Kornimate/medical-research-clean huggingface dataset:
a study of lucar-20sp in subjects with relapsed/refractory b-cell non-hodgkin lymphoma

Conditions: Relapsed B-cell Non-Hodgkin Lymphoma; Refractory B-cell Non-Hodgkin Lymphoma

Summary: this is a prospective, single-arm, open-label, exploratory clinical study of lucar-20sp in adult subjects with relapsed/refractory b-cell non-hodgkin lymphoma.

this is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor efficacy profiles of lucar-20sp, an allogenic car-t cell therapy in subjects with relapsed/refractory b-cell non-hodgkin lymphoma. patients who meet the eligibility criteria will receive lucar-20sp infusion. the study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment and follow-up.

Eligibility criteria:
inclusion criteria: * subjects voluntarily participate in clinical research; * age ≥18 years old; * eastern cooperative oncology group (ecog) score 0-1; * histologically confirmed large b-cell lymphoma, follicular lymphoma, mantle cell lymphoma, histologically indolent lymphoma to diffuse large b-cell lymphoma; cd20 positive; * at least one measurable tumor lesion according to the lugano 2014. * expected survival ≥3 months; * clinical laboratory values in the screening period meet criteria. * effective contraception. exclusion criteria: * prior antitumor therapy with insufficient washout period. * previous treatment with allogeneic cell and gene therapy (such as car-t); except subjects with evidence that previous allogeneic cell and gene therapy products (such as car-positive t cells and car transgenes) in the subject have been below the lower limit of detection; * previously received allogeneic hematopoietic stem cell transplantation; * previously received gene therapy; * donor specific antibody (dsa) positive subjects will be excluded; * severe underlying diseases; * hepatitis b virus deoxyribonucleic acid (hbv dna), hepatitis c virus ribonucleic acid (hcv rna) or human immunodeficiency virus antibody (hiv-ab) positive; * presence of other serious pre-existing medical conditions that may limit patient participation in the study. any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.

Keywords: relapsed b-cell non-hodgkin lymphoma refractory b-cell non-hodgkin lymphoma
hgwd improve the paclitaxel-related neurotoxicity in patients with bc

Conditions: Breast Cancer

Summary: the current treatments for albumin-bound paclitaxel (nab-ptx) -related peripheral neurotoxicity (pn) mainly included cryotherapy and compression therapy , oral b group vitamin , and duloxetine. however, treatment effectiveness of these three methods is limited. huangqi guizhi wuwu decoction (hgwd) is an herbal formula recorded in "synopsis of the golden chamber" for improving limb pain, tingling, and numbness, which is composed of five crude drugs (astragali radix, cinnamomi ramulus, paeoniae radix alba, zingiberis rhizoma recens, and jujubae fructus)(9). recently, hgwd has been shown to be effective in the treatment of oxaliplatin- and diabetic-related pns . but there are no prospective studies to explore the efficacy of hgwd in the treatment of nab-ptx-induced pn in patients with bc. therefore, we conducted this prospective randomized controlled study to investigate the efficacy and safety of hgwd to prevent nab-ptx-induced pn in patients with bc. the primary aim of this study was to assess the prevention of nab-ptx-induced pn by soaking hands and/or feet with hgwd when compared to placebo.

this open-label, single-center, prospective, randomized controlled trial was planned to be conducted in the national cancer center in china from january 2020 to june 2022.the eligible paticipants were assigned randomly in a 1:1 ratio to a study group (hgwd group) or a control group. pass software (version 15.0) (kaysville, utah, usa) was used to calculate the sample size. assuming α = 0.05 and 1-β = 0.8, a total of 80 patients were needed for the aim of decreasing the grade 2-3 pn from 60% to 30%. assuming a lost-to-follow-up rate of 15%, a total of 92 patients were needed. the primary aim of this study was to assess the prevention of nab-ptx-induced pn by soaking hands and/or feet with hgwd when compared to placebo.

