Kornimate/medical-research-clean huggingface dataset:
pain assessment and transcranial magnetic stimulation tolerability in patients with a functional neurological disorder

Conditions: Functional Neurological Disorder

Summary: functional neurological disorders (fnd) are motor, sensory or cognitive symptoms without an identified lesion. this is a very common reason for consultation in neurology. transcranial magnetic stimulation (tms) may be performed in these patients both for diagnostic purposes (in the context of motor evoked potentials) and for therapeutic purposes. the main objective of the study is to evaluate tolerability of tms in patients with fnd, in particular the pain caused by stimulation and the possible modification of painful or non-painful symptoms generated by this tms. the secondary objectives are to assess chronic pain symptoms of these patients quantitatively and qualitatively, to assess expectations of these patients with regard to the performed examinations and to assess their expectations regarding magnetic stimulation performed for therapeutic purposes.

the investigators have therefore developped a questionnaire that will be submitted to all consecutive patients who meet the inclusion criteria and who have given their consent to participate. this questionnaire will be performed in three phases: 1) a few minutes before the realization of evoked potentials and tms 2) 10 minutes after evoked potentials and tms 3) two weeks after evoked potentials and tms (by telephone). the data collected will be: - phase 1 (a few minutes before the explorations): quantitative assessment of pain brief pain inventory characteristics of pain analgesic treatments already received and respective efficacy expectation for diagnostic tests (confirmation/exclusion of diagnosis, ...) expectation for tms performed for therapeutic purposes (partial/complete recovery, motor/pain symptoms, ...) - phase 2 (10 minutes after diagnostic explorations and therapeutic tms): quantification of pain generated by tms quantification of discomfort generated by tms change in pain symptoms after tms change in motor, sensory or cognitive symptoms after tms other side effects of tms - phase 3 (two weeks after tms, by telephone): quantitative assessment of pain brief pain inventory quantification of pain generated by tms quantification of discomfort generated by tms change in pain symptoms after tms change in motor, sensory or cognitive symptoms after tms other side effects of tms

Eligibility criteria:
inclusion criteria: * patient referred to avicenne hospital to explore a suspected functional neurological disorder * patient able to complete the questionnaire exclusion criteria: - lack of consent

Keywords: functional neurological disorder pain tms
the effects of cognitive rehabilitation on motor performance, balance and fear of falling in stroke patients

Conditions: Stroke; Cognition Disorder; Fear Anxiety

Summary: one of the most common complications in stroke patients is cognitive impairment. cognitive impairment affects a large part of the life of stroke patients. however, the relationship between cognitive impairment and fear of falling in stroke patients has not been investigated in any study yet. various treatment approaches have been developed to improve cognitive function. while some of these approaches focus on improving cognitive function, others aim to reach the maximum functional level with various compensation methods taught to the patient in the current cognitive situation. as a result of cognitive interventions, stroke patients' participation in daily life, adherence to treatment and quality of life increase. the aim of this study is to investigate the effects of cognitive interventions on motor performance, balance and fear of falling. this study will contribute to the literature by investigating these effects of cognitive rehabilitation.

participants will be randomized into two groups as control and experimental groups. the control group will receive traditional rehabilitation intervention, while the experimental group will receive additional cognitive intervention to traditional rehabilitation. two groups will be evaluated before and after the study. participants' motor performance, balance and fear of falling will be determined by evaluation criteria.

Eligibility criteria:
inclusion criteria: * having been diagnosed with stroke * the duration of the disease is in the range of 1-24 months * having a score of 21 or lower on the mini mental state test * having received 3 or more according to the functional ambulation scale * not having a vision problem that will affect the vision of the materials to be used during the treatment * being able to communicate sufficiently to understand the simple orders given exclusion criteria: * having been diagnosed with bilateral stroke * having a neurological disease other than the diagnosis of stroke * development of aphasia after stroke
study on home obstructive respiratory exacerbations

Conditions: COPD Exacerbation; COPD (Chronic Obstructive Pulmonary Disease) with Acute Lower Respiratory Infection; COPD Exacerbation Acute; COPD

Summary: listening to breath sounds with a stethoscope/auscultation is used by pulmonary physicians in conjunction with pulmonary function, signs and symptoms, oxygen saturation and diagnostic testing to admit, follow, and discharge patients from the hospital. of these, only auscultation routinely ceases upon discharge from the hospital. healthcare utilization statistics have shown that for more than a decade, readmission after discharge for an exacerbation of copd remains a major problem. the strados resp biosensor has been designed to extend the range of lung sound recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring. the primary purpose of this study is to assess the associations between resp biosensor-acquired lung findings and subjective measures of respiratory symptoms as measured by validated measurement tools, and objective measure of respiratory physiology as determined by home pulse oximetry.


