Kornimate/medical-research-clean huggingface dataset:
april car-t cell therapy for patients with bcma/taci positive relapsed and/or refractory multiple myeloma

Conditions: Multiple Myeloma in Relapse; Multiple Myeloma, Refractory

Summary: a study of april car-t cells therapy for patients with bcma/taci positive relapsed and/or refractory multiple myeloma

this is a single arm, open-label, single-center study. this study is indicated for relapsed or refractory bcma/taci positive relapsed and/or refractory multiple myeloma. the selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 36 patients will be enrolled. primary objective is to explore the safety, main consideration is dose-related safety.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed diagnosis of bcma/taci+ multiple myeloma (mm)： 1. patients with mm relapsed after bcma car-t therapy; or mm with positive bcma/taci expression; 2. relapsed after hematopoietic stem cell transplantation; 3. cases with recurrent positive minimal residual disease; 4. extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy. 2. male or female aged 18-75 years; 3. total bilirubin ≤ 51 umol/l, alt and ast ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/l; 4. echocardiogram shows left ventricular ejection fraction (lvef) ≥50%; 5. no active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%; 6. estimated survival time ≥ 3 months; 7. ecog performance status 0 to 2; 8. patients or their legal guardians volunteer to participate in the studyand sign the informed consent. exclusion criteria: subjects with any of the following exclusion criteria were not eligible for this trial: 1. history of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases; 2. electrocardiogram shows prolonged qt interval, severe heart diseases such as severe arrhythmia in the past; 3. pregnant (or lactating) women; 4. patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); 5. active infection of hepatitis b virus or hepatitis c virus; 6. concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids; 7. previously treated with any car-t cell product or other genetically modified t cell therapies; 8. creatinine\>2.5mg/dl, or alt / ast \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl; 9. other uncontrolled diseases that were not suitable for this trial; 10. patients with hiv infection; 11. any situations that the investigator believes may increase the risk of patients or interfere with the results of study

Keywords: multiple myeloma car t-cell therapy bcma/taci positive
early ambulation after adductor canal block for total knee arthroplasty

Conditions: Pain; Osteoarthritis

Summary: the purpose of this study is to assess early ambulation following total knee replacement in patients receiving continuous adductor canal block with posterior capsular injection compared to continuous femoral nerve block with tibial nerve block.


Eligibility criteria:
inclusion criteria: * knee arthroplasty * ages 18-80 exclusion criteria: * history of neurological disease * diabetes * pregnancy * neuropathy * chronic narcotic use * allergy to local anesthetic solution or nsaids * inability to give consent or cooperate with the study protocol

Keywords: early ambulation knee arthroplasty
intraprostatic injection of botulinum toxin a versus ethanol for treatment of patients with benign prostatic hyperplasia

Conditions: Male; Ultrasonography; Botulinum Toxins, Type A; Injection; Complications, Infection; Prostatic Hyperplasia

Summary: to compare safely and efficacy of intraprostatic injection of botulinum toxin a versus ethanol for treatment of benign prostatic hyperplasia (bph).

to compare safely and efficacy of transrectal intraprostatic injection of botulinum toxin a versus ethanol for treatment of symptomatic benign prostatic hyperplasia (bph) refractory to medical treatment.

Eligibility criteria:
inclusion criteria: * international prostate symptoms score (ipss) \> 7 * qmax \< 15 * patients with refractory symptomatic bph to medications * patients high risk for surgery or unwilling to do surgery exclusion criteria: * bladder stones * acute or chronic urinary retention * urethral stricture * bladder or prostatic carcinoma. * neurogenic bladder dysfunctions

Keywords: ethanol ablation of the prostate benign prostatic hyperplasia (bph) prostate ethanol transrectal bph onabont-a botox lower urinary tract symptoms botulinum toxin onabotulinumtoxina quality of life ipss randomised controlled study
immunogenicity of covid-19 vaccination in immunocompromised patients (auto-covid-vacc)

Conditions: COVID-19; Adult; Immunocompromised Patients

Summary: this multicenter, prospective, non-interventional study aims to evaluate data on humoral and cellular immune response generated within the covid-19 vaccination standard in immunocompromised patients.

this study aims to analyze the immune response data generated within the procedures of the standard-of-care covid-19 vaccination. for immunocompromised patients. additional blood will be drawn from the patients at each visit defined within the vaccination standard by using the same vein puncture as used for blood drawings of routine blood samples. study related blood samples will be used for evaluation of t and b cell response to covid-19 vaccinations. for this study, no additional visits or invasive procedures will be performed in addition to the standard interventions.

