Kornimate/medical-research-clean huggingface dataset:
expanded access study of bexxar® for low grade and transformed low-grade non-hodgkin's lymphoma

Conditions: Lymphoma, Non-Hodgkin

Summary: this is a single arm, multi-center, expanded access study of iodine i 131 tositumomab (bexxar) therapeutic regimen for patients with relapsed or refractory low-grade or transformed low-grade non-hodgkin's b-cell lymphoma. the primary objective is to make iodine i 131 tositumomab more broadly available to patients. secondary endpoints will be to obtain additional safety and efficacy information for this treatment regimen. post study drug administration follow-ups will continue for up to ten years. these will include blood-work and adverse event assessments for 13 weeks post dosing, patient response evaluations at week 13, months 6, 12, 18, 24, and long-term follow-ups every 6 months until the elapse of 5 years from the dosimetric dose and then annually thereafter through year 10. thyroid function will be monitored annually during long-term follow-up.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of low- grade nhl or transformed low-grade nhl (tumor must be cd 20 positive). * prior treatment with at least one chemotherapy regimen and have relapsed or progressed, or failed to achieve an objective response on last chemotherapy regimen. * karnofsky performance status of at least 60% and anticipated survival of at least 3 months. * absolute granulocyte of \>/= 1,500/mm3. * platelet count of \>/= 100,000/mm3, and not require sustained support of hematopoietic cytokines, or transfusion of blood products. * adequate renal function (i.e., \<1.5x upper limit of normal), and hepatic transaminases (ast \<5 times uln). * signed irb/iec-approved informed consent. exclusion criteria: * patients with a mean of \>25% of the intratrabecular marrow space involved with lymphoma. * patients who received cytotoxic chemotherapy, radiation therapy, immunotherapy, or cytokine treatment within 4 weeks prior to study entry (6 weeks for nitrosurea compounds) or who exhibit persistent clinical evidence of toxicity. * patients who have undergone stem cell or bone marrow transplant, active obstructive hydronephrosis, active infection, new york heart association class iii or iv heart disease or other serious illness that would preclude evaluation. * known hiv infection. * pregnant or nursing patients. * patients with prior malignancy other than lymphoma, except for adequately-treated skin cancer, in-situ cervical cancer, or cancer for which the patient has been disease-free for 5 years. * patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with more than 3500 cgy. * patients who received prior radioimmunotherapy, known brain or leptomeningeal metastases, hama positivity. * patients who are receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.

Keywords: expanded access study refractory low-grade non-hodgkin's lymphoma bexxar® iodine i 131 tositumomab eap relapsed low-grade non-hodgkin's lymphoma
inter-mountain project on antimicrobial resistance and therapy (impart)

Conditions: Upper Respiratory Infections

Summary: this is a four-year study, funded by the center for disease control and prevention, related to antimicrobial resistance in rural communities. the project consists of four components: a) surveillance of antimicrobial resistance, b) promotion of appropriate antimicrobial drug prescribing, c) preliminary assessment of the environmental impact of antimicrobials, and d) the development of new antimicrobial products. six rural communities in utah, and six rural communities in idaho are participating in this study. component d is being performed by investigators at harvard university, under the direction of co-investigator roger inouye.


Eligibility criteria:
inclusion criteria: * suspected upper respiratory infection patients in 12 rural communities in utah and idaho exclusion criteria: -
study of t-pred(tm) compared to pred forte(r)

Conditions: Cataract

Summary: study of t-pred(tm) compared to pred forte(r)


Eligibility criteria:
inclusion criteria: * 18 years of age exclusion criteria: * no active or adverse disease
functional mri study in healthy children engaged in aggressive behaviors

Conditions: Impulsive Aggression

Summary: the purpose of this non-interventional study is to optimize the point subtraction aggression paradigms (psap) task in typically developing children (tdc).

the psap is a behavioral aggression test used to evaluate behavioral response related to impulsive aggression. the task will be combined with functional mri to establish a reliable bold signal during testing in developing healthy subjects (8-12 years old) and, to determine the feasibility to perform the task. additionally, the levels of neurotransmitters glutamate and gaba will be measured using magnetic resonance spectroscopy (mrs).

