Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy and safety of bendamustine hydrochloride injection

Conditions: Indolent B-Cell Non-Hodgkin's Lymphomas

Summary: this is a study to evaluate the efficacy and safety of bendamustine hydrochloride injection in subjects with rituximab-resistant indolent b-cell non-hodgkin's lymphomas.


Eligibility criteria:
inclusion criteria: * 1. inert lymphoma, including follicular lymphoma (fl), extranodal marginal zone b-cell lymphomas of the mucosa-associated lymphoid tissue (malt), lymphoplasmacytic lymphoma, mantle cell lymphoma, small lymphocyte b-cell lymphoma and chronic lymphoblastic leukemia (cll). 2. at least one measurable lesion with the longest diameter \> 1.5 cm and the short diameter \> 1.0 cm, or the peripheral blood b lymphocyte ≥ 5.0×109/l. 3.adequate laboratory indicators. 4. has received one to three chemotherapy regimens (with or without rituximab) before enrollment. 5. eastern cooperative oncology group (ecog) performance status of 0 to 1; life expectancy ≥ 3 months. 6. understood and signed an informed consent form. exclusion criteria: * 1. patients who could not tolerate bendamustine treatment according to the investigators' judgment. 2. has received anti-tumor treatment (including major surgery) in the last 4 weeks. 3. transformed into high malignant lymphoma (secondary to low-grade follicular lymphoma); grade 3b follicular lymphoma. 4. has received corticosteroids regularly in the last 4 weeks. 5. has a history of central nervous system disease or central nervous system disease. 6. has other tumors. 7. has suffered from serious infection and other drugs or mental illness,which affects signing informed consent form and follow-up visit. 8. pregnant or breastfeeding women. 9. has participated in other clinical trials within three months.
characterization of endocannabinoid and endogenous opioid levels in adolescents with cannabis use disorder

Conditions: Cannabis Use

Summary: this project seeks to learn more about the effects of cannabis use on the endocannabinoid system and endogenous opioid systems in adolescents to address a fundamental gap in knowledge and identify biomarkers that may help distinguish youth who relapse from youth who remain sober.

learning the effects of cannabis use on the endocannabinoid system and endogenous opioid systems in adolescents addresses a fundamental gap in knowledge and may identify biomarkers that help distinguish youth who relapse from youth who remain sober. the specific aims of the project are to: 1. measure endocannabinoid (ecb) and endogenous opioid (endorphin) levels in the blood of adolescents who use cannabis regularly and adolescents who never use cannabis. we expect ecb and endorphin levels to differ significantly in adolescents who use cannabis regularly compared to adolescents who do not. 2. characterize circulating ecb and endorphin levels at baseline, during abstinence, and after natural resumption of cannabis use. 3. collect data to evaluate cannabis craving and to test for association of craving with ecb and endorphin levels in adolescents who use cannabis regularly. we expect that larger changes in ecb and endorphin levels will be associated with higher craving scores.

Eligibility criteria:
inclusion criteria: 1. 14 to 25 years of age. 2. use cannabis at least twice a week for the past month. exclusion criteria: 1. refusal of valid written consent, 2. current psychosis, 3. obvious intoxication, 4. current risk of suicide, 5. violence sufficiently great to interfere with evaluation or to endanger evaluators, 6. obvious intellectual deficiency as noted during the informed consent process, or inability of patient or family to comply with the study protocol. 7. use of other illicit drugs in the past 90 days by self-report or detected by urine drug test. 8. use of opioid medications for medical or recreational purposes currently or within the past 90 days. 9. does not have access to an internet connected devise or cannot use zoom.
assessment of rectus abdominis muscle thickness and residual bladder volume before and after pelvic floor exercises