Eligibility criteria:
the inclusion criteria comprised: ˑ histologically confirmed untreated bc; ˑ female; ˑage from 18 to 65 years old; ( ˑ eastern cooperative oncology group (ecog) performance status (ps) score of 0 or 1; ˑat least receiving 4 cycles of nab-ptx (260mg/m2); ˑ grade 2 or greater nab-ptx induced-pn evaluated by european organisation for the research and treatment of cancer-chemotherapy-induced peripheral neuropathy (eortc qlq-cipn20)(12, 13); ˑ estimated survival time \> 6 months. the exclusion criteria were： ˑ a history of diabetes or neurological disorders; ˑmental disorder; ˑabnormal hepatic functions (total bilirubin upper limit of normal (uln), alanine transaminase/aspartate transaminase ≥ 2.5 × uln ), renal functions(creatinine ≥ 1.5 × uln), and hematological functions (absolute neutrophil count ≤ 1.5 × 109/l, platelet count ≤ 80 × 109/l, hemoglobin \< 90 g/l); ˑfailure to complete chemotherapy due to treatment-related adverse events; ˑ a family history of a genetic neuropathy; ˑhad received previous treatment with neurotoxic chemotherapy, including oxaliplatin, cisplatin, vinca alkaloid and etc.; ˑ a history of allergy to chinese medicine.
analysis of transcriptomic profile of graft-versus-host disease (ghvd) after allogeneic grafting of hematopoietic stem cells

Conditions: Graft Vs Host Disease; Hematopoietic Stem Cells

Summary: graft-versus-host disease (gvhd) is a frequent and severe complication of hematopoietic stem cell transplantation (hsc), and is responsible for significant early mortality despite prophylactic strategies developed in recent decades, especially since it is resistant to first-line treatment. the present diagnosis is difficult, non-specific and is based on the combination of an evocative clinical context (csh allograft, time to appearance before j100, characteristic clinical manifestations), suggestive anatomo-pathological analysis (predominantly inflammatory infiltrate lymphocyte, mucosal edema and presence of apoptotic bodies), and the exclusion of any differential diagnosis (in particular serology / negative viral pcr). however, to date there is no molecular characterization of this manifestation, and therefore no specific treatment. the ncounter® nanostring technology allows the rapid and simple analysis of the simultaneous expression of a group of genes (up to 800 on the same sample), from a very small amount of rna, and from samples with difficulty such as fabrics already fixed to formaldehyde and included in paraffin. it allows the detection of a "molecular signature" of the tissue analyzed. no transcriptomic analysis has ever been performed on human tissues with gvhd.


Eligibility criteria:
inclusion criteria: * person aged ≥ 18 years * patients who have received an hsc allograft since june 2012 * having presented a suspicion of cutaneous or digestive gvhd before j100 post-allograft * of which the diagnosis was retained by the combination of clinical and histological criteria * or whose diagnosis has been reversed by histological analysis, for the reactive / inflammatory biopsies that serve as control * the diagnosis of which was made between 01/01/2013 and 31/12/2015 * survived at least 1 month to monitor clinical progress exclusion criteria: * whose biopsy specimens were also the sites of a viral reactivation (ebv, cmv, hhv) that could mimic a gvhd * having survived less than 1 month after the diagnosis of gvhd
evaluation of spectra optia red blood cell exchange in sickle cell patients

Conditions: Sickle Cell Disease

Summary: the purpose of this study is to evaluate the performance of the spectra optia system red blood cell exchange (rbcx) protocols (exchange and depletion/exchange) in study participants with sickle cell disease.

evaluate the performance of the spectra optia system red blood cell exchange (rbcx) protocols (exchange and depletion/exchange) in study participants with sickle cell disease. open label design.

