Kornimate/medical-research-clean huggingface dataset:
electrical epidural stimulation test for detecting epidural catheter reactivation in obstetric population

Conditions: Obstetric Pain; Anesthesia, Local

Summary: following labor, epidural or combined spinal-epidural (cse) catheters are kept in place and deactivated. however, many women opt for procedures such as tubal ligation, which may require epidural anesthesia as a method of pain relief. our study aims to confirm the ability to predict reactivation of epidural catheter in postpartum females through the electrical epidural stimulation test (est) which was first described by the pi of this study approximately 20 years ago.

in this study, investigators hope to investigate the ability of the electrical epidural stimulation test (est) to predict reactivation of epidural catheter in postpartum females. the standard practice for confirming the reactivation of epidural or cse catheters requires methods such as dosing the local anesthetic. with the est test this will allow for the anesthesiologist to determine whether or not the epidural can be activated immediately.

Eligibility criteria:
inclusion criteria: * females, 18 years and older * american society of anesthesiologists physical status i or ii * status post natural labor/birth process or c-section * has epidural or cse catheter * upcoming procedure requiring epidural/cse anesthesia for pain management exclusion criteria: * contraindication to regional anesthesia * allergy or hypersensitivity to lidocaine, bupivacaine, or fentanyl * use of sedatives or opioids * abnormal vertebrae anatomy * neurological disorder with lumbar involvement * implanted electronic devices * did not receive epidural or cse anesthesia

Keywords: electrical epidural stimulation test
world health organization disability assessment schedule ii (whodas-ii) for patients with symptomatic lumbar spinal stenosis

Conditions: Lumbar Spinal Stenosis

Summary: the main purpose of this study is to determine the measurement characteristics of whodas-ii (world health organization disability assessment schedule ii), as well as to analyze its correlation with symptomatic lumbar spinal stenosis (visual analog scale, vas), disability (spanish version of the roland morris questionnaire, rmq), fear avoidance beliefs and attitudes (spanish version of the fab questionnaire, fabq), and quality of life (sf-12). measurements will be taken at baseline and 6 days later (day 7).


Eligibility criteria:
inclusion criteria: * patients seen for symptomatic lumbar spinal stenosis * with signs of neurogenous claudication * mri or cat scan concordant with observed signs * able to read and write * have signed the informed consent form exclusion criteria: * central nervous system pathology (with or without treatment) * diagnosis of rheumatic inflammatory disease or fibromyalgia * red flags for underlying systemic disease * criteria for diagnosis of disc herniation * symptoms suggesting saddle anesthesia, cauda equina, loss of sphincter tone or paraparesis * motor deficit that progresses or does not improve in 6 weeks

Keywords: symptomatic lumbar spinal stenosis disability fear avoidance beliefs quality of life
study to evaluate the safety and efficacy of denosumab and actonel® in post menopausal women transitioned from alendronate therapy

Conditions: Osteoporosis

Summary: a randomized, open label study to assess the safety and effectiveness of denosumab, administered every 6 months and actonel ® (risedronate), administered monthly in post menopausal women transitioned from weekly or daily alendronate therapy.