Conditions: Pelvic Floor Disorders

Summary: the study will be conducted on 40 women between the ages of 20-40 who volunteer to participate in the study. all participants will be selected from individuals who have been diagnosed with pelvic floor dysfunction and have no history of pelvic surgery. pelvic floor dysfunction will be diagnosed by an obstetrics and gynecology specialist. participants will be divided into two groups as the pelvic floor exercise group and the control group.

the study will be conducted on 40 women between the ages of 20-40 who volunteer to participate in the study. all participants will be selected from individuals who have been diagnosed with pelvic floor dysfunction and have no history of pelvic surgery. pelvic floor dysfunction will be diagnosed by an obstetrics and gynecology specialist. participants will be divided into two groups as the pelvic floor exercise group and the control group. group distributions will be made by randomization.org website. participants in the pelvic floor exercise group will be instructed to do daily pelvic floor exercises under the guidance of a physiotherapist specialized in pelvic health. no exercises will be given to women diagnosed with pelvic floor dysfunction in this group. women will continue their routine lives and their evaluations will be made.

Eligibility criteria:
inclusion criteria: * were being between 20-40 years of age, * having pelvic floor dysfunction, * not having any problems that would prevent performing pelvic floor exercises exclusion criteria: * previous pelvic surgery * active urinary tract infections * neurological conditions affecting bladder control

Keywords: pelvic floor exercises rectus abdominis muscle thickness residual bladder
safety and efficacy of daratumumab in patients with anti-aquaporin 4 antibody positive neuromyelitis optica spectrum disorders

Conditions: Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorder; NMO Spectrum Disorder

Summary: the objectives of this time-to-event study are to assess the efficacy and safety of daratumumab as compared with placebo in participants with neuromyelitis optica spectrum disorder (nmosd) who are anti-aquaporin-4 (aqp4) antibody-positive. nmosd is an autoimmune disease of the central nervous system that predominantly affects the spinal cord, optic nerves, and area postrema. it is usually mediated by the pathogenic aqp4-igg. antibody-secreting cells (ascs) have been recognized as essential sources of aqp4-igg. cd38 is a glycoprotein that is highly expressed on ascs. daratumumab, a cd38-directed monoclonal antibody, has been shown to decrease the levels of autoantibodies in lupus, myasthenia gravis, or autoimmune encephalitis. this randomized controlled study aims to evaluate the therapeutic potential of daratumumab in nmosd.


Eligibility criteria:
inclusion criteria: 1. male or female participants ≥ 18 years old. 2. diagnosis of nmo or nmosd. 3. anti-aqp4 antibody seropositive. 4. historical relapse of at least 1 relapses in the last 12 months or 2 relapses in the last 24 months with at least 1 relapse in the 12 months prior to the screening. 5. expanded disability status scale score ≤ 7.5. 6. patients must give written informed consent. exclusion criteria: 1. use of intravenous steroid pulse therapy or intravenous immunoglobulin or plasma exchange/adsorption within 3 weeks prior to screening. 2. use of tocilizumab, satralizumab, belimumab, ofatumumab within 1 months prior to screening. 3. patients treated with oral immunosuppressive agents other than steroids (e.g. azathioprine, mycophenolate mofetil, methotrexate, tacrolimus, cyclosporine in the 3 months prior to allocation. 4. use of rituximab or inebilizumab within 6 months prior to screening. 5. patients infected with hepatitis b or c virus, or human immunodeficiency virus, or those having active infectious diseases. 6. patients with a severe chronic infection or a history of recurrent infections. 7. patients with a history of radiation treatment (whole body irradiation or lymphoid irradiation) or stem cell transplantation. 8. patients who are pregnant or breast-feeding. 9. patients who are participating in other clinical trials for nmosd. 10. patients diagnosed with cancer.
health care management for the elderly in community through screening

