Kornimate/medical-research-clean huggingface dataset:
a phase 2 study of firi-cel in patients with relapsed/refractory large b-cell lymphoma

Conditions: Cancer; Relapsed/Refractory Large B-cell Lymphoma (LBCL)

Summary: this is a prospective, open-label, multi-center clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of firicabtagene autoleucel (firi-cel), a cd22-directed autologous chimeric antigen receptor (car) t-cell therapy for the treatment of relapsed or refractory large b-cell lymphoma (lbcl).

firicabtagene autoleucel (firi-cel) is an autologous car t-cell therapy targeting cd22, a common b-cell antigen widely expressed in lbcl. this phase 2 study is designed to evaluate the safety and the efficacy of firi-cel in patients with r/r lbcl that has progressed after cd19-directed car t-cell therapy. the study is designed to treat up to 123 patients with a single infusion of firi-cel.

Eligibility criteria:
key inclusion criteria: * aged ≥18 years * relapsed or refractory, histologically confirmed large b-cell lymphoma. * must have relapsed or refractory diseae after last therapy. * for enrollment in cohort 1, patients must have previously received a cd19-directed car t-cell therapy * for enrollment in cohort 3, patients must have received at least two prior lines of therapy including a bispecific t-cel engaging antibody therapy. * must have at least one radiographically measurable lesion. * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate hematological, renal, and liver function * willing and able to remain within 1 hour of the treating center for at least 4 weeks after infusion. key exclusion criteria: * clinically significant concurrent medical illness * active fungal, bacterial, viral or other infection. * prior allogeneic stem cell transplant or allogeneic cell therapy note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: lymphoma cd-22 expressing tumor chimeric antigen receptor adoptive immunotherapy lymphoma, b-cell lymphoma, large b-cell, diffuse lymphoma, primary mediastinal b-cell lymphoma, transformed lymphoma, transformed non-hodgkin lymphoma, non-hodgkin car t car t-cell therapy cell therapy cellular immuno-therapy crg-022 cd22 firce-1 firicabtagene autoleucel firi-cel
study of the utility of the bomet-qol questionnaire patients with breast cancer and bone metastasis

Conditions: Breast Carcinoma Metastatic to the Bone

Summary: epidemiological, prospective and multicenter study to evaluate the utility of the bomet-qol questionnaire in patients with breast cancer (bc) and bone metastases (bm).

population: patients over 18 with breast cancer and bone metastasis. inclusion criteria: * patient over 18 years of age. * patient diagnosed with breast cancer (bc) and bone metastases (bm). * patient who has granted informed consent in writing to participate in the study. * patient capable of understanding and completing the questionnaires. exclusion criteria: * patient with another type of disease that, in the investigator's opinion, could mask the study results. * patients with a life expectancy of less than 8 months. * patient who is participating in a clinical trial with an unregistered drug at the start of the study.

Eligibility criteria:
inclusion criteria: * patient over 18 years of age. * patient diagnosed with bc and bm. * patient who has granted informed consent in writing to participate in the study. * patient capable of understanding and completing the questionnaires exclusion criteria: * patient with another type of disease that, in the investigator's opinion, could mask the study results. * patients with a life expectancy of less than 8 months. * patient who is participating in a clinical trial with an unregistered drug at the start of the study.

Keywords: metastatic breast cancer bone metastasis quality of life psychometric treatment assessments
whole body exercise in spinal cord injury: effects on psychosocial function