Eligibility criteria:
inclusion criteria: * ambulatory, post menopausal women aged 55 years or older at screening. have received their first prescription of daily or weekly alendronate therapy, for the treatment for post menopausal osteoporosis at least 1 month prior to screening. use of raloxifene, calcitonin or hormone replacement therapy (hrt) prior to alendronate treatment will be allowed. prior and/or current use of vitamin d and calcium will be allowed. * has stopped oral alendronate therapy (is denoted as non-persistent) before the screening visit or, is still taking oral alendronate therapy but does not take on a regular basis (this will be assessed by the completion of a compliance questionnaire at screening). * provide signed informed consent before any study-specific procedures are conducted. exclusion criteria: * any prior or current use of medications prescribed for osteoporosis treatment other than oral daily alendronate, calcium and vitamin d. prior use of raloxifen, calcitonin or hrt before alendronate therapy was started will be allowed. * hypersensitivity to actonel® or any ingredient of actonel® tablets. * contraindicated or poorly tolerant of alendronate therapy. * active gastric or duodenal ulcer. * known sensitivity to mammalian cell derived products. * known intolerance to calcium supplements. * malignancy within the last 5 years (except for cervical or basal cell carcinoma). * vitamin d deficiency (serum 25-oh vitamin d less than 20ng/ml (equivalent to 49.9 nanomoles per liter) at screening. * current hypo- or hypercalcemia based on the central laboratory reference ranges. * uncontrolled hyper- or hypothyroidism (stable on antithyroid therapy or post-ablation is allowed, if the laboratory results from screening show that thyroid stimulating hormone (tsh) is within the normal range). * any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta, paget's disease of bone that may interfere with the interpretation of the findings. * height, weight or girth which may preclude accurate dual x-ray absorptiometry (dxa measurements). * fewer than 2 lumbar vertebrae (l1-l4) able to be evaluated by dxa. * known to have tested positive for human immunodeficiency virus. * previous participation in clinical trials with denosumab within the last 12 months (regardless of treatment). * any laboratory abnormality, physical or psychiatric disorder (including substance abuse in last 12 months) which, in the opinion of the investigator, will prevent the subject from giving written informed consent or completing the study or interfere with the interpretation of the study results. * currently enrolled in or within 30 days of ending another investigational device or drug trial(s).

Keywords: menopausal osteoporosis
a double masked, placebo controlled, single center, randomized clinical trial to assess the safety and efficacy of subjects with mild asthma induced by the bronchial allergen challenge (bac)

Conditions: Atopic Asthma

Summary: a double masked, placebo controlled, single center, randomized clinical trial to assess the safety and efficacy of adx-629 in subjects with mild asthma induced by the bronchial allergen challenge (bac)


Eligibility criteria:
inclusion criteria: * male or non-pregnant female, between 18 to 65 years of age (inclusive) at screening visit. * subjects must give their signed and dated written informed consent (in english) to participate prior to commencing any study-related activities and must be willing to comply with study procedures, study restrictions, study protocol, and return for the required assessments. * female subjects of either non-childbearing potential or of child-bearing potential who commit to consistent and correct use of at least one highly effective or two effective forms of contraception starting at least 4 weeks prior to the screening visit and for at least 30 days post last dose of study drug. * generally healthy subjects with mild controlled asthma for 2 years at screening visit according to the global initiative for asthma criteria. exclusion criteria: * history and presence of clinically significant cardiovascular, renal, neurologic, hepatologic, endocrinologic, gastrointestinal, genitourinary, autoimmune, hematological, or metabolic disease other than asthma, which in the opinion of investigator may either put the subject at risk or influence the results during the study. * positive skin prick test to other perennial allergens (i.e., mold, dog with ≥ 3 mm wheal compared to negative control). subjects with seasonal allergy symptoms that occur or are anticipated to occur during the study should result in subject exclusion or rescheduling until the subject is out of the allergy season. * any relevant pulmonary disease within 1 year prior to dosing at the discretion of the investigator. * recent hospitalization with asthma in the last 6 months or any other medical condition that the investigator deems incompatible with participation in the trial.
acid reflux and stromal fibroblasts in barrett's esophagus

Conditions: Barrett's Esophagus; GERD

Summary: patients with barrett's esophagus are known to have excessive distal esophageal acid exposure comparable to patients with erosive esophagitis. a significant proportion of patients with be who are not symptomatic on treatment continue to have persistent acid reflux. high dose esomeprazole is able to control acid reflux in patients with be. the effect of acid reflux on barrett's esophagus stroma is currently unknown. it is our hypothesis that stromal fibroblast activation in barrett's esophagus is influenced by acid reflux. the specific aim of this proposal will be: to assess the association between acid reflux and subepithelial fibroblasts in barrett's esophagus.

