Kornimate/medical-research-clean huggingface dataset:
a study of arv-393 in relapsed/refractory non-hodgkin lymphoma.

Conditions: Relapsed/Refractory (R/R) Mature B Cell Non Hodgkin Lymphoma (NHL); Relapsed/Refractory (R/R) Angioimmunoblastic T-cell Lymphoma (AITL)

Summary: this clinical trial is studying the safety and potential anti-tumor activity of an investigational drug called arv-393 in patients diagnosed with advanced relapsed/refractory non-hodgkin's lymphoma to determine if arv-393 may be a possible treatment option. arv-393 is thought to work by breaking down a protein present in many types of non-hodgkins lymphomas, which may prevent, slow or stop tumor growth. this is the first time arv-393 will be used by people. the investigational drug will be given as an oral tablet.

this is an open-label, multicenter, phase 1, dose escalation study to evaluate the safety, tolerability and preliminary anti-tumor activity of arv-393 as a single agent in adult patients with relapsed/refractory non-hodgkin lymphoma.

Eligibility criteria:
inclusion criteria: * eligible participants aged ≥18 years. * have relapsed/refractory mature b-cell non-hodgkin lymphoma (nhl) and ≥2 prior systemic therapies, or histologically confirmed aitl that has recurred or progressed following institutional standard-of-care therapy. * participants must also have ≥1 measurable lesion at study entry * eastern cooperative oncology group performance status of 0 or 1, * freshly biopsied or archival tumor tissue available, * participants with adequate organ function, * participants must accept and follow pregnancy prevention guidance. exclusion criteria: * no prior allogeneic stem cell transplant or solid organ transplantation, autologous stem cell transplant, must not have occurred ≤100 days, previous car t-cell therapy ≤60 days, radiotherapy ≤ 2 weeks, systemic anticancer treatment ≤ 5 half-lives or 4 weeks, prior to arv-393 treatment initiation. * participants must not have significant acute or chronic medical illness, including hypereosinophilic syndrome, active interstitial lung disease or pneumonitis, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study. * participants with an inability to comply with listed prohibited treatments.

Keywords: relapsed/refractory b cell non hodgkin lymphoma (nhl) relapsed/refractory angioimmunoblastic t-cell lymphoma (aitl) advanced non-hodgkin lymphoma advanced nhl relapsed non-hodgkin lymphoma refractory non-hodgkin lymphoma b cell advanced non-hodgkin lymphoma
comparing the location of the motor cortex in children using two methods

Conditions: Congenital Hemiparesis

Summary: hypothesis: in typically developing children (tdc), use of conventional eeg landmarks to determine the brain area that controls hand function will not differ from tms-guided determination of individual motor hotspots. in children with hemiparesis, however, those two locations will diverge. the prediction is that tms will best guide transcranial direct current stimulation (tdcs) interventions

congenital hemiparesis, mainly due to stroke, affects approximately 25% of children with cerebral palsy. noninvasive brain stimulation has emerged to influence improvements in hand function specifically in children with congenital hemiparesis due to stroke. the use of one type of noninvasive brain stimulation, transcranial direct current stimulation (tdcs), in conjunction with rehabilitation training intervention for a child with hemiparesis proposes a synergistic approach to improving hand function. application of electrodes over certain targeted areas are placed with the intent to stimulate and influence neuronal activity. our preliminary evidence suggests that in children with hemiparesis due to stroke, the area for placement is variable as noted by electroencephalogram (eeg) and transcranial magnetic stimulation (tms) measurement methods, influencing the site location of optimal stimulation for tdcs. due to this variation, the optimal site of stimulation warrants investigation for the optimal placement of tdcs.

Eligibility criteria:
inclusion criteria: typically developing children: * ages 8-17 children with congenital hemiparesis due to hemispheric stroke: * ages 8-17 * equal of greater than 10 degrees of active motion at the metacarpophalangeal joint * no evidence of seizure activity within the last 2 years. exclusion criteria: typically developing children: * neurologic disorders * indwelling metal * pregnancy * history of seizures children with hemiparesis: * metabolic disorders * neoplasm * epilepsy * disorders of cellular migration and proliferation * expressive aphasia * pregnancy * indwelling metal * botulinum toxin or phenol intramuscular block within the one-month preceding tms application.

Keywords: hemiparesis cerebral palsy congenital stroke congenital infarct
effects of tirzepatide on weight loss and chronic inflammation in people with hiv

Conditions: Obesity and Overweight; HIV; Chronic Inflammation

Summary: this is a prospective cohort study of 12 overweight (with one or more weight-related condition) or obese adults with well controlled hiv-1 on antiretroviral therapy (art). an initial dose of tirzepatide (tzp) 2.5 mg subcutaneous (sq) once weekly will be given, escalated by 2.5 mg at 4-week intervals to a final dose of 7.5mg. the investigators will collect the following information via review of the medical record: age, race/ethnicity, gender, medical conditions, medications, most recent standard of care hiv labs (including t-cell panel and hiv-1 viral load). the primary outcome will be the change in baseline body weight at 12 weeks. secondary outcomes will be changes in inflammatory markers, cardiometabolic markers (lipids and hba1c), and monocytes at 12 weeks. there will be a 4-week safety follow up off tzp.


