up to 12 sites with up to 6 patients per site.


Eligibility criteria:
inclusion criteria: * patient was enrolled in the reach svs study control group and has completed their participation in the study including the 12 month follow-up visit. * patient has received standard-of-care medical management and it has been stable for 6 weeks. * patient is willing to participate in a study, complete the required follow-up visits, and maintain consistent nutrition and exercise habits during the study period. exclusion criteria: * patient is classified as asa class greater than p4 including presence of co-morbidity that could significantly increase the risk of a bronchoscopy procedure. * patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study. * patient has demonstrated unwillingness or inability to complete baseline data collection procedures. * patient has co-existing major medical disease that will limit evaluation, participation, or follow-up in the study. * patient is unable to provide informed consent. * patient is not an appropriate candidate for or is unable to tolerate, flexible bronchoscopy procedures. * patient has history of 4 or more hospitalizations for copd exacerbation or respiratory infections in the past year and none have occurred in the prior 3 months. * patient has evidence of systemic disease or neoplasia expected to compromise survival during the 3-month study period * patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.
cognitive behavioral sleep intervention for prevention of type 2 diabetes

Conditions: PreDiabetes; Insomnia; Sleep Deprivation

Summary: the proposed study aims to evaluate if improving sleep could enhance the intensive lifestyle intervention for improving weight loss and glycemic control in prediabetic individuals who have insomnia with short sleep duration. a cognitive behavioral intervention for insomnia with adjustments aimed at increasing sleep duration (cbt-sleep) will be used for this study.


Eligibility criteria:
inclusion criteria: * (a) hong kong residents, * (b) bmi \> 23kg/m2, * (c) aged 18 to 65 year-old, * (d) have prediabetes, defined by a plasma fasting glucose concentration of 5.6 to 6.9 mmol/l, impaired glucose tolerance (2hglucose 7.8-11.0 on ogtt), or hba1c 5.7-6.4%, * (e) have average habitual sleep duration \< 6.5 hours, confirmed by actigraphy measure of sleep for 2 weeks or have insomnia, confirmed in a clinical sleep interview and actigraph-measure of greater than 30 minutes of sleep onset latency or nighttime awakening for 3 nights or more per week exclusion criteria: * (a) have unmanaged sleep apnea or other sleep disorders, * (b) have any current severe mental illnesses, * (c) have any medical conditions or medication use that could undermine the efficacy of the sleep intervention, * (d) have shift work schedules, * (e) have any environmental constraints on the feasibility of implementing a sleep schedule of at least 7.5 hours

Keywords: cognitive behavioral therapy lifestyle intervention
an observational study on infusion-related adverse events at administration of mabthera (rituximab) in patients with chronic lymphocytic leukemia

Conditions: Lymphocytic Leukemia, Chronic

Summary: this observational study will monitor and register infusion-related adverse events and their handling in patients with chronic lymphocytic leukemia on treatment with mabthera (rituximab). data will be collected from patients receiving intravenous mabthera at a dose of 375mg/m2 in cycle 1 and 500mg/m2 in subsequent cycles at each treatment visit for up to 6 months. target sample size is 100 patients.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * chronic lymphocytic leukemia treated with rituximab (mabthera) * rituximab (mabthera) dosage 375 mg/m2 in cycle 1, 500 mg/m2 in subsequent cycles * informed consent to data collection exclusion criteria: * participation in an interventional clinical study
gastric arterial embolization for weight loss

Conditions: Obesity

Summary: title: embolization of gastric arterial supply for weight loss sample size: 10 patients study population: morbidly obese patients who were seen by the bariatric surgery program at toronto western hospital but are either not interested or not eligible for surgery. study design: single center, randomized, prospective, non-blinded pilot study. study duration: 12 months (november 2015 - december 2015). agent: 150-250 micron polyvinyl alcohol particles primary objective: to further evaluate the safety of embolization of the left gastric and gastroepiploic arteries. to determine if either or both will result in significant weight loss and decrease in waist circumference among obese patients. primary objective measure: the number of adverse events in a 1 year period will be recorded. the weight change from baseline will be recorded.


Eligibility criteria:
inclusion criteria: * meet standard eligibility criteria for bariatric surgery. bmi of \>= 40 -or- bmi of \>=35 with one of the following comorbid conditions: hypertension, type 2 diabetes, obstructive sleep apnea, coronary artery disease exclusion criteria: basic unable to provide informed consent (legally authorized representative is acceptable) unable or unwilling to come for follow up appointments age \ 80 weight \>400 lbs or 180kg due to weight limits on angiographic tables moderate or severe allergy to iodinated contrast media not amenable to premedication as defined by the acr contrast guidelines pregnant, breastfeeding or actively trying to become pregnant in the next year inability to lie flat for the duration of the procedure limited life expectancy \< 1 year patient enrolled in another interventional study, they will be permitted to enter this study 30 days after reaching the prior studies primary endpoint arterial anatomy not feasible for intervention based on investigator assessment gastrointestinal pre-existing chronic abdominal pain history of inflammatory bowel disease history of gastroparesis prior history of gastric surgery, embolization or radiation prior or current history of peptic ulcer disease significant risk factors for peptic ulcer disease including daily nsaid use, active smoking or active h. pylori infection abnormal upper endoscopy hepatic cirrhosis portal venous hypertension hepatic bilirubin \> 2.0 mg/dl albumin \< 2.5 g/l cardiovascular known aortic pathology such as aneurysm or dissection peripheral arterial disease renal renal insufficiency as evidenced by estimated gfr \< 60ml/min.1.73m2 hematologic/immunologic/oncologic/infectious acute or chronic infection active cancer or prior history of cancer \ 1.7 psychiatric major diagnosed psychiatric comorbidities such a major depressive disorder, schizophrenia, bipolar disorder that are deemed to likely interfere with follow up history of an eating disorder such as anorexia or bulimia
prevalence of familial hypercholesterolaemia (fh) in italian patients with coronary artery disease