Eligibility criteria:
inclusion criteria: healthy male or female subjects, aged 8-12 years (inclusive) at the time of screening. exclusion criteria: 1. current history of developmental, psychiatric, or neurologic disorder, including seizures (except for uncomplicated brief febrile seizures), tumor, severe head injury/traumatic brain injury, stroke, lesion, or disease. 2. known or suspected intelligence quotient (iq) \<70, diagnosis of mental retardation or cerebral palsy or speech/language disorder and history of implanted brain stimulator, vagal nerve stimulator, ventriculoperitoneal shunt, cardiac pacemaker, orthodontic braces, or implanted medication port. 3. visual and hearing (≥25 db) impairment. 4. pre-existing medical or psychological conditions that preclude being in the mri scanner (e.g., claustrophobia, morbid obesity, or marked anxiety about the procedure).
a phase 1 study to evaluate the potential drug interactions between repotrectinib and metformin, digoxin, and rosuvastatin in patients with advanced solid tumors

Conditions: Advanced Solid Tumor; Metastatic Solid Tumor

Summary: this is a phase 1 study to evaluate the potential drug-drug interaction (ddi) effect of repotrectinib on certain drug transporters in patients with advanced cancer.

this is a phase 1, open-label, fixed-sequence study to evaluate the potential drug-drug interaction (ddi) effect of repotrectinib on drug transporters (metformin, digoxin and rosuvastatin) following multiple dose administration of repotrectinib in patients with advanced cancer harboring ros1 and ntrk1 rearrangements.

Eligibility criteria:
key inclusion criteria: 1. histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary central nervous system \[cns\] tumors) that harbors a ros1 or ntrk1-3 gene fusion. 2. patient must have a documented ros1 or ntrk1-3 gene fusion determined by tissue-based local testing. 3. patients must have an eastern cooperative oncology group (ecog) performance status 0-2 (≥ 18 years). 4. protocol specified baseline hematology, liver function and kidney function laboratory values. key exclusion criteria: 1. concurrent participation in another therapeutic clinical trial. 2. symptomatic brain metastases or leptomeningeal involvement. 3. major surgery within 4 weeks of start of repotrectinib treatment. 4. clinically significant cardiovascular disease. 5. history of non-pharmacologically induced prolonged qtc interval 6. known active infections requiring ongoing treatment (bacterial, fungal, viral including human immunodeficiency virus positivity). 7. gastrointestinal disease or other malabsorption syndromes. 8. current or anticipated use of drugs that are known to be moderate or strong cyp3a inhibitors or inducers. 9. patients who have received, or are expected to receive metformin, digoxin or rosuvastatin within 14 days prior to beginning of the ddi assessment period. 10. patients who have received or are expected to receive drugs that are inhibitors of p-gp, oatp1b1, bcrp, and mate2-k within 14 days or 5 half-lives (whichever is longer) prior to beginning of the ddi assessment period until the ddi assessment period is completed.
reducing the risk of p. vivax after falciparum infections in co-endemic areas

Conditions: Malaria; Vivax Malaria; Falciparum Malaria

Summary: this study is designed as a multi-centre randomized, open label trial to compare the safety and efficacy of a high dose primaquine (pq) treatment in g6pd normal patients with p. falciparum to reduce the risk of subsequent p. vivax episodes to current standard practice of providing only schizontocidal treatment.

