Kornimate/medical-research-clean huggingface dataset:
chronic pain master protocol (cpmp): a study of ly3526318 in participants with diabetic peripheral neuropathic pain

Conditions: Diabetic Peripheral Neuropathic Pain

Summary: the purpose of this study is to test the safety and efficacy of study drug ly3526318 for the treatment of diabetic peripheral neuropathic pain (dpnp). this trial is part of the chronic pain master protocol h0p-mc-cpmp (nct05986292) which is a protocol to accelerate the development of new treatments for chronic pain.


Eligibility criteria:
inclusion criteria: * have a visual analog scale (vas) pain value ≥40 and \<95 during screening. * have a history of daily pain for at least 12 weeks based on participant report or medical history. * have a body mass index \<40 kilograms per meter squared (kg/m²) (inclusive). * are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation. * are willing to discontinue all pain medications taken for chronic pain conditions for the duration of the study. * have daily symmetrical foot pain secondary to peripheral neuropathy present for at least 6 months and as diagnosed through use of the michigan neuropathy screening instrument part b ≥3 (©university of michigan). * have a history and current diagnosis of type 1 or type 2 diabetes mellitus. * have stable glycemic control as indicated by a glycated hemoglobin ≤11 at time of screening. * are men, or women able to abide by reproductive and contraceptive requirements. exclusion criteria: * have had a procedure within the past 6 months intended to product permanent sensory loss in the target area of interest (for example, ablation techniques). * have surgery planned during the study for any reason, related or not the disease state under evaluation. * have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation. * have a substance use disorder as defined by the diagnostic and statistical manual of mental disorders (5th edition; dsm-5; american psychiatric association). * have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision. * have fibromyalgia * are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide. * have a positive human immunodeficiency virus (hiv) test result at screening. * have an intolerance to acetaminophen or paracetamol or any of its excipients. * have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening. * have a current drug-induced neuropathy, for example, due to some types of chemotherapy, or other types of peripheral neuropathy. * have known hereditary motor, sensory or autonomic neuropathies. * are pregnant or breastfeeding.
efficacy of pantoprazole in patients older than 12 years with reflux associated sleep disorders (puls)

Conditions: Erosive Gastroesophageal Reflux Disease; Non-Erosive Reflux Disease

Summary: the aim of the study was to evaluate the effect of pantoprazole 20 mg/40 mg for 14 days on symptoms in patients with nerd (non-erosive reflux disease) or egerd (erosive gastroesophageal reflux disease) with special focus on the reduction of symptomatic sleep disorders.


Eligibility criteria:
main inclusion criteria: * gerd * nerd main exclusion criteria: * criteria as defined in the summary of product characteristics

Keywords: pantoprazole egerd (erosive gastroesophageal reflux disease) nerd (non-erosive reflux disease) sleep disorders
exploration of parameters of transcranial direct current stimulation (tdcs) in chronic pain

Conditions: Chronic Pain

Summary: the purpose of this study is to assess the effects of high-definition transcranial direct current stimulation (hd-tdcs) on subjects with chronic musculoskeletal pain. the investigators hypothesize that subjects will show a decrease in pain symptoms in the active anodal stimulation group when compared to sham stimulation.


Eligibility criteria:
study eligibility criteria inclusion criteria: 1. providing informed consent to participate in the study 2. 18 to 64 years old 3. having chronic musculoskeletal pain (existing pain for more than 6 months with an average of at least 3 on a 0-10 vas scale) 4. pain resistant to common analgesics and medications for chronic pain such as tylenol, aspirin, ibuprofen, soma, parafon forte dcs, zanaflex, and codeine. 5. must have the ability to feel pain as self reported exclusion criteria: 1. pregnancy 2. contraindications to tdcs * metal in the head * implanted brain medical devices 3. history of alcohol or drug abuse within the past 6 months as self reported 4. use of carbamazepine within the past 6 months as self reported. 5. severe depression (with a score of \>30 in the beck depression inventory) 6. history of neurological disorders as self reported. 7. history of unexplained fainting spells as self reported, 8. history of head injury resulting in more than a momentary loss of consciousness as self reported 9. history of neurosurgery as self reported

Keywords: high-definition transcranial direct current stimulation
efficacy and safety of cyclosporine a microemulsion in maintenance patients with chronic plaque psoriasis

Conditions: Chronic Plaque Psoriasis

Summary: the study will evaluate the efficacy of cyclosporine at 2, 5 mg/kg/day bid (i.e. bis in a day), when administered twice a week compared to continuous administration, in patients with chronic plaque psoriasis.


Eligibility criteria:
inclusion criteria: * outpatients 18 years of age and older (max 65 years) * patients with chronic plaque psoriasis on disease remission (i.e. pasi ≤75% of pasi before cyclosporine continuous treatment course) entering a maintenance period * disease remission obtained with only cyclosporine as systemic therapy (maximum dose 5 mg/kg/day) for \>8 weeks and \<16 weeks * pasi still \<75% of pasi before cyclosporine continuous treatment course, at randomization to study treatment (8±2 days after disease remission) exclusion criteria: * abnormal renal function (creatinine ≥ 10% the upper limit of the reference range) * severe chronic degenerative diseases * severe uncontrolled hypertension * body weigh \>110 kg * abnormal liver function * hyperkalemia or hyperuricemia * clinically significant impairment of hematopoietic and cardiovascular function * concomitant therapy with nephrotoxic medications * patients with malignancy or a history of malignancy * females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception * clinically significant uncontrolled bacterial, viral or fungal infection * evidence of drug and/or alcohol abuse

Keywords: cyclosporine, chronic plaque psoriasis, intermittent therapy
mindfulness training, mental fatigue, endurance performance and neurocognitive functions

Conditions: Mindfulness Training; Neurocognitive Function; Sports Performance; Mental Fatigue

Summary: mental fatigue has been suggested that would impair neurocognitive functions and sports performance. on the other hand, mindfulness training (mt) seems to as a promising approach to attenuate mental fatigue and counteract its detrimental effect on cognitive functions and sports performance. the purpose of the present study is to examine the effect of mt on behavioral and neuroelectric indices of inhibitory control, and endurance performance in mentally fatigued athletes.

accumulating research indicates that mental fatigue induced by prolonged cognitive tasks would impair neurocognitive functions and sports performance. additionally, recent studies demonstrate that inhibitory control and endurance performance are significantly susceptible to detrimental effects of mental fatigue. on the other hand, mindfulness training (mt) has been widely been used to enhance cognitive functions and sports performance in neurocognitive and sports research, which has been considered a promising approach for attenuating mental fatigue and counteracting the detrimental effect of mental fatigue. however, the effect of mt on inhibitory control, endurance performance, and underlying mechanisms in mentally fatigued athletes remain unclear. therefore, the purpose of the present study is to examine the effect of mt on behavioral and neuroelectric indices of inhibitory control, and endurance performance in mentally fatigued athletes. specifically, the targeted primary outcomes are neurocognitive functions (i.e., reaction time, accuracy and erps in flanker task) and endurance performance (i.e., vo2max \& time to exhaustion); the secondary outcomes are changes in dispositional mindfulness, subjective (i.e., scores in visual analog scale)/objective (i.e., reaction time, accuracy in stroop task) mental fatigue, motivation in tasks, and changes in mood state (i.e., brums-c).

Eligibility criteria:
inclusion criteria: 1. regular sports training at least 4 hours weekly 2. normal or corrected-to-normal vision 3. right-handed exclusion criteria: 1. physical limitation or injury in lower limbs before and during the study 2. diagnosed or self-reported neurological disorders (e.g., epilepsy) 3. diagnosed or self-reported major psychiatric illness (e.g., major depression, schizophrenia) 4. major previous experience with mindfulness training

Keywords: mindfulness training mental fatigue inhibitory control endurance performance erp
family caregiver online survey (dementia and swallowing difficulties)

Conditions: Dementia; Dysphagia; Dementia Alzheimers; Dementia, Vascular; Dementia, Mixed; Dementia With Lewy Bodies; Dementia Frontal; Dementia, Mild; Dementia Moderate; Dementia Severe; Parkinson Disease Dementia; Dementia Frontotemporal

Summary: the family caregiver survey is a one-time, 30-minute, online survey for people living with and caring for a family member with dementia. the goal of this research is to explore the needs of family caregivers, specifically when it comes to managing swallowing difficulties (dysphagia).

this research aims to increase our understanding of dysphagia-related caregiver burden and inform the development of a comprehensive dysphagia intervention, one that promotes the health and quality of life of both the caregiver and the person with dementia. aim 1. quantify dysphagia's contribution to burden among family caregivers of persons with dementia across the disease trajectory to identify when may be best to intervene. aim 2. characterize the moderating effects of caregiver readiness and support on dysphagia-related burden and care recipient quality of life to identify what are the most appropriate intervention targets.

Eligibility criteria:
inclusion criteria: * be a caregiver for a family member (or chosen family member) with dementia * have been caregiving for at least 2 months * live at home with the care recipient * not be paid for the care provided * be over the age of 18 * live in the us exclusion criteria: * not be a caregiver for a family member (or chosen family member) with dementia * have been caregiving for less than 2 months * not live at home with the care recipient * be paid for the care provided * be under the age of 18 * live outside in the us

Keywords: caregiver family caregiver care partner survey remote virtual dementia dysphagia
a bioequivalence study comparing amodiaquine tablet (pfizer) to amodiaquine tablets (arsuamoon-guilin china) in healthy subjects

Conditions: Falciparum Malaria

Summary: the study will determine if amodiaquine tablet (pfizer), an antimalaria agent, is pharmaceutically equivalent to a comparator product (arsuamoon-guilin china).


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 21 and 55 years, inclusive. * bmi of 18 to 30 kg/m2; and a total body weight \>45 kg (99 lbs). * an informed consent document signed and dated by the subject or a legally acceptable representative. exclusion criteria: * evidence or history of clinically significant abnormalities. * a positive urine drug screen, history of regular alcohol consumption.

Keywords: bioequivalence, healthy volunteers
cranial radiotherapy or intensive chemotherapy with hematopoietic stem cell rescue for primary central nervous system lymphoma in young patients

Conditions: Primary Central Nervous System Lymphoma

Summary: purpose of the study : to evaluate the antitumoral effect of two therapeutic procedures and to evaluate their respective toxicity on the cns.


Eligibility criteria:
inclusion criteria: * histopathologically or cytologically proven diagnostic of primary cns lymphoma * all histological types of non-hodgkin's lymphoma, except malt * age \> 18 and \< 60 ans. * negative for hiv, hcv and hbv * written informed consent - exclusion criteria: * age \ 60 ans * isolated intra-ocular lymphoma * previous history of indolent lymphoma * previous chemotherapy or radiotherapy for pcnsl * isolated cns relapse of systemic nhl * previous history of cancer in the last 5 years, except basocellular carcinoma and non invasive cervix cancer * renal insufficiency or creatinin clearance \< 60 ml/min * liver enzymes \> 3n. * platelets \< 100 000/mm3 or neutrophils \< 1500/mm3) * previous history of organ transplantation or other cause of severe immunodeficiency * pregnancy or active sexual women with no contraception * unable to follow the protocol for any reason
etanercept versus adalimumab in the treatment of patients with ankylosing spondylitis. a switch study

Conditions: Ankylosing Spondylitis

Summary: to determine the safety and efficacy of switch effects to adalimumab in etanercept-treated as patients.

this single-centre, open-labeled randomized controlled study will evaluate the safety and efficacy of adalimumab in etanercept-treated ankylosing spondylitis(as) patients. thirty patients will be enrolled and randomized equally into two arms. dosage and administration：for standard dose(etanercept 50 mg weekly) treated patients, the treatment arm will receive adalimumab 40 mg subcutaneously biweekly for 8 weeks. the control arm will continue etanercept 25 mg subcutaneously twice a week for 8 weeks. at week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks.for half dose(etanercept 25 mg weekly) treated patients, the treatment arm will receive adalimumab 40 mg subcutaneously monthly for 8 weeks. the control arm will continue etanercept 25 mg subcutaneously weekly for 8 weeks. at week 8, the control arm will be switched to adalimumab 40 mg subcutaneously monthly for another 8 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of as, as defined by 1984 modified new york criteria for as. * stable background therapy as non-steroid anti-inflammatory for 2 weeks. * stable glucocorticoid for 4 weeks. * stable disease-modifying anti-rheumatic drugs, eg. sulphasalazine, methotrexate for 8 weeks. * stable anti-tnf biologics for 4 weeks. * written informed consent. exclusion criteria: * serum creatinine ≥3.0 mg/dl. * gpt≥5 times the laboratory's upper limit of normal. * pregnant or breast-feeding women.

Keywords: etanercept adalimumab ankylosing spondylitis switch study
pre-malignant states to hematologic malignancies in firefighters

Conditions: Clonal Hematopoiesis of Indeterminate Potential; Monoclonal Gammopathy; Non Hodgkin Lymphoma; Leukemia; Multiple Myeloma; Plasma Cell Disorder

Summary: the purpose of the study is to evaluate if firefighter exposure to hazardous compounds will increase the incidence of premalignant hematological states which subsequently increases the risk of the development of hematologic malignancies, and potentially other pathophysiological consequences.

firefighters from the charlotte fire department, ages 40-49 and with at least 5 years on the job experience will be offered consent for this study. consented and eligible participants will have labs collected at the baseline visit to evaluate for chip and monoclonal gammopathy. buccal swabs (also collected at baseline) and any remaining blood from the baseline labs will be collected from participants who consent to collection and banking of their samples for future research. participants will also complete the firefighter history assessment at baseline. if clonal hematopoiesis (chip) results are interpreted by the investigator as abnormal, the participant will be given a clinical referral if indicated for discussion of diagnosis, potential further diagnostic tests, and implications per standard chip management guidelines. if monoclonal gammopathy or other (concerning) abnormality of the complete blood count is detected, the participant will be provided a referral for a clinic visit for diagnostic assessments and followed up per standard of care. if the participant proceeds with the referral and diagnostic work-up, the final diagnosis (if any) resulting from the initial diagnostic assessment(s) will be collected

Eligibility criteria:
inclusion criteria: 1. written informed consent and hipaa authorization for release of personal health information. 2. age ≥ 40-49 years at the time of consent (self-reported) 3. ability of the participant to understand and comply with study procedures for the entire length of the study 4. currently employed by charlotte fire department (cfd) with at least 5 years on-the -job experience (self-reported) exclusion criteria: anyone with a current diagnosis of a hematologic malignancy will be excluded.

Keywords: firefighters chip mgus
medial branch radiofrequency ablation and lumbar multifidi

Conditions: Spondylosis; Osteoarthritis

Summary: the purpose of this study is to evaluate the effects of lumbar medial branch radiofrequency ablation (rfa) on lumbar multifidi muscle size and clinical spinal stability. specifically, this study is designed to highlight the comparison of multifidi muscle architecture using ultrasound imaging (usi) and mri before and after lumbar medial branch rfa. this study will also include a commonly utilized functional assessment of the lumbar spine to evaluate the effects of rfa on lumbar spinal stability.

radiofrequency ablation (rfa) for the lumbar spine (lower back) is a procedure used to treat lower back pain secondary to facet arthritis. the procedure ablates (burns) a small nerve that goes to the arthritic joint in the back. this nerve also innervates a muscle called the multifidus, thought to be important for lumbar stability. the investigators are conducting a study to evaluate if rfa has any impact on multifidi size, spinal stability, and overall function. the tools the investigators will be using to assess the multifidi muscles are musculoskeletal ultrasound, mri, physical therapy assessment, and functional questionnaires. the goal of the study is to determine if rfa impacts the multifidi in a clinically significant fashion, causing atrophy, spinal instability, and/or functional decline.

Eligibility criteria:
inclusion criteria are: * aged over 18 years * presence of lumbar spondylosis or facet arthropathy (as determined by a radiologist) \*unilateral back pain without radicular symptoms * positive physical findings for facet mediated pain (pain with lumbar extension and rotation to affected side) * ability to complete outcome measure forms. exclusion criteria are: * prior spinal surgery * prior rfa procedures * pregnancy * contraindications to mri * presence of therapeutic anti-coagulation, medical co-morbidities that would interfere with the ability to perform the procedure safely * presence of neurologic changes * active tobacco smoking history * presence of active litigation * presence of open workers compensation case

Keywords: lower back pain radiofrequency ablation spine
comparison between right and left radial approach in patients undergoing percutaneous coronary procedures

Conditions: Coronary Artery Disease

Summary: our aim is to compare between right and left radial approach in patients undergoing percutaneous coronary procedures regarding feasibility and complications.

the radial artery has progressively became the standard access site for percutaneous coronary procedures both diagnostic and interventional. the first trans-radial access for cardiovascular diagnostics dates to 1947. in 1989, the first case series of 100 coronary angiographies performed through the radial access, demonstrating the safety and the fast mobilization of patients with the radial approach . the main advantages of the radial approach are increased safety and comfort of the patients with reduction of bleeding complications and immediate post-procedure ambulation .with these advantages, current guidelines highly recommend radial access for coronary angiography and percutaneous coronary intervention. most clinical trials focused solely on the right radial approach and rarely consider the left radial approach. indeed, the rra has technical obstacles related to anatomy and clinical practice like increased incidence of tortuosity of the subclavian artery and radial-ulnar artery loop with the right radial approach. most operators use the right radial access as the left radial access increase operator discomfort during vascular access and procedure, especially in obese patients. however, the left radial access has potential benefits for both the patient and operator. one of which is that the left radial approach is associated with lower fluoroscopy time compared with the right radial approach. left radial artery as well is an appropriate alternative access for coronary catheterization with less anatomical variations like tortuosity than the right radial artery moreover, left radial access is preferred for right handed patients because of temporary post-procedural disability caused by hemostasis process in right radial artery access also subclavian artery tortuosity is significantly more common on the right side and is an important cause of difficult, prolonged, or failed radial procedure.

Eligibility criteria:
inclusion criteria: * • all patients presented to assiut university cardiac catheterization laboratory and eligible for radial coronary procedures (either diagnostic or interventional ) exclusion criteria: * • patients with acute coronary syndrome. * patients with chronic upper limb ischemia * patients with av fistula * patients with severe renal impairment * failure to successfully cannulate the radial artery