Eligibility criteria:
age ≥ 18 years hiv-1 infection (well controlled) * documented hiv-1 infection ≥ 1 year prior to study entry (elisa confirmed by western blot or hiv-1 rna) and * hiv-1 rna \<200 copies/ml for ≥ 6 months stable art · receiving a stable antiretroviral regimen for at least 1 year prior to study entry overweight * bmi ≥27 kg/m2 plus at least one weight-related condition (defined as a medical history of dyslipidemia, hypertension, cardiovascular disease, or obstructive sleep apnea) or obese * bmi ≥ 30 kg/m2
exploring patient impact & value in epilepsy wearables for seizure monitoring

Conditions: Epilepsy

Summary: the purpose of this research study is to determine the accuracy and reliability of the wearable device in a controlled environment. this study will inform patients, healthcare professionals, and the wider community of the accuracy of the device in detecting seizures.

epilepsy is a common serious neurological disorder, regularly presenting with seizures that can affect patients without warning. any seizure has the potential to cause significant injury to patients or sudden unexplained death in epilepsy (sudep). as such, many patients with epilepsy and their caregivers live with a fear that a seizure may occur, fundamentally impacting their quality of life. new technology including the use of wearable devices have the potential to identify a seizure and notify caregivers immediately of a person in danger. these devices use sensors that look out for the types of movements demonstrated during a seizure and are able to send alerts automatically when connected to a smartphone and the internet. one example of this device is the empatica embrace2 which is a wrist worn wearable that has been approved for use in epilepsy. this relatively new technology is available to purchase by the public, but it is not yet clear what value this device offers. whilst man of these devices may be been cleared for use by regulators and available to buy on the consumer market. it remains unclear on the value that they can offer to patients. the purpose of this research study is to determine the accuracy and reliability of the wearable device in a controlled environment. this study will inform patients, healthcare professionals, and the wider community of the accuracy of the device in detecting seizures.

Eligibility criteria:
inclusion criteria: 1. the participant is over the age of 18 2. the participant has access to a smartphone 3. the participant has a history of generalised tonic-clonic seizures in the past year exclusion criteria: 1. the participant lacks capacity to give informed consent (e.g. has intellectual disability) 2. the participant is a paediatric patient (aged below 18)

Keywords: wearable device
pegylated interferon - α2b with sarscov- 2 (covid-19)

Conditions: Covid19

Summary: this is a phase ii, multicenter, open-label, randomized, comparator-controlled study to evaluate the efficacy and safety of pegylated interferon -α2b in the treatment of adult patients diagnosed with sars-cov2 (covid-19).initial 1 mcg/kg of pegylated interferon-α2b will be administered on day 1. after safety evaluation of first dose, next dose (second dose) 1 mcg/kg on day 8 will be administered with recommended standard care during the trial.

this is a phase ii, multicenter, open-label, randomized, comparator-controlled study to evaluate the efficacy and safety of pegylated interferon -α2b in the treatment of adult patients diagnosed with sars-cov2 (covid-19).moderate covid-19 subjects will be randomly assigned to receive test arm or reference arm in a 1:1 ratio.

Eligibility criteria:
inclusion criteria: 1. ability to comprehend and willingness to sign a written icf for the study. 2. male or non-pregnant females, ≥18 years of age at the time of enrolment. 3. understands and agrees to comply with planned study procedures. 4. agrees to the collection of pharyngeal swabs and blood sample as per protocol. 5. has laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen within one week 6. patients with spo2 \> 93% and respiratory rate \<30 breaths/min. 7. illness of any duration, and at least one of the following: 1. radiographic infiltrates by imaging (chest x-ray) 2. clinical assessment (evidence of rales/crackles or other clinical symptoms on exam). 8. women of childbearing potential must agree to use at least one primary form of contraception exclusion criteria: 1. alt/ast \>5 times the upper limit of normal. 2. patients with respiratory rate \<20 breaths/min and normal spo2 with confirmed sars-cov-2 infection as determined by pcr (mild covid-19 subjects). 3. patients with respiratory rate ≥30 breaths/min and spo2 at rest ≤93% (severe covid-19 subjects). 4. stage ≥4 severe chronic kidney disease or requiring dialysis (i.e. egfr \<30 ml/min/1.73 m2). 5. pregnant or breast feeding. 6. allergy to any study medication or usage of test drug during last 14 days prior to screening 7. severe co-morbidity (e.g. uncontrolled hypertension and uncontrolled dm, systemic disease which affect the vital organs severity, immunocompromised patients etc.) as per investigator's assessment. 8. comorbid condition like myocardial infarction or heart failure within 90 days of recruitment. 9. prolong qt interval (\>450 ms).
a new tablet containing two fda-approved drugs in hiv-infected patients who have not received prior therapy

Conditions: HIV Infection

Summary: this is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two fda-approved drugs in hiv-infected patients who have not received prior therapy. this tablet will be taken with one of two fda-approved drugs as a once-daily regimen. study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.