Eligibility criteria:
inclusion criteria: 1. males and females between the ages of 40 and 80 with documented physician-diagnosed copd and fev1/fvc\<0.70 or lln based on post-bronchodilator spirometry 2. history of 2 moderate copd exacerbations and/or 1 severe copd exacerbation within the past 6 months 3. at least 30 days since hospital discharge from copd exacerbation 4. 6-month risk of 20% for moderate exacerbation and 7.5% for severe exacerbation based on accept score (with possibility of changing to 15% for moderate exacerbation and 5% for severe exacerbation if enrollment is insufficient) 5. tobacco history: current or former smoker 1. has smoked at least 100 cigarettes in his/her lifetime 6. patient can follow study procedures, including instructions for self-placement and operation of biosensor 1. patient has experience/owns a smartphone 7. patient is accessible by telehealth/telephone for duration of the study 8. patient is able and willing to return to study site for study visits as necessary exclusion criteria: 1. patient is unable or unwilling to provide informed consent 2. any condition that, in the opinion of the investigator, would limit the patient's activity in the study and/or adequate lung sound capture using the resp™ wearable device 3. patient with end-stage medical condition with expected survival no more than 6 months 4. history of adverse reaction or allergy to adhesives such as tegaderm®
the time-2 study: a phase 2 study of akb-9778, a novel tie-2 activator, in patients with diabetic macular edema

Conditions: Diabetic Macular Edema (DME)

Summary: the purpose of this study is to evaluate the safety and efficacy of akb-9778 administered as daily subcutaneous injections with and without monthly intravitreal injections of ranibizumab for 3 months in patients with diabetic macular edema.


Eligibility criteria:
the following is an abbreviated list of inclusion criteria: * adults between 18 to 80 years of age, inclusive * diagnosis of diabetes mellitus (type 1 or type 2) * decrease in vision in the study eye determined to be primarily the result of dme * definite retinal thickening due to diffuse dme involving the central macula in the study eye * central subfield thickness of at least 325 µm by sdoct with presence of intraretinal fluid in the study eye * etdrs bcva letter score ≤ 76 and ≥ 24 in the study eye the following is an abbreviated list of exclusion criteria: * hemoglobin a1c (hba1c) ≥ 12.0% at screening * history of non infectious uveitis * decrease in visual acuity due to causes other than dme in the study eye * history of any of the following in the study eye (however, the following are not exclusionary in the fellow eye): 1. prior pars plana vitrectomy 2. any ocular surgery within 3 months prior to day 1 3. yag capsulotomy within 3 months prior to day 1 4. panretinal scatter photocoagulation (prp) or focal laser within 3 months prior to day 1 or anticipated need for prp during the course of the study 5. prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to day 1 6. prior treatment with intravitreal anti-vascular endothelial growth factor (vegf) treatment within 8 weeks prior to day 1
funen anorexia nervosa study - retrospective cohort study and 10 year follow-up study

Conditions: Anorexia Nervosa; Eating Disorder

Summary: the aim of the study are: 1. retrospectively to study the clinical characteristics and features (somatic, psychological and social variables) of patients treated in center for eating disorders, odense university hospital 1994-2004. 2. to study the predictive power of the psychosocial and morphometric data with regard to drop outs, relapse and outcome. 3. to investigate eating habits, social functions and quality of life in weight recovered and chronicly ill patients with eating disorder.


Eligibility criteria:
inclusion criteria: * patients treated in center for eating disorders, odense university hospital 1994 - 2004. exclusion criteria: * patients, who according to the primary clinical evaluation was found not to suffer from eating disorder. * patients who at admission did not live in the funen county.

Keywords: anorexia nervosa eating disorder quality of life
study of subcutaneous continuous administration of levodopa/carbidopa solution (nd0612) in healthy volunteers

Conditions: Parkinson's Disease

Summary: it will be a single dose, single-center, randomized, double-blind, placebo-controlled dose escalation study of sc continuously-delivered ld/cd solution (nd-0612) for 24 hours in healthy volunteers. objectives are to determine: 1. the maximal tolerated dose of sc nd-0612 2. the steady state plasma concentration of ld and cd following sc nd-0612 administration. each treatment group will include 6 healthy volunteers. dosing will be done in a sequential manner.


