Kornimate/medical-research-clean huggingface dataset:
sc versus iv isatuximab in combination with pomalidomide and dexamethasone in rrmm

Conditions: Plasma Cell Myeloma Recurrent

Summary: this is a randomized, multicenter, phase 3, open-label study evaluating subcutaneous (sc) vs intravenous (iv) administration of isatuximab in combination with pomalidomide and dexamethasone (pd) in rrmm patients (study participants) who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (pi). eligible participants will be randomized 1:1 into 1 of 2 study arms: arm sc: isatuximab sc + pd arm iv: isatuximab iv + pd participants will be allowed to continue therapy until disease progression, unacceptable adverse events (aes), participant request to discontinue therapy or any other reason, whichever comes first.

two study arms will be treated in 4-week cycles until disease progression, unacceptable adverse events (aes), participant request to discontinue therapy or any other reason, whichever comes first.

Eligibility criteria:
inclusion criteria: * participants with multiple myeloma who have received at least one prior line of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor given alone or in combination. * measurable serum m-protein (≥ 0.5 g/dl) and/or urine m-protein (≥ 200 mg/24 hours) and/or serum free light chain (flc) assay (involved flc assay ≥10 mg/dl and abnormal serum flc ratio (\ 1.65)). exclusion criteria: * primary refractory multiple myeloma participants * participants with prior anti-cd38 treatment: (a) administered less than 9 months before randomization or, (b) intolerant to the anti-cd38 previously received * prior therapy with pomalidomide * participants with inadequate biological tests. * significant cardiac dysfunction * participants diagnosed or treated for another malignancy within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy * concomitant plasma cell leukemia * active primary amyloid light -chain amyloidosis * known acquired immunodeficiency syndrome (aids)-related illness or known human immunodeficiency virus (hiv) disease requiring antiviral treatment * know active hepatitis a infection. current active or chronic hepatitis b (hbv) or hepatitis c (hcv) infection. participants with chronic hbv or hcv disease that is controlled under antiviral therapy are allowed. * women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
general anesthesia management in 15 preterm infant

Conditions: Anesthesia Management of Premature Infants

Summary: anesthesia management of preterm infants is challenging for the anesthesiologist. because of rudimentary build, many medical and physical problems have shown in treatment of disease such as complications, airway problems, temperature disregulation and deficient drug metabolism. this retrospective study evaluates the perioperative management and postoperative course in premature infants undergoing diode laser photocoagulation (dlp) for retinopathy of prematurity (rop).

participants retrospectively investigate clinical data and anesthesia process of 15 preterm infant from anesthesia charts with rop who underwent dlp between 2014 and 2016. this presented retrospective study was confirmed by the institutional clinical research ethics board. neonates burns under 30 weeks gestation and low birth weigh under 2000 g were admitted to the study. no infant were excluded from the study. preterm infants were appreciated before surgery and informed consent was obtained form their parents. we recorded gestational age, american society of anesthesiologists (asa) physical status scores, post-conceptual age, weight at birth and surgery, duration of anesthesia and surgery, blood glucose values at surgery, the management of airway, total hospital stay period, analgesia management, complications and comorbidities. bradycardia ( \<90 beats/mean), desaturation (spo2 \<90%) and arrhythmia were recorded. electrocardiography (ecg), pulse oximetric saturation (spo2), end-tidal carbon dioxide pressure, heart rate (hr) and body temperature were monitored in operating room. topical 0.5% proparacaine eye drops were administered to all infants routinely. anesthesia was induced with thiopental 6 mg kg-1 and fentanyl 1 µg kg-1 and it was maintained with 50% oxygen 50% air 1%-3% sevoflurane in all cases. inhaled anesthetic agent was not preferred for induction of anesthesia because of causing hypotension. the premature infants were intubated by same experienced anesthesiologist. in all infants, were intubated the patients without muscle relaxant under spontaneous ventilation. perioperative complications, blood glucose value, devices in airway management and extubation value were recorded. after surgery, extubation was performed when spontanea ventilation was enough and extubation was recorded. all infants were taken to newborn intensive care unit (nicu). data are reported as mean ± standard deviation and percentage(%).

