Kornimate/medical-research-clean huggingface dataset:
the lvivo-tavec100 product in the treatment of relapsed/refractory b-cell malignancies

Conditions: Relapsed/Refractory B-cell Malignancies

Summary: a phase i clinical study to evaluate the safety, tolerability, and efficacy of the lvivo-tavec100 product in the treatment of relapsed/refractory b-cell malignancies.

this is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of lvivo-tavec100 product in the patient ≥ 18 years of age with relapsed or refractory b-cell malignancies. subjects who meet the eligibility criteria will receive a single dose of lvivo-tavec100 product. the study will include the following sequential phases: screening, bridging therapy (if needed), treatment, and follow-up.

Eligibility criteria:
inclusion criteria: 1. subjects voluntarily participate in clinical studies; fully informed of this study and signed informed consent; informed consent form must be obtained prior to initiation of any study-related tests or procedures that are not part of the standard treatment for the subject's disease; good compliance and cooperation with follow-up. 2. aged 18-65 years (inclusive). 3. eastern cooperative oncology group (ecog) performance status of 0 or 1. 4. at least one evaluable tumor lesion. 5. relapsed and/or refractory nhl , and relapsed and/or refractory cll with treatment indications 6. life expectancy≥ 3 months 7. clinical laboratory values meet screening visit criteria 8. adequate organ function; exclusion criteria: subject eligible for this study must not meet any of the following criteria: 1. prior antitumor therapy with insufficient washout period ; 2. prior treatment with other autologous cells or gene therapies other than targeting cd19 autologous car-t; 3. patients who are positive for hepatitis b surface antigen (hbsag), hepatitis b virus core antibody (hbcab), hepatitis b virus deoxyribonucleic acid (hbv dna), hepatitis c antibody (hcv-ab), hepatitis c virus ribonucleic acid (hcv rna), and human immunodeficiency virus antibody (hiv-ab). 4. known life-threatening allergic reaction, hypersensitivity reaction, or intolerance to study drug excipients and related excipients, including but not limited to dmso; or those with a history of severe allergic reactions in the past (such as hypersensitivity reactions, or those with severe immune-related reactions such as the need for glucocorticoids to prevent anaphylaxis as assessed by the investigator). 5. lactating women;
uterine elastography: a potential predictor of embryo transfer success

Conditions: Infertility, Female

Summary: to determine if the mean elasticity value (measured in kilopascals, kpa) of a patient's endometrium, myometrium and cervix in a sonographically normal appearing uterus predict frozen embryo transfer (fet) success and long term reproductive outcomes when measured the day prior to fet.


Eligibility criteria:
inclusion criteria: 1. female patients, 18yo-45yo, presenting for ultrasound the day prior to embryo transfer 2. patients planning to undergo single embryo transfer (set) of a euploid embryo by preimplantation genetic testing for aneuploidy (pgt-a) 3. uterine evaluation prior to transfer (saline sonogram or hysteroscopy) within 1 year 4. egg recipients exclusion criteria: 1. gestational carriers 2. bmi \> 35 3. diagnosis of a uterine anomaly 4. history of uterine surgery, excluding polypectomy, c-section, d\&c 5. communicating hydrosalpinx 6. transfer of an embryo of unknown ploidy status or embryos of undetermined safety 7. surgically retrieved sperm 8. embryos that were cryopreserved on day 7 of development 9. poor quality embryos defined by modified gardner grading criteria used in the embryology lab 10. sonographically abnormal appearing uteri, including distortions from leiomyomas and thin endometrium
the nigerian surgical outcomes study. this study is aimed at observing for complications within 30 days after surgery

Conditions: Postoperative Complications

Summary: the nigerian surgical outcome study is a national 30-day observational cohort study of complications after surgery. various institutions across nigeria will be involved. the study aims at providing detailed data describing post-operative complications, requirement for intensive care and mortality. all patients undergoing either elective surgery during a 7-day study period with a planned overnight stay will be recruited.