Eligibility criteria:
inclusion criteria: * healthy caucasian males between 18 and 40 years (inclusive) of age * normal bmi (18.5-24.9) * subjects with negative urinary drugs of abuse, hiv, hepatitis b or hepatitis c serology tests * subjects must be able to adhere to the protocol requirements * subjects must provide written informed consent to participate in the study. exclusion criteria: * history of significant psychiatric disorder, neurological diseases or sleep disorders * history of significant systemic diseases, by medical history or tests performed during screening examinations * clinically significant laboratory tests at screening * history of drug or alcohol abuse. * allergy to levodopa, carbidopa or any inactive component of the test formulation. * subjects with dark skin * subjects with skin diseases or neoplasms * subjects with narrow-angle glaucoma * subjects with significant allergic response to other drugs. * presence of clinically significant scars or other skin disorders in the area of placement of the pump. * use of any prescription or over-the-counter (otc) medications * subjects who donated blood or received blood, in the last 3 months * participation in another clinical trial in the last 30 days * subjects which do not have the ability to communicate well or will not adhere to the protocol procedures
angiotensin-converting enzyme gene polymorphism and the risk of chronic allograft nephropathy

Conditions: Kidney Disease

Summary: this study is intended to help doctors learn about the relationships between specific genetic makeup (gene markers) and the development of chronic rejection. this study is being done to see if there is a relationship between genetic patterns and the development of chronic allograft nephropathy (can). medical scientists also hope to learn more about how genetic differences between people determine their response to a drug or a disease by storing a small blood sample in a special "bank". this sample may be tested at some point in the future in an attempt to better understand the factors that may influence rejection, transplantation outcomes and transplant success rates.


Eligibility criteria:
inclusion criteria: * all subjects must be recipients of a renal allograft. * study subjects must have evidence of biopsy-proven chronic allograft nephropathy (can). * control subjects must not have evidence of can.

Keywords: chronic allograft nephropathy (can) transplantation immunology genetics graft rejection
erector spinae vs. peng block for total hip arthroplasty

Conditions: Hip Arthropathy; Hip Osteoarthritis; Hip Pain Chronic

Summary: effect of peng block and espb on pain management, and nlr and plr following knee arthroplasty

hip arthroplasty is one of the most common orthopedic procedures, especially in elderly patients, due to the deformation of joints. patients may complain of severe pain due to surgical trauma and prosthesis. regional anesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects. in recent years, the influence of regional anesthesiology on reducing the inflammatory response after surgical procedures has been emphasized. however, very few studies have evaluated the effect of various methods of anesthesia on the nlr. this is the first study to investigate the effect of regional anesthesia on the nlr and plr in patients undergoing hip replacement surgery.

Eligibility criteria:
inclusion criteria: * patients with asa classification i-iii, aged 20-90 years, who will be scheduled for hip arthroplasty under spinal anesthesia. exclusion criteria: * patients who have a history of bleeding diathesis, take anticoagulant therapy, have a history of chronic pain before surgery, have multiple trauma, cannot assess their pain (dementia), have been operated on under general anesthesia, have an infection in the area and do not accept the procedure
polyneuropathy in diabetes mellitus type 2

Conditions: Diabetes Mellitus Type 2 Without Complication; Polyneuropathies, Diabetic; Diabetes Complications; Diabetic Peripheral Neuropathy; Chronic Pain

Summary: this is a population-based study of type 2 diabetes patients with and without neuropathy recruited from the danish national type 2 diabetes cohort (dd2). perspective: the study will identify risk factors for developing diabetic polyneuropathy and painful diabetic polyneuropathy and provide information on the underlying mechanisms, which will hopefully contribute to significant improvements in the treatment and prevention of diabetic polyneuropathy in future.

diabetic polyneuropathy is one of the most common long-term complications of diabetes. neuronal hyperexcitability is thought to be a key factor in the development of neuropathic pain. the overall purpose of this study is to evaluate the prevalence and underlying mechanisms of diabetic polyneuropathy and painful diabetic polyneuropathy.

Eligibility criteria:
inclusion criteria t2d patients: * clinical diagnosis of type 2 diabetes exclusion criteria: * pregnancy * poor or no danish language skills * insufficient mental capacity to provide informed consent or complete questionnaires additional criteria for healthy controls: * any neurological or psychiatric disorder * chronic pain * severe illness * pain treatment 3 days before the examination

Keywords: diabetes mellitus, type 2 polyneuropathies, diabetic
osig-eye drops treatment for dry eye disease

Conditions: Dry Eye

Summary: the main objective of this study is to assess the clinical and mechanistic effect of using ocular surface immunoglobulin (osig) eye drops for treating dry eye disease. therefore, the investigator will perform a prospective, phase ii, randomized, placebo-controlled, double-masked, tolerability and efficacy clinical trial using osig-eye drops in patients with dry eye disease. this clinical trial will be powered to detect efficacy of the treatment. this will be a randomized controlled trial, in which a total of 40 subjects will be enrolled at one clinical site. subjects will be randomly assigned to one of two groups (#1, #2), with 20 subjects per group. one group will be given placebo (normal saline eye drops) and the other group will be given eye drops containing the study drug (osig). treatment will be for eight weeks.


Eligibility criteria:
inclusion criteria: 1. able to sign and date the informed consent form approved by the institutional review board (irb) 2. ≥ 18 years of age 3. patient reported dry eye-related ocular symptoms for at least 3 months before the screening visit and use or desire to use artificial tears, ointments or dry eye treatments in the 2 weeks preceding the screening visit 4. women must be post-menopausal ≥ 1 year, or surgically sterilized. if not, a negative urine pregnancy test is required within 14 days of receiving her first dose of test medication (placebo/ study drug) along with definite evidence of contraceptive use during the duration of the study. women of reproductive age should use a method of birth control that is acceptable to the subject and the study doctor. this may include oral contraceptive pills, birth control implants, barrier methods or abstinence. if a subject mentions she suspects she may be pregnant after being enrolled, another pregnancy test will be administered. if the test is positive, she will be discontinued from the study immediately. 5. be willing/able to return for all study visits and to follow instructions from the study investigator and his staff exclusion criteria: 1. inability to provide informed consent. 2. vulnerable populations, such as neonates, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations. 3. contact lens wear within two weeks of baseline visit.
study of the bruton's tyrosine kinase inhibitor in subjects with relapsed/refractory marginal zone lymphoma

Conditions: Marginal Zone Lymphoma; B-cell Lymphoma

Summary: phase 2, open-label, non-randomized, monotherapy study to evaluate the safety and efficacy of ibrutinib in subject with relapsed/refractory marginal zone lymphoma (mzl).

ibrutinib is a first-in-class, potent, orally administered covalent inhibitor of bruton's tyrosine kinase (btk). inhibition of btk blocks downstream b-cell receptor (bcr) signaling pathways and thus prevents b-cell proliferation. in vitro, ibrutinib inhibits purified btk and selected members of the kinase family with 10-fold specificity compared with non-btk kinases. phase 1 and 2 studies of ibrutinib in b-cell malignancies demonstrate modest toxicity and significant single agent activity in a variety of b-cell malignancies, including nhl.

Eligibility criteria:
key inclusion criteria: * histologically documented marginal zone lymphoma including splenic, nodal, and extranodal sub-types; subjects with splenic mzl must have an additional measurable lesion, nodal or extranodal, as described in inclusion criteria 5 * previously received one or more lines of therapy including at least one cd20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least pr or documented pd after, the most recent systemic treatment regimen * men and women ≥18 years of age * ecog performance status of ≤2 * ≥1 measurable lesion site on ct scan (\>1.5 cm in longest dimension). lesions in anatomical locations (such as extremities or soft tissue lesions) that are not well visualized by ct may be measured by mri instead. (subjects with spleen-only disease are considered as not having measurable disease.) * life expectancy of \>3 months, in the opinion of the investigator key exclusion criteria: * medically apparent cns lymphoma or leptomeningeal disease * history of other malignancies except adequately treated non melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for ≥2 years * history of allogeneic stem-cell (or other organ) transplantation * any chemotherapy, anticancer antibodies, or other systemic anticancer therapy within 21 days of the first dose of study drug * any external beam radiation therapy within 6 weeks prior to the first dose of the study drug * concurrent use of warfarin or other vitamin k antagonists * concurrent use of a strong cyp3a inhibitor. subjects who have received a strong cyp3a inhibitor prior to entering the study must have discontinued therapy for at least 5 half lives of the prohibited medication. * recent infection requiring iv anti-infective treatment that was completed ≤14 days before the first dose of study drug * unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to ctcae grade 0 or 1, or to the levels dictated in the eligibility criteria with the exception of alopecia * inadequate organ function as defined on laboratory tests

Keywords: mzl nhl smzl nmzl malt
mycophenolate mofetil versus cyclosporin a in the treatment of primary biliary cholangitis-autoimmune hepatitis overlap syndrome due to nonresponse to standard therapy

Conditions: Hepatitis, Autoimmune; Primary Biliary Cholangitis; Immunosuppression

Summary: biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by mycophenolate mofetil versus cyclosporin a


Eligibility criteria:
inclusion criteria: 1. patients aged 18-70 years; 2. diagnosed with pbc-aih overlap syndrome according to paris criteria; 3. patients have a nonresponse to azathioprine; 4. the wbc count ≥2.5x10\^9/l and platelet count ≥50x10\^9/l. 5. agreed to participate in the trial, and assigned informed consent; exclusion criteria: 1. the presence of hepatitis a, b, c, d, or e virus infection; 2. patients with presence of serious decompensated cirrhosis; 3. patients have a history of glucocorticoid or immunosuppressant medication before enrollment; 4. liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or wilson's disease. 5. pregnant and breeding women and women of childbearing age in need of reproduction 6. severe disorders of other vital organs, such as severe heart failure, cancer; 7. patients with presence of renal insufficiency; 8. parenteral administration of blood or blood products within 6 months before screening; 9. recent treatment with drugs having known liver toxicity; 10. taken part in other clinic trials within 6 months before enrollment. 11. patients who are allergic to these drugs; 12. uncontrolled infection and hypertension ;