Eligibility criteria:
inclusion criteria: * all preterm infants who was decided to apply rop exclusion criteria: * no patient was excluded
a safety and efficacy study of multiple administration regimens for nivolumab plus ipilimumab in subjects with melanoma

Conditions: Melanoma

Summary: this is a safety and efficacy study of different administration regimens of nivolumab plus ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * males and females, ages 15 years ≥ of age (except where local regulations and/or institutional policies do not allow for subjects \< 18 years of age to participate) * subjects must have been diagnosed with stage iii or/and stage iv histologically confirmed melanoma that is unresectable or metastatic * eastern cooperative oncology group (ecog) performance status of 0-1 * subjects have not been treated by systemic anticancer therapy for unresectable or metastatic melanoma exclusion criteria: * subjects with active brain metastases or leptomeningeal metastases * subjects with ocular melanoma * subjects with active, known or suspected autoimmune disease other protocol defined inclusion/exclusion criteria could apply
proton beam radiation therapy in treating patients with retroperitoneal sarcoma

Conditions: Adult Soft Tissue Sarcoma

Summary: rationale: specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue in patients with retroperitoneal sarcoma. purpose: this phase i trial is studying the side effects and and best dose of proton beam radiation therapy in treating patients with retroperitoneal sarcoma.

detailed descriptionprimary objectives: i. to determine the feasibility and toxicity of proton radiotherapy for retroperitoneal sarcomas. ii. to determine the maximum safe proton radiotherapy dose for retroperitoneal sarcomas. iii. to determine the maximally tolerated dose of proton radiotherapy for patients with potentially resectable retroperitoneal sarcoma. (pre-operative cohort) iv. to assess acute side effects from irradiation using proton beam therapy and dose/volume constraints that are derived from conventional radiotherapy. (postoperative cohort) secondary objectives: i. to assess the clinical effectiveness of proton radiotherapy for retroperitoneal sarcoma. ii. to determine the long-term toxicity of proton radiotherapy to the abdomen and pelvis region. iii. to monitor for effects of proton treatment on tumor and normal tissues using radiographic imaging (both cohorts) or ex-vivo analysis of tissue samples (preoperative cohort only).

Eligibility criteria:
inclusion criteria: * patients with a histologic diagnosis of sarcoma in the peritoneum/retroperitoneum/pelvis are eligible for this study * patients must have either radiographic(pre-operative) or pathologic (post-operative) evidence of disease limited the peritoneum/retroperitoneum/pelvis without evidence of peritoneal sarcomatosis * for pre-operative cases, the patient must be considered operable/resectable as judged by the attending surgeon (this is determined by an extensive radiographic and medical evaluation that includes but is not limited to: ct chest and abdomen with contrast, mri/ct brain and medical/cardiac clearance) * patients should have an egoc status of 0-2 * patients must sign a document that indicates that they are aware of the investigative nature of the treatment of this protocol, and the potential benefits and risks (patients unwilling or unable to sign informed consent are excluded from the study) * women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, iud, condoms or other barrier methods etc.); hysterectomy or menopause must be clinically documented exclusion criteria: * prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma) * pregnant women, women planning to become pregnant and women that are nursing * patients who experience surgical complications that prevent radiation from starting for 5 months or more, unless there is evidence of gross residual disease
tranexamic acid in reducing gross hemorrhage and transfusions of spine surgeries