Eligibility criteria:
inclusion criteria: * patient is vaccinated according to the recent version of the covid-19 vaccination standard for immunocompromised patients. * patient is 18 years of age or older at enrollment. * written informed consent from patient has been obtained prior to any study related procedures exclusion criteria: • patient is not vaccinated according to the recent version of the covid-19 vaccination standard. patient has a positive sars-cov-2 antigen test at the first visit.

Keywords: covid-19 mrna vaccination immunocompromised patients
the threshold value of regional cerebral oxygenation in detecting cerebral ischemia

Conditions: Cerebral Ischemia; Regional Cerebral Oxygenation

Summary: using patients receiving spinal anesthesia as a model to evaluate the treshold value of cerebral oximeter to detect the symptoms of cerebral ischemia

56 patients has been recruited for the analysis of relationship between the symptoms of cerebral ischemia and the value of cerebral oximeter. all patients were recieved spinal anesthesia for the procedure of ceserean section.

Eligibility criteria:
inclusion criteria: patients who are going to undergo cesarean section under spinal anesthesia exclusion criteria: conditons contraindicated for regional anesthesia
phase ii study of tas-109 to treat advanced colorectal cancer

Conditions: Advanced Colorectal Cancer

Summary: the purpose of this study is to evaluate progression free survival primarily. the secondary objectives are to evaluate the antitumor activity, as assessed by objective tumor response, duration of clinical benefit, overall survival, and the safety profile of tas-109


Eligibility criteria:
inclusion criteria: * histologically confirmed colorectal adenocarcinoma * received prior therapy, at least two regimens, containing a fluoropyrimidine, oxaliplatin, and irinotecan * have at least one measurable tumor, as defined by recist * must be capable of maintaining a central venous line access exclusion criteria: * had previous anti-tumor therapy in the 3 weeks prior to study entry * have not recovered from all toxicities (excluding alopecia) from prior therapy to baseline or ≤grade 1 prior to study entry * have another malignancy in the past 3 years except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix
effects of inhaled nitric oxide in the treatment of acute hypoxemic respiratory failure (ahrf) in pediatrics

Conditions: Respiratory Insufficiency; Anoxemia

Summary: the purpose of this study is to determine the effect of nitric oxide for inhalation on the duration of mechanical ventilation in pediatric patients with ahrf.

patients will receive 5-ppm study gas (nitric oxide for inhalation or placebo) until day 28 or extubation, whichever comes first. the following will be performed / recorded at specified times during the study: arterial blood gases, ventilator settings, methemoglobin, prism iii score, and patient positioning. selected centers will also be performing plasma cytokine assays, broncho-alveolar lavage fluid assays and a 6 month follow-up assessment.

Eligibility criteria:
inclusion criteria: * admitted to pediatric intensive care unit and have the diagnosis of acute respiratory failure * 44 weeks post conceptional age to 16 years of age * oxygenation index (oi) \>=12 cm h2o/mmhg (as determined by two separate measurement taken 30 minutes to 4 hours apart) * recent chest x-ray (within 24 hours) showing at least unilateral infiltrations * mechanically ventilated \<= 7 days exclusion criteria: * immunocompromised * received a bone marrow transplant * active oncological condition * persistent right to left intracardiac shunt * cardiovascular surgery within the last 14 days * status asthmaticus * decision by primary care physician not to provide full support * received treatment with nitric oxide for inhalation or other investigational medications within 24 hours prior to study initiation, participating in surfactant trials * chronically ventilated * pregnant

Keywords: acute hypoxemic respiratory failure
a study of cc-99712, a bcma antibody-drug conjugate, in participants with relapsed and refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: study cc-99712-mm-001 is an open-label, phase 1, dose escalation (part a) and expansion (part b), first-in-human (fih) clinical study of cc-99712 in monotherapy or combination with bms-986405 in participants with relapsed and refractory multiple myeloma (mm). the dose escalation part (part a) of the study will evaluate the safety and tolerability of escalating doses of cc-99712, administered intravenously (iv) in monotherapy (arm 1) or combination with bms-986405 (arm 2), to determine the maximum tolerated dose (mtd) of cc-99712 guided by a bayesian logistic regression model (blrm). a modified accelerated titration design will also be used for arm 1 and arm 2. the mtd may be established separately for cc-99712 administered at q3w and/ or q4w schedules. the expansion part (part b) will further evaluate the safety and efficacy of cc-99712 in monotherapy (arm 1) or combination (arm 2) administered at or below the mtd in selected expansion cohorts in order to determine the rp2d. one or more doses or dosing regimens may be selected for cohort expansion. all participants will be treated until confirmed disease progression per imwg criteria, unacceptable toxicity, or participants//investigator decision to withdraw.