Conditions: Spinal Cord Injuries

Summary: persons with spinal cord injury (sci) are confronted with a multitude of psychological and physiological changes post-injury leading to seemingly insurmountable barriers to participating in daily life. after injury persons with sci engage in fewer social interactions, spend more time sedentary, and are less likely to leave the home. this leads to restricted social participation that, in turn, contributes to greater psychological problems and negatively impacts the lives of adults with sci. intense, structured exercise has substantial potential benefits for improving psychosocial wellbeing among persons with sci, but accessible exercise options are few and cannot achieve high intensities of whole-body exercise. this work will use approaches to overcome the barriers to intense exercise. the investigators will use hybrid functional electrical stimulation row training (fesrt) to allow for a more intense exercise stimulus, potentially having a greater impact on psychosocial wellbeing. there is initial evidence that persons with mobility impairments who are highly physically active demonstrate better psychosocial wellbeing compared with those who have low levels of physical activity. a limitation to understanding the influence of exercise on psychosocial wellbeing is the lack of robust and time-dependent measures. the investigators will use a smartphone-based research application to measure psychosocial well-being, thus decreasing self-report bias and capturing in-the-moment behavioral and self-report data.


Eligibility criteria:
inclusion criteria: * adults (\>18 years of age) * be in good health (asymptomatic for acute treatable illness) and medically cleared to exercise * own an iphone or android smartphone with the capacity to download and run the research platform (able to log into to the relevant app store, install the app on their own phone, and run the app). * be able to understand, communicate with and be understood by research personnel or interpreters * be interested in participating and provide informed consent * have a sci with motor or sensory deficits and use a wheelchair as primary means of mobility * have an injury level only as high as c4 to allow sufficient arm function for rowing exclusion criteria: * participants will not have previously completed fesrt * acute illness * musculoskeletal injuries that have not healed completely * had heart surgery or are status post-myocardial infarction (mi) in the last 4 to 6 months, -unstable angina * uncontrolled hypertension (systolic blood pressure ≥160 mm hg and/or diastolic blood pressure ≥100 mm hg) * uncontrolled dysrhythmias * recent history of congestive heart failure that has not been evaluated and effectively treated * severe stenotic or regurgitant valvular disease * hypertrophic cardiomyopathy * unhealed pressure ulcer stage 2 or higher at relevant contact sites during exercise.
clinical characteristics and outcome of patients xith spontaneous pneumothorax

Conditions: Spontaneous Pneumothorax

Summary: pneumothorax occurs when air accumulates between the visceral and parietal pleura, and canbe defined as spontaneous, iatrogenic or traumatic. spontaneous pneumothorax further classified as primary or secondary. primary spontaneous pneumothorax (psp) occur in the absence of underlying lung disease. primary spontaneous pneumothorax is more common in men and in younger patients and associated with smoking. secondary spontaneous pneumothorax (ssp) occur in the presence of underlying lung disease, most commonly chronic obstructive pulmonary disease, cystic fibrosis, pneumocystis pneumonia, lung cancer,and interstitial lung diseases (ilds) in older adults.


Eligibility criteria:
inclusion criteria: * the study will include patients ≥18 years old with spontaneous pneumothorax admitted at sohag university hospital exclusion criteria: * patients with traumatic or iatrogenic pneumothorax.
survey of running following a tka

Conditions: Arthroplasty; Knee Replacement

Summary: the hypothesis of this study is that there are people running following a total knee arthroplasty (tka). the objective is (1) to determine if there are people that ran/run following their tka and (2), in case (1) is true, to identify some general running parameters such as duration, frequency, perceived barriers for running. patients with a tka and a score equal or higher than 9 on the ucla activity scale at any time between 2 years prior to surgery and at present will be invited to participate in the trial by phone. all these patients will receive the study's information form and questionnaire by post with a pre-stamped envelope to return the documents.the survey was created and piloted internally for this study. there are 21 questions, most of them are "yes or no" and some others open questions to assess parameters such as duration of difficulties faced. the questionnaire is composed of three parts. the first part is interested in the preoperative activity (during the 2 years before surgery), the second part in the postoperative activity (during the 2 years after surgery) and the third part refers to the current practice. for each part, people are asked about specific practice parameters and modalities. furthermore, we seek to determine whether there was/is a willingness to run following tka, if patients receive any education/information about it and their personal attitudes towards running with a tka. the anonymized data will be collected by the main author for subsequent analysis.


Eligibility criteria:
inclusion criteria: * tka and ucla score = or \> 9 exclusion criteria: * inability to read/write in french language * cognitive or neurological impairment
the impact of a short intervention during rsv prophylaxis on influenza vaccination rate.