Conditions: Spinal Stenosis; Intervertebral Disc Displacement

Summary: multilevel decompression and bone graft fusion is a most effective measure for treating degenerative lumbar spinal diseases. yet, the surgery is commonly associated with large amount of perioperative blood loss and high demand for homologous blood transfusion. tranexamic acid (txa) has been proved as efficient in reducing the gross blood loss in various kinds of surgeries. however, high quality evidence of its efficacy and safety is still lacking in lumbar spinal surgeries. besides, systemic use of txa carries the risks of thromboembolic complications such as deep venous thrombosis and pulmonary embolism, thus the optimal drug delivery route of txa remains undetermined. the aim of this study is to test the non-inferiority of topical txa application to its intravenous use in multilevel decompression and bone graft fusion surgeries. a prospective, randomized, double-blind, head-to-head comparison study design will be adopted.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists(asa)classification of physical status i-ii. * aged over 50yrs. * patients suffering from spinal stenosis or intervertebral disc displacement and require multilevel decompression and bone graft fusion surgeries. * written informed consent. exclusion criteria: * asa iii-iv. * age≤ 50yrs. * history of chronic renal dysfunction (preoperative blood creatinine\> 120mmol/l), liver dysfunction (preoperative blood aspartate or alanine aminotransferase\> 50 units/l) or history of coronary artery disease with stent placement. * abnormal preoperative coagulation profile (preoperative prothrombin time elongation\> 3s, activated partial thromboplastin time elongation\> 10s, platelet counts\ 400\*10\^9/l, or inr\> 1.4). * pre-existing anemia (male\< 12g/dl, female\<11g/dl). * long-term medications of aspirin and/or other anticoagulants. * patients known as allergic to txa. * patients who have religious and/or other beliefs limiting blood transfusion. * dura mater laceration and/or unexpected massive bleeding during operation. * cell saver application during operation.
a 12-week study comparing pitavastatin 4 mg vs. pravastatin 40 mg in hiv-infected subjects

Conditions: Dyslipidemia

Summary: a 12-week, randomized, double-blind, active-controlled, parallel-group study.


Eligibility criteria:
inclusion criteria: * males and females (non-pregnant, non-lactating females) 18-70 years of age, inclusive, at time of consent. * both men and women of child bearing potential (i.e., not surgically sterile or post-menopausal defined as age \>40 years without menses for ≥2 years) must agree to use at least 2 reliable forms of contraception * documented hiv infection. exclusion criteria: * homozygous familial hypercholesterolemia * any conditions that may cause secondary dyslipidemia * history of coronary artery disease (cad) or cad equivalent
approach to dance for autism

Conditions: Autism Spectrum Disorder

Summary: this study will be a randomized trial that will examine the impact of a recreational ballet program on children with autism spectrum disorder (asd). the research team are primarily interested in assessing changes in motor skills with secondary objectives focused on the social, psychological, and behavioral effects. the study will aim to collect data from 24 participants with asd. participants must be 7-12 years old, have a confirmed diagnosis of asd, and speak english or spanish. all participants will be enrolled in a 12 week ballet program. the ballet program is based off the curriculum and structure of ballet for all kids, a non-profit organization that has been tailoring ballet classes for children with asd for over one decade. all research team members and volunteers will be trained in the bfak program's curriculum and structure. ballet instruction and all research materials will be provided in both english and spanish. the research team will randomize the sample into an intervention group and waitlist control. the research team will measure outcomes through validated self-reports that caregivers will complete. for the intervention group, questionnaires will be completed at baseline and throughout the intervention (weeks 4, 8, and 12). for those in the waitlist control group, questionnaires will be completed at baseline, throughout the intervention group's ballet classes, and throughout their own participation in the program. results of this study will help to determine if how a recreational ballet program can impact the motor, psychological, social, and behavioral skills of a child with asd, informing the direction of future research and interventions.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of autism spectrum disorder * fluent in english or spanish * between 7-12 years old exclusion criteria: * for any reason the individual appears unable to participate in study procedures per the principal investigator * not fluent in english or spanish * unable to commit to at least 8 of the 12 scheduled intervention sessions

Keywords: ballet autism motor recreational children dance
surgical treatment of symptomatic neuroma "stop neuroma"

Conditions: Neuroma

Summary: this study is conducted to clinically assess safety and performance of the polyganics nerve capping device for the treatment of symptomatic neuroma. there is sufficient clinical experience with regard to the safety of the commercially available nerve guide, neurolac®. this new nerve capping device is identical in material and manufacturing. the exception is in design, where neurolac® has two open ends, the nerve capping device has one closed (sealed) end. this study will be conducted to obtain data on the clinical performance of the capping device's ability to isolate the nerve end, resulting in a reduction of pain of experienced from the symptomatic neuroma and prevention of the reoccurrence of a symptomatic neuroma.