Eligibility criteria:
inclusion criteria: * at least 12 years old * enrolled in a program of regular red blood cell exchange (rbcx) to prevent symptoms/complications of sickle cell disease (scd) or initiating a program of regular rbcx or receiving rbcx as a pre-surgical procedure. * medically stable * previous documentation of diagnosis by hemoglobin electrophoresis of a type of sickle cell disorder requiring rbcx. * sufficient vascular access to accommodate the rbcx procedure as determined by the apheresis technician performing the procedure or phlebotomist responsible for obtaining intravenous access. * availability of sickle trait negative, leukoreduced, abo blood group, rhesus factor d (rh (d)) compatible, unexpired replacement blood. see glossary for definition of replacement blood. * able to commit to the study follow-up schedule. * agree to report adverse events (aes) during the required reporting period. exclusion criteria: * inability to obtain informed consent/assent from patient, or permission from parent or guardian. * pregnancy (negative serum pregnancy test required for females of childbearing potential). * life expectancy is fewer than 30 days from time of procedure. * incarcerated or a ward of the court. * refusal of blood products. * failure to comply with site standard requirements for cessation of medications (e.g., angiotensin converting enzyme (ace) inhibitors) that interfere with or increase risk of rbcx procedures. * history of drug or alcohol abuse that, in the opinion of the investigator, could affect the ability of the patient to comply with the study requirements inability to comply with the protocol in the opinion of the investigator.
project rap: reaching adolescents for prevention

Conditions: Alcohol Related Morbidity; Alcohol Dependence

Summary: the purpose of the study is to determine if a brief motivational interview in the context of an emergency health care visit will reduce high-risk drinking and drug-taking and associated health consequences among adolescents ages 14-21 years old.

many studies have shown that a brief motivational interview in the context of a routine or emergency health care visit may assist adults to reduce high-risk drinking and drug-taking. center researchers are conducting a 1,400-person, randomized clinical trial involving teen patients at the boston medical center pediatric emergency department in order to determine if a similar approach will be effective with youth. all patients aged 14 to 21 get a brief alcohol and drug screen, and those whose scores indicate they drink or use marijuana are invited to participate in the study. one-third of the enrollees will receive an assessment, a brief motivational interview performed by a trained peer counselor, direct referrals to community-based resources for adolescents, and a 10-day follow-up phone call. one-third will receive only the assessment and a list of community resources; and the final third will receive only the list of resources. all participants will be followed over time and re-screened to measure the impact of the initial brief intervention on their drinking and drug-taking. the key hypothesis is that individuals who receive the brief motivational interview in the emergency department setting will have lower rates of alcohol and illicit drug use and fewer health consequences over time.

Eligibility criteria:
inclusion criteria: * pediatric emergency department patients * aged 14-21 * an alcohol use disorders identification test (audit) score above selected cut-point for age or with history of alcohol-related consequences exclusion criteria: * not resident in area or able to provide contact information for 12 month follow-up * medically unstable * not oriented to person, time and place

Keywords: high risk drinking alcohol dependence alcohol related injury
effects of high intensity stepping training on gait in patients with ataxia

Conditions: Cerebellar Ataxia

Summary: the purpose of this study is to examine the effects of high intensity stepping training on gait recovery, including walking speed and endurance, in patients with cerebellar ataxia. the hypothesis is that there will be a significant improvement in gait outcome measures (6 minute walk test and 10 meter walk test) in patients who receive high-intensity stepping training during physical therapy.


Eligibility criteria:
inclusion criteria: * diagnosis of ataxia * admitted to the institute for rehabilitation and research (tirr) texas medical center (tmc) inpatient or tirr kirby glenn outpatient * pathology that primarily affects the brain/cerebellum, including degenerative diseases, stroke, traumatic brain injury (tbi), posterior fossa tumor, and multiple sclerosis (ms) * ambulatory at initial evaluation or will have functional ambulation goals at initial evaluation (as noted by 10 meter walk test and 6 minute walk test measures documented as 0) * chronicity of injury will be of at least 1 month or greater exclusion criteria: * diagnoses that may have cerebellar involvement but without cerebellar ataxia as a principal impairment such as autism, down syndrome, schizophrenia, etc * non ambulatory or who are not able to participate in high intensity stepping training due to cardiac involvement (such as cardiac rehabilitation parameters) or due to orthopedic limitations (such as weight bearing parameters)
the influence of day-to day bpv on long-term adverse outcomes in patients ischemic stroke