Conditions: Prematurity; RSV; Influenza; Upper Respiratory Tract Infection; Lower Respiratory Tract Infection

Summary: premature infants (born before 34 wk) are routinely vaccinated against rsv but vaccination rate against influenza are low in spite of national programs. study goal is to evaluate the effectiveness of short intervention during rsv prophylaxis visit, planned to educate parents about the importance of influenza vaccination.


Eligibility criteria:
inclusion criteria: * infants coming for rsv prophylaxis exclusion criteria: * already vaccinated against influenza * contraindication for influenza vaccination

Keywords: vaccination rsv influenza prematurity
study of aggreguide a-100 (adp) assay

Conditions: Risk Factor, Cardiovascular; Platelet Dysfunction Due to Drugs

Summary: study to evaluate the performance of the aggreguide a-100 adp assay for detection of platelet dysfunction caused by p2y12 inhibitor antiplatelet therapy.

study subjects will have a-100 adp measurements performed at baseline and after initiation of p2y12 inhibitor antiplatelet therapy, following loading and maintenance doses.

Eligibility criteria:
inclusion criteria: * subject has a history of cardiovascular disease or * subject has 2 or more cardiac risk factors: * smoking * hypertension * hyperlipidemia * family history of heart disease * post-menopausal female * diabetes * obesity (bmi \> 30) * sedentary lifestyle exclusion criteria: taken nonsteroidal anti-inflammatory drugs (nsaids) drugs, anti-platelet drugs or anticoagulant drugs within the past seven (7) days, over age 75, under 60 kg body weight, in the last trimester of pregnancy or breastfeeding, with a diagnosed history of: stroke or transient ischemic attacks, or other thromboembolic disease, anemia, thrombocytopenia, uncontrolled hypertension,platelet disorders,hemophilia or other bleeding disorder, gastrointestinal disease, severe renal disease, expect to engage in contact sports, scheduled for elective surgery, have a medical history as determined by the investigator that would pose safety concerns, or possess contraindications for any of the study medications.
evaluation of omeprazole effect on glaucoma

Conditions: Glaucoma

Summary: omeprazole is a safe drug listed in otc drug due to its safety. it acts by irreversible inhibition of k/h atp ase pump and also na/k atp ase, na/h atp ase.considering these actions the effect of omeprazole on decreasing intra ocular pressure is an issue of debate.in this randomized clinical trial conducted in labafinejad hospital, patients with glaucoma who need to take omeprazole due to gi problem are evaluated in two groups including placebo and drug users. the effect will be finally assessed.

omeprazole is a safe drug listed in otc drug due to its safety. it acts by irreversible inhibition of k/h atp ase pump and also na/k atp ase, na/h atp ase.considering these actions the effect of omeprazole on decreasing intra ocular pressure is an issue of debate.in this randomized clinical trial conducted in labafinejad hospital, patients with glaucoma who need to take omeprazole due to gi problem are evaluated in two groups including placebo and drug users. the effect will be finally assessed.

Eligibility criteria:
inclusion criteria: * patients with glaucoma * 18 to 70 years * poag patients, pseudoexfoliation * no history of other systemic disease * no history of intraocular intervention * no history of h2 blocker or ppi consumption during the past month consuming 2 or less topical anti-glaucoma medication * no present immune deficiency * no addiction habit exclusion criteria:
efficacy, safety and satisfaction of vitaros (transdermal topical alprostadil) in men with erectile dysfunction

Conditions: Erectile Dysfunction

Summary: a phase 4 clinical trial that is open, with no blinding of subjects or randomization of treatment. patients with erectile problems will be given the approved drug vitaros to treat their condition. they will be given forms and questionnaires to complete. the information collected will be used to assess the effectiveness, safety and the satisfaction levels with this drug.

transdermal topical alprostadil has been approved for use in canada as a treatment for erectile dysfunction. however, as this form of treatment is new, and canada is the first country in the world to approve its use. there are very few published articles in literature to evaluate its clinical acceptance. by performing a phase 4, open-label, non-randomized, clinical trial to evaluate the efficacy, safety and satisfaction of vitaros (transdermal topical alprostadil) in men with erectile dysfunction, this study can improve understanding of this method of treatment as compared to conventional treatment.