Eligibility criteria:
participants must satisfy the following criteria to be enrolled in the study: inclusion * participant is ≥ 18 years of age at the time of signing the icf. * participant has a history of multiple myeloma (mm) with relapsed and/or refractory disease * participant must have measurable disease. * participant has an eastern cooperative oncology group performance status (ecog ps) of 0 or 1. exclusion criteria * participant has symptomatic central nervous system involvement of mm. * participant had a prior autologous stem cell transplant ≤ 3 months prior to starting cc-99712. * participant had a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting cc-99712 or is on systemic immunosuppression for graft-versus host disease. * subject is a pregnant or lactating female. * subject has known human immunodeficiency virus (hiv) infection. * subject has active hepatitis b or c (hbv/hcv) infection. other protocol-defined inclusion/exclusion criteria apply

Keywords: multiple myeloma relapsed and refractory cc-99712 bcma antibody drug conjugate bms-986405
a study to assess the efficacy and safety of iv/po moxifloxacin in subjects with community-acquired pneumonia

Conditions: Pneumonia

Summary: the purpose of this study is to assess if a therapy with oral and intravenous moxifloxacin is as effective as a therapy with intravenous ceftriaxone + intravenous azithromycin followed by oral amoxicilline/clavulanate and oral clarithromycin in the treatment of community-acquired pneumonia.


Eligibility criteria:
inclusion criteria: * hospitalized non-icu patients (age, \>= 18 years) * clinical signs and symptoms of cap, with psi score iv or v * radiologically confirmed evidence of a new and/or progressive infiltrate(s) * requirement for initial parenteral therapy * at least 2 of the following conditions: * productive or non productive cough with or without purulent or mucosus or mucopurulent sputum * dyspnea and/or tachypnea (respiratory rate of \> 20 breaths/min) * rigors and/or chills * pleuritic chest pain * auscultatory findings of rales and/or crackles on pulmonary examination and/or evidence of pulmonary consolidation * fever (an oral temperature of \>= 38 °c, a rectal temperature of \>= 39 °c, or a tympanic temperature of \>= 38.5 °c) or hypothermia (rectal or core temperature of \ = 10,000 cells/mm3 or \>= 15% immature neutrophils bands; regardless of peripheral wbc count) or leukopenia (total wbc count of \< 4500 cells/mm3) * written informed consent exclusion criteria: * psi class i-iii and v with need for icu admission * hospitalization for \> 48 hours before developing pneumonia, or discharge from hospital \< 30 days prior. note: patients currently residing in residential long-term facilities can be enrolled in the study

Keywords: cap community-acquired pneumonia
personalized accelerated chemoradiation (pacer) for lung cancer

Conditions: Lung Cancer

Summary: the purpose of this study is to examine the use of hypofractionated accelerated radiation therapy (hart) to treat locally advanced lung cancer. depending on the location and size of the tumor.


Eligibility criteria:
inclusion criteria: * histologically or cytologically documented malignancy of the lung including non-small cell lung cancer or small cell lung cancer planned for definitive therapy with fractionated radiation (60-66 gy) and concurrent systemic therapy * ecog performance status of 0-2 * age \> 18 years old * ability to understand and the willingness to personally sign the written irb approved informed consent document * estimated life expectancy of 12 weeks or longer exclusion criteria: * contraindication to receiving radiotherapy or systemic therapy as determined by treating radiation and medical oncologist * age \< 18 years old * tumor directly invading the major pulmonary arteries, aorta, heart or proximal bronchial tree * diagnosis of interstitial pulmonary fibrosis * previous radiation therapy to the thorax that would result in overlapping high dose radiation fields
a study in participants with a newly confirmed diagnosis of spondyloarthritis (spa) who are new to conventional, targeted and biological dmards

Conditions: Spondyloarthritis, Axial and Peripheral

Summary: the purpose of this italian multicenter study is to collect prospective clinical data in participants with first diagnosis or confirmation diagnosis of spondyloarthritis (spa), according to assessment of spondyloarthritis classification (asas) criteria, in order to describe spa characteristics and pattern of clinical presentation.