Conditions: Stroke

Summary: stroke is one of the most devastating disorder worldwide. hypertension has been confirmed to be a major modifiable risk factor for stroke.even the casual visit hypertension has been managed ideally,there is still surplus risk for stroke re-attack.the purpose of this study is to explore whether variation of 24-hour ambulatory and visit-to-visit blood pressure variability (bpv) contribute to recurrent stroke.

system hypertension has been reported to play the most important role in the development of stroke,and the anti-hypertension therapy is regarded as the cornerstone for stroke secondary prevention. however, even though some proper measures have been taken,there is still surplus risk for recurrent stroke. recently the variation of system blood pressure has been focused as the candidate of another risk factor.up to date,this hypothesis remains an intense debate and few studies has been done to clarify it.besides, the definition of bpv and measurement of bpv parameters are still beyond conformity.in the current study, the long-term and short-term bpv will be taken respectively for patients with prior stroke. bsed on these parameters, the cohort will be followed up for average 2 years. the predefined outcome include composite cardiovascular events, neuropsychiatric wording, and mortality during followup.

Eligibility criteria:
inclusion criteria: - exclusion criteria: * comorbidity of dementia ( including ad, pdd, ftld, vad and so on ) * coexisting severe systematic diseases on admission such as acute coronary syndrome, malignant tumor, plasma dialysis therapy for renal failure, cirrhosis, rheumatic disease that would influence mortality. * discharge with severe sequelae with mrs\>5

Keywords: stroke, blood pressure, prognosis
a randomized controlled study of uterine incision diverticulum repair vs. no repair during second/third cesarean section

Conditions: Cesarean Scar Diverticulum

Summary: the goal of this study is to assess the efficacy and safety of uterine incision diverticulum repair during repeat cesarean section.the main questions it aims to answer are: * can this surgical method improve the symptom of menorrhagia？ * is this procedure safe？ researchers will compare experimental group(cesarean section + diverticulum repair group) to control group(conventional cesarean section group) to see if this surgical method works to treat or improve menorrhagia. participants will: * randomly assigned 1:1 to the experimental group（repairing uterine diverticula during cesarean section) and the control group （routine cesarean section without repairing the uterine incision diverticulum） * visit the hospital 42 days after surgery * followed up by telephone 6-12 months after surgery


Eligibility criteria:
inclusion criteria: * women aged ≥18 years, gestational age ≥37 weeks, singleton pregnancy, previous lower segment cesarean section, second or third cesarean section, and diagnosed with uterine incision diverticulum by imaging before or during early pregnancy. exclusion criteria: * preoperative indications of placenta accreta or previa, interdelivery interval less than 18 months from the last cesarean section, history of other uterine surgeries, and severe obstetric or medical complications requiring emergency care.
pilot study of strength testing in overweight women with or without insulin resistance

Conditions: Obesity

Summary: background: - some people who are obese may have decreased muscle strength. they may have greater muscle mass shown in scans, but they show poor results in exercise tests. poor muscle strength might cause some of the difficulty with exercise performance. researchers want to test muscle strength in the arms and legs of overweight women. they will also see how insulin resistance affects muscle strength in these women. objectives: * to test muscle strength in overweight women. * to see if insulin resistance affects muscle strength. eligibility: - women at least 18 years of age who are overweight (body mass index greater than 25 kg/m2). design: * participants will be asked to fast before having an initial blood test to measure glucose and insulin levels. * on a different day, they will have the strength testing. the first test will measure leg muscle strength by testing the quadriceps and the hamstrings. the second test will measure arm muscle strength by testing the biceps and triceps. the final test will measure hand muscle (grip) strength. * all the tests should take about an hour.

