Kornimate/medical-research-clean huggingface dataset:
the effect of diflunisal on familial amyloidosis

Conditions: Familial Amyloid Polyneuropathy; Familial Amyloidosis

Summary: the purpose of this study is to determine if diflunisal can prevent progressive lower leg nerve damage in patients with familial amyloidosis polyneuropathy. funding source - fda office of orphan products development (oopd); national institute of neurological disorders and stroke (ninds)

familial amyloidosis polyneuropathy (fap) is a rare, lethal, autosomal dominant, neurodegenerative disease characterized by misfolding of variant transthyretin tetramer (ttr) - a transport protein produced by the liver. the disease causes ttr to become unstable, triggering amyloid fibrils to form and leading to peripheral and autonomic nerve dysfunction. currently, the only treatment for fap is a liver transplant, which is expensive and risk-filled. medicines are needed to treat this disease. previous in vitro (in a test tube) studies have shown that a common anti-inflammatory drug called diflunisal stabilizes ttr, preventing the formation of amyloid fibrils. the goal of this 2-year randomized, double-blind, placebo-controlled research study is to establish whether diflunisal can stop the nerve damage, or peripheral neuropathy, resulting from amyloid production in patients with fap. scientists already know that diflunisal prevents formation of amyloid in the test tube. this study will determine if the drug can block amyloid production in fap patients. participants will be randomly chosen to receive either diflunisal or an inactive (placebo) pill twice daily for 24 months. participants will be carefully monitored through 7 follow-up visits, either at the study center or with individual primary care physicians. participating in the study does not preclude patients from being listed for liver transplantation.

Eligibility criteria:
inclusion criteria: * age 18 to 75 years * biopsy proven amyloidosis * genotyping of variant transthyretin * signs of peripheral or autonomic neuropathy exclusion criteria: * use of other non-steroidal anti-inflammatory drugs * other causes of sensorimotor polyneuropathy * anticipated survival \<2 years or liver transplantation in \<1 yr * liver transplantation * profound nerve, heart or kidney impairment * pregnancy or unwillingness to use contraception by women of childbearing age * active or recent gastrointestinal bleeding * non-steroidal or aspirin drug allergy/hypersensitivity

Keywords: familial amyloid polyneuropathy familial amyloidosis diflunisal amyloidosis transthyretin peripheral neuropathy autonomic neuropathy amyloid cardiomyopathy
telehealth in lewy body dementia

Conditions: Lewy Body Dementia With Behavioral Disturbance; Lewy Body Parkinson Disease; Lewy Body Disease

Summary: lewy body dementia (lbd) is the 2nd most common neurodegenerative dementia in the us. optimal care requires an interdisciplinary approach, however often faced barriers include rural residence, limited access to specialists, travel distance, limited awareness of resources, and physical, cognitive, and behavioral impairments making travel to appointments challenging. delivering interdisciplinary care remotely using video technology has the potential to improve access to care for patients with lbd.

the purpose of this study is to convert an in-person patient-centric interdisciplinary care model to a virtual platform using stakeholder engagement from individuals with lbd, their caregivers and healthcare providers. subsequently researchers will conduct a prospective, randomized, controlled pilot study implementing the virtual stakeholder developed interdisciplinary care model (tele-neurohub) for 6 month and assess the implementation outcomes of feasibility, acceptability, and appropriateness of the tele-neurohub model. the research goal is to establish and iteratively improve a virtual interdisciplinary model of care allowing patients with lbd and their caregivers to access sub-specialty care from their home.

Eligibility criteria:
participant with lewy body dementia (lbd) inclusion criteria: * lbd diagnosis by a dementia or movement disorders specialist * clinician-determined mild-moderate dementia severity * internet access with a zoom-compatible device * caregiver who resides in the patient's home and is willing to participate * fluency in english
prenatal us assessment of superior mesenteric vessels for digestive rotation