Eligibility criteria:
inclusion criteria: * 18y rs old and above * has mild-to-moderate erectile dysfunction * currently or previous treated for erectile dysfunction using pde5 inhibitors, vacuum erection devices (ved), intra-cavernosal injections (ici) and medical urethral system for erection (muse). * sexually active * has a regular sexual partner exclusion criteria: * known allergy to alprostadil * unable to provide own informed consent * unable to understand and complete a questionnaire in english * unable to return for a post-treatment clinic evaluation * regular sexual partner is unable to understand and complete a questionnaire in english * sexual partner is a pregnant or lactating female

Keywords: erectile dysfunction topical alprostadil
faith moves mountains: a community based participatory research (cbpr) appalachian wellness & cancer prevention program

Conditions: Lung Cancer; Cervical Cancer; Breast Cancer; Colorectal Cancer

Summary: the study purpose is to evaluate the effectiveness of a set of culturally appropriate, faith-placed lay health advisor interventions aimed at facilitating smoking cessation and increasing cancer screening among appalachian participants.

the developmental phase of this project incorporated community based participatory research (cbpr) principles to identify the needs and preferences of community members with regard to cancer prevention. in the intervention phase, this group-randomized trial administers and evaluates a set of culturally appropriate interventions aimed at facilitating smoking cessation and increasing cancer screening among participants in 6 distressed appalachian counties. faith institutions are recruited and randomized to treatment or wait-list control conditions, and participants are recruited and enrolled within those institutions. participants select one or more targeted health behaviors from a menu including smoking cessation, colorectal cancer screening, cervical cancer screening, and breast cancer screening, and subsequently receive the intervention(s) aimed at their selected health behaviors.

Eligibility criteria:
inclusion criteria: * for smoking cessation: age 18 or older; current cigarette smoker; able to provide informed consent * for cervical cancer screening: female; age 18 or older and outside of screening guidelines; able to provide informed consent * for breast cancer screening: female; age 40 or older and outside of screening guidelines; able to provide informed consent * for colorectal cancer screening: age 40 or older and outside of screening guidelines; able to provide informed consent exclusion criteria: * for smoking cessation: none * for cervical cancer screening: history of cervical cancer; history of hysterectomy * for breast cancer screening: history of breast cancer * for colorectal cancer screening: history of colorectal cancer

Keywords: smoking cessation cancer screening appalachia group-randomized trial faith-placed
comparison between oral contraceptive pills and calcium supplements in treatment of premenstrual syndrome

Conditions: Premenstrual Syndrome

Summary: premenstrual syndrome represents a group of problems affecting most of women in reproductive age. these problems include emotional and physical symptoms. in this study the efficacy of oral contraceptive pills and calcium supplements in relieving these symptoms will be assessed .

premenstrual syndrome (pms) is deﬁned as the recurrence of psychological and physical symptoms in the luteal phase, which remit in the follicular phase of the menstrual cycle \[1\].pms will be prospectively diagnosed using the royal college of obstetricians and gynecologists (rcog) recommended daily record of severity of problems (drsp) . women will be asked to fill the diary for 2 months, only women with 30% increase in the drsp score in the week before menses in both months will be diagnosed as having pms. women with pms will be invited to participate in the study.the invitation will include a clear full explanation of the study and patients will provide written consents. all patients consenting to participate will be included in the trial. yasmin, calver and placebo will be enclosed in sequentially numbered similar bottles which will be numbered using a computer generated random table. women will be asked to choose a sealed envelope, each envelope will contain the number allocated to the jar and special instructions on how to use the medication. yasmin will be taken once daily for 21 days starting from the 2nd day of menstruation, calver and placebo will be taken continuously. neither the patients nor the physician will be aware of the drug used. patients will be categorized in 3 groups: group1 who will receive yasmin cyclically for 3 months (yasmin, schering, cairo, egypt) and daily oral placebo, group 2 who will receive calver continuously for 3 months (calver, marcryl/vertex, cairo egypt) and oral placebo for 21 days, group 3 who will receive a daily placebo and a placebo similar to coc for 21 days and will act as a control group.

Eligibility criteria:
inclusion criteria: * patients diagnosed by prospective dairy to have pms * consenting to be included in the study * age 18-40 years exclusion criteria: * medical disorders as hypertension or diabetes.

Keywords: premenstrual syndrome oral contraceptive pills calcium supplements
comparison of two topical anesthetics: benzocaine versus pliaglis

Conditions: Anesthesia of Mucous Membrane

Summary: the efficacy of the topical anesthetics will be determined by how much pain the patient felt (using a heft-parker pain analog scale) upon needle penetration.

this project will be a double blind study comparing the efficacy of two different topical anesthetics used to reduce the pain associated with insertion of dental needles on the palatal mucosa. the two topical anesthetics being compared are 20% benzocaine, and pliaglis. in order to complete a number of different dental procedures, it is often necessary to provide local anesthesia of the palate. intraoral injections into the palatal mucosa are often uncomfortable and even painful. in an effort to increase patient comfort, a topical anesthetic is often used prior to the injection. test subjects undergoing routine endodontic treatment on maxillary teeth will have a 27- gauge dental needle inserted into the mucosa of the hard palate as part of the initial step in standard local anesthetic injection. at the injection site and prior to the needle stick, the mucosa will be topically anesthetized by using one of the two different test compounds (benzocaine or pliaglis). after the injection, patients will be asked to score the level of discomfort associated with the needle stick. the purpose of the project is to determine if there is a clinical difference in the level of pain felt upon needle stick, between the two different topical anesthetics.

Eligibility criteria:
inclusion criteria: * normal healthy adults 18+ yrs old requiring root canal treatment of maxillary molars * patients with healthy mucosal tissues, and who do not have pain on palpation at injection site * ability to use and understand a vas score * ability to use and understand a vas score * no know allergies to topical anesthetics being used exclusion criteria: * allergy or other contraindications to topical anesthetics * allergy to epinephrine or local anesthetics * broken/unhealthy mucosal tissues and pain on palpation at injection site * patients needing endodontic therapy on maxillary anterior teeth * inability to consent to participate in the study * patients who have used analgesics within 6 hours of appointment time * pregnant and nursing women
study of recombinant human n-acetylgalactosamine 4-sulfatase in patients with mps vi

Conditions: Mucopolysaccharidosis VI

Summary: the purpose of the study is to evaluate the safety, efficacy and pharmacokinetics of two dose levels of weekly intravenous infusions of recombinant human n-acetylgalactosamine 4-sulfatase (rhasb) for a minimum of 24 weeks in patients diagnosed with mps vi.


Eligibility criteria:
inclusion criteria: * patient consent * patient must be five years of age or older * patient must have documented diagnosis of mps vi, confirmed at screening by measurable clinical signs and symptoms of mps vi * leukocyte asb enzyme activity level less than 20% of the normal range * clinical evidence of significant mps vi disease that provides adequate opportunity to achieve quantitative, short-term therapeutic benefit in three or more of the following parameters: endurance (as measured by a six-minute walk test), forced vital capacity (as measured by spirometry), joint range of motion, urinary glycosaminoglycans, and hepatomegaly. * ability to perform all protocol tests * ability to stand independently for six minutes * sexually active subjects must agree to use an adequate form of contraception exclusion criteria: * history of bone marrow transplantation * pregnant or lactating patient * use of an investigational drug or device within 30 days prior to study participation. * a medical condition, serious intercurrent illness, or other extenuating circumstances that may significantly decrease study compliance including prescribed follow-up * known hypersensitivity to rhasb or to components of the study drug * history of cancer (except low grade and fully resolved skin malignancy)