Eligibility criteria:
inclusion criteria: subjects will be eligible according to the following criteria: 1. subjects who are able to provide a written informed consent prior to participating in the clinical investigation. 2. subjects who are \> 18 years year old. 3. subjects with a diagnosis of symptomatic primary or secondary end-neuroma. 4. symptomatic neuroma located on the upper limb between the metacarpophalangeal (mcp) joints to shoulder. 5. symptomatic neuroma confirmed by pain relief following a 10min ±2min nerve block with xylocaine (lidocaine) - pain relief defined as any reduction in vas questionnaire score. 6. subjects with history of pain in the area of the end-neuroma for at least 6-months. 7. subjects with a positive tinel's sign. exclusion criteria: subjects who meet any of the following criteria will be excluded from participation: 1. inability to comply with the clinical investigation follow-up or other clinical investigation requirements. 2. subjects who are pregnant or intend to become pregnant during the duration of the clinical investigation or subjects who are not using appropriate birth control. 3. subjects who have had historical radiotherapy in the area of the end-neuroma. 4. symptomatic neuroma located proximally from the shoulder or distally from mcp joints. 5. subjects not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone). 6. subjects is involved in another pain study. 7. subjects who have a known allergy to anesthetic agent or bioresorbable copolyester poly(68/32\[15/85 d/l\] lactide-ԑ-caprolactone) (plcl). 8. subjects with a symptomatic neuroma that underwent surgical treatment for pain management on two or more occasions. 9. insufficient soft tissue at the end-neuroma site to cover the investigational device. 10. immunosuppressed patients, or patients with planned immunosuppressive therapy within 12-month following the study procedure.
safety and efficacy of rescriptor in patients for human immunodeficiency virus (hiv) patients

Conditions: HIV-1 Infection

Summary: the objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the local product document (lpd) (unlisted adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

all the patients whom an investigator prescribes the first rescriptor® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria:
inclusion criteria: patients need to be administered rescriptor® in order to be enrolled in the surveillance. exclusion criteria: patients not administered rescriptor®.
a study to evaluate efficacy and safety of hgp2102 in essential hypertension patients

Conditions: Hypertension

Summary: a multicenter, randomized, double-blind, phase 3 study to evaluate the efficacy and safety of hgp2102 in patients with essential hypertension


Eligibility criteria:
inclusion criteria: 1. subjects whose clinic blood pressure measured in visit 1 corresponds to the following conditions * sitsbp\<180 mmhg and sitdbp\<110mg for patients receiving any bp-lowering drug within 1 month prior to visit 1 * 140mmhg≤sitsbp\<180mmhg and 60mmhg≤sitdbp\<110mmhg 2. subjects whose clinic and ambulatory blood pressure measured in visit 2 corresponds to the following conditions * 24h-abpm: 130mmhg≤ sbp \<170mmhg * clinic bp: 140 mmhg ≤ sitsbp \< 180 mmhg and 60 mmhg ≤ sitdbp \< 110 mmhg exclusion criteria: 1. difference between arms greater than 20 mmhg for mean sitsbp or 10mmhg for mean sitdbp at visit 1 2. patients who have taken more than three components of blood pressure medication within 3 months prior to visit 1 3. orthostatic hypotension with symptoms within 3 months prior to visit 1 4. secondary hypertension patient or suspected to be 5. uncontrolled type ii diabetes mellitus (hba1c \> 9%) or type i diabetes mellitus 6. severe heart disease or severe neurovascular disease 7. moderate or malignant retinopathy 8. severe renal diseases (egfr\<30ml/min/1.73m2) 9. severe or active hepatopathy (ast or alt ≥ 2 times of normal range) 10. hypokalemia or hyperkalemia (k\<3.5mmol/l or k ≥ 5.5mmol/l) 11. hyponatremia or hypernatremia (na\<135mmol/l or na ≥ 155mmol/l) 12. history of malignancy tumor 13. history of alcohol or drug abuse 14. positive to pregnancy test, nursing mother, intention on pregnancy 15. considered by investigator as not appropriate to participate in the clinical study with other reason
study for adolescents and adults with ornithine transcarbamylase deficiency to evaluate safety and tolerability of arct-810

Conditions: Ornithine Transcarbamylase Deficiency; OTC Deficiency; OTCD

Summary: the primary objective is to evaluate the safety and tolerability of repeated doses of intravenously administered arct-810.

this study is a phase 2, randomized, placebo-controlled study of arct-810 in people living with otc deficiency 12 years of age and older. after an at least 4 week screening and diet stabilization period, participants will be randomized 3:1 to receive arct-810 or placebo. following the first dose and safety evaluation, participants will receive up to an additional 5 doses of arct-810 or placebo, each separated by 14 days. the treatment period is followed by a 12-week observation period.

Eligibility criteria:
key inclusion criteria: 1. adequate cognitive ability to understand study requirements and give informed consent 2. males and females aged 12 to 65 years inclusive, at screening 3. documented diagnosis of otc deficiency 4. clinical stability (no clinical symptoms of hyperammonemia within 1 month, no hospitalizations for metabolic decompensation within 3 months, ≤ 2 hospitalizations within 1 year) 5. stable protein-restricted diet, dietary supplements, and ammonia scavenger regimen (if applicable) for at least 28 days. 6. bmi = 18.0 - 32.0 kg/m2, inclusive for adults, and \>5th percentile for adolescents ≥12 to 17 years 7. must be willing to adhere to contraception guidelines key exclusion criteria: 1. history of any otc gene therapy, or history of liver-derived stem cell therapy in the past 3 years 2. history of other medical conditions that may make the participant unsuitable for inclusion or could interfere with study participation (e.g., uncontrolled hypertension or diabetes, malignancy, hiv, hepatitis b or c) 3. history of severe allergic reaction to liposomal or peg-containing products 4. abuse of illicit drugs, medications or alcohol 5. clinically significant laboratory abnormalities on screening labs

Keywords: otc otcd ornithine transcarbamylase mrna ornithine transcarbamylase deficiency otc deficiency
temporally interfering electric field stimulation in the treatment of epilepsy

Conditions: Epilepsy

Summary: this study investigates the potential for temporally-interfering electric field stimulation (tiefs) to treat epilepsy. in this case series within and between subjects design, the impact of tiefs on epilepsy biomarkers was studied in patients with medial temporal lobe epilepsy. secondary analyses examine the underlying physiological effects of tief on local brain activity and brain networks.

participants patients with drug-resistant focal epilepsy and a clinical diagnosis of medial temporal epilepsy undergoing invasive intracranial electrophysiology studies will be consented in accord with institutional review boards at emory university, saint-anne university hospital, and the institute of neurosurgery and neurointervention, semmelweis university. the determination of medial temporal epilepsy is based on clinical semiology, eeg, pet, mri, and invasive electrophysiology. across all centers, patients underwent the stimulation protocols 6 to 10 days post-implantation after patient-specific electric field modeling to determine tiefs electrode placement. patients then undergo two sessions of tiefs on separate days, one sham (aligned carriers), and one active (with an offset in frequency between the carriers to provide a lower-frequency modulation envelope at the anatomical target.

Eligibility criteria:
inclusion criteria: * patients undergoing invasive intracranial eeg studies exclusion criteria: * none

Keywords: temporally-interfering electric fields