Conditions: Major Depressive Disorders; Senile; Depression

Summary: depression in late life has been associated with losses in functioning and quality of life, mortality, and increased health care costs. although late life depression can be successfully treated with antidepressant medication or psychotherapy, few older adults receive adequate trials of such treatment in community in korea. barriers, such as loss of loved ones, medical illnesses, and social stigma associated with depression, lack of social and financial support, to effective treatment of depression can be especially problematic for older adult. screening has been valuable in overcoming barriers to diagnosis. over 60 year old community dwelling people will be screened for symptoms of four geriatric conditions (depression, dementia, urinary incontinence, and sleep disorder). those who will be screened positive for each condition will be refer to clinic for diagnosis. among them only those cases confirmed as depression by psychiatrists will be enrolled in this study. enrolled patients will be randomly assigned to either case management or usual care conditions. the objective of the study is to test whether a system of screening, assessment, and follow-up provided by case manager improves in recognizing the target geriatric conditions (depression, dementia, urinary incontinence, and sleep disorder) and healthcare outcomes.


Eligibility criteria:
inclusion criteria: * over 60 year old * having medicare insurance exclusion criteria: * dementia and other psychiatric disorders

Keywords: screening depression case management
a study of shr-a1811 combined with capecitabine in treatment of unresectable or metastatic breast cancer with low her2 expression.

Conditions: Breast Cancer

Summary: the study is being conducted to evaluate the safety, tolerability， preliminary efficacy, pharmacokinetics, and immunogenicity of shr-a1811 combined with capecitabine in treatment of unresectable or metastatic breast cancer with low her2 expression.


Eligibility criteria:
inclusion criteria: 1. women aged 18 to 75 (inclusive). 2. her2 low expression unresectable or metastatic breast cancer confirmed by histology or cytology. 3. ecog score is 0 or 1. 4. an expected survival of ≥ 12 weeks. 5. at least one measurable lesion according to recist v1.1 criteria. 6. women of childbearing potential (wocbp) subjects must agree to use highly effective contraception for 7 months from the start of study screening until the last study medication and agree not to breastfeeding. 7. patients voluntarily joined the study and signed informed consent, had good compliance and willingness to cooperate with the visit and study related procedures. exclusion criteria: 1. have other malignancies within the past 5 years. 2. presence with uncontrollable third space effusion. 3. have surgical treatment, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biological therapy or other drug clinical studies within 4 weeks before the first medication. 4. accepted antibody drug conjugates containing etoisomercan derivative topoisomerase i inhibitor. 5. clinically significant cardiovascular disorders. 6. presence of active hepatitis b, hepatitis c, cirrhosis,or serious infected persons requiring antibiotic, antiviral or antifungal control. 7. the toxicity from previous anti-tumor treatment has not recovered to ≤ grade i. 8. known to be allergic to any study drug or any of its excipients, or to humanized monoclonal antibody products. 9. failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other factors affecting drug administration and absorption. 10. presence of other serious physical or mental diseases or laboratory abnormalities.
efficacy and safety study of apremilast to treat active psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: the purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis, specifically in improving signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

psoriatic arthritis (psa) is an inflammatory arthritis that occurs in 6-39% of psoriasis patients. the immunopathogenesis of psa, which mirrors but is not identical to that seen in psoriatic plaques, reflects a complex interaction among resident dendritic, fibroblastic and endothelial cells, and inflammatory cells attracted to the synovium by cytokines and chemokines. apremilast (cc-10004) is a novel oral agent that modulates multiple inflammatory pathways through targeted phosphodiesterase type 4 (pde4) enzyme inhibition. therefore, apremilast has the potential to be effective in the treatment of psa.