Eligibility criteria:
inclusion criteria: * participants must be able to provide informed consent. * have documented hiv-1 infection. * have not received more than 14 days of prior treatment with antiretroviral drugs. * meet laboratory test criteria. * women of childbearing potential must abstain from sexual intercourse or use acceptable contraception. * must be able to take study medications as directed and complete all study visits and evaluations during the 48 week study. exclusion criteria: * enrolled in other hiv treatment studies. * pregnant or breastfeeding.

Keywords: hiv-1 efavirenz tenofovir
clinical outcomes with omni apex ultracongruent knee system

Conditions: Osteoarthritis, Knee

Summary: a prospective, matched case comparison of total knee arthroplasty with the omni apex ultracongruent vs. triathlon® cs tibial insert vs. the triathlon® ps tibial insert.


Eligibility criteria:
inclusion criteria: * patients willing to sign the informed consent. * patients able to comply with follow-up requirements including postoperative weight bearing restrictions and self-evaluations. * male and non-pregnant female patients ages 21-80 years of age at time of surgery. * patients requiring a primary total knee replacement. * patients with a diagnosis of osteoarthritis (oa), traumatic arthritis (ta), or avascular necrosis (avn). * patients with intact collateral ligaments. exclusion criteria: * patients with inflammatory arthritis. * patients that are morbidly obese, body mass index (bmi) \> 40. * patients with a history of total or unicompartmental reconstruction of the affected joint. * patients that have had a high tibial osteotomy or femoral osteotomy. * patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. * patients with a systemic or metabolic disorder leading to progressive bone deterioration. * patients that are immunologically compromised, or receiving chronic steroids (\>30 days). * patients bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis. * patients with knee fusion to the affected joint. * patients with an active or suspected latent infection in or about the knee joint. * patients that computer-assisted surgical navigation (caos) techniques will be used. * patients that minimally invasive surgical technique will be used. * patients that are prisoners.

Keywords: osteoarthritis total knee replacement total knee arthroplasty tka knee
the use of dxa in scoliosis

Conditions: Scoliosis Idiopathic

Summary: this is a pilot study to look at image quality of idxa ap supine spinal images to see if the investigators can accurately measure the size of the curve from idxa images and to see how patients with scoliosis feel about idxa imaging compared to normal x-rays. with normal x-rays being taken standing (or sitting if patients are in a wheelchair), it is important that the investigators understand how the lying down images compare to the standing images. where there may be some clinical benefit, images will be taken standing (normal x-rays) and lying down (idxa images). the investigators will see if the addition of idxa images can help in brace design and brace monitoring.

this pilot study is an interventional study where patients having routine standing or sitting spinal x-rays for scoliosis monitoring or as part of a treatment protocol will be approached to see if they would have an additional supine ap dxa image. participants will only have one additional dxa image during the pilot study. the consent will be obtained by one of the spinal surgeons or a specialist spinal nurse. the dxa scan will be performed by one of the radiographers. this study may be performed by a medical student or junior doctor (either would be part of the care team) and supervised by the pi. the pilot study is expected to last 9 months and consist of 25 patients. the dxa images will be reviewed by 2 consultant spinal surgeons and a consultant radiologist who will make a collective decision every month as to whether the study, or that part of the study, should continue. two scoliosis patients have read the study protocol and given their input. the sheffield children's hospital scoliosis ppi group will feedback on key aspects during the study and help define future studies suggested by this study.

Eligibility criteria:
inclusion criteria: * patients with adolescent idiopathic scoliosis (ais, aged 10-16 years) or juvenile idiopathic scoliosis (jis, aged 4-9 years) having an x-ray to look for curve progression or to guide design of a new brace. * patients with quadriplegic cerebral palsy (cp) having an x-ray to look for curve progression. within the age range for inclusion for patients with cp, the recruiting clinician will make a clinical judgement on whether the patient is able to lie still long enough to undertake the idxa, before inviting the patient to take part. exclusion criteria: * parents unable to understand the study procedures. * patients unable to lie still for 1-2 minutes

Keywords: scoliosis juvenile scoliosis adolescent scoliosis
a study to collect information of people with narcolepsy in spain