Conditions: Singleton-Merten Syndrome; Postnatal Complication

Summary: digestive malrotation is an anatomical anomaly of the positionning of the mesenteric vessels and the digestive tract that can lead in some form to a dangerous neonatal complication: intestinal volvulus. this requires emergency surgery with a risk of digestive resection. visualizing during pregnancy the normal or abnormal anatomical positionning of the mesenteric vessels could make it possible to diagnose this malrotation and prevent the occurrence of this complication. the aim of the study is ti evaluate the ability to identiy prenataly during ultrasound examination, the relative positionning of the fetal mesenteric vessels, and then to correlate it with the real postnatal positionning (gold standard)

* prenatal us assessment of mesenteric vessels positioning (relative position of the vein vs artery) during routine 3rd trimester us scan * description of various anatomical situation * comparison of this prenatal positioning with postnatal positioning obtained through abdominal ultrasound examination. post-natal ultrasound being the gold standard

Eligibility criteria:
inclusion criteria: * pregnant women attending for 3rd trimester ukltrasound * uneventfull pregnancy * no foetal malformation * singleton pregnancy * age \>18 years exclusion criteria: - other condition

Keywords: evolution and complication mesenteric vessels positionning 3rd ultrasound examination pediatric follow up +/- treatment
effects of stellate ganglion block in post-traumatic stress disorder

Conditions: Post Traumatic Stress Disorder

Summary: this study will enroll patients meeting diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for post-traumatic stress disorder (ptsd). following an initial screening visit, clinical assessment, and enrollment, subjects will be randomized into treatment and placebo arms. both cohorts will undergo a pre-intervention functional magnetic resonance imaging (fmri) of their brain. treatment subjects will receive unilateral two-level stellate ganglion block via ultrasound-guided injection of anesthetic (bupivacaine) into the cervical sympathetic tissue; placebo subjects will receive an identical volume of saline via the same procedures. at approximately 4 weeks post-procedure, both cohorts will then undergo a post-intervention clinical assessment. finally, both cohorts will undergo a post-intervention fmri of their brain.


Eligibility criteria:
inclusion criteria: 1. 18-65 years of age 2. chronic (at least one month post-trauma) dsm-5 ptsd symptoms 3. caps-5 past month score ≥ 26 4. meets current dsm-5 ptsd diagnosis 5. stable medications for 3 or more months by the time of study entrance (with the exception of benzodiazepines) 6. willing and able to provide informed consent exclusion criteria: 1. history of stellate ganglion block treatment 2. allergy to local anesthetics (e.g. ropivacaine, bupivacaine) 3. allergy to iodinated contrast agents 4. diagnosis of bipolar i disorder with a past year manic episode 5. diagnosis of a psychotic disorder or psychotic symptoms 6. diagnosis of current moderate or severe substance use disorder 7. history of neurological disease (that involves the brain), seizure, or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion) 8. significant recent suicidal ideation or significant suicidal behavior in the past 12 months or suicidal ideation with imminent risk that warrants a higher level of care 9. concurrent trauma focused psychotherapy 10. pregnancy (to be ruled out by urine ß-hcg) 11. metallic implants or devices contraindicating magnetic resonance imaging by interfering with patient safety or fmri data collection; cases will be cleared by the principal investigator and center for brain imaging 12. morbid obesity (bmi \>4 kg/m2) 13. current use of opioids, cocaine, or benzodiazepines (as assessed by urine toxicology) 14. self-injurious behavior that involves suicidal intent, requires medical attention, or occurs daily. 15. cardiac conditions or any prior heart surgeries 16. respiratory conditions such as copd or untreated asthma 17. history of heavy metal poisoning 18. history of neck or throat surgeries 19. vocal cord problems or paralysis 20. untreated high blood pressure 21. current cancer diagnosis 22. diagnosis of guillain-barré syndrome 23. diagnosis of parkinson's disease 24. unable to take 7 days off of blood thinners
multi-center study to evaluate the conformis iuni knee implant

Conditions: Osteoarthritis

Summary: study is prospective and multi-center. study will include 100 to 200 patients across up to 20 sites.the study sites will be located in the united states.the study objective is to evaluate the safety and performance of the conformis iuni® unicompartmental knee resurfacing device in patients with single compartment osteoarthritis.

the iuni g2 unicompartmental resurfacing device (iuni) is an fda cleared and ce marked implant designed for patients with damage isolated to either the medial or lateral tibiofemoral compartment of the knee. the study subjects will be followed for 10 years post implant. the study objective is to evaluate the safety and performance of the conformis iuni® unicompartmental knee resurfacing device in patients with single compartment osteoarthritis. the iuni is a patient-specific unicompartmental resurfacing device designed from the patient's unique anatomy using proprietary software which interprets data from the patient's ct scan. the patient matched implant design is then coupled with unique patient-matched disposable instrumentation designed using the same ct data and software. the follow-up visit schedule will include visits at 6 weeks, 6 months (optional), 1 year, 2 years, 5 years and 10 years post implant.the remaining follow-up data collected at years 3, 4, 6, 7, 8, and 9 may be collected via phone call/email and does not require a subject visit to the site.the study sites will be located in the united states.

Eligibility criteria:
inclusion criteria: 1. clinical condition included in the approved indications for use 2. unicompartmental osteoarthritis of the medial or lateral tibiofemoral compartment 3. willingness to participate in the clinical study, to give informed consent and to attend all follow-up visits 4. \> 18 years of age exclusion criteria: 1. simultaneous bilateral procedure required 2. bmi \> 35 3. treatment for cancer within the past 5 years, with the exception of skin cancer 4. poorly controlled diabetes 5. neuromuscular conditions which prevent patient from participating in study activities 6. active local or systemic infection 7. immunocompromised 8. fibromyalgia or other general body pain related condition 9. advanced tricompartmental osteoarthritis 10. symptomatic patellofemoral disease 11. rheumatoid arthritis or other forms of inflammatory joint disease 12. loss of bone or musculature, osteoporosis, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified 13. advanced loss of osteochondral structure on the affected femoral condyle 14. compromised acl, pcl or collateral ligament 15. severe (\>15º) fixed valgus or varus deformity 16. extension deficit \> 15 º 17. prior history of failed implant surgery of the joint to be treated 18. unwilling or unable to comply with study requirements 19. participation in another clinical study which would confound results

Keywords: knee osteoarthritis unicompartmental arthroplasty knee resurfacing conformis patient specific
study of recombinant interleukin 21 in combination with rituxan for non-hodgkin's lymphoma

Conditions: Lymphoma, Non-Hodgkin

Summary: the purpose of the study is to evaluate whether recombinant il-21 used in combination with rituximab is safe for patients with non-hodgkin's lymphoma (nhl).

this is a phase 1 open-label dose-escalation study of rituximab + ril-21 combination therapy, administered once weekly for 4 weeks following an initial treatment with one dose of rituximab alone to patients with b-cell non-hodgkin's lymphoma (nhl) who have failed prior therapy(ies). a standard dose of rituximab will be used. increasing doses of ril-21 will be studied sequentially in different groups of patients, starting with 30 μg/kg. before starting treatment with rituximab + ril-21, patients will be treated with one dose of rituximab alone to look for rituximab infusion-related symptoms (such as fever, chills, and rigors). patients who have severe infusion-related side effects after the first dose of rituximab will not go on to receive il-21. those who do not have unacceptable rituximab-related side effects will receive intravenous ril-21 at least 60 minutes after completing the rituximab infusion at the rest of the weekly dosing visits. patients will be evaluated for safety over the course of the study. disease evaluation (tumor restaging) will be performed 2 weeks following completion of the first 4-week treatment cycle. patients with stable disease or better at this evaluation may go on to receive a second 4-week treatment cycle of rituximab + ril-21. patients may be in the study for 2 to 4 months.

Eligibility criteria:
inclusion criteria: * diagnosis of cd20+ b-cell nhl * disease measurable by computed tomography (ct) scan * has failed at least one prior systemic therapy for nhl * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate hepatic and renal function * adequate bone marrow function exclusion criteria: * presence of acute infection or other significant systemic illness * white blood cell (wbc) count \> 50,000/mm3 in peripheral blood * central nervous system involvement by malignancy * previous allogenic transplant or autotransplant within 6 months of enrollment * other current malignancy or known history of cancer within 5 years * received systemic corticosteroids, chemotherapy, immunotherapy, biologic therapy, antibody therapy (e.g., rituximab), radiation therapy, and/or investigational agent(s) within 1 month of enrollment

Keywords: lymphoma, non-hodgkin interleukin-21 rituximab immunotherapy
influence of marker of insulin resistance upon hepatitis c virus (hcv) treatment responses to peg intron and rebetol therapy

Conditions: Chronic Hepatitis C

Summary: the objective of this study is to better understand the influence of insulin resistance upon treatment response in hepatitis c virus treated with peg intron and rebetol.

the relationship between hcv and ir is an evolving one. this study will allow a more formal evaluation of this relationship. four hundred patients will be treated using weight based peg intron and rebetol. clinical and biochemical data related to ir will be collected to determine if any such factors can predict who will have a sustained virological response. to evaluate patients for insulin resistance, the homa score (the product of the fasting insulin level and blood glucose level), waist circumference, and body mass index will be measured.

Eligibility criteria:
inclusion criteria: * evidence of chronic hepatitis c infection (viremia) by rt-pcr superquantitative * hcv genotype 1 * liver biopsy within 36 months of enrollment consistent with chronic hepatitis * compensated liver disease with laboratory parameters at entry visit as follows: * hemoglobin values of \> 12 gm/dl * wbc \> 2,500/mm3 * neutrophil count \> 1,000/mm3 * platelets \> 100,000/mm3 * prothrombin time \< 2 seconds prolonged compared to control, or equivalent inr ratio * bilirubin within 20% of the upper limit of normal unless non-hepatitis related factors exists such as gilbert's syndrome. * albumin \> 3.0 g/dl * serum creatinine \< 1.4 mg/dl * normal thyroid stimulating hormone (tsh) or thyroid disease clinically controlled * antinuclear antibodies (ana)\< 1:160 * fbs \< 126 mg/dl * no significant co-existing psychiatric disease * free from substance abuse for past 2 years exclusion criteria: * previous treatment for hcv. * evidence of being hiv positive. * hypersensitivity to alpha interferon, peg intron or rebetol. * any other causes for chronic liver disease other than chronic hepatitis c besides obesity. * hemoglobinopathies (e.g., thalassemia) or any other cause of hemolytic anemia. * evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or hepatic encephalopathy. * preexisting medical condition that could interfere with the patient's participation in the protocol including: cns trauma or active seizure disorders requiring medication; diabetes mellitus; serious pulmonary disease; immunologically mediated diseases; gout attack within 12 months; or any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids. * patients with evidence of ischemia on stress testing, an arrhythmia, cardiac failure, coronary surgery, uncontrolled hypertension, angina or a myocardial infarction within 12 months. * patients with a history of organ transplantation will be excluded. * patients taking insulin sensitizing drugs.

Keywords: hcv
guidant microwave ablation system for the treatment of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of the randomized study of surgical ablation with microwave energy for the treatment of atrial fibrillation (resolve-af) trial is to determine the safety and effectiveness of the guidant flex® microwave surgical ablation system in the treatment of permanent atrial fibrillation (af).


Eligibility criteria:
inclusion criteria: * patient age \>= 18 years * documented permanent af (for at least three months) * scheduled for an open chest cardiac surgery for the primary indication of mitral valve repair or replacement * has been informed of the nature of the study, agrees to its provisions, and provided written informed consent, which was approved by the appropriate institutional review board/ethics committee of the respective clinical site exclusion criteria: * cerebral vascular accident (cva, stroke) or transient ischemic attack (tia) within the previous 6 months * myocardial infarction within the previous 6 weeks * documented history of pulmonary vein stenosis * previous ablation attempt for af * previous thoracic procedures * left atrial size \> 7.0 cm * left ventricular ejection fraction \< 30% * presence of left atrial or left atrial appendage thrombi * esophageal fistula or other stricture, untreated esophagitis, varices, dysphagia or odynophagia contraindicating transesophageal echocardiography * known allergy or contraindication to warfarin therapy * known allergy or contraindication to antiarrhythmic (classes ia, ic, iii) therapy * other comorbidity with reduced life expectancy of less than 1 year or protocol noncompliance that would limit follow-up * geographically remote or unable to return for follow-up examinations * pregnant or planning to become pregnant during the study * enrolled in any concurrent study, without guidant written approval, that may confound the results of the study

Keywords: atrial fibrillation
studying an investigational drug crizotinib (pf-02341066) in non non-small cell lung cancer tumors that are positive for anaplastic lymphoma kinase (alk)

Conditions: Neoplasms Malignant

Summary: this is a phase 1 trial evaluating the safety and efficacy of crizotinib in patients with tumors except non-small cell lung cancer that are positive for alk.