Eligibility criteria:
inclusion criteria: * males or females, aged ≥ 18 years at time of consent. * have a diagnosis of psoriatic arthritis (psa, by any criteria) of ≥ 6 months duration. * meet the classification criteria for psoriatic arthritis (caspar) at time of screening. * must have been inadequately treated by disease-modifying antirheumatic drugs (dmards) * may not have axial involvement alone * concurrent treatment allowed with methotrexate, leflunomide, or sulfasalazine * have ≥ 3 swollen and ≥ 3 tender joints. * males \& females must use contraception * stable dose of nonsteroidal anti-inflammatory drugs (nsaids), narcotics and low dose oral corticosteroids allowed. exclusion criteria: * pregnant or breast feeding. * history of allergy to any component of the investigational product. * hepatitis b surface antigen and/or hepatitis c antibody positive at screening. * therapeutic failure on \> 3 agents for psa or \> 1 biologic tumor necrosis factor (tnf) blocker

Keywords: psoriatic arthritis psoriasis arthritis inflammation skin condition inflammatory cells apremilast cc-10004 phosphodiesterase type 4
improving management of post-partum haemorrhage with quantra® system

Conditions: Post Partum Haemorrhage

Summary: post partum haemorrhage is a concerning situation in maternity wards, though it is not the first cause of maternal mortality anymore. it has been already shown that low fibrinogen level is a major predictive factor of massive bleeding after delivery. in this situation, the early knowledge of fibrinogen level could enhance care of women experiencing post partum haemorrhage. in a cohort of women suffering from post partum haemorrhage, this study will evaluate whether assessing fibrinogen level would be faster using the quantra® system than the standard coagulation test.


Eligibility criteria:
inclusion criteria: women ≥ 18 years old experiencing post partum haemorrhage ≥ 500 ml within 24 hours after delivery exclusion criteria: * previous anemia ≤ 7g/dl * known bleeding disorders * ongoing antiplatelets treatment * ongoing anticoagulant treatment

Keywords: post partum haemorrhage bleeding labour vaginal delivery caesarean section
follow-up of patients' physical activity in post-hospitalization

Conditions: Stroke

Summary: physical exercise has been identified as a major item of many affecting many chronic diseases and stroke rehabilitation. it contributes to an improvement in the quality of life and to a decrease in the current treatment side-effects and mortality. stroke in association with an inactive lifestyle lead to a decrease in physical capability and causes problems in daily activities. the physical capacity and the tolerance for exercise fall simultaneously leading to vicious circle of less and less mobility. therefore, physical activity for the health is a valid and relevant way to improve the quality of life and to recover functional capacity. the aim of the study is the assessment of the effects of a incentive program for physical activity on people following/with stroke.


Eligibility criteria:
inclusion criteria: * person having stroke (ischemic or hemorrhagic) * whatever the area of stroke * person supported by hemipass (monitoring team and home support) * stroke less than 6 months * patient walking with or without technical or human assistance: fcc score exclusion criteria: * disability limiting the gait before the stroke * age \< 18 years * cognitive impairment limiting participation to the program * non signature of the consent * cardiopulmonary pathology which forbid/banned effort
effects of music therapy and white noise on pre-procedural fear, anxiety by elderly colonoscopy patients

Conditions: Colonoscopy; the Elderly; White Noise; Music Therapy; Fear; Anxiety

Summary: the aim of the study was to examine the effect of two different interventions (music therapy and white noise listening) on anxiety, fear and vital signs in elderly patients undergoing colonoscopy. the study was a double-blind, pre-test and post-test

colonoscopy patients experience high levels of fear and anxiety due to the procedure. fear and anxiety can activate the patient's autonomic nervous system, leading to increased sweating, increased heart rate, blood pressure and respiratory rate, and procedure-related complications. reducing fear and anxiety and relaxing the patient not only prevents potential harm to the patient due to the procedure, but also facilitates the work of the healthcare team performing the procedure and ensures accurate results. in this context, this study aimed to investigate the effects of music therapy and white noise listening on the fear, anxiety and vital signs of patients undergoing colonoscopy.