plasmodium vivax forms dormant liver stages that reactivate weeks or months following an acute infection. recurrent infections can be associated with a febrile illness, a cumulative risk of severe anaemia, direct and indirect mortality, and are the most important source of onward transmission of the parasite. in co-endemic areas, there is a very high risk (up to 50%) of patients representing with p. vivax malaria following treatment of p. falciparum. hence, in co-endemic regions there is a strong rationale for eradicating p. vivax hypnozoites from the liver in patients presenting with uncomplicated p. falciparum infections. the recently completed multicentre improv study compared the efficacy of a 7 day primaquine regimen (1.0 mg/kg/day for 7 days) with a 14 day regimen (0.5 mg/kg/day for 14 days). the 7 day pq regimen was non-inferior to the 14 day regimen and 5-fold more efficacious at reducing p. vivax recurrence than the control. this study is designed as a multicentre randomized, open label trial to compare the safety and efficacy of a high dose pq treatment in g6pd normal patients with p. falciparum to reduce the risk of subsequent p. vivax episodes to current standard practice of providing only schizontocidal treatment.

Eligibility criteria:
inclusion criteria: * p. falciparum mono-infection * fever (axillary temperature ≥37.5⁰c) or history of fever in preceding 48 hours * age \>1 years (≥ 18 years at the ethiopia site) * g6pd normal as defined by the biosensor (sd biosensor, rok) at ≥70% of the adjusted male median (amm) for each site * written informed consent * able to comply with all study procedures and timelines exclusion criteria: * general danger signs or symptoms of severe malaria * anaemia, defined as hb \<8g/dl * pregnant women as determined by urine β-hcg pregnancy test * breast feeding women * known hypersensitivity to any of the drugs given * regular use of drugs with haemolytic potential * blood transfusion within the last 4 months
home-based balance training in adults with multiple sclerosis

Conditions: Multiple Sclerosis; Multiple Sclerosis, MS

Summary: this single-group pretest-posttest study aims to examine the feasibility domains in response to 12 weeks of home-based balance training in persons with multiple sclerosis (ms). the feasibility domains include 1) process (e.g., recruitment, attendance, adherence rate), 2) resources (e.g., total monetary costs), 3) management (e.g., assessment time), and 4) scientific outcomes (adverse events, intervention acceptability, satisfaction, treatment effects). moreover, this study aims to evaluate physical function (i.e., balance, mobility, dual-task ability), cognitive function (i.e., cognitive processing speed, verbal memory, visuospatial memory), real-world ambulation (i.e., gait speed, gait variability, gait quantity), and self-report questionnaires (fatigue, fear of falling, walking disability, dual-tasking difficulty). our proposed intervention is expected to deliver a feasible and accessible exercise modality for balance and cognitive improvement in persons with multiple sclerosis.

acknowledging the complex system of balance, this home-based balance training aims to address comprehensive balance control components, such as static balance, limit of stability, postural response (reactive balance), anticipatory postural transition, weight shifting, stability in gait, and stepping exercise. these balance components will be encompassed in every session to train balance function comprehensively. exercise program will be progressed by varying sensory integrations, base of support, and simultaneous motor-cognitive tasks (i.e., dual-task).

Eligibility criteria:
inclusion criteria: * physician-diagnosed ms * ages 18-75 years * patient determined disease steps (pdds) scale score between 2-5 (i.e., gait disability-late cane) * able to participate in exercise (i.e., one or fewer affirmatives on the physical activity readiness questionnaire (par-q+)) * have a webcam on a device at least the size of a full tablet (i.e., larger than a smartphone) * have an exercise supporter (e.g., spouse or family member) who is willing to participate in the intervention * not currently participating in any balance-related exercise program exclusion criteria: * cognitively unable to read and sign informed consent form and follow verbally delivered screening assessment * unable to communicate in english

Keywords: balance training home-based exercise
dose effects of scf on calcium metabolism and gi microflora in adolescents

Conditions: Osteoporosis

Summary: soluble corn fiber (scf) has been shown to enhance calcium utilization and bone properties in rats and in adolescent boys and girls.

