Kornimate/medical-research-clean huggingface dataset:
comparative trial for pixantrone in combination with rituximab in indolent non-hodgkin's lymphoma

Conditions: Lymphoma, Follicular; Lymphoma, Mixed-Cell, Follicular; Lymphoma, Small Cleaved-Cell, Follicular; Lymphoma, Low-Grade

Summary: the purpose of this study is to determine whether combining pixantrone (bbr 2778, inn name pending) with the monoclonal antibody rituximab, leads to an increase in the period of patients' remission, compared to rituximab alone.

this trial is being conducted in patients with indolent (or low-grade) non-hodgkin's lymphoma, who have either relapsed or been refractory to previous treatment. pixantrone belongs to the dna intercalator family of chemotherapy agents, which includes anthracyclines. dna intercalators are commonly used to treat patients with indolent nhl, often in combination with the monoclonal antibody rituximab. this study represents the first large-scale, comparative trial in indolent nhl, designed to determine whether the response rate and time to tumour progression in patients treated with a combination of rituximab and a dna intercalator, is significantly higher than seen in patients treated with rituximab alone. this trial is randomized and controlled, which means that participating patients will be randomly assigned to one of two treatment groups: 1. patients treated with both pixantrone and rituximab, in combination 2. patients treated with only rituximab this trial is expected to recruit around 800 patients in the us, europe and israel, with 400 patients recruited to each group. patients will be treated for around 18 weeks and will recieve regular physician monitoring for five years from the end of treatment.

Eligibility criteria:
inclusion criteria: * patients with relapsed or refractory indolent non-hodgkin's lymphoma (nhl), including follicular lymphoma grade i and ii * presenting with an episode of progressive disease, following 1-5 prior treatments (with either radiation, chemotherapy or rituximab). exclusion criteria: * patients that failed to respond to previous rituximab treatment, or relapsed within 6 months of the first rituximab infusion * patients known to have an allergic reaction to rituximab or murine derived proteins.

Keywords: pixantrone bbr 2778 chemotherapy dna intercalator anthracycline rituximab rituxan mabthera monoclonal antibody antibody nhl non-hodgkin's lymphoma indolent low grade novuspharma
evaluating thermal ablation in the treatment of cervical neoplasia

Conditions: Cervical Neoplasia

Summary: longitudinal study in burundi to evaluate the effectiveness, the acceptability and safety of thermal ablation in the treatment of cervical neoplasia.

the study population consisted of women with an abnormal via test or an abnormal colposcopy examination. a total of 86 women with lesions eligible to ablative treatment were counselled and treated by thermal ablation. informed consent was signed by each participant. just after treatment, they were inquired about the level of pain during the procedure, and their level of satisfaction with the treatment. they were followed-up at 6 weeks for any complication and re-assessed by via and colposcopy at 12 months for any persistent or recurrent lesion and for any adverse event.

Eligibility criteria:
inclusion criteria: * women residing in burundi and referred to the tertiary hospital after a positive via test exclusion criteria: * lesion occupying the 4 quadrants of the cervix * not visible squamous columnar junction (not type 1 tz) * vaginal or endocervical lesion * lesion subjective of cervical cancer

Keywords: cervical neoplasia treatment thermal ablation longitudinal study lmic
virtual reality mindfulness meditation after acl reconstruction

Conditions: Anterior Cruciate Ligament Injury

Summary: to evaluate the effect of virtual reality mindfulness meditation on patients after aclr, the investigators will determine the effect of virtual reality mindfulness meditation to 1) decrease self-reported injury-related fear, 2) improve poor jump-landing movement patterns, and 3) improve brain activity in women 1 to 5 years post-aclr when compared to a virtual reality sham group.

injury-related fear after anterior cruciate ligament (acl) injury significantly contributes to decreased return to sport, decreased physical activity engagement, and increased acl reinjury risk in previously high functioning, physically active individuals. injury-related fear is also associated with poor jump-landing movement patterns in patients after acl reconstruction (aclr). unfortunately, current rehabilitation practices do not specifically address injury-related fear in patients after aclr. virtual reality mindfulness meditation is a mental practice that involves focusing the mind on experiences in the present moment and has been used to address depression, anxiety, and chronic musculoskeletal pain. to evaluate the effect of virtual reality mindfulness meditation on patients after aclr, the investigators will determine the effect of virtual reality mindfulness meditation to 1) decrease self-reported injury-related fear, 2) improve poor jump-landing movement patterns, and 3) improve brain activity in women 6 months to 10 years post-aclr when compared to a virtual reality sham group. patients in the intervention group will complete 8-weeks of virtual reality mindfulness meditation + an advanced rehabilitation training program. patients in the sham group will complete 8-weeks of the virtual reality sham + an advanced rehabilitation training program. the central hypothesis is that women 6 months to 10 years post aclr who undergo virtual reality mindfulness meditation will demonstrate decreased injury-related fear, improved jump-landing movement patterns, and improved brain activity.

Eligibility criteria:
inclusion criteria: * female * ages 14-25 years * have self-reported levels of fear on the tampa scale of kinesiophobia-11 * have poor jump-landing movement quality as measured by the landing error scoring system-real time * injured their knee playing or training for sports (recreational or organized) * right-hand dominant * 6 months to 10-years post-aclr * demonstrate magnetic resonance imaging (mri) compliance exclusion criteria: * male * concussion in the past 3 months * presence of metal fragments, pins, plates, or clips, shrapnel, permanent makeup, body piercings that cannot be removed, surgical implants, or orthodontics that cannot be removed * on any medication that affects the central nervous system * any neurological conditions (i.e. epilepsy) * claustrophobia * under the influence of alcohol or other recreational drugs * pregnancy or suspicion of pregnancy

Keywords: neurosciences rehabilitation
hyperbaric oxygen, oxidative stress, no bioavailability and tissue oxygenation

Conditions: Diabetic Foot Ulcers

Summary: hyperbaric oxygen therapy (hbot) increases tissue oxygenation and serves as an adjunct therapy for diabetic wounds. however, some patients have insufficient increase or even paradoxical decrease in tissue o2 due to vasoconstriction. the aim of the present study was to investigate the pathophysiology responsible for the different consequences of hbot and to evaluate the effect of n-acetylcysteine (nac) on these changes. methods: prospective, randomized, cross-over trial including fifty diabetic patients with non-healing ulcers. all patients had two hbot (100%oxygen, 2ata) with nac at the first or the second evaluation. at the beginning and at the end of each evaluation, ulcer oxygenation and plasma levels of malondialdehyde (mda), total anti-oxidant status (taos) and nitric oxide (no) were measured. patients with ulcer oxygenation above 200mmhg, were subjected to complete hbot protocol.


Eligibility criteria:
inclusion criteria: * diabetic patients, aged 18 years or older, with non-healing foot ulcers exclusion criteria: * patients with macrovascular disease amenable for revascularization with more than 70% obstruction in femoral artery (evaluated by us doppler) were excluded from the study. similarly, patients with a documented allergy to nac, liver cirrhosis or those receiving nac for other indications were excluded. finally, patients with chest pathology incompatible with pressure changes, patients with inner ear disease, or those suffering from claustrophobia were excluded.
evaluation of the h-coil transcranial magnetic stimulation (tms) device - safety and feasibility study for treatment of major depressive episode in the elderly

Conditions: Depression

Summary: purpose: to evaluate the safety and anti-depressive response of the h1 coil tms device in elderly patients suffering from major depressive episode. twenty-seven (27) treatment resistance depressed-patients, 68 years of age and above, currently in a depressive episode.all subjects will receive prefrontal deep rtms of h1 coil (42 trains of 2 seconds, 10 hz, with 20 seconds inter-train intervals, up to 120% of motor threshold), for 4 weeks, 5 days a week, overall 20 sessions.safety and efficacy tests will be conducted before starting the trial (screening), once a week for the trial duration and one month following end of treatment.


Eligibility criteria:
inclusion criteria: * diagnosed by a senior psychiatrist as suffering from major depression episode according to dsm-iv (either as a part of a unipolar or a bipolar disorder). * rating on hdrs ≥ 20. * age: 68 years and above * treated for the current depressive episode, at least 6 weeks per antidepressant with one antidepressant in accepted dose, without improvement, and/or intolerance to 2 antidepressants, according to medical chart and athf (antidepressant treatment history form) instruction guidelines. * gave informed consent for participation in the study. * negative answers on safety screening questionnaire for tms. * if referred by a treating psychiatrist, he or she approves of the subject's participation in the study. exclusion criteria: * axis 2 diagnosis, which is considered prominent to the current depressive episode. * substantial suicidal risk as judged by the treating psychiatrist or by an independent psychiatrist. * attempted suicide in the past year. * cognitive impermanent - if mmse \< 24, patient will be further assessed , and may be excluded according to the primary investigator's discretion * history of seizure. * history of epilepsy or seizure in first degree relatives. * any cns disorder that may increase risk of seizure significantly * history of a significant head injury. * history of any metal in the head (outside the mouth). * known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps. * history of frequent or severe headaches. * use of hearing aids for hearing loss. * known history of cochlear implants. * history of drug abuse or alcoholism. * serious and unstable medical condition, which is likely to exacerbate or endanger the patient during the treatment period. * inadequate communication with the patient. * under custodial care. * participation in current clinical study or clinical study within 30 days prior to this study. * patients suffering from bipolar disorder, not currently treated by mood stabilizers * patients declared as legally incompetent, with an appointed physical guardian and/or cannot sign informed consent due to cognitive incompetence.
study to evaluate the relative bioavailability of fixed-dose combination tablet darunavir/cobicistat/emtricitabine/tenofovir alafenamide (d/c/f/taf) as a whole tablet, as a split tablet, and as crushed tablet in healthy adult participants

Conditions: Healthy

Summary: the purpose of this study is to evaluate the single-dose pharmacokinetics and relative bioavailability of darunavir (drv) 800 milligram (mg), cobicistat (cobi) 150 mg, emtricitabine (ftc) 200 mg, and tenofovir alafenamide (taf) 10 mg when administered as a fixed-dose combination (fdc) (d/c/f/taf) tablet in healthy adult participants when given as treatment a (reference): a single dose of d/c/f/taf (800/150/200/10 mg) fdc tablet swallowed as a whole, intact tablet with 240milliliter (ml) of noncarbonated water.treatment b (test): a single dose of d/c/f/taf (800/150/200/10 mg) fdc tablet as a split tablet swallowed with 240 ml of noncarbonated water. treatment c (test): a single dose of d/c/f/taf (800/150/200/10 mg) fdc tablet as a crushed tablet mixed in 4 ounces (oz) of applesauce.


Eligibility criteria:
inclusion criteria: * non-smoker for at least 3 months prior to selection * body mass index (bmi) of 18.0 to 32 kilogram per square meter (kg/m\^2), inclusive * woman must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hcg\]) pregnancy test at screening and a negative sensitive urine pregnancy test on day -1 before the first dose of study drug * woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 90 days after receiving the last dose of study drug * during the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug, a non-vasectomized man who is sexually active with a woman of childbearing potential must agree to use a highly effective barrier method of contraception exclusion criteria: * positive human immunodeficiency virus -1 (hiv-1) or hiv-2 test at screening * hepatitis a, b, or c infection, confirmed by a positive hepatitis a antibody immunoglobulin m (igm), hepatitis b surface antigen (hbsag), or hepatitis c virus antibody (anti-hcv) test, respectively, at screening * history of renal insufficiency * history of significant drug-induced skin reactions (such as, but not limited, to stevens-johnson syndrome (sjs), toxic epidermal necrolysis (ten), and/or erythema multiforme) or history of allergies to drugs (such as, but not limited to, sulfonamides and penicillins) * previously participated in a multiple-dose study with darunavir (drv), cobicistat (cobi), emtricitabine (ftc), tenofovir alafenamide (taf), or tenofovir disoproxil fumarate (tdf)
clinical study on strategy for refractory henoch-schönlein purpura

Conditions: Henoch-Schönlein Purpura

Summary: iga vasculitis is relatively common in children,especially in asian countries. abdominal manifestation could be severe, including bleeding, pancreatitis,appendicitis and intestinal intussusception. delayed diagnosis could be fatal and cause severe complications.nowadays no guidelines for those with severe abdominal manifestations in china.however, the most used treatment is steroid. for those severe forms are methylprednisolone pulse, ivig, immunosuppressants and blood purification. given the fact that different strategies lead to different endings which varies in cost, adverse effect and clinical outcomes in different medical centers, it is necessary to give birth to a useful and feasible strategy. this clinical trial is a muti-center, randomized,controlled prospective study.patients with gastrointestinal disease will be recruited in three children's medical centres in shanghai and will be randomized to two groups: mp group and ivig group. cost effect and clinical outcomes will be evaluated. blood purification will be evaluated as a remedy when mp and ivig fail to cure.


Eligibility criteria:
inclusion criteria: 1. both genders 2. age between 2-16 years old 3. iga vasculitis with gastrointestinal involvement 4. course of disease less than 2 months 5. refractory to ordinary dosage of prednisolone (less than 2mg/kg/d） exclusion criteria: 1. patients with severe sepsis 2. patients with central nervous system infection, 3. patients with severe pneumonia 4. patients with chronic infection (such as ebv, cmv, tuberculosis) 5. patients complicated by ckd who need renal replacement therapy 6. patients suffering from severe central nervous system complications as intracranial hemorrhage or neuropathy

Keywords: severe gastrointestinal involvement
study of ampion for the treatment of adult covid-19 patients requiring oxygen supplementation

Conditions: COVID-19

Summary: this is a phase 1 randomized study to evaluate the safety, tolerability and efficacy of iv ampion in improving the clinical course and outcomes of patients hospitalized with covid-19 infection who require supplemental oxygen.


Eligibility criteria:
inclusion criteria: 1. male or female, 18 years to 89 years old (inclusive). 2. hospitalized and diagnosed with covid-19, as evaluated by pcr test confirming infection with sars-cov-2. 3. patient is receiving supplemental oxygen (e.g. oxygen saturation (spo2) \<88%, labored breathing, increased respiratory rate, dyspnea on rest or exertion). 4. a signed informed consent form from the patient or the patient's legal representative must be available. exclusion criteria: 1. in the opinion of the clinical team, progression to death is imminent and inevitable, irrespective of the provision of treatments. 2. patient has severe chronic obstructive pulmonary disease (copd), chronic renal failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.). 3. patient is on chronic immunosuppressive medication. 4. as a result of the medical review and screening investigation, the principal investigator considers the patient unfit for the study. 5. a history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or excipients in 5% human albumin (n-acetyltryptophan, sodium caprylate). 6. patient has known pregnancy or is currently breastfeeding. 7. participation in another clinical trial. 8. baseline qt prolongation.
cumulative stress and mental health in young adults

Conditions: Stress, Psychological; Stress-related Problem; Cumulative Trauma; Mental Health Issue; Mental Stress; Psychological Well-Being

Summary: the goal of this observational study is to learn about the needs of young adults - "policrisis generation", exposed to cumulative stress during 2020-2023, in terms of quality of mental health, the psychosocial resources, protective factors for cumulative stress effect, and the standards for effective prevention. the main questions to be answered are: * how does cumulative stress affect young adults? * is there a specific cumulative stress syndrome that can be described? * what are the risk and the protective factors for cumulative stress? * how does the "policrisis generation" deal with the cumulative stress they have been exposed to? participants will complete psychological questionnaires

background: epidemiological data are not sufficient to determine the mental health outcomes of exposure to cumulative stress of 2020-2023. holistic knowledge of risk and protective factors, pathways leading to symptoms (not yet observed), and stress management strategies for the generation living under cumulative stress conditions (pandemic, war, refugee migration, economic crisis) is needed. participants: 400 young adults, recruited among university students. research methodology: analysis of data collected by screening questionnaires, psychological scales, and questionnaires, related to mental health conditions.

Eligibility criteria:
inclusion criteria: * age between 19 and 25 years * standard educational opportunities * attending the university course cycle exclusion criteria: * age below 19 * intellectual disability * inability to self-complete the research questionnaires

Keywords: cumulative stress mental health young adults stress syndrome risk factors protective factors
the realtime detection for prediction of opioid analgesic

Conditions: Surgery; Individuality

Summary: this study aimed to find a quick and timely way to predict the individual variation of efficacy of opioid analgesic during the operation and postoperative analgesia in chinese patients undergoing elective surgeries. methods: female patients receiving elective surgery under general anesthesia were recruited into this study. at the time of routine intravenous anesthetic induction we observe the efficacy of opioid analgesic including analgesic effect, effects on narcotrend index, sedative effect, effects on respiratory system, and aslo effects on cardiovascular system. then we record the consumption of of opioid analgesic during the operation and postoperative analgesia. also we record the side effect of the opioid analgesic.

patients with the following diseases were excluded: known history of chronic pain, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy smoker, pregnancy or at the lactation period.

Eligibility criteria:
inclusion criteria: * aged 20-65 years * anesthesiologists (asa) physical status i or ii; * within ±20% of ideal body weight; * agreed to participate the research exclusion criteria: •history of chronic pain; * psychiatric diseases; * diabetes mellitus; * severe cardiovascular diseases; * kidney or liver diseases; * alcohol or drug abuse (according to the criteria of dsm-iv); * pregnancy or at lactation period; * disagree to participate to the research

Keywords: sufentanil individual variation pain threshold narcotrend index
percutaneous transhepatic intrahepatic portosystemic shunt for treatment of portal vein occlusion with symptomatic portal hypertension after splenectomy

Conditions: Hypertension, Portal; Portal Vein, Cavernous Transformation Of

Summary: to evaluate the values of percutaneous transhepatic intrahepatic portosystemic shunt for treatment of portal vein occlusion with symptomatic portal hypertension after splenectomy.


Eligibility criteria:
inclusion criteria: * all patients with portal hypertension who have the history of splenectomy and have enough image information to confirm occlusion of portal vein exclusion criteria: * patients with known severe dysfunction of heart, lung, brain, kidney and other vital organs

Keywords: hypertension, portal portal vein, cavernous transformation of portosystemic shunt radiology, interventional
the rise in robotic atypical segmentectomies

Conditions: Lung Carcinoma

Summary: this study investigates the increased rate of robotic atypical segmentectomies. segmentectomy refers to removing a section of a lobe of the lung. reviewing patients' data retrospectively may help researchers determine whether robotic surgery has led to an increase in atypical segmentectomy.

primary objectives: i. to evaluate the rate of increase in robotic segmentectomies performed at our institution per year. ii. to evaluate the rate of typical and atypical segmentectomies performed at our institution per year. iii. to characterize the differences in robotic versus other types of resections such as open and vats (video-assisted thoracic surgery). outline: patients' medical records are reviewed retrospectively.

Eligibility criteria:
inclusion criteria: * patients who underwent a lung resection from 2004 to 2019