Eligibility criteria:
inclusion criteria: 1. the one to be colonoscoped, 2. 65 years of age or older, 3. participated in the research voluntarily 4. no vision, hearing and perception problems, 5. no communication problems (able to speak turkish), 6. those who are hemodynamically stable before colonoscopy, 7. no psychiatric diagnosis, no use of antidepressants, anxiolytics and sedative agents, 8. no analgesic or anesthetic medication 24 hours before the procedure. exclusion criteria: 1. developing complications during the procedure, 2. removing the headset during the procedure, 3. participants with visual and hearing impairment or a medical history of dementia, cognitive impairments or psychiatric disorders 4. the general condition deteriorated during the procedure or a different intervention was performed with anesthesia, 5. who wants to leave the study on their own accord.

Keywords: colonoscopy;anxiety;fear;vital signs;musictherapy;whitenoise
tj202 combined with dexamethasone in subjects with relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma in Relapse; Refractory Multiple Myeloma

Summary: this trial is a multi-center, single-arm phase 2 study to evaluate the efficacy and safety of tj202 combined with dexamethasone in subjects with relapsed or refractory multiple myeloma (rrmm) who received at least 2 prior lines of treatment.

a total of 82 subjects with relapsed or refractory multiple myeloma (rrmm) who have received at least 2 prior lines of treatment will be enrolled in this study. prior lines of treatment must include a proteasome inhibitor (pi) and an immunomodulator (imid). all subjects will receive tj202 and dexamethasone (dex) in the study. the treatment will continue until endpoint events such as intolerance or progressive disease (pd).

Eligibility criteria:
inclusion criteria: 1. age ≥ 18, male or female; 2. subject must have had documented mm; 3. at screening phase, subject must have measurable disease; 4. subject is in a state of progressive disease (pd); 5. subject must have life expectancy of no less than 6 months; 6. subject must have an ecog (eastern cooperative oncology group) performance status score of 0\~2; exclusion criteria: 1. subject has received anti-cd38 monoclonal antibody treatment previously; 2. subject has received car-t cell therapy previously; 3. subject has previously received allogenic stem cell transplant, or subject has received autologous stem cell transplant within 3 months before administration of the study agent; 4. primary refractory multiple myeloma (subject failed to generate any minimal response or any degree of response to any therapy); 5. subject has received anti-myeloma treatment (radiotherapy is excluded) within 4 weeks or 5 pk half-lives of the treatment, whichever longer, before the first study agent administration.
intestinal microbiome and chronic inflammatory bowel disease

Conditions: Colitis

Summary: the aim is to examine the role of intestinal microbiota in the pathogenesis of chronic inflammatory bowel diseases (ibd)

ibd patients to whom colonoscopy is performed will be recruited. mucosal specimens from large intestine and terminal ileum will be collected as well as stool specimens. the microbiota will be analyzed at the microbiology laboratory and the results will be correlated with endoscopical, laboratory and histopathological findings.

Eligibility criteria:
inclusion criteria: * ibd exclusion criteria: * patient refusal to participate
a phase i study of tq-b3234 on tolerance and pharmacokinetics

Conditions: Advanced Cancer

Summary: to study the pharmacokinetic characteristics of tq-b3234 in the human body, recommend a reasonable regimen for subsequent research.


Eligibility criteria:
inclusion criteria: * histological documentation of advanced solid tumors,such as malignant melanoma,colorectal cancer,pancreatic carcinoma,thyroid carcinoma * lack of the standard treatment or treatment failure * 18-65 years,ecog ps:0-1,life expectancy of more than 3 months * main organs function is normal * stop other previous chemotherapy drugs more than 4 weeks * women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped * patients should participate in the study voluntarily and sign informed consent exclusion criteria: * patients participated in other anticancer drug clinical trials within 4 weeks or patients participating in other clinical trials now * blood pressure unable to be controlled(systolic pressure\>140 mmhg，diastolic pressure\>90 mmhg). patients with grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including qtc≥440ms) * patients with non-healing wounds or fractures * patients with drug abuse history and unable to get rid of or patients with mental disorders * history of immunodeficiency * patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment