Kornimate/medical-research-clean huggingface dataset:
intraosseous basivertebral nerve ablation for the treatment of chronic low back pain

Conditions: Chronic Low Back Pain

Summary: objective of study is to evaluate the procedural success rate, clinical effectiveness, and heath-economic profile using the intercept intraosseous nerve ablation system in adult subjects with chronic low back pain in the post-market setting

this is a prospective, open-label, single-arm, single-center study. there is no randomization or blinding. subjects will receive the intercept system procedure to treat one or two motion segments at l3/l4, l4/l5, or l5/s1 as identified by modic type 1 or 2 changes.

Eligibility criteria:
inclusion criteria: * skeletally mature subjects age 25-70 years, inclusive * chronic lower back pain for at least six months * failure to respond to at least six months of non-operative conservative management * oswestry disability index (odi) at time of evaluation of at least 30 points * modic changes (type 1 or 2) in at least one vertebral endplate, at one or more levels from l3 to s1 exclusion criteria: * radicular pain by history or evidence of pain neurological deficit within the past one year. * previous surgery performed on the lumbar spine * current or history of symptomatic spinal stenosis * current or history of osteoporotic or tumor-related vertebral body compression fracture * current or history of vertebral cancer or spinal metastasis * current or history of spinal infection * metabolic bone disease * bmi greater or equal to 40 * any radiographic evidence of other important back pathology * mri evidence of modic changes, type 1 or 2 at greater than 3 vertebral bodies or at non-consecutive levels, or at vertebral bodies other than l3 to s1 * any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain * subjects who are bed bound * demonstrates 3 or more waddell's signs of inorganic behavior * any evidence of current systemic infection
diagnostic study of gene alterations in children who have been treated for relapsed acute lymphocytic leukemia

Conditions: Leukemia

Summary: rationale: diagnostic procedures, such as genetic testing, may improve the ability to detect acute lymphocytic leukemia and determine the extent of disease. purpose: diagnostic study to try to detect changes in the genes of children who have been treated for relapsed acute lymphocytic leukemia.

objectives: * determine the incidence of p16/p15 homozygous deletions and p15 promoter hypermethylation in acute lymphocytic leukemia cells of children treated on protocol ccg-1941. * determine the prognostic importance of p16/p15 abnormalities in these children. * determine the presence or absence of p16/p15 abnormalities in the dominant clone at diagnosis if present at relapse in these patients. outline: frozen cells are obtained from samples collected on protocol ccg-1941. dna is isolated and examined using southern blot analysis to assay for deletions and promoter hypermethylation of p16 and/or p15. projected accrual: approximately 100 samples will be obtained for this study.

Eligibility criteria:
disease characteristics: * diagnosis of acute lymphocytic leukemia and treated on protocol ccg-1941 * material cryopreserved in the ccg cell bank patient characteristics: age: * children performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * not specified radiotherapy: * not specified surgery: * not specified other: * see disease characteristics

Keywords: recurrent childhood acute lymphoblastic leukemia
a study of ocrelizumab in comparison with interferon beta-1a (rebif) in participants with relapsing multiple sclerosis

Conditions: Relapsing Multiple Sclerosis

Summary: this randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (rebif) in participants with relapsing multiple sclerosis. participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (iv) as 300 mg infusions on days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a sc three times per week; or interferon beta-1a 44 mcg sc injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).


Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis, in accordance with the revised mcdonald criteria (2010) * at least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the years prior to screening (but not within 30 days prior to screening) * neurologic stability for greater than or equal to (\>/=) 30 days prior to both screening and baseline * expanded disability status scale (edss) score 0 to 5.5 inclusive exclusion criteria: * primary progressive multiple sclerosis * disease duration of more than 10 years in patients with edss score less than or equal to (\</=) 2.0 at screening * contraindications for mri * known presence of other neurological disorders which may mimic multiple sclerosis * pregnancy or lactation * requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study * history of or currently active primary or secondary immunodeficiency * history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies * active infection, or history of or known presence of recurrent or chronic infection (for example, hepatitis b or c, human immunodeficiency virus \[hiv\], syphilis, tuberculosis) * history of progressive multifocal leukoencephalopathy * contraindications to or intolerance of oral or iv corticosteroids * contraindications to rebif or incompatibility with rebif use
effect of lowering the dialysate sodium on blood pressure in hemodialysis patients

Conditions: Hemodialysis

Summary: patients currently receiving hemodialysis will be randomized to receive 1 of 3 dialysate sodium prescriptions. the effects on blood pressure, interdialytic weight gain, thirst, and intradialytic symptoms will be assessed.


Eligibility criteria:
inclusion criteria: * patients on 3 times weekly hemodialysis of at least 3 months * elevated average ambulatory blood pressures * current dialysate sodium prescription 140meq/l * average pre-dialysis serum sodium \<140meq/l exclusion criteria: * frequent intradialytic hypotension * estimated life expectancy \<1 year * non-adherence to dialysis prescription * pregnancy * inability or unwillingness to complete study measures

Keywords: dialysate sodium hemodialysis blood pressure thirst intradialytic symptoms interdialytic weight gain extracellular fluid balance mechanisms
laparoscopic versus open appendectomy in pregnancy

Conditions: Appendicitis; Pregnancy Loss; Pregnancy Preterm

Summary: the aim of this retrospective trial is to compare surgical and pregnancy outcomes of pregnant patients who underwent laparoscopic or open appendectomy for acute appendicitis.

the aim of this retrospective trial is to compare surgical and pregnancy outcomes of pregnant patients who underwent laparoscopic or open appendectomy for acute appendicitis. patients' medical records from 2010-2020 were extracted using billing information of the national health insurance fund of estonia and icd-10 codes (pregnancy, appendicitis). collected data was stored on redcap electronic database and analyzed with r studio. two group of patients were compared: pregnant patients who had laparoscopic appendectomy and pregnant patients who had open appendectomy.

Eligibility criteria:
inclusion criteria: women with confirmed pregnancy who underwent appendectomy for acute appendicitis. exclusion criteria: women who were not pregnant when having an appendectomy
tracheal intubation of morbidly obese patients. glidescope versus direct laryngoscopy

Conditions: Intubation, Endotracheal; Anesthesia, General; Obesity

Summary: the purpose of this study is to examine whether orotracheal intubation in morbidly obese patients is faster, gentler and safer using the glidescope videolaryngoscope than with the macintosh direct laryngoscope.


Eligibility criteria:
inclusion criteria: * approved for elective bariatric surgery at glostrup university hospital, copenhagen. * body mass index at least 35 kg/m2 * written informed consent to participate exclusion criteria: * mental illness * abuse of alcohol or other substances * previous difficult tracheal intubation * considered non-eligible for safety-reasons by the anesthetist in charge
parenting a child with autism spectrum disorder and marital status

Conditions: Autism Spectrum Disorder

Summary: the purpose of this study is to investigate whether the presence of a child with autism spectrum disorder places parents at increased risk for divorce.

autism spectrum disorders (asds) are lifelong neurodevelopmental disorders involving a triad of impairments in communication and social reciprocity and increases in repetitive/restricted interests and behaviors. asd includes: autistic disorder, asperger's syndrome, pervasive developmental disorder not otherwise specified (pdd-nos), rett's syndrome, and childhood disintegrative disorder as pervasive developmental disorders (american psychiatric association \[dsm-iv-tr\], 2000). few disabilities appear to be more taxing on parents than asds.parents of children with asd fare worse on a variety of measures of well-being than parents of children without disabilities as well as parents of children with other types of disabilities. studies investigating the impact of a child with disabilities, specifically asd, are inconclusive. however, parents of children with asd may be at increased risk for divorce due to a variety of personal and disability related factors. in israel the relationship of having a child with autism on the probability of divorce has not been tested yet. the aim of this study is to profile this relationship and determine the magnitude and directionality of the effect raising asd children has on the resilience of the institution of marriage and the satisfaction both partners derive. this will be tested using a short telephone survey.

