Kornimate/medical-research-clean huggingface dataset:
acvbp followed by asct in patients with bcl-2 positive diffuse large b-cell lymphoma

Conditions: Lymphoma, Large-Cell, Diffuse

Summary: the primary objective of the study is to evaluate the efficacy of asct as consolidation in case of bcl-2 overexpression in non previously treated patients aged 60 years or less with low-intermediate risk diffuse large b-cell lymphoma who responded to acvbp regimen. our goal is to obtain a 15% increase of event-free survival at 2 years.


Eligibility criteria:
inclusion criteria: * patient with diffuse large b-cell lymphoma according to the who classification (anti cd20 labeling) * aged 18 to 60 years * non previously treated * with one and only one of the following adverse characteristics: ecog performance status 2 or more, or ann arbor stage iii or iv, or elevated ldh level * negative hiv, hbv and hcv serologies (except vaccination) * with a minimum life expectancy of 3 months * having previously signed a written informed consent exclusion criteria: * any history of treated or non-treated indolent lymphoma. * t-cell lymphoma. * central nervous system or meningeal involvement by lymphoma. * any contra-indication to any drug contained in the chemotherapy regimens. * poor renal function (creatinin level\>150µmol/l), poor hepatic function (total bilirubin level\>30mmol/l, transaminases\>2.5 maximum normal level) unless these abnormalities are related to the lymphoma. * serious active disease (according to the investigator's decision). * poor bone marrow reserve as defined by neutrophils \<1.5g/l or platelets\<100g/l, unless related to bone marrow infiltration. * any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. * treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study. * childbearing woman. * patients previously treated with an organ transplantation.

Keywords: lymphoma autologous stem cell transplant chemotherapy bcl2
prep and alcohol - enhancing hiv pre-exposure prophylaxis (prep)

Conditions: Hazardous Alcohol Use

Summary: the present investigation entails a pilot randomized controlled trial to explore whether a stand-alone, alcohol-reduction, brief intervention (with a module on substance use and depression) would be feasible, acceptable, and potentially efficacious within the context of hiv pre-exposure prophylaxis (prep) treatment.

although hiv pre-exposure prophylaxis (prep) is an effective tool that can help prevent the acquisition of hiv, its degree of effectiveness has been shown to be linked to a number of key behaviors, including treatment adherence, attendance in follow-up care, and the concurrent use of condoms. hazardous alcohol consumption has the potential to contribute to suboptimal prep adherence, poor retention in prep care, and condomless sex/sexually transmitted infections (stis); and its impact on these prep-related behaviors may also become exacerbated in the presence of concurrent issues such as substance use and depression, thus reflecting a potential syndemic effect. the present investigation entails a pilot randomized controlled trial in which 120 hazardous drinking, prep-prescribed men who have sex with men (msm) will be randomly assigned to receive either a tablet-based, alcohol-reduction brief intervention or treatment-as-usual. participants assigned to the former condition for whom substance use- and/or depression-related concerns are identified will additionally be provided with links to relevant supportive resources. feasibility and acceptability of the intervention will be examined. furthermore, biomarker testing and self-report electronic surveys at baseline, 3-months, and 6-months will be employed to assess the preliminary impact of the intervention on alcohol use, prep adherence, retention in prep care, and the engagement in condomless sex/sti acquisition.

Eligibility criteria:
inclusion criteria: participants must be: * aged 18 years or older, * be a patient of toronto general hospital (tgh) or maple leaf medical clinic (mlmc), * be a man who identifies as gay, bisexual, and/or a man who has sex with other men, * have been prescribed prep for at least 3 months, and * meet the criteria for hazardous drinking, (i.e., based on a score of ≥4 on the alcohol use disorders identification test-consumption measures (audit-c)). exclusion criteria: * participants will be excluded if they do not meet all of the above-mentioned inclusion criteria.