we will conduct a prospective cohort study to assess the degree of stromal activation in patients with lsbe (without dysplasia) who have adequate and inadequate control of acid reflux in the distal esophagus. the study will be conducted in two phases. phase 1 (pilot): 20 patients with lsbe without dysplasia will undergo endoscopy with biopsies and a 24 hour ph study on treatment. patients will then be divided into 2 groups: * group a (ger): those with ongoing acid reflux (characterized by either presence of esophagitis \[la classification b,c or d1\] on endoscopy, and/or a positive ph study on treatment defined using standard criteria) * group b (nger): those with controlled acid reflux (negative endoscopy and ph study on treatment). stromal markers that will be assessed and compared between the 2 groups will include: presence of activated myofibroblasts (detected by immunohistochemistry for vimentin and smooth muscle actin).

Eligibility criteria:
inclusion criteria: * prior histological demonstration of barrett's esophagus that is endoscopically visible; length of visible segment \>/= 1 cms * absence of dysplasia on prior biopsies * laboratory studies: * prothrombin time (inr) \< 1.5 * hemoglobin \> 8.0 gm/dl * ability to provide informed consent exclusion criteria: * eastern cooperative oncology group performance status 3 or 4 * inability to tolerate endoscopic procedures * pregnancy: females of child-bearing age will be screened with pregnancy test. although none of the procedures in the study are contraindicated in pregnancy, sedation used in endoscopy can be contraindicated in early pregnancy * prior esophageal surgery, or cancer

Keywords: barrett's esophagus gerd
mindfulness-based cognitive therapy for chronic depression

Conditions: Chronic Major Depression

Summary: the propose of the study is to investigate the efficacy of mindfulness-based cognitive therapy (mbct, segal, williams, \& teasdale, 2002) for patients suffering from chronic major depression. the efficacy of mbct will be compared with the cognitive behavioral analysis system of psychotherapy (mccullough, 2003), a treatment approach, which has proven it's efficacy yet, and with a treatment-as-usual condition (standard psychiatric outpatient care).

cognitive behavioral analysis system of psychotherapy (cbasp) is a treatment approach specifically developed for the treatment of chronic depression. cbasp aims to change dysfunctional interpersonal patterns. mindfulness-based cognitive therapy (mbct) has recently been proposed as a further treatment option for chronic depression. mbct trains patients to step out of negative ruminative states of mind. there are no direct comparisons of the psychological treatment options for chronic depression.

Eligibility criteria:
inclusion criteria: * clinical diagnoses of major depression, single episode, chronic or * major depression, recurrent, chronic * hamilton rating scale for depression score \> 14 * beck depression inventory ii score \> 14 exclusion criteria: * history of schizophrenia or schizoaffective disorder * current substance dependence or eating disorder * mental disorder due to general medical condition * borderline personality disorder

Keywords: depressive disorder psychotherapy
effect of pmscs and their secretome for the treatment of gvhd

Conditions: GVHD

Summary: in this clinical trial study, 60 patients with gvhd referred to shahid qazi hospital in tabriz, were randomly divided into 2 intervention and control groups (n= 30 in each) that received secretome and distilled water by injection, respectively. the method of blinding was triple-blinded and all the names and personal information of the patients were coded at the time of data collection and remained completely confidential.