Eligibility criteria:
inclusion criteria: * parents to a child with asd exclusion criteria: * none

Keywords: asd divorce
brief interventions with text messaging to reduce adolescent alcohol and marijuana use

Conditions: Alcohol Drinking; Marijuana

Summary: this study tests the feasibility of an intervention to prevent risky alcohol or marijuana use that adds a 4-week course of tailored text messaging to a brief motivational intervention for 13-18-year-old adolescents.


Eligibility criteria:
inclusion criteria: * 13 to 18 years old * able to provide consent or assent and parental permission * have a functioning cell phone without pay-as-you-go text messaging exclusion criteria: * currently enrolled in any substance abuse program; * have medical/psychiatric condition that precludes participation
the influence of coping strategies and catastrophizing on patients with back and neck pain

Conditions: Back Pain; Neck Pain

Summary: the purpose of this study is to evaluate the influence of coping strategies and catastrophizing thoughts on disability and the prognosis of back and neck pain in patients treated within the spanish national health service. patients will be given a visual analog scale (vas) to rate intensity of pain, the roland morris questionnaire (rmq) or the neck disability index (ndi) to rate the degree of disability, and the coping strategies questionnaire (csq) to rate coping strategies and catastrophizing. questionnaires will be given at baseline and three months later.


Eligibility criteria:
inclusion criteria: * subjects treated for back or neck pain in the spanish national health service. * able to read and write spanish. * have signed the informed consent form. exclusion criteria: * diagnosis or "red flags" for systemic diseases (e.g., cancer, infection). * pain due to fracture or direct trauma to the neck or back. * criteria for referral to surgery (e.g., neurogenic claudication due to spinal stenosis, cauda equina syndrome, serious nerve root compression for more than 6 weeks due to disc herniation).

Keywords: back pain neck pain prognosis catastrophizing coping strategies disability prognosis for back and neck pain
safety and efficacy of trastuzumab bs

Conditions: Gastric Cancer

Summary: to confirm the safety and efficacy of this drug under the actual use


Eligibility criteria:
inclusion criteria: * patients with unresectable advanced/recurrent gastric cancer who are confirmed to have her2 overexpression and started treatment with this drug\* * patients who receive this drug\* for the first time after this drug\* is launched \* not including the biological product, herceptin, and biosimilars of herceptin other than this drug exclusion criteria: - not specified in this study

Keywords: recurrent her2-overexpressing gastric cancer trastuzumab bs
combinatorial single cell strategies for a crohn's disease gut cell atlas

Conditions: Crohn Disease

Summary: inflammatory bowel disease (ibd), consisting of two major forms, crohn's disease (cd) and ulcerative colitis, affects more than 1.6 million people in the united states alone. despite current therapies, remission only occurs in approximately half of patients. the goal of study is to map single-cell spatial relationships across the spectrum of ileum/ascending colon from healthy control patients to uninvolved/quiescent and involved/active cd patients and assess for relationships between single-cell data and patient clinical data. the investigators will utilize endoscopic mucosal biopsies and surgical resection specimens with rapid transfer of fresh tissue to the single-cell preparation for rna-sequencing and use of tissues for rna-fluorescence in situ hybridization and multiplex immunofluorescence. along with machine learning image analysis and bioinformatics, this will generate a robust/detailed single-cell gut cell atlas (gca) of ileo-colonic cd at all disease activities versus normal tissues. the study will also compare the results of endoscopic mucosal biopsies to those obtained from full thickness surgical specimens by utilizing the cooperative human tissue network (chtn). the investigators anticipate the gca data will provide new insights into disease pathogenesis, leading to new therapeutic targets.