the growing knowledge of non-digestible oligosaccharide (ndo)-related health benefits has led to the identification of other fermentable carbohydrates which may improve bone balance and bone health parameters. one such carbohydrate is the corn derivative, soluble corn fiber (scf). already known for its association with improved intestinal health and influence on colonic microflora content, we have been studying the effects of scf on calcium absorption and bone health. first we found that soluble corn fiber (scf) greatly enhanced calcium utilization and bone properties in a growing rat model. results from this study demonstrated that scf was capable of increasing bone mineral content, density and bone strength parameters in 4-week old, male rats. our study in adolescent boys and girls showed a 12% increase in calcium absorption after consuming 12 g scf for 21 days compared to a control period in a crossover design using a controlled feeding metabolic balance approach. given these profound changes on calcium absorption and in bone, a logical next step is to study a dose-response effect of scf on calcium absorption, bone turnover, and gut microflora in free-living adolescents.

Eligibility criteria:
inclusion criteria: * healthy adolescent caucasian girls between the ages of 12-14. this population has been chosen because they exhibit higher risk for osteoporosis later in life. exclusion criteria: * habitual dietary patterns including less than 550 and greater than 1500 mg ca per day. this represents the 5th and 95th percentile of usual intake of girls 9-13 y in the us. * history of smoking, alcohol use, illegal or non-prescription drug use * history of disordered calcium or bone metabolism e.g. paget's disease, hyper or hypo-calcemia * history of gastrointestinal diseases (crohn's, celiac, inflammatory bowel disease) * history of diseases that affect kidney or liver function. * body mass index (bmi) less than 5th percentile for age or greater than the 90th percentile for age * having a broken bone within the last 6 months. * regular consumption of foods or supplements containing prebiotics or probiotics * history of pregnancy or use of contraceptives

Keywords: calcium absorption osteoporosis bone health adolescent
strategies for musculoskeletal symptoms relieving and ergonomy in operating room

Conditions: Musculoskeletal Pain; Surgery

Summary: it is well known that surgery requires not only a mental diligence, but also a real physical stress due to the need to assume particular postures for many hours or to repeat specific maneuvers several times. to this peculiar condition of surgical specialities over the years has been added the development of a series of instruments and technologies ranging from the use of loopes, to laparoscopic and robotic surgery. from the studies reported in the literature, between 74% and 87% of surgeons report symptoms related to their work with consequent effects on the quality of life (sleep loss, inability to carry out their recreational activities, etc.). similarly, a lack of knowledge of the principles of ergonomics to be applied during the performance of one's surgical activity emerged, which could improve musculoskeletal symptoms with a positive effect on the quality of life of surgeons and consequently hoping for an improvement in professional performance.


Eligibility criteria:
inclusion criteria: * young surgeons exclusion criteria: * no consent to partecipate

Keywords: musculoskeletal pain; ergonomics; surgery
freedom - m: oral treprostinil as monotherapy for the treatment of pulmonary arterial hypertension (pah)

Conditions: Pulmonary Hypertension

Summary: this study was an international, multicenter, randomized (2:1 active:placebo), double-blind, placebo-controlled study in subjects with pah who were not currently receiving approved therapy for their pah. study visits occurred at 4 week intervals for 12 weeks (with an additional visit at week 11) with the key measure of efficacy being the 6-minute walk test. study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. two optional substudies were also a part of freedom-m at select centers - a hemodynamic substudy with a right heart catheterization at baseline and week 12 and a genetics and biomarkers substudy with blood samples collected at baseline and week 12. patients who completed all assessments for 12 weeks were also eligible to enter an open-label, extension phase study (freedom - ext).