this study is a safety, feasibility, and efficacy trial that was conducted on eligible gvhd patients with the diagnosis of expert doctors after obtaining permission from the respected ethics committee and registering the trial at the iranian trial registration center. during the phone call, while stating the title and objectives of the study, the entry and exclusion criteria were checked. if they are eligible, they were asked to attend the ghazi hospital if they wish to participate in the study. in the face-to-face meeting, the objectives of the research were fully explained and the study criteria were re-examined. the written informed consent was obtained and questionnaires fulfilled three times which include personal-social characteristics, medical characteristics, appetite questionnaire, 24-hour food record (food record), and family members. at the beginning of the study, 50 cc of blood was used to collect serum and to culture and condition mesenchymal stem cells. 200 men with gvhd were randomly assigned using random block method using blocks of 4 and 6 and ras (random allocation software) and allocation ratio 1:1 to two groups receiving intravenous secretome with the first protocol (30 people) and receiving the mesenchymal stem cells secretome of the second protocol (30 people) were allocated and they received the skin spray for 1 year. participants in the first protocol group at the beginning of the study, day 3, end of the week, the end of the second week, and the end of the month 5 times and in the second protocol group at the beginning of the study, skin spray were done. the secretome of both groups was the same.

Eligibility criteria:
inclusion criteria: * patients with acute gvhd with fever and requiring hospitalization exclusion criteria: * patients with sepsis

Keywords: bone marrow mesenchymal stem cell secretome severe graft-versus-host disease
comparison of safety, effectiveness and quality of life outcomes between labeled versus "treat and extend" regimen in turkish patients with choroidal neovascularisation due to age-related macular degeneration (amd)

Conditions: Age-related Macular Degeneration

Summary: the purpose of the study was to compare 2 treatment regimens for patients suffering from choroidal neovascularisation secondary to age-related macular degeneration (amd). the first treatment regimen was the approved amd treatment of 1 injection each month for 3 months and than re-treatment of patients who have a visual loss of more than 5 letters with monthly control (treat and observe). the second treatment regimen was 1 injection each month for 3 months and than extending the control period if the macula is dry during the monthly control (treat and extend). if the "treat and extend" regimen is found effective and safe, the number of ranibizumab injections, the number of patient visits, the risk of adverse events due to the intravitreal injections, and policlinic occupation number could all be reduced.


Eligibility criteria:
inclusion criteria: * male or female patients over the age of 50. * patients with primary, secondary, or recurrent subfoveal choroidal neovascularization (cnv) to amd with classic, minimal classic, or occult lesions. * patients with cnv area ≥ %50 of the total lesion. * total lesion area ≤ 12 disc areas for minimal classic/occult lesions and ≤ 9 disc areas for the classic lesions. * best-corrected visual acuity (bcva) score between 73 and 34 letters in the study eye. exclusion criteria: * bcva \< 34 letters. * patients using anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, corticosteroids, or protein kinase c inhibitors, etc) or inclusion in another trial (for any eye). * verteporphin, external radiational therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy application to the eye before the study. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: macula degeneration ranibizumab choroidal neovascularisation treat and extend treat and observe
does vestibular system effected in chronic obstructive pulmonary disease patients

Conditions: Vestibular Disorder

Summary: . the main question is whether the vestibular system is affected by copd. if there is an influence, the second question is what is the relationship between balance and vestibular interaction in copd patients. a total of 10 copd patients and 10 healthy adults will include the study. respiratory functions, vestibular functions and postural stability of participants will be assessed. this research is planned to be carried out as a cross-sectional/descriptive research. it's planned as a pilot study. comparisons between study and control groups will be made with independent samples t-test for parametric values and mann whitney u for non-parametric values.

chronic obstructive pulmonary disorder (copd) is a common preventable and treatable disease that is characterized by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. hypoxia caused by restrictive airflow is one of the symptoms of copd. hypoxia can affect the inner ear and vestibular nuclei. also, balance impairment can be caused by hypoxia. previous studies show that balance affected negatively in copd patients. the aim of this study is to investigate of vestibular system influence in individuals with copd. a total of 10 copd patients and 10 healthy adults will include the study. this research is planned to be carried out as a cross-sectional/descriptive research. it's planned as a pilot study. respiratory functions (respiratory function test), vestibular functions (head shake test, head trust test, unterberger test) and postural stability (sensory organization test) of participants will be assessed.comparisons between study and control groups will be made with independent samples t-test for parametric values and mann whitney u for non-parametric values.