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven diagnosis of malignancy other than nsclc * positive for translocation or inversion event involving the alk gene locus * positive for alk amplification events * positive for alk activating point mutations exclusion criteria: * mutations of amplifications involving the c-met gene but not the alk gene * concurrent treatment on another therapeutic clinical trial * prior therapy specifically directed against alk

Keywords: neoplasm malignant lymphoma neuroblastoma crizotinib anaplastic lymphoma kinase alk
granulocyte-monocyte apheresis in ulcerative colitis

Conditions: Ulcerative Colitis

Summary: background: granulocyte-monocyte apheresis has been proposed for the treatment of ulcerative colitis, although is limited by costs and variability of results.


Eligibility criteria:
inclusion criteria: * moderate uc with steroid-dependence and azathioprine intolerance or resistance
mechanics of knee bracing

Conditions: Osteoarthritis, Knee

Summary: the overall objective of this project is to determine whether the provision of a pneumatic knee brace in patients with medial knee osteoarthritis (oa) improves knee mechanics. secondary objectives will be to assess if the brace relieves knee pain and improves function. we will test the hypothesis that compared to the control treatment (see below for the definition) the use of a pneumatic knee brace is effective in medial knee oa.

this study is closed to enrollment and in the data analysis phase

Eligibility criteria:
inclusion criteria: * knee pain, aching or stiffness on most of the past 30 days * x-ray verified predominant medial tibiofemoral osteoarthritis (tfoa) * overall pain that is due to the medial tfoa (versus being referred from the back, hips, or other pre-existing conditions) * ambulatory persons exclusion criteria: * use of a crutch, walker, or wheelchair or cane more than 50% of the time * history of deep vein thrombosis * pain emanating more from back or hip than from knee * low pain score on womac * predominant patellofemoral disease or knee pathology other than medial compartment oa likely to be causing their knee pain. * planning to move from area within 1 month of study screening. * unable to fit the brace properly * bmi greater than 35 * corticosteriod injections in the past month * bilateral total knee replacements or plan for tkr * other types of arthritis including rheumatoid arthritis, systemic lupus erythematosus, gout, psoriatic arthritis, pseudogout. * woman who are pregnant (due to x-rays taken to determine eligibility)

Keywords: knee osteoarthritis pneumatic bracing
gait asymmetry assessed using portable gait analysis system

Conditions: Ankle Osteoarthritis; Knee Osteoarthritis; Hip Osteoarthritis; Lumbar Spine Stenosis; Muscle Contracture

Summary: to date, detailed analysis of movement patterns in orthopaedic conditions are mainly performed in research projects. because these tests are time consuming, they are not feasible in clinical routine or in standard examinations. novel technologies allow capturing detailed movement patters within a few minutes. the aim of this regional study is to compare aspects of movement tasks measured using a mobile gait analysis system to those measured using laboratory based systems and to determine aspects of gait patterns relevant for different orthopaedic conditions. moreover, the researchers will investigate if these relevant aspects can be altered using surgical treatment or manual therapy.

this is a cross-sectional study. pre- and post-treatment data will only be collected in patients undergoing routine orthopaedic treatment.

Eligibility criteria:
inclusion criteria: * age ≥ 40 years, for patients: diagnosed osteoarthritis at the ankle, knee or hip, lumbar spinal stenosis or limited range of motion at the knee exclusion criteria: * body mass index \> 35kg/m2 * use of walking aids * inability to walk for 6 minutes * neuromuscular disorders affecting gait * cardiovascular disease * inability to follow procedures due to psychological disorders or dementia

Keywords: gait asymmetry joint angles