Eligibility criteria:
inclusion criteria: * between 12 and 75 years of age, inclusive. * body weight at least 40 kg with a body mass index \< 45 * pah that is either idiopathic/heritable; associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular disease; associated with hiv. * previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of pah. * baseline 6-minute walk distance between 200 and 425 meters, inclusive. * reliable and cooperative with protocol requirements. exclusion criteria: * nursing or pregnant. * currently receiving an endothelin receptor antagonist, a phosphodiesterase-5 inhibitor, or prostacyclin within 30 days of baseline. * pah due to conditions other than noted in the above inclusion criteria. * history of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart disease, uncontrolled systemic hypertension, or parenchymal lung disease. * use of an investigational drug within 30 days of baseline.

Keywords: pulmonary arterial hypertension
methoxyflurane vs standard analgesic treatment for trauma pain in spanish emergency units

Conditions: Acute Pain Due to Trauma

Summary: clinical trial to compare pain relief between methoxyflurane and any analgesic treatment used in usual clinical practice, in patients with trauma and associated pain, treated in spanish emergency units.

open, randomized clinical trial to compare emergency pain relief between methoxyflurane and standard of care in patients with trauma and associated pain, treated in spanish emergency units. methoxyflurane is a fluorinated ethyl methyl ether, with the chemical name 2:2-dichloro-1:1-difluoroethyl methyl ether. it belongs to the fluorinated hydrocarbon group of volatile anaesthetics. it is inhaled as a vapour at low (sub-anaesthetic) concentrations to achieve an analgesic effect for the management of pain. in europe countries, where methoxyflurane is already marketed, it is indicated for emergency relief of moderate to severe pain in conscious adult patients with trauma and associated pain. on the other hand, current clinical practice includes a variety of analgesic agents, with the choice of which to employ based on consideration of the risk-benefit factors of each class of drug, as well as the type of pain, its severity, and the risk of adverse effects. the main objective of this study is to assess methoxyflurane's significant advantage in terms of anaglesic effectiveness, as it is known as a rapidly acting, non-narcotic analgesic for the treatment of emergency pain.

Eligibility criteria:
inclusion criteria: * adult patients: ≥ 18 years of age * moderate to severe pain (nrs 0-10; \>=4) secondary to trauma * without anticipating surgery due to the trauma, requiring hospitalization (hospital stay 12h) * conscious patient. * giving informed consent in writing exclusion criteria: * hypersensitivity to methoxyflurane (meof) or any fluorinated anaesthetic. * malignant hyperthermia: patients with known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives. * patients who have a history of showing signs of liver damage after previous meof use or halogenated hydrocarbon anaesthesia * known clinically significant renal impairment * known pregnant or likely to be pregnant women at the time of inclusion. * clinically evident cardiovascular instability * clinically evident respiratory depression * patients taken any analgesic for the traumatic pain before inclusion * altered level of consciousness due to any cause, including head injury, drugs or alcohol * degenerative diseases, mental illness or other conditions that could affect ability of valuing pain intensity * patients to be unable to understand the purpose of the study and perform self-assessments, following investigator's criteria. * participation in another clinical trial within 30 days prior to randomization

Keywords: methoxyflurane emergency trauma pain inhaled analgesia
open label extension study of epratuzumab in japanese systemic lupus erythematosus (sle) subjects

Conditions: Systemic Lupus Erythematosus

Summary: the study is an open-labeled extension study to continue to assess the safety and tolerability of epratuzumab in moderate to severe sle subjects who have previously participated in sl0026 \[nct01449071\] phase i/ii trial.


Eligibility criteria:
inclusion criteria: * subject has completed the double-blind study sl0026 \[nct01449071\] or terminated prematurely at week 8 or later in sl0026 \[nct01449071\] due to lack of efficacy * women of childbearing potential must agree to use an acceptable method of birth control/written informed consent exclusion criteria: * subjects with active, severe sle disease activity which involves the renal system and active, severe, neuropsychiatric sle, defined as any neuropsychiatric element scoring british isles lupus assessment group index (bilag) level a * subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections * substance abuse or dependence * significant hematologic abnormalities * history of malignant cancer * subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion

Keywords: lupus monoclonal antibody b-cell immunotherapy epratuzumab