Kornimate/medical-research-clean huggingface dataset:
a study comparing pre- and post-change teclistamab in participants with relapsed or refractory multiple myeloma

Conditions: Relapsed or Refractory Multiple Myeloma

Summary: the purpose of this study is to compare the pharmacokinetics (processes by which drugs are absorbed, distributed in the body, and excreted) between teclistamab made from the current commercial manufacturing process (pre-change) and the new manufacturing process (post-change).


Eligibility criteria:
inclusion criteria: * documented diagnosis of multiple myeloma as defined by the criteria below: (a) multiple myeloma diagnosis according to international myeloma working group (imwg) diagnostic criteria (b) measurable disease at screening as defined by any of the following: (1) serum m-protein level greater than or equal to (\>=) 0.5 grams per deciliter (g/dl) (central laboratory); or (2) urine m-protein level \>=200 milligrams (mg)/24 hours (central laboratory); or (3) serum immunoglobulin free light chain \>=10 milligrams per deciliter (mg/dl) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio * received 1 to 3 prior lines of antimyeloma therapy, including a minimum of 2 consecutive cycles each of a protease inhibitor (pi), lenalidomide, and an anti-cluster of differentiation 38 (cd38) monoclonal antibody (or minimum of 6 doses if anti cd38 monoclonal antibody was only part of a maintenance regimen) in any prior line * documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by imwg criteria * have an eastern cooperative oncology group (ecog) performance status score of 0 to 2 * a female participant of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study exclusion criteria: * received any bispecific antibody and/or chimeric antigen receptor t cell (car-t) cell therapy * contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients * received a live, attenuated vaccine within 4 weeks before the first dose of study drug. non-live or non-replicating vaccines authorized for emergency use by local health authorities are allowed * central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma. if either is suspected, negative whole brain magnetic resonance imaging (mri) and lumbar cytology may be required * participant had major surgery or had significant traumatic injury within 2 weeks prior to randomization, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study

Keywords: 1-3 prior lines
a pilot study to determine a candidate protocol for transcranial electrical stimulation in the treatment of anxiety

Conditions: Anxiety

Summary: the investigators examine the efficacy of two different transcranial direct current stimulation (tdcs) stimulation protocols in the treatment of anxiety in an open-label pilot study.

the investigators examine the efficacy of two different transcranial direct current stimulation (tdcs) stimulation protocols in the treatment of anxiety in an open-label pilot study in patients with chronic pain. the investigators also seek to detect autonomic nervous system changes induced by the tdcs, and develop new methods for the measurement of autonomic nervous system functions.

Eligibility criteria:
inclusion criteria: * age 18-65 years * naïve to tdcs * right-handed * beck anxiety scores \>= 26 exclusion criteria: * metal implants inside skull or eye * severe skin lesions at the electrode placement area * history of epilepsy or previous seizures * pregnant or breast-feeding * pacemaker * history of intracerebral bleeding during the past six months * lifetime dsm-iv diagnosis of bipolar mood disorder or psychotic disorder * dsm-iv diagnosis for substance abuse or dependence during the past six months
start: enhancing speech treatment with smartphone-delivered biofeedback

Conditions: Speech Sound Disorder

Summary: previous research suggests that biofeedback can outperform traditional interventions for rse, but no controlled studies have tested this hypothesis in the context of app-delivered biofeedback. the objective of this aim is to use the start app to test our working hypothesis that speakers will make larger gains in /r/ accuracy when app-based treatment incorporates biofeedback, compared to a non-biofeedback condition. with a network of cooperating slps, this project will recruit 15 children with /r/ misarticulation to receive 8 weeks of intervention using start. individual sessions will be randomly assigned to include or exclude the visual biofeedback display. randomization tests will be used to evaluate, for each individual, whether larger increments of change are associated with biofeedback and non-biofeedback sessions.


Eligibility criteria:
inclusion criteria: * normal performance on a pure-tone hearing screening at 20 db hl, a screening examination of oral-motor structure and function, and a test of receptive language. exclusion criteria: * history of major behavioral, neurological, or hearing impairment, per parent and/or slp report.

Keywords: speech articulation motor development
slow-wave sleep deprivation in depression

Conditions: Major Depressive Disorder

Summary: sleep deprivation can acutely reverse depressive symptoms in patients with major depression. although underlying mechanisms of the antidepressant action in sleep deprivation are unclear, many of these observations can be explained by abnormal slow wave homeostasis. this study will test the prediction that selectively reducing slow waves during sleep (slow wave deprivation; swd), without disrupting total sleep time, will yield an antidepressant effect.