Eligibility criteria:
inclusion criteria: * provision of consent form * male or female greater than or equal to 18 years old * healthy volunteers without ibd undergoing colonoscopy for colorectal cancer screening or patients with a diagnosis of crohn's disease (cd) confirmed by endoscopy or radiology assessment undergoing colonoscopy for clinical care exclusion criteria: * pregnancy * coagulopathy or bleeding disorder * renal or hepatic impairment * history of organ transplantation
opioid use after laparoscopic salpingectomy

Conditions: Opioid Use; Post-operative Pain; Sterility, Female

Summary: the purpose of this study is to evaluate patient-reported post-operative pain scores following minimally invasive tubal sterilization procedures to determine if a multimodal, non-opioid pain control regimen is non-inferior to a pain control regimen including opioids. the study team hypothesizes that with extensive counseling on pain management, multimodal medication use, and expectation with non-opioid methods can effectively eliminate the need for opioid prescriptions after laparoscopic salpingectomy.


Eligibility criteria:
inclusion criteria: * individuals with a fallopian tube (unilateral and/or bilateral) * age 18 years old and above * undergoing minimally invasive (laparoscopic or robotic) unilateral or bilateral salpingectomy or other tubal sterilization procedure as the primary procedure * benign indications for salpingectomy/tubal sterilization * agreeing to participate exclusion criteria: * chronic pain syndromes patients including fibromyalgia * patients currently on long-term (i.e. for more than three months) opioid use * conversion to laparotomy * allergy or other contraindication to the prescribed medications such as acetaminophen or oxycodone * salpingectomy that occurs in conjunction with a major gyn surgery (i.e. hysterectomy, etc) * salpingectomy performed for treatment of ectopic pregnancy * patients with a history of gastritis and/or gi bleeding
study to assess oropharyngeal carriage of n. meningitidis in south australian school leavers

Conditions: Neisseria Meningitidis

Summary: this is an observational cross sectional study to evaluate the impact of a 4cmenb vaccination program on oropharyngeal n. meningitidis carriage in vaccinated and unvaccinated school leavers.

this carriage study of a cohort of school leavers in south australia (sa) will provide an opportunity to assess carriage rates in the young adult population (school leavers) following introduction of a 4cmenb vaccination program in senior school students from 2017-2018.this will allow a comparison of carriage prevalence in the two years (2018 and 2019) following implementation of the school program to assess impact on carriage at a population level and compare carriage prevalence in vaccinated versus non-vaccinated groups. assessment of any association between risk factors and prevalence of nasopharyngeal carriage in school leavers will be made and compared between vaccinated and unvaccinated students. school leavers are defined as students who were enrolled in year 12 at school in the preceding year of recruitment and have been chosen as they are likely to have the highest carriage rates. a high proportion (approximately two thirds) of students will be immunised by the time of throat swab collection in years 2018 and 2019. assessing carriage in both vaccinated and unvaccinated cohorts will further inform the effect of 4cmenb vaccine on carriage at a population level. this will help determine any herd immunity impact of 4cmenb vaccine and persistence of any effect.

Eligibility criteria:
inclusion criteria: * south australian school leavers between 17 to 25 years of age (enrolled in year 12 in the previous year ie year 2018, students are eligible if they were enrolled in year 12 in 2017, year 2019, students are eligible if they were enrolled in year 12 in 2018). exclusion criteria: * no exclusion criteria
kinesiotaping and rigid taping in sacroiliac joint dysfunction

Conditions: Pain

Summary: objective: to evaluate the effects of rigid-taping and kinesiotaping (lymphatic correction) on pain, joint mobility and disability in patients with sacroiliac joint dysfunction (sijd). methods: a total of 84 patients with unilateral sjid were included in this randomized controlled study. patients were divided into kinesiotaping (kt) (n=28), rigid-taping (rt) (n=28) and control (n=28) groups. pain levels at rest and during movement with visual analog scale (vas) (0-10 cm), oswestry disability index (odi), mobility and pain provocation tests were recorded on days 1 and 15.