Keywords: prep alcohol substance use depression
low dose plerixafor plus g-csf in mobilizing stem cells for autologous peripheral blood transplantation

Conditions: Lymphoma, Non-Hodgkin; Lymphoma, Hodgkin; Myeloma; Stem Cell Transplant Complications

Summary: plerixafor, is added to mobilizing chemotherapy and g-csf to overcome poor stem cell mobilization. we want to demonstrate that half of the commonly prescribed dose can be safely administered once as a single dose in first attempt leading to apheresis yields of \>2 x 106 cd34+ cells/kg body weight.

plerixafor, is added to mobilizing chemotherapy and g-csf to overcome poor stem cell mobilization. consecutive patients in autologous transplant protocol will receive mobilization consisted of daily subcutaneously g-csf 10 mg/kg for 4 days and plerixafor 0.12 mg/kg as a single dose 11 hours prior to initiation of apheresis. hsc collection was performed with a cobe spectra® or spectra optia® apheresis system. the planned target blood volume to be processed will be 4-fold total blood volume calculated according to patients' weight and size. peripheral blood cd34+ counts will be analyzed using flow cytometry. for each asct, we aimed for target yields of at least 2 x 106 cd34+cells/kg. toxicities and engraftment will be documented.

Eligibility criteria:
inclusion criteria: 1. candidates planned for an autologous haematopoietic stem cell transplantation without previous mobilization attempts with chemotherapy. 2. eastern cooperative oncology group (ecog) performance status of 0 to 2. 3. wbc count ≥2.5x109/l. 4. absolute neutrophil count ≥1.5x109/l. 5. platelet count ≥100x109/l exclusion criteria: 1. prior allogeneic or autologous transplantation. 2. pregnant women. 3. acute infection (febrile, i.e. temperature \> 38c) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of gcsf. 4. positive serology for hepatitis b or c or hiv. 5. left ventricular ejection fraction \< 40% 6. ast alt \>2.5x or creatinine \>2 md/dl
safety and effectiveness evaluation of teosyal® tpvm versus comparator for the remodeling of the lower face

Conditions: Aging; Chin Retrusion

Summary: the clinical study is designed to prospectively evaluate the safety and effectiveness of teosyal® tpvm when compared to comparator for the remodeling of the lower face

this is a prospective, randomized, blinded evaluator, multicenter, clinical study to evaluate safety and effectiveness of teosyal® tpvm versus comparator for the remodeling of the lower face. subject will be enrolled in the study based on evaluation of their chin retrusion severity. for the purpose of this study, all injections will be done by principal investigators (pis) with several years of experience in aesthetic treatment. an external aesthetic and cosmetic surgeon will act as a be to assess the performance of the treatment and the product based on photographs.

Eligibility criteria:
inclusion criteria: * healthy adult subjects over 18 years old seeking correction of their lower face * subject scored grade 2 or 3 on the tcrs * female subjects of childbearing potential must have a negative upt and practice a reliable method of contraception throughout the study. * willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations * able to follow study instructions and complete all required visits. * having given its signed informed consent exclusion criteria: * known hypersensitivity or previous allergic reaction to any component of the study devices * known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock. * history of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study. * subject exhibits any physical attribute that may prevent assessment or treatment of the lower face as judged by the pi * clinically significant alcohol or drug abuse. * subject has received any investigational product within 90 days prior to visit 1 or planning to participate in another investigation during the course of the study.

Keywords: dermal filler hyaluronic acid (ha) chin
dual antithrombotic therapy in patients with af and acs

Conditions: Atrial Fibrillation; Acute Coronary Syndromes

Summary: the study aims to show inferiority of rivaroxaban plus ticagrelor when compared to rivaroxaban plus clopidogrel in terms of safety. safety will be determined by comparing the rates of death or ischemic event-including myocardial infarction, definite or probable stent thrombosis, stroke, or urgent revascularization.

the main objective of this study is to compare a dual antithrombotic therapy (dat) regimen of rivaroxaban plus ticagrelor with rivaroxaban plus clopidogrel in patients with non valvular atrial fibrillation (nvaf) and acute coronary syndrome. the study aims to show inferiority of rivaroxaban plus ticagrelor when compared to rivaroxaban plus clopidogrel in terms of safety. safety will be determined by comparing the rates of death or ischemic event-including myocardial infarction, definite or probable stent thrombosis, stroke, or urgent revascularization.

Eligibility criteria:
inclusion criteria: 1. adults with either active or a history of non-valvular atrial fibrillation or flutter with the planned or existing use of an oral anticoagulant for prophylaxis of thromboembolism. in addition, subjects must have had an acute coronary syndrome 2. planned use of antiplatelet agents for at least 12 months 3. males and females ≥ 18 years of age 4. women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug exclusion criteria: 1. conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve) 2. severe renal insufficiency (serum creatinine \> 2.5 mg/dl or a calculated creatinine clearance \< 30 ml/min 3. patients with a history of intracranial hemorrhage 4. patients have had or will undergo coronary arterial bypass graft (cabg) for their index acute coronary syndrome (acs) event 5. patients with known ongoing bleeding and patients with known coagulopathies 6. any contraindications or allergies to rivaroxaban, or to intended p2y12 antagonists 7. have a history of stroke or transient ischemic attack (tia) 8. have known significant liver disease or liver function test (lft) abnormalities 9. have any severe condition that would limit life expectancy to less than 12 months
enhancing acupuncture treatment effect through non-invasive neuromodulation

Conditions: Chronic Pain

Summary: in this study, investigators will examine the brain mechanism behind the synergistic effects of combining acupuncture and transcranial direct current stimulation (tdcs) treatments. specifically, chronic low back pain (clbp) patients will be recruited and randomized to one of four groups (30 per group, one month of treatment): 1) verum acupuncture + real tdcs, 2) sham acupuncture + real tdcs, 3) verum acupuncture + sham tdcs, and 4) sham acupuncture + sham tdcs. investigators will study 1) the longitudinal (one-month) effects of different treatments as indicated by changes in resting state functional connectivity (rsfc), cerebral blood flow (cbf), clinical outcomes of low back pain, and quantitative sensory test (qst) and 2) the association between these changes.


Eligibility criteria:
inclusion criteria: * volunteers 18-60 years of age * meet the classification criteria of chronic low back pain (having low back pain for more than 6 months), as determined by the referring physician * at least 4/10 clinical pain on the 11-point low back pain numeric rating scale (lbp nrs) * at least a 10th grade english-reading level; english can be a second language provided that the patients understand all questions used in the assessment measures exclusion criteria: * history of epilepsy or loss consciousness (loc) * specific causes of back pain (e.g. cancer, fractures, spinal stenosis, infections) * complicated back problems (e.g. prior back surgery, medicolegal issues) * the intent to undergo surgery during the time of involvement in the study * history of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcomes. for example: asthma or claustrophobia * presence of any contraindications to magnetic resonance imaging (mri) scanning. for example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, inability to remain still in mri scanner * history of medical or psychiatric illness as determined by the investigator * history of substance abuse or dependence
biomarker for duchenne muscular dystrophy

Conditions: Increased Lordosis/Scoliosis; Hyporeflexia; Duchenne Muscular Dystrophy; Red-Green Color Blindness; Lordosis; Scoliosis; Muscular Atrophy; Muscular Weakness

Summary: international, multicenter, observational, longitudinal study to identify biomarker/s for duchenne muscular dystropy (dmd) and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s.

duchenne muscular dystrophy (dmd) is a devastating inherited neuromuscular disorder that affects 1 in 3300 live male births (females can be mildly affected carriers). dmd causes progressive weakness and loss of muscle mass, with symptoms usually appearing in early childhood. dmd arises from mutations in the dmd gene that codes for dystrophin. the dmd gene is located on the short arm of chromosome x (locus xp21) and codes for dystrophin, containing 3685 amino acid residues. 60-65% of dmd mutations are large dele-tions, 10-30% are nonsense and frame-shift mutations, 5-15% are duplications, and 2% are intronic or 5'- and 3'-utr alterations.dystrophin aggregates as a homotetramer in the skeletal muscles or associates with actin and dystrophin-associated glycoproteins (dags), forming a stable complex that interacts with laminin in the extracellular matrix. dystrophin is considered a key structural element in the muscle fiber, whose primary function is to stabilize plasma mem-brane, while the dags maintain the sarcolemmal stability by mediating the complex interactions of the muscle membrane and extracellular environment. the low levels of dystrophin lead to cellular instability and progressive leakage of intracellular components, explaining the characteristically high levels of creatine phosphokinase (cpk) in the blood of dmd patients. biomarkers serve as measurable indicators of normal biological or pathological processes. they are typically directly linked to genetic variants in specific genes and can predict, diagnose, monitor, and assess the severity of a disease. it is the goal of this study to identify, validate, and monitor biochemical markers from dmd affected participants.

Eligibility criteria:
inclusion criteria * informed consent is obtained from the parent/ legal guardian * the participant is aged between 2 months and 50 years * the diagnosis of dmd is genetically confirmed by centogene exclusion criteria * informed consent is not obtained from the parent/ legal guardian. * the participant is younger than 2 months or older than 50 years * the diagnosis of dmd is not genetically confirmed by centogene

Keywords: duchenne disease biomarker
the effect of anodal tdcs on motor learning in multiple sclerosis

Conditions: Anodal tDCS; Recruitment Curves

Summary: the current study investigates the effects of tdcs in patients with multiple sclerosis (ms). the investigators hypothesize that anodal tdcs will increase motor performance in patients with ms.


Eligibility criteria:
inclusion criteria: * at least 18 years old * male and female exclusion criteria: * relapse in the last 3 months * when not suitable for tdcs (screening) * if tms measures can not be completed
short versus long post-operative restrictions following lumbar discectomy

Conditions: Lumbar Disc Herniation

Summary: post-operative restrictions following lumbar discectomy is a controversial topic. while the most widely accepted protocol restricts bending, lifting, and twisting for four to six weeks following discectomy, a number of studies support an early return to full activity without restriction. since the goal of discectomy is to promptly provide pain relief and a return to a fully active lifestyle, perhaps post-operative restrictions are more hindering than beneficial. hypothesis: post-operative restrictions following lumbar discectomy do not influence reherniation rate. specific aim 1: to compare the reherniation rates between the 6-weeks of restriction and the 2-weeks of restriction groups. specific aim 2: to determine the return to full activity and return to work dates of both the 6-weeks of restriction and 2-weeks of restriction groups. specific aim 3: to assess the health outcomes of both the 6-weeks of restriction and 2-weeks of restriction groups.

upon enrollment, subjects will be randomized to the "6-weeks of restriction" or "2-weeks of restriction" group. subjects will also be asked to provide/complete: * demographical information * vas back and leg score * modified oswestry questionnaire all of the surgeries will be performed using a so-called limited discectomy in which the herniated disc fragment is removed without an aggressive disc space curettage. prior to surgery, the subjects' discs will be classified by the primary investigator and site responsible investigator on a t-2 weighted mri according to the carragee disc herniation classification system. the discs will be reassessed intraoperatively by the surgeon to confirm the assigned classification. in addition, a radiologist will review a random sampling set of discs on t-2 weighted mri to eliminate bias and validate the classifications. subjects will be followed for a 2 year time period with study visits at 2 weeks, 6 weeks, 3 months, 1 year, and 2 years. at every follow-up visit, the following will be completed and/or documented: * a reherniation (any clinical symptoms of a reherniation will be verified and documented by mri) * return to full activity and/or work (date) * vas back and leg score * modified oswestry questionnaire

Eligibility criteria:
inclusion criteria: * 18 years of age or older * english speaking * single level lumbar disc herniation * surgical candidate * no previous lumbar surgery * primary radicular pain exclusion criteria: * less than 18 years of age * non-english speaking * multi-level lumbar disc herniation * disc reherniation * previous lumbar surgery * primary low back pain

Keywords: disc lumbar herniation
efficacy of yoga based self-management program for chronic pain

Conditions: Chronic Pain

Summary: chronic pain is a major health issue with substantial economic burden.to support chronic pain patients during the covid-19 pandemic, yoga based self-managed intervention was delivered through tele-health platform. project was designed as community-based program, creating new social networks for patients, health care providers and academics. platform to deliver intervention and data collection was aim covid mobile app. our objective was to determine the efficacy of yoga based self-management intervention for people living with chronic pain pain intensity, disability and health related quality of life.


Eligibility criteria:
inclusion criteria: * chronic pain for at least 3 months * having access to internet and video calls exclusion criteria: * pregnant or breast-feeding women, * patients not willing to give written consent * patients with severe psychiatric or personality disorder * malignancy
evaluate the safety and effectiveness of the endoscopic surgical instrument control system (sp1000).

Conditions: Urologic Neoplasms

Summary: robot-assisted surgery has been successfully adopted rapidly over the last decade. robotic technology with tridimensional imaging can improve operating dexterity, visualization of difficult anatomic locations. this is a prospective study aims to evaluate the safety and effectiveness of the domestic surgical robot.

in this clinical trial, the subjects will be randomly divided into two groups, and the urological typical surgical procedures (prostatectomy, and partial or radical nephrectomy) will be performed with the endoscopic surgical instrument control system sp1000 and is3000.and the non-inferiorly comparison will be made between the surgical results of two systems to verify the safety and effectiveness of the endoscopic surgical instrument control system (sp1000).

Eligibility criteria:
inclusion criteria: 1. any male or female age from 18 to 80 2. bmi 18-30kg/m2 3. have urological surgery indications (cystectomy, prostatectomy, and nephrectomy) 4. patients with physiologic conditions capable of receiving laparoscopic surgery 5. be able to cooperate and complete the follow-up and related examinations 6. volunteer to participate in this study and sign the informed consen exclusion criteria: 1. the researchers assess patients with severe cardiovascular or circulatory disease and cannot tolerate the surgery 2. history of epilepsy or mental illness 3. pregnant and lactation 4. surgery history at the relevant surgical site, which is considered to influence surgical procedures 5. severe allergic or addiction of drug and alcohol 6. abdominal infection, peritonitis, diaphragmatic hernia, severe systemic infection or metastasis disease 7. inability to understand the trial or complete the follow-up 8. participated in other therapeutic clinical trials within 90 days 9. patients who had undergone major operation and major trauma within 28 days prior to enrollment, which the researchers considered to have an impact on the outcome of surgery 10. patients deemed unsuitable to participate in this trial by researchers
study using combined virtual 4-d electromagnetic (em) tip-tracked devices & ebus in diagnosis of lung nodules

Conditions: Lung Cancer

Summary: the purpose of this study is to determine the safety and biopsy yield of em tip tracked devices compared to standard bronchoscopy.


Eligibility criteria:
inclusion criteria: * any adult patient aged 18 and older, able to sign an informed consent and is scheduled for flexible bronchoscopy with biopsies of peripheral nodules. patient needs to have a recent chest cat scan within last 4 weeks or will obtain a chest cat scan prior to bronchoscopy. exclusion criteria: * pulmonary nodules less than 1.0 cm * patients must be able to tolerate general anesthesia * patients with significant coagulopathy having international ratio (inr)\>2.0 or prothrombin time (ptt) \>2x normal * patients unable to tolerate bronchoscopy * pregnant patients or patients who believe they are pregnant * patients with implantable devices susceptible to radio frequency (rf) fields * severely obese patients