see above

Eligibility criteria:
inclusion criteria: * among the inclusion criteria will be: * age range 18-35 years * right handedness * major depressive disorder according to dsm-iv (diagnostic and statical manual-revision 4) criteria (as determined by the structured clinical interview for diagnostic and statical manual-revision 4), with hamilton rating scale for \*depression scores of at least 18 on the first 17 items * no psychotropic medications for at least 4 weeks * no joint and muscular di * normal hearing * regular bedtimes and sleep duration, no time zone shifts in the last three weeks. exclusion criteria: * diabetes requiring insulin treatment * a serious heart disorder or subjects who have had a heart attack within the last 3 months * a diagnosis of cancer in the past 3 years and/or has active neoplastic disease * clinically significant abnormalities on pre-study physical exam or physician evaluation * subjects who meet dsm-iv (diagnostic and statical manual-revision 4) criteria for alcohol/drug abuse problems within the last six months or are currently using illegal drugs. * female subjects of child-bearing potential who are pregnant or planning to become pregnant. * women of child-bearing must be practicing a medically acceptable form of birth control. * women of childbearing potential will be questioned about pregnancy status and form of birth control to be used at each visit. * women who are unsure of their pregnancy status will be given a urine pregnancy test. * subjects taking investigational medications * subjects currently undergoing electroconvulsive therapy (ect) or therapeutic transcranial magnetic stimulation (tms). * subjects who regularly perform night or late evening shift work (e.g. - "second" or "third" shifts) or have had travel with time zone shifts \>3h in the last 3 weeks
a study of bupivacaine liposome injection in local analgesia of pediatric patients

Conditions: Local Analgesia Via Infiltration

Summary: the study is being conducted to evaluate the safety and efficacy of bupivacaine liposome injection for local infiltration analgesia in pediatric orthopedic surgery in the real world.


Eligibility criteria:
inclusion criteria: 1. subjects and guardians are willing to sign the informed consent. 2. subjects undergoing orthopedic surgery under general anesthesia with expected cumulative incision length≥3cm. 3. 6 years old ≤ age ≤17 years old , male or female. 4. asa physical status classification i-iii. exclusion criteria: 1. subjects received liposomal bupivacaine or bupivacaine hydrochloride within the past 30 days; 2. subjects with a history of immunodeficiency diseases (such as congenital immunodeficiency disease, aids or malignant tumors) or received immunosuppressants within 30 days; 3. subjects with comorbid mental diseases (such as schizophrenia, depression, etc.) or difficult to communicate; 4. subjects with a history of chronic pain or visceral pain; 5. subjects with abnormal liver and kidney function; 6. subjects with clinically significant abnormal heart rate or rhythm; 7. subjects who are participating or planning to participate in any interventional clinical trial; 8. the investigators determined that other conditions were inappropriate for participation in this clinical trial.
back rubs or foot flicks for neonatal stimulation at birth in a low-resource setting

Conditions: Neonatal Resuscitation

Summary: physical stimulation is the most common intervention during neonatal stabilization/resuscitation at birth and is recommended by neonatal resuscitation guidelines in high as well low-income settings. two modalities of stimulation (back rubs or foot flicks) are recommended. this is a single center, unblinded, randomized superiority trial. immediately after birth, all "not crying" infants will be randomly assigned in a 1:1 ratio to two different modes of stimulation (back rubs or foot flicks). exclusion criteria will be stillbirths and presence of major neonatal malformations. the primary outcome measure will be the need for fmv. secondary outcome measures will include apgar score at 5 minutes, time of initiation and duration of fmv, time to first cry (defined as the first audible cry spontaneously emitted by the infant), death or moderate to severe hypoxic-ischemic encephalopathy within 7 days of life or at discharge, admission to special care, and procedure-associated complications. the results of the present study will help to identify the most appropriate mode for stimulating the apneic newly infants in delivery room. in clinical practice, this information is very relevant because effective stimulation at birth will elicit spontaneous respiratory in a certain percentage of apneic neonates avoiding the need for positive pressure ventilation and, possibly, further advanced resuscitative maneuvers.


Eligibility criteria:
inclusion criteria: 1. newly born infants who are apneic (not crying) immediately after birth (and) 2. expected birthweight \> 1500 g (and) 3. parental consent exclusion criteria: 1. still births 2. twins 3. major congenital malformations (i.e. congenital cardiac malformation, pulmonary hypoplasia, major spina bifida, etc.)