Eligibility criteria:
inclusion criteria: * participants must have a first or confirmed diagnosis of spondyloarthritis (spa) according to assessment of spondyloarthritis classification (asas) criteria * participants must be naïve to conventional, targeted and biological disease modifying anti-rheumatic drugs (dmards) treatment * participants must understand the purpose of the study * participants must sign a participation agreement/ informed consent form (icf) allowing data collection and source data verification in accordance with local requirements exclusion criteria: * participants who already started conventional, targeted and biological dmards treatment for spa * participants who participate to an investigational study in the last 30 days * participants unwilling or unable to participate in long-term, 24 months, data collection * participants unwilling or unable to fill in the participant-reported outcome (pro) foreseen by the protocol * participants unwilling or unable to sign the informed consent to the study
assessing repeat fit testing for crc

Conditions: Colo-rectal Cancer

Summary: this study will randomly assign 220 men and women to either a social media intervention or a standard reminder system to have a repeat screening test for colo-rectal cancer.

only persons initially screening by fit (through a rural cancer prevention center service program) will be eligible for study participation. the objective is to test a social media-based intervention designed to promote annual repeat colo-rectal cancer screening using the fecal immunochemical test (fit) among person who have taken the fit test once before. 220 men and women (50 to 75 years of age) will be recruited and randomly assigned to either the intervention condition (monthly social media contact) or a control condition (standard of care reminder for repeat testing one month before the annual test is due). the dependent variable will be whether volunteers requested and retuned a fit kit with 60 days of the annual due date (one year from their initial screening).

Eligibility criteria:
inclusion criteria: * must have completed and returned an initial fit kit to us as part of a rural cancer prevention center service program to the community exclusion criteria: * visible blood in stool or prior diagnosis of cool-rectal cancer
speech perception impairment follow complete recovery of sudden sensorineural hearing loss

Conditions: Sudden Sensorineural Hearing Loss

Summary: at present, few research on the auditory perception function and possible neural mechanisms of unilateral sudden hearing loss patients with complete or partial recovery of peripheral hearing.this project evaluate the speech perception function in noise of unilateral sudden hearing loss patients with with complete and partial hearing recovery by cognitive behavioral experiments, event-related potentials (erps) and functional magnetic resonance imaging (fmri), and longitudinal follow-up to explore its underlying neural mechanisms.

in clinical practice, many unilateral sudden hearing loss patients with complete and partial recovery of peripheral hearing still complain of hearing discomfort, especially difficulty in speech recognition in noisy environments. at present, there is still a lack of research on the auditory perception function and possible neural mechanisms of unilateral sudden hearing loss patients with complete or partial recovery of peripheral hearing. from the perspective of cognitive psychology, this project uses cognitive behavioral experiments, event-related potentials (erps) and functional magnetic resonance imaging (fmri) to evaluate the reverberation environment of unilateral sudden hearing loss patients with complete and partial hearing recovery, and longitudinal follow-up to explore its underlying neural mechanisms. the investigators hope to understand the possible difficulties of binaural processing and auditory perception in patients with unilateral sudden deafness, and to explore the changes of central and cortical functions. this study not only has important guiding significance for the treatment and rehabilitation of patients with unilateral sudden deafness, but also expands the research group on auditory perception function and the psychological and neural mechanisms involved in binaural processing, which has important theoretical significance.

Eligibility criteria:
inclusion criteria: * 18-65 years old; * patients with unilateral idiopathic sudden sensorineural hearing loss (at least three adjacent frequencies of hearing loss ≥ 30 db ); * the first onset; * contralateral hearing is normal; 5) hearing is cured after treatment exclusion criteria: * sudden deafness with possible definite etiology, such as meniere's disease, large vestibular aqueduct syndrome, trauma, retrocochlear tumor, etc.; * severe underlying diseases, heart disease, blood disease, pregnancy, breastfeeding, etc.; * suffering from other central diseases that may affect speech perception disorders, such as alzheimer's disease, etc.; * those who cannot cooperate with the whole study inspection; * those who do not agree to be enrolled or refuse to sign the informed consent form; * those who are using may affect the medications or treatments for speech perception disorders.

Keywords: unilateral sudden sensorineural hearing loss information masking energy masking neural mechanisms
assessment of near vision capacity in different light conditions following bilateral trifocal intraocular implantation

Conditions: Presbyopia

Summary: patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (adls) that require near vision acuity (nv), (ie. book reading). however, it is known that light intensity and temperature has a great impact on near vision capacity. primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and temperature) for adls that demand near vision acuity for a sample of patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation

patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (adls) that require near vision acuity (nv), (ie. book reading). however, it is known that light intensity and temperature has a great impact on near vision capacity. primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and temperature) for adls that demand near vision acuity for a sample of patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation. the following light intensities will be evaluated: 25, 50, and 75 foot candles. moreover, the following light temperatures will be evaluated: 3000, 4000, and 6000 kelvins.

Eligibility criteria:
inclusion criteria: presbyopia exclusion criteria: glaucoma corneal pathology fundus pathology severe neurological/mental diseases that interfere with visual acuity