Eligibility criteria:
inclusion criteria: * patients aged 18-50 years * patients who had subacute and chronic (lasting longer than 1 month), mechanical type low back and/or hip pain thought to be due to unilateral sijd (spreading between 3 cm above and 10 cm below the posterior superior iliac spine, not extending above the 5th lumbar vertebra) * patients who had at least 3 positive results out of 6 pain provocation tests for the sacroiliac joint. exclusion criteria: * the presence of known infectious, inflammatory, tumoral and advanced degenerative diseases that may cause low back pain, pain referred from abdominal or pelvic organs, history of spine or hip fracture/surgery, * presence of nerve root involvement findings, * presence of pregnancy, presence of inflammatory pathology in routine blood tests seen at the examination application * presence of inflammatory or advanced degenerative changes in the sacroiliac joint in imaging methods, * presence of findings suggesting bilateral sacroiliac joint dysfunction.
a study to evaluate safety and tolerability in patients with metastatic breast cancer receiving treatment with caelyx (study p04878)(completed)

Conditions: Breast Neoplasm

Summary: this is a study to evaluate the safety and tolerability of caelyx used for the treatment of metastatic breast cancer (mbc), focusing on infusion reaction and palmar-plantar erythrodysesthesia (ppe).

patients selected by investigator according to clinical routine

Eligibility criteria:
inclusion criteria: * patients with metastatic breast cancer exclusion criteria: * history of hypersensitivity to caelyx or its components * women who are pregnant or breast-feeding * patients with severe myelosuppression
a study to evaluate the safety and effectiveness of asoprisnil in the treatment of women with endometriosis.

Conditions: Endometriosis

Summary: the objective of this study is to determine the safety and efficacy of 3 asoprisnil doses (0.5 mg, 1.5 mg, and 5.0 mg) for 12 weeks in women with endometriosis.

endometriosis, the presence of endometrial tissue outside the uterus, is a progressive, estrogen-dependent disease that occurs in menstruating women of reproductive age. although all major endometriosis therapies are effective for the treatment of pain, no single treatment is superior to others in terms of efficacy. the major drawbacks of the current medical therapies are severe side effects such as hot flushes and osteoporosis. the objective of this study is to determine if a dose-response relationship exists between asoprisnil and endometriosis-associated pelvic pain and dysmenorrhea or to establish the lowest effective dose of asoprisnil in the treatment of pelvic pain and dysmenorrhea associated with endometriosis. women with surgically confirmed endometriosis will be administered asoprisnil 0.5, 1.5, and 5 mg tablets or a placebo once daily for 3 months and efficacy will be assessed by improvement in pelvic pain, dysmenorrhea, dyspareunia, bleeding, analgesic use, global efficacy, and quality of life questionnaires. safety will be based on assessments of the endometrium, lipid profiles, adverse events, and changes from baseline laboratory values and vital signs.

Eligibility criteria:
inclusion criteria: * premenopausal women (18-40 years) * surgically confirmed endometriosis within 3 years * history of menstrual cycles between 21 and 35 days * moderate or severe pelvic pain or moderate or severe dysmenorrhea or moderate or severe pelvic tenderness accompanied by at least mild non-menstrual pelvic pain * negative pregnancy test * agrees to use double barrier method of contraception * pap smear with no evidence of malignancy or pre-malignant changes * ultrasound with no significant gynecological disorder. * otherwise in good health exclusion criteria: * less than 3 months after having a baby or breast-feeding * any abnormal lab or procedure result the study-doctor considers important * severe reaction(s) to hormone therapy * anticipated need for excluded hormonal therapy or unapproved narcotics * current use of an iud * history or prolactinoma

Keywords: pelvic pain dysmenorrhea dyspareunia infertility asoprisnil