Keywords: neonatal resuscitation stimulation asphyxia
the clinical role of intravenous glutamine in trauma patients receiving enteral nutrition

Conditions: Multiple Trauma; Critically Ill

Summary: the purpose of this trial is to investigate if pharmacologically safe dose intravenous glutamine dipeptide supplementation to multiple trauma patients receiving enteral nutrition is associated with improved clinical outcomes in terms of decreased organ dysfunction, infectious complications, and other secondary outcomes

trauma patients are characterized by alteration in the immune response, increased exposure to infectious complications, sepsis, and consequently organ failure and death. glutamine supplementation to parenteral nutrition is one of the nutritional interventions that have been proven to be associated with improved survival rate, decreased infectious morbidity, costs, intensive care unit, and hospital length of stay. however, glutamine supplementation in patients receiving enteral nutrition and its best route are still controversial. a number of trials investigated the beneficial effects of intravenous alanyl-glutamine supplementation in critically ill patients receiving enteral nutrition. however, these trials were: pilot trials, investigated surrogate outcomes, or supplementation was for a short period of time. therefore, a well designed trial is needed to investigate the effect of intravenous alanyl-glutamine supplementation in critically ill patients with multiple trauma receiving enteral nutrition on major clinical outcomes. our hypothesis is that trauma patients receiving standard enteral nutrition supplemented with intravenous alanyl-glutamine will demonstrate improved clinical outcomes compared to patients receiving standard enteral nutrition without supplementation.

Eligibility criteria:
inclusion criteria: * age 18-58 years * patients admitted with a diagnosis of multiple trauma requiring enteral feeding for \> 48 hours * expected length of stay in icu \> 48 hours * has a functional access for enteral tube feeding and a central access for administration of test solution * negative beta hcg (pregnancy test) in females (18-60 years) exclusion criteria: * age \< 18 years * significant hepatic failure (patients with childs c cirrhosis) * severe renal failure (estimated glomerular filtration rate \[egfr\] \< 50 ml/min) * patients with severe metabolic acidosis (ph \<7.35) * not expected to be in the icu \> 48 hours (due to imminent death) * unable to tolerate enteral nutrition within 72 hours * enrolment in other icu intervention study if contraindicated * patients in whom parenteral nutrition is required from the outset * absolute contraindication to enteral nutrition

Keywords: glutamine trauma alanyl-glutamine
insignia™ hip stem outcomes study

Conditions: Hip Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis; Post-traumatic Osteoarthritis; Femoral Neck Fractures; Trochanteric Fractures; Surgery

Summary: the objective of this study is to evaluate the safety and effectiveness of the insignia™ hip stem for global market access and post-market clinical follow-up up to 10 years postoperative.

this study is a prospective, post-market, multi-center clinical investigation of the insignia™ hip stem for primary and revision total hip arthroplasty (tha) in a consecutive series of patients who meet the eligibility criteria. the total enrollment goal for the study is a minimum of 313 cases, all of which will receive the insignia™ hip stem.

Eligibility criteria:
inclusion criteria: * the subject has signed an institutional review board (irb)-approved, study specific informed consent form (icf). * the subject is skeletally mature * the subject has a diagnosis as listed in the instructions for use (ifu), which include non inflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis, correction of functional deformity, treatment of nonunion, femoral neck and trochanteric fractures. * the subject is a candidate for a primary or revision cementless tha. * the subject is willing and able to comply with postoperative scheduled clinical evaluations. exclusion criteria: * the subject is pregnant or breastfeeding * the subject has an active or suspected latent infection in or about the affected hip joint at the time of study device implantation. * the subject has any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care. * the subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis. * the subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days). * the subject has a known sensitivity to device materials. * the subject is involved in any ongoing legal matter, investigation, or dispute pertaining to the operative site. * the subject is a prisoner.
a placebo-controlled trial to evaluate the safety and efficacy of galantamine in the treatment of vascular dementia

Conditions: Dementia, Vascular

Summary: this is a trial to evaluate the safety and effectiveness of galantamine in patients with dementia secondary to blood vessel disease in the brain.

in a previous 6-month study in patients with both vascular dementia and alzheimer's dementia, galantamine demonstrated positive results on thinking, functioning, behavior, speech and overall well being of patients, and prevented the behavior symptoms of dementia from appearing. this combined study consists of two almost identical 26-week studies that examine the same criteria as the previous study, but in a larger patient population (dementia has been identified as having been caused by blood vessel disease without alzheimer's disease). the study starts with a 4-week period in which current medications for dementia are withdrawn followed by a 26-week double-blind treatment period when patients will receive either placebo or galantamine 8 milligrams or 12 milligrams twice a day. effectiveness will be measured by changes in scores on the alzheimer's disease assessment scale cognitive subscale, alzheimer's disease cooperative study scale, the clinician's interview-based impression of change plus, and the neuropsychiatric inventory, as well as (in english-speaking countries only) a 10-minute interview of the patient (exit-25 scale). safety will be evaluated throughout the study based on the incidence and severity of unexpected events, laboratory and physical tests, and vital signs. the hypothesis of the study is that galantamine will improve thinking, function, behavior, speech, and overall well being, better than placebo. a voluntary pharmacogenomic study will be incorporated into the study plan to evaluate whether specific genes are related to the dementia or drug response. 8 milligrams (mg) 2 times a day for 8 weeks, then increasing to12 mg, if tolerated. after 12 weeks dose can be reduced to 8 mg or matching placebo