we have observed in our protocol (08-h-0108: effects of worksite wellness interventions on vascular function, insulin sensitivity and high-density lipoprotein in overweight or obese women) that despite increased lean (muscle) mass in the extremities as measured by dual x-ray absorptiometry, obese women have poorer exercise tolerance than overweight women who have less muscle mass.1 exercise testing, however, is an integrated function of cardiopulmonary capacity, in addition to muscle strength and endurance. we propose to determine whether muscle strength of elbow flexors and knee extensor muscle groups correlates with muscle mass of these groups in overweight and obese women selected for normal or abnormal insulin sensitivity. our hypothesis is that subjects with impaired insulin sensitivity and high insulin levels will have greater muscle mass but lower muscle strength than subjects with normal insulin sensitivity and normal insulin levels. this is a feasibility study to be conducted in 10 non-diabetic women (5 with insulin resistance, 5 with normal insulin sensitivity) who previously participated in 08-h-0108, the outcome of which will provide data for planning a larger study of muscle mass and strength which may be important to achieving exercise goals important to successful weight loss.

Eligibility criteria:
* inclusion criteria: * non-diabetic female employees of nih who participated in protocol 08-h-0108 and underwent insulin sensitivity testing and also protocol 02-h-0050 for muscle mass determination. * bp\< 140/90 mmhg (medications allowed) * subject understands protocol and provides written, informed consent. exclusion criteria: * medical or surgical condition that would prohibit upper and lower extremity strength testing (e.g., painful arthritis, prior knee or elbow surgery) * infection or injury to hand, knee or elbow requiring medical attention within 3 months of testing

Keywords: obesity insulin skeletal muscle strength testing
feasibility of optimizing organized cervical cancer screening by urine self-sampling

Conditions: Cervical Cancer

Summary: this project addresses the issue of promoting organized cervical cancer screening (ccs) from the perspective of the use of urine self-sampling (uss). via a prospective and monocentric study, the present study aims to evaluate the acceptability of women to collect a urine self-sample and to respond to a questionnaire on their feelings about this screening method.

in france, individual cervical cancer screening (ccs) has reduced the annual frequency of cervical cancer (cc), both in terms of incidence (2920 cases) and mortality (1117 deaths) : 2.5% reduction in cc incidence was observed per year between 1980 and 2012. more than 6 millions ccs are performed each year leading to the diagnosis of approximately 170,000 cytological abnormalities, including about 15,000 high-grade intraepithelial lesions, precursors of cancer. since 2019, ccs is now recommended in france with cytology-based screening before 30 and high risk human papillomavirus (hpv) testing from 30 to 65 years-old (screening interval of 5 years after a negative test). since only 50 to 60% of the target population is currently screened, the french high authority for health (has) has recently recommended the implementation of an organized screening program (osp) to increase screening-participation and to reduce inequalities in access to screening. this osp includes sending an invitation to under screened women for a consultation and a clinician taken cervical sample. however, the response rate to the osp of cancers to a first letter of invitation is generally low, less than 20% (for example, the rate of participation in colon cancer screening in the french department of gironde is 18.8% in 2020 (data from french regional coordination center for cancer screening). this trend is particularly true in rural areas with low medical density: northern and southern areas of gironde are concerned with 2/3 of under-screened women for ccs. reducing social and territorial inequalities in participation in organized ccs and optimizing the screening process for the least participating women remain a challenge. self-sampling kits, with the possibility to be sent to the women, seem to be a promising alternative to overcome the low participation in these areas. vaginal self-sampling has already been shown to increase participation. more recent studies have focused on urine self-sampling for the detection of cervical precancer.

Eligibility criteria:
inclusion criteria: * women aged 31 to 49 * coming to the bordeaux university hospital for a gynecological consultation in order to have a cervical swab (pcc) for screening or follow-up. * patient affiliated to or benefiting from a social security system * non-objection to study participation exclusion criteria: * patient unable to speak french and/or illiterate * patient under legal protection

Keywords: cervical cancer screening urine self-sampling