Conditions: Coronary Artery Disease

Summary: evaluate the prevalence of familial hypercholesterolemia (fh) in patients with documented coronary artery disease (cad) event \[acute myocardial infarction (ami), acute coronary syndrome (acs), coronary artery bypass graft (cabg) or percutaneous coronary intervention (pci)\] followed by 100 cardiological centers representative of the whole italian territory

familial hypercholesterolemia (fh) is a disease that causes exposure to elevated plasma levels of ldl cholesterol (ldl-c, low-density lipoprotein) and increasing the risk of premature coronary heart disease (coronary artery disease, cad). the fh is a co-dominant genetic disease and can occur in heterozygous and homozygous form, with different severity. the prevalence in whites is estimated to be 1.500 for heterozygous familial hypercholesterolemia (hefh) and 1.1000000 for homozygous familial hypercholesterolemia (hofh). this prevalence is probably an underestimate, as it is based on prevalence rates in in-patient and disease registries, and is influenced by the early mortality of patients with fh. the situation does not improve if we consider patients admitted for acute coronary event (myocardial infarction - ami and / or unstable angina, - acs). if we consider ldl cholesterol cumulative load in a person affected by fh, the best approach intervention to reduce cardiovascular mortality is an early diagnosis and treatment. the primary aim of the study is to evaluate the prevalence of fh in patients with documented cad event (ami, acs, cabg or pci) followed by 100 cardiologic centers representative of the whole italian territory. the results will also permit to increase the cardiologists awareness of fh. secondary objective will be the validation of dutch lipid clinic network (dlcn) criteria (annex 1), in the italian cad population (12). the characterization of the patients, carried out during the study, will allow to identify the priorities for health inteventions aimed at improving the fh diagnosis in the general population through the a cascade screening in the relatives of the genetically characterized subjects.

Eligibility criteria:
inclusion criteria: * patients must have a documented coronary artery disease, more precisely: acs pci cabg the index event must be occurred between 15 days and 8 weeks preceding the enrollment. - written informed consent to participate to the study exclusion criteria: * patients unwilling to give their written informed consent.

Keywords: familial hypercholesterolemia coronary artery disease
the fast track rehabilitation in thoracic surgery

Conditions: Thoracic Surgery

Summary: this prospective, randomized study is designed to evaluate the effectiveness of postoperative care pathway using the fast track rehabilitation protocol (ftr) in comparison with the traditional postoperative care. in order to conduct this study, patients having a thoracic surgery will be randomly attributed to ftr protocol group or control group.

traditionally, patients who underwent thoracic surgery have been treated with a classical protocol which include; bed rest, ambulation prohibited for 24-48 hours and starvation for several postoperative days till the recovery of bowel. some studies reported the efficacy of early rehabilitation protocols or ftr protocols in thoracic surgery to reduce postoperative complications and to minimize hospital stay. but these studies are few and retrospective. prospective randomized trials focuses based on the "fast track regimen" or medical fast track that interest only on the medical component . this prospective, randomized study is designed to evaluate the effectiveness of postoperative care pathway using ftr protocol in comparison with the traditional postoperative care. in order to conduct this study, patients having a thoracic surgery will be randomly attributed to ftr protocol group or control group.

Eligibility criteria:
inclusion criteria: * all patients who have lung surgery during the study period after their consents are included. exclusion criteria: * patients who have bad general state are unable to move or require a wake in the resuscitation. * the patients with thoracic soft tissue surgery. * patients having mediastinoscopy, surgery of the chest wall or mediastinum.

Keywords: fast track rehabilitation post operative complications
role of intracoronary imaging in plaque identification

Conditions: Coronary Artery Disease

Summary: nste-acs patients are more likely to exhibit high-risk plaque characteristics in non-culprit lesions. both ivus and oct imaging techniques interact in a complementary manner to provide morphological characterization of the atherosclerotic coronary plaques and help identification of high-risk vulnerable plaques. using morphological parameters obtained from oct and ivus, a new plaque vulnerability score will be established for more precise definition of the most vulnerable plaques that carry the greatest risk of rupture and subsequent detrimental clinical outcomes in the future. such score might help in targeting these plaques with certain therapeutic interventions aiming to their stabilization.

patients with nste-acs presented to the study site fulfilling the eligibility criteria during enrollment period of 1 year. the culprit lesion(s) being responsible for the acute event will be revascularized by percutaneous coronary intervention (pci). both oct (optistm, st. jude medical inc., st. paul, mn, usa) and ivus (boston scientific ilabtm ultrasound imaging system, ma, usa) will be performed after pci to examine the non-culprit lesion(s) for detection of atherosclerotic plaques with the morphological characteristics consistent with high-risk plaques, namely "vulnerable plaques". plaque characteristics from ivus and oct imaging will be merged to establish novel scores, which help improve diagnostic accuracy for detection of high-risk lesions. correlations ivus and oct images will be performed to identify most reliable factors associated with plaque vulnerability.patients will be followed up to 6 months after pci for detection of major adverse cardiovascular outcomes (mace) after ischaemia-driven revascularization of the culprit lesion(s).

Eligibility criteria:
no formal inclusion or exclusion criteria