Eligibility criteria:
inclusion criteria: * diagnosed with vascular dementia per ninds-airen criteria * radiologic evidence of vad on mri * clinical evidence of vad (ie focal signs) * onset of dementia between ages 40 and 90 years * ability to read, write, communicate, and understand cognitive testing instructions * no uncontrolled medical conditions exclusion criteria: * presence of other diseases or disorders that could cause loss of mental functioning (such as trauma, cancer, infections, mental retardation) * current significant cardiovascular disease that could limit the patient's ability to complete the study * major psychiatric diseases * peptic ulcer or significant urine outflow obstructions * seizures * other serious diseases * history of drug or alcohol abuse within the past year

Keywords: dementia vascular dementia cerebral vascular disease
multicentre trial to evaluate the safety and efficacy of cp-316,311 in major depressive disorder

Conditions: Depressive Disorder, Major

Summary: a six week, fixed dose, double-blind, double-dummy, placebo, and active controlled, multicentre trial to evaluate the safety and efficacy of cp-316,311 in outpatients with major depressive disorder.

this study was terminated on march 17th, 2006. the results of the primary analysis at the interim showed that the cp-316,311 group was not significantly different than the placebo on the primary endpoint and therefore the data monitoring committee recommended termination of the trial. the decision to terminate the trial was not based on any safety concerns.

Eligibility criteria:
inclusion criteria: * outpatients with dsm-iv major depressive disorder exclusion criteria: * women of child bearing potential

Keywords: major depressive disorder, recurrent
reverse total shoulder arthroplasty versus hemiarthroplasty for displaced 3- and 4-part proximal humeral fractures

Conditions: Humeral Fracture, Proximal

Summary: proximal humeral fractures are common injuries with the highest incidence being amongst the elderly. most proximal humeral fractures are nondisplaced or minimally displaced. the majority of these are reliably treated nonoperatively with an acceptable functional outcome. the treatment of displaced fractures is more controversial. consensus is lacking as to when surgery is indicated or what type of procedure to choose if surgery is elected. displaced 3- and 4-part fractures where internal fixation is deemed unreliable have been considered an indication for hemiarthroplasty. hemiarthroplasty gives reasonable control of pain but the resulting shoulder function and range of motion is unpredictable. the use of reverse total shoulder arthroplasty is increasing and might result in a better range of motion then hemiarthroplasty. the aim of this multicenter study is to test the hypothesis that reverse total shoulder arthroplasty gives better shoulder function than hemiarthroplasty for displaced 3- and 4-part proximal humeral fractures.


Eligibility criteria:
inclusion criteria * displaced 3- or 4-part fracture of the proximal humerus * age over 70 years * independent living * low energy trauma exclusion criteria * pre-existing shoulder disease * severe cognitive dysfunction * more than 14 days from injury to surgery * comorbidity that affects shoulder rehabilitation considerably * concurrent injury that affect shoulder rehabilitation considerably

Keywords: humeral fracture, proximal arthroplasty, replacement, shoulder reverse total shoulder arthroplasty shoulder hemiarthroplasty
near-continuous, noninvasive blood pressure monitoring to improve outcomes in pediatric transport

Conditions: Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)

Summary: a randomized controlled trial compared the clinical outcomes of transported pediatric patients monitored with an oscillometric blood pressure device versus those monitored with a near-continuous, noninvasive blood pressure.

94 transported patients were randomized to a control arm, monitored with a standard oscillometric blood pressure device (dinamap), or an experimental arm, monitored with a near-continuous, noninvasive blood pressure device (vasotrac).

Eligibility criteria:
inclusion criteria: 1. pediatric patients transported by angel one to arkansas children's hospital. 2. age group: 1 year - 17 years and 3. patients at risk of developing sirs (systemic inflammatory response syndrome), according to the criteria below. i. the presence of at least two of the following four criteria (one of which must be abnormal temperature or leukocyte count): a. core temperature of \>38.5 c or \ 95th percentile for age in absence of external stimulus, chronic drugs, or painful stimuli. c. mean respiratory rate \>95th percentile for age, or \>10% immature neutrophils. or 4. patients with moderate or severe head trauma, at risk of developing secondary ischemic brain injury, according to the criteria below. i. glasgow coma scale \<15 with one or more of the following: a. mass lesion or cerebral edema on ct or mri scan. b. post-traumatic seizure. c. multiple trauma. d. focal neurologic signs. e. intubation for control of suspected intracranial hypertension. - exclusion criteria: 1. wrist circumference less than 11cm (minimum size for the vasotrac device). 2. contractures of the wrists, not allowing correct placement of the vasotrac device. 3. hematoma(s) located on both wrists from recent redial (\<24hr) artery puncture. 4. patients likely to proceed to brain death per assessment of the referring physician. 5. patients being treated for malignant hypertension.