Conditions: Narcolepsy

Summary: this study aims to review information of people with a sleep condition called narcolepsy. narcolepsy is a condition that causes extreme sleepiness during the day including falling asleep suddenly. study doctors will review the medical records of the participants from sleep clinics in spain. they will do this from 1 year before the participant was diagnosed with narcolepsy up to the start of this study. participants will visit the sleep clinic once. during this visit, the study doctors will carry out a short medical exam. participants will also complete a few questionnaires during this visit. if participants cannot visit the clinic for any reason, the clinic staff will arrange a phone call instead.

this is a non-interventional, cross-sectional study with retrospective medical chart review conducted in public and private spanish sleep clinics, to describe the management of adult participants diagnosed with narcolepsy defined by icds-3 in real world practice. this study will enroll approximately 196 participants (137 with nt1 and 59 with nt2). participants will be enrolled in 2 cohorts: * cohort a: nt1 participants * cohort b: nt2 participants the data will be collected retrospectively through clinical records and at study visit (clinical and demographic data, and participant related outcomes \[pro\]) in an electronic case report form (ecrf). this multi-center study will be conducted in spain. the overall duration of this study is approximately 24 months. participants will attend a single visit in the participating centers. in the event of a possible outbreak of coronavirus disease 2019 (covid-19) participants will have a telepathic visits, the invitation to participate, the obtention of participant's informed consent and the collection of participant's questionnaires will be carried out remotely (by phone or via email).

Eligibility criteria:
inclusion criteria: 1. with confirmed diagnosis of narcolepsy defined by icds-3. 2. with at least 1-year follow-up with data available at the participating site after initial narcolepsy diagnosis and before study inclusion. 3. with data available at the participant site at least 1-year before first narcolepsy diagnosis. 4. capable to fulfill the study questionnaires. exclusion criteria: 1. participating in a clinical trial (less than or equal to \[\<=\] 12 months). 2. with any serious degenerative disease (alzheimer, parkinson or epilepsy) or psychiatric condition.

Keywords: drug therapy
impact of adapted physical activity on patient's recovery following allogeneic stem cell transplantation for hematological malignancy

Conditions: Haematological Malignancy

Summary: it is a study about adaptated physical activity for patients receiving a stem cell transplantation. they will benefit of 6 adaptated individuals lessons at home between 1 month and 3 months after stem cell transplantation. the study's goal is to observe if adaptated activity has an positive impact on weight loss and on life quality.


Eligibility criteria:
inclusion criteria : * patient aged 18 or more * patient with social security * patient who accept the study and sign the consent form * patient programmed for an allogenic stem cell transplantation non inclusion criteria : * patients with a guardianship * patients with a significant additional physic or mental disease exclusion criteria * patients who did not receive an allogeniac stem cell transplantation * patients still hospitalized between day 30 and day 100 after stem cell transplantation * patients who finally refuses the study * patients who develop a physical or mental incapacity to practice physical activity
hybrid procedure in patients with persistent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: in this study, the investigators therefore comparatively analyzed the mid-term results (at 1 year) including electrocardiogram, 24 hour holter monitoring, and 2 week long-term electrocardiogram of thoracoscopic ablation and rfca performed individually or as a hybrid procedure in patients with long-lasting persistent atrial fibrillation. antiarrhythmic medication, discontinuation of anticoagulation medication, and echocardiographic findings were also analyzed.

atrial fibrillation is highly associated with sudden death and stroke, requiring definitive treatment. in korea, atrial fibrillation is a common disease predicted to affect more than 5% of the population over 65 years of age and more than 10% over 80 years. totally thoracoscopic ablation has been adopted and performed successfully on february 2012 at samsung medical center for the first time in korea. more than 120 operations have been performed up to date. in korea, treatment for atrial fibrillation is still dependent on percutaneous rfca, and life-long medication and anticoagulation is needed when recurrent atrial fibrillation occurs. the investigators expected thoracoscopic ablation to be an alternative to overcome this limitation. also, thoracoscopic ablation and rfca are recently being performed simultaneously or stage by stage as a hybrid procedure, and the results are being reported. in this study, the investigators therefore comparatively analyzed the mid-term results (at 1 year) including electrocardiogram and 24 hour holter monitoring of thoracoscopic ablation and rfca performed individually or as a hybrid procedure in patients with long-lasting persistent atrial fibrillation. antiarrhythmic medication, discontinuation of anticoagulation medication, and echocardiographic findings were also analyzed.

Eligibility criteria:
inclusion criteria: 1. long-lasting persistent atrial fibrillation 2. persistent atrial fibrillation refractory to antiarrhythmic drug therapy 3. over 18 years exclusion criteria: 1. valvular heart disease of more than moderate degree 2. unresponsive ischemic cardiomyopathy 3. follow-up of over 1 year was not possible 4. warfarin was unable to be used 5. refusal of informed consent 6. left atrial thrombus

Keywords: atrial fibrillation ablation hybrid