Eligibility criteria:
for study group inclusion criteria: * volunteering to participate in the study * diagnosed with copd exclusion criteria: * communication - coordination problems of patients * using medicine which is increasing the risk of fall * any neurologic or musculoskeletal disorders which affect mobility and balance * loss of hearing for control group inclusion criteria: * volunteering to participate in the study exclusion criteria: * communication - coordination problems of patients * using medicine which is increasing the risk of fall * any neurologic, musculoskeletal or respiratory disorders which affect mobility and balance * loss of hearing

Keywords: vestibular dysfunction copd balance
the effects of tiszasüly and kolop mud-pack therapy in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: in this double-blind, randomized, follow-up study investigators evaluated and compared the effects of tiszasüly and kolop mud-pack therapy on pain, function and quality of life in patients with knee osteoarthritis. 30 patients were treated with tiszasüly hot mud-pack (group 1), 30 patients with kolop hot mud-pack (group 2) for 10 working days. knee pain, function a nd qualitiy of life were measured at baseline, at the end of treatment and 3 months later.

the aim of this non-inferiority study was to evaluate and compare the effects of tiszasüly and kolop mud-pack therapy on pain, function and quality of life in patients with knee osteoarthritis. methods: in this double-blind, randomized, follow-up study 60 patients with knee osteoarthritis were treated with either tiszasüly hot mud-pack (group 1), or with kolop hot mud-pack (group 2) on 10 occasions for 2 weeks (10 working days). 100 mm visual analogue scale (vas) for knee pain, western ontario and mcmaster universities arthritis index (womac), knee injury and osteoarthritis outcome score (koos), lequesne index for physical function and euroqol-5d for quality-of-life measure were recorded at baseline, at the end of treatment (week 2) and 3 months later (week 12).

Eligibility criteria:
inclusion criteria: * patients over 18 years of age with knee osteoarthritis (radiologically kellgren-laurence ii-iii. stage) * resting vas pain is \> 50 mm exclusion criteria: * infection * fever * tumour * neurologic disorders with numbness and tingling sensation in the lower extremeties * skin disease aroud the knee * untreated hypertension * heart failure (nyha ii-iv. stage) * inflammatory rheumatic diseases * knee arthroplasty * steroid or hialuronic acid injection into the knee joint within 3 months * physiotherapy of the knee within 3 months * inflammatory knee osteoarthitis

Keywords: mud-pack therapy osteoarthritis of the knee hot-pack therapy non-inferiority study
observational study of nivolumab monotherapy or in combination with ipilimumab in participants with advanced melanoma and in participants with adjuvant nivolumab therapy

Conditions: Melanoma

Summary: the purpose of this study is to describe the safety and effectiveness of nivolumab treatment, either in monotherapy or in combination with ipilimumab, overall and according to various subgroups of interest, in participants with advanced melanoma and in participants with adjuvant nivolumab therapy.


Eligibility criteria:
inclusion criteria: for cohort 1 and 2: (recruitment ended by 02/20/2020) * advanced melanoma (stage iii/stage iv) * histologically confirmed diagnosis * treatment decision for nivolumab monotherapy or nivolumab/ipilimumab combination therapy has already been taken for cohort 3: (recruitment ended by 08/31/2020) * primary diagnosis of advanced melanoma after complete surgical tumor resection and no evidence of disease * treatment decision for adjuvant nivolumab therapy has already been taken exclusion criteria: for cohort 1 and 2: (recruitment ended by 02/20/2020) * current primary diagnosis of a cancer other than advanced melanoma, that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator) * previous treatment with nivolumab, for nivolumab monotherapy cohort only * current active participation in an interventional clinical trial for cohort 3: (recruitment ended by 08/31/2020) * current diagnosis of persisting advanced melanoma or a cancer other than advanced melanoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator) * current active participation in an interventional clinical trial other protocol-defined inclusion/exclusion criteria apply