it is widely known that complications after surgery are responsible for a good number of morbidity and mortality following surgery. this national cohort study will help contribute to, and allow a better computation of data on post-operative complications and mortality following elective surgery in nigeria. this study therefore has important public health implications for nigeria. this study will also provide a baseline for other similar studies in future being the first of such in nigeria. objectives are: 1. to determine the mortality rate on the day of surgery for patients undergoing surgery in nigeria. 2. to determine the in-hospital mortality rate for patients undergoing surgery in nigeria. 3. to describe the relationship between anaesthetic complications and postoperative mortality. 4. to describe the relationship between postoperative complications and postoperative mortality. 5. to describe the proportional contribution of communicable, non-communicable diseases and traumatic injuries to critical care admissions and in-hospital mortality in nigeria. we plan to recruit a minimum of 5 centres per state, made up of federal, state and private hospitals. the national coordinating centre shall be the university college hospital, ibadan. regional coordinating centres shall be in lagos, kwara, enugu, kaduna, port-harcourt, maiduguri and abuja.the plan is to recruit all eligible patients during the recruitment week. all recruited patients would have had the routine preoperative surgical and anaesthetic review. since the study is purely observational, all basic intraoperative procedures as it relates to surgery and anaesthesia will not be altered. following informed written consent by the patient, the following information will be obtained. * results of preoperative haemoglobin, total white cell count, and creatinine. * patient's socio-demographics. * co-morbid conditions * type of anaesthesia and surgical procedure. * anaesthetic and surgical details * critical care admission post-operatively, and * postoperative complications observed till discharge or up to 30 days if on admission.

Eligibility criteria:
inclusion criteria: all consecutive patients admitted to participating centres undergoing elective surgery with a planned overnight hospital stay following surgery during a seven-day study period. the recruitment week will run between june and july 2018. exclusion criteria: patients undergoing planned day-case surgery or procedures outside the operating theatre.
the impact of standard medical care (dopamine) and practice on postural motor learning in parkinson's disease

Conditions: Parkinson Disease

Summary: the study determines whether standard medical care (dopamine) affects learning and retention of a postural stepping task in people with parkinson's disease (pd) and whether training on a postural stepping task generalises to performance on an untrained postural task. half the participants will train on the stepping task after they have taken their first dose of dopamine for the day (i.e. "on" medication state) while the other half will train on the same stepping task before taking their first daily dose of dopamine (i.e. "off" medication state).

motor learning is critical for acquiring new skills and adapting behaviour, therefore the success of rehabilitation depends on successful motor learning through practice. motor learning involves the basal ganglia, including both the associative and sensorimotor striatum. although people with pd are capable of motor learning, they are less efficient and do not achieve the same extent of skill acquisition and retention as people without neurological deficit. reductions in endogenous dopamine and reduced dopamine binding associated with loss of dopaminergic receptors due to disease progression may impair motor learning in people with pd. conflicting evidence suggests that impaired motor learning in pd is due on the one hand to the absence of dopamine but on the other hand to "overdosing" of the basal ganglia with dopamine replacement therapy which suppresses activation of the associative striatum during the early acquisition stages of motor learning. understanding which factors improve or degrade motor learning of tasks will allow rehabilitation parameters to be adjusted around standard medical care in order to optimize learning and improve the efficacy of exercise interventions for people with pd. in particular, successful learning of postural tasks that challenge stability may in turn reduce falls.

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease confirmed by neurologist * hoehn and yahr stages 1 to 3 * on a stable dose of antiparkinsonian medication for the past month and will continue on this regime for at least another subsequent month * walks unaided exclusion criteria: * not taking dopamine replacement therapy * with prior surgical management for pd (e.g. deep brain stimulation) * with medication-resistant freezing of gait * significant cognitive impairment (montreal cognitive assessment score \<18) * unstable medical conditions * other neurological conditions * unable to follow instructions or safely complete the training tasks

Keywords: learning practice
a study of baricitinib (ly3009104) in participants with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: the reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (sle).


Eligibility criteria:
inclusion criteria: * have a clinical diagnosis of sle at least 24 weeks prior to screening. * have documentation of having met at least 4 of 11 revised criteria for classification of systemic lupus erythematosus according to the 1997 update of the 1982 american college of rheumatology (acr) criteria for classification of sle prior to randomization. * have a positive antinuclear antibody (ana) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsdna), and/or a positive anti-smith (anti-sm) as assessed by a central laboratory during screening. * have a total systemic lupus erythematosus disease activity index 2000 (sledai-2k) score ≥6 during screening. * have a clinical sledai-2k score ≥4 at randomization. * have at least 1 british isles lupus assessment group (bilag) a score or 2 bilag b scores during screening. * are receiving at least one of the following standard of care medications for sle: * a single antimalarial at a stable dose for at least 8 weeks prior to screening * a single immunosuppressant at a stable dose for at least 8 weeks prior to screening * an oral corticosteroid, initiated at least 4 weeks prior to screening, at a stable dose ≤40 milligrams/day prednisone (or equivalent) for at least 2 weeks prior to screening. if the participant is not receiving an antimalarial or immunosuppressant, the dose of corticosteroid must be ≥7.5 milligrams/day prednisone (or equivalent) exclusion criteria: * have severe active lupus nephritis. * have active central nervous system (cns) lupus. * have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data. * have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection. * have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.

Keywords: sle
platelet-rich and concentrated platelet-poor plasma to reduce air leak post-lobectomy: a randomized controlled trial

Conditions: Lung Cancer

Summary: the purpose of this study is to determine whether the use of platelet-rich plasma (prp) and concentrated platelet-poor plasma (pppc) can reduce the duration of post-operative air leak after lobectomy for lung tumours.


Eligibility criteria:
inclusion criteria: * patients requiring a lobectomy exclusion criteria: * pneumonectomy * sleeve lobectomy * determination of unresectability (prior to the initiation of lobectomy) * wedge resection alone
evaluation of contrast-enhanced ultrasound to detect endoleaks after endovascular aortic aneurysm repair

Conditions: Endoleaks

Summary: this study will be a cross-sectional survey of interobserver variability associated with contrast enhanced ultrasound (ceus) to detect endoleaks using computed tomographic angiography (cta) as the practice standard. the investigators will enroll 40 consecutive patients undergoing endovascular abdominal aortic aneurysm repair (evar). at the first follow-up visit after the procedure, participants will undergo two abdominal ultrasound examinations with and without contrast, and one cta. analyses will be conducted to examine interobserver variability in the detection and characterization of endoleaks using contrast-enhanced ultrasound (ceus). other endpoints include examination of sensitivity and specificity of ceus compared to cta, and characterization of the number and types of endoleaks detected.


Eligibility criteria:
inclusion criteria: 1. age 18 years of age or greater; 2. diagnosed with abdominal aortic aneurysm and has undergone or is scheduled to undergo endovascular repair procedure. 3. has not completed the first scheduled post-treatment follow-up exam 4. voluntary participation and signature of irb-approved informed consent. exclusion criteria: 1. inability to consent (includes non-english speaking patients) 2. has already completed the first scheduled post-treatment follow-up exam. 3. clinical instability; 4. pregnancy / breast feeding; 5. known allergy to perflutren; 6. known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts (based on manufacturer recommendations for use); 7. recent heart attack (\<6 months), unstable angina or uncontrolled cardiopulmonary disease 8. clinically unstable or recent worsening congestive heart failure (based on fda warning) 9. serious ventricular arrhythmias or at high risk for arrhythmias 10. respiratory failure (based on fda warning) 11. severe emphysema, pulmonary emboli or other conditions that compromise pulmonary arterial vasculature (based on fda warning) 12. any reason judged by the investigators to hamper inclusion.

Keywords: evar ultrasounds aaa endoleaks after endovascular repair of aaa
a study to determine if ibuprofen in combination with pseudoephedrine hcl is more effective than each drug alone in the treatment of nighttime bedwetting

Conditions: Enuresis

Summary: the purpose of the study is to determine if ibuprofen in combination with pseudoephedrine hcl in the treatment of nightime bedwetting in children is more effective than each drug alone and if the individual drugs are more effective than placebo.

the objective of this double-blind, placebo-controlled, randomized, parallel-group study is to determine whether the effectiveness of ibuprofen in combination with pseudoephedrine hcl is greater than the individual drugs alone and greater than placebo for the treatment of nighttime bedwetting in children. after a screening visit, parents of eligible patients are to record in a diary, the number of urinations and wet and dry nights. patients then return and those who continue to be eligible are randomized to study medication, which they will take for two weeks. patients are randomized into four treatment groups, and the dose of treatment medication is determined based on body weight. the four treatment groups are: 12.5 mg of ibuprofen suspension/kg of body weight (200-450 mg of ibuprofen) plus 15 mg or 30 mg of pseudoephedrine hcl, 12.5 mg of ibuprofen suspension / kg of body weight (200 - 450 mg of ibuprofen) plus placebo suspension, or two doses of placebo suspension. the primary efficacy measurement is the mean reduction in wet nights, for the 14-day baseline period to the 14-day treatment period. safety assessments consist of monitoring adverse events, physical examination and assessment of vital signs. the study hypothesis is that ibuprofen in combination with pseudoephedrine hcl has a greater effect in the treatment of nighttime bedwetting than either ibuprofen or pseudoephedrine hcl alone, and the combination is well tolerated. treatment medication are an oral suspension, expressed as mg/kg body weight. patients will receive 1 of 4 treatments for 2 weeks: ibuprofen (12.5 mg/kg of body weight) plus 15 or 30 mg of pseudoephedrine, ibuprofen (12.5 mg/kg of body weight) + placebo, 15 or 30 mg of pseudoephedrine, or placebo

Eligibility criteria:
inclusion criteria: * subject has nighttime bedwetting * between the 5th and 95th percentiles for weight based on age and gender * has a minimum of eight wet nights per 14 days of the baseline period * healthy with no symptoms of any other complicating disease as determined by medical history review, physical examination, and clinical laboratory tests. exclusion criteria: * subject has daytime urinary incontinence or abnormal bowel habits (i.e. fecal incontinence or constipation) * has had episodes of dryness lasting one month or longer, at any time in the past * has a medical condition which may be relevant to participation in the study * has a known sensitivity or allergy to the study medications.

Keywords: nocturnal enuresis bedwetting ibuprofen
posterior capsule opacification after lens capsule polishing

Conditions: Posterior Capsule Opacification

Summary: investigate the effect of polishing of the lens capsule during cataract surgery on the development of posterior capsule opacification

cataract, the clouding if the eye's lens, is the leading cause of blindness worldwide, with phacoemulsification and implantation of an intraocular lens being the only therapeutic option. cataract surgery is nowadays considered a safe and efficient procedure. however, one of the most frequent complications after surgery is posterior capsule opacification (pco), that results in diminished postoperative visual acuity. pco occurs due to remaining lens epithelial cells in the capsular bag, that start to migrate and proliferate. pco can be easily treated by performing a neodymium-doped yttrium aluminium garnet (nd-yag) laser capsulotomy. however, even if laser capsulotomy is considered a simple procedure, possible complications are rise of intraocular pressure, inflammation, cystoid macular edema, or retinal detachment. furthermore, several patients are no suitable candidates for laser capsulotomy, for example children and patients with high myopia. therefore, it would be necessery to identify different approaches to prevent generation of pco. one approach could be "cleaning" of the lens epithelial cells in the capsular bag by polishing of the lens capsule during surgery. hence, the aim of this study is to examine whether capsular polishing is beneficial to decrease the growth and proliferation of lecs.

Eligibility criteria:
inclusion criteria: * age-related cataract. * patients in the age group of 21 years and above. * patients with uncomplicated cataract. * patients without any relevant systemic or ocular morbidity. * patients with well dilating pupils. * written informed consent prior to any study specific action. exclusion criteria: * patients with complicated cataract. * patients having corneal pathology. * patients with any form of ocular inflammation. * patients with glaucoma, retinal pathologies. * patients with traumatic cataracts, subluxated and dislocated lens, prior h/o ocular surgery, pseudoexfoliation. * any intraoperative complications like posterior capsule rupture. * in case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

Keywords: polishing cataract surgery
treatment of upper cluneal nerve entrapment syndrome for reduction of low back pain

Conditions: Superior Cluneal Nerve Entrapment

Summary: superior cluneal nerve entrapment (scn) is a painful symptomatic condition related to compression by the thoracolumbar and gluteal bands of nerve outcrop, above the iliac crest. this syndrome is not considered in the classical differential diagnosis of lumbosacral spine disorders and is almost unknown in italy. it is a neuropathic pain, acute, subacute, or chronic, evoked by mechanical stress at the level of the sensory territory corresponding to the superior cluneal nerve, easily found anatomically and evoked at a trigger point on the posterior iliac crest approximately 70mm from the midline and 45mm from the posterior superior iliac spine. scn entrapment syndrome represents a not so infrequent syndrome. it is easily framed and treatment is effective in most cases. therefore, diagnosis and treatment of this syndrome represents an excellent option in all those patients with low back pain that cannot be otherwise framed and resolved.


Eligibility criteria:
inclusion criteria: * patients with age between 18 and 99 years * male and female sex * superior cluneal nerve trigger point positivity at clinical evaluation * absence of urgent criteria for spinal surgery exclusion criteria: * patients younger than 18 years old * patients who have not given consent to be included in the study * patients with negative upper cluneal nerve trigger point - emergency criteria for spine surgery * pregnant women - patients allergic to local anesthetic * patients with language barrier

Keywords: superior